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insulin

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Cross-References

ID SourceID
PubMed CID135537069
CHEMBL ID2403179
MeSH IDM0011417

Synonyms (5)

Synonym
CHEMBL2403179
AKOS024406060
5,10,15,20-tetrakis(1-methylpyridinium-4-yl)porphyrin tetraiodide
36674-90-5
5,10,15,20-tetra(n-methyl-4-pyridyl)porphyrin tetraiodide
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (59)

Assay IDTitleYearJournalArticle
AID757740Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in cell survival at 5 uM preincubated for 10 mins followed by visible light irradiation for 270 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1336590Phototoxicity against human HaCaT cells assessed as cell viability at 1 uM after irradiation with light at 180 J/cm'2 for 30 mins by MTT assay2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Photodynamic effect of meso-(aryl)porphyrins and meso-(1-methyl-4-pyridinium)porphyrins on HaCaT keratinocytes.
AID757755Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in genomic DNA level at 5 uM preincubated for 10 mins followed by visible light irradiation for 15 mins by agarose gel electrophoresis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757754Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in rRNA level at 5 uM preincubated for 10 mins followed by visible light irradiation for 15 mins by agarose gel electrophoresis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757739Photodynamic inactivation of Staphylococcus warneri assessed as reduction in intracellular double stranded DNA concentration at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 5 mins by fluorimetric analysis relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1551991Photodynamic antibacterial activity against Pseudomonas aeruginosa assessed as reduction in bacterial burden at 100 to 225 uM preincubated with bacteria followed by exposure of mercury vapor lamp light at 100 J/cm2 for 10 mins2019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID757744Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in intracellular double stranded DNA concentration at 5 uM preincubated for 10 mins followed by visible light irradiation for 60 mins by fluorimetric analysis relative to contr2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757764Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in cell survival at 5 uM preincubated for 10 mins followed by visible light irradiation for 90 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757747Photodynamic inactivation of Staphylococcus warneri assessed as reduction in DNA level at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 5 to 30 mins by agarose gel electrophoresis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757732Photodynamic inactivation of Staphylococcus warneri assessed as reduction in cell survival at at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 10 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757729Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in cell survival at at 5 uM preincubated for 10 mins followed by visible light irradiation at 8 J cm'-2 light dose2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757757Drug uptake in Staphylococcus warneri at 0.5 uM incubated for 10 mins followed by compound washout by spectrofluorimetric analysis relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757765Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in cell survival at 5 uM preincubated for 10 mins followed by visible light irradiation for 180 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1551997Photodynamic antibacterial activity against Pseudomonas aeruginosa assessed as reduction in bacterial burden at 1 to 10 uM preincubated for 10 mins in dark condition followed by exposure of LED light at 66 to 266 J/cm22019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID757758Drug uptake in Escherichia coli ATCC 25922 at 5 uM incubated for 10 mins followed by compound washout by spectrofluorimetric analysis relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757766Photodynamic inactivation of Staphylococcus warneri assessed as reduction in DNA level at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 40 mins by agarose gel electrophoresis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1552022Photodynamic antibacterial activity against Enterococcus faecalis assessed as reduction in bacterial burden at 5 uM after 15 mins in presence of light irradiation at 21.6 J/cm22019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID757742Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in intracellular double stranded DNA concentration at 5 uM preincubated for 10 mins followed by visible light irradiation for 180 mins by fluorimetric analysis relative to cont2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1349631Photobactericidal activity against Staphylococcus aureus CIP76.25 irradiated with white light at 4.83 mW/cm2 for 20 hrs2018ACS medicinal chemistry letters, Jan-11, Volume: 9, Issue:1
Lysine Analogue of Polymyxin B as a Significant Opportunity for Photodynamic Antimicrobial Chemotherapy.
AID757759Drug uptake in Escherichia coli ATCC 25922 at 5 uM after 10 mins by spectrofluorimetric analysis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757752Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in 23S rRNA level at 5 uM preincubated for 10 mins followed by visible light irradiation for 30 mins by agarose gel electrophoresis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757725Butanol-water partition coefficient, log P of the compound2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757728Photodynamic inactivation of Staphylococcus warneri assessed as reduction in cell survival at at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 30 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757751Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in 16S rRNA level at 5 uM preincubated for 10 mins followed by visible light irradiation for 30 mins by agarose gel electrophoresis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757727Photodynamic inactivation of Staphylococcus warneri assessed as reduction in cell survival at at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 40 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1551995Photodynamic antibacterial activity against Pseudomonas aeruginosa assessed as reduction in biofilm formation at 5 mg/ml in presence of light at 100 J/cm2 relative to control2019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID1551998Photodynamic antibacterial activity against Pseudomonas aeruginosa assessed as bacterial burden at 1 to 10 uM preincubated for 10 mins in dark condition followed by exposure of LED light at 66 to 266 J/cm2 relative to control2019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID757731Photodynamic inactivation of Staphylococcus warneri assessed as reduction in cell survival at at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 15 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1336589Photostability of compound in aqueous media assessed as amount of soret band remaining after irradiation with white light at 100 mW/cm'2 for 30 mins by UV-spectrophotometric analysis2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Photodynamic effect of meso-(aryl)porphyrins and meso-(1-methyl-4-pyridinium)porphyrins on HaCaT keratinocytes.
AID757734Photodynamic inactivation of Staphylococcus warneri assessed as reduction in intracellular double stranded DNA concentration at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 40 mins by fluorimetric analysis relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757735Photodynamic inactivation of Staphylococcus warneri assessed as reduction in intracellular double stranded DNA concentration at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 30 mins by fluorimetric analysis relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1349633Photobactericidal activity against Pseudomonas aeruginosa CIP76110 irradiated with white light at 4.83 mW/cm2 for 20 hrs2018ACS medicinal chemistry letters, Jan-11, Volume: 9, Issue:1
Lysine Analogue of Polymyxin B as a Significant Opportunity for Photodynamic Antimicrobial Chemotherapy.
AID757738Photodynamic inactivation of Staphylococcus warneri assessed as reduction in intracellular double stranded DNA concentration at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 10 mins by fluorimetric analysis relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1552023Photodynamic antibacterial activity against Enterococcus faecalis assessed as reduction in bacterial burden at 5 uM after 15 mins in presence of light irradiation at 14.4 J/cm22019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID757745Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in intracellular double stranded DNA concentration at 5 uM preincubated for 10 mins followed by visible light irradiation for 30 mins by fluorimetric analysis relative to contr2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757743Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in intracellular double stranded DNA concentration at 5 uM preincubated for 10 mins followed by visible light irradiation for 90 mins by fluorimetric analysis relative to contr2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757761Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in cell survival at 5 uM preincubated for 10 mins followed by visible light irradiation for 15 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757756Drug uptake in Staphylococcus warneri at 0.5 uM after 10 mins by spectrofluorimetric analysis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1336595Phototoxicity against human HaCaT cells assessed as reduction in cell viability after irradiation with white light at 120 J/cm'2 for 20 mins by MTT assay2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Photodynamic effect of meso-(aryl)porphyrins and meso-(1-methyl-4-pyridinium)porphyrins on HaCaT keratinocytes.
AID1845442Butan-l-ol/water partition coefficient, logP of the compound2021Bioorganic & medicinal chemistry, 01-15, Volume: 30Porphyrin and phthalocyanine photosensitizers designed for targeted photodynamic therapy of colorectal cancer.
AID757763Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in cell survival at 5 uM preincubated for 10 mins followed by visible light irradiation for 60 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757762Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in cell survival at 5 uM preincubated for 10 mins followed by visible light irradiation for 30 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757746Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in intracellular double stranded DNA concentration at 5 uM preincubated for 10 mins followed by visible light irradiation for 15 mins by fluorimetric analysis relative to contr2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757736Photodynamic inactivation of Staphylococcus warneri assessed as reduction in intracellular double stranded DNA concentration at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 20 mins by fluorimetric analysis relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1349635Photobactericidal activity against Escherichia coli CIP54.8T irradiated with white light at 4.83 mW/cm2 for 20 hrs2018ACS medicinal chemistry letters, Jan-11, Volume: 9, Issue:1
Lysine Analogue of Polymyxin B as a Significant Opportunity for Photodynamic Antimicrobial Chemotherapy.
AID1551994Photodynamic antibacterial activity against Pseudomonas aeruginosa assessed as bacterial killing at 2.5 mg/ml in presence of light at 100 J/cm2 relative to control2019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID757737Photodynamic inactivation of Staphylococcus warneri assessed as reduction in intracellular double stranded DNA concentration at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 15 mins by fluorimetric analysis relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757733Photodynamic inactivation of Staphylococcus warneri assessed as reduction in cell survival at at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 5 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1552025Photodynamic antibacterial activity against Enterococcus faecalis assessed as reduction in bacterial burden at 10 uM after 15 mins in presence of light irradiation at 64.8 J/cm22019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID757760Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in intracellular double stranded DNA concentration at 5 uM preincubated for 10 mins followed by visible light irradiation by fluorimetric analysis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1336591Induction of singlet oxygen production assessed as amount of DPiBF remaining after irradiation with light at 9 mW/cm'2 for 30 mins by DPiBF photooxidation based spectrophotometric analysis (Rvb = 80%)2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Photodynamic effect of meso-(aryl)porphyrins and meso-(1-methyl-4-pyridinium)porphyrins on HaCaT keratinocytes.
AID757741Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in intracellular double stranded DNA concentration at 5 uM preincubated for 10 mins followed by visible light irradiation for 270 mins by fluorimetric analysis relative to cont2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1551999Photodynamic antibiofilm activity against Mycobacterium smegmatis preincubated for 5 mins in dark condition followed by e illuminated with visible light at 3.6 to 108 J/cm2 subsequent incubation in dark for 40 hrs2019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID1552024Photodynamic antibacterial activity against Enterococcus faecalis assessed as reduction in bacterial burden at 5 uM after 15 mins in presence of light irradiation at 64.8 J/cm22019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID1551996Photodynamic antibacterial activity against Pseudomonas aeruginosa assessed as reduction in bacterial burden at 225 uM in presence of light at 100 J/cm22019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID757724Photodynamic inactivation of Staphylococcus warneri assessed as reduction in cell survival at at 0.5 uM preincubated for 10 mins followed by visible light irradiation at 5 J cm'-2 light dose2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID757730Photodynamic inactivation of Staphylococcus warneri assessed as reduction in cell survival at at 0.5 uM preincubated for 10 mins followed by visible light irradiation for 20 mins2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
AID1336592n-butanol/water partition coefficient, log P of compound at 5 uM by shake-flask method2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Photodynamic effect of meso-(aryl)porphyrins and meso-(1-methyl-4-pyridinium)porphyrins on HaCaT keratinocytes.
AID757750Photodynamic inactivation of Escherichia coli ATCC 25922 assessed as reduction in nucleic acid level at 5 uM preincubated for 10 mins followed by visible light irradiation for 60 mins by agarose gel electrophoresis2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Nucleic acid changes during photodynamic inactivation of bacteria by cationic porphyrins.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (5)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's4 (80.00)24.3611
2020's1 (20.00)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Reviews1 (20.00%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other4 (80.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (1659)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes [NCT04416269]Phase 4260 participants (Anticipated)Interventional2020-08-07Recruiting
Study of Nasal Insulin to Fight Forgetfulness (SNIFF) - 3-Week Aptar CPS Device [NCT05006599]Phase 240 participants (Anticipated)Interventional2025-05-31Not yet recruiting
A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus [NCT01269606]Phase 113 participants (Actual)Interventional2011-01-31Completed
Metabolic Substrate Modulation in Insulin Treated Diabetics With and Without Heart Failure: The Effect of Hyperglycemia on Left Ventricular Function and Exercise Capacity. [NCT01071772]Phase 218 participants (Actual)Interventional2009-04-30Completed
Successful Transition From Insulin Pump to Multiple Daily Injections Using Insulin Degludec in Adults With Type 1 Diabetes [NCT03987191]Phase 438 participants (Actual)Interventional2020-01-10Completed
The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin® Log-G With Its Reference Lantus® in Patients With Type 2 Diabetes Mellitus [NCT04591457]Phase 2120 participants (Anticipated)Interventional2020-10-31Not yet recruiting
A Single Center, Randomized, Open-Label, Crossover Study, Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro Either in Combination With a Basal Insulin Infusion or With Insulin Glargine Relative to a St [NCT01000922]Phase 224 participants (Actual)Interventional2006-06-30Completed
[NCT00849576]Phase 315 participants (Actual)Interventional2008-04-30Completed
Use of the Guardian™ Connect System With Smart Connected Devices [NCT04809285]500 participants (Anticipated)Interventional2021-04-06Recruiting
Intranasal Insulin for Treating Posttraumatic Stress Disorder [NCT04044534]Phase 220 participants (Anticipated)Interventional2023-12-31Recruiting
Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial [NCT04599075]Phase 470 participants (Actual)Interventional2021-03-15Completed
An International, Multicenter, Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus [NCT00359801]Phase 41,976 participants (Actual)Interventional2006-07-31Completed
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 and Type 2 Diabetes [NCT01121276]Phase 182 participants (Actual)Interventional2010-04-30Completed
A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec After Administration in Different Injection Regions in Subjects With Type 2 Diabetes [NCT04582448]Phase 125 participants (Actual)Interventional2020-10-01Completed
A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes [NCT01134224]Phase 139 participants (Actual)Interventional2010-05-31Completed
Autologous Bone Marrow Mesenchymal Stem Cell and Bone Marrow Mononuclear Cell Infusion in Type 2 Diabetes Mellitus [NCT01719640]Phase 1/Phase 222 participants (Actual)Interventional2011-01-31Completed
A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Ins [NCT00757588]Phase 3455 participants (Actual)Interventional2008-11-30Completed
A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects [NCT01151072]Phase 120 participants (Actual)Interventional2010-06-30Completed
A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes [NCT01173926]Phase 127 participants (Actual)Interventional2010-07-31Completed
A Longitudinal, Open-label Study on the Short-term Effects of Roux-en-Y Gastric Bypass Surgery vs. Gastric Banding on Glucose Homeostasis in Obese Subjects [NCT01063127]23 participants (Actual)Observational2010-02-28Completed
A Trial of High Dose Immunosuppression and Autologous Hematopoietic Stem Cell Support Versus Intensive Insulin Therapy in Adults With Early Onset Type I Diabetes Mellitus [NCT01285934]Phase 1/Phase 20 participants (Actual)Interventional2009-01-31Withdrawn(stopped due to No participant enrolled)
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 5 [NCT03858062]36 participants (Actual)Interventional2019-03-10Completed
A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants. [NCT01093638]Phase 233 participants (Actual)Interventional2010-08-31Terminated
[NCT01195454]Phase 124 participants (Actual)Interventional2010-08-31Completed
A Study of Effectiveness and Safety of Apidra in Combination With Lantus Therapy in Basal-bolus Insulin Regimen in Inadequately Controlled Children and Adolescents With Type 1 Diabetes in the Russian Federation. [NCT01202474]Phase 4100 participants (Actual)Interventional2011-05-31Completed
Basal and Insulin Mediated VLDL-triglyceride Kinetics in Obesity; Relationship With Hepatic Insulin Sensitivity [NCT01205750]24 participants (Actual)Interventional2010-03-31Completed
Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period [NCT03211858]Phase 3597 participants (Actual)Interventional2017-08-02Completed
A Phase 3b, Multicenter, Clinical Trial to Evaluate Pulmonary Function in a Subset of Subjects With Type 1 or Type 2 Diabetes [NCT01201928]3 participants (Actual)Observational2010-10-31Terminated(stopped due to Parent trials were either not initiated or terminated)
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without [NCT03175120]Phase 3453 participants (Actual)Interventional2017-05-26Completed
Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 DM - a Randomised Controlled Trial [NCT01338922]211 participants (Actual)Interventional2011-04-30Completed
Safety and Efficacy of Insulin Glargine Injection [rDNA Origin] Treatment in Place of the TZD or the Sulfonylurea or Metformin in Triple Agent Therapy for T2DM Adult Subjects With Unsatisfactory Control [NCT00283049]Phase 4390 participants (Actual)Interventional2006-02-28Terminated(stopped due to Due to technical issues relating to the Electronic diary data.)
A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Saudi Arabia [NCT03785522]597 participants (Actual)Observational2018-12-23Completed
Comparison of a Low Dose to a Standard Dose of Insulin in Adult Diabetic Ketoacidosis in ICU to Reduce Metabolic Complications : a Randomized, Controlled Study [NCT05443802]150 participants (Anticipated)Interventional2022-08-16Recruiting
Recurrent Hypoglycaemia in Type 1 Diabetes: Effects on Cognitive Function, Cerebral Electrical Activity, and Skin Temperature [NCT01337362]23 participants (Actual)Interventional2011-05-31Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs [NCT03078478]Phase 31,609 participants (Actual)Interventional2017-03-13Completed
Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study [NCT06024928]20 participants (Anticipated)Interventional2023-11-01Recruiting
Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease [NCT04251585]Phase 230 participants (Anticipated)Interventional2020-02-04Recruiting
A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes [NCT01114542]Phase 166 participants (Actual)Interventional2010-05-03Completed
A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults With Type 1 Diabetes [NCT01138488]Phase 138 participants (Actual)Interventional2010-06-30Completed
A Randomised Controlled Trial Comparing the Effect of the Faster-acting Insulin Analog - Insulin Fiasp® - Versus Insulin Novorapid® in the Treatment of Women With Type 1 or Type 2 Diabetes During Pregnancy and Lactation. The Copen-fast Trial [NCT03770767]Phase 3216 participants (Actual)Interventional2019-11-11Completed
Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes [NCT01143948]Phase 445 participants (Anticipated)Interventional2011-01-31Not yet recruiting
A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus [NCT03922750]Phase 2154 participants (Actual)Interventional2019-05-09Completed
A Pilot Study to Assess Closed-loop Insulin Delivery to Regulate Glucose Levels in Children With Type 1 Diabetes in Outpatient Free-living Settings. [NCT04612257]10 participants (Actual)Interventional2019-06-18Terminated(stopped due to The sponsor has requested to end the study prematurely due to the accumulation of delays caused by COVID-19 as potential participants were hesitant to allow staff members into their homes or stay at the hospital per the study design.)
Experimental Medicine Study to Validate the Modified Glucose Disposal Test in Healthy Subjects and Subjects With Type 2 Diabetes [NCT01152372]Phase 136 participants (Actual)Interventional2010-06-30Completed
Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes [NCT02526810]Phase 470 participants (Anticipated)Interventional2015-07-31Recruiting
Prevalence and Risk Factors of Insulin Resistance in Overweight and Obese Adolescents [NCT05810883]50 participants (Anticipated)Observational2023-05-11Not yet recruiting
A Randomised Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes [NCT01296438]Phase 140 participants (Actual)Interventional2011-02-28Completed
Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml [NCT01194882]Phase 3479 participants (Actual)Interventional2010-11-16Completed
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Travelling Across Multiple Time Zones. A Pilot Study. [NCT03668808]Phase 425 participants (Actual)Interventional2018-11-16Completed
A Phase 1, Randomized, 3-Way Crossover, Investigator Initiated Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Two Doses of Intranasally Administered Regular Human Insulin Compared to a Single [NCT01201278]Phase 120 participants (Anticipated)InterventionalNot yet recruiting
A Multiple-dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Japanese Subjects With Type 1 Diabetes [NCT03766854]Phase 124 participants (Actual)Interventional2018-12-07Completed
An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Efficacy of MDI Treatment With Physician Adjusted and Optimization Algorithm Adjusted Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp [NCT03764280]21 participants (Actual)Interventional2018-07-02Completed
Fixed Dose for Fixed Carbohydrates vs. Variable Dosing for Variable Carbohydrates: A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus. [NCT04157738]Phase 424 participants (Actual)Interventional2019-11-27Completed
Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy: To Assess How the 670G System Adapts to the Introduction of Fiasp® Insulin [NCT03554486]Phase 427 participants (Actual)Interventional2018-07-23Completed
An Open Label, Multi-center, Randomized, Parallel Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Insulin Tregopil (IN-105) Compared With Insulin Aspart in the Treatment of Patients With Type 2 Diabetes Mellitus on Stable Dose of [NCT03430856]Phase 2/Phase 3143 participants (Actual)Interventional2017-12-26Completed
A Canadian Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus CAN-TREAT (CANadian TREsiba AudiT) [NCT03674866]662 participants (Actual)Observational2018-10-29Completed
Management of the Patient With Heart Failure and Diabetes: May Insulin be a Problem? A Pilot Randomized Clinical Study (Insulin-HF) [NCT03665350]Phase 210 participants (Actual)Interventional2018-11-08Terminated(stopped due to Insulin-HF study was prematurely ended due principally to low recruitment rate.)
A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination I [NCT02911948]Phase 3210 participants (Actual)Interventional2016-09-21Completed
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes [NCT05662332]Phase 3796 participants (Actual)Interventional2023-01-14Active, not recruiting
Performance Study Using the OptiScanner on Healthy Diabetics [NCT01135771]Phase 160 participants (Actual)Interventional2009-11-30Completed
Effect of 50-week Treatment With Stepwise Insulin Intensification of Basal-bolus Insulin Analogues (Insulin Detemir and Aspart) or Biphasic Insulin Aspart 30 (NovoMix 30) All in Combination With Fixed Dose of Metformin on Glycaemic Control (Measured as Hb [NCT01068652]Phase 4403 participants (Actual)Interventional2010-03-31Completed
Protocol Driven Management of Type 2 Diabetes After Gastric Bypass Surgery [NCT01213563]50 participants (Actual)Interventional2009-01-31Terminated(stopped due to Data were published that superseded this study.)
A 24-week, Open, Multicenter, Comparative Study of 2 Strategies (Including Insulin Glargine Versus Premixed Insulin) for the Therapeutic Management of Patients With Type 2 Diabetes Failing Oral Agents [NCT01121835]Phase 4934 participants (Actual)Interventional2010-02-28Completed
The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers [NCT01124487]10 participants (Actual)Interventional2009-08-31Completed
Effect of Normalization of Fasting Glucose by Intensified Insulin Therapy on the Incidence of Restenosis After Peripheral Angioplasty in Patients With Type 2 Diabetes. [NCT01150617]Phase 446 participants (Actual)Interventional2008-12-31Terminated(stopped due to end-point reached)
A Randomized, Double Blind Study to Assess the Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart [NCT01159353]Phase 137 participants (Actual)Interventional2007-09-30Completed
Single-center, Randomized, Double-blind, 2-treatment, 2-period Crossover Trial in Healthy Subjects to Demonstrate PK Bioequivalence and to Compare the PD Properties of Julphar Insulin N and Huminsulin® Basal [NCT02634528]Phase 185 participants (Actual)Interventional2016-11-16Completed
Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen. [NCT01204593]Phase 4206 participants (Actual)Interventional2010-11-30Completed
Efficacy and Safety of Intensive Insulin Therapy With Insulin Glulisine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs [NCT01203111]Phase 4207 participants (Actual)Interventional2010-12-31Completed
Early Feasibility Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAS) in the Outpatient Setting [NCT02463682]9 participants (Actual)Interventional2015-05-31Completed
A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration [NCT01334151]Phase 113 participants (Actual)Interventional2011-03-31Completed
5 Versus 10 Units of Insulin in Hyperkalemia Management: Multi-center, Prospective, Double-blind, Non-inferiority, Randomized Control Trial. [NCT06036823]Phase 4336 participants (Anticipated)Interventional2023-10-01Recruiting
A Randomized Controlled Trial Comparing the Safety and Efficacy of IDegLira Versus Basal Bolus in Patients With Poorly Controlled Type 2 Diabetes [NCT03737240]Phase 3145 participants (Actual)Interventional2019-01-15Completed
A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL) [NCT01045447]Phase 3465 participants (Actual)Interventional2010-01-31Completed
HAND IN Insulin-001: Intranasal Treatment of HIV-associated Neurocognitive Disorders [NCT03277222]Phase 24 participants (Actual)Interventional2018-11-01Terminated(stopped due to Unable to find further eligible participants)
Incretin-based Drugs and the Risk of Heart Failure: A Multi-center Network Observational Study [NCT02456428]1,499,650 participants (Actual)Observational2014-03-31Completed
Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Type 2 Diabetes (Onset® 9) [NCT03268005]Phase 31,264 participants (Actual)Interventional2017-09-19Completed
A Pan Asian Trial Comparing Efficacy and Safety of Insulin NN1250 and Insulin Glargine as Add on to OAD(s) in Subjects With Type 2 Diabetes (BEGIN™: ONCE ASIA) [NCT01059799]Phase 3435 participants (Actual)Interventional2010-02-01Completed
Comparison of Efficacy and Safety of Prandilin and NovoRapid Evaluated by Continuous Glucose Monitoring System in Newly Diagnosed Type 2 Diabetes [NCT03226210]Phase 4110 participants (Actual)Interventional2015-02-01Completed
Day and Night Closed-Loop Glycemic Control With Faster-Acting Insulin Aspart in Young Adults With Type 1 Diabetes Using DreaMed Glucositter - The Fast PHYSI-DREAM Study [NCT03212950]20 participants (Actual)Interventional2017-07-10Completed
Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology [NCT02443714]Phase 418 participants (Actual)Interventional2015-04-30Completed
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes [NCT03682640]Phase 260 participants (Anticipated)Interventional2018-09-30Recruiting
Effect of the Combination of Dipeptidyl Peptidase-4 Inhibitor (DPP4i) and Insulin in Comparison to Insulin on Metabolic Control and Prognosis in Hospitalized Patients With COVID-19 [NCT04542213]Phase 370 participants (Actual)Interventional2020-08-01Completed
A Prospective Non-interventional Study Investigating the Treatment Effect of Switching From Insulin Glargine to Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real World Adult Population With Type 2 Diabetes in Japan [NCT03745157]246 participants (Actual)Observational2018-11-21Completed
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE) [NCT03337477]Phase 270 participants (Actual)Interventional2018-02-13Completed
Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study) [NCT03018938]Phase 4814 participants (Actual)Interventional2017-02-06Completed
Relative Bioavailability of LY2963016 to LANTUS® After Single-Dose Subcutaneous Administration in Healthy Chinese Subjects [NCT03555305]Phase 158 participants (Actual)Interventional2018-09-26Completed
Pilot Study for the Evaluation of Algorithms for the Detection of Subcutaneous Insulin Pump Malfunctions in Subjects With Type 1 Diabetes [NCT06147583]20 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Does Glycated Hemoglobin Variability in Type 2 Diabetes Differ Depending on the Diabetes Treatment Threshold Used in the Qatari Population: Implication on Diabetes Complication Risk? [NCT02879409]150 participants (Anticipated)Interventional2016-11-30Active, not recruiting
A Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated With Differing Baseline D [NCT01068860]Phase 2246 participants (Actual)Interventional2010-02-28Completed
A Multi-centre, Randomised, Two-period, Crossover Study to Evaluate Home Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart [NCT04055480]25 participants (Actual)Interventional2019-08-10Completed
Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere® Insulin Inhalation Powder (3 U and 4 U Insulin/mg) Usi [NCT01365117]Phase 150 participants (Actual)Interventional2011-01-31Completed
Effects of Shifting From Twice Daily Insulin Glargine or Detemir to Once Daily Insulin Degludec in Type 1 Diabetic Patients. An Observational Study. [NCT02360254]26 participants (Actual)Observational2015-01-31Completed
Investigation of Pharmacokinetics and Safety Profile of a Single Dose NNC0148-0287 C (Insulin 287) in Subjects With Various Degrees of Renal Impairment [NCT03723785]Phase 158 participants (Actual)Interventional2018-11-09Completed
Effect of Ischemia on the Insulin-sensitizing Effect of Exercise [NCT04872426]10 participants (Actual)Interventional2018-08-31Completed
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects [NCT03726125]Phase 189 participants (Actual)Interventional2018-11-20Completed
Glycemic Outcomes and Safety With Minimed 780G System in Children With Type 1 Diabetes Aged 2-6 Years [NCT04949022]38 participants (Anticipated)Interventional2021-08-23Recruiting
A Six Month, Open Label, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combin [NCT00418522]Phase 4413 participants (Actual)Interventional2007-03-31Completed
Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G) [NCT04051632]96 participants (Actual)Observational2018-06-13Completed
Mechanisms for Restoration of Hypoglycemia Awareness [NCT03738852]Early Phase 154 participants (Anticipated)Interventional2018-11-07Recruiting
Gestational Diabetes and Pharmacotherapy (GAP) - A Randomized Controlled Trial Investigating Timing of Pharmacotherapy Initiation for Patients With Gestational Diabetes [NCT03527537]Phase 4416 participants (Anticipated)Interventional2021-05-04Recruiting
Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes [NCT04079881]Phase 1/Phase 21 participants (Actual)Interventional2020-02-13Terminated(stopped due to Loss of funding)
Does Maintenance of Normoglycemia Change Neurological Outcome in Patients Recovering From Traumatic Brain Injury and Subarachnoid or Intraparenchymal Hemorrhage? [NCT01137773]Phase 456 participants (Actual)Interventional2007-01-31Terminated(stopped due to Slow enrollment)
Prevalence of Metabolic Associated Fatty Liver Disease in Patients With Type 2 Diabetes in Jiangsu Province of China: a Prospective, Multicenter, Real-world Study [NCT05597709]2,900 participants (Anticipated)Observational2022-07-01Recruiting
A Multicenter, Randomized, Open, Parallel-controlled Clinical Trial to Compare the Efficacy and Safety of IDegAsp BID and IDegAsp QD+2IAsp in Patients With Type 2 Diabetes Mellitus [NCT05417841]224 participants (Anticipated)Interventional2022-07-01Not yet recruiting
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro With an Open-Label Postprandial LY900014 Treatment Group, in Combination With Insulin Glargine or Insulin Degludec, in Adults With Type 1 Diabetes PRONTO-T1D [NCT03214367]Phase 31,392 participants (Actual)Interventional2017-07-17Completed
Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus: a Randomised Controlled Trial of Different Glycemic Targets During Pregnancy [NCT03610178]850 participants (Anticipated)Interventional2015-08-31Recruiting
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM) [NCT01068678]Phase 3460 participants (Actual)Interventional2010-02-28Completed
The COpenhagen-BOston-Sydney Study, The COBOS-study [NCT04178603]21 participants (Actual)Interventional2018-07-05Completed
Intranasal Insulin for COVID-19-related Smell Loss [NCT05461365]Phase 327 participants (Actual)Interventional2021-01-04Completed
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes [NCT03740919]Phase 3751 participants (Actual)Interventional2019-04-07Completed
Intranasal Insulin and Post-stroke Cognition: A Pilot Study [NCT02810392]Phase 220 participants (Actual)Interventional2016-04-30Completed
Comparison of the Efficacy of Sensor-augmented Pump Therapy Versus Hybrid Closed-loop Glucose Management (MiniMed670G™) in Patients With Type 1 Diabetes at Home in a Randomized Controlled Trial [NCT03815487]40 participants (Actual)Interventional2018-11-19Completed
A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Pre [NCT00309244]Phase 3677 participants (Actual)Interventional2006-02-28Completed
Real-life Data From Diabetic Patients on Closed-loop Pumps [NCT05418699]150 participants (Anticipated)Observational2022-09-26Recruiting
The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans [NCT04461015]Phase 312 participants (Actual)Interventional2020-10-14Completed
Insulin Resistance and Recurrent Abortion [NCT02088424]30 participants (Anticipated)Observational [Patient Registry]2014-03-31Not yet recruiting
Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise [NCT04292535]Phase 2116 participants (Actual)Interventional2018-06-15Completed
Feasibility Study of the JewelPump Version 3 [NCT02097316]Phase 321 participants (Actual)Interventional2014-06-30Completed
Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients [NCT03554590]50 participants (Anticipated)Interventional2016-12-31Recruiting
A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naïve Patients With Type 2 Diabetes Mellitus: An Open-Label, Randomized, 52-week Study [NCT02106364]Phase 30 participants (Actual)Interventional2015-02-28Withdrawn(stopped due to Lilly's decision to cancel this trial is due to regulatory uncertainty in China.)
Regulation of Endogenous Glucose Production by Brain Insulin Action [NCT02131948]Phase 18 participants (Actual)Interventional2013-11-30Completed
Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, Outpat [NCT00138671]Phase 3105 participants (Actual)Interventional2003-01-31Terminated(stopped due to See termination reason in detailed description.)
A Multicenter, Randomized, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of Insuman Comb 25 (Insulin Human) Versus Novolin® 30R Twice Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus Who Are Under Insulin Therapy [NCT01353469]Phase 3485 participants (Actual)Interventional2011-05-31Completed
Lantus® (Insulin Glargine[rDNA Origin] Injection) vs Humalog® Mix 75/25 (75% Insulin Lispro Protamine Suspension and 25% Insulin Lispro Injection) as add-on Therapy in Type 2 Diabetes Patients Failing Sulfonylurea and Glucophage (Metformin) Combination Tr [NCT01336751]Phase 3212 participants (Actual)Interventional2001-07-31Completed
An Open-label, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Treatment in Adults With Type 2 Diabetes on Non-insulin Glucose-lowering Agents [NCT01359241]16 participants (Actual)Interventional2011-11-30Completed
An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients. [NCT01352663]Phase 30 participants (Actual)InterventionalWithdrawn(stopped due to Business strategy decision)
Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial Study to Test Bioequivalence Between Two Recombinant Human Mixed Insulins-Wockhardt's Human/Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects [NCT01358435]Phase 153 participants (Actual)Interventional2011-01-31Completed
Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study [NCT01354925]Phase 4245 participants (Actual)Interventional2011-09-30Completed
Improving Postprandial Glycaemia by a New Developed Closed-loop Control System (Closedloop4meals). An Interdisciplinary, Investigator's Initiated Project for Optimization of Glucose Control in Type1 Diabetic Subjects [NCT02100488]20 participants (Actual)Interventional2014-03-31Completed
Metformin and Sitagliptin Therapy for Adult Patients With Type 2 Diabetes Admitted to the General Medical Unit [NCT02250794]Phase 40 participants (Actual)Interventional2014-10-31Withdrawn(stopped due to No subjects enrolled.)
"A Randomized Duble Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of Insulin Lispro Mix 25 (LLC GEROPHARM, Russia) Versus Humalog® Mix 25 (Eli Lilly) in Healthy Subjects Using the Euglycemic Clamp Technique" [NCT03606018]48 participants (Actual)Interventional2017-04-12Completed
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3) [NCT05275400]Phase 3986 participants (Actual)Interventional2022-03-08Active, not recruiting
The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy [NCT05578352]20 participants (Anticipated)Interventional2022-08-05Recruiting
SAFE-AP: Automatic Control of Blood Glucose Under Announced and Unannounced Exercise [NCT03577158]10 participants (Actual)Interventional2018-06-01Completed
Interactions Between Metabolic, Cognitive and Reward Processes in Appetite - Effects of Intranasal Administration of Insulin [NCT03632681]64 participants (Actual)Interventional2018-04-23Completed
A 24-week, Randomized, Open-label, Parallel Group Multinational Comparison of Lantus® (Insulin Glargine) Given in the Morning as Once-a-day Basal Insulin Versus Neutral Protamine Hagedorn (NPH) Insulin, in Children With Type 1 Diabetes Mellitus Aged at Le [NCT00993473]Phase 3125 participants (Actual)Interventional2009-10-31Completed
Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome [NCT01151176]Phase 4130 participants (Anticipated)Interventional2012-08-31Suspended(stopped due to Administrative problems makes changes in hospital staff New clinical research team will restart)
A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin na [NCT00469092]Phase 4480 participants (Actual)Interventional2007-05-31Completed
Variability of Glucose Assessed in a Randomized Trial Comparing the Initiation of A Treatment Approach With Biosimilar Basal Insulin Analog Or a Titratable iGlarLixi combinatioN in Type 2 Diabetes Among South Asian Subjects (VARIATION 2 SA Trial) [NCT03819790]Phase 4119 participants (Actual)Interventional2018-10-02Completed
Comparison of HbA1c in Type 1 or Type 2 Diabetic Patients Using Insulin Treated Twice Daily With Either Insulin Lispro Low Mixture or Human Insulin Mix 30/70 [NCT00420095]Phase 4117 participants (Actual)Interventional2007-01-31Completed
Comparison of Twice-Daily Insulin Lispro Low Mixture Versus Once-Daily Basal Insulin Glargine and Once-Daily Prandial Insulin Lispro as Insulin Intensification Strategies in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insul [NCT01175824]Phase 4478 participants (Actual)Interventional2011-04-30Completed
A Multi-centre, Open-labeled, Randomized, Parallel Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After 26 Weeks Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily [NCT01310452]50 participants (Anticipated)Interventional2011-01-31Active, not recruiting
Efficacy and Safety of Exubera (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 1 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial [NCT00137046]Phase 3582 participants (Actual)Interventional2002-05-31Terminated(stopped due to See termination reason in detailed description.)
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes [NCT01076634]Phase 133 participants (Actual)Interventional2010-02-28Completed
Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial [NCT00136916]Phase 3635 participants (Actual)Interventional2002-06-30Terminated(stopped due to See termination reason in detailed description.)
National, Phase IV, Multicentric, Open Label, Comparative Study to Evaluate the Efficacy and Safety of Insulin Glargine Plus Glulisine and Sliding Scale Plus Glulisine in Hospitalized Patients With Diabetes Metabolism Type II Under Enteral Nutrition. [NCT01081938]Phase 415 participants (Actual)Interventional2010-02-28Terminated(stopped due to Recruitment challenges)
Better Acceptance of a Single Injection Apidra (Insulin Glulisine) Added to Once Daily Lantus (Insulin Glargine) Versus Twice Daily Premixed Insulin in a Real Life Use Setting [NCT01079364]Phase 452 participants (Actual)Interventional2010-01-31Terminated(stopped due to Slow recruitment)
Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus [NCT00600626]Phase 3394 participants (Actual)Interventional2004-01-31Completed
Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, [NCT03689374]Phase 32,274 participants (Actual)Interventional2018-10-01Completed
A 12-months Multi-national, Multi-centre, Double Blind, Randomised, Parallel Safety and Efficacy Comparison of Insulin Detemir Produced by the Current Process and Insulin Detemir Produced by the NN729 Process in Subjects With Type 1 Diabetes on a Basal-bo [NCT00447382]Phase 3330 participants (Actual)Interventional2007-03-31Completed
Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia [NCT01088451]20 participants (Anticipated)Interventional2009-12-31Active, not recruiting
Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting [NCT05933759]60 participants (Anticipated)Interventional2023-07-15Not yet recruiting
A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes [NCT04460885]Phase 3984 participants (Actual)Interventional2020-11-25Completed
A Phase 1, Randomized, Placebo- and Active-Controlled, 4-Period Crossover, Proof of Concept Glucose Clamp Study to Compare the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single Doses of TAK-329 With a Single Dose of a Subcutan [NCT01311076]Phase 137 participants (Actual)Interventional2011-03-31Completed
A Monocentric, Controlled, Randomized, Open-label Cross-over Study to Explore the Possible Insulin Treatment of Beverages Containing Alcohol and Carbohydrates in Adolescents and Young Adults With Type 1 Diabetes [NCT02518022]0 participants (Actual)Interventional2015-09-30Withdrawn(stopped due to unexpected low willingness of patient to participate on the study)
Comparison of the Efficacy on Glycaemic Control and Safety Profile of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 Both in Combination With Metformin in Insulin-naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antid [NCT00807092]Phase 4145 participants (Actual)Interventional2008-12-31Completed
Efficacy and Safety of Human Insulin Versus Analog Insulin in Hospitalized Acute Stroke Patients With Hyperglycemia: a Randomized, Open-label, Single Center Trial [NCT04834362]Phase 4452 participants (Actual)Interventional2021-04-05Completed
A Double-blinded, Randomized, Comparative, Crossover Pharmacokinetics Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly Fran [NCT04501250]52 participants (Actual)Interventional2017-10-23Completed
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients [NCT03324776]Phase 328 participants (Actual)Interventional2017-10-16Completed
An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 5 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabe [NCT02488616]Phase 20 participants (Actual)Interventional2018-03-31Withdrawn(stopped due to Medtronic support terminated)
Prevalence of Hyperandrogenism in Young Women With Type 1 Diabetes and Study of the Underlying Pathophysiological Mechanisms [NCT04979377]150 participants (Anticipated)Observational2020-03-09Recruiting
Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes [NCT04964128]28 participants (Actual)Interventional2021-07-22Completed
An Open-label, Randomized, Five-way, Cross-over Study to Compare the Efficacy of Single- and Dual-hormone Closed-loop Operations Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation, and Sensor-augmented [NCT02490098]Phase 20 participants (Actual)Interventional2018-01-31Withdrawn(stopped due to Funding terminated)
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects [NCT02479022]Phase 184 participants (Actual)Interventional2015-06-30Completed
The Use of Incretin-based Drugs and the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes [NCT02476760]1,417,914 participants (Actual)Observational2014-03-31Completed
A Phase I, Randomized, Double-Blind Crossover Pharmacokinetic, Pharmacodynamic, and Safety Study of Subcutaneously Administered Humalog® (Insulin Lispro Injection; Rapid-Acting Insulin) With and Without Recombinant Human Hyaluronidase (rHuPH20) Versus Sub [NCT00705536]Phase 126 participants (Actual)Interventional2007-12-31Completed
A Single-Center, Randomized, Double-Blind, 3-Treatment, 3-Period, 6-Sequence Cross-Over Study To Compare The Pharmacokinetic And Pharmacodynamic Effects of Single Doses of Insulin Glargine Given As U200 And U500 To Lantus® In A Euglycemic Clamp Setting In [NCT02201199]Phase 136 participants (Actual)Interventional2014-08-31Completed
Phase 1, Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional MRI [NCT06144255]Phase 16 participants (Anticipated)Interventional2023-11-30Recruiting
Insulin Superheroes Club: Diabetes Prevention Program in Youth (12-month Supplement to the CDC DPP for Adults) [NCT03042936]33 participants (Actual)Interventional2015-03-31Completed
A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin [NCT03736785]Phase 2399 participants (Actual)Interventional2018-11-15Completed
Evaluation of Insulin Therapy by Multiwave Bolus Based on the Lipid and Protein Content in Addition to the Carbohydrates Content Compared to Insulin Therapy Based Only on the Carbohydrates Content in type1 Diabetes Treated by Insulin Pump [NCT03311516]150 participants (Anticipated)Interventional2019-10-10Recruiting
A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Cont [NCT03798080]Phase 3426 participants (Actual)Interventional2019-02-19Completed
A Phase3, Multi-Center, Open-Label, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With Lantus® Versus Humalog® in Combination With Lantus® in Subjects With Type 1 Diabetes Mellitus [NCT00700622]Phase 3130 participants (Actual)Interventional2008-05-31Terminated(stopped due to Sponsor stopped development of the MedTone inhaler in favor of an improved device (Gen2 inhaler))
A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes [NCT02131246]Phase 133 participants (Actual)Interventional2014-05-31Completed
Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With an Intravenous Insulin Infusion [NCT00795015]Phase 493 participants (Actual)Interventional2006-04-30Completed
A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus [NCT00356109]Phase 3494 participants (Actual)Interventional2006-08-31Completed
Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised [NCT00322257]Phase 3596 participants (Actual)Interventional2006-05-01Terminated(stopped due to See termination reason in detailed description)
A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus [NCT00391209]Phase 3379 participants (Actual)Interventional2006-10-31Completed
Glucose Regulation in Acute Stroke Patients (GRASP) Study [NCT00282867]Phase 274 participants (Actual)Interventional2006-05-31Completed
Cross-Sectional Study on Association Between the Estimation of Insulin Resistance and Beta Cell Function Through Homeostasis Model Assessment With HbA1C Among Oral Anti-Diabetics Treatment Non-Responders [NCT03196154]255 participants (Actual)Observational2017-08-01Completed
Pilot Study to Evaluate the Effects of Insulin Deprivation on Brain Structure and Function in Humans With Type 1 Diabetes [NCT03392441]28 participants (Actual)Interventional2017-11-30Completed
Effects of Local Insulin on Angiogenesis in Acute Wounds in Non-diabetic Patients [NCT02396888]Phase 320 participants (Anticipated)Interventional2014-10-31Active, not recruiting
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects [NCT02304627]Phase 145 participants (Actual)Interventional2014-11-24Completed
A Prospective Randomized Study of a Personalized Approach to the Inpatient Management of Hospitalized Oncology Patients With Hyperglycemia [NCT03904199]Early Phase 19 participants (Actual)Interventional2019-04-04Completed
A Trial Comparing the Effect and Safety of Insulin Degludec Versus Insulin Detemir, Both in Combination With Insulin Aspart, in the Treatment of Pregnant Women With Type 1 Diabetes [NCT03377699]Phase 3225 participants (Actual)Interventional2017-11-22Completed
Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. Clinical Trial of Low Level of Intervention. (Ineox Study) [NCT03328845]Phase 4300 participants (Actual)Interventional2017-01-20Completed
Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis [NCT02988401]Phase 1/Phase 2105 participants (Actual)Interventional2017-12-01Completed
An Open-label, Three-center, Randomized, Two-session, Crossover Study, to Assess 4 Days Inpatient, and 6-week Follow-up Home Study Phase Under Remote Monitoring at Only French Centers, the Efficacy and the Safety of the Diabeloop Closed-loop Glucose Contr [NCT03671915]21 participants (Actual)Interventional2019-05-06Completed
Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery [NCT00884494]Phase 120 participants (Actual)Interventional2011-08-31Completed
A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Recep [NCT02738151]Phase 4929 participants (Actual)Interventional2016-05-19Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Subjects With Type 2 Diabetes Mellitus (BEGIN™: COMPARE) [NCT01364428]Phase 3373 participants (Actual)Interventional2011-06-30Completed
A Phase 1 Safety and Dose-Finding Study of a Human Insulin Receptor Monoclonal Antibody-Human Alpha-L-iduronidase (HIRMAb-IDUA) Fusion Protein, AGT-181 in Adult Patients With Mucopolysaccharidosis I (MPS I, Hurler Syndrome) [NCT02371226]Phase 13 participants (Actual)Interventional2015-07-31Completed
This Trial is Conducted Globally. The Aim of This Trial is to Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidi [NCT02906917]Phase 3532 participants (Actual)Interventional2016-09-20Completed
Pupillographie Als Screeningtest für Cerebrale Insulinresistenz [NCT03651661]22 participants (Actual)Interventional2018-07-03Completed
Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes [NCT04361799]45 participants (Actual)Interventional2020-09-25Completed
OmniPod®-Type 1 Diabetes Insulin Management for Exercise Study [NCT03130101]17 participants (Actual)Interventional2017-04-03Completed
Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery [NCT04451655]72 participants (Actual)Interventional2018-09-01Completed
A Study to Assess the Effect and Safety of Artificial Intelligence Assisted Insulin Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients: A Single-center, Open-labeled, Parallel, Randomized Controlled Trial [NCT04053959]Phase 446 participants (Actual)Interventional2019-09-27Completed
A Parallel, Controlled, Multi-Center, Single-Dose, One-Period Euglycemic Clamp Study Comparing Prandial Inhalation of Technosphere Insulin in Smokers and Non-Smokers With Type 2 Diabetes [NCT00934414]Phase 224 participants (Actual)Interventional2004-08-31Completed
A Phase III, Randomized, Parallel, Double-blind, and Non-inferiority Clinical Trial to Compare Efficacy and Safety of CinnaGen-liraglutide to Innovator Liraglutide Product (Victoza®) in Patients With Type II Diabetes (T2D) [NCT03421119]Phase 3300 participants (Anticipated)Interventional2019-06-20Not yet recruiting
Improving Glycaemic Control in Malaysian Patients With Type 2 Diabetes Mellitus With Insulin Pump Therapy [NCT03112538]Phase 4118 participants (Anticipated)Interventional2016-01-31Recruiting
Treatment of Carpal Tunnel in Rheumatoid Arthritis [NCT03394131]90 participants (Anticipated)Interventional2017-07-01Recruiting
To Assess the Pharmacokinetics and Pharmacodynamics of IN-105 in Relation to the Pre-meal Dosing Time, Between-meal Interval and Type of Meal - A Phase 1, Three Cohort, Randomized, Placebo Controlled, Crossover Trial in Type 2 Diabetes Patients [NCT03392961]Phase 151 participants (Actual)Interventional2014-03-27Completed
A Trial Investigating the Pharmacodynamic Response of FIAsp in Subjects With Type 1 Diabetes [NCT02033239]Phase 146 participants (Actual)Interventional2014-01-31Completed
A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years [NCT01223131]Phase 3162 participants (Actual)Interventional2011-02-28Completed
DOS [Dosing Optimization Study]: Open-label, Single-arm, Proof-of-Concept Dosing Study of Afrezza® in Adult Subjects 18 Years and Older With Type 1 or Type 2 Diabetes Mellitus [NCT04849845]Phase 420 participants (Actual)Interventional2021-04-09Completed
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes [NCT04582435]Phase 146 participants (Actual)Interventional2020-10-16Completed
Multi-center, Randomized, Parallel, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control (CSII, MDI and SAP) at Home [NCT02748018]280 participants (Anticipated)Interventional2017-05-25Recruiting
Phase 4 Crossover Study Comparing the Effect of Insulin Glulisine to Insulin Aspart on Breakfast Post Prandial Blood Glucose Levels in Prepubertal Children With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy [NCT00913497]Phase 416 participants (Actual)Interventional2009-06-30Completed
Effect of Antipsychotics on Central Insulin Action in Relation to Glucose Metabolism and Cognition in Healthy Volunteers [NCT03741478]Phase 164 participants (Anticipated)Interventional2019-10-22Recruiting
The Effect of Insulin Degludec on Risk of Symptomatic Nocturnal Hypoglycaemia in Subjects With Type 1 Diabetes and High Risk of Nocturnal Severe Hypoglycaemia [NCT02192450]Phase 4149 participants (Actual)Interventional2015-01-31Completed
A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus [NCT02198846]140 participants (Anticipated)Interventional2014-06-30Recruiting
Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes: a One Year, Randomised, Parallel Study [NCT00942318]Phase 452 participants (Actual)Interventional2009-03-31Completed
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus [NCT02220296]Phase 162 participants (Actual)Interventional2014-08-20Completed
Impact of Two Standardized Clinical Care Protocols on Pregnancy Outcomes in Women With Monogenic Diabetes MODY2 [NCT02556840]46 participants (Actual)Interventional2016-04-25Completed
Comparison of Meal-Time Dosing of Rapid Acting Insulin Using Carbohydrate Counting vs. Fixed Doses Utilizing Continuous Glucose Monitoring In Patients With Cystic Fibrosis Related Diabetes [NCT04533646]Phase 420 participants (Anticipated)Interventional2021-03-17Active, not recruiting
A Double-blind Study of the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy [NCT01110746]Phase 320 participants (Actual)Interventional2010-02-28Completed
[NCT00875108]Phase 3116 participants (Actual)Interventional2007-07-31Completed
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) at Steady State Conditions in Subjects With Type 1 Diabetes [NCT03723772]Phase 166 participants (Actual)Interventional2018-11-29Completed
Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes [NCT02660827]151 participants (Actual)Interventional2016-04-18Completed
Safety And Efficacy Of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents Ages 6-17 Years With Type 1 Diabetes Mellitus: A 12 Month, Outpatient, Randomized, Open Label, Parallel Group Comparative Trial. [NCT00479258]Phase 32 participants (Actual)Interventional2007-10-31Terminated(stopped due to See termination reason in detailed description.)
An Open-Label Pilot Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Potential of Oral Insulin to Reduce Liver Fat Content and Fibrosis in Patients With Nonalcolholic Steatohepatitis (NASH) [NCT02653300]Phase 210 participants (Actual)Interventional2018-09-20Completed
Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes [NCT00427154]Phase 3227 participants (Actual)Interventional2007-01-10Terminated(stopped due to See termination reason in detailed description)
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus. [NCT00325364]Phase 3415 participants (Actual)Interventional2006-04-30Completed
A Phase IV, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Trial and Subsequent Open-Label, Extension Trial to Assess the Safety and Efficacy of Addition of Omarigliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Hav [NCT02906709]Phase 4184 participants (Actual)Interventional2016-10-17Completed
Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021 in Healthy and Diabetic Patients [NCT05089942]Phase 416 participants (Anticipated)Interventional2021-12-31Not yet recruiting
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in In [NCT02117622]1,056 participants (Actual)Observational2015-07-24Completed
A Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus [NCT00127634]Phase 3385 participants (Actual)Interventional2005-07-31Completed
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes [NCT01934712]Phase 150 participants (Actual)Interventional2013-08-30Completed
Health Economic Analysis of Islet Cell Transplantation for Patients With Severe Forms of Brittle Type 1 Diabetes [NCT02854696]Phase 342 participants (Actual)Interventional2016-07-07Active, not recruiting
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Healthy Subjects and in Subjects With Type 1 Diabetes [NCT04569994]Phase 168 participants (Actual)Interventional2020-09-30Completed
The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes [NCT02143440]65 participants (Actual)Interventional2012-03-31Active, not recruiting
Comparison of Patient's Preference, Pain Perception, and Usability Between Inner and Outer Upper Thigh for Insulin Therapy [NCT02307968]20 participants (Actual)Observational2014-10-31Completed
Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis. [NCT03501680]Phase 4200 participants (Anticipated)Interventional2018-06-06Not yet recruiting
Multi-centre, Open, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled With SU +/ Biguanide Therapy, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin vs. Insulin Alone [NCT00799448]Phase 440 participants (Actual)Interventional2003-09-16Terminated(stopped due to Low recruitment status)
Insulin Scheme for Glycemic Control in Non-critical Hospitalized Patients With Type 2 Diabetes in the Context of a Health System in Mexico. [NCT03350984]Phase 475 participants (Actual)Interventional2017-11-02Completed
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus. DUALTM IX - Add-on to SGLT2i [NCT02773368]Phase 3420 participants (Actual)Interventional2016-05-23Completed
A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Tr [NCT01336023]Phase 31,663 participants (Actual)Interventional2011-05-23Completed
Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy [NCT02155374]Phase 426 participants (Actual)Interventional2014-05-31Completed
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes [NCT02035371]Phase 141 participants (Actual)Interventional2014-01-13Completed
The Role of IntraNasal Insulin in Regulating HepaTic Lipid COntent in HUMANS a Randomized, Controlled, Double Blinded Trial [NCT02164032]Phase 220 participants (Actual)Interventional2014-09-30Active, not recruiting
A Randomised, Cross-over, Open-label, Multi-centre Trial Comparing the Effect of Insulin Degludec and Insulin Glargine 100U/mL, With or Without OADs in Subjects With Type 2 Diabetes Using Flash Glucose Monitoring [NCT03687827]Phase 4498 participants (Actual)Interventional2018-10-02Completed
"A Randomized Duble Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of Insulin Lispro (LLC GEROPHARM, Russia) Versus Humalog® (Eli Lilly) in Healthy Subjects Using the Euglycemic Clamp Technique" [NCT03604575]28 participants (Actual)Interventional2016-08-22Completed
Multicenter Prospective Cohort Study of the Hypoglycemic Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes: Triple Combination Therapy Using Metformin, Saxagliptin Plus Dapagliflozin Versus Premixed Insulin [NCT03700801]Phase 4130 participants (Anticipated)Interventional2018-10-31Not yet recruiting
A Randomized Controlled Trial to Evaluate Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes: REmission Studies Evaluating Type 2 DM - Intermittent Insulin Therapy (RESET-IT) [NCT02192424]Phase 3109 participants (Actual)Interventional2014-07-31Completed
The Effect Of Direct Acting Antiviral Drugs on miRNA-122 And Insulin Resistance In Chronic HCV Patients [NCT03687229]60 participants (Anticipated)Observational [Patient Registry]2019-01-31Not yet recruiting
The Effects of Hypoglycaemia on Platelets Function and Inflammatory Markers in People With Type 2 Diabetes and Normal Controls. [NCT02205996]18 participants (Actual)Interventional2011-11-30Completed
A Multi-Center,Open-Label, Single-Arm, Multiple Dose Study With HOE901-U300 to Assess The Ease of Use And Safety of a New U300 Pen Injector in Insulin-Naïve Patients With T2DM [NCT02227212]Phase 340 participants (Actual)Interventional2014-08-31Completed
Combination of Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes and Poor Glycemic Control Related to Very Few Self-blood Glucose Measurements [NCT03671161]19 participants (Actual)Interventional2016-01-01Completed
Randomized, Open Label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog® Versus Continuous Use of NovoLog in Participants With Type 1 Diabetes Mellitus Also Using Insulin Glargine [NCT03874715]Phase 3210 participants (Actual)Interventional2019-03-11Completed
Linagliptin Plus Insulin for Hyperglycemia Immediately After Renal Transplantation: A Comparative Study [NCT03970668]28 participants (Actual)Observational2016-01-01Completed
Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose [NCT05866367]Phase 112 participants (Anticipated)Interventional2023-08-16Recruiting
Neurodevelopmental Outcome of Very Preterm Infants With Glucose Level Disturbances at the Age of Two [NCT03530189]150 participants (Actual)Observational2018-01-01Completed
LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-2 Multicentre Randomized Controlled Trial [NCT02056353]1,550 participants (Actual)Interventional2014-02-28Completed
Measurement of Beta Cell Death in Individuals With Cystic Fibrosis [NCT03713437]40 participants (Actual)Observational2019-04-04Completed
Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen [NCT02408120]Phase 4226 participants (Actual)Interventional2015-10-31Completed
Intraoperative Insulin Administration (Infusion Regimen vs. Bolus Regimen) at Cardiac Surgery for Type II Diabetic Patients; A Randomised Control Trial. [NCT04824586]Phase 470 participants (Actual)Interventional2019-06-01Completed
Food Intake and Intra-Nasal Insulin for African American Adults [NCT04739371]Phase 140 participants (Actual)Interventional2021-06-17Completed
A Phase 3, Open-Label, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes Mellitus on Oral Agents [NCT00437112]Phase 3142 participants (Actual)Interventional2007-02-28Completed
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 1 Diabetes Mellitus [NCT00542724]Phase 3462 participants (Actual)Interventional2006-09-30Completed
Fully Automated Glycemic Control With Ultrarapid Insulin in a Bihormonal Closed Loop System in Patients With Type 1 Diabetes [NCT05508061]12 participants (Actual)Interventional2022-10-19Completed
The Effect of Insulin on Protein Metabolism After Cardiac Surgery [NCT01601561]30 participants (Anticipated)Interventional2010-06-30Recruiting
Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice [NCT02105103]80 participants (Actual)Interventional2013-10-31Completed
Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity in the Department of Health of Valencia Clínico-Malvarrosa [NCT05535322]26,944 participants (Actual)Observational2014-01-01Completed
A Comparison of Insulin Sensitivity and Management in Hyperglycemic Patients in the Perioperative Period: ESRD vs. Non-ESRD [NCT03526536]Phase 440 participants (Actual)Interventional2018-05-01Terminated(stopped due to The study required more participants than anticipated for statistical significance.)
Egulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance [NCT03383822]Phase 1/Phase 27 participants (Actual)Interventional2015-09-08Completed
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes [NCT02148861]Phase 149 participants (Actual)Interventional2014-05-26Completed
An Open, Single-centre, Non-controlled Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors Used for Continuous Glucose Monitoring in Patients With Type 1 Diabetes [NCT02155023]8 participants (Actual)Interventional2014-01-31Completed
An Exploratory Randomized Open-Label 2-Arm Comparison of Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec to Determine Optimum Basal Insulin Dosing Regimens in Type 1 Diabetes Mellitus Subjects [NCT03938740]Phase 261 participants (Actual)Interventional2019-03-18Completed
A Single Center, Open-label, Randomized Study Examining the Glycemic Effects of ID vs SC Bolus Dosing of Insulin Lispro in Patients With Type 1 Diabetes [NCT01120444]Phase 1/Phase 220 participants (Anticipated)Interventional2010-04-30Completed
A Single Center, Non-randomized, Single Blind, Placebo Controlled, Single Dose Study of the Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients - Phase 1 Study [NCT01120912]Phase 18 participants (Actual)Interventional2010-10-31Completed
Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein [NCT01227148]Phase 3112 participants (Actual)Interventional2006-04-30Completed
A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Therapy [NCT03467932]Phase 2373 participants (Actual)Interventional2018-05-29Completed
Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Asthma: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Paral [NCT00139659]Phase 3288 participants (Actual)Interventional2003-01-31Completed
[NCT02165566]Phase 428 participants (Actual)Interventional2013-03-31Completed
[NCT02847806]Phase 36 participants (Actual)Interventional2008-01-31Completed
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes [NCT05403502]183 participants (Actual)Interventional2022-08-31Completed
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical [NCT02230618]1,029 participants (Actual)Observational2015-11-24Completed
The Effect of Central Insulin on Insulin Sensitivity and Energy Metabolism [NCT01479075]Phase 430 participants (Actual)Interventional2011-08-31Completed
Effect of Intranasal Insulin Administration on Glycaemia and Insulin Concentrations in Plasma and Cerebrospinal Fluid During Surgery [NCT02729064]Phase 1141 participants (Anticipated)Interventional2016-09-30Recruiting
An 18-Week Randomized, Double-Blind, Multicenter, Comparator Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus [NCT00814294]Phase 2/Phase 3239 participants (Actual)Interventional2008-12-31Completed
Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy [NCT01100125]Phase 4140 participants (Actual)Interventional2010-04-30Completed
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients [NCT01209403]Phase 412 participants (Actual)Interventional2010-09-30Completed
Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety [NCT00523042]Phase 310 participants (Actual)Interventional2007-08-30Terminated(stopped due to See termination reason in detailed description)
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin [NCT00338104]Phase 475 participants (Actual)Interventional2004-07-31Completed
Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes [NCT05922033]Phase 456 participants (Anticipated)Interventional2023-10-19Recruiting
Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes [NCT00411892]Phase 3196 participants (Actual)Interventional2006-11-29Terminated(stopped due to See termination reason in detailed description)
National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure. [NCT01122979]Phase 472 participants (Actual)Interventional2010-07-31Completed
Comparison of a Basal Plus (Insulin Glargine/Insulin Glulisine) Regimen to Biphasic Insulin (InsulinAspart/Insulin Aspart Protamine 30/70) in T2DM Patients Who Require Insulin Intensification After Basal Insulin Optimization. [NCT01212913]Phase 4161 participants (Actual)Interventional2010-08-31Completed
Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents? [NCT01215331]Phase 373 participants (Actual)Interventional2010-08-31Completed
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study [NCT03143816]Phase 460 participants (Actual)Interventional2017-09-30Completed
A Trial to Test for Bioequivalence Between Two NN5401 Formulations in Healthy Subjects [NCT01125553]Phase 126 participants (Actual)Interventional2010-05-31Completed
A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Chinese Subjects With Type 2 Diabetes [NCT04857398]Phase 124 participants (Actual)Interventional2021-04-28Completed
Application of Needle-free Injection of Insulin in Pregnant Women With Gestational Diabetes Mellitus [NCT05394727]20 participants (Anticipated)Interventional2021-04-01Recruiting
The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial [NCT03740581]50 participants (Anticipated)Interventional2017-11-01Recruiting
"Effect of Central Insulin Administration on Whole-body Insulin Sensitivity in Women" [NCT03929419]29 participants (Actual)Interventional2019-04-21Completed
An Open-label, Multi-centre, Randomised, Two Arm Single Period Parallel Study to Assess the Efficacy, Safety and Utility of Hybrid Closed-loop Glucose Control Compared to Standard Insulin Therapy Combined With Continuous Glucose Monitoring in Young People [NCT05562492]128 participants (Anticipated)Interventional2023-04-12Recruiting
An Open-label, Single-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Closed-loop Glucose Control Compared to Standard Insulin Pump Therapy Combined With Continuous Glucose Monitoring in Adults With Type 1 Dia [NCT04977908]26 participants (Actual)Interventional2021-08-31Completed
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 1 Diabetes [NCT01135927]Phase 122 participants (Actual)Interventional2010-06-30Completed
A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day [NCT01234597]Phase 4219 participants (Actual)Interventional2012-12-31Completed
A Trial to Investigate Pharmacokinetics, Safety and Tolerability of Insulin Degludec/Liraglutide (A3) Compared With Insulin Degludec and Liraglutide in Healthy Subjects [NCT01319240]Phase 124 participants (Actual)Interventional2011-03-31Completed
The Effect of Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose Control in Type - II Diabetic Patients in Baqiyatollah Hospital and Clinic, Tehran, 2019 -2020 [NCT04460092]100 participants (Anticipated)Interventional2020-05-25Recruiting
Pilot Evaluation Study of the Feasibility of a Permanent Use in Free-life of inControl Artificial Pancreas System for the Treatment of Type 1 Diabetes [NCT02892604]3 participants (Actual)Interventional2015-11-24Terminated(stopped due to not enough participants)
A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State in Subjects With Type 2 Diabetes [NCT01154881]Phase 149 participants (Actual)Interventional2010-06-30Completed
Study of Sequential Perfusion of Liver Grafts With Low-viscosity and High-viscosity Preservation Solutions to Decrease the Incidence of Nonanastomotic Biliary Strictures After Liver Transplantation [NCT01271179]141 participants (Actual)Interventional2004-07-31Completed
An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes [NCT03751657]Phase 2247 participants (Actual)Interventional2018-11-29Completed
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Young Adults and Geriatric Subjects With Type 1 Diabetes [NCT01174303]Phase 128 participants (Actual)Interventional2010-08-31Completed
A Prospective Multi-centre, Non-randomized, Open-label, Non-interventional Study to Evaluate the Safety, Efficacy and Injection Compliance of Scilin N, Scilin R or Scilin M30 in Chinese Type 2 Diabetes Mellitus (T2DM) [NCT01588639]2,683 participants (Actual)Observational2012-08-31Completed
Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old [NCT04084171]12 participants (Actual)Interventional2019-09-26Completed
Early Insulin Treatment in Patients With Latent Autoimmune Diabetes (LADA) [NCT01109927]Phase 442 participants (Actual)Interventional1995-02-28Completed
A Longitudinal, Single Centre Study to Assess the Effects of Artificial Pancreas-related Changes in Diabetic Neuropathy [NCT05951283]102 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Flexible Insulin Therapy Untethered Insulin Regimen Using Insulin Degludec and Continuous Subcutaneous Insulin Infusion in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered [NCT03838783]Phase 430 participants (Anticipated)Interventional2018-05-15Recruiting
Pilot Study of Intensive Care Unit Continuous Glucose Monitoring [NCT01301053]20 participants (Anticipated)Interventional2011-02-28Enrolling by invitation
Observational Study of Drug Naive Type 2 Diabetes Receiving Continuous Subcutaneous Insulin Infusion Therapy [NCT03710811]150 participants (Anticipated)Observational2017-09-01Recruiting
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi [NCT03130426]Phase 3161 participants (Actual)Interventional2017-06-27Completed
Effects of Insulin Pump Versus Multiple Daily Injections of Insulin on Glycemic and Metabolic Control in Type 1 Diabetic Patients Transitioned to the Adult Center: the Management and Technology for Transition Study (METRO) [NCT03463564]Phase 4150 participants (Anticipated)Interventional2016-01-31Recruiting
Intensive Insulin Therapy in Deceased Donors - to Improve Renal Allograft Function and Transplanted Allograft Outcomes [NCT01140035]200 participants (Anticipated)Interventional2009-01-31Completed
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus [NCT01235819]Phase 420 participants (Actual)Interventional2010-11-30Completed
An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery in Comparison With Standard Care in Adults With Type 2 Diabetes Not Requiring Dialysis [NCT04701424]30 participants (Actual)Interventional2020-12-16Completed
Evaluation of Minimed 670G Hybrid Closed Loop System On-Boarding Protocol, for Patients With Type 1 Diabetes on Multiple Daily Insulin Injection Therapy [NCT03755479]30 participants (Actual)Observational2019-02-01Completed
Evaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation [NCT01149005]30 participants (Anticipated)Interventional2010-06-30Not yet recruiting
A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring in Patients With Type 1 Diabetes Mellitus [NCT04075513]Phase 4343 participants (Actual)Interventional2019-10-09Completed
Evaluation of Virtual Versus Traditional Study Conduct in a 6-month, Multicenter, Randomized, Open-label, Two-parallel Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus [NCT03260868]Phase 415 participants (Actual)Interventional2017-09-19Terminated(stopped due to "Due to prolonged low participant recruitment")
Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients [NCT01281605]181 participants (Actual)Interventional2011-01-31Completed
Determination of the Root Causes of Obstructions of Catheters in Patients With Type 1 Diabetes Treated by Insulin Implanted Pumps [NCT03230266]94 participants (Actual)Interventional2017-06-02Terminated(stopped due to Inclusion of the last patient)
Development of a Closed Loop for the Treatment of Type 2 Diabetes: Collection of Clinical Data at Home for the Creation of an Algorithmic Laboratory Test Bench [NCT04522882]35 participants (Actual)Interventional2020-09-09Completed
Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan [NCT03349840]Phase 4273 participants (Actual)Interventional2018-01-07Terminated(stopped due to The study was terminated by the IRB and the Institutional Official after the MOPH and WCMQ audits)
Topic Insulin Accelerates Wound in Diabetes [NCT01295177]Phase 1/Phase 222 participants (Actual)Interventional2004-01-31Completed
A Trial to Test for Bioequivalence Between Identical NN1250 Formulations, IM1 and IM2, in Healthy Subjects [NCT01193387]Phase 126 participants (Actual)Interventional2010-08-31Completed
Comparison of Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis in Patients Without Diabetes [NCT05487833]Phase 430 participants (Anticipated)Interventional2022-11-30Not yet recruiting
The Role of TBC1D4 in Exercise- and Insulin-induced Glucose Metabolism in Human Skeletal Muscle [NCT04170972]16 participants (Actual)Interventional2017-10-17Completed
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D [NCT03214380]Phase 3933 participants (Actual)Interventional2017-07-14Completed
Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes [NCT03478969]181 participants (Actual)Interventional2018-05-17Completed
The Primary Objective of This Study Was to Investigate the Effect of Insulin on Myocardial Perfusion in Patients Undergoing Cardiac Surgery for CPB Using Transesophageal Echocardiography (TEE) to Detect CSBF and the Secondary Objective Was to Observe the [NCT05464966]60 participants (Anticipated)Interventional2022-01-13Recruiting
Effectiveness and Safety of Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Type 1 Diabetes Mellitus Adult Patients in Routine Clinical Practice [NCT03793283]90 participants (Actual)Observational2019-01-01Completed
A 26-week Randomized, Open-label, Active-controlled, 2-treatment Arm, Parallel Group Multi-center Study, Comparing the Efficacy and Safety of Soliqua™100/33 Versus Lantus® in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately [NCT03434119]Phase 3241 participants (Actual)Interventional2018-02-20Terminated(stopped due to "(Trial terminated (recruitment delays))")
Assessment of an Integrated Continuous Glucose Monitor and Insulin Injection Port in Type 2 Diabetes [NCT05185518]18 participants (Anticipated)Interventional2025-09-30Not yet recruiting
Influence of Dairy Protein Breakfast on Overall Daily Glycemia, Weight Loss HbA1c and Clock Genes mRNA Expression, in Type 2 Diabetes [NCT03772067]60 participants (Anticipated)Interventional2018-12-28Not yet recruiting
Premium With Afrezza vs. One Drop [NCT03313960] Premium With Afrezza vs. One Drop 0 participants (Unknown status)Interventional2017-10-05"A-One: A Randomized Controlled Trial Evaluating One Drop (stopped due to Informed Data Systems, Inc.)
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania [NCT00873639]417 participants (Actual)Observational2009-04-30Completed
A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy [NCT00874809]30 participants (Actual)Interventional2009-03-31Completed
Reappraisal of Glucose-insulin-potassium Therapy in Acute St-segment Elevation Myocardial Infarction by Pre-hospital Administration [NCT02591927]Phase 3334 participants (Anticipated)Interventional2016-02-29Not yet recruiting
Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study [NCT00592241]30 participants (Anticipated)Interventional2007-11-30Completed
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novol [NCT00593255]Phase 4220 participants (Actual)Interventional2004-07-31Completed
A Randomized, Single Center, Double Blind, Two Period, Crossover Glucose Clamp Study to Test for Bioequivalence Between Two Recombinant Human Soluble Insulins- Wockhardts Insulin Human Regular for Injection and Novolin R in Healthy Subjects [NCT00596063]Phase 125 participants (Actual)Interventional2008-01-31Completed
Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus [NCT00597233]Phase 491 participants (Actual)Interventional2002-10-31Completed
Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy [NCT00598793]Phase 3242 participants (Actual)Interventional2002-11-30Completed
Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes [NCT00626080]40 participants (Anticipated)Interventional2009-01-31Completed
A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without [NCT01006291]Phase 3687 participants (Actual)Interventional2009-11-30Completed
NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficac [NCT01074268]Phase 3456 participants (Actual)Interventional2010-02-28Completed
The Effects of Finesse on Glycemic Control in Adults With Diabetes Using MDI: Finesse vs. Pen or Syringe and Vial as Bolus Prandial Insulin Device [NCT01073566]Phase 238 participants (Actual)Interventional2010-01-31Completed
The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis [NCT01282164]43 participants (Actual)Interventional2011-01-31Completed
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study [NCT05124457]Phase 2336 participants (Anticipated)Interventional2022-02-01Recruiting
A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon [NCT04712266]Early Phase 115 participants (Actual)Interventional2020-09-15Completed
Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) to Improve Insulin Secretion and Action in Subjects With Type 2 Diabetes [NCT00998335]Phase 430 participants (Actual)Interventional2007-06-30Completed
Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy [NCT02868931]268 participants (Actual)Interventional2016-04-01Completed
An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on [NCT01215435]Phase 4245 participants (Actual)Interventional2011-03-31Completed
NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime In [NCT00972283]Phase 31,006 participants (Actual)Interventional2009-09-01Completed
Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes [NCT00715351]342 participants (Actual)Observational2007-05-31Completed
Basal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus [NCT00979628]Phase 4375 participants (Actual)Interventional2010-01-31Completed
"A Four-year, Safety and Tolerability, Open-Label, Follow on Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus." [NCT00754624]Phase 2229 participants (Actual)Interventional2004-05-31Completed
Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT) [NCT03912363]74 participants (Anticipated)Interventional2019-11-01Recruiting
Sigi Insulin Management System - First-in-Human Study [NCT05973422]10 participants (Anticipated)Interventional2023-11-30Not yet recruiting
A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen [NCT00604344]Phase 3401 participants (Actual)Interventional2003-04-30Completed
6-Month, Multicenter, Randomized, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglyce [NCT02855684]Phase 3604 participants (Actual)Interventional2016-08-24Completed
Randomized, Long-Term Study About the Effects of Analogue Versus Human Insulin Based Regimens (Insulin Detemir and Aspart Versus NPH- and Regular Human Insulin) on Metabolic Control and Myocardial Function in People With Type 2 Diabetes. [NCT00747409]Phase 4120 participants (Anticipated)Interventional2004-07-31Active, not recruiting
Comparative Pharmacokinetics and Pharmacodynamics of Human Regular U-500 Insulin Administered Subcutaneously as a Bolus Via Syringe Versus Continuous Subcutaneous Insulin Infusion and Characterization of TID and BID Dosing at Steady State in High-Dose Ins [NCT02588950]Phase 111 participants (Actual)Interventional2016-01-12Terminated(stopped due to Slow enrollment)
A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide [NCT00560417]Phase 3339 participants (Actual)Interventional2007-11-30Completed
Molecular Regulation of Muscle Glucose Metabolism [NCT01581736]Phase 148 participants (Actual)Interventional2012-04-30Terminated(stopped due to PI job change)
A Randomized, Open, Two-Way Cross-Over, Single-Centre, Phase I Study to Assess the Counter Regulatory Response During Hypoglycaemia in Healthy Male Volunteers After a Single Oral Dose of AZD1656 Suspension in Comparison With Insulin Infusion [NCT00790153]Phase 112 participants (Anticipated)Interventional2008-11-30Completed
"A Phase 2, Open-Label, Randomized, 2-Way Crossover, Clinical Trial to Compare the Pharmacokinetics of 2 Formulations of Intended Commercial Product Technosphere® Insulin Inhalation Powder and to Determine the Bioavailability of a 30 Unit Cartridge of Int [NCT00662857]Phase 229 participants (Actual)Interventional2008-04-30Completed
A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispr [NCT00976391]Phase 3586 participants (Actual)Interventional2009-09-30Completed
Clinical Outcome of Tight Glucose Control of Diabetic Patients Hospitalized In General Internal Medicine Wards A National Israeli Study [NCT00813475]200 participants (Anticipated)Interventional2009-01-31Not yet recruiting
A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial to Compare the Pharmacodynamic Effects of Single Doses of Insulin Detemir and Neutral Protamin Lispro (NPL) Insulin in Subjects With Type 1 Diabetes [NCT00810589]Phase 130 participants (Actual)Interventional2008-11-30Completed
A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus [NCT00842361]Phase 266 participants (Actual)Interventional2009-01-31Completed
Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes [NCT00627445]Phase 3441 participants (Actual)Interventional2008-02-29Completed
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy [NCT00574405]24 participants (Actual)Interventional2005-04-30Completed
Impact of a Paper-based Dynamic Insulin Infusion Protocol on Glycemic Variability, Time in Target and Hypoglycemic Risk: a Stepped Wedge Trial in Medical ICU Patients [NCT02847104]131 participants (Actual)Observational2013-02-28Completed
A Randomised, Open-labelled, 4-period Crossover Trial Characterising Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 Administered Once, Twice or Thrice Daily and Biphasic Human Insulin 30 Administered Once Daily in Subjects With Type 2 [NCT00825253]Phase 124 participants (Actual)Interventional2007-03-31Completed
Ultra-Short Acting Insulin Versus Short Acting Insulin Effect on Postprandial Hyperglycemia AKA RCT Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Glycemia [NCT01067118]Phase 20 participants (Actual)Interventional2010-04-30Withdrawn(stopped due to The study was suspended due to lack of study drug)
A Multi-centre Prospective Non-interventional Study Investigating the Clinical Effectiveness of Ryzodeg® (Insulin Degludec/Insulin Aspart) in Patients With Type 2 Diabetes Mellitus in a Real-world Setting [NCT04042441]1,122 participants (Actual)Observational2019-07-29Completed
[NCT02798250]Phase 211 participants (Actual)Interventional2016-06-30Completed
Tight Glycemic Control Increases Cardiac Stem Cells and Reduces Heart Remodeling During Acute Myocardial Infarction in Hyperglycemic Patients [NCT00863629]Phase 465 participants (Actual)Interventional2001-01-31Completed
Glycemic Control and Variability for Congestive Heart Failure Exacerbation [NCT00812487]Phase 1/Phase 275 participants (Actual)Interventional2009-01-31Completed
Intensive Glycemic Control for Congestive Heart Failure Exacerbation [NCT00812253]Phase 274 participants (Actual)Interventional2009-01-31Completed
Effect of Simplified Insulin Regimen on Glycemic Control and Quality of Life in an Elderly Population With Type 2 Diabetes [NCT03660553]Phase 47 participants (Actual)Interventional2018-10-10Terminated(stopped due to PI left University of Miami)
Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients in an Institution in Bogotá, Colombia [NCT05752929]Phase 4116 participants (Actual)Interventional2016-01-01Completed
A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatm [NCT00613951]Phase 2182 participants (Actual)Interventional2008-01-31Completed
The Metabolic and Glycaemic Effects of a Combined Basal-Bolus Insulin Reduction And Carbohydrate Feeding Strategy For Evening Exercise in Type 1 Diabetes Mellitus [NCT02204839]10 participants (Actual)Interventional2014-01-31Completed
A Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus [NCT02688933]Phase 4638 participants (Actual)Interventional2016-05-05Completed
The Effect of a Checklist on the Education of Simulated Patients During Insulin Initiation: a Randomized Controlled Trial [NCT02266303]100 participants (Anticipated)Interventional2014-07-31Recruiting
A Three-part Study Parts I, II and III: Rising Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Subjects (Part I) and Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Subjects With Typ [NCT02269735]Phase 174 participants (Actual)Interventional2014-11-26Completed
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 4 [NCT02160275]16 participants (Actual)Interventional2014-06-30Completed
Randomized Controlled Clinical Study of Intensive Versus Nonintensive Insulin Therapy for Hyperglycemia After Traumatic Brain Injury [NCT02161055]Phase 4144 participants (Anticipated)Interventional2014-06-30Recruiting
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes [NCT02670915]Phase 3834 participants (Actual)Interventional2016-05-04Completed
Double-blinded, Randomized, Controlled Paired Trial Comparing Sitagliptin to Placebo in Closed Loop. [NCT02328040]Phase 117 participants (Actual)Interventional2014-09-30Completed
A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine [NCT00355849]Phase 3555 participants (Actual)Interventional2006-08-31Completed
Study on the Efficacy and Safety of Henagliflozin Combined With Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring System [NCT05677334]Phase 4200 participants (Anticipated)Interventional2023-03-01Recruiting
A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon's Human Insulin R U-500 and Humulin® R U-500 (RHINE-4: [NCT05413863]Phase 178 participants (Actual)Interventional2022-05-30Completed
Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions. A Double-blinded, Single Centre, Randomised, Two-period, Crossover Extension Phase to Evaluate Home Use of Closed-loop Applying Ultra-rapid Insulin Lispro Versus Standard Insuli [NCT05257460]28 participants (Actual)Interventional2022-01-25Completed
Brain Insulin Resistance and Motivation in Mood Disorders [NCT03915613]Phase 1/Phase 2150 participants (Anticipated)Interventional2021-10-06Recruiting
Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other. [NCT01998113]2,509 participants (Actual)Observational2013-03-31Completed
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes [NCT02003677]Phase 167 participants (Actual)Interventional2013-11-29Completed
A Randomised, Double Blind, Crossover Euglycaemic Clamp Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus [NCT04501107]Phase 132 participants (Actual)Interventional2020-08-03Completed
A Phase 1, Exploratory, Randomized, Double-Blind, Two-Way Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Subjects With Type 1 Diabetes Mellitus [NCT02506647]Phase 141 participants (Actual)Interventional2015-12-31Completed
Phase I Study in Humans Evaluating the Safety of Rectus Sheath Implantation of Diffusion Chambers Encapsulating Autologous Malignant Glioma Cells Treated With Insulin-like Growth Factor Receptor-1 Antisense Oligodeoxynucleotide (IGF-1R/AS ODN) in 32 Patie [NCT02507583]Phase 133 participants (Actual)Interventional2015-09-01Completed
Randomized, Controlled, Multicenter Studies of the Effects of Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis [NCT03342807]Phase 4220 participants (Anticipated)Interventional2017-11-30Not yet recruiting
The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery [NCT03324867]316 participants (Anticipated)Interventional2022-04-30Not yet recruiting
Does High-Protein High-Fat Meal Increase Postprandial Glucose Concentrations and Meal-Time Insulin Requirements in Patients With Type 1 Diabetes on Basal-Bolus Insulin Regimen: A Randomized Controlled Trial [NCT03333525]30 participants (Actual)Interventional2013-09-10Completed
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes [NCT02825251]Phase 3472 participants (Actual)Interventional2016-07-06Completed
A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, 3-Period, 4 Treatment Incomplete Crossover Study to Assess the Effects of Single Oral Doses of L-001241689 on Glucagon-Induced Glycemic Excursion in Healthy Male Subjects Following Intravenous A [NCT02012166]Phase 118 participants (Actual)Interventional2005-07-31Completed
Memory Advancement by Intranasal Insulin in Type 2 Diabetes [NCT02415556]Phase 2289 participants (Actual)Interventional2015-10-06Completed
An Open, Non-randomized, Single-center Pilot Study Investigating the Feasibility of Determining the Endogenous Glucose Production During a Hypoglycaemic Clamp in Type 1 Diabetes Mellitus Subjects [NCT02028078]Phase 220 participants (Actual)Interventional2014-01-31Completed
The Impact of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus [NCT05244200]100 participants (Anticipated)Interventional2022-01-20Recruiting
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery [NCT01361594]Phase 3338 participants (Actual)Interventional2011-06-30Completed
Sitagliptin for the Prevention and Treatment of Stress Hyperglycemia in Non-Diabetic Patients Undergoing Cardiac Surgery [NCT02443402]Phase 468 participants (Actual)Interventional2016-01-31Completed
The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes [NCT06127433]Phase 4210 participants (Anticipated)Interventional2023-03-07Recruiting
Role of Hyperinsulinemia in NAFLD: Dexamethasone-Pancreatic Clamp Pilot & Feasibility Study [NCT06126354]Phase 116 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes. [NCT06046417]Phase 2/Phase 330 participants (Anticipated)Interventional2023-11-30Recruiting
A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ Technology in Adults With Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP) [NCT05785832]300 participants (Anticipated)Interventional2023-06-01Recruiting
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial [NCT01369069]Phase 31,151 participants (Actual)Interventional2012-04-30Completed
A Randomized Controlled Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro Alone to Further Improve Glycemic Control in Type 1 Diabetes Mellitus Subjects With Good Glycemic Control [NCT03096392]Phase 246 participants (Actual)Interventional2017-04-18Completed
A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects [NCT03292185]Phase 124 participants (Actual)Interventional2017-09-29Completed
Insulin Degludec Titration Using Mobile Insulin Dosing System [NCT03091712]240 participants (Actual)Interventional2017-05-05Completed
Study of Molecular Causes of Metabolic Disorders in Obese Premenopausal Women After Breast Cancer [NCT05010356]24 participants (Anticipated)Interventional2021-08-31Recruiting
The Safety and Efficacy of QS-M Needle -Free Injector Versus Needle-insulin Pen as a Drug Carrier for Controlling the Blood Glucose in T2DM：a Randomized, Parallel Controlled, Open-label, Multicenter Trial [NCT03243903]427 participants (Actual)Interventional2017-08-18Completed
Randomized, Double-blind, Placebo-controlled Trial on the Effectiveness and Safety of Dapagliflozin for Blood Glucose Control During Glucocorticoid Treatment for Acute Exacerbation COPD [NCT02253121]Phase 446 participants (Actual)Interventional2015-02-28Completed
A Pilot Study of the Effect of Continuous Subcutaneous Insulin Infusion in Adolescents With Newly-diagnosed Type 1 Diabetes on Insulin Resistance, Beta-cell Function and the Honeymoon Period. [NCT00357890]12 participants (Actual)Interventional2005-12-31Completed
"Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The CGM-IBC Study" [NCT05229445]27 participants (Actual)Interventional2022-07-05Completed
Tight Glycemic Control and Insulin Administration During Parenteral Nutrition, in Critical Ill Patients [NCT02035943]20 participants (Actual)Interventional2008-01-31Completed
Comparison of Continuous Subcutaneous Insulin Infusion (CSII) With Multiple Daily Injections (MDI) for the Treatment of Pregestational Diabetes During Pregnancy [NCT02064023]2 participants (Actual)Interventional2014-04-30Terminated(stopped due to Some sites withdrew because no contract with insulin pump supplier)
Research on Clinical Application of New Therapies for Diabetes and Its Complications and Related Translational Medicine Research [NCT04975022]Phase 112 participants (Actual)Interventional2019-12-10Completed
A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study to Compare the Efficacy and Safety of Insulin Degludec Injection Versus Tresiba® in Subjects With Type 2 Diabetes [NCT04955834]Phase 3344 participants (Anticipated)Interventional2021-07-27Recruiting
INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi [NCT04945070]Phase 496 participants (Anticipated)Interventional2021-07-31Recruiting
Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life in Type 1 Diabetic Patients With Continuous Glucose Monitoring (CGM) [NCT04939766]250 participants (Anticipated)Interventional2021-06-30Not yet recruiting
Optimal Insulin Correction Factor in Post- High Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes: The FIT Study [NCT03057470]Phase 418 participants (Anticipated)Interventional2016-05-31Recruiting
The Relationship Between Coronavirus Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome [NCT04912934]214 participants (Actual)Observational2020-06-20Completed
A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen. [NCT03220425]Phase 3752 participants (Actual)Interventional2001-02-01Completed
A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR341402 to NovoRapid® and NovoLog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus [NCT03202875]Phase 130 participants (Actual)Interventional2012-11-14Completed
Explore the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin in Chinese Type 2 Diabetes by CGMS [NCT02438397]Phase 480 participants (Anticipated)Interventional2014-12-31Recruiting
Effects of Topical Insulin on Levels of Tear Inflammatory Mediators Compared to Standard Artificial Tears and Normal Saline in Diabetics With Dry Eye Disease [NCT04877210]Phase 160 participants (Anticipated)Interventional2020-10-22Recruiting
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes [NCT02146651]Phase 238 participants (Actual)Interventional2014-05-31Completed
Diabeloop WP6-1 : Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital [NCT02101229]Phase 2/Phase 317 participants (Actual)Interventional2014-05-31Completed
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial [NCT03862716]Phase 3159 participants (Actual)Interventional2019-04-23Completed
Effect of Preoperative Oral Carbohydrates on Postoperative Nausea and Vomiting and Quality of Recovery in DM Patients Undergoing Total Knee Arthroplasty [NCT02432781]82 participants (Actual)Interventional2015-06-25Completed
Effects of Degludec/Liraglutide on Time in Range, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates [NCT05360537]Phase 4100 participants (Actual)Interventional2021-04-01Completed
A Randomised, Three-period Crossover Trial in Healthy Subjects Investigating the Relationship Between the Pharmacodynamic Steady State and the Pharmacokinetic Steady State in the Interstitial Fluid Following iv Infusion of Insulin Detemir and Human Insuli [NCT02162407]Phase 113 participants (Actual)Interventional1999-10-31Completed
A Randomized Controlled, Open-label, Multi-center Study With 104-week Saxagliptin or (and) Vitamin D3 Assessing Protective Effects on Beta Cell Function in Latent Autoimmune Diabetes in Adults (LADA) Treated With Metformin (and Insulin) [NCT02407899]Phase 4300 participants (Actual)Interventional2015-03-31Completed
Health Status of Children Born After Assisted Reproductive Technologies With the Development of Prediction Model and Principles of Child Management. [NCT06094998]252 participants (Anticipated)Observational2023-10-23Recruiting
Interdisciplinary Care for the Patient With Type 2 Diabetes: Promoting Improvement in the Quality of Care at an Outpatient Level and Seeking Answers to Clinical Practice Questions - Reuse of Inputs and Placebo Intervention Effects [NCT05407233]71 participants (Actual)Interventional2019-10-14Completed
A Pilot Study to Evaluate Eli Lilly's Insulin Dosing Algorithm to Control Glycemia in Insulin-treated Adults With Type 2 Diabetes [NCT05514080]10 participants (Actual)Interventional2019-12-06Completed
Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting [NCT02189395]Phase 452 participants (Actual)Interventional2013-04-30Terminated(stopped due to difficulty in subject recruitment)
Safety and Efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial [NCT02561078]Phase 3420 participants (Actual)Interventional2015-10-20Completed
An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes [NCT00527397]Phase 324 participants (Actual)Interventional2007-08-31Terminated(stopped due to See termination reason in detailed description.)
Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes [NCT00487240]Phase 3387 participants (Actual)Interventional2007-06-30Completed
The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality [NCT00487162]56 participants (Actual)Interventional2007-06-30Terminated(stopped due to potential harm of insulin infusion outweights the benefit.)
Intravenous Insulin Protocol in Diabetes and Renal Transplantation Study [NCT00609986]104 participants (Actual)Interventional2007-07-31Completed
A 32-week National, Single-centre, Open-labelled, Randomised, Crossover Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-Bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes [NCT00509925]Phase 423 participants (Actual)Interventional2007-07-31Terminated(stopped due to See detailed description)
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes [NCT01028404]Phase 184 participants (Actual)Interventional2009-11-30Completed
An Open-Label, Randomized, Two-Period, Crossover Study to Characterize the Insulin Exposure and Glucose Response to Meals in Type 1 Diabetic Subjects Administered Two Different Insulin Regimens Compared to the Endogenous Insulin Exposure and Glucose Respo [NCT00927524]24 participants (Actual)Interventional2005-04-30Completed
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG): Effects of ESG on Non-Alcoholic Steatohepatitis (NASH) and Portal Pressure Gradient in Patients With Obesity and NASH With Advanced Fibrosis [NCT04820036]12 participants (Anticipated)Interventional2021-05-06Recruiting
A Canadian, Phase IV, Multicenter, Comparative, Open-label Study Evaluating 2 Approaches of Blood Glucose Monitoring and Insulin Titration (Patient-managed vs Health Care Professional) in T2DM Patients While Receiving the Addition of 1 Injection of Insuli [NCT01013571]Phase 4493 participants (Actual)Interventional2009-10-31Completed
A Study Investigating the Pharmacokinetic Properties of Insulin Icodec in Children and Adolescents With Type 2 Diabetes [NCT05790681]Phase 116 participants (Anticipated)Interventional2023-04-25Recruiting
Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication [NCT00548808]Phase 4426 participants (Actual)Interventional2007-11-30Completed
Insulin Dose Titration System in Diabetic Patients Using a Short Messaging Service Automatically Produced by a Knowledge Matrix [NCT00948584]100 participants (Actual)Interventional2007-11-30Completed
Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled [NCT00949442]Phase 4708 participants (Actual)Interventional2009-07-31Completed
Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone in the Early Management of Acute Coronary Syndrome: Randomised Controlled Study [NCT00965406]Phase 3772 participants (Actual)Interventional2010-08-31Completed
A Comparison of the Pharmacodynamic and Pharmacokinetic Properties of Oral Insulin vs. s.c. Regular Insulin in Type 2 Diabetic Patients [NCT00982254]Phase 110 participants (Actual)Interventional2001-10-31Completed
A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal Hepatic Function [NCT00976326]Phase 112 participants (Actual)Interventional2009-08-31Completed
Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children [NCT04600648]0 participants (Actual)Interventional2018-09-20Withdrawn(stopped due to poor enrollment)
A Pilot Study of Intensive Insulin Regimen as a Primary Treatment of New Onset of Type 2 DM [NCT01087567]Phase 423 participants (Actual)Interventional2010-07-31Completed
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 in Young and Geriatric Subjects With Type 1 Diabetes [NCT00964418]Phase 127 participants (Actual)Interventional2009-08-31Completed
Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine [NCT00964574]Phase 468 participants (Actual)Interventional2009-07-31Completed
A Trial Assessing the Number of Hypoglycaemic Episodes and Glycaemic Variability During Two Different Regimens of SIBA 200 U/ml in Subjects With Type 1 Diabetes [NCT00964964]Phase 118 participants (Actual)Interventional2009-08-31Completed
A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects [NCT00966368]Phase 127 participants (Actual)Interventional2009-08-31Completed
Open Randomised, Two Period Cross-over Study to Assess the Feasibility, Efficacy and Safety of Automated Closed-loop Glucose Control Initiated at the Time of Dinner or Before Sleep in Children and Adolescents With Type 1 Diabetes [NCT00989898]16 participants (Actual)Interventional2009-02-28Completed
A Double-Blind Two Part Placebo-Controlled Study Consisting of a Single Ascending and Multiple-Dose Tolerance Study of Peroral Insulin in Patients With Type 2 Diabetes [NCT00990444]Phase 1/Phase 232 participants (Anticipated)Interventional2009-09-30Suspended
A Randomized Single Center Double Blind 2 Period Crossover Glucose Clamp Study to Test for Bioequivalence Between 2 Recombinant Human Isophane Insulins Wockhardt's Human Isophane Insulin Injection100IU/ml With Novolin N in Healthy Subjects [NCT00772265]Phase 156 participants (Actual)Interventional2010-09-30Completed
Outcome of Using Long Acting Glargine Insulin With Low Dose Regular Insulin Infusion in Diabetic Ketoacidosis Patients :A Comparative Study [NCT05219942]52 participants (Anticipated)Interventional2020-12-01Recruiting
The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism [NCT01564550]30 participants (Actual)Observational2012-11-30Completed
Evaluation of User Satisfaction Using the ADI Insulin Pump [NCT00797771]20 participants (Anticipated)Interventional2008-12-31Completed
A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections [NCT01045954]50 participants (Anticipated)Interventional2010-01-31Recruiting
A Randomised, Parallel-group, Open-labelled, Multinational Trial Comparing the Efficacy and Safety of Insulin Detemir (Levemir®) Versus Human Insulin (NPH Insulin), Used in Combination With Insulin Aspart as Bolus Insulin, in the Treatment of Pregnant Wom [NCT00474045]Phase 3470 participants (Actual)Interventional2007-05-31Completed
Pathogenesis of the Impaired Incretin Effect in Type 2 Diabetes [NCT00469833]17 participants (Actual)Interventional2008-04-30Completed
A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes [NCT00467649]Phase 4112 participants (Actual)Interventional2007-05-31Completed
A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes [NCT00993096]Phase 133 participants (Actual)Interventional2009-09-30Completed
Phase 2, Double-Blind Randomized, 3-way Cross-Over Liquid Meal Study With Optimal Doses of SC Administered Insulin Lispro With and Without rHuPH20 and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Opti [NCT00916357]Phase 223 participants (Actual)Interventional2009-07-31Completed
A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes [NCT01002768]Phase 128 participants (Actual)Interventional2009-10-31Completed
Impact of Tight Blood Glucose Control Within Normal Fasting Ranges With Insulin Titration Prescribed by the Leuven Algorithm in Adult Critically Ill Patients [NCT03665207]Phase 39,230 participants (Actual)Interventional2018-09-18Active, not recruiting
A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled [NCT00437489]Phase 449 participants (Actual)Interventional2007-06-30Terminated(stopped due to This protocol was terminated not for safety reasons, but because Pfizer decided to return the worldwide rights for Exubera to Nektar, on 18 October 2007.)
An Open-Label, Phase 2, Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus Participating in Extension Protocols 217-102, 103, or 104 [NCT00143247]Phase 2173 participants (Actual)Interventional2003-03-31Terminated(stopped due to See termination reason in detailed description.)
Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes [NCT04020445]150 participants (Actual)Observational2016-01-01Completed
Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation [NCT03522181]80 participants (Actual)Interventional2016-02-29Completed
Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration: Evaluation of a Novel Single-Port Treatment Approach in Type 1 Diabetic Patients During a 1-Day Stay in a Clinical Research Center and a 6-Day Period at Home [NCT02359617]10 participants (Actual)Interventional2013-02-28Completed
Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus [NCT00607087]Phase 4289 participants (Actual)Interventional2008-01-31Completed
A Comparison of Two Sensor-Augmented Glycemic Control Systems in Persons With Type 1 Diabetes Mellitus: Subcutaneous (SC) Insulin and Glucagon Delivery vs. SC Insulin Only [NCT00797823]Phase 214 participants (Actual)Interventional2008-11-30Completed
Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus [NCT00604253]Phase 3362 participants (Actual)Interventional2003-12-31Completed
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®. [NCT02821052]1,355 participants (Actual)Observational2016-07-01Completed
A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a [NCT02739906]Phase 1/Phase 236 participants (Actual)Interventional2016-04-30Completed
The Impact of the Overnight Closed Loop System on Glycemia, Subsequent Day-time Metabolic Control, Insulin Delivery, Counter Regulatory Hormones, Sleep Quality, Cognition and Satisfaction With Treatment, Compared to Open Loop System (Sensor Augmented Pump [NCT02040571]28 participants (Actual)Interventional2014-01-31Completed
An Evaluation of the Tandem IQ Insulin Pump and DEXCOM G6 Continuous Blood Glucose Monitoring Hybrid Closed Loop Insulin Delivery System (Control-IQ) on Patient Wellbeing and Diabetes Control in Adults With Type 1 Diabetes [NCT05059860]30 participants (Anticipated)Observational2023-06-09Recruiting
A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension Assessing Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for Preservation of Pancreatic β-cell Function in Adu [NCT06111586]Phase 2192 participants (Anticipated)Interventional2023-12-11Recruiting
[NCT00232375]42 participants Interventional1996-01-31Completed
Assessment of Changes in Liver Fibrosis and Stiffness, Lipid Profile and Insulin Resistance in Patients With Chronic Hepatitis C Viral Infection Who Received Direct Acting Antiviral Therapy [NCT03612973]80 participants (Actual)Interventional2019-06-01Completed
Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke [NCT00472381]Phase 2/Phase 3180 participants (Actual)Interventional2007-05-31Completed
Pharmacodynamic and Pharmacokinetic Properties of Insulin Aspart: Dose - Ranging vs. Human Soluble Insulin [NCT00513643]Phase 116 participants (Actual)Interventional2002-04-30Completed
A Randomised, Single Centre, Double-blind, Two-period Crossover, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin 454 Formulations, With or Without Buffer, and Between Two SIAC Formulations, With or Without Buffer, in Healthy Male Subjec [NCT01868581]Phase 158 participants (Actual)Interventional2008-05-31Completed
Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study) [NCT01914146]0 participants (Actual)Interventional2015-04-30Withdrawn(stopped due to Study was changed to Insulin, hypotension and sarcopenia)
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects [NCT01916174]Phase 150 participants (Actual)Interventional2013-08-31Completed
A Study Investigating the Pharmacokinetic Properties of a Single Dose of IcoSema Compared With Insulin Icodec and Semaglutide Given Separately in Chinese Participants With Type 2 Diabetes [NCT05435677]Phase 120 participants (Actual)Interventional2022-06-22Completed
Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial [NCT00424333]Phase 3320 participants Interventional1999-05-31Completed
An Open-Label Treatment Investigational New Drug (IND) for the Use of Generex Oral-lyn™ in Patients With Type 1 or Type 2 Diabetes Mellitus [NCT00948493]0 participants Expanded AccessNo longer available
An Open-label, Randomized, Four-way, Cross-over Study to Examine the Efficacy of Single-hormone Closed-loop System in Regulating Glucose Levels in Adults With Type 1 Diabetes Following Meals of Various Macronutrient Contents: a Pilot Study [NCT02774876]Phase 215 participants (Actual)Interventional2016-06-30Completed
Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of Technosphere®/Insulin in Subjects With Diabetes Mellitus After a Meal Challenge [NCT00642681]20 participants (Actual)Observational2007-12-31Completed
Assessment of the Impact of Food Carbohydrate and Insulin Dose Computing by an Application on Smart Phone on Glucose Control in Patients With Type 1 Diabetes [NCT02676609]30 participants (Actual)Interventional2016-02-29Completed
A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine With Metformin in Japanese Patients With Type 2 Diabetes Mellitus In [NCT02752412]Phase 3513 participants (Actual)Interventional2016-05-17Completed
A Pilot Study Evaluating the Safety and Performance of an Artificial Pancreas With Carbohydrate Suggestion for Patients With Type 1 Diabetes Prone to Hypoglycemia [NCT05628662]12 participants (Actual)Interventional2021-10-22Completed
A Randomised, 2-period Cross-over Study to Assess the Feasibility of Overnight Computer-based Glucose Control Based on Continuous Subcutaneous Glucose Monitoring, and Compare it With Conventional Pump Therapy in Adults With Type 1 Diabetes [NCT00910767]12 participants (Actual)Interventional2009-02-28Completed
Natriuretic Peptides and Metabolic Risk in Obesity [NCT02642523]Early Phase 10 participants (Actual)InterventionalWithdrawn(stopped due to Preliminary data run on rat samples showed that this study question and design would not produce conclusive results. The PI decided not to carry out the study.)
Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections [NCT05201846]66 participants (Anticipated)Interventional2022-01-18Recruiting
An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 12 Days in Free-living Outpatient Conditions in Patients With Type 1 Diab [NCT02846831]Phase 236 participants (Actual)Interventional2019-01-24Completed
"A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of Insulin Aspart (LLC GEROPHARM, Russia) Versus NovoRapid® Penfill® (Novo Nordisk) in Healthy Subjects Using the Euglycemic Clamp Technique" [NCT04184466]26 participants (Actual)Interventional2018-10-18Completed
A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects [NCT02660502]Phase 115 participants (Actual)Interventional2016-01-31Completed
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes [NCT05362058]Phase 3912 participants (Anticipated)Interventional2022-06-03Active, not recruiting
A Physician-Initiated Randomised, Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine Transdermal Human Insulin In Adult Healthy Volunteer Patients [NCT04857320]Early Phase 17 participants (Actual)Interventional2021-03-12Completed
A Phase 2 Randomized, Open Label Crossover Study to Compare ORMD-0801 Given Once Daily at Bedtime to ORMD-0801 Given Three Times Daily (45-90 Minutes Before Meals) in Subjects With Type 1 Diabetes [NCT04150107]Phase 230 participants (Actual)Interventional2019-10-17Completed
Effect of Dosage Reduction of Glucose-Lowering Multidrug Regimens on the Incidence of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: An Open-Label, Parallel-Group, Randomized, Controlled Trial [NCT04237493]Phase 4687 participants (Actual)Interventional2017-02-14Completed
"A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of GP-40081 (LLC GEROPHARM, Russia) Versus NovoMix® 30 Penfill® (Novo Nordisk) in Healthy Subjects Using the Euglycemic Clamp Technique" [NCT04184492]34 participants (Actual)Interventional2019-04-15Completed
A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Insulin-naïve Subjects With Type 2 Diabetes Mellitus [NCT03951805]Phase 2205 participants (Actual)Interventional2019-05-09Completed
Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec: a Retrospective Study [NCT05434559]475 participants (Actual)Observational2022-02-20Completed
Effectiveness and Safety of Insulin Faster Aspart on Continuous Subcutaneous Insulin Infusion Treated Adult Type 1 Diabetes Mellitus Patients in Routine Clinical Practice [NCT04233203]48 participants (Actual)Observational2020-01-31Completed
Effects of Pulsatile Intravenous Insulin Therapy on Diabetic Subjects With Non Healing Wounds [NCT00967837]Phase 2/Phase 3152 participants (Actual)Interventional2006-01-31Terminated(stopped due to Administrative)
Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon [NCT02632032]46 participants (Actual)Interventional2013-07-31Completed
Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-related and General Health-related Quality of Li [NCT00665808]8,125 participants (Actual)Observational2007-10-31Completed
Ketoacidosis in Individuals With T1DM [NCT00970567]19 participants (Actual)Interventional2007-11-30Completed
Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily [NCT00971659]Phase 148 participants (Actual)Interventional2008-01-31Completed
The Effect of Tresiba® (Insulin Degludec) in Type 2 Diabetes Patients in Real World Clinical Practice in China - Noninterventional, Retrospective Chart Review Study [NCT04227431]938 participants (Actual)Observational2020-01-17Completed
"An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40081 (OOO GEROPHARM, Russia) Compared to NovoMix® 30 FlexPen® (Novo Nordisk A/S, Denmark) in Type 2 Diabetes Mellitus Patients" [NCT04226105]Phase 3264 participants (Anticipated)Interventional2020-01-20Active, not recruiting
A 26-Week, Open-Label, Randomized, Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin In Subjects With Type-1 Diabetes Mellitus [NCT00668850]Phase 3500 participants (Anticipated)Interventional2008-04-30Active, not recruiting
Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus [NCT00670722]6,500 participants (Actual)Observational2008-01-31Completed
Examining the Neural Correlates of Memory in Response to Intranasal Insulin Through fMRI & Device Testing [NCT02758691]Phase 145 participants (Actual)Interventional2015-12-31Completed
Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents [NCT00715780]1,667 participants (Actual)Observational2008-06-30Completed
Insulin and Sarcopenia in the Elderly [NCT00690534]Phase 188 participants (Actual)Interventional2005-09-30Completed
Effects of a Fixed Low Dose Growth Hormone Therapy on Insulin Sensitivity, Metabolic Profile, Adipocyte IGF-I and Insulin Signalling, Intramyocellular and Intrahepatic Lipids, and Cortisol Metabolism in Subjects With Metabolic Syndrome. [NCT00720616]0 participants (Actual)Interventional2010-10-31Withdrawn
To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion [NCT00441129]115 participants (Actual)Interventional2006-06-30Completed
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese Subjects With Type 1 Diabetes [NCT01051102]Phase 121 participants (Actual)Interventional2010-01-31Completed
Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study [NCT00841919]Phase 460 participants (Anticipated)Interventional2006-12-31Completed
Efficacy of a Continuous GLP-1 Infusion in Comparison to a Structured Insulin Infusion Protocol to Reach Normoglycemia in Non-Fasted Type 2 Diabetic Patients [NCT00859079]Phase 48 participants (Actual)Interventional2006-06-30Completed
Effects of Pulsatile Intravenous Insulin Delivery on Hypoglycemic Unawareness [NCT01029639]Phase 2/Phase 30 participants (Actual)Interventional2007-01-31Withdrawn(stopped due to Administrative)
A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Bioequivalence Study Comparing Two Formulations of Insulin Glulisine (Insulin Glulisine 300 Units/mL Versus Insulin Glulisine 100 Units/mL Marketed as Apidra® 100 Units/m [NCT02910518]Phase 144 participants (Actual)Interventional2017-02-17Completed
"Effect of Weekly GLP1 Agonist Treatment in Double Diabetes: a Randomized Open-label Study" [NCT05305794]Phase 376 participants (Anticipated)Interventional2022-07-12Recruiting
A Multi-center, Randomized, Open-label, Parallel-group, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Insulin Aspart Injection in Patients With Diabetes Mellitus Compared to NovoRapid® [NCT02491528]Phase 3563 participants (Actual)Interventional2015-06-19Completed
Comparative Study of the Pharmacokinetics and Pharmacodynamics of Rinsulin® R, Solution for Injection, 100 IU/ml (GEROPHARM LLC) and Humulin® Regular, Solution for Injection, 100 IU/ml (Eli Lilly) in Euglycemic Hyperinsulinemic Clamp Method [NCT06050343]20 participants (Actual)Interventional2018-02-19Completed
Evaluation of Dual-hormone Artificial Pancreas With Closed-loop Glucose Control Versus Single-hormone With Carbohydrate Recommendations Under Unannounced Exercise and Meal Challenge in Adults With Type 1 Diabetes. [NCT06082973]15 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM [NCT05714059]250 participants (Actual)Interventional2023-02-28Active, not recruiting
Study of Nasal Insulin to Fight Forgetfulness - Combination Intranasal Insulin and Empagliflozin Trial [NCT05081219]Phase 260 participants (Anticipated)Interventional2021-10-14Recruiting
Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting? [NCT00899483]100 participants (Anticipated)Interventional2009-07-31Not yet recruiting
Enhancement of Glucagon Counterregulation in Type 1 Diabetes by Basal Amylin Replacement [NCT03547427]13 participants (Actual)Interventional2018-05-20Terminated(stopped due to Clinical staffing issues and COVID-19 pandemic)
Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes [NCT00564395]Phase 418 participants (Actual)Interventional2007-08-31Completed
Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen [NCT02991365]40 participants (Anticipated)Interventional2016-12-31Recruiting
A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basa [NCT00308308]Phase 3589 participants (Actual)Interventional2006-02-28Completed
"An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Rinsulin® NPH (Geropharm, Russia) With Humulin® NPH (Lilly France, France) in Type 2 Diabetes Mellitus Patients" [NCT04012775]Phase 3201 participants (Actual)Interventional2017-04-20Completed
Phase IV Study to Compare the Accuracy and Precission of Five Different Home Glucose Monitors;Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart [NCT01013402]Phase 451 participants (Actual)Interventional2008-12-31Completed
A Comparison of Insulin Lispro MM Intensive Mixture Therapy With Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70 [NCT00393705]Phase 4302 participants (Actual)Interventional2006-10-31Completed
A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Met [NCT00332488]Phase 3547 participants (Actual)Interventional2004-12-31Completed
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin [NCT00941369]Phase 4345 participants (Actual)Interventional2009-06-30Completed
Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia [NCT00943709]Phase 30 participants (Actual)Interventional2009-05-31Withdrawn(stopped due to lack of accrual)
Effects of Different Insulin Regimens on Artery Compliance, Endothelium Function and Autonomic Cardiac Function in Patients With Poorly Controlled Type 2 Diabetes: a Pilot Study [NCT01022658]42 participants (Actual)Interventional2010-01-31Completed
Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance [NCT04010903]330 participants (Anticipated)Interventional2019-09-16Recruiting
Comparison of a Basal Plus One Insulin Regimen (Insulin Glargine/Insulin Glulisine) With a Biphasic Insulin Regimen (Insulin Aspart/Insulin Aspart Protamine 30/70) in Type 2 Diabetes Patients Following Basal Insulin Optimisation [NCT00965549]Phase 4463 participants (Actual)Interventional2009-07-31Completed
A Randomized Study to Evaluate the Efficacy and Acceptability of Laparoscopic Placement of Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients Sub-optimally Controlled With Oral Anti-diabetic Agents. [NCT00975533]Phase 324 participants (Anticipated)Interventional2009-10-31Not yet recruiting
An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform [NCT04007003]170 participants (Actual)Interventional2018-06-26Terminated(stopped due to Sponsor decision)
Newly Diagnosed Hyperglycemia and Stress Hyperglycemia in a Coronary Intensive Care Unit [NCT00984737]0 participants Interventional2007-05-31Completed
A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects [NCT00983021]Phase 124 participants (Actual)Interventional2009-09-30Completed
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes [NCT01030926]Phase 139 participants (Actual)Interventional2009-12-31Completed
A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus [NCT00356421]Phase 458 participants (Actual)Interventional2006-11-30Terminated(stopped due to See termination reason in detailed description.)
A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product [NCT03544996]1 participants (Actual)Observational2017-09-09Completed
A Prospective, Single Center, Post-Market Observational Study to Assess the Efficacy, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus [NCT02158078]8 participants (Actual)Observational2014-06-30Terminated(stopped due to Terminated to allow continued optimization of the product.)
A Phase 2a, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study to Compare Safety, Efficacy, and Pharmacodynamics of Single and Multiple Doses of ORMD-0801 in Adult Subjects With Type 2 Diabetes Mellitus [NCT02954601]Phase 231 participants (Actual)Interventional2016-10-31Completed
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes BOOST: INTENSIFY PREMIX/ALL 2 [NCT02762578]Phase 3543 participants (Actual)Interventional2016-05-03Completed
A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus [NCT02273258]Phase 130 participants (Actual)Interventional2013-03-31Completed
Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes [NCT00619697]Phase 4260 participants (Actual)Interventional2003-12-31Completed
Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes [NCT00698802]Phase 2397 participants (Actual)Interventional2008-06-30Completed
A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin [NCT00623194]Phase 3146 participants (Actual)Interventional2008-02-29Completed
A Randomised, Open-labelled, 2-period Crossover Trial Investigating Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 Thrice Daily and Basal-bolus Therapy With Insulin Glargine & Insulin Glulisine in Subjects With Type 2 Diabetes [NCT00824668]Phase 124 participants (Actual)Interventional2007-08-31Completed
Tight Glycemic Control During Angioplasty Revascularization for Acute Coronary Syndrome Reduces Circulating Inflammatory Cytokines and Coronary Stent Restenosis [NCT01016509]200 participants (Actual)Interventional2009-12-31Completed
Heart & Diabetes - Feasibility Study [NCT00922402]0 participants (Actual)Interventional2009-06-30Withdrawn
The Effect of Insulin-Glucose Infusion on Metabolic Control (Primary) and Inflammation (Secondary) in Diabetic Patients Treated for Acute Foot Ulcer Infection or Surgical Wound Infection [NCT00700362]0 participants (Actual)Observational2011-12-31Withdrawn(stopped due to Local regulations)
A Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients [NCT00834262]339 participants (Actual)Observational2009-04-30Completed
Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial. [NCT02685449]Phase 470 participants (Anticipated)Interventional2016-02-29Recruiting
An International Multicentre Randomized Controlled Trial of Intensive Insulin Therapy Targeting Normoglycemia In Acute Myocardial Infarction: the RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia) Pilot Study [NCT00640991]Phase 3500 participants (Anticipated)Interventional2008-04-30Completed
A Multi-center, Open, Randomized, Parallel-group, 2 Arm Study to Compare the Efficacy and Safety of Amaryl®M 1/500mg Twice Daily Versus Amaryl® 4mg Both in Combination With Lantus® Once-daily Regimen in Type 2 Diabetes Mellitus Patients With Inadequate Gl [NCT00913367]Phase 4110 participants (Anticipated)Interventional2009-05-31Completed
Study of Minimed 640G Insulin Pump With SmartGuard in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia [NCT02657213]20 participants (Actual)Interventional2016-02-29Completed
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study [NCT00698126]4,099 participants (Actual)Observational2007-10-31Completed
A Doctor and Nurse Survey on Using NovoLet® Within the Hospital Practice in Indonesia [NCT01492205]203 participants (Actual)Observational2005-09-30Completed
The Effect of Insulin Infusion on Metabolic Control and Inflammation in Diabetic Patients During Cardio-vascular Intervention and/or Treatment for Acute Foot Ulcer Infection. [NCT00700154]40 participants (Actual)Interventional2011-11-30Terminated(stopped due to participants are no longer being examined or receiving intervention)
Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients [NCT02956655]60 participants (Anticipated)Interventional2016-07-31Recruiting
Evaluation of Glycemic Control and User Acceptability of the BD Ultra-Fine Nano 4 mm x 32G Pen Needle for Injection of Long-acting or Basal Insulin Doses Above 40 Units [NCT01334606]21 participants (Actual)Interventional2011-03-31Terminated(stopped due to This study was terminated due to unanticipated recruitment difficulties.)
A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus [NCT04450394]Phase 2278 participants (Actual)Interventional2020-07-01Completed
Short and Long Term Effects of a Dypeptidil-peptidase-4 Versus Bedtime NPH Insulin as add-on Therapy in Patients With Type 2 Diabetes [NCT02607410]Phase 440 participants (Actual)Interventional2010-01-31Completed
Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study B [NCT00858273]41 participants (Actual)Interventional2008-03-31Completed
RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery) [NCT00596687]Phase 4234 participants (Actual)Interventional2007-12-31Completed
A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus [NCT00447213]Phase 2/Phase 370 participants (Actual)Interventional2007-04-30Completed
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin [NCT00824616]Phase 268 participants (Actual)Interventional2009-01-31Completed
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia [NCT00665093]1,569 participants (Actual)Observational2007-05-31Completed
Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study) [NCT00443599]989 participants (Actual)Interventional2006-11-30Completed
A Comparison of PK/PD Dose Response Characteristics of Glargine in Type 2 Diabetics [NCT00574912]Phase 120 participants (Actual)Interventional2007-03-31Completed
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study of the Safety of TAK-559 in the Treatment of Patients With Type 2 Diabetes Mellitus [NCT00762190]Phase 3348 participants (Actual)Interventional2003-11-30Terminated(stopped due to Hepatic safety signal identified.)
Pilot Study for Evaluation of the Impact of Pulsatile Insulin Infusion Therapy on Vascular Function in Patients With Type 1 and Type 2 Diabetes Mellitus [NCT04030091]Phase 424 participants (Actual)Interventional2019-09-06Completed
A Multi-center, Phase 3b, Stratified, Randomized, Open-label Clinical Trial to Evaluate the Efficacy of Intensive Apidra®/Lantus® Therapy vs Sliding Scale Insulin on Infarct Size in Hyperglycemic Subjects With Anterior STEMI (ST Elevation Myocardial Infar [NCT00670228]Phase 334 participants (Actual)Interventional2008-04-30Terminated(stopped due to Due to Negative feasibility assessment of recruiting the planned number of subjects within the study timelines)
Autologous Bone Marrow Mononuclear Cell Infusion With Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus [NCT00767260]Phase 1/Phase 282 participants (Actual)Interventional2008-03-31Completed
A Randomized, Single-center, Double-blind, 2-period Crossover, Euglycemic Glucose Clamp Study in Healthy Subjects to Demonstrate PK and PD Equivalence of Julphar Insulin R and Huminsulin® Normal [NCT02634515]Phase 126 participants (Actual)Interventional2014-12-31Completed
Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes [NCT00922649]58 participants (Actual)Interventional2008-02-01Completed
Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome [NCT04142411]Early Phase 190 participants (Anticipated)Interventional2019-11-30Not yet recruiting
A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes [NCT00666718]Phase 3374 participants (Actual)Interventional2008-04-30Completed
Phase II Study Evaluating Pharmacokinetics and Postprandial Glycemic Response of Subcutaneously Injected Humalog and Humulin R With/Without Co-Injected Recombinant Human Hyaluronidase Following Liquid Meal in Type1 Diabetes Mellitus Patients [NCT00774800]Phase 222 participants (Actual)Interventional2008-10-31Completed
Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast [NCT00664534]Phase 4344 participants (Actual)Interventional2008-04-30Completed
Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy [NCT00287651]Phase 2/Phase 3150 participants (Actual)Interventional2005-11-30Terminated(stopped due to Administrative)
The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery [NCT00788242]200 participants (Actual)Interventional2009-01-31Completed
Comparative Trial Between Computer-Guided Intravenous Infusion Protocol Versus a Standard Insulin Infusion Algorithm Versus a Simple Calculated Infusion Protocol in Medical and Surgical ICU [NCT00582309]151 participants (Actual)Interventional2007-08-31Completed
An Extension Study of AGT-181-102 Evaluating Safety and Glycosaminoglycans (GAGs) in Adult Patients With Hurler-Scheie or Scheie Syndrome Who Have Completed 8-Weeks of Dosing With AGT-181 in Study AGT-181-102 [NCT02597114]Phase 13 participants (Actual)Interventional2015-11-30Completed
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes [NCT00435019]Phase 3348 participants (Actual)Interventional2007-02-28Completed
Phase 4 Study of Comparison of Combination Therapy of Gliclazide MR and Basal Insulin With Pre-mix Insulin Monotherapy for the Patients With Type 2 Diabetes Mellitus [NCT00736515]Phase 4160 participants (Actual)Interventional2008-10-31Completed
Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm [NCT00541515]38 participants (Actual)Interventional2007-10-31Completed
Abatacept Combined With Nasal Insulin to Preserve Beta-cell Function in Recently-diagnosed Type 1 Diabetes [NCT05742243]Phase 262 participants (Anticipated)Interventional2023-02-13Recruiting
Advancing INSIGHT Methods in General Practice [NCT00593489]154 participants (Actual)Interventional2006-07-31Completed
A Multi-centre, Open-labelled, Randomised, Two-group Parallel Trial Comparing the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After 26 Weeks of Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily, B [NCT00795600]Phase 460 participants (Actual)Interventional2009-04-30Completed
A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030 [NCT00741429]649 participants (Actual)Observational2007-05-31Completed
A Phase 3, Open-label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder in Type 1 or Type 2 Diabetic Subjects With Obstructive Pulmonary Disease (Asthma or Chronic Obstructive Pulmonary Disease) Over a 12 Months [NCT00642616]Phase 334 participants (Actual)Interventional2009-03-31Terminated(stopped due to Terminated upon recommendation of the Data Safety Monitoring Board (DSMB))
Pharmacokinetics, Pharmacodynamic, Safety and Immunogenicity Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection ( Tresiba®）in Healthy Subjects: a Phase I Single-center, Randomized, Open-label, Single-dose, Cross-over Cl [NCT05576298]Phase 146 participants (Actual)Interventional2021-10-08Completed
Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Typ 2 [NCT00638209]42 participants (Anticipated)Interventional2008-02-29Recruiting
Early Metabolic Support as a Potential Solution to Multi-Organ Dysfunction Syndrome (MODS) During Severe Sepsis [NCT02885688]Phase 20 participants (Actual)Interventional2016-10-31Withdrawn
Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: Insulin-Glucose-Infusion Versus Observational Approach - Is There a Difference in Neonatal Hypoglycemia Rate? [NCT02590016]Phase 450 participants (Anticipated)Interventional2015-09-30Recruiting
Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes [NCT00469586]Phase 3174 participants (Actual)Interventional2007-04-26Terminated(stopped due to See termination reason in detailed description)
A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 [NCT02713477]Phase 120 participants (Actual)Interventional2016-04-30Completed
The Effect of Exenatide Compared to Insulin Glargine on Cardiac Function and Metabolism in Type 2 Diabetic Patients With Congestive Heart Failure: a Randomized Comparator-controlled Trial [NCT00766857]Phase 427 participants (Actual)Interventional2009-05-31Completed
Impact of Pioglitazone, Metformin and the Combination of Both on Cardiovascular Risk in Insulin-treated Patients With Type 2 Diabetes - The PIOcomb Study [NCT00770445]Phase 4121 participants (Actual)Interventional2008-05-31Completed
[NCT00570687]Phase 230 participants (Actual)Interventional2007-09-30Completed
A Phase 1b, Single-Dose, Open-Label, Parallel, Controlled Pharmacology Trial of Inhaled Technosphere®/Insulin in Non-Diabetic Subjects With COPD Versus Matched Non-Diabetic Subjects Without COPD. [NCT01021891]Phase 139 participants (Actual)Interventional2006-07-31Completed
NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401- [NCT00978627]Phase 3548 participants (Actual)Interventional2009-08-31Completed
The Importance of Insulin Timing in Type 1 Diabetes [NCT00789945]40 participants (Actual)Interventional2008-12-31Completed
Transport Von Peripheren Sättigungshormonen in Das Zentrale Nervensystem [NCT04038086]30 participants (Anticipated)Interventional2019-07-15Recruiting
Glucose Control In Hematopoetic Stem Cell Transplant [NCT00582036]11 participants (Actual)Interventional2007-02-28Terminated(stopped due to study terminated due to lack of enrollment)
A Multicentre, Open-label, Nonrandomised, Non-interventional, Observational Study to Compare Safety and Effectiveness of Biphasic Insulin Aspart 30 (NovoMix 30) and Insulin Detemir (Levemir) for the Treatment of Diabetes Mellitus [NCT00789711]3,131 participants (Actual)Observational2008-11-30Completed
Prevention of Clinical Onset of Type 1 Diabetes by Daily Administration of Metabolically Active Insulin in High Risk First Degree Relatives. [NCT00654121]Phase 2112 participants (Actual)Interventional2000-02-29Completed
Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial to Test Bioequivalence Between Two Recombinant Human Soluble Insulins - Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects [NCT00719108]Phase 142 participants (Actual)Interventional2008-07-31Completed
"A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of RinGlar® (LLC GEROPHARM, Russia) Versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients Using the Euglycemic Clamp Technique" [NCT04101383]42 participants (Actual)Interventional2017-10-16Completed
An Open-labelled, Randomised, Parallel Group, 3 Week run-in and 24 Week Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Chinese and Japanese Insul [NCT01123980]Phase 4521 participants (Actual)Interventional2010-05-31Completed
EFFECTS OF MOXIFLOXACIN AND GEMIFLOXACIN ON BLOOD GLUCOSE LEVEL OF EUGLYCEMICS:A PRE-CLINICAL AND CLINICAL STUDY [NCT04692623]Phase 125 participants (Actual)Interventional2021-03-01Completed
A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY) [NCT01135992]Phase 3143 participants (Actual)Interventional2010-06-30Completed
Insulin Therapy for Postreperfusion Hyperglycemia in Liver Transplantation [NCT03152890]Phase 420 participants (Anticipated)Interventional2017-05-15Recruiting
Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial [NCT02574156]Phase 3500 participants (Actual)Interventional2017-01-01Terminated(stopped due to Finished)
Randomised Trial to Investigate the Correlation Between the Interstitial and Arterial Blood Concentrations of Glucose During Subcutaneous Microdialysis Glucose Monitoring in Post Surgery Patients at the Intensive Care Unit. [NCT00733148]40 participants (Actual)Observational2004-07-31Completed
The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Stu [NCT00869908]66,726 participants (Actual)Observational2008-11-30Completed
Open-label, 3 Center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of 60 Hours Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy at T1D Patients at Home [NCT02636491]45 participants (Actual)Interventional2015-12-31Completed
Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction in Middle Aged Patients Undergoing Non Cadiac Surgery. [NCT04154449]57 participants (Anticipated)Observational2019-02-25Recruiting
An Open-Label, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus [NCT01109316]Phase 3132 participants (Actual)Interventional2010-04-30Completed
A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Ty [NCT00612040]Phase 2178 participants (Actual)Interventional2008-01-31Completed
A 16 Week Randomised, Open-labelled, Four-armed, Treat-to-target, Parallel-group Trial Comparing SIBA D Once Daily, SIBA E Once Daily, SIBA D Monday, Wednesday and Friday and Insulin Glargine Once Daily, All in Combination With Metformin in Subjects With [NCT00611884]Phase 2245 participants (Actual)Interventional2008-01-31Completed
Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart) or Levemir® (Insulin Detemir) - for Treatment of Diabetes Mellitus [NCT00676741]3,809 participants (Actual)Observational2008-02-29Completed
Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus [NCT00676819]Phase 419 participants (Actual)Interventional2002-01-10Completed
Evaluation of Glycemic Changes and Optimization of Glycemic Control During Exercise in Children With Type 1 Diabetes Under Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injection Regimen (MDI) (TREAD-DIAB Study) [NCT02824510]24 participants (Actual)Interventional2014-08-31Completed
A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens [NCT00606034]Phase 421 participants (Actual)Interventional2007-12-31Completed
A Phase 2, Randomized, Crossover Study to Evaluate the Effect of Intranasal Insulin and NovoLog on Postprandial Glycemic Control in Type 2 Diabetic Patients [NCT00624767]Phase 218 participants (Actual)Interventional2008-03-31Completed
An Exercise Intervention in Insulin-Resistant Minority Adolescents [NCT00906724]40 participants (Anticipated)Observational2005-03-31Active, not recruiting
Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic 6-Way Crossover Study of SC Administered Insulin Lispro With Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin With Recombinant Human Hyaluronidase (rHuPH20) Compared to [NCT00862849]Phase 122 participants (Actual)Interventional2009-03-31Completed
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes [NCT02855307]Phase 237 participants (Actual)Interventional2016-09-30Completed
An Observational Study of Glycemic Control and Cardiovascular Outcomes Among Patients With Type 2 Diabetes Newly Initiating Glucagon-like Peptide-1 Receptor Agonists (GLP1) Versus Basal Insulin in Routine Care Settings [NCT04034524]20,000 participants (Anticipated)Observational2019-05-01Active, not recruiting
Evaluation of the Efficacy and Safety of INS068 Injection and Insulin Degludec Subcutaneous Injection Once Daily in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With One or Two Oral Antidiabetics (A Randomized, Open-Label, Two-Arm, Tre [NCT04663282]Phase 2179 participants (Actual)Interventional2021-02-04Completed
Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus [NCT00698269]5,926 participants (Actual)Observational2008-02-29Completed
A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine on Top of OADs in Japanese Patients With Type 2 Diabetes Mellitus (T [NCT02752828]Phase 3521 participants (Actual)Interventional2016-05-23Completed
A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlle [NCT00391027]Phase 4261 participants (Actual)Interventional2006-12-31Completed
A Randomized, Double-blind, Single-dose, 2-treatment, 2-period, 2-sequence Crossover Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus [NCT03903016]Phase 190 participants (Actual)Interventional2019-03-26Completed
Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM) [NCT03436498]Phase 145 participants (Actual)Interventional2018-05-10Completed
Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy [NCT00625781]72 participants (Actual)Interventional2008-02-29Completed
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion [NCT03830281]Phase 3471 participants (Actual)Interventional2019-02-14Completed
Intranasal Insulin and Its Effect on Postprandial Glucose Metabolism in Comparison to Subcutaneous Insulin [NCT00850161]Phase 20 participants (Actual)Interventional2009-07-31Withdrawn(stopped due to Business purposes.)
The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy [NCT00686712]Phase 4108 participants (Actual)Interventional2003-02-28Completed
Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital [NCT02868606]40,391 participants (Actual)Observational2015-07-31Completed
Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING) [NCT00549887]2,459 participants (Actual)Observational2007-09-30Completed
A Prospective, Multi-center, Randomized, Open-label, Parallel Group Study to Evaluate Safety and Efficacy of Needle-free Injector Versus Insulin Pen in Patients With Type 2 Diabetes Mellitus [NCT04682795]200 participants (Anticipated)Interventional2021-09-01Recruiting
Impact of Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention [NCT04651842]240 participants (Actual)Observational2018-05-01Completed
Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism [NCT00862875]Phase 442 participants (Actual)Interventional2009-03-31Completed
Transition of Patients With T1D From Multiple Daily Injection (MDI) and Self-Monitoring of Blood Glucose (SMBG) Directly to MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) System :Impact on Glucose Control and Quality of Life Measures [NCT04616391]40 participants (Anticipated)Interventional2020-11-02Not yet recruiting
Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients [NCT00742976]Phase 424 participants (Actual)Interventional2008-06-30Completed
A Trial Investigating the Hypoglycaemic Response to Overdosing of NNC0148-0287 C (Insulin 287) in Subjects With Type 2 Diabetes [NCT03945656]Phase 143 participants (Actual)Interventional2019-05-07Completed
A Randomised Crossover Study Comparing Hybrid Closed-loop Insulin Delivery Using Ultra-rapid Acting Insulin to Hybrid Closed-loop Insulin Delivery Using Standard Rapid-acting Insulin in Children With Type 1 Diabetes in the Home Setting (FAST-Kids) [NCT04759144]27 participants (Actual)Interventional2021-03-12Completed
Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells on Autoimmune Diabetes [NCT02932826]Phase 1/Phase 240 participants (Anticipated)Interventional2016-10-31Recruiting
All to Target Trial Lantus® (Insulin Glargine) With Stepwise Addition of APIDRA® (Insulin Glulisine) or Lantus With One Injection of Apidra vs a Twice-Daily Premixed Insulin Regimen (Novolog® Mix 70/30) in Adult Subjects With Type 2 Diabetes Failing Dual [NCT00384085]Phase 4588 participants (Actual)Interventional2006-05-31Completed
A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatmen [NCT00614055]Phase 2178 participants (Actual)Interventional2008-01-31Completed
Tight Intra-Operative Glucose Control Using Continuous Insulin Infusion During Coronary Artery Bypass Surgery: Randomized Controlled Trial [NCT00394303]Phase 41,400 participants (Anticipated)Interventional2007-02-28Terminated(stopped due to Trial suspended on 26 February, following the publication of a trial with negative results (Ann Intern Med 146(4), 2007). Pending ethics committee re-approval.)
Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index Meal in Children With Type 1 Diabetes Mellitus- Randomized Study [NCT04019821]Phase 472 participants (Actual)Interventional2020-01-01Completed
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately [NCT05013229]Phase 3680 participants (Anticipated)Interventional2021-11-30Active, not recruiting
Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics [NCT02922179]103,951 participants (Actual)Observational2011-01-01Completed
A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia NIFT-D [NCT04115384]Phase 23 participants (Actual)Interventional2019-09-09Terminated(stopped due to COVID - unable to restart after restrictions were lifted)
Effect of Splitting Mealtime Insulin Doses Used for Mixed Meals High in Fat and Protein on Postprandial Blood Glucose Levels in Children and Adolescents With Type 1 Diabetes Mellitus Using Multiple Daily Injection Regimen [NCT04783376]Phase 443 participants (Actual)Interventional2021-04-12Completed
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Single-Center Randomized, Double-b [NCT05539872]Phase 2/Phase 369 participants (Actual)Interventional2022-08-22Completed
Randomized Trial of Liraglutide and Insulin Therapy on Hepatic Steatosis as Measured by MRI and MRS in Metformin-treated Patients With Type 2 Diabetes: an Open Pilot Study [NCT01399645]Phase 235 participants (Actual)Interventional2011-05-31Completed
PILGRIM - Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus Type II [NCT02036372]150 participants (Actual)Interventional2014-01-31Completed
The Effect of Food Content and Optimal Timing of Pre-meal Insulin Bolus on the Postprandial Glycemic Control in Children With Type 1 Diabetes [NCT01406496]24 participants (Anticipated)Interventional2011-08-31Recruiting
An Open, Single-centre, Controlled Trial to Investigate the Efficacy and Usability of Published Best Practice to Control Glycaemia in Hospitalised Patients With Type 2 Diabetes [NCT01407289]Phase 474 participants (Actual)Interventional2011-06-30Completed
Intravenous Insulin for 24 Hours in Patients With Diabetes Mellitus Submitted to Percutaneous Coronary Intervention With Stent: Effects Upon Oxidative Stress and Inflammatory Markers [NCT00967642]70 participants Interventional2006-08-31Terminated
A Randomised, Single-centre, Double-blind, Parallelgroup, Multiple Dose Trial Comparing the Within-subject Variability of SIBA and Insulin Glargine With Respect to Pharmacodynamic Response at Steady State Conditions in Subjects With Type 1 Diabetes [NCT00961324]Phase 154 participants (Actual)Interventional2009-07-27Completed
Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates [NCT01419873]Phase 430 participants (Actual)Interventional2008-08-31Completed
Comparison of the Effects of Pioglitazone vs. Placebo When Given in Addition to Standard Insulin Treatment in Patients With Type 2 Diabetes Mellitus and Renal Failure [NCT00770640]Phase 240 participants (Actual)Interventional2008-08-31Completed
Comparing Two Glucose Sampling Frequencies for an Intensive Insulin Protocol During Craniotomy in Non-Diabetic Patients-How Efficiently and Safely Can We Maintain Target Glucose Levels [NCT00993057]Early Phase 1120 participants (Actual)Interventional2009-10-31Completed
Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards [NCT00764556]Phase 220 participants (Actual)Interventional2008-05-31Completed
Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU [NCT00996099]24 participants (Actual)Interventional2008-09-30Completed
An Efficacy and Safety Evaluation of Frequently Modified Intensive Insulin Therapy in Subjects With Uncontrolled Type-I or Type-2 Diabetes [NCT01014832]14 participants (Actual)Interventional2008-12-31Completed
Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients [NCT00764712]120 participants (Actual)Interventional2008-02-29Completed
Insulin Balanced Infusion System Control of Glucose [NCT01291719]Phase 1/Phase 240 participants (Anticipated)Interventional2008-11-30Active, not recruiting
A Phase 2, Single-Dose, Randomized, Open-Label, Active-Controlled, Crossover, Pharmacodynamic, and Pharmacokinetic Comparative Study of a Novel Pramlintide-Insulin Co-Formulation in Adults With Type 1 Diabetes Mellitus [NCT04074317]Phase 218 participants (Actual)Interventional2019-08-22Completed
Impact of Insulin (I.)Glargine Compared to NPH I. and to I. Detemir in Combination With Metformin on Prandial ß-cell Function and Overall Metabolic Control in Type 2 Diabetic Patients With Insufficient Metabolic Control During OAD Treatment [NCT00941148]Phase 430 participants (Actual)Interventional2008-04-30Completed
Phase 1, Open Label Dose-Finding Study of Intranasal Insulin in Healthy Participants [NCT05062785]Phase 124 participants (Actual)Interventional2021-10-04Completed
Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay [NCT00687466]Phase 370 participants (Anticipated)Interventional2005-08-31Active, not recruiting
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight [NCT03106870]62 participants (Actual)Interventional2016-06-30Completed
Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Combination With Metformin in Subjects With Type 2 Diabetes [NCT00097877]Phase 3293 participants (Actual)Interventional2005-01-31Completed
A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes [NCT00772356]14 participants (Actual)Interventional2008-01-31Completed
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents [NCT00925977]44 participants (Actual)Interventional2009-07-31Terminated
28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/ [NCT00783744]Phase 3375 participants (Actual)Interventional2001-12-31Completed
A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL) [NCT01059812]Phase 3424 participants (Actual)Interventional2010-02-01Completed
Comparison of Serum Sphingolipidomic Analyses in Healthy, Pre-diabetic and Diabetic Subjects [NCT02826759]200 participants (Anticipated)Observational2016-07-31Not yet recruiting
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus [NCT02420262]Phase 3506 participants (Actual)Interventional2015-07-26Completed
A Multi-center, Randomized, Open, Phase III Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared Efficacy and Safety With Insulin Degludec/Insulin Aspart(Ryzodeg) in Chinese Subjects With Type 2 Diabetes [NCT05802862]Phase 3408 participants (Anticipated)Interventional2023-05-01Not yet recruiting
Observational, Data Collection Study for Subjects With Diabetes Using Daily Insulin Injections and Monitoring Glucose by Continuous Glucose Monitoring or Self-Monitoring Blood Glucose [NCT04013919]260 participants (Anticipated)Observational2019-09-20Recruiting
A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects With Type 2 Diabetes Mellitus (T2DM) [NCT04100473]Phase 224 participants (Actual)Interventional2018-04-23Completed
Phase 2b, Multicenter, Randomized, Double Blind, Titration Trial for Efficacy and Safety of HDV Insulin Lispro in Combination With a Basal Insulin Versus Insulin Lispro in Combination With a Basal Insulin in Patients With Type 1 Diabetes [NCT02794155]Phase 2157 participants (Actual)Interventional2016-06-30Completed
Intranasal Insulin Treatment in Patients With Schizophrenia [NCT00575666]Phase 445 participants (Actual)Interventional2007-12-31Completed
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Tresiba® FlexTouch® (Insulin Degludec) to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 1 [NCT02779413]3,303 participants (Actual)Observational2016-06-02Completed
ANALYSIS OF THE EFFECTIVENESS OF A STAGED MANAGEMENT PROGRAM AIMED AT CONTROLLING BLOOD PRESSURE AND BLOOD GLUCOSE OF TYPE 2 DIABETIC PATIENTS USING EXCLUSIVELY THE RESOURCES AVAILABLE IN A PRIMARY CARE SETTING IN BRAZIL [NCT00935805]124 participants (Anticipated)Observational2006-07-31Active, not recruiting
Randomised, Two-Period Crossover Study to Assess the Efficacy of Overnight Computer-based Glucose Control Compared With Conventional Pump Therapy Following the Consumption of Alcohol in Adults With Type 1 Diabetes [NCT00944619]12 participants (Actual)Interventional2009-09-30Completed
Demonstration Study of the Interest of the MEDTRUM A7+ TouchCare Insulin Patch Pump Versus INSULET Omnipod® Patch Pump [NCT04223973]82 participants (Actual)Interventional2020-01-29Completed
Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia [NCT06178874]90 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Closed-Loop Insulin Delivery in Pregnant Women With Type 1 Diabetes [NCT05661149]14 participants (Actual)Observational2023-05-11Completed
Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control. [NCT00308737]Phase 32,053 participants (Actual)Interventional2005-06-30Completed
Trial Investigating the Hypoglycaemic Response to Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes [NCT00760448]Phase 125 participants (Actual)Interventional2004-04-30Completed
The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp [NCT00814008]Phase 264 participants (Anticipated)Interventional1999-03-31Completed
Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes. [NCT00771680]10,408 participants (Actual)Observational2008-10-31Completed
Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation? [NCT00645528]39 participants (Actual)Interventional2008-04-30Completed
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis [NCT00590044]Phase 474 participants (Actual)Interventional2007-12-31Completed
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN) [NCT01272193]Phase 3296 participants (Actual)Interventional2011-01-31Completed
The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients [NCT00447239]117 participants Interventional2004-09-30Completed
Liver and Metabolic Effects of Insulin Pump Therapy in a Population of Type 2 Diabetics With Non-alcoholic Hepatic Steatosis [NCT04270656]52 participants (Anticipated)Interventional2021-02-05Recruiting
Clinical Trial of Euglycemia Maintenance With Supraphysiologic Insulin vs Conventional Intensive Insulin Therapy to Improve Outcomes (Neurologic, Neuropsychiatric, and Biomarkers) After Surgical Treatment of Unruptured Cerebral Aneurysms [NCT00615381]0 participants (Actual)Interventional2009-01-31Withdrawn(stopped due to Study was not initiated and has been withdrawn due to lack of appropriate cases)
An Open-label, Multi-centre, Randomized, Single-period, Parallel Study to Assess the Efficacy, Safety and Utility of 6 Month Day-and-night Automated Closed-loop Insulin Delivery Under Free Living Conditions Compared to Insulin Pump Therapy in Children and [NCT02925299]131 participants (Actual)Interventional2017-05-12Completed
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction [NCT05244694]Early Phase 128 participants (Actual)Interventional2020-08-06Completed
A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects [NCT01865331]Phase 132 participants (Actual)Interventional2006-12-31Completed
Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes [NCT04133922]Early Phase 10 participants (Actual)Interventional2019-10-14Withdrawn(stopped due to the study drug could not be obtained)
A Randomised, Double-blind, Single Centre, Placebocontrolled, Parallel Group, Multiple s.c. Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Two SIAC Preparations and Two Insulin 454 (SIBA) Preparations in Healthy Japanese Male Su [NCT01868555]Phase 132 participants (Actual)Interventional2007-12-31Completed
Early Administration of Long-acting Insulin Glargine for the Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: A Randomized Double Blind Trial [NCT02548494]17 participants (Actual)Interventional2015-11-30Terminated(stopped due to Project terminated due to insufficient resources for recruitment.)
An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen [NCT00832182]Phase 375 participants (Actual)Interventional1999-12-22Completed
The Safety and Efficacy of Correcting Preoperative Hyperglycemia in Ambulatory Surgical Patients With Diabetes: A Randomized Controlled Clinical Trial [NCT01971047]Phase 40 participants (Actual)Interventional2013-10-31Withdrawn
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes [NCT03952143]Phase 3628 participants (Actual)Interventional2019-05-27Completed
An Observational Study to Assess the Safety and Effectiveness of Automated Insulin Delivery (AID) Systems in Physically Active Adults With Type 1 Diabetes in Free-living Conditions (AIDE-1) [NCT05626725]60 participants (Anticipated)Observational2022-12-01Recruiting
[NCT00006508]0 participants InterventionalCompleted
An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and [NCT00313742]Phase 451 participants (Actual)Interventional2006-04-30Completed
The PERSISTENT Trial: A Prospective Randomized Trial Comparing Insulin Lispro Protamine Suspension to Insulin Glargine in Patients With Type 2 Diabetes on Anti-hyperglycemic Medications [NCT00510952]Phase 3471 participants (Actual)Interventional2007-08-31Completed
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation [NCT00001624]Phase 116 participants Interventional1997-03-31Completed
[NCT00973401]30 participants (Anticipated)Observational2009-09-30Recruiting
Effects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Metabolic Profile, Adipocyte IGF-I and Insulin Signaling, Intramyocellular Lipids, and Cortisol Metabolism in Obese Women With Polycystic Ovary Syndrome (PCOS) [NCT00518635]0 participants (Actual)Interventional2010-10-31Withdrawn
A Phase I, Randomized, Dose-Ranging, Pharmacokinetic, Glucodynamic, Safety, and Tolerability Study of SC Administered Humulin R and Humalog With or Without Recombinant Human Hyaluronidase (rHuPH20) in Healthy Volunteers [NCT00803972]Phase 142 participants (Actual)Interventional2008-11-30Completed
Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells in Patients With Type 2 Diabetes: a Partially Double-Blind, Randomized, Three-Arm Unicenter Study [NCT00523393]Phase 475 participants (Anticipated)Interventional2007-08-31Recruiting
Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs [NCT00174642]Phase 3811 participants (Actual)Interventional2004-12-31Completed
Evaluation of the Effects of Oral Anti-Hyperglycemic Agents, Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion on Glycemic Control, B-Cell Function and the Remission Rate in Newly-Diagnosed Type 2 Diabetic Patients [NCT00147836]436 participants (Actual)Interventional2004-09-30Completed
A 16-week Multicentre, Open Label, Non-interventional, Observational Study to Investigate the Status of Human Insulin or Insulin Analogue Treatments With Focusing on Efficacy and Safety in Type 2 Diabetes Subjects Inadequately Controlled With Two or More [NCT00806936]4,847 participants (Actual)Observational2008-12-31Completed
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin in Patients With Type 1 Diabetes, A Randomised, Quadruple Crossover Trial [NCT00888732]Phase 324 participants (Actual)Interventional2009-06-30Completed
A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Con [NCT00150410]Phase 3626 participants (Actual)Interventional2003-01-31Completed
A Single Center, Open-Labeled Exploratory Study to Evaluate a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue of Type-1 Diabetic Patients [NCT00813410]14 participants (Actual)Interventional2007-02-28Completed
Study to Assess the Efficacy and Safety of iNCDSS Assisted Insulin Dosage Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients : a Muticenter, Single-blind, Randomized Controlled Study [NCT04642378]106 participants (Anticipated)Interventional2021-10-01Recruiting
Human Versus Analogue Insulin in Patients After Pancreatectomy - Open, Prospective, Randomized, Intervention Study. [NCT04690309]Phase 4100 participants (Anticipated)Interventional2018-07-01Recruiting
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associa [NCT00635492]2,515 participants (Actual)Observational2008-01-31Completed
Insulin Cardioplegia Trial for Poor Left Ventricular Function [NCT00188994]800 participants Interventional1999-08-31Recruiting
A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin [NCT00539890]Phase 30 participants Interventional2005-11-30Completed
The Influence of the Needle Length on Long Term Glycaemic Control in Insulin Using Obese Diabetic Subjects [NCT00541372]Phase 4130 participants (Anticipated)Interventional2007-09-30Completed
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes. [NCT00184665]Phase 3501 participants (Actual)Interventional2004-06-30Completed
A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes [NCT00992537]Phase 127 participants (Actual)Interventional2009-10-31Completed
Nebulized Salbutamol Facilitate Management of Hyperkalemia Postreperfusion During Liver Transplantation: a Single-center, Randomized, Positive-controlled Clinical Study [NCT05589441]100 participants (Anticipated)Interventional2022-10-28Not yet recruiting
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus [NCT00419562]Phase 3560 participants (Actual)Interventional2007-02-28Completed
Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes [NCT00537303]Phase 4296 participants (Actual)Interventional2007-10-31Completed
Trial Between a Computer-Guided Intravenous Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU [NCT00394524]160 participants (Actual)Interventional2006-06-30Completed
Induction of Long-term Glycemic Remission Via Structured Simplified Short-term Intensive Insulin Therapy in Patients With Newly Diagnosed Type 2 Diabetes: a Multiple Centered, Randomised Controlled Trial. [NCT03972982]Phase 4330 participants (Anticipated)Interventional2019-06-01Not yet recruiting
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 at Steady State Conditions in Subjects With Type 2 Diabetes of Different Race and/or Ethnicity [NCT01043510]Phase 163 participants (Actual)Interventional2010-01-31Completed
A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes In [NCT00184600]Phase 3708 participants (Actual)Interventional2004-11-30Completed
A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS) [NCT01055808]677 participants (Actual)Observational2010-01-31Completed
Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients [NCT00519623]Phase 1/Phase 29 participants (Actual)Interventional2007-08-31Completed
A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification [NCT05813912]Phase 3148 participants (Anticipated)Interventional2023-09-22Recruiting
INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza® Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric [NCT04974528]Phase 3264 participants (Anticipated)Interventional2021-09-29Recruiting
Device Study for Intranasal Delivery of Insulin [NCT03857321]Phase 230 participants (Anticipated)Interventional2019-04-12Active, not recruiting
The Effect of Detemir Compared to Exenatide and/or the Combination of Detemir and Exenatide on Glycemic Control and Weight in Patients With Type 2 Diabetes Mellitus Who Have Failed Oral Hypoglycemic Agents [NCT01076842]Phase 475 participants (Anticipated)Interventional2008-04-30Completed
Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study. [NCT00360698]Phase 4106 participants (Actual)Interventional2006-07-31Completed
An Open-label, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of 36-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment in Adolescents With Type 1 Diabetes [NCT01074801]Phase 212 participants (Anticipated)Interventional2010-03-31Completed
Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections [NCT00377858]Phase 4484 participants (Actual)Interventional2006-08-31Completed
A Mono-center, Open Label, Randomised 2-period Crossover Study to Compare the Pharmacokinetics and Pharmacodynamics of Continuous Insulin Infusion Administered Either Intradermally or Subcutaneously in Subjects With Type 1 Diabetes Mellitus [NCT01061216]Phase 1/Phase 220 participants (Actual)Interventional2010-01-31Completed
Impact of Tight Control of Perioperative Blood Glucose in Patients Undergoing Vascular Surgery on Their Perioperative Cardiovascular and Overall Morbidity and Mortality [NCT00328094]242 participants (Actual)Interventional2006-03-31Terminated(stopped due to The recruitment rate slowed considerably)
Reimplantation of Subjects With Implantable Insulin Pump Therapy [NCT00298740]12 participants (Actual)Interventional2003-02-28Completed
A Randomized, Double-blind, Single-dose, Cross-over Study in Two Cohorts to Compare Exposure and Activity of SAR341402 Mix 70/30 to Novolog® Mix 70/30, Novomix® 30 and SAR341402 Rapid-Acting Solution Using the Euglycemic Clamp Technique, in Patients With [NCT03916601]Phase 152 participants (Actual)Interventional2017-12-13Completed
A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk Peopl [NCT00069784]Phase 312,537 participants (Actual)Interventional2003-08-31Completed
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients [NCT01875107]Phase 40 participants (Actual)Interventional2013-08-31Withdrawn(stopped due to Time constraints of primary investigator.)
Effect Of Obesity And Hyperglycemia on Endothelial Function in Inner City Bronx Adolescents [NCT01879033]60 participants (Actual)Interventional2011-03-31Completed
Spectroscopic Evaluation of Lesion Evolution in Stroke: Trial of Insulin for Acute Lactic Acidosis (SELESTIAL) [NCT00124826]Phase 245 participants Interventional2004-05-31Completed
Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia [NCT01886365]75 participants (Actual)Interventional2011-10-31Completed
Treatment by Subcutaneous Continuous Infusion of Insulin by Portable Pump Versus Discontinuous Infusion of Insulin by Multi-injections in the Type 2 Diabetes: Study of the Insulinosensibility in the 2 Types of Treatments [NCT01889914]Phase 460 participants (Anticipated)Interventional2012-01-31Recruiting
A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges [NCT01902121]Phase 140 participants (Actual)Interventional2013-08-31Completed
The Role of Adding Metformin in Insulin-Resistant Diabetic Pregnant Women - a Randomized Controlled Trial [NCT01915550]Phase 390 participants (Actual)Interventional2012-04-30Completed
A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Patients After Vascular Surgery [NCT01916733]89 participants (Actual)Observational2013-01-31Completed
Intracellular Counter-regulatory Mechanisms Following Low Blood Glucose [NCT01919788]9 participants (Actual)Interventional2013-08-31Completed
A Randomized Comparison of Transitioning From Insulin GLargine to Insulin Degludec usING a Bridging Dose of Glargine Versus Direct Conversion, in Patients With Type 1 Diabetes Mellitus - a Pilot Study [NCT04623086]Phase 440 participants (Actual)Interventional2020-02-14Active, not recruiting
Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial [NCT00424437]Phase 3320 participants Interventional1999-09-30Completed
Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes [NCT01939834]6 participants (Actual)Interventional2013-12-31Terminated(stopped due to Subjects preferred the 5 night overnight system in terms of ease of use.)
Effects of Pulsatile Insulin Delivery on Peripheral Diabetic Neuropathy [NCT00228891]Phase 2/Phase 3152 participants (Actual)Interventional2004-02-29Terminated(stopped due to Administrative)
Randomized Study to Evaluate the Efficacy and Safety of Two Endovenous Insulin Protocols and a Subcutaneous Insulin Protocol in Critically Ill Patients [NCT00410852]168 participants (Actual)Interventional2005-05-31Completed
Effects of Intense Glycemic Control on Markers of Inflammation and Thrombosis in Patients Treated With Percutaneous Coronary Intervention for Acute Myocardial Infarction. [NCT00209144]Phase 158 participants (Actual)Interventional2004-10-31Completed
Acceleration of Insulin Action by Hyaluronidase During Closed-Loop Therapy [NCT01945099]Early Phase 113 participants (Actual)Interventional2013-09-30Completed
Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY [NCT04620967]Phase 440 participants (Anticipated)Interventional2021-02-01Recruiting
Can Hypoglycaemia Awareness Be Restored in Individuals With Type 1 Diabetes and Severe Hypoglycaemia Employing Optimised Subcutaneous Insulin Regime or Continuous Subcutaneous Insulin Infusion Pump [NCT00360984]Phase 421 participants Interventional2003-05-31Completed
Intravenous Exenatide (Byetta®) Versus Insulin for Perioperative Glycemic Control in Cardiac Surgery: the Open-labeled Randomized Phase II/III ExStress Study [NCT01969149]Phase 2/Phase 3110 participants (Actual)Interventional2015-01-31Completed
A Single Center, Multiple-dose, Non-randomized, Dose Adjustment, Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Tolerability of Oshadi Icp in Patients With Type 1 Diabetes Mellitus -A Phase II Clinical Study [NCT01973920]Phase 212 participants (Actual)Interventional2013-12-31Completed
Use of the Glycemic Load for the Adjustment of the Dose of Preprandial Insulin in Patients With Type 1 Diabetes Mellitus in Insulin Pump Therapy [NCT01978704]9 participants (Actual)Interventional2013-02-28Completed
A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under [NCT01984372]6,163 participants (Actual)Observational2013-11-06Completed
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes [NCT01992588]Phase 148 participants (Actual)Interventional2013-11-30Completed
Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe, a Randomized Crossover Study [NCT01996189]Phase 250 participants (Actual)Interventional2012-05-31Completed
Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects [NCT03959423]288 participants (Actual)Interventional2019-07-24Completed
Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus [NCT00567775]Phase 227 participants (Actual)Interventional2002-10-21Completed
Intranasal Insulin for Prevention of Type 1 Diabetes in Children Carrying Increased HLA-Conferred Genetic Risk [NCT00223613]Phase 3240 participants Interventional1997-08-31Recruiting
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate [NCT00569452]12 participants (Actual)Interventional2006-01-31Completed
Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients [NCT00673309]Phase 2/Phase 3644 participants (Actual)Interventional2000-07-31Completed
A Comparison of Premixed and Basal-Bolus Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Twice-daily Premixed Insulin [NCT01175811]Phase 4402 participants (Actual)Interventional2011-02-28Completed
Validation of Insulin Protocol for Prevention and Management of Hyperglycemia in Oncology Patients With Diabetes Receiving High Dose Glucocorticoid Therapy [NCT02012465]Early Phase 115 participants (Actual)Interventional2013-09-30Completed
Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus [NCT00605137]Phase 383 participants (Actual)Interventional2004-05-21Completed
Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin in a Limited Resources Setting: a Multicenter Randomized Controlled Crossover Clinical Trial [NCT05768191]Phase 420 participants (Anticipated)Interventional2023-06-15Recruiting
Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study A [NCT00858897]10 participants (Actual)Interventional2007-06-30Completed
Effects of Pulsatile IV Insulin Delivery on Peripheral Diabetic Neuropathy [NCT00228904]Phase 2/Phase 30 participants (Actual)Interventional2005-02-28Withdrawn(stopped due to Administrative)
A Multiple Dose, Randomised, Double Blinded, Double Dummy Trial Investigating Efficacy and Safety of NNC0268-0965 Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus [NCT04575181]Phase 186 participants (Actual)Interventional2020-10-21Completed
The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation [NCT05125185]180 participants (Actual)Interventional2021-08-01Completed
Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With Type-2 Diabetes Mellitus (TRANSITION-T2D) A Prospective Randomized Controlled Trial [NCT04538352]Phase 460 participants (Actual)Interventional2021-01-18Completed
FLAT-SUGAR: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR [NCT01524705]Phase 4102 participants (Actual)Interventional2012-08-31Completed
A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes [NCT00909480]Phase 4457 participants (Actual)Interventional2009-05-31Completed
Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity [NCT01847456]10 participants (Actual)Interventional2013-04-30Completed
No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans [NCT00566124]Phase 410 participants (Actual)Interventional2005-01-31Completed
Studying the Effect of Mediterranean Diet on Insulin Resistance Compared to the Regular Diet Among Obese Children and Adolescents Aged 10-16 Years. [NCT04313452]50 participants (Anticipated)Interventional2020-02-27Enrolling by invitation
Effect of Prandial Treatment With Insulin Glulisine Compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients [NCT00562133]Phase 315 participants (Actual)Interventional2006-12-31Completed
Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus [NCT00569400]Phase 3241 participants (Actual)Interventional2003-05-01Completed
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes Mellitus [NCT00571935]Phase 461 participants (Actual)Interventional2003-08-31Completed
Mechanisms of Insulin Facilitation of Memory [NCT01145482]12 participants (Actual)Interventional2010-07-31Completed
A Randomized, Double-blind, Placebo-controlled Cross-over Trial Evaluating the Effect of Intranasal Insulin on Depressive Symptoms in Individuals With Major Depressive Disorder Insufficiently Responsive to Antidepressant Therapy [NCT00570050]Phase 335 participants (Actual)Interventional2013-06-30Completed
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use [NCT05204134]35 participants (Actual)Interventional2022-03-24Completed
Randomized Clinical Trial of Subcutaneous Analog Basal Bolus Therapy Versus Sliding Scale Human Regular Insulin in the Hospital Management of Hyperglycemia in Non-Critically Ill Patients Without Known History of Diabetes: The HMH Trial [NCT01136746]Phase 316 participants (Actual)Interventional2011-03-31Terminated(stopped due to Low enrollment)
A Randomised, Single-centre, Double-blind, Two-period Cross-over, Multiple Dose Trial Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Me [NCT02536859]Phase 160 participants (Actual)Interventional2015-08-31Completed
Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects [NCT01133392]Phase 141 participants (Actual)Interventional2010-05-31Completed
Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes (HEART2D) [NCT00191282]Phase 41,116 participants (Actual)Interventional2002-10-31Completed
Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU [NCT04554615]86 participants (Actual)Interventional2017-09-14Completed
Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients [NCT02853799]26 participants (Actual)Interventional2016-08-31Completed
Intranasal Insulin and Neurocognitive Function [NCT04635774]Phase 1/Phase 230 participants (Anticipated)Interventional2021-02-25Recruiting
Ultrasound Characterization of Lipo-hypertrophy in Type 1 Diabetes Mellitus [NCT02278926]60 participants (Actual)Observational2012-01-31Completed
A Randomized Open-label Study to Compare Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Patients With Type 2 Diabetes Mellitus That do Not Reach Adequate Glycemic Control on Their Current Sulfonylurea Monotherapy. [NCT01649466]Phase 4162 participants (Actual)Interventional2012-08-31Completed
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy Subjects [NCT01931137]Phase 145 participants (Actual)Interventional2013-08-31Completed
Basal Bolus Regimen With Insulin Analogs Versus Human Insulin in Medical Patients With Type 2 Diabetes: A Randomized Controlled Trial in Paraguay [NCT02278913]Phase 4134 participants (Actual)Interventional2009-04-30Completed
A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combinati [NCT01196104]Phase 339 participants (Actual)Interventional2010-09-30Terminated(stopped due to For Business Reasons)
Glargine Insulin Versus Continous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN) [NCT02216799]Phase 461 participants (Actual)Interventional2013-03-31Completed
TECHNICAL EVALUATION OF JEWELPUMP IN TYPE 1 DIABETIC PATIENTS TREATED WITH EXTERN INSULIN PUMP [NCT01640210]28 participants (Actual)Interventional2011-11-30Completed
EXCEED - A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs [NCT05663515]2,400 participants (Anticipated)Observational2024-01-01Not yet recruiting
Postprandial Glucose Control Using an Extended Bolus for High-fat High Protein Meals in a Closed-loop System in Patients With Type 1 Diabetes [NCT05454891]Phase 430 participants (Anticipated)Interventional2022-07-15Recruiting
A Multi-centre Prospective Non-interventional Clinical Investigation Studying the Glycaemic Control in Patients With Type 1 Diabetes When Introducing a NovoPen® 6 for Treatment With Tresiba® (Insulin Degludec) & Fiasp® (Fast-acting Insulin Aspart) in a Re [NCT05069545]227 participants (Anticipated)Observational2021-10-12Enrolling by invitation
Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets: A Randomised Controlled Trial - The Steno 780G Study [NCT04914910]40 participants (Actual)Interventional2021-06-08Completed
Improving Glycemic Control and Clinical Outcomes in DM2 Patients in the Ambulatory Setting, a Pilot Study [NCT04800471]30 participants (Anticipated)Interventional2021-08-16Active, not recruiting
A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes M [NCT01689142]Phase 3240 participants (Actual)Interventional2012-09-30Completed
A Pilot Study for the Systematic Evaluation of the Inflammatory Response to Commercially Available Insulin Infusion Catheters in Subcutaneous Adipose Tissue [NCT03298295]20 participants (Anticipated)Interventional2018-02-01Recruiting
[NCT02054429]Phase 130 participants (Actual)Interventional2013-01-31Completed
Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars [NCT06021275]40 participants (Anticipated)Interventional2023-09-30Recruiting
Treat-To-Target Trial of Continuous Subcutaneous, Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation (SAPT-NODAT) [NCT01680185]Phase 385 participants (Actual)Interventional2012-08-31Completed
Comparison of the Two Different Closed-loop Hybrid Systems - AndroidAPS and Control-IQ in Patients With Type 1 Diabetes [NCT05165615]20 participants (Anticipated)Interventional2020-12-01Recruiting
A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period [NCT01689129]Phase 3243 participants (Actual)Interventional2012-09-30Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE) [NCT01365507]Phase 3276 participants (Actual)Interventional2011-06-30Completed
The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI) [NCT00592410]Phase 20 participants (Actual)Interventional2007-02-28Withdrawn(stopped due to no enrollment)
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus [NCT00595374]Phase 3114 participants (Actual)Interventional2003-12-02Completed
Flexible, Intensive Insulin Management in Patients With Type 1 Diabetes and Changes in Metabolic Control, Quality of Life, Locus of Control and Diabetes Knowledge [NCT00595569]45 participants (Actual)Observational2002-04-30Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE) [NCT01326026]Phase 3222 participants (Actual)Interventional2011-03-31Completed
Open-Label, Uncontrolled, Single-Arm, Single-Center, 16-Week Study Assessing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device Software in 3-Groups of Subjects With Diabetes [NCT01170208]46 participants (Actual)Interventional2010-06-30Completed
A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of I [NCT01076647]Phase 3467 participants (Actual)Interventional2010-03-31Completed
Effects of Recombinant Human Insulin Like Growth Factor-1 (rhIGF-1) on Bone Metabolism in Adolescent Girls With Anorexia Nervosa [NCT00720122]Phase 228 participants (Actual)Interventional2008-07-31Completed
Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke [NCT00747279]Phase 470 participants (Anticipated)Interventional2007-06-30Recruiting
A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes [NCT00725036]Phase 3305 participants (Actual)Interventional2002-09-02Completed
Pilot Study Using Oral Insulin at Early Age for Immune Efficacy in Primary Prevention of Type 1 Diabetes [NCT02547519]Phase 244 participants (Actual)Interventional2015-08-31Completed
Comparison of Pharmacodynamics and Pharmacokinetics of the Two Fast-acting Insulin Analogs Insulin Glulisine and Insulin Aspart in Healthy Volunteers [NCT00969592]Phase 112 participants (Actual)Interventional2007-11-30Completed
A Single Dose,Single Centre,Double Blind,Crossover Study Comparing the Pharmacokinetic Profiles of Wockhardt's Insulin Human Injection, Soluble (Recombinant DNA Origin) for Injection and Actrapid in Type 1 Diabetics [NCT00752180]Phase 128 participants (Actual)Interventional2008-08-31Completed
Observational Study Evaluating Safety in Patients With Type 2 Diabetes Treated With NovoMix® 30 or NovoMix® 50 or NovoMix®70 (Biphasic Insulin Aspart) [NCT00775736]611 participants (Actual)Observational2008-10-31Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Insulin in Subjects With Type 2 Diabetes [NCT00286429]Phase 3390 participants (Actual)Interventional2006-02-28Completed
A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients [NCT00271284]Phase 388 participants (Actual)Interventional2005-10-31Completed
The Effect of Acute Hyperglycemia on Cardiac Output, Amino Acid, Lipid and Glucose Metabolism in Patients With Type 2 Diabetes [NCT00653510]18 participants (Actual)Interventional2008-03-31Completed
Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance. [NCT00654056]8 participants (Actual)Interventional2008-03-31Completed
Samba-01: A Phase 1/2 Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of Inhaled Insulin in Subjects With Type 1 Diabetes [NCT02713841]Phase 1/Phase 212 participants (Actual)Interventional2013-05-31Completed
A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function [NCT01006057]Phase 132 participants (Actual)Interventional2009-11-30Completed
Pilot Study To Identify Effective Methods Of Training Pump Naïve Subjects To Use The Paradigm® 722 System And To Describe Clinical Effectiveness Compared To Subjects Continuing With Multiple Dose Injections (MDI) of Insulin [NCT00530023]Phase 429 participants (Actual)Interventional2006-02-28Completed
Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes [NCT00419718]Phase 123 participants (Actual)Interventional2005-10-31Completed
A Randomised Trial Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes [NCT02568280]Phase 142 participants (Actual)Interventional2015-10-06Completed
Subcutaneous Versus Intravenous Basal Insulin in Non-critical Hospitalized Diabetic Patients That Receive Total Parenteral Nutrition [NCT02706119]Phase 4163 participants (Actual)Interventional2016-07-01Completed
Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus [NCT00662714]Phase 373 participants (Actual)Interventional2001-09-30Completed
Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus [NCT00604396]Phase 3477 participants (Actual)Interventional2003-03-31Completed
Pilot Study of the Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG) [NCT01030341]45 participants (Actual)Interventional2011-05-31Completed
Efficacy and Safety Comparison of Insulin Detemir and Insulin Glargine Plus Insulin Aspart in Patients With Type 2 Diabetes [NCT00106366]Phase 3389 participants (Actual)Interventional2005-03-31Completed
Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus [NCT00605020]Phase 3719 participants (Actual)Interventional2003-12-02Completed
NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as [NCT00982228]Phase 3629 participants (Actual)Interventional2009-09-01Completed
A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on Basal [NCT03529123]Phase 3247 participants (Actual)Interventional2018-06-19Completed
Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use. [NCT01500850]Phase 460 participants (Anticipated)Interventional2011-10-31Recruiting
At Home Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAs) System and Run-to-Run Adaptation [NCT02705053]Phase 332 participants (Actual)Interventional2016-02-29Completed
Einfluss Der zentralnervösen Insulinsensitivität Auf Die Insulinsekretion [NCT02870361]15 participants (Actual)Interventional2016-08-31Completed
A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes [NCT01194245]Phase 2135 participants (Actual)Interventional2010-08-31Completed
Bedtime Insulin Glargine or Bedtime Neutral Protamine Lispro Combined With Sulfonylurea and Metformin in Type 2 Diabetes. A Randomized, Controlled Trial [NCT00641407]Phase 4100 participants (Actual)Interventional2007-01-31Completed
Efficacy and Durability of Glucagon Like Peptide 1 Receptor Agonists (GLP-1 RA)/Thiazolidinedione Versus Basal Bolus Insulin Therapy in Poorly Controlled Type 2 Diabetic Patients (T2DM) Patients on Sulfonylurea Plus Metformin [NCT02887625]410 participants (Anticipated)Interventional2015-02-28Recruiting
The Effects of Glucose Control and Monitor on Inflammation in the Hospitalized Patients With Hyperglycemia [NCT02885909]Phase 4600 participants (Anticipated)Interventional2016-09-30Recruiting
A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects [NCT02844790]Phase 124 participants (Actual)Interventional2016-07-26Completed
Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin. [NCT00653341]Phase 3764 participants (Actual)Interventional2000-01-31Completed
The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial [NCT00657943]Phase 4415 participants (Actual)Interventional2008-04-30Completed
Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus [NCT00658099]699 participants (Actual)Observational2007-11-30Completed
A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus [NCT01134107]Phase 3133 participants (Actual)Interventional2010-11-30Completed
NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens [NCT02758522]Phase 4105 participants (Actual)Interventional2013-10-31Completed
A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Russia [NCT04315688]494 participants (Actual)Observational2020-03-30Completed
A Single-Centre, Randomised, Double-Blind, 2- Period Crossover Trial Investigating the Steady State Pharmacokinetics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes [NCT01524809]Phase 126 participants (Actual)Interventional2001-01-31Completed
NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Sub [NCT00982644]Phase 31,030 participants (Actual)Interventional2009-09-30Completed
Mechanistic Study Using Oral Insulin for Immune Efficacy in Secondary Prevention of Type 1 Diabetes [NCT02620072]Phase 2220 participants (Actual)Interventional2015-12-11Active, not recruiting
Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs Given as a Bolus by Continuous Subcutaneous Insulin Infusion (CSII) and in MDI Basal-Bolus Therapy in Pediatric Subjects With Type 1 Diabetes (TID) [NCT00652288]Phase 136 participants (Actual)Interventional2007-04-30Completed
Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine [NCT00656422]Phase 366 participants (Actual)Interventional2007-11-30Terminated
A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes [NCT00883558]Phase 248 participants (Actual)Interventional2009-05-31Completed
Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas [NCT03262116]Phase 2/Phase 320 participants (Actual)Interventional2019-03-19Terminated(stopped due to Devices are not available)
An Open-label, Randomized, Multicenter Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 15 Weeks in Free-living Outpatient Conditions [NCT02846857]Phase 20 participants (Actual)InterventionalWithdrawn
Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency [NCT00911625]Phase 4114 participants (Actual)Interventional2009-01-21Completed
Single-center, Randomized, Double-blind, 2-treatment, 2-period Crossover Trial in Healthy Subjects to Demonstrate PK Bioequivalence and to Compare the PD Properties of Julphar Insulin 30/70 and Huminsulin® Profil III [NCT02631928]Phase 173 participants (Actual)Interventional2016-02-29Completed
Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus [NCT00671008]400 participants (Actual)Observational2007-12-31Completed
A Single-blind, Randomized, Two-way, Cross-over Study to Examine the Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation Combined With a Simplified Qualitative Meal-size Estimation in Adults With Type 1 Di [NCT02626936]Phase 210 participants (Actual)Interventional2016-01-31Completed
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke: A Multi-center, Randomized Control Study [NCT02607943]Phase 3120 participants (Anticipated)Interventional2015-12-31Recruiting
Modulating the Stress Response in Diabetes Mellitus Type 2 Patients Undergoing Colon Surgery [NCT02863276]18 participants (Actual)Interventional2009-12-31Completed
NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subject [NCT01045707]Phase 3530 participants (Actual)Interventional2010-01-31Completed
The Therapeutic Effects of Combination of Insulin With Berberine on the Patients With Stess Hyperlipemia:a Prospective, Double Blind, Randomized, Placebo-controlled, Single-center Clinical Trial [NCT02806999]Phase 4200 participants (Anticipated)Interventional2016-07-31Not yet recruiting
A 24 Weeks, Randomized, 2 Arms, Controlled, Multi-centre, National, Open-labeled, Parallel Study in Insulin naïve Patients With Type 2 Diabetes to Compare a Lantus Titration Algorithm vs. Physician's Standard Practice [NCT00627471]Phase 49 participants (Actual)Interventional2008-01-31Terminated(stopped due to Low recruitment in spite of strategies implemented)
A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus In [NCT00539396]Phase 2110 participants (Anticipated)Interventional2005-03-31Completed
Effects of Pulsatile Intravenous Insulin Therapy on Cardiac Disease in Patients With Diabetes [NCT00539435]Phase 30 participants (Actual)Interventional2007-09-30Withdrawn(stopped due to Administrative)
Topical Insulin Versus Autologous Serum and Enhanced Corneal Epithelial Healing After Keratorefractive Surgeries [NCT05331859]Phase 1250 participants (Anticipated)Interventional2022-05-31Not yet recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD) [NCT05266417]Phase 256 participants (Anticipated)Interventional2022-02-07Recruiting
A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 2 Diabetes [NCT01194258]Phase 2132 participants (Actual)Interventional2010-08-31Completed
The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4) [NCT01191268]Phase 3884 participants (Actual)Interventional2010-11-30Completed
A Randomised, Controlled, Open Label, Multicentre, Multinational, Treat-to-target Trial Investigating the Efficacy and Safety of Intensification With Addition of Bolus Insulin Aspart in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insuli [NCT01165684]Phase 4401 participants (Actual)Interventional2010-10-31Completed
Comparison of the Immunogenicity of Wockhardt's Insulin Analogue Lispro and Lispro Mix With Eli Lilly's Insulin Analogue Humalog® and Humalog® Mix in Type 1 Diabetic Patients [NCT01398670]Phase 30 participants (Actual)Interventional2012-02-29Withdrawn(stopped due to Study was not initiated)
Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery [NCT01398722]Phase 2800 participants (Anticipated)Interventional2011-08-31Not yet recruiting
To Consider the Effect of the Timing of a Reduction in Basal Insulin Infusion Rate to 50% of Normal Prior to Exercise on Glycaemic Control in People With Type 1 Diabetes Treated With CSII [NCT01398995]6 participants (Actual)Interventional2011-05-31Terminated(stopped due to Recruitment was terminated due to elevated levels of hypoglycaemia)
A Single-center, Randomized, Controlled, 2-period Cross-over, Open-labelled Trial to Evaluate the Impact of Different Application Volumes on Pharmacokinetic and Pharmacodynamic Properties of Insulin Aspart in Subjects With Type 1 Diabetes [NCT01399346]Phase 112 participants (Actual)Interventional2011-04-30Completed
A Phase 1, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Effect Following Inhalation of Technosphere® Insulin Inhalation Powder at Multiple Doses Using the Gen2C Inhaler [NCT01490762]Phase 135 participants (Actual)Interventional2011-12-31Completed
Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy [NCT00331604]Phase 3618 participants (Actual)Interventional2006-08-31Terminated(stopped due to See termination reason in detailed description)
Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study [NCT01417897]Phase 412 participants (Anticipated)Interventional2011-09-30Active, not recruiting
Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or Insulin Detemir. [NCT00405418]Phase 4973 participants (Actual)Interventional2006-11-30Completed
A Prospective, Open-labelled, Non-controlled Observational Study to Assess Patient Satisfaction, Physician Acceptability and Safety of Mixtard® 30 NovoLet® for the Treatment of Diabetes Mellitus [NCT01492218]1,330 participants (Actual)Observational2004-03-15Completed
LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial [NCT01420302]Phase 2/Phase 3300 participants (Actual)Interventional2011-08-31Completed
A Randomised, Double-blind, Placebo-controlled Trial of Intranasal Insulin (440 IU) in Children and Young Adults at Risk of Type 1 Diabetes: Intranasal Insulin Trial II [NCT00336674]Phase 2110 participants (Actual)Interventional2006-12-31Completed
A Randomized, Double-blind, 3-sequence, 3-period Cross-over, Single-dose Study of a New Formulation of Insulin Glargine Compared to the Marketed Lantus® in Japanese Patients With Type 1 Diabetes Mellitus Using the Euglycemic Clamp Technique [NCT01493115]Phase 118 participants (Actual)Interventional2011-11-30Completed
Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump [NCT03882463]34 participants (Actual)Interventional2019-04-30Completed
In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2 - Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes [NCT05238142]500 participants (Anticipated)Interventional2022-02-25Recruiting
Virtual Clinical Study Exploring Remote Collection of Glycaemic and Behaviometric Data Among Patients With Type 2 Diabetes Mellitus on Different Treatment Regimens [NCT04809311]500 participants (Anticipated)Observational2023-11-13Not yet recruiting
Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery: A Randomized, Controlled Pilot Study [NCT04784637]31 participants (Actual)Interventional2021-07-23Completed
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes [NCT00097084]Phase 3324 participants (Actual)Interventional2004-09-30Completed
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia [NCT00842894]3,421 participants (Actual)Observational2009-05-31Completed
Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s) [NCT00935532]Phase 3427 participants (Actual)Interventional2009-07-31Completed
A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1) [NCT01079234]Phase 3493 participants (Actual)Interventional2010-03-31Completed
Prospective Evaluation of iDECIDE: A Smartphone App for Insulin Bolus Dosing [NCT02835183]0 participants (Actual)Interventional2017-01-31Withdrawn
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics [NCT00617565]Phase 3219 participants (Actual)Interventional2003-07-08Completed
"An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO GEROPHARM, Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients" [NCT04079413]Phase 3264 participants (Actual)Interventional2019-06-03Completed
Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis [NCT00920725]50 participants (Actual)Interventional2005-01-31Completed
An Open-label, Single-centre, Randomised Controlled Trial to Assess the Safety and Efficacy of Automated Closed-loop Blood Glucose Control in Comparison With Standard Care in Adults in Intensive Care Unit [NCT01440842]Phase 224 participants (Actual)Interventional2012-05-31Completed
[NCT00277342]18 participants Interventional2006-01-31Completed
An 8-week Randomised, Double-blind, Parallel, Multiple Dose Trial Comparing NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy [NCT02470039]Phase 250 participants (Actual)Interventional2015-06-01Completed
A 26-week, Randomised, Open-labelled, Two-arm, Parallel-group, Treat-to-target Trial Comparing Efficacy and Safety of Soluble Insulin Analogue Combination (SIAC) Twice Daily (BID) With Biphasic Insulin Aspart (BIAsp) 30 BID, With or Without Metformin, Wit [NCT01009580]Phase 3447 participants (Actual)Interventional2009-11-05Completed
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME) [NCT01068665]Phase 3460 participants (Actual)Interventional2010-03-31Completed
The Effect of Insulin Glargine on Glycemic Control, Morbidity, and Length of Stay in Hospitalized Subjects With Diabetes Receiving Enteral Nutrition [NCT00177398]Phase 450 participants Interventional2005-02-28Completed
Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients [NCT00576394]Phase 1108 participants (Actual)Interventional2006-10-31Completed
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Subjects With Type 2 Diabetes [NCT02964104]Phase 150 participants (Actual)Interventional2016-11-15Completed
A Randomized, Double-blind, Controlled, Stepwise Titration Study to Evaluate Dose Response to Prandial Administration of Inhaled Technosphere/Insulin or Technosphere in Patients With Type 2 Diabetes Mellitus Who Are Sub-optimally Treated [NCT00511732]Phase 2227 participants (Actual)Interventional2004-06-30Completed
Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients [NCT00166491]238 participants (Actual)Interventional2005-07-31Completed
Comparative Trial Between Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Type 2 Diabetes [NCT00590226]Phase 4130 participants (Actual)Interventional2006-12-31Completed
Zentrale Insulinsensitivität Bei Personen Mit Typ-2-Diabetes Sowie Bei Personen Mit erhöhtem Risiko für Die Entwicklung Von Typ-2-Diabetes [NCT05856877]180 participants (Anticipated)Interventional2023-05-08Not yet recruiting
A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes [NCT05823948]Phase 350 participants (Anticipated)Interventional2023-04-11Active, not recruiting
Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin [NCT01854723]Phase 40 participants (Actual)Interventional2013-04-30Withdrawn
Metformin in Gestational Diabetes and type2 Diabetes in Pregnancy in a Developing Country [NCT01855763]Phase 2/Phase 3300 participants (Actual)Interventional2008-12-31Active, not recruiting
A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe [NCT01857375]35 participants (Actual)Observational2009-10-31Completed
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes [NCT05294822]20 participants (Anticipated)Interventional2019-09-30Recruiting
A Randomised, Double-blind, Placebo-controlled Single Dose, Dose Escalation Trial With Insulin 454 in Healthy Male Subjects, Followed by a Two-period Cross-over Trial With Insulin 454 and Insulatard® in Male Subjects With Type 1 and Type 2 Diabetes Mellit [NCT01865279]Phase 164 participants (Actual)Interventional2005-12-31Completed
A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes [NCT01865292]Phase 140 participants (Actual)Interventional2006-08-31Completed
A Randomised, Double-blind, Multiple Period Crossover Trial Comparing Insulin 454 and Insulin Aspart Premixes With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared With Biphasic Insulin Aspart 30 (NovoMix® 30) in Male Su [NCT01865305]Phase 159 participants (Actual)Interventional2006-09-30Completed
A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes [NCT01865318]Phase 136 participants (Actual)Interventional2006-09-30Completed
A Randomised, Single Centre, Double-blind, Two-Period Cross-over, Multiple Dose Trial Comparing the Pharmacodynamic Response of Insulin 454 With Insulin Glargine at Steady-State Conditions in Subjects With Type 1 Diabetes Mellitus [NCT01868529]Phase 163 participants (Actual)Interventional2008-01-31Completed
A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMi [NCT01868568]Phase 155 participants (Actual)Interventional2008-04-30Completed
A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairme [NCT05552859]Phase 462 participants (Actual)Interventional2022-12-05Terminated(stopped due to Sponsor decision to cancel trial due to poor recruitment/ severe recruitment delay and not related to safety concern.)
This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Sub [NCT02933853]Phase 161 participants (Actual)Interventional2016-10-14Completed
Glycemic Control and Prevention of Hypoglycemia in Intensively Treated Subjects With Type 1 Diabetes Using Accu-Chek® Advisor Insulin Guidance Software [NCT00552734]123 participants (Actual)Observational2005-07-31Completed
Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial [NCT04687878]Phase 240 participants (Anticipated)Interventional2020-01-01Recruiting
Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients. [NCT00539448]Phase 498 participants (Actual)Interventional2007-04-30Completed
Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes [NCT01206322]Phase 230 participants (Actual)Interventional2010-05-31Completed
Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems [NCT05932966]386 participants (Anticipated)Observational2023-07-06Recruiting
Prospective Randomized Trial for the Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS) [NCT01220557]160 participants (Actual)Interventional2010-09-30Completed
The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed [NCT01487421]2,134 participants (Actual)Observational2003-07-31Completed
Insulinsensitivität Des Menschlichen Zentralnervensystems: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin [NCT01797601]48 participants (Actual)Interventional2013-02-28Completed
Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age [NCT01421225]10 participants (Actual)Interventional2011-08-31Completed
Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic, 6-Way Crossover Study of Subcutaneously Administered Insulin Analogs With Recombinant Human Hyaluronidase (rHuPH20) Compared to Insulin Analogs Alone in Healthy Volunteers [NCT00979875]Phase 114 participants (Actual)Interventional2009-09-30Completed
A Study of Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion (CSII) in Adults With Type 1 Diabetes [NCT04267770]17 participants (Actual)Interventional2018-04-10Completed
Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia [NCT05748990]20 participants (Anticipated)Interventional2023-04-01Not yet recruiting
A Phase IIa Dose Escalation Pilot Study to Investigate the Safety and Tolerability of Intranasal Insulin in Subjects With Diabetic Polyneuropathy. [NCT01469559]Phase 212 participants (Actual)Interventional2011-08-31Completed
A Double-blind, Randomised, Crossover Study to Investigate the Difference in Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 Compared to Biphasic Human Insulin 30 in Patients With Well-controlled Type 2 Diabetes [NCT01487798]Phase 4170 participants (Actual)Interventional2002-06-30Completed
A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia [NCT01492153]1,981 participants (Actual)Observational2003-02-11Completed
A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Mixtard® 30 NovoLet® as Monotherapy, or in Combination With Oral Hypoglycaemic Agent ( OHA ), in Treatment of Subjects With Type 2 Diabetes in Routine Clinic [NCT01492166]1,935 participants (Actual)Observational2006-11-30Completed
A Prospective, Open, Uncontrolled, Observational Study With Innolet in Daily Clinical Situations According to the Product Labelling, Without Any Study Specific Investigations [NCT01492959]1,030 participants (Actual)Observational2004-03-23Completed
Observational, Cross-sectional and Retrospective Study on Diabetes Mellitus Type 1 in Tunisian Children and Adolescents Under 15 Years [NCT01493388]402 participants (Actual)Observational2012-03-31Completed
12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glarg [NCT00467376]Phase 3485 participants (Actual)Interventional2007-01-31Completed
Evaluation of the Pharmacokinetics and Pharmacodynamics of Spray-Dried Recombinant Human Insulin Powder for Inhalation Administered Via a Dry Powder Inhalation Device Relative to SC Recombinant Human Insulin in Healthy Male Volunteers [NCT00426920]Phase 114 participants Interventional2007-02-28Not yet recruiting
The Suppression of Toll Like Receptors by Insulin [NCT01151605]Phase 260 participants (Actual)Interventional2008-09-30Completed
Effect of Pulsatile IV Insulin Delivery on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes [NCT00361907]Phase 2/Phase 3105 participants (Actual)Interventional2005-02-28Terminated(stopped due to Administrative - Suspended by IRB)
Randomized Controlled Trial to Evaluate Blood Glucose Control by the Model Predictive Control Algorithm With Variable Sampling Rate (eMPC) vs. Routine Glucose Management Protocol in Peri- and Postoperative Period in Cardiac Surgery Patients [NCT00444171]60 participants Interventional2006-09-30Completed
[NCT00460499]Phase 1250 participants (Actual)Interventional2004-07-31Completed
Open-Label, Randomised Trial Comparing Efficacy of Continuous Subcutaneous Insulin Infusion(CSII) and Multiple Daily Insulin Injections (MDII) in Improving Glycemic Control and Quality of Life in Poorly Regulated Type 1 Diabetic Children. [NCT00462371]Phase 438 participants Interventional2002-01-31Completed
A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents [NCT00490854]Phase 2/Phase 3129 participants (Actual)Interventional2007-07-31Completed
Self-control Trial to Evaluate the Remission Rate and Safety in Newly Diagnosed Type 2 Diabetes Patients After Short-term Intensive Insulin Aspart and Insulin NPH Treatment [NCT00494988]Phase 433 participants (Actual)Interventional2004-12-31Completed
Effects of Insulin on Post Burn Hypermetabolism [NCT00137254]14 participants (Actual)Interventional2005-12-31Completed
Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes [NCT01613807]Phase 440 participants (Actual)Interventional2008-10-31Completed
Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration [NCT06126419]70 participants (Anticipated)Interventional2023-11-08Recruiting
A Prospective, Controlled, Single-Center, Open-Label,Randomized, Replicated, Crossover Isoglycemic Glucose Clamp Study Evaluating Intrapatient Variability in Bioavailability of Technosphere® Insulin Compared With Subcutaneous Regular Human Insulin in Pati [NCT00511719]Phase 213 participants (Actual)Interventional2004-02-29Completed
Efficacy and Safety of Inhaled Technosphere Insulin Compared to Technosphere Placebo in Patients With Type 2 Diabetes Mellitus Following Diabetes Education [NCT00511602]Phase 2123 participants (Actual)Interventional2003-12-31Completed
[NCT00513201]Phase 40 participants InterventionalCompleted
The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients [NCT02496780]Phase 2/Phase 366 participants (Actual)Interventional2015-08-31Completed
Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial [NCT00424411]Phase 3300 participants Interventional1999-09-30Completed
A Comparison of Insulin Detemir in a BID Insulin Regimen Versus a TID Insulin Regimen in Children With Type 1 Diabetes: A Randomized Controlled Trial [NCT00522210]18 participants (Actual)Interventional2008-03-31Completed
The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps [NCT02276859]Phase 470 participants (Actual)Interventional2014-10-31Completed
A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process [NCT01448070]Phase 128 participants (Actual)Interventional2002-10-15Completed
A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics [NCT02094534]Phase 225 participants (Actual)Interventional2014-03-31Completed
A Randomised, Multiple-Dose, Single Period, Phase II/III Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients [NCT05159453]Phase 2/Phase 330 participants (Anticipated)Interventional2024-01-02Not yet recruiting
Breast Milk Hormones and Early Infant Growth of Women With Gestational Diabetes Mellitus [NCT03145649]96 participants (Actual)Observational2010-01-12Completed
Individual Patient Data Meta-analysis of Randomised Controlled Trials Comparing Glycaemic Control During Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Insulin Injections in Type 2 Diabetes Mellitus [NCT02910141]590 participants (Actual)Observational2014-01-31Completed
Effects of Intranasal Insulin Administration on Tissue Specific Insulin Sensitivity [NCT02933645]10 participants (Actual)Interventional2016-04-30Completed
Does Implementation of a Standard Operating Procedure for Blood Sugar Control Into Daily Clinical Routine Improve Care of Patients [NCT00596128]800 participants (Actual)Interventional2006-12-31Completed
Effects on Diabetic Metabolic Integrity With Treatment of Pulsatile Intravenous Insulin Therapy as Evidenced by Monitoring of Diabetic Complications. [NCT00539409]Phase 2/Phase 3152 participants (Actual)Interventional2006-11-30Terminated(stopped due to Administrative)
Effects of Continuous Subcutaneous Insulin Infusion (CSII) on Erectile Dysfunction in T2DM Patients: A Prospective, Exploratory, Controlled Trial [NCT01468519]Phase 420 participants (Actual)Interventional2012-01-31Completed
A Double-blind, Randomized, Cross-over Study to Compare the Impact of Rapid-acting Insulin Aspart and Faster Acting Aspart (FiAsp) on Glucose Excursion During Postprandial Exercise in Adults With Type 1 Diabetes [NCT03659799]Phase 440 participants (Actual)Interventional2019-04-12Completed
A Mono Center Open Labeled, Randomized Study Examining the Effects of Intra-Dermal vs Subcutaneous Application of Regular Insulin or Rapid Acting Insulin Analogue on Postprandial Glycemic Excursions in Patients With Type 1 Diabetes [NCT00553488]Phase 230 participants (Actual)Interventional2007-09-30Completed
SNIFF Multi-Device Study 2 - Study of Nasal Insulin to Fight Forgetfulness [NCT04199767]Phase 230 participants (Anticipated)Interventional2020-07-16Active, not recruiting
Lipoatrophy in Children, Adolescents and Adults With Modern Treatment Modalities: is There a Beneficial Effect of Insulin Glulisine? [NCT02914886]Phase 414 participants (Actual)Interventional2016-09-30Completed
An Exploratory Study Assessing Time in Target Glucose Range Using a New Titration Scheme of LY900014 and Insulin Degludec in Patients With Type 1 Diabetes [NCT04585776]Phase 231 participants (Actual)Interventional2020-10-30Completed
ASPIRE (Automation to Simulate Pancreatic Insulin Response): Pivotal In Home Study to Determine Safety and Efficacy of the LGS Feature in Sensor-augmented Pumps [NCT01497938]Phase 3247 participants (Actual)Interventional2011-12-31Completed
A Randomized, Double-Blind, Crossover Trial Comparing the Safety and Efficacy of Insulin Lispro With the Safety and Efficacy of Insulin Aspart in Subjects With Type 2 Diabetes on CSII Therapy [NCT01474538]Phase 3122 participants (Actual)Interventional2011-12-31Completed
Effect of Intranasal Insulin on LH Concentrations in Man [NCT02154477]Phase 1/Phase 214 participants (Actual)Interventional2014-12-31Completed
Reversibility of Brain Glucose Transport and Metabolism in T2DM: an Intervention Study [NCT04283617]30 participants (Anticipated)Interventional2021-10-12Suspended(stopped due to Paused due to funding issues.)
Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes: a Randomized Controlled Trial [NCT04196231]Phase 4258 participants (Actual)Interventional2019-11-27Completed
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus Wit [NCT01499095]Phase 3811 participants (Actual)Interventional2011-12-31Completed
No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial. [NCT00282594]317 participants Interventional2003-07-31Completed
A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin 70/30 and Humulin® 70/30 [NCT04022291]Phase 178 participants (Actual)Interventional2019-06-15Completed
Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia [NCT00362778]Phase 428 participants (Actual)Interventional2006-01-31Completed
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A [NCT01724814]Phase 186 participants (Actual)Interventional2012-12-20Completed
Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue [NCT05767255]Phase 366 participants (Anticipated)Interventional2022-12-01Recruiting
A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulin Mixtard® 30 (600 Nmol/ml) and Insulin Mixtard® 30 (1998 Nmol/ml) in Healthy Subjects [NCT01486888]Phase 145 participants (Actual)Interventional2006-05-31Completed
A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects [NCT01486901]Phase 144 participants (Actual)Interventional2006-05-31Completed
A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen [NCT01486940]Phase 3598 participants (Actual)Interventional2002-03-31Completed
Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus [NCT00063128]Phase 2119 participants (Actual)Interventional2003-04-30Completed
Effects of Pulsatile IV Insulin on Cognitive Deficits in Diabetic Patients [NCT00228865]Phase 2/Phase 375 participants (Actual)Interventional2003-06-30Terminated(stopped due to Administrative)
Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes [NCT00097071]Phase 3299 participants (Actual)Interventional2004-10-31Completed
"A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to Standard of Care Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Unco [NCT02967224]Phase 4705 participants (Actual)Interventional2015-11-05Completed
A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients [NCT00107601]3,500 participants Interventional2004-10-31Completed
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes. A Multi-cen [NCT00282451]Phase 479 participants (Actual)Interventional2006-02-28Completed
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes [NCT03215498]Phase 158 participants (Actual)Interventional2017-07-03Completed
The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study [NCT00264641]20 participants (Actual)Interventional2006-01-31Completed
Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2 Infection and Inflammation in Human Adipose Tissue [NCT05833217]55 participants (Anticipated)Interventional2023-05-02Not yet recruiting
Comparison Of The Outcome Of Treatment of Microneedling With Autologous Platelet- Rich -Plasma Versus Microneedling With Topical Insulin In The Treatment Of Post Acne Atrophic Scars. [NCT06002854]Phase 250 participants (Actual)Interventional2022-08-01Completed
Timing of Meal Insulin Boluses to Achieve Optimal Postprandial Glycemic Control in Patients With Type 1 Diabetes [NCT01693302]23 participants (Actual)Interventional2007-08-31Completed
A Randomized, Double-Blind Controlled Trial Evaluating the Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder [NCT00314314]Phase 360 participants (Anticipated)Interventional2006-05-31Completed
Comparison of Insulin Glargine Mixed With Regular Insulin Versus the Standard Neutral Protamine Hagedorn (NPH) and Regular Insulin in the Treatment of Type 1 Diabetes Mellitus [NCT05709938]Phase 468 participants (Actual)Interventional2019-11-01Completed
[NCT00419302]Phase 216 participants Interventional2003-10-31Completed
An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System [NCT05951569]8 participants (Actual)Observational2023-06-20Completed
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings: A Randomized Controlled Trial [NCT05614089]Phase 4400 participants (Anticipated)Interventional2023-03-15Recruiting
Kisspeptin Influence on Glucose Homeostasis [NCT02953834]Phase 1413 participants (Anticipated)Interventional2017-07-18Recruiting
The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients [NCT00346996]Phase 4179 participants (Actual)Interventional2007-05-31Completed
Insulin Glulisine Administered in a Fixed Bolus Regimen Versus Variable Bolus Regimen Based on Carbohydrate Counting in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin [NCT00135057]Phase 3281 participants Interventional2004-04-30Completed
APIDRA® (Insulin Glulisine) Administered Premeal vs Postmeal in Adult Subjects With Type 2 Diabetes Mellitus Receiving LANTUS® (Insulin Glargine) as Basal Insulin: a Multicenter, Randomized, Parallel, Open Label Clinical Study [NCT00135096]Phase 3345 participants (Actual)Interventional2004-08-31Completed
A Randomized, Double-blind, Parallel, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of Oral GW677954 Capsules (15 mg) in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus [NCT00437164]Phase 21 participants (Actual)Interventional2006-09-30Terminated(stopped due to Company decision not related to safety.)
Therapeutic Effects of Intranasal Insulin Administration in AD [NCT00438568]Phase 2173 participants (Actual)Interventional2006-06-30Completed
Flexible, Intensive vs. Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes - a Non-Blinded, Randomized Controlled Cross-Over Clinical Trial of Metabolic Control and Patient Preference [NCT00440284]Phase 338 participants Interventional2004-01-31Active, not recruiting
Tight Glycemic Control in Acute Exacerbations of COPD [NCT00452296]84 participants (Anticipated)Interventional2007-04-30Active, not recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes [NCT00110864]Phase 290 participants (Anticipated)Interventional2005-05-31Completed
KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients [NCT00115479]Phase 21,200 participants Interventional2002-03-31Completed
Changes of the Infusion Rate in Insulin Pump Treatment. A Randomized, Unblinded Cross-Over Study. [NCT00449839]Phase 410 participants (Actual)Interventional2007-04-30Completed
An Open, Mono-Centre Randomised Controlled Trial to Investigate the Feasibility of Blood Glucose Control With the Software-Algorithm eMPC (Enhanced Model Predictive Control) Via the Arterial-Intravenous Route in Patients at the Medical Intensive Care Unit [NCT00460252]50 participants Interventional2006-05-31Completed
Molecular Regulation of Muscle Glucose Metabolism in Man, Protocol 4 [NCT01240252]Phase 114 participants (Actual)Interventional2012-03-31Completed
Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes [NCT00117780]Phase 4520 participants (Actual)Interventional2005-06-30Completed
The Effects of Spasticity on Glucose Metabolism and Soft Tissue Body Composition in Individuals With Motor Complete and Motor Incomplete Spinal Cord Injury [NCT03859960]33 participants (Actual)Observational2014-09-21Completed
The Effect of Using Terbutaline or a Reduction in Basal Insulin Infusion as a Therapeutic Agent to Prevent Delayed Nocturnal Hypoglycemia in Children and Adolescents With Type 1 Diabetes [NCT00974051]16 participants (Actual)Interventional2008-03-31Completed
Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution. [NCT00497536]Phase 412 participants (Anticipated)Interventional2007-07-31Completed
A Randomized Controlled Trial of Two Versus Three Daily Insulin Injections in Children and Adolescents With New Onset Type 1 Diabetes Mellitus [NCT00146484]Phase 2100 participants Interventional1996-04-30Completed
Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients [NCT03510078]600 participants (Anticipated)Interventional2018-04-17Recruiting
Insulin Analogue Versus Conventional Premixed Insulin in the Treatment of Diabetes Mellitus With Pregnancy: A Prospective Cohort Study [NCT04726631]110 participants (Actual)Interventional2015-01-01Completed
A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Ag [NCT00134147]Phase 31,100 participants Interventional2005-04-30Completed
Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock [NCT00135473]Phase 3600 participants Interventional2003-04-30Completed
Insulin Glargine Plus Insulin Glulisine MDI Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2) Evaluating Differences in Patient Reported Outcomes [NCT00135941]Phase 3582 participants (Actual)Interventional2005-08-31Completed
Inpatient Self Monitoring and Administration Study (ISMAS) [NCT00506272]1 participants (Actual)Interventional2007-12-31Active, not recruiting
Comparison of Carbohydrate Metabolism During the Night and at Hypoglycemia in Type-2 Diabetic Patients Either on Glargine or NPH Insulin [NCT00468364]12 participants (Actual)Observational2003-07-31Completed
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine [NCT00468754]50 participants (Actual)Interventional2003-07-31Completed
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. [NCT05352815]Phase 31,290 participants (Anticipated)Interventional2022-06-01Active, not recruiting
Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation [NCT04742023]Early Phase 140 participants (Actual)Interventional2020-04-21Completed
Comparison of Postprandial Glycemic Control in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus Using Novolog vs. Fiasp Insulin: a Randomized Controlled Open Label Trial [NCT04460326]Phase 3139 participants (Actual)Interventional2020-12-07Completed
The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery [NCT00524472]1,439 participants (Actual)Interventional2007-07-31Completed
Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder [NCT01798914]0 participants Expanded Access2008-10-31No longer available
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes [NCT01773798]Phase 133 participants (Actual)Interventional2013-01-31Completed
Comparison of Early Versus Late Administration of Insulin Glargine in Patients With type1 Diabetes During Fasting Ramadan [NCT04383990]185 participants (Actual)Interventional2020-02-28Completed
Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3 [NCT04820010]20 participants (Actual)Observational2018-10-01Completed
[NCT03030300]Phase 4170 participants (Actual)Interventional2008-01-31Completed
Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes. [NCT02987556]71 participants (Actual)Interventional2017-03-30Completed
Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation [NCT01211730]Phase 4164 participants (Actual)Interventional2009-04-30Completed
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake [NCT01232946]30 participants (Actual)Interventional2012-01-31Completed
Comparison of the Impact of Biphasic Insulin Aspart 30 (BiAsp 30), Biphasic Insulin Aspart 70 (BiAsp 70) and Insulin Aspart on Postprandial Glucose and Lipid Metabolism During Two Consecutive Meals in Type 2 Diabetics. [NCT01293396]Phase 420 participants (Actual)Interventional2010-06-30Completed
Role of Hyperinsulinemia in Non-Alcoholic Fatty Liver Disease (NAFLD) Pathogenesis: Pancreatic Clamp Pilot & Feasibility Study [NCT05724134]Phase 120 participants (Anticipated)Interventional2023-08-29Recruiting
Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections in Type 2 Diabetes [NCT00712478]114 participants (Actual)Observational2007-09-30Completed
Comparison of the Effect of Insulin Detemir Versus Insulin NPH Both With Insulin Aspart on Weight Change in Overweight and Obese Subjects With Type 2 Diabetes [NCT00504673]Phase 3277 participants (Actual)Interventional2005-04-30Completed
Safety and Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Human Insulin 50 in Patients With Type 2 Diabetes Mellitus. [NCT00476437]Phase 381 participants (Actual)Interventional2007-04-30Completed
Pilot Study Investigating the Effects of Insulin Lispro Low Mixture Therapy Compared With Insulin Glargine on Perceived Mood Symptoms in Patients With Type 2 Diabetes Mellitus [NCT00191178]Phase 460 participants Interventional2003-08-31Completed
Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes. [NCT00184626]Phase 497 participants (Actual)Interventional2004-09-10Completed
Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes [NCT00348712]Phase 3301 participants (Actual)Interventional2006-10-30Terminated(stopped due to See termination reason in detailed description)
52-week, Open, Randomized, Multinational, Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients Wi [NCT00174668]Phase 3311 participants (Actual)Interventional2004-11-30Completed
An Open-label, Randomised, In-patient, Cross Over PK/PD Trial Investigating the Pharmackinectic and Pharmacodynamic Profiles Following Continuous Subcutaneous Infusion of Insulin Aspart or Injection of Insulin Glargine in Subjects With Type 2 Diabetes Mel [NCT00184613]Phase 122 participants (Actual)Interventional2005-05-31Completed
Insulin Infusion and Outcomes for Non-Critical Wards [NCT00412347]200 participants (Actual)Observational2006-08-31Completed
Safety/Efficacy Trial Using Stored Serum Samples to Investigate the Immunogenicity of Insulin Aspart and Soluble Human Insulin in Children and Adolescents From Onset of Type 1 Diabetes [NCT00410033]74 participants (Actual)Interventional1989-12-31Completed
Impact of Tight Glycaemic Control With Insulin on Novel Vascular Disease Risk Factors and Myocardial Function and Perfusion in Acute Myocardial Infarction Patients With Hyperglycaemia [NCT00237471]Phase 440 participants Interventional2005-10-31Terminated(stopped due to difficulty recruiting patients)
A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Ins [NCT00960661]Phase 31,036 participants (Actual)Interventional2009-09-30Completed
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Ro [NCT04952779]750 participants (Anticipated)Observational2021-06-02Enrolling by invitation
Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients. [NCT05331469]Phase 470 participants (Anticipated)Interventional2021-07-19Recruiting
[NCT02877771]Phase 110 participants (Actual)Interventional2016-08-31Completed
Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, Parallel Trial to Investigate Long-term Safety [NCT00472953]Phase 338 participants (Actual)Interventional2007-05-15Terminated(stopped due to See termination reason in detailed description)
Hyperinsulinemic Therapy in Sepsis [NCT01244178]15 participants (Anticipated)Interventional2010-11-30Active, not recruiting
A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter [NCT01726621]55 participants (Actual)Interventional2013-03-31Completed
Study to Assess Artificial Intelligence-Assisted Insulin Titration System on Inpatients Glucose Control [NCT04517201]120 participants (Anticipated)Interventional2020-11-04Recruiting
Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients [NCT00505505]Phase 4800 participants (Anticipated)Interventional2002-01-31Recruiting
Effect of Different Doses of Inhaled Technosphere Insulin on Glucose Infusion Rates During Euglycemic Clamps in Comparison to a Subcutaneous Injection of Regular Human Insulin [NCT00511979]Phase 112 participants (Actual)Interventional1999-08-31Completed
Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps [NCT01512680]Phase 252 participants (Actual)Interventional2011-11-30Completed
A 32-week Randomised, Multinational, Treat-to-target, Open Label, Parallel Group Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp) 30 and Basal-bolus Therapy With Insulin Glargine and Insulin Aspart in Insulin naïve Type 2 [NCT02453685]Phase 4335 participants (Actual)Interventional2015-08-31Completed
Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes [NCT01517490]100 participants (Anticipated)Observational2011-08-31Recruiting
A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes [NCT01520753]Phase 316 participants (Actual)Interventional1999-03-31Completed
A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes [NCT01520818]Phase 3666 participants (Actual)Interventional2000-03-31Completed
A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart [NCT01520831]Phase 135 participants (Actual)Interventional1999-04-30Completed
A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male Subjects [NCT01523041]Phase 124 participants (Actual)Interventional1999-11-03Completed
A New Drug Delivery System - Silk Fibroin Film Loaded or Not With Insulin on Palatal Mucosa Wound Healing: in Vitro Study and a Randomized Clinical Trial. [NCT05171400]75 participants (Anticipated)Interventional2021-07-02Recruiting
Insulin-dependent and Exercise-induced Myocellular Signalling in Skeletal Muscle [NCT03203317]8 participants (Actual)Interventional2017-05-01Completed
Oral Insulin Therapy for Prevention of Autoimmune Diabetes [NCT03364868]Phase 21,050 participants (Actual)Interventional2018-02-07Active, not recruiting
A Pilot Study to Describe the Glycaemic Variability of Insulin Glargine 300U/ml Versus NPH (Neutral Protamine Hagedorn) in the Insulin-naïve Type 2 Diabetes Patients Following a Patient-adjusted Insulin Algorithm in Hong Kong [NCT03389490]Phase 450 participants (Actual)Interventional2018-01-01Completed
A Double-blind, Randomised, Two-Period Crossover Trial Comparing the Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes [NCT01526941]Phase 127 participants (Actual)Interventional2001-05-31Completed
A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen W [NCT01526980]Phase 231 participants (Actual)Interventional2002-05-31Completed
The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial. [NCT01678235]Phase 464 participants (Actual)Interventional2011-09-30Completed
A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIBA Once Daily + NovoRapid® Compared to Insulin Detemir Once Daily + NovoRapid®, All in a Basal-bolus Regimen in Subjects With Type 1 Diabet [NCT00841087]Phase 265 participants (Actual)Interventional2009-01-31Completed
Neurologic Biomarkers of Smoking Behavior [NCT03811951]Phase 24 participants (Actual)Interventional2018-09-12Terminated(stopped due to Different study initiation)
The Metabolic and Glycaemic Responses to Reductions in Rapid-acting Insulin Dose After Running Exercise in People With Type 1 Diabetes Mellitus. [NCT01531855]13 participants (Actual)Interventional2012-02-29Completed
A Study Evaluating the Feasibility of Use and Performance of PaQ™ in Patients With Type 2 Diabetes Mellitus Who Are Currently Treated With Basal/Bolus Insulin Therapy [NCT01535612]20 participants (Actual)Interventional2012-03-31Completed
A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 [NCT01536028]Phase 132 participants (Actual)Interventional2006-04-30Completed
Phase 1b Study of Proinsulin (PI) Peptide Immunotherapy in New-Onset Type 1 Diabetes [NCT01536431]Phase 1/Phase 227 participants (Actual)Interventional2012-01-31Completed
A Two-centre, Randomised, Open-labelled, Four-week, Parallel-group Pharmacokinetics Trial in Japanese Type 2 Diabetic Subjects Characterising the Insulin Profile of Thrice Daily Regimen With Biphasic Insulin Aspart 70 (NN2000-Mix70) With Reference to That [NCT01538511]Phase 159 participants (Actual)Interventional2006-06-05Completed
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia [NCT01542424]1,889 participants (Actual)Observational2006-03-31Completed
A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir) and NPH Human Insulin in Japanese Subjects With Type 1 Diabetes Mellitus [NCT01542450]Phase 123 participants (Actual)Interventional2002-08-31Completed
An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes [NCT01542489]480 participants (Actual)Observational2006-10-31Completed
A Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Study in Subjects With Type 1 Diabetes Comparing Insulin Exposure & Response Following Inhalation of Technosphere Insulin Inhalation Powder Using the Gen2C Inhaler Vs Subcutaneous [NCT01544881]Phase 117 participants (Actual)Interventional2012-03-31Completed
A Prospective, Randomized, Open-label, Parallel Group Study to Evaluate Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With Type 1 Diabetes Mellitus [NCT04965051]40 participants (Anticipated)Interventional2021-08-31Recruiting
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days [NCT01547169]Phase 260 participants (Actual)Interventional2011-03-31Completed
An Observational 3-months Study to Evaluate Efficacy and Safety of Insulin Levemir® Used as Basal Insulin on the Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes [NCT01548248]631 participants (Actual)Observational2006-01-31Completed
Evaluation of Insulin Start Therapy Application With Resources and Training (I-START) to Address Barriers to Insulin Therapy [NCT03999268]41 participants (Actual)Interventional2019-11-25Completed
Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy [NCT00099619]Phase 3138 participants (Actual)Interventional2004-09-30Completed
Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes [NCT00104182]Phase 3503 participants (Actual)Interventional2005-02-28Completed
Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data [NCT02003898]372 participants (Actual)Interventional2013-11-26Completed
Efficacy and Safety of Insulin Glulisine Compared With Insulin Lispro in Children and Adolescents With Type 1 Diabetes Mellitus: A 26 Week, Multicenter, Open, Parallel Clinical Trial [NCT00115570]Phase 3572 participants (Actual)Interventional2005-04-30Completed
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery. [NCT01270451]165 participants (Actual)Interventional2008-09-30Completed
South Danish Diabetes Study: A Prospective Randomised Multi-Centre Study for the Evaluation of the Optimal Pharmacological Antidiabetic Treatment of Type 2 Diabetes Mellitus [NCT00121966]Phase 4400 participants Interventional2003-01-31Completed
Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes [NCT00383877]Phase 3263 participants (Actual)Interventional2006-09-30Completed
Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass [NCT01516138]Phase 2930 participants (Actual)Interventional2012-02-29Active, not recruiting
Action to Control Cardiovascular Risk in Diabetes (ACCORD) [NCT00000620]Phase 310,251 participants (Actual)Interventional1999-09-30Completed
Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study [NCT01973413]32 participants (Actual)Interventional2013-07-31Completed
Clinical Assessment of a Closed-loop System With Glucagon, Exercise and Mixed Meals [NCT02397265]24 participants (Actual)Interventional2014-12-03Completed
Morning LANTUS v. Intermediate-acting Insulin 2x/Day as Basal Insulin in a Multiple Daily Inj. w/ Humalog in Adolescents w/ Type 1 Diabetes Mellitus: an Active-controlled, Open, Randomized, Gender-stratified, Two-arm, Parallel-group Study [NCT00046501]Phase 3250 participants Interventional2002-11-30Completed
Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes [NCT05641337]Phase 3184 participants (Anticipated)Interventional2022-10-01Recruiting
"A Twenty-six Week, Randomized, Open-label, 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to Standard of Care Insulin in Basal Insulin Treated Patients With Uncontrolled [NCT02967211]Phase 4609 participants (Actual)Interventional2015-12-21Completed
A Randomised, Multicentric, Open Labelled, Parallel Group Trial With Insulin Aspart and Insulin Detemir, Investigating the Glycaemic Effect and Profile in Children With Type 1 Diabetes, of Two Separate Levemir® + NovoRapid® Injections and Extemporaneous M [NCT00542620]Phase 425 participants (Actual)Interventional2007-09-30Completed
A Phase 2, Exploratory Study to Examine the Effects of Inhaled Insulin, Compared With Subcutaneously Administered Insulin, on Airway Lining Fluid Composition in Subjects With Type 1 Diabetes Mellitus. [NCT00143104]Phase 220 participants Interventional2004-12-31Completed
A Phase 2, Exploratory Study to Examine the Effects of Inhaled Insulin, Compared With Subcutaneously Administered Insulin, on Airway Lining Fluid Composition in Subjects With Type 2 Diabetes Mellitus. [NCT00143338]Phase 220 participants Interventional2004-11-30Completed
Randomized Trial Comparing Insulin Glargine to Ultra-Lente Insulin in Type I Diabetes [NCT00276393]Phase 422 participants Interventional2002-07-31Completed
Comparative Trial Between Insulin Glargine Plus Supplemental Glulisine (Apidra) Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes [NCT00394407]Phase 4130 participants (Actual)Interventional2005-09-30Completed
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120) [NCT01595646]Phase 237 participants (Actual)Interventional2011-11-30Completed
A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec, Both With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes Treated With Basal Insulin [NCT04770532]Phase 3526 participants (Actual)Interventional2021-03-05Completed
Comparison of Glycemic Response to Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes Using Continuous Glucose Monitoring [NCT00869414]16 participants (Actual)Interventional2009-07-31Terminated(stopped due to PI deceased)
The Role of Aldosterone on Sympathetic Nerve Activity and Insulin Sensitivity [NCT02102243]Phase 40 participants (Actual)Interventional2010-11-30Withdrawn(stopped due to No longer interested in study topic)
Pilot Study to Evaluate Glycaemic Control Using GlucoTab® With Insulin Degludec and Aspart in Hospitalized Patients With Diabetes Mellitus Type 2 [NCT03387787]Phase 2/Phase 315 participants (Actual)Interventional2018-01-30Completed
A Study of the Relationship Between the Proportional Insulin Glargine Evening Dose and the Perioperative Serum Glucose Values in Patients With Diabetes Undergoing Surgery [NCT00309465]Phase 4402 participants (Actual)Interventional2005-10-31Completed
Intensive Glucose Control Versus Conventional:Tendency Of Better Clinical Outcome In Open Heart Surgery [NCT00370643]Phase 198 participants Interventional2002-10-31Completed
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes [NCT00065130]Phase 327 participants (Actual)Interventional2000-04-30Completed
Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabete [NCT00071448]Phase 3378 participants (Actual)Interventional2002-06-30Completed
Intranasal Insulin and Memory in Early Alzheimer's Disease [NCT00581867]Phase 1/Phase 231 participants (Actual)Interventional2007-10-31Completed
Acute Insulin Effects on Cardiac Function in Patients With Diabetes Mellitus [NCT02962921]Phase 46 participants (Actual)Interventional2003-02-28Completed
Does Reduction of Hyperglycemia With Insulin Impact Restenosis and Improve Clinical Outcomes Following PCI? [NCT00412126]240 participants Interventional2002-07-31Completed
A Multi-Center, Open Label Randomized Stratified Controlled Trial of the Effects of Blood Glucose Management on 90-Day All-Cause Mortality in a Heterogenous Population of Intensive Care Unit (ICU) Patients. [NCT00220987]Phase 46,104 participants (Actual)Interventional2005-04-30Completed
A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety [NCT01683266]Phase 3549 participants (Actual)Interventional2012-09-30Completed
Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices [NCT04726657]36 participants (Actual)Interventional2016-01-18Completed
Effect of Ultrasonographic Guided Insulin Injection With Dexamethasone and Local Anesthetic Mixture in Diabetic Patients With Mild to Moderate Carpal Tunnel . [NCT04781777]250 participants (Anticipated)Interventional2021-03-01Not yet recruiting
Does the Use of Faster Insulin Aspart vs. Aspart Lead to the Prolonged Glycemic Time in Range in Children Suffering From Type 1 Diabetes Who Use Continuous Glucose Monitoring? [NCT04772729]Phase 477 participants (Anticipated)Interventional2021-03-01Not yet recruiting
Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection [NCT03212833]50 participants (Anticipated)Observational2017-05-01Recruiting
Effect of Hyperglycemia in PAI-1 Activity and the Relationship With Outcome in Severe Sepsis and Septic Shock [NCT00159952]Phase 2/Phase 390 participants (Actual)Interventional2004-11-30Completed
Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes: A Comparison of Premeal Insulin Lispro Mixtures to Once-Daily Insulin Glargine [NCT00191464]Phase 4320 participants Interventional2003-12-31Completed
Comparison of 2-Hour Postprandial Blood Glucose Excursion in Response to a Standard Test Meal in Insulin-Requiring Diabetic Patients Treated Twice Daily With Either Insulin Lispro Mix 50/50 or Human Insulin Mix 50/50 [NCT00191581]Phase 3120 participants Interventional2005-03-31Completed
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes [NCT00095082]Phase 3447 participants (Actual)Interventional2004-09-30Completed
Prospective Comparison of Early Subcutaneous Insulin Glargine Plus Standard of Care Versus Standard of Care for Treatment of Diabetic Ketoacidosis in the Emergency Department [NCT02930044]18 participants (Actual)Interventional2016-10-31Completed
My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin [NCT04678661]180 participants (Actual)Interventional2021-02-15Completed
The I-KAN Study: Internet Initiation of Insulin for Type 2 Diabetes in Kansas [NCT01408628]51 participants (Actual)Interventional2011-08-31Completed
A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus [NCT02392117]1,262 participants (Actual)Observational2015-03-16Completed
A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diab [NCT04795531]Phase 3588 participants (Actual)Interventional2021-03-24Completed
KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients [NCT00214916]Phase 2700 participants (Actual)Interventional2004-10-31Active, not recruiting
Evaluation Of Hybrid Closed Loop (HCL) System On-Boarding Protocol, For Patients With Type 1 Diabetes On Multiple Daily Insulin Injections (MDI) Therapy [NCT04145804]40 participants (Anticipated)Interventional2020-01-01Recruiting
Randomized, Cross Over, Controlled, Multi-centric Study to Assess Whether Type 1 Diabetic Patients in Sub-optimal Glycemic Control Can Improve Using the Continuous Glucose Values of the MiniMed Paradigm REAL-Time Insulin Pump System Versus the MiniMed Par [NCT00598663]153 participants (Actual)Interventional2008-01-31Completed
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study [NCT05220917]781,430 participants (Anticipated)Observational2021-08-01Active, not recruiting
A Prospective, Multicentric, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog Glargine Plus Glulisine With Premixed Insulin in Adult Patients With Type 2 Diabetes Mellitus [NCT02987751]Phase 4200 participants (Actual)Interventional2016-12-29Completed
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, PK and PD of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With T2DM Who Are Inadequately Controlled With Diet and Exercise or Diet, Exercise and Metformin [NCT01889667]Phase 230 participants (Actual)Interventional2013-06-30Completed
A Phase 3, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With a Basal Insulin Versus Insulin Aspart in Combination With a Basal Insulin in [NCT01445951]Phase 3518 participants (Actual)Interventional2011-09-30Completed
Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System [NCT01271023]Phase 157 participants (Actual)Interventional2011-03-31Completed
An Open-label, Multicenter, Randomized, Crossover Study, to Assess 4 Weeks Outpatient, the Clinical Efficacy of the Diabeloop Closed-loop Glucose Control Without the Declaration of Meals Compared With the Diabeloop Closed-loop Glucose Control With the Dec [NCT04725591]50 participants (Anticipated)Interventional2023-01-19Recruiting
Exploration of the Weight Neutral Effects of Insulin Detemir Compared to Insulin Glargine: A Measure of Satiety and Calories Consumed in Type 1 Diabetes [NCT00659165]10 participants (Actual)Interventional2008-04-30Completed
Open, Controlled, and Randomized Cross-Over Pilot Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes Mellitus [NCT04591925]13 participants (Actual)Interventional2021-02-05Terminated(stopped due to Interim analysis)
Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy [NCT00821795]Phase 4120 participants (Actual)Interventional2009-03-11Completed
Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD) [NCT00835861]Phase 231 participants (Actual)Interventional2008-08-31Completed
Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer. Randomized Controlled Trial [NCT05444842]45 participants (Anticipated)Interventional2022-07-05Not yet recruiting
Cost Effectiveness of Glargine Insulin Versus NPH Insulin in Diabetic Patients in Iran [NCT01832935]Phase 4200 participants (Actual)Interventional2011-07-31Completed
Impact of Blood Glucose at the First Trimester of Pregnant Women With Gestational Diabetes on Maternal and Fetal Outcomes and Metabolic Disorders: a Multi-central Prospective Cohort Study [NCT01833559]3 participants (Anticipated)Interventional2012-06-30Recruiting
The Impact of Insulin Pump Therapy to Oxidative Stress in Patients With Diabetic Nephropathy [NCT03174821]160 participants (Actual)Interventional2010-10-20Completed
A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy [NCT01720303]Phase 4159 participants (Actual)Interventional2002-09-19Completed
Comparison of Effectiveness of Glulisine and Lispro in Decreasing Post-Prandial Hyperglycemia in a Real-World Setting [NCT01621776]107 participants (Actual)Interventional2011-06-30Completed
Randomized Study of the Impact of Peri-operative Glucose Control on Short Term Renal Allograft Function After Transplantation [NCT01643382]60 participants (Actual)Interventional2012-08-31Completed
Closed-loop Insulin Delivery by Glucose Responsive Computer Algorithms In Type 1 Diabetes Pregnancies (CIRCUIT) [NCT04902378]90 participants (Anticipated)Interventional2021-06-15Recruiting
Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold [NCT04876079]30 participants (Actual)Interventional2021-06-01Completed
Early Nutritional Intake and Growth in Very Preterm or Very Low Birth Weight Infants: a Prospective Cohort Study [NCT04143204]180 participants (Actual)Observational2019-08-01Completed
A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy. [NCT04754334]Phase 3346 participants (Actual)Interventional2021-03-16Terminated(stopped due to The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.)
An Open Label,Randomized,Comparison of the Immunogenicity and Safety of Wockhardt's Human Insulin Basal Bolus Regimen With the Novo Nordisk's Yeast Based Human Insulin Basal Bolus Regimens, Marketed in United States, in Type 1 Diabetics. [NCT01308437]Phase 3134 participants (Actual)Interventional2011-03-31Terminated(stopped due to Business reasons)
Insulin Delivery Using Microneedles in Type 1 Diabetes [NCT00837512]Phase 2/Phase 316 participants (Actual)Interventional2008-09-30Completed
Quality of Life With and Without Pulsatile IV Insulin Therapy in Diabetes. [NCT00228878]Phase 2/Phase 3152 participants (Actual)Interventional2003-03-31Terminated(stopped due to Administrative)
A 16-week, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine Versus Lantus in Patients With Type 1 Diabetes Mellitus [NCT01658579]Phase 259 participants (Actual)Interventional2012-08-31Completed
A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type [NCT02213146]Phase 1/Phase 238 participants (Actual)Interventional2014-08-31Completed
Study on the Feasibility and Treatment Experience of Community Doctors in Shenzhen Guided by Specialists to Use Basic Insulin in the Treatment of Adult Type 2 Diabetes Mellitus [NCT04553380]150 participants (Anticipated)Interventional2020-12-01Not yet recruiting
Pilot Study Evaluating Use of Insulin-Glucose Algorithm and Glucose Monitoring Techniques to Control Hyperglycemia in the Pediatric Intensive Care Unit [NCT00240149]0 participants Interventional2005-10-31Completed
A 24-Week Randomised, Double-Blind, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Insulin [NCT00242372]Phase 3370 participants Interventional2004-08-31Terminated(stopped due to The development program has been terminated)
Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes [NCT00284232]Phase 4140 participants Interventional2004-10-31Completed
A Randomized Cross-Over Single Centre Study Comparing the Effects of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus Patients [NCT00286962]Phase 324 participants (Actual)Interventional2006-02-28Completed
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes [NCT01682902]Phase 143 participants (Actual)Interventional2012-09-30Completed
Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy [NCT02272348]13 participants (Actual)Interventional2015-02-10Terminated(stopped due to Change in methodology too important - end of randomization)
Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG). [NCT00272064]Phase 3352 participants (Actual)Interventional2005-10-31Completed
[NCT00292890]50 participants Interventional2004-01-31Completed
Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation [NCT00779701]Phase 427 participants (Actual)Interventional2007-03-31Completed
Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes [NCT00274274]Phase 4373 participants (Actual)Interventional2005-09-30Completed
Outcomes With Use Of Intensive Insulin Therapy In Intraoperative Management Of Hyperglycemia In Adult Patients Undergoing Cardiac Surgery [NCT00282698]Phase 3400 participants Interventional2004-07-31Completed
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes [NCT00283751]Phase 3583 participants (Actual)Interventional2003-03-31Completed
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes [NCT00312156]Phase 3347 participants (Actual)Interventional2002-08-31Completed
Open-Label Randomized Two-Way Crossover Pilot Study To Estimate The Effects Of Inhaled Versus IV Infusion Of Human Insulin With Regards To Glucose Disposal In Subjects With Type 1 Diabetes Mellitus [NCT00287066]Phase 322 participants Interventional2006-02-28Terminated(stopped due to See termination reason in detailed description.)
[NCT00287456]0 participants (Actual)Interventional2006-02-02Withdrawn
Fully Closed-Loop Insulin Delivery in Abdominal Surgery: a Randomised Controlled Two-centre Trial (CLAB-Study) [NCT05392452]38 participants (Actual)Interventional2022-08-09Active, not recruiting
Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study [NCT00288743]Phase 230 participants Interventional2002-09-30Completed
Effect of an Intensive Insulin Therapy on the Production of LTE4 in Patients With Diabetes [NCT00324792]45 participants (Anticipated)Interventional2006-05-31Completed
A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficien [NCT01768559]Phase 3894 participants (Actual)Interventional2013-01-31Completed
Intensified Insulin Treatment and Skin Microcirculation; Its Relation to Ischemic Foot Ulcer in Patients With Type 1 Diabetes Mellitus: A Long-term Follow-up Study [NCT01957930]91 participants (Actual)Interventional1984-01-31Completed
A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma [NCT00332826]Phase 33 participants (Actual)Interventional2006-06-30Terminated(stopped due to Non-safety related business decision to combine special population protocols)
Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability [NCT01439672]35 participants (Actual)Interventional2010-08-31Completed
Dietary Glycemic Index, Brain Function and Food Intake in Patients With Type 1 Diabetes Mellitus [NCT02772783]15 participants (Actual)Interventional2016-07-31Completed
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes. [NCT00312104]Phase 3325 participants (Actual)Interventional2002-04-30Completed
Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes [NCT00343980]Phase 3363 participants (Actual)Interventional2006-10-10Terminated(stopped due to See termination reason in detailed description)
[NCT00348231]60 participants Interventional2004-11-30Recruiting
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes [NCT00891995]Phase 2/Phase 371 participants (Actual)Interventional2010-09-30Terminated(stopped due to Primary outcome evaluation determined lack of treatment group difference)
Effects of Insulin Resistance in Non-diabetic Acute Coronary Syndrome Patients by the Homeostasis Model Assessment Index (HOMA2-IR) [NCT06163768]1 participants (Anticipated)Interventional2023-12-31Recruiting
A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties [NCT01497535]Phase 140 participants (Actual)Interventional2004-05-27Completed
A Randomised, Double-blind, Four-period, Cross-over, Dose Response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 2 Diabetes [NCT01497561]Phase 115 participants (Actual)Interventional2003-03-31Completed
A Single-centre, Randomised, Double-blind, Cross-over Trial Comparing the Within-subject Variability of the Pharmacokinetic Profiles of Insulin Detemir and Insulin Glargine in Children and Adolescents With Type 1 Diabetes [NCT01497574]Phase 132 participants (Actual)Interventional2005-05-31Completed
A Randomised, Double-blind, Six-period, Cross-over, Dose-response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects of Blacks or African American, Whites of Hispanic or Latino Orig [NCT01497600]Phase 150 participants (Actual)Interventional2004-02-29Completed
A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects [NCT01498926]Phase 134 participants (Actual)Interventional2005-11-30Completed
[NCT01500928]40 participants (Anticipated)Interventional2011-07-31Recruiting
Performance Evaluation of BGStar and iBGStar in Terms of Accuracy (Polaris), Intra-assay Precision, and Hematocrit Interference (Helios Substudy) Following ISO15197 and TNO Guidelines [NCT01504620]Phase 4106 participants (Actual)Interventional2011-01-31Completed
A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection [NCT01511159]Phase 132 participants (Actual)Interventional2001-10-31Completed
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes [NCT01618188]Phase 152 participants (Actual)Interventional2012-06-11Completed
A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Characterizing the Pharmacokinetics and Pharmacodynamics of NN-X14Mix50 and NN-X14Mix70 in Healthy Male Subjects [NCT01620333]Phase 124 participants (Actual)Interventional2000-02-29Completed
A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Investigating the Pharmacokinetics and Pharmacodynamics of NN-X14Mix30 and NN-X14Mix50 in Type 2 Diabetic Patients [NCT01620424]Phase 110 participants (Actual)Interventional2001-02-28Completed
A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects [NCT01620450]Phase 134 participants (Actual)Interventional2004-11-20Completed
Intraperitoneal Insulin Administration as Alternative for Intensive Subcutaneous Insulin Therapy in Patients With Type 1 Diabetes Mellitus. [NCT01621308]190 participants (Actual)Observational2012-12-31Completed
Safety of Topical Insulin Eye Drops for the Treatment of Open-angle Glaucoma [NCT04118920]Phase 118 participants (Anticipated)Interventional2023-03-27Recruiting
A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects [NCT01623375]Phase 118 participants (Actual)Interventional2012-06-30Completed
French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients [NCT01628341]4,424 participants (Actual)Observational2012-05-31Completed
[NCT01629251]Phase 28 participants (Actual)Interventional2011-04-30Completed
An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment Simulating Non-compliant Behaviours in Adolesc [NCT01629277]Phase 212 participants (Actual)Interventional2011-07-31Completed
Multicenter, Open, Non-randomized 6 Months Study to Evaluate Efficacy and Safety Insuman® Basal, Insuman® Comb 25, Insuman® Rapid in Insulin-naÏve Patients With T2DM Who Received Baseline Education Course in the Diabetes School. [NCT01630369]Phase 4552 participants (Actual)Interventional2012-02-29Completed
Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia and Hyperglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting [NCT01638299]Phase 120 participants (Actual)Interventional2012-07-31Completed
A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers [NCT01638325]Phase 137 participants (Actual)Interventional2012-07-31Completed
Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia [NCT01648218]Phase 45 participants (Actual)Interventional2012-08-31Terminated(stopped due to Poor enrollment)
An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects [NCT01650129]Phase 383 participants (Actual)Interventional2000-12-13Completed
Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes. [NCT01662921]Phase 217 participants (Actual)Interventional2013-04-30Completed
A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients [NCT01476475]Phase 2323 participants (Actual)Interventional2011-11-30Completed
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia [NCT00500240]Phase 352 participants (Actual)Interventional2004-04-30Terminated(stopped due to Terminated early due to futility.)
A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy [NCT04450407]Phase 2266 participants (Actual)Interventional2020-07-06Completed
Comparing the Effects of Insulin Glargine on Peripheral Blood Glucose Between Needle-free Jet Injection and Conventional Insulin Pen [NCT04074603]150 participants (Actual)Interventional2019-09-01Completed
Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. ACARB-GDM Study. [NCT03380546]Phase 3341 participants (Actual)Interventional2018-07-04Active, not recruiting
[NCT00004825]10 participants Interventional1998-05-31Completed
YpsoPump Occlusion Detection Algorithm: Collection of Real-world Data for In-silico Evaluation of a New Software Algorithm to Refine Occlusion Detection in Subjects With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion [NCT05096325]40 participants (Actual)Observational2022-01-03Completed
6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus [NCT02735044]Phase 3463 participants (Actual)Interventional2016-04-14Completed
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension [NCT01499082]Phase 3807 participants (Actual)Interventional2011-12-31Completed
A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Dia [NCT01697618]Phase 213 participants (Actual)Interventional1997-04-30Completed
Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, O [NCT01697631]Phase 4131 participants (Actual)Interventional2002-07-22Completed
A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen [NCT01697657]Phase 3131 participants (Actual)Interventional2001-09-30Completed
A Trial Comparing the Effect of Exercise on Blood Glucose Between Insulin Degludec and Insulin Glargine in Subjects With Type 1 Diabetes [NCT01704417]Phase 140 participants (Actual)Interventional2012-10-31Completed
An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic [NCT01707134]Phase 3753 participants (Actual)Interventional1997-09-30Completed
A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers [NCT01707160]Phase 124 participants (Actual)Interventional1995-11-30Completed
Control-IQ 2.0 Feasibility Study #2: Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes [NCT05683392]72 participants (Actual)Interventional2023-02-01Completed
New Strategies for Automated Glycaemic Control: the Issue of Continuous Glucose Monitoring Accuracy Under Hypoglycaemic Conditions [NCT01714895]14 participants (Actual)Interventional2011-10-31Completed
Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. An Efficacy Study. [NCT01715090]73 participants (Actual)Interventional2012-12-31Completed
Efficacy, Safety and Satisfaction of the New Pen Needle 33G x 4 mm 33G x 4 mm: Cross-over Randomized Controlled Clinical Trial. Studio AGO 01 [NCT01745549]87 participants (Actual)Interventional2012-12-31Completed
Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations. [NCT01754181]Phase 318 participants (Actual)Interventional2013-03-31Completed
A Randomized Controlled Trial to Evaluate Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes: REmission Studies Evaluating Type 2 DM - Intermittent Insulin Therapy (RESET-IT Pilot Study) [NCT01755468]Phase 324 participants (Actual)Interventional2013-04-30Completed
Gestational Diabetes in Non Obese Women and Metformine [NCT01756105]Phase 284 participants (Anticipated)Interventional2012-06-30Terminated
Evaluation of Galvus (Vildagliptin) Efficacy Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled by Metformin and Basal Insulin, This One Having Been Properly Titrated. [NCT01757587]Phase 439 participants (Actual)Interventional2011-12-31Completed
A Single-Center, Multiple-dose, Randomized, Cross-Over, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics, Safety, and Tolerability of Oshadi Icp In Patients With Type 1 Diabetes Mellitus - Phase Ib Clinical Study [NCT01772251]Phase 1/Phase 210 participants (Actual)Interventional2013-02-28Completed
A Randomised Study to Assess the Efficacy and Safety of Automated Closed-loop Glucose Control in Insulin Treated Type 2 Diabetes (Phase 1), Inpatient Hyperglycaemia Requiring Subcutaneous Insulin Therapy (Phase 2 and Phase 3) and to Evaluate Use of Closed [NCT01774565]43 participants (Actual)Interventional2016-08-31Completed
Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy on β-cell Function and Glycemic Remission Rate in Newly Diagnosed Type 2 Diabetic Patients [NCT01776788]Phase 4156 participants (Actual)Interventional2012-08-31Completed
Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes: The AP Ski Camp Continued [NCT03369067]55 participants (Actual)Interventional2017-12-18Completed
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan [NCT02648217]Phase 3263 participants (Actual)Interventional2016-01-04Completed
INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes [NCT05904743]Phase 4141 participants (Actual)Interventional2023-06-29Active, not recruiting
Intranasal Insulin: A Novel Treatment for Gulf War Multisymptom Illness [NCT01802944]Phase 2114 participants (Anticipated)Interventional2014-04-30Recruiting
Effects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot Study [NCT01804413]10 participants (Anticipated)Interventional2011-03-31Recruiting
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects [NCT01809184]Phase 184 participants (Actual)Interventional2013-03-04Completed
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration [NCT01811849]Phase 112 participants (Actual)Interventional2012-08-31Completed
A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options [NCT00330473]Phase 31,019 participants (Actual)Interventional2006-06-30Completed
[NCT01825720]106 participants (Actual)Interventional2013-03-31Completed
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes [NCT02500706]Phase 31,108 participants (Actual)Interventional2016-05-04Completed
Dapagliflozin Effect in Cognitive Impairment in Stroke Trial [NCT05565976]Phase 2/Phase 3270 participants (Anticipated)Interventional2020-08-01Recruiting
Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Diabetes [NCT04588259]Phase 3331 participants (Actual)Interventional2020-10-09Completed
Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT) [NCT02558829]Phase 3157 participants (Actual)Interventional2015-12-03Completed
A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes [NCT01392573]Phase 3413 participants (Actual)Interventional2011-11-28Completed
A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections [NCT05462756]Phase 3730 participants (Actual)Interventional2022-08-11Active, not recruiting
Is Premixed Insulin Therapy an Alternative to Basal Bolus Therapy in Type 2 Diabetes Mellitus People Older Than 65 Years Old: A Pilot Randomised Trial [NCT04739241]Phase 460 participants (Actual)Interventional2014-01-24Completed
Dysglycemia and COVID-19 Disease: A Reciprocal Relationship. Can Intensive Insulin Therapy Cut This Vicious Circle? [NCT05441631]Phase 1436 participants (Actual)Interventional2020-04-01Completed
Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D [NCT04335513]84 participants (Anticipated)Interventional2020-04-30Enrolling by invitation
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes [NCT04259775]0 participants (Actual)Interventional2022-09-30Withdrawn(stopped due to Needed FDA approval)
A Comparison of LY2605541 Once Daily at a Fixed Time With LY2605541 Variable Time of Dosing in Participants With Type 1 Diabetes Mellitus: An Open Label, Randomized, Crossover Study [NCT01792284]Phase 3212 participants (Actual)Interventional2013-02-28Completed
A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes [NCT03449433]Phase 180 participants (Actual)Interventional2018-03-15Completed
An Open-label, Single-centre, Randomised, Two-period, Cross-over Study to Assess the Efficacy and Safety of Day and Night Automated Closed-loop Glucose Control for 24 Hours in Adults With Type 1 Diabetes Comparing Faster-acting Insulin Aspart With Insulin [NCT03579615]18 participants (Actual)Interventional2020-12-23Completed
The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients [NCT01810952]Phase 437 participants (Actual)Interventional2010-09-30Completed
Use of Neutral Protamine Hagedorn (NPH) Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia [NCT03511521]Phase 43 participants (Actual)Interventional2018-03-27Terminated(stopped due to Unable to recruit sufficient number of patients)
A 24 Week Randomised, Open Label, 3 Parallel-group Comparison of Once and Twice Daily Biphasic Insulin Aspart (BIAsp) 30 Plus Sitagliptin and Twice Daily BIAsp 30, All in Combination With Metformin in Insulin naïve Type 2 Diabetic Subjects Inadequately Co [NCT01519674]Phase 4582 participants (Actual)Interventional2012-06-30Completed
The Effect of Gastric Emptying on Blood Glucose Profile of Type 1 Diabetes Mellitus and Its Therapeutic Strategies [NCT06173934]50 participants (Anticipated)Interventional2023-12-01Recruiting
Bioequivalence Studyof INS062 Injection and NovoRapid ®in Healthy Subjects and Pharmacokinetics and Pharmacodynamics Study of Single Subcutaneous Injection of HR20014 in Healthy Subjects [NCT05719961]Phase 160 participants (Anticipated)Interventional2023-01-05Recruiting
Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes [NCT04938557]124 participants (Actual)Interventional2019-09-26Completed
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders [NCT03943537]Phase 290 participants (Anticipated)Interventional2019-10-01Recruiting
[NCT00358553]Phase 10 participants InterventionalCompleted
Diabetes Control and Complications Trial (DCCT) [NCT00360815]1,441 participants Interventional1983-08-31Completed
A Randomized, Active Control, Multi-Center Study Comparing the Effect of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration on Glycemic Control and the Frequency of Severe Hypoglycemia [NCT00211536]Phase 3107 participants (Actual)Interventional2002-06-30Completed
Evaluation of Continuous Blood Glucose Monitoring Method for Detection of Alterations in Glucose Homeostasis in Beta Thalassemia Patients [NCT03591900]200 participants (Actual)Interventional2014-04-30Completed
Evaluation of the Clinical and Economic Outcomes Associated With Exenatide Versus Basal Insulin in People With Type 2 Diabetes [NCT02987348]18,000 participants (Actual)Observational2015-06-30Completed
A Clinical Trial to Prevent New Onset Diabetes After Transplantation [NCT01683331]Phase 4251 participants (Actual)Interventional2012-08-31Completed
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline - a PET Study in Healthy Human Subjects [NCT01435213]Phase 110 participants (Actual)Interventional2011-09-30Completed
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects [NCT01437592]Phase 124 participants (Actual)Interventional2011-09-06Completed
Pharmacology of Rapid-acting Insulin Injected by Needle-free Jet-injection in Patients With Diabetes [NCT01438632]Phase 424 participants (Actual)Interventional2011-09-30Completed
An Open-label, Three-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Real-time Continuous Subcutaneous Glucose Monitoring Combined With Overnight Closed-loop Glucose Control in the Home Setting in Comparison W [NCT01440140]Phase 224 participants (Actual)Interventional2012-12-31Completed
Impact of Insulin Detemir Versus Insulin Glargine on Glycaemic Control and Metabolism During Exercise in Type 1 Diabetes [NCT01440439]Phase 430 participants (Anticipated)Interventional2011-11-30Recruiting
Evaluation of Interests of the Functional Insulin Therapy (FIT Therapy) on Metabolic Control, Hypoglycemia Prevention and Life Quality of Diabetics Children Insulin-dependent Treated With Insulin Pump. [NCT01443741]Phase 288 participants (Anticipated)Interventional2012-01-31Not yet recruiting
[NCT01446120]Phase 17 participants (Anticipated)InterventionalNot yet recruiting
Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care: A Randomized, Prospective, Controlled Study in Ealing, United Kingdom [NCT02271594]31 participants (Actual)Interventional2015-01-31Terminated
The Effect of Sensor-Augmented Continuous Subcutaneous Insulin Infusion Compared to Multiple Daily Insulin Injections in Prevention of Increasing Urinary Albumin Excretion Rate in Type 1 Diabetes Mellitus [NCT01454700]Phase 460 participants (Actual)Interventional2011-12-31Completed
Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation [NCT05153395]Early Phase 127 participants (Anticipated)Interventional2021-12-01Recruiting
Diluted Insulin in Young Children: Bigger Volumes for Smaller Patients [NCT03666065]Early Phase 13 participants (Actual)Interventional2020-01-01Completed
Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on IGFBP-1 Production and Serum IGF-I in Subjects With Type 1 Diabetes Mellitus: An Open-label, Randomised, Triple Cross-over Trial [NCT01461616]Phase 319 participants (Actual)Interventional2012-02-29Completed
A Single Center, Randomized, Double-blind, Balanced Two-period Cross-over Trial to Test for Bioequivalence Between a Marketed NovoLog® Formulation Containing 100 U/mL Versus a New NovoLog® Formulation Containing 200 U/mL in a Combined Regimen of a Continu [NCT01464099]Phase 124 participants (Actual)Interventional2008-06-30Completed
Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial [NCT01467141]Phase 426 participants (Actual)Interventional2002-06-19Completed
An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects [NCT01467323]Phase 3303 participants (Actual)Interventional1998-04-30Completed
A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes [NCT01467401]Phase 4292 participants (Actual)Interventional2002-08-19Completed
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 2 Diabetes [NCT01467414]Phase 11 participants (Actual)Interventional2011-10-31Terminated(stopped due to This trial was terminated due to low recruitment)
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes [NCT01469143]Phase 140 participants (Actual)Interventional2011-11-30Completed
Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study [NCT06072963]Phase 280 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Insulin Modulation of fMRI Connectivity and Food Reward [NCT02982551]Early Phase 10 participants (Actual)Interventional2016-01-01Withdrawn(stopped due to Principal Investigator Departed University)
The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin With Insulin Lispro: a Double-Blind, Randomized, 26-week Study - The IMAGINE 4 Study [NCT01468987]Phase 31,369 participants (Actual)Interventional2011-12-31Completed
Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control in Elective Laparotomy Surgeries [NCT05136157]Early Phase 160 participants (Actual)Interventional2021-11-01Completed
The Insulin-Only Bionic Pancreas Bridging Study [NCT03565666]Phase 2/Phase 336 participants (Actual)Interventional2018-07-09Completed
A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma [NCT00157339]Phase 3299 participants (Actual)Interventional2005-08-31Completed
Intra-Arterial Microdosing: Proof-of-Concept in Humans [NCT02304211]Early Phase 110 participants (Actual)Interventional2014-12-31Completed
The Effect of a Checklist on the Quality of Education During Insulin Initiation by Trained Medical Students: a Randomized Controlled Trial [NCT02313805]100 participants (Anticipated)Interventional2014-07-31Recruiting
OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy [NCT01182493]331 participants (Actual)Interventional2010-12-31Completed
Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Clinic in China [NCT04129424]180 participants (Anticipated)Interventional2019-12-01Not yet recruiting
[NCT00875459]Phase 3233 participants (Actual)Interventional2007-04-30Completed
New Onset Type 1 Diabetes: Role of Exenatide [NCT01269034]Phase 413 participants (Actual)Interventional2010-12-31Completed
Sitagliptin for the Prevention and Treatment of Hyperglycemia in Patients With Type 2 Diabetes Undergoing Cardiac Surgery [NCT02556918]Phase 4202 participants (Actual)Interventional2016-01-31Completed
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Ther [NCT05463744]Phase 3692 participants (Actual)Interventional2022-08-12Active, not recruiting
Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial [NCT01147627]416 participants (Actual)Interventional2010-08-31Completed
Validation of a Novel Screening Test for Maternal Insulin Resistance and Predicting Maternal Fetal Outcomes: A Pilot Study. [NCT03388697]100 participants (Actual)Observational2017-12-15Completed
Survey of Practices on the Management of Glycemia in Patients Hospitalized in Intensive Care Units [NCT05775770]525 participants (Anticipated)Observational2023-03-20Recruiting
The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1) [NCT00004984]Phase 3711 participants (Actual)Interventional1994-02-28Completed
A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections [NCT04125082]Phase 429 participants (Actual)Interventional2019-02-27Active, not recruiting
[NCT01409239]Phase 442 participants (Actual)Interventional2011-07-31Completed
Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery. [NCT01257087]35 participants (Actual)Interventional2010-12-31Completed
A Phase IV Study of Teneligliptin (MP-513) in Combination With Insulin in Japanese Patients With Type 2 Diabetes Mellitus [NCT02081599]Phase 4148 participants (Actual)Interventional2014-01-31Completed
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes [NCT01924637]Phase 136 participants (Actual)Interventional2013-08-31Completed
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 (EE-ASI-1): A Phase 1a Study of Gold Nanoparticles Administered Intradermally by Microneedles to Deliver Immunotherapy With a Proinsulin Derived Peptide in Type 1 Diabetes [NCT02837094]Phase 16 participants (Actual)Interventional2016-09-29Completed
Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy. [NCT05321251]Phase 2/Phase 360 participants (Anticipated)Interventional2022-06-01Recruiting
A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal [NCT04880850]Phase 3582 participants (Actual)Interventional2021-05-14Completed
Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes [NCT04617795]24 participants (Actual)Interventional2020-11-23Completed
Prospective Study, Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel. [NCT01883024]6 participants (Actual)Interventional2013-06-30Completed
A 26-Week, Multi-Center, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-Term Intensive Insulin Therapy: Basal Insulin Based Treatment (With Prandial O [NCT03359837]Phase 4384 participants (Actual)Interventional2018-01-20Completed
Effects of High-intensity Interval Training on Cardiorespiratory Performance and Substrate Oxidation in Insulin-resistant and Insulin-sensitive Obese Adolescents: A Before-and-after Clinical Study [NCT03042234]25 participants (Actual)Interventional2017-07-08Completed
Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere [NCT01459133]0 participants (Actual)Interventional2013-05-31Withdrawn(stopped due to Unable to register Treatment IND with the US Food And Drug Administration's new process of establishing TLS encryption for email correspondence.)
The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitoring (CGM) [NCT04414579]Phase 445 participants (Anticipated)Interventional2019-03-27Recruiting
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus [NCT02607306]Phase 3819 participants (Actual)Interventional2015-11-18Completed
Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes [NCT02120794]194 participants (Actual)Interventional2014-06-30Completed
Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial [NCT00091507]Phase 3911 participants (Actual)Interventional2006-11-30Completed
Efficacy and Safety Of Different Hypoglycemic Regimens Compared With Premixed Insulin In Patients With Type 2 Diabetes Receiving Short-term Intensive Insulin Therapy [NCT05545800]Phase 378 participants (Anticipated)Interventional2022-09-01Recruiting
An Immune Efficacy Study for Primary Prevention Using Intranasal Insulin Therapy in Islet Autoantibody Negative Children at High Genetic Risk for Type 1 Diabetes [NCT03182322]Phase 238 participants (Actual)Interventional2018-05-25Completed
Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia According to the Composition of the Meal in Adolescents With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion [NCT03179280]10 participants (Actual)Interventional2011-03-31Completed
A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism [NCT02563834]18 participants (Actual)Interventional2007-01-31Completed
A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents [NCT00282971]Phase 3354 participants (Actual)Interventional2006-03-06Terminated(stopped due to Terminated as marketing of this product will be discontinued)
Investigation of Appropriate Timing of Additional Insulin Dosing for Fat and Protein in Children With Type 1 Diabetes Using Multiple Daily Injections [NCT02680054]Phase 438 participants (Actual)Interventional2016-02-29Terminated(stopped due to No eligible participants left to approach/ recruit)
Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling [NCT01684943]33 participants (Actual)Interventional2010-07-31Completed
A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED) [NCT02535715]Phase 211 participants (Actual)Interventional2015-01-31Completed
Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1 [NCT02580877]Phase 292 participants (Actual)Interventional2016-01-31Completed
Insulinsensitivität Des Menschlichen Zentralnervensystems Mit Fortschreitendem Alter: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin [NCT04372849]70 participants (Actual)Interventional2017-04-28Completed
Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes - the HypoADAPT Study [NCT05095259]60 participants (Anticipated)Interventional2019-12-16Active, not recruiting
An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of Overnight Closed-loop Insulin Delivery Using Diluted Insulin in Comparison With Closed-loop With Non-diluted Insulin in Children With Type 1 Diabetes [NCT01557634]Phase 212 participants (Anticipated)Interventional2012-12-31Recruiting
Multi-day (3) In-patient Evaluation of Intradermal vs Subcutaneous Basal/Bolus Insulin Infusion [NCT01557907]Phase 1/Phase 223 participants (Actual)Interventional2012-02-29Completed
Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes: a Randomized Controlled Trial vs Usual Care [NCT04233229]43 participants (Actual)Interventional2019-12-30Completed
Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders [NCT01571609]40 participants (Actual)Interventional2012-08-31Completed
[NCT01574508]Phase 4120 participants (Anticipated)Interventional2011-12-31Recruiting
Duration of Action and Peak Effect of High Dose of U-500 Regular Insulin In Severly Insulin Resistant Subjects With Type 2 Diabetes Mellitus [NCT02148250]Phase 217 participants (Actual)Interventional2015-07-31Completed
The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial)) [NCT00995501]381 participants (Actual)Interventional2007-01-31Terminated(stopped due to Per interim analysis, for futility.)
Effect Of Intraoperative Strict Glycemic Control During Liver Transplantation On Postoperative Morbidity And Mortality [NCT00780026]Phase 4100 participants (Actual)Interventional2008-07-31Completed
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes [NCT01590836]Phase 122 participants (Actual)Interventional2012-04-30Completed
Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT): A Randomized Controlled Pilot Trial [NCT01181674]Phase 483 participants (Actual)Interventional2011-01-31Completed
A Randomized, Comparative Study of Basal-bolus Insulin Versus Conventional Sliding-scale Regular Insulin Therapy in Management of Non-critically Ill Patients Hospitalized in the Medical Ward. [NCT01594060]Phase 436 participants (Actual)Interventional2012-06-30Completed
Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia [NCT01184014]Phase 472 participants (Actual)Interventional2010-08-31Completed
Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ) [NCT05422053]34 participants (Actual)Interventional2022-06-29Completed
[NCT01614496]0 participants InterventionalCompleted
[NCT01615081]20 participants (Actual)Interventional2012-05-31Completed
The Relative Effectiveness of Pumps Over Multiple Dose Injections and Structured Education Trial [NCT01616784]Phase 3267 participants (Actual)Interventional2011-11-30Completed
Study on the Relationship of Gut Microbiota and Changes of SCFAs With Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns [NCT04399434]120 participants (Anticipated)Observational2019-01-01Recruiting
ABC [Afrezza With Basal Combination]: A Phase 4 Study of Mealtime Control With Afrezza in Adult Subjects With Type 1 Diabetes Mellitus in Combination With an Automated Insulin Pump or Insulin Degludec [NCT05243628]Phase 433 participants (Actual)Interventional2022-03-31Completed
A Multiple-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus [NCT04276428]Phase 128 participants (Actual)Interventional2020-02-28Completed
Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents [NCT00634842]Phase 4244 participants (Actual)Interventional2008-02-29Completed
Diabetes Care in Nursing Home Residents: A Randomized Controlled Study [NCT01131052]Phase 4150 participants (Actual)Interventional2011-03-31Completed
The Role of Proper Insulin Injection Technique in the Treatment of Diabetes [NCT04120974]90 participants (Actual)Interventional2019-10-01Completed
InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial [NCT04012138]Phase 4525 participants (Anticipated)Interventional2019-12-20Recruiting
Individualized Blood Glucose Control in ICU. [NCT02244073]2,069 participants (Actual)Interventional2015-05-31Terminated(stopped due to Data safety monitoring board decision)
Impact of Intravenous Exenatide Versus Insulin on Quality of Life in Cardiac Surgery Patients: an Ancillary Study of the ExSTRESS Phase II/III Clinical Trial [NCT02432976]Phase 2/Phase 364 participants (Actual)Interventional2015-05-31Completed
Clinical Trial of Intranasal Insulin for the Treatment of HIV-associated Neurocognitive Disorder (HAND) [NCT03081117]Phase 1/Phase 221 participants (Actual)Interventional2017-08-01Terminated(stopped due to On 3/15/2020 study visits were suspended due to COVID-19 pandemic. With safety concerns surrounding COVID-19 and difficulty recruiting, the investigators decided to close enrollment 10/16/2020 after interim data were reviewed by the DSMB and NIH.)
Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock [NCT00320099]Phase 3508 participants (Actual)Interventional2006-01-31Completed
A New Wizard for Insulin Sensitivity Estimation From SAP: a Randomized Controlled Trial in Adolescents With T1D [NCT03034759]0 participants (Actual)Interventional2019-10-01Withdrawn(stopped due to Investigator has moved to another institution)
A Phase IV, Open Label, Randomized Trial on the Effect of Metformin Plus Lantus Insulin, Pioglitazone, or DPP4 Inhibitor on Fatty Liver in Patients With Type II Diabetes [NCT02365233]Phase 45 participants (Actual)Interventional2013-05-01Terminated(stopped due to IRB withheld the data due to inadequate supporting documentation)
Heart And Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT) [NCT01565941]Phase 3713 participants (Actual)Interventional2012-04-30Completed
Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes [NCT01850615]Phase 3323 participants (Actual)Interventional2013-09-23Completed
A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE) [NCT01849289]Phase 3833 participants (Actual)Interventional2013-06-02Completed
A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (SWITCH 1) [NCT02034513]Phase 3501 participants (Actual)Interventional2014-01-05Completed
Safety Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Diabetes [NCT02463097]124 participants (Actual)Interventional2015-06-30Completed
A Randomized, Double Blind, Phase 2b Study to Evaluate the Effect of ORMD-0801 Compared to Placebo on Endogenous Glucose Production in Patients With Type 2 Diabetes Mellitus [NCT04564846]Phase 250 participants (Actual)Interventional2020-11-23Completed
The Effect of Treatment With Basal Insulin Peglispro or Insulin Glargine on Insulin Sensitivity and the Effect of Prandial Insulin Lispro in Patients With Type 2 Diabetes Mellitus [NCT02197520]Phase 124 participants (Actual)Interventional2014-07-31Completed
A Comparison of Pharmacodynamics When Receiving a Double Dose of Insulin Peglispro or Insulin Glargine in Patients With Type 2 Diabetes Mellitus: A Double-Blind, Crossover Design Study [NCT02132637]Phase 368 participants (Actual)Interventional2014-05-31Completed
A 26-week Open Label, Randomised, 2-armed, Parallel Group, Multi-centre Trial Investigating Efficacy and Safety of Insulin Detemir Versus Insulin Neutral Protamine Hagedorn in Combination With the Maximum Tolerated Dose of Metformin and Diet/Exercise on G [NCT02131272]Phase 342 participants (Actual)Interventional2014-06-11Terminated
Subcutaneous Insulin Glargine Versus NPH Insulin in Patients With Chronic Kidney Disease Stages III and IV: Randomized Controlled Trial. [NCT02451917]Phase 434 participants (Actual)Interventional2013-12-31Completed
A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabete [NCT02451137]Phase 43,304 participants (Actual)Interventional2015-06-16Completed
Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT) [NCT01963728]Phase 42 participants (Actual)Interventional2013-11-27Terminated(stopped due to Blood sugar status of the enrolled subjects wasn't evaluable)
A Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control Associated With the Use of Dose Check App and Insulin Degludec in Patients With Type 2 Diabetes Mellitus in Saudi Arabia Under Real-world Setting [NCT06153537]175 participants (Anticipated)Observational2023-12-03Not yet recruiting
Open-label, Single-arm, Multiple-dose Safety, Titration, and Pharmacokinetic Trial of Afrezza® in Pediatric Patients Ages 4 to 17 Years With Type 1 Diabetes Mellitus [NCT02527265]Phase 230 participants (Actual)Interventional2017-09-28Completed
A 1 Month, Open-Label Inpatient, Randomized Cross-Over Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On 24-Hour Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled [NCT00367445]Phase 430 participants Interventional2006-09-30Completed
Effect of the Administration of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus Drug-naïve [NCT02680457]Phase 412 participants (Actual)Interventional2013-11-30Completed
Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial. [NCT00370565]Phase 3345 participants Interventional1999-06-30Completed
Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study [NCT02741687]Phase 480 participants (Actual)Interventional2016-06-30Completed
Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis: A Pilot Study [NCT02006342]40 participants (Actual)Interventional2012-11-30Completed
Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) and Technosphere® Insulin Inhalation System From MannnKind Corp. [NCT01874392]9 participants (Actual)Interventional2012-10-31Completed
Intranasal Insulin for Treatment of Alcohol Use Disorder [NCT05988632]Phase 1/Phase 240 participants (Anticipated)Interventional2023-09-21Not yet recruiting
Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting [NCT04760626]Phase 31,085 participants (Actual)Interventional2021-03-01Completed
The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes. [NCT00506662]Phase 486 participants (Actual)Interventional2007-07-31Terminated(stopped due to See termination reason in detailed description)
Effects of the Insulin Self-titration Education on Glycemic Control in Type 2 Diabetes Mellitus Patients: A Quasi-Experimental Study [NCT04736225]120 participants (Actual)Interventional2010-06-01Completed
Individualized, Technological Interventions for Diabetes Care in the COVID-19 Ward [NCT04871958]66 participants (Actual)Interventional2021-03-19Terminated(stopped due to Shift of the participating wards to non-Covid patients)
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 1 Diabetes [NCT03952130]Phase 3354 participants (Actual)Interventional2019-05-29Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) [NCT03172494]Phase 3720 participants (Actual)Interventional2017-05-26Completed
A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With I [NCT01814137]Phase 340 participants (Actual)Interventional2013-03-31Completed
A Comparison of the Impact of Basal Insulin Dosing Strategies on Next-day Surgery Blood Glucose Control [NCT03104738]40 participants (Actual)Interventional2013-11-20Completed
The Effectiveness of Intervention on Insulin Injection in Insulin-naive Patients With Type 2 Diabetes: Application of the Transtheoretical Model [NCT03324451]151 participants (Actual)Interventional2018-03-01Completed
Intranasal Insulin: A Novel Therapy for Hypoglycemia Unawareness in Type 1 Diabetes [NCT04028960]Phase 24 participants (Actual)Interventional2019-10-23Terminated(stopped due to Funding was rescinded)
Postprandial Blood Glucose Control and Gastric Emptying in Patients With Type 1 Diabetes: Pathogenetic Factors, Clinical Relevance and Possible Therapeutic Options [NCT02365740]80 participants (Anticipated)Interventional2014-11-30Recruiting
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes [NCT01569841]Phase 324 participants (Actual)Interventional2012-04-30Completed
Reducing Postprandial Hyperglycemia With Adjuvant Premeal Pramlintide and Postmeal Insulin in Children With Type 1 Diabetes Mellitus. [NCT00442767]Phase 48 participants (Actual)Interventional2007-02-28Completed
The Hepatic Glucose Response to Glucagon at Varying Insulin Levels: Implications for Closed Loop Glycemic Control. [NCT01483651]11 participants (Actual)Interventional2011-11-30Completed
A Comparison of the Efficacy Beyond 48 Hours of Insulin Aspart (Novolog) and Lispro (Humalog) in Insulin Pumps [NCT00461331]Phase 420 participants (Actual)Interventional2004-10-31Completed
User Experience and Daily Use Patterns With the Integrated Insulin Management (IIM) System [NCT04484779]67 participants (Actual)Interventional2020-07-14Completed
A Randomized, Controlled, 6-treatment, 6-sequence, 6-period Cross-over Dose Response Study of 3 Single Doses of Afrezza Inhaled Technosphere Insulin and of 3 Single Doses of SC Insulin Lispro in Patients With Diabetes Mellitus Type 1 Using the Euglycemic [NCT02470637]Phase 130 participants (Actual)Interventional2015-06-30Completed
[NCT02468999]21 participants (Actual)Interventional2015-01-31Completed
Basal-bolus Insulin Therapy With Insulin Degludec and Insulin Aspart Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study [NCT03244241]Phase 4100 participants (Anticipated)Interventional2017-04-01Recruiting
Safety and Efficacy of Linagliptin Therapy in the Setting of Internal Medicine Department Type 2 Diabetes Mellitus [NCT03051243]Phase 360 participants (Anticipated)Interventional2017-10-01Not yet recruiting
Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study [NCT04864977]Phase 40 participants (Actual)Interventional2021-08-16Withdrawn(stopped due to Study was stopped prior to study start date due to business decision.)
The Effect of Treatment With Basal Insulin Peglispro or Insulin Glargine on the Dose Response Effect of Prandial Insulin Lispro in Patients With Type 1 Diabetes Mellitus. [NCT02152384]Phase 128 participants (Actual)Interventional2014-06-30Completed
Nanjing First Hospital, Nanjing Medical University [NCT05553093]Phase 4150 participants (Anticipated)Interventional2022-03-15Recruiting
A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Chinese Subjects in China With Type 2 Diabetes Who Have Inadequate Glyca [NCT02104804]Phase 3953 participants (Actual)Interventional2014-05-07Completed
Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care [NCT00591227]Phase 4176 participants (Actual)Interventional2008-05-31Completed
[NCT02420171]360 participants (Actual)Interventional2015-01-31Completed
A Prospective, Single Center Study to Assess the Performance, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus [NCT02419859]20 participants (Actual)Interventional2015-02-28Completed
A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial [NCT02409017]20 participants (Actual)Interventional2015-04-30Terminated(stopped due to Lack of time and participation in the study)
A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy [NCT02064166]Phase 215 participants (Actual)Interventional2014-02-28Completed
A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patie [NCT02058160]Phase 3736 participants (Actual)Interventional2014-01-31Completed
The Effect of Intranasal Insulin on Hepatic and Intestinal Triglyceride-rich Lipoprotein Production [NCT03141827]Phase 2/Phase 39 participants (Actual)Interventional2016-04-14Completed
Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery? [NCT03415061]494 participants (Anticipated)Interventional2021-11-01Not yet recruiting
A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE) [NCT01680341]Phase 3272 participants (Actual)Interventional2012-08-31Completed
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance(rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus i [NCT03416855]768 participants (Actual)Observational2018-01-31Completed
A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Subjects With Various Degrees of Hepatic Impairment [NCT04597697]Phase 125 participants (Actual)Interventional2020-12-22Completed
Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy [NCT00428207]4 participants (Actual)Interventional2007-02-28Terminated(stopped due to Treatment differences not detected with 7 point fingerstick monitoring)
Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia [NCT03748433]35 participants (Actual)Interventional2019-01-03Completed
Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injection in Pregnant Women With Type 2 Diabetes: A Single-center Open Label Randomized Controlled Trial [NCT05001815]80 participants (Anticipated)Interventional2021-12-15Not yet recruiting
Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India [NCT02382757]3,089 participants (Actual)Observational2011-09-30Terminated
Characterizing the Incretin Effect of Amino Acids (AA) and Defining the Effect of GLP-1 on Muscle Microvascular Blood Flow and Muscle Protein and Glucose Metabolism in Older Age. [NCT02370745]40 participants (Actual)Interventional2014-11-30Completed
A Single Dose Study to Evaluate the Pharmacokinetics and Glucodynamics of Insulin Peglispro (LY2605541) in Healthy Male Japanese Subjects [NCT01995526]Phase 111 participants (Actual)Interventional2013-12-31Completed
United Kingdom User Evaluation, MiniMed Paradigm® X54 System [NCT01267175]Phase 431 participants (Actual)Interventional2009-01-31Completed
A Retrospective, Single Centre, Non-interventional Study Investigating the Effect of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in Lebanon [NCT04892069]60 participants (Actual)Observational2021-05-27Completed
Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes: the GLYMETY Study [NCT05258292]86 participants (Anticipated)Observational2022-05-02Recruiting
A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin [NCT01570751]Phase 3145 participants (Actual)Interventional2012-04-30Completed
Effect of Single Dose Intranasal Insulin on Cognitive Function in Patients With Schizophrenia [NCT00646581]Phase 430 participants (Actual)Interventional2006-10-31Completed
A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects [NCT03025009]Phase 157 participants (Actual)Interventional2017-03-06Completed
The Effect of Exenatide Compared to Lantus Insulin on Vascular Function Before and After a Meal Tolerance Test in Patients With Type 2 Diabetes [NCT00353834]Phase 472 participants (Actual)Interventional2006-08-31Completed
Clinical Assessment of a Closed-loop Insulin Delivery System [NCT01534013]23 participants (Actual)Interventional2011-08-31Completed
Connected Pens for Diabetes Study [NCT03830216]21 participants (Actual)Interventional2019-05-30Terminated(stopped due to Selective inclusion/exclusion criteria led to low enrollment which was not viable for the sponsor and site.)
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Diet and Metformin [NCT02496000]Phase 2188 participants (Actual)Interventional2015-07-27Completed
Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin [NCT05592860]100 participants (Actual)Interventional2021-07-10Completed
Evaluating the Benefits of Physiologic Insulin Delivery [NCT04416737]16 participants (Actual)Interventional2021-11-01Completed
A Single Center, Double Blind, Randomized Crossover Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Me [NCT01235039]Phase 1/Phase 243 participants (Actual)Interventional2009-07-31Completed
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-center, Randomized Controlled Trial [NCT00211510]146 participants (Actual)Interventional2005-06-30Completed
Study to Assess the Efficacy and Safety of Insulin Titration System Based on Deep Learning on Glucose Control in Type 2 Diabetes Mellitus Patients [NCT05409391]16 participants (Actual)Interventional2022-06-15Completed
Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents [NCT02542631]278 participants (Actual)Interventional2015-08-01Completed
A Multi-centre, Randomised, Open-labelled, 2-sequence, 2-period Crossover Trial to Investigate the Efficacy and Safety of Biphasic Insulin Aspart 50 (BIAsp 50) Twice Daily Versus Biphasic Human Insulin 50 (BHI 50) Twice Daily Both in Combination With Metf [NCT01892020]Phase 4161 participants (Actual)Interventional2013-06-30Completed
Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus [NCT01771250]Phase 115 participants (Actual)Interventional2013-10-31Completed
A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen [NCT01513473]Phase 3350 participants (Actual)Interventional2012-01-16Completed
Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study [NCT03824002]Phase 492 participants (Actual)Interventional2017-04-01Completed
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes [NCT01455142]Phase 132 participants (Actual)Interventional2011-10-31Completed
The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study. [NCT04124302]Phase 470 participants (Anticipated)Interventional2019-11-30Not yet recruiting
A Phase 4, Randomized, Double-Blind, 2-Way Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) With, Compared to Without, Pretreatment With Recombinant Human Hyaluronidase (rHuPH20) [NCT01526733]Phase 425 participants (Actual)Interventional2011-12-31Completed
Insulin Resistance in Non-diabetic Multiple Sclerosis Patients: Prevalence, Pre and Post-treatment Effect on Clinical, Cognitive Profile, Laboratory, and Radiological Markers [NCT06017726]100 participants (Anticipated)Observational2024-01-31Not yet recruiting
A Single and Multiple-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus [NCT06132126]Phase 188 participants (Anticipated)Interventional2023-11-17Not yet recruiting
A Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study [NCT01790438]Phase 3641 participants (Actual)Interventional2013-03-31Completed
Phase 1 Study of Medtronic Closed Loop Device With ePID Algorithm and Enlite Sensors on Adjuvant Therapy With Insulin and Liraglutide to Minimize Post-prandial Hyperglycemia [NCT01755416]Phase 218 participants (Actual)Interventional2013-01-31Completed
[NCT01781234]Phase 251 participants (Actual)Interventional2013-08-31Completed
Fast Track Continuous Subcutaneous Insulin Infusion (CSII) in Children With Newly Diagnosed Type 1 Diabetes Mellitus: An Evaluation of a Novel CSII Device in the Immediate Period Following Diagnosis of Type 1 Diabetes (T1DM) [NCT00476788]14 participants (Actual)Interventional2007-04-30Completed
Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study [NCT01432275]179 participants (Actual)Interventional2011-09-30Completed
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabet [NCT01835431]Phase 3362 participants (Actual)Interventional2013-10-17Completed
A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEG [NCT01388361]Phase 3413 participants (Actual)Interventional2011-09-30Completed
The Mobile Insulin Titration Intervention (MITI) Study: Innovative Chronic Disease Management of Diabetes [NCT01879579]61 participants (Actual)Interventional2013-06-30Completed
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes [NCT01831765]Phase 31,290 participants (Actual)Interventional2013-08-26Completed
Premix 70/30 Insulin Plus Supplemental Lunch Insulin in Comparison to Basal Plus Prandial Supplemental Scale and Sliding Scale Insulin in Hospitalized Patients With Type 2 Diabetes [NCT01855243]63 participants (Actual)Interventional2010-03-31Completed
Examining the Effect of the Mobile Application Developed for Individuals With Type 2 Diabetes Using Insulin on the Perception of Insulin Use and Self-Management [NCT06060743]88 participants (Actual)Interventional2022-11-01Completed
The Efficacy and Safety of Degludec Insulin Use for Glycemic Control in Critically Ill Patients: A Prospective Interventional Study (Protocol) [NCT06056167]155 participants (Anticipated)Interventional2023-05-17Recruiting
The Adjustment of Doses in Diabetes Mellitus Can Lead to Fluctuation of Glucose Level in Type I [NCT06055829]1 participants (Actual)Observational [Patient Registry]2022-10-24Completed
"Evaluating the Utility of the sMart InPen Wireless-Enabled System to impRove Glycemic Control in Pediatric Type 1 Diabetes (EMPoWER Study)" [NCT05515939]34 participants (Anticipated)Observational2022-09-09Enrolling by invitation
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes [NCT01819129]Phase 3881 participants (Actual)Interventional2013-09-09Completed
An Open-label, Two-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery in Comparison With Standard Care, in Adults With Type 2 Diabetes Requiring Maintenance Dialysis [NCT04025775]27 participants (Actual)Interventional2019-08-01Completed
Inpatient Diabetes on Corticosteroids [NCT01970241]Phase 485 participants (Actual)Interventional2014-07-31Completed
High Dose Insulin Therapy to Improve Liver Function in Patients With HCV Liver Cirrhosis [NCT01271140]5 participants (Anticipated)Interventional2011-01-31Active, not recruiting
An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients [NCT01278160]Phase 4179 participants (Actual)Interventional2011-01-31Completed
Effects of Nasulin v.Placebo on Blood Glucose Control in Patients With Type 2 DM Treated With Basal Insulin & Oral Antidiabetic Meds, Excluding Secretagogues in Phase 2A, Randomized, Parallel, Double-Blind, Placebo-Controlled, Multi-Center Study [NCT00850096]Phase 294 participants (Actual)Interventional2009-01-31Completed
A 20-week Study Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients Uncontrolled on NPH Insulin [NCT01589653]Phase 4155 participants (Actual)Interventional2012-05-26Completed
A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insuli [NCT01713530]Phase 3274 participants (Actual)Interventional2013-02-21Completed
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus [NCT03320694]Phase 3278 participants (Actual)Interventional2016-02-01Completed
The Impact of Insulin Pump Bolus Calculator and Wireless Communication With Blood Glucose Meter on Metabolic Control in Children With Type 1 Diabetes Mellitus - Randomised Control Trial [NCT01677546]156 participants (Actual)Interventional2011-01-31Completed
The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, P [NCT01966978]Phase 4157 participants (Actual)Interventional2014-11-30Completed
Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children With Type 1 Diabetes and Primary Caregivers. [NCT03103867]32 participants (Actual)Interventional2017-02-23Completed
Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study [NCT05613491]438 participants (Anticipated)Interventional2022-11-07Recruiting
Assessment of Body Composition and Physical Function in Older Adults With Obesity [NCT05784571]40 participants (Actual)Observational2023-03-13Completed
A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes [NCT01880736]Phase 3458 participants (Actual)Interventional2013-06-30Completed
CONtinuous Subcutaneous Insulin Infusion STudy ENrolling Type 1 (CONSISTENT 1): Evaluation of Metabolic Outcomes and Safety of Hylenex Recombinant (Hyaluronidase Human Injection) Used as a Preadministration Infusion Site Treatment in Subjects With Type 1 [NCT01848990]Phase 4456 participants (Actual)Interventional2013-03-31Completed
Reducing the Risk of Metabolic Decompensation in Adolescents With Poorly Controlled Type 1 Diabetes by Supervised School Administration of Insulin Degludec [NCT03400501]Early Phase 132 participants (Actual)Interventional2017-10-01Completed
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes [NCT01796366]Phase 140 participants (Actual)Interventional2013-02-21Completed
Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome [NCT00605696]Phase 218 participants (Actual)Interventional2008-04-30Completed
Stockholm Diabetes Intervention Study [NCT02138006]102 participants (Actual)Interventional1982-09-30Completed
Gene Expression Changes in Young and Geriatric Skin [NCT03932162]Early Phase 124 participants (Anticipated)Interventional2019-09-06Recruiting
A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 2 Diabetes Mellitus [NCT02059187]Phase 3531 participants (Actual)Interventional2014-02-11Completed
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events [NCT01959529]Phase 37,637 participants (Actual)Interventional2013-10-29Completed
A 6-week Randomised, Double-blind, Parallel-group Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes [NCT01999322]Phase 337 participants (Actual)Interventional2013-11-19Completed
A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-weekly Dulaglutide With Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes and Moderate or Severe Chronic Kidney Disease [NCT01621178]Phase 3577 participants (Actual)Interventional2012-07-31Completed
A Phase 3, Open Label, Randomized, Parallel, 26 Week Treatment Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti Hyperglycemia Medications in Asian Insulin Naïve Patients With Type 2 Diabetes Mellitus [NCT01894568]Phase 3388 participants (Actual)Interventional2013-07-31Completed
Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients [NCT03352674]Phase 2133 participants (Actual)Interventional2016-09-30Completed
A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor and Pump Therapy in the Management of Type 1 Diabetes Prone to Hypoglycemia [NCT04266379]72 participants (Anticipated)Interventional2020-05-13Recruiting
Double-blinded, Randomized, Comparative, Crossover Study of the Pharmacokinetics of Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, Suspension for Subcutaneous Administration, 100 [NCT04498884]32 participants (Actual)Interventional2017-07-18Completed
Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis [NCT05795309]16 participants (Anticipated)Interventional2023-08-16Recruiting
Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Gr [NCT04848480]Phase 3582 participants (Actual)Interventional2021-04-30Completed
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study [NCT03469492]Early Phase 18 participants (Actual)Interventional2018-01-18Completed
Samba-AC: A Randomized, Open-Label, Cross-Over Study to Investigate the PK and PD Profiles of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Healthy Subjects and Non-Diabetic Subjects With Mild to Moderate Asthma or COPD [NCT03307512]Phase 240 participants (Actual)Interventional2018-02-06Terminated(stopped due to Termination due to incomplete enrollment; planned data analysis not performed)
Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study) [NCT01773473]Phase 4403 participants (Actual)Interventional2013-01-31Completed
Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation [NCT01945138]14 participants (Actual)Interventional2014-02-28Completed
Effect of Insulin on Wound Healing- A Randomized Controlled Trial [NCT04390815]Phase 430 participants (Anticipated)Interventional2020-08-31Not yet recruiting
Specialized Technology Education for Pumps & Pens in Underserved Populations With Diabetes [NCT04550585]63 participants (Actual)Observational2017-04-01Completed
Reduction of Basal Insulin to Prevent Hypoglycemia During Two Types of Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy [NCT03845114]37 participants (Anticipated)Interventional2019-06-30Recruiting
A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter [NCT01991548]52 participants (Actual)Interventional2013-11-30Completed
Glycemic Index & Glycemic Responses to Majia Pomelos [NCT02006836]59 participants (Actual)Interventional2013-01-31Completed
A Randomized, 24 Week, Active-controlled, Open-label, 3-arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to Insulin Glargine and Lixisenatide in Type 2 Diabetes Mellitus Patients Insufficiently Controlled With Oral Anti [NCT03798054]Phase 3878 participants (Actual)Interventional2019-02-15Completed
Ultrasonographic Insulin Versus Dexamethasone Injection With Local Anestheticss in Diabetic Patients With Mild to Moderate Median Nerve Entrapement Neuropathy . [NCT04781751]150 participants (Anticipated)Interventional2021-02-28Recruiting
Insulin Detemir Versus Insulin NPH: A Randomized Prospective Study Comparing Glycemic Control in Pregnant Women With Diabetes [NCT01837680]105 participants (Actual)Interventional2013-03-31Completed
Pharmacological Treatment of Rett Syndrome by Stimulation of Synaptic Maturation With Recombinant Human IGF-1(Mecasermin [rDNA] Injection) [NCT01777542]Phase 230 participants (Actual)Interventional2013-01-31Completed
Two Treatment Approaches for Human Regular U-500 Insulin (Thrice-Daily Versus Twice-Daily) in Subjects With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Open [NCT01774968]Phase 4325 participants (Actual)Interventional2013-02-28Completed
MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes [NCT03624062]Phase 128 participants (Anticipated)Interventional2020-08-31Recruiting
A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellit [NCT01513590]Phase 3394 participants (Actual)Interventional2012-01-16Completed
A Randomized Controlled Trial Comparing 21 Days of Continuous Subcutaneous Insulin Infusion (CSII) Using Hepatic Directed Vesicle (HDV) Insulin to Standard CSII in Type 1 Diabetes Mellitus [NCT03156361]Phase 224 participants (Actual)Interventional2017-05-18Completed
Insulin Therapy for the Prevention of New Onset Diabetes After Transplantation (ITP-NODAT) Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients [NCT03507829]Phase 3263 participants (Actual)Interventional2012-11-21Completed
Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus Using CGMS [NCT03513055]60 participants (Anticipated)Interventional2018-05-07Not yet recruiting
Primary Intervention With Mucosal Insulin for Prevention of Type 1 Diabetes in Infants at High Genetic Risk to Develop Diabetes POINT (Primary Oral Insulin Trial) A Dose Finding and Safety Study ( Pre-POINT ) [NCT02620553]Phase 1/Phase 225 participants (Actual)Interventional2007-09-30Completed
The Impact of Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in Short-term Intensive Insulin Therapy(SIIT) [NCT05084079]Phase 456 participants (Anticipated)Interventional2021-11-30Recruiting
An Open-label, Multi-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Closed-loop Glucose Control Compared to Standard Insulin Pump Therapy Combined With Continuous Glucose Monitoring in Adolescents With Type 1 [NCT05653050]30 participants (Anticipated)Interventional2023-02-20Recruiting
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 2 Diabetes Mellitus [NCT00542633]Phase 3472 participants (Actual)Interventional2006-12-31Completed
A Digital Health Tool for Insulin Titration (DHIT) for Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group. [NCT03138447]30 participants (Actual)Interventional2017-03-30Completed
"Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation." [NCT04657809]Phase 240 participants (Actual)Interventional2020-10-01Completed
An Open-label, Multi-centre, Randomised, Single-period, Parallel Design Study to Assess the Efficacy, Safety, Utility and Psychosocial Effect of 12 Week Day and Night Automated Closed Loop Glucose Control Combined With Pump Suspend Feature Compared to Sen [NCT02523131]84 participants (Anticipated)Interventional2016-05-31Completed
Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy [NCT03234491]Phase 115 participants (Actual)Interventional2017-11-22Completed
Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL) [NCT02194595]Phase 3105 participants (Actual)Interventional2014-09-30Completed
BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes [NCT05161429]550,000 participants (Anticipated)Observational2021-07-01Recruiting
Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy [NCT03349489]20 participants (Anticipated)Interventional2018-05-18Recruiting
Safety and Efficacy Study of Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation for Early Onset Type 1 Diabetes-a Phase II Study [NCT00807651]Phase 240 participants (Actual)Interventional2008-02-29Completed
Observational Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update [NCT05118945]50 participants (Actual)Observational2021-03-03Completed
Insulin Resistance in Multiple System Atrophy [NCT04250493]124 participants (Anticipated)Interventional2020-10-28Recruiting
Evaluation of the Glycemic Profile During the Ramadan Fasting in People With Type 1 Diabetes Treated With Closed-loop Hybrid Insulin System [NCT05747352]23 participants (Actual)Observational2023-06-05Completed
Topical Insulin for Glaucoma and Optic Neuropathies [NCT05206877]Phase 132 participants (Anticipated)Interventional2022-04-01Recruiting
Phase 2 Randomized Placebo-Controlled Double-Blind Parallel Study to Evaluate Glucagon RTU (Glucagon Injection) Compared to Standard of Care for Prevention of Exercise-Induced Hypoglycemia During Regular Aerobic Exercise in Adults With T1D [NCT03841526]Phase 248 participants (Actual)Interventional2019-08-22Completed
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin An [NCT01676220]Phase 3878 participants (Actual)Interventional2012-08-31Completed
Intensive Glycemic Control For Diabetic Foot Ulcer Healing: A Multicenter Randomized Control Study (IN-GLOBE Study) [NCT04323462]Phase 4326 participants (Anticipated)Interventional2021-10-01Recruiting
A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin R and Humulin® R [NCT04022317]Phase 142 participants (Actual)Interventional2019-06-18Completed
A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin [NCT01676233]Phase 120 participants (Actual)Interventional2012-09-30Completed
Characterization of Insulin Action and Dopamine-signaling in the Human Brain of Normal Weight and Obese Subjects by [11C]-Raclopride-PET/MRT [NCT03637075]24 participants (Anticipated)Interventional2017-02-20Recruiting
A 2-week, Randomised, Controlled, Open-label, Two-group Parallel, Multi-centre Trial Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin Both in a Basal Bolus Regimen With or Without Metformin in [NCT01486966]Phase 458 participants (Actual)Interventional2011-11-30Terminated(stopped due to Trial terminated prematurely due to slow recruitment.)
In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor [NCT02130284]80 participants (Actual)Interventional2014-10-31Completed
Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study [NCT02229227]Phase 3814 participants (Actual)Interventional2014-11-21Completed
A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere® Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabete [NCT01451398]Phase 3353 participants (Actual)Interventional2011-11-30Completed
A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Int [NCT02100475]Phase 331 participants (Actual)Interventional2014-04-30Completed
[NCT02028871]Phase 226 participants (Actual)Interventional2014-07-31Completed
A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2) [NCT02030600]Phase 3721 participants (Actual)Interventional2014-01-06Completed
Therapeutic Effects of Intranasally-Administered Insulin in Adults With Amnestic Mild Cognitive Impairment (aMCI) or Mild Alzheimer's Disease (AD) [NCT01767909]Phase 2/Phase 3240 participants (Actual)Interventional2014-01-08Completed
Use of Open-Flow Microperfusion to Measure LY2605541 and Human Insulin Concentrations in Adipose Tissue Interstitial Fluid [NCT02109029]Phase 124 participants (Actual)Interventional2014-04-30Completed
Comparison of Plasma Exchange and Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis With Mildly Elevated Triglycerides [NCT02622854]22 participants (Actual)Interventional2016-06-30Completed
Assessment of the Efficacy on the Reduction of Nocturnal Hypoglycemia in Children With Type 1 Diabetes of a Closed-loop Insulin Therapy (Artificial Pancreas) Compared to Insulin Pump Therapy Combined With Continuous Glucose Monitoring With Threshold Low G [NCT02509429]Phase 224 participants (Actual)Interventional2015-06-16Completed
A Study to Identify Biomarkers of Hypoglycaemia in Patients With Type 2 Diabetes [NCT03102801]50 participants (Actual)Interventional2017-03-01Completed
Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin [NCT02486341]30 participants (Actual)Interventional2016-03-31Completed
An Open-label, Randomized, Two-way, Cross-over Multicenter Study to Assess the Efficacy of Closed-loop Strategy as Compared to Multiple Daily Injections in Regulating Glucose Levels During 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Th [NCT02490085]Phase 215 participants (Actual)Interventional2015-10-31Completed
An Open-label, 2 Replicate Single Dose Euglycemic Glucose-Clamp Trial to Characterize PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) [NCT02485327]Phase 122 participants (Actual)Interventional2015-07-31Completed
Research on Human Insulin rDNA (Insuget) Safety and Efficacy in Patients With Type 2 Diabetes Mellitus [NCT05161741]Phase 4238 participants (Actual)Interventional2021-01-01Completed
A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top [NCT02058147]Phase 31,170 participants (Actual)Interventional2014-02-28Completed
Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart [NCT02462161]Phase 124 participants (Actual)Interventional2015-03-20Completed
Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis [NCT03246295]140 participants (Actual)Observational2015-10-20Active, not recruiting
Effectiveness of Regimen Switch After Intensive Insulin Therapy in Hospitalized Patients With Type 2 Diabetes [NCT04833413]1,000 participants (Anticipated)Observational2021-04-15Recruiting
Microneedling With Topical Glycolic Acid 35% Versus Microneedling With Topical Insulin in the Treatment of Atrophic Post-acne Scars [NCT05600075]30 participants (Anticipated)Interventional2023-02-22Not yet recruiting
Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes (Close the GAP) [NCT04542148]Phase 2120 participants (Anticipated)Interventional2022-02-10Recruiting
Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine [NCT02294474]Phase 3505 participants (Actual)Interventional2015-01-31Completed
Management of Prolonged Aerobic Exercise in Patients With Type 1 Diabetes on Advanced Technologies [NCT05936203]15 participants (Anticipated)Interventional2023-01-11Enrolling by invitation
A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With T2DM With Inadequate Glycemic Control on 1, 2 or 3 Oral Glucose-lowering Agents. [NCT04606576]Phase 3710 participants (Actual)Interventional2020-12-15Terminated(stopped due to ORA-D-013-1 was terminated based on the primary results analyzed at the end of the treatment, week 26.)
Insulin Complexation With Hydroxypropyl-beta-cyclodextrin: Spectroscopic Evaluation of Molecular Inclusion and Use of the Complex in Gel for Healing of Pressure Ulcers [NCT02418676]Phase 1/Phase 215 participants (Actual)Interventional2013-03-31Completed
A Double-Blind, Placebo-Controlled Pilot Investigation of the Safety of Intranasal Glulisine in Down Syndrome [NCT02432716]Phase 112 participants (Actual)Interventional2015-04-30Completed
A Comparison of LY2605541 Versus Insulin Glargine Alone or in Combination With Pre-study Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Stud [NCT01582451]Phase 3466 participants (Actual)Interventional2012-05-31Completed
A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, [NCT00365170]Phase 4419 participants (Actual)Interventional2002-09-30Completed
A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus [NCT02501161]Phase 31,012 participants (Actual)Interventional2016-01-31Completed
Assessment of an Automatic Closed-loop Insulin Delivery System [NCT02366767]21 participants (Actual)Interventional2014-06-30Completed
Optimising Glycaemia Around Dynamic Physical Exercise With Advanced Hybrid-closed-loop Therapy Use in Type 1 Diabetes: ''The SMART Study'' [NCT05133765]11 participants (Actual)Interventional2021-09-14Completed
A Randomized, Single-Blind, Two-Way Crossover, Placebo-Controlled Phase I Study to Compare the 24-hour Glucose Profile and Safety of Pramlintide and Insulin, Co-Administered in a Fixed-Dose Ratio, Versus Placebo and Insulin in Patients With Type 1 Diabete [NCT02500979]Phase 134 participants (Actual)Interventional2015-08-17Completed
A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 1 Diabetes Mellitus [NCT02059161]Phase 3508 participants (Actual)Interventional2013-10-17Completed
A Double-Blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) [NCT04618744]Phase 233 participants (Actual)Interventional2020-11-24Completed
An Open-Label Multi-Center Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) [NCT04616014]Phase 27 participants (Actual)Interventional2021-03-01Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monothe [NCT02033889]Phase 3621 participants (Actual)Interventional2013-12-13Completed
A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients With Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, [NCT02320721]Phase 31,014 participants (Actual)Interventional2015-01-31Completed
Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period [NCT02273180]Phase 3507 participants (Actual)Interventional2014-10-31Completed
A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use [NCT02246582]118 participants (Actual)Interventional2014-09-30Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch) [NCT01952145]Phase 3557 participants (Actual)Interventional2013-09-20Completed
Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain [NCT04761094]2,977 participants (Actual)Observational [Patient Registry]2021-09-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00000620 (6) [back to overview]First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.
NCT00000620 (6) [back to overview]First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.
NCT00000620 (6) [back to overview]First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.
NCT00000620 (6) [back to overview]First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.
NCT00000620 (6) [back to overview]Death From Any Cause in the Glycemia Trial.
NCT00000620 (6) [back to overview]Stroke in the Blood Pressure Trial.
NCT00069784 (7) [back to overview]Total Mortality (All Causes)
NCT00069784 (7) [back to overview]Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)
NCT00069784 (7) [back to overview]Number of Patients With Various Types of Symptomatic Hypoglycemia Events
NCT00069784 (7) [back to overview]Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG
NCT00069784 (7) [back to overview]Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke
NCT00069784 (7) [back to overview]Number of Patients With First Occurrence of Any Type of Cancer
NCT00069784 (7) [back to overview]Composite Diabetic Microvascular Outcome (Kidney or Eye Disease)
NCT00091507 (5) [back to overview]Progression of Acute Coronary Syndrome to Myocardial Infarction
NCT00091507 (5) [back to overview]Mortality
NCT00091507 (5) [back to overview]Heart Failure or Death
NCT00091507 (5) [back to overview]Cardiac Arrest or Acute Mortality
NCT00091507 (5) [back to overview]Cardiac Arrest
NCT00136916 (16) [back to overview]Change From Baseline in Body Weight
NCT00136916 (16) [back to overview]Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
NCT00136916 (16) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT00136916 (16) [back to overview]Change From Baseline in FEV1
NCT00136916 (16) [back to overview]Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
NCT00136916 (16) [back to overview]Insulin Antibodies
NCT00136916 (16) [back to overview]Hypoglycemic Event Rates
NCT00136916 (16) [back to overview]Summary of ≥ 20 % Decliners in DLco
NCT00136916 (16) [back to overview]Total Daily Long-acting Insulin (Adjusted for Body Weight)
NCT00136916 (16) [back to overview]Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
NCT00136916 (16) [back to overview]Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
NCT00136916 (16) [back to overview]High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
NCT00136916 (16) [back to overview]High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
NCT00136916 (16) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c)
NCT00136916 (16) [back to overview]Summary of ≥ 15 % Decliners in FEV1
NCT00136916 (16) [back to overview]Severe Hypoglycemic Event Rates
NCT00137046 (14) [back to overview]Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
NCT00137046 (14) [back to overview]Change From Baseline Body Weight
NCT00137046 (14) [back to overview]Change From Baseline in Fasting Plasma Glucose
NCT00137046 (14) [back to overview]Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
NCT00137046 (14) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c)
NCT00137046 (14) [back to overview]Hypoglycemic Event Rates
NCT00137046 (14) [back to overview]Insulin Antibodies
NCT00137046 (14) [back to overview]Severe Hypoglycemic Event Rates
NCT00137046 (14) [back to overview]Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
NCT00137046 (14) [back to overview]Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
NCT00137046 (14) [back to overview]Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
NCT00137046 (14) [back to overview]Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
NCT00137046 (14) [back to overview]Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
NCT00137046 (14) [back to overview]Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
NCT00138671 (16) [back to overview]Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
NCT00138671 (16) [back to overview]Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)
NCT00138671 (16) [back to overview]Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)
NCT00138671 (16) [back to overview]Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)
NCT00138671 (16) [back to overview]Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
NCT00138671 (16) [back to overview]Insulin Dose Responsiveness for FEV1
NCT00138671 (16) [back to overview]Severe Hypoglcyemic Event Rates
NCT00138671 (16) [back to overview]Insulin Dose Responsiveness for DLco
NCT00138671 (16) [back to overview]Incidence of Severe COPD Exacerbations
NCT00138671 (16) [back to overview]Hypoglycemic Event Rates
NCT00138671 (16) [back to overview]Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
NCT00138671 (16) [back to overview]Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)
NCT00138671 (16) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c)
NCT00138671 (16) [back to overview]Bronchodilator Responsiveness as Determined by the Change in FEV1
NCT00138671 (16) [back to overview]Change From Baseline in Body Weight
NCT00138671 (16) [back to overview]Change From Baseline in Fasting Plasma Glucose
NCT00139659 (30) [back to overview]Body Weight: Mean Baseline and Change From Baseline
NCT00139659 (30) [back to overview]Number of Systemic Corticosteroid Rescues
NCT00139659 (30) [back to overview]Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)
NCT00139659 (30) [back to overview]Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)
NCT00139659 (30) [back to overview]Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)
NCT00139659 (30) [back to overview]Fasting Plasma Glucose
NCT00139659 (30) [back to overview]Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)
NCT00139659 (30) [back to overview]Baseline Dyspnea Index (BDI)
NCT00139659 (30) [back to overview]Glycosylated Hemoglobin (HbA1c)
NCT00139659 (30) [back to overview]Hypoglycemic Event Rates
NCT00139659 (30) [back to overview]Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)
NCT00139659 (30) [back to overview]Severe Hypoglycemic Event Rates
NCT00139659 (30) [back to overview]Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin
NCT00139659 (30) [back to overview]Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin
NCT00139659 (30) [back to overview]Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)
NCT00139659 (30) [back to overview]Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)
NCT00139659 (30) [back to overview]Incidence of Non-severe Asthma Exacerbations
NCT00139659 (30) [back to overview]Incidence of Severe Asthma Exacerbations
NCT00139659 (30) [back to overview]Asthma Control as Measured by the Asthma Control Questionnaire©
NCT00139659 (30) [back to overview]Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)
NCT00139659 (30) [back to overview]Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)
NCT00139659 (30) [back to overview]Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)
NCT00139659 (30) [back to overview]Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)
NCT00139659 (30) [back to overview]Transition Dyspnea Index (TDI): Change in Total Score
NCT00139659 (30) [back to overview]Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
NCT00139659 (30) [back to overview]Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
NCT00139659 (30) [back to overview]Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol
NCT00139659 (30) [back to overview]Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
NCT00139659 (30) [back to overview]Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
NCT00139659 (30) [back to overview]Lipids: Median Change From Baseline to Last Observation
NCT00143247 (11) [back to overview]Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment
NCT00143247 (11) [back to overview]Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment
NCT00143247 (11) [back to overview]Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment
NCT00143247 (11) [back to overview]Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment
NCT00143247 (11) [back to overview]Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)
NCT00143247 (11) [back to overview]Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)
NCT00143247 (11) [back to overview]Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes
NCT00143247 (11) [back to overview]Hypoglycemic Event Rates by Interval of Exubera Treatment
NCT00143247 (11) [back to overview]Change in Glycosylated Hemoglobin by Duration of Exubera Treatment
NCT00143247 (11) [back to overview]Severe Hypoglycemic Event Rates by Interval of Exubera Treatment
NCT00143247 (11) [back to overview]Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment
NCT00184600 (15) [back to overview]Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months
NCT00184600 (15) [back to overview]HbA1c (Glycosylated Haemoglobin) at Month 12
NCT00184600 (15) [back to overview]Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%
NCT00184600 (15) [back to overview]Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
NCT00184600 (15) [back to overview]Change From Baseline in Body Weight at Month 12
NCT00184600 (15) [back to overview]Change From Baseline in Body Weight at Month 36
NCT00184600 (15) [back to overview]Number of Participants Having an 'Other' Adverse Event
NCT00184600 (15) [back to overview]Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
NCT00184600 (15) [back to overview]Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months
NCT00184600 (15) [back to overview]Percentage of Participants Who Required A Second Insulin Therapy by Month 12
NCT00184600 (15) [back to overview]HbA1c (Glycosylated Haemoglobin) at Month 36
NCT00184600 (15) [back to overview]Percentage of Participants Who Required A Second Insulin Therapy by Month 36
NCT00184600 (15) [back to overview]Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%
NCT00184600 (15) [back to overview]Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months
NCT00184600 (15) [back to overview]Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Coronary Angiography Planned After Randomization
NCT00191282 (27) [back to overview]Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3
NCT00191282 (27) [back to overview]Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6
NCT00191282 (27) [back to overview]Number of Participants Who Experienced a Primary Combined Outcome
NCT00191282 (27) [back to overview]Number of Participants With Self-Reported Hypoglycemia During Month 12
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control
NCT00191282 (27) [back to overview]Number of Participants With Self-Reported Hypoglycemia During Month 18
NCT00191282 (27) [back to overview]Number of Participants With Self-Reported Hypoglycemia During Month 3
NCT00191282 (27) [back to overview]Number of Participants With Self-Reported Hypoglycemia During Month 9
NCT00191282 (27) [back to overview]Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9
NCT00191282 (27) [back to overview]Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18
NCT00191282 (27) [back to overview]Summary of Reasons for Deaths
NCT00191282 (27) [back to overview]Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12
NCT00191282 (27) [back to overview]Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1
NCT00191282 (27) [back to overview]Number of Participants With Self-Reported Hypoglycemia During Month 6
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Cardiovascular (CV) Death
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Myocardial Infarction (MI)
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Coronary Revascularization Procedures
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Death From Any Cause
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Congestive Heart Failure
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization
NCT00191282 (27) [back to overview]Number of Participants Who Experienced Stroke
NCT00191282 (27) [back to overview]Number of Participants With Self-Reported Hypoglycemia During Month 1
NCT00211510 (6) [back to overview]Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26
NCT00211510 (6) [back to overview]Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26
NCT00211510 (6) [back to overview]Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26
NCT00211510 (6) [back to overview]Glucose Sensor Accuracy as Measured in the 722 Group
NCT00211510 (6) [back to overview]Change in A1c From Baseline to 26 Weeks
NCT00211510 (6) [back to overview]Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups
NCT00211536 (5) [back to overview]Average Daily Blood Glucose
NCT00211536 (5) [back to overview]Change in HbA1c and Compared Between Groups
NCT00211536 (5) [back to overview]Low Blood Glucose Index (LBGI);
NCT00211536 (5) [back to overview]Incidence of Severe Hypoglycemia Events
NCT00211536 (5) [back to overview]Mean Amplitude of Glycemic Excursions (MAGE)
NCT00264641 (1) [back to overview]Cerebral Activation During Hypoglycaemia
NCT00282867 (4) [back to overview]Symptomatic Hypoglycemia
NCT00282867 (4) [back to overview]Hypoglycemic Events
NCT00282867 (4) [back to overview]Favorable 3 Month Modified Rankin
NCT00282867 (4) [back to overview]Target Glucose Concentration
NCT00282971 (3) [back to overview]Percentage of Participants Achieving Glycemic Control by Visit
NCT00282971 (3) [back to overview]Change From Baseline in FEV1 at Week 24 LOCF
NCT00282971 (3) [back to overview]Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
NCT00283049 (3) [back to overview]Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
NCT00283049 (3) [back to overview]Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
NCT00283049 (3) [back to overview]Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
NCT00286429 (33) [back to overview]Change From Baseline in C-peptide (Week 8).
NCT00286429 (33) [back to overview]Change From Baseline in C-peptide (Week 4).
NCT00286429 (33) [back to overview]Change From Baseline in C-peptide (Week 26).
NCT00286429 (33) [back to overview]Change From Baseline in Body Weight (Week 12).
NCT00286429 (33) [back to overview]Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.
NCT00286429 (33) [back to overview]Change From Baseline in C-peptide (Week 16).
NCT00286429 (33) [back to overview]Change From Baseline in C-peptide (Week 12).
NCT00286429 (33) [back to overview]Change From Baseline in Body Weight (Week 8).
NCT00286429 (33) [back to overview]Change From Baseline in Body Weight (Week 26).
NCT00286429 (33) [back to overview]Change From Baseline in Body Weight (Week 20).
NCT00286429 (33) [back to overview]Change From Baseline in Glycosylated Hemoglobin (Week 20).
NCT00286429 (33) [back to overview]Change From Baseline in Glycosylated Hemoglobin (Week 4).
NCT00286429 (33) [back to overview]Number of Participants Requiring Rescue.
NCT00286429 (33) [back to overview]Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.
NCT00286429 (33) [back to overview]Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.
NCT00286429 (33) [back to overview]Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.
NCT00286429 (33) [back to overview]Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.
NCT00286429 (33) [back to overview]Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.
NCT00286429 (33) [back to overview]Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.
NCT00286429 (33) [back to overview]Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).
NCT00286429 (33) [back to overview]Change From Baseline in Glycosylated Hemoglobin (Week 8).
NCT00286429 (33) [back to overview]Change From Baseline in Fasting Plasma Glucose (Week 20).
NCT00286429 (33) [back to overview]Change From Baseline in Fasting Plasma Glucose (Week 2).
NCT00286429 (33) [back to overview]Change From Baseline in Fasting Plasma Glucose (Week 16).
NCT00286429 (33) [back to overview]Change From Baseline in Fasting Plasma Glucose (Week 26).
NCT00286429 (33) [back to overview]Change From Baseline in Fasting Plasma Glucose (Week 4).
NCT00286429 (33) [back to overview]Change From Baseline in Fasting Plasma Glucose (Week 8).
NCT00286429 (33) [back to overview]Change From Baseline in Fasting Plasma Glucose (Week 12).
NCT00286429 (33) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
NCT00286429 (33) [back to overview]Change From Baseline in Glycosylated Hemoglobin (Week 12).
NCT00286429 (33) [back to overview]Change From Baseline in Glycosylated Hemoglobin (Week 16).
NCT00286429 (33) [back to overview]Change From Baseline in Fasting Plasma Glucose (Week 1).
NCT00286429 (33) [back to overview]Change From Baseline in C-peptide (Week 20).
NCT00308308 (8) [back to overview]Change From Baseline in Weight to Week 52
NCT00308308 (8) [back to overview]Change From Baseline in Fasting Plasma Glucose to Week 52
NCT00308308 (8) [back to overview]Incidence of Severe Hypoglycemia
NCT00308308 (8) [back to overview]Severe Hypoglycemia Event Rate
NCT00308308 (8) [back to overview]Incidence of Total Hypoglycemia
NCT00308308 (8) [back to overview]Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
NCT00308308 (8) [back to overview]Total Hypoglycemia Event Rate
NCT00308308 (8) [back to overview]Compare the Mean Change From Baseline to Week 52 in HbA1c
NCT00308737 (12) [back to overview]Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement
NCT00308737 (12) [back to overview]FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
NCT00308737 (12) [back to overview]Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement
NCT00308737 (12) [back to overview]Change in Weight From Baseline at Month 24
NCT00308737 (12) [back to overview]Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care
NCT00308737 (12) [back to overview]Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM
NCT00308737 (12) [back to overview]Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
NCT00308737 (12) [back to overview]Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care
NCT00308737 (12) [back to overview]Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement
NCT00308737 (12) [back to overview]Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement
NCT00308737 (12) [back to overview]Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM
NCT00308737 (12) [back to overview]Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM
NCT00309244 (8) [back to overview]Severe Hypoglycemia Event Rate
NCT00309244 (8) [back to overview]Total Hypoglycemia Event Rate
NCT00309244 (8) [back to overview]Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
NCT00309244 (8) [back to overview]Change From Baseline in Fasting Plasma Glucose to Week 52
NCT00309244 (8) [back to overview]Change From Baseline in HbA1c to Week 52
NCT00309244 (8) [back to overview]Change From Baseline in Weight to Week 52
NCT00309244 (8) [back to overview]Incidence of Severe Hypoglycemia
NCT00309244 (8) [back to overview]Incidence of Total Hypoglycemia
NCT00309465 (1) [back to overview]Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery
NCT00328094 (2) [back to overview]Incidence of Wound Infections
NCT00328094 (2) [back to overview]Composite (Myocardial Infarction and CHF)
NCT00332488 (3) [back to overview]Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)
NCT00332488 (3) [back to overview]Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue
NCT00332488 (3) [back to overview]Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue
NCT00338104 (3) [back to overview]Percentage of Glucose Values < 50 mg/dL
NCT00338104 (3) [back to overview]Percentage of Blood Glucose Values Between 80 - 140
NCT00338104 (3) [back to overview]Percentage of Glucose Levels > 180 mg/dL
NCT00353834 (2) [back to overview]First Will be the Changes in TNG Stimulated Arterial Dilation (Endothelial-independent) in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements
NCT00353834 (2) [back to overview]The Primary Endpoint Was the Change in FMD at the End of the Study Compared to Baseline Measurements in Subjects Treated With Exenatide Compared to Subjects Treated With Lantus.
NCT00357890 (4) [back to overview]Insulin Sensitivity
NCT00357890 (4) [back to overview]Percent Body Fat
NCT00357890 (4) [back to overview]Beta Cell Function
NCT00357890 (4) [back to overview]Hemoglobin A1c
NCT00359801 (8) [back to overview]All-cause Mortality: Number of Deaths
NCT00359801 (8) [back to overview]Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm
NCT00359801 (8) [back to overview]Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
NCT00359801 (8) [back to overview]Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
NCT00359801 (8) [back to overview]Change in Glycosylated Hemoglobin (HbA1c) From Baseline
NCT00359801 (8) [back to overview]Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline
NCT00359801 (8) [back to overview]Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis
NCT00359801 (8) [back to overview]Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects
NCT00360698 (11) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) Value
NCT00360698 (11) [back to overview]Change in Daily Mean Plasma Glucose
NCT00360698 (11) [back to overview]Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
NCT00360698 (11) [back to overview]Rate of Severe Symptomatic Hypoglycemia
NCT00360698 (11) [back to overview]Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
NCT00360698 (11) [back to overview]Daily Mean Plasma Glucose
NCT00360698 (11) [back to overview]Daily Dose of Insulin Glulisine
NCT00360698 (11) [back to overview]Daily Dose of Insulin Glargine
NCT00360698 (11) [back to overview]Change in Weight
NCT00360698 (11) [back to overview]Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
NCT00360698 (11) [back to overview]Glycosylated Haemoglobin (HbA1c) Value
NCT00377858 (12) [back to overview]Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
NCT00377858 (12) [back to overview]Hemoglobin A1c (HbA1c) at 36 Week Endpoint
NCT00377858 (12) [back to overview]30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
NCT00377858 (12) [back to overview]Number of Insulin Injections Per Day
NCT00377858 (12) [back to overview]Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
NCT00377858 (12) [back to overview]Hemoglobin A1c (HbA1c) at Interval Visits
NCT00377858 (12) [back to overview]Glycemic Variability
NCT00377858 (12) [back to overview]Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
NCT00377858 (12) [back to overview]Number of Patients With at Least One Severe Hypoglycemia Episode
NCT00377858 (12) [back to overview]Endpoint Insulin Dose; Total, Basal, and Prandial
NCT00377858 (12) [back to overview]7-point Self-monitored Blood Glucose Profiles
NCT00377858 (12) [back to overview]Change From Baseline in Absolute Body Weight at 36 Week Endpoint
NCT00384085 (8) [back to overview]Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis)
NCT00384085 (8) [back to overview]Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl
NCT00384085 (8) [back to overview]Adjusted Hypoglycemic Event Rates (Event/Patient-year)
NCT00384085 (8) [back to overview]Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)
NCT00384085 (8) [back to overview]Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)
NCT00384085 (8) [back to overview]Adjusted Incidence Rate of Hypoglycemia
NCT00384085 (8) [back to overview]Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population
NCT00384085 (8) [back to overview]Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)
NCT00391027 (17) [back to overview]Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)
NCT00391027 (17) [back to overview]Number of Subjects With HbA1c < 7.0 %
NCT00391027 (17) [back to overview]Number of Subjects With HbA1c < 6.5 %
NCT00391027 (17) [back to overview]Number of Subjects Discontinued Due to Insufficient Clinical Response
NCT00391027 (17) [back to overview]Number of Events of Nocturnal Hypoglycemia
NCT00391027 (17) [back to overview]Number of Subjects With HbA1c < 8.0 %
NCT00391027 (17) [back to overview]Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)
NCT00391027 (17) [back to overview]Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients
NCT00391027 (17) [back to overview]Change From Baseline in HbA1c Prior to Week 26
NCT00391027 (17) [back to overview]Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)
NCT00391027 (17) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) Level
NCT00391027 (17) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
NCT00391027 (17) [back to overview]Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)
NCT00391027 (17) [back to overview]Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)
NCT00391027 (17) [back to overview]Change From Baseline in Body Mass Index (BMI)
NCT00391027 (17) [back to overview]Number of Subjects With Hypoglycemic Events by Severity
NCT00391027 (17) [back to overview]Change From Baseline in Body Weight
NCT00393705 (10) [back to overview]2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint
NCT00393705 (10) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint
NCT00393705 (10) [back to overview]Change From Baseline in Weight at 16 Week Endpoint
NCT00393705 (10) [back to overview]Hemoglobin A1c (HbA1c) at 16 Week Endpoint
NCT00393705 (10) [back to overview]Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint
NCT00393705 (10) [back to overview]30-Day Adjusted Rate of Hypoglycemic Events
NCT00393705 (10) [back to overview]Total Daily Insulin Dose at 4 Weeks and 12 Weeks
NCT00393705 (10) [back to overview]Mean Daily Blood Glucose Values at 16 Week Endpoint
NCT00393705 (10) [back to overview]Number of Patients With Self-reported Hypoglycemic Episodes
NCT00393705 (10) [back to overview]Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint
NCT00394524 (4) [back to overview]Number of Patients With Severe Hypoglycemia Episodes Among the Glucommander Group Compared to Standard Algorithm
NCT00394524 (4) [back to overview]Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion
NCT00394524 (4) [back to overview]Mean Hospital Length of Stay in Days Among the Glucommander Group Compared to Standard Insulin Infusion
NCT00394524 (4) [back to overview]Mean Length of Intensive Care Unit (ICU) in Days Stay Among Glucommander Group Compared to Standard Insulin Infusion Group
NCT00418522 (20) [back to overview]Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26
NCT00418522 (20) [back to overview]Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26
NCT00418522 (20) [back to overview]Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26
NCT00418522 (20) [back to overview]Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
NCT00418522 (20) [back to overview]Number of Nocturnal Hypoglycemic Events
NCT00418522 (20) [back to overview]Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26
NCT00418522 (20) [back to overview]Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
NCT00418522 (20) [back to overview]Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
NCT00418522 (20) [back to overview]Change From Baseline in Fasting Plasma Glucose at Week 26
NCT00418522 (20) [back to overview]Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26
NCT00418522 (20) [back to overview]Number of Subjects With Hypoglycemic Events
NCT00418522 (20) [back to overview]Number of Total Hypoglycemic Events
NCT00418522 (20) [back to overview]Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26
NCT00418522 (20) [back to overview]Change From Baseline in Body Mass Index (BMI) at Week 26
NCT00418522 (20) [back to overview]Number of Total Subject Months of Treatment
NCT00418522 (20) [back to overview]Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26
NCT00418522 (20) [back to overview]Change From Baseline in Lipids at Week 26
NCT00418522 (20) [back to overview]Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26
NCT00418522 (20) [back to overview]Crude Hypoglycemic Event Rate
NCT00418522 (20) [back to overview]Change From Baseline in Body Weight at Week 26
NCT00419562 (3) [back to overview]Rate of Type 1 Diabetes Per Year in Secondary Stratum (Stratum 2) When Treated With Oral Insulin Versus Placebo
NCT00419562 (3) [back to overview]Rate of Type 1 Diabetes Per Year Among Individuals in the Primary Stratum When Treated With Oral Inulin Versus Placebo
NCT00419562 (3) [back to overview]Rate of Type 1 Diabetes in Secondary Stratum (Stratum 3+4) When Treated With Oral Insulin Versus Placebo
NCT00420095 (7) [back to overview]Number of Participants With Laboratory Parameters Significantly Different From Baseline
NCT00420095 (7) [back to overview]Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment
NCT00420095 (7) [back to overview]Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment
NCT00420095 (7) [back to overview]Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment
NCT00420095 (7) [back to overview]Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
NCT00420095 (7) [back to overview]Hypoglycemia Rate Per Participant Per 30 Days
NCT00420095 (7) [back to overview]Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%
NCT00435019 (3) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00435019 (3) [back to overview]Observed Insulin Antibody Values
NCT00435019 (3) [back to overview]Number of Subjects Reporting Adverse Events
NCT00437489 (4) [back to overview]Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)
NCT00437489 (4) [back to overview]Hypoglycemia Event Rate Per Month
NCT00437489 (4) [back to overview]Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia
NCT00437489 (4) [back to overview]Change in HbA1c From Baseline
NCT00441129 (3) [back to overview]Difference in HbA1C From Baseline and 6 Months
NCT00441129 (3) [back to overview]Change From Baseline in Total Daily Dose (TDD)
NCT00441129 (3) [back to overview]Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
NCT00442767 (2) [back to overview]Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.
NCT00442767 (2) [back to overview]Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone
NCT00443599 (14) [back to overview]Incidence of Nosocomial Infections in the Cardiac ICU
NCT00443599 (14) [back to overview]Mortality at 30 Days.
NCT00443599 (14) [back to overview]Mortality at Hospital Discharge.
NCT00443599 (14) [back to overview]Neurodevelopmental Evaluation, Cognitive
NCT00443599 (14) [back to overview]Neurodevelopmental Evaluation, Language
NCT00443599 (14) [back to overview]Neurodevelopmental Evaluation, Motor
NCT00443599 (14) [back to overview]Nutritional Status
NCT00443599 (14) [back to overview]Immune Function
NCT00443599 (14) [back to overview]Cardiac Function
NCT00443599 (14) [back to overview]Cardiac Index (CI)
NCT00443599 (14) [back to overview]Duration of Endotracheal Intubation
NCT00443599 (14) [back to overview]Duration of Hospital Stay
NCT00443599 (14) [back to overview]Duration of ICU Stay
NCT00443599 (14) [back to overview]Endocrine Function
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Lymphocytes)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Leucocytes)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Haemoglobin)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Eosinophils)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Basophilis)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Total Protein)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Sodium)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Creatinine)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Albumin)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
NCT00447382 (24) [back to overview]Adverse Events
NCT00447382 (24) [back to overview]Change From Baseline in Total Antibodies
NCT00447382 (24) [back to overview]Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
NCT00447382 (24) [back to overview]Change From Baseline in Detemir Specific Antibodies
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Potassium)
NCT00447382 (24) [back to overview]Hypoglycaemic Episodes
NCT00447382 (24) [back to overview]Glycaemic Control Parameters (Change in HbA1c)
NCT00447382 (24) [back to overview]Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
NCT00447382 (24) [back to overview]Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Thrombocytes)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Neutrophils)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Monocytes)
NCT00461331 (3) [back to overview]Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change
NCT00461331 (3) [back to overview]Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place
NCT00461331 (3) [back to overview]Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place
NCT00467649 (12) [back to overview]Percentage of Patients Achieving HbA1c <=7% at Week 24
NCT00467649 (12) [back to overview]Percentage of Patients With a Severe Hypoglycemia Adverse Event
NCT00467649 (12) [back to overview]Percentage of Patients With no Weight Gain at Week 24
NCT00467649 (12) [back to overview]The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
NCT00467649 (12) [back to overview]Fasting Serum Lipids Change From Baseline to Week 24
NCT00467649 (12) [back to overview]Hypoglycemia Adverse Events
NCT00467649 (12) [back to overview]Phase 2: Change in HbA1c at Week 36
NCT00467649 (12) [back to overview]Phase 2: Change in Body Weight at Week 36
NCT00467649 (12) [back to overview]Change in Body Weight From Baseline at Week 24
NCT00467649 (12) [back to overview]Change in Fasting Plasma Glucose From Baseline at Week 24
NCT00467649 (12) [back to overview]Change in HbA1c From Baseline at Week 24
NCT00467649 (12) [back to overview]Change in Waist Circumference From Baseline at Week 24
NCT00469092 (6) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00469092 (6) [back to overview]9-point Self-measured Plasma Glucose Profiles
NCT00469092 (6) [back to overview]Number of Subjects Reporting Treatment Emergent Adverse Events
NCT00469092 (6) [back to overview]Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
NCT00469092 (6) [back to overview]Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
NCT00469092 (6) [back to overview]Number of Hypoglycaemic Episodes
NCT00469833 (4) [back to overview]Insulin Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.
NCT00469833 (4) [back to overview]HbA1c Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.
NCT00469833 (4) [back to overview]ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.
NCT00469833 (4) [back to overview]C-peptide Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.
NCT00474045 (47) [back to overview]Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36
NCT00474045 (47) [back to overview]Maternal Safety - Acceleration of Nephropathy
NCT00474045 (47) [back to overview]Maternal Safety - Electrocardiogram (ECG)
NCT00474045 (47) [back to overview]Maternal Safety - Nocturnal Hypoglycaemic Episodes
NCT00474045 (47) [back to overview]Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood
NCT00474045 (47) [back to overview]Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies
NCT00474045 (47) [back to overview]Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies
NCT00474045 (47) [back to overview]Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies
NCT00474045 (47) [back to overview]Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36
NCT00474045 (47) [back to overview]8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36
NCT00474045 (47) [back to overview]8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24
NCT00474045 (47) [back to overview]Fasting Plasma Glucose (FPG)
NCT00474045 (47) [back to overview]Glycosylated Haemoglobin (HbA1c) During Pregnancy
NCT00474045 (47) [back to overview]Maternal Safety - Acceleration of Retinopathy in Any Eye
NCT00474045 (47) [back to overview]Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit
NCT00474045 (47) [back to overview]Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit
NCT00474045 (47) [back to overview]Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up
NCT00474045 (47) [back to overview]Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit
NCT00474045 (47) [back to overview]Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Albumin Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Creatinine Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Haemoglobin Level (Haematology)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Insulin Aspart Specific Antibodies
NCT00474045 (47) [back to overview]Maternal Safety - Change in Insulin Detemir Specific Antibodies
NCT00474045 (47) [back to overview]Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies
NCT00474045 (47) [back to overview]Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Leukocytes Level (Haematology)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Potassium Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Sodium Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Thrombocytes Level (Haematology)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Total Protein Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)
NCT00474045 (47) [back to overview]Maternal Safety - Hypoglycaemic Episodes
NCT00474045 (47) [back to overview]Maternal Safety - Mode of Delivery
NCT00474045 (47) [back to overview]Maternal Safety - Number of Subjects With Adverse Events (AEs)
NCT00474045 (47) [back to overview]Pregnancy Outcome at Delivery
NCT00474045 (47) [back to overview]Pregnancy Outcome at Follow-Up
NCT00474045 (47) [back to overview]Safety - Composite Pregnancy Outcome
NCT00474045 (47) [back to overview]Safety - Total Daily Insulin Dose During Pregnancy
NCT00474045 (47) [back to overview]Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events
NCT00474045 (47) [back to overview]Maternal Safety - Change in Urine Albumin Level (Urinalysis)
NCT00474045 (47) [back to overview]Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36
NCT00476788 (2) [back to overview]Number of Reported Adverse Events
NCT00476788 (2) [back to overview]Mean Glycated Hemoglobin (A1c)
NCT00487240 (11) [back to overview]30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
NCT00487240 (11) [back to overview]7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint
NCT00487240 (11) [back to overview]Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values
NCT00487240 (11) [back to overview]Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%
NCT00487240 (11) [back to overview]Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint
NCT00487240 (11) [back to overview]Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])
NCT00487240 (11) [back to overview]Change From Baseline in Absolute Body Weight at 32 Week Endpoint
NCT00487240 (11) [back to overview]Insulin Dose (Total and By Component [Basal and Bolus])
NCT00487240 (11) [back to overview]Glycemic Variability at Endpoint
NCT00487240 (11) [back to overview]Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
NCT00487240 (11) [back to overview]1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
NCT00500240 (3) [back to overview]1-Year Overall Survival Rate
NCT00500240 (3) [back to overview]Overall Survival
NCT00500240 (3) [back to overview]Progression Free Survival (PFS)
NCT00506662 (3) [back to overview]Mean Number of Total Hypoglycaemic Episodes, Month 1
NCT00506662 (3) [back to overview]Mean Number of Total Hypoglycaemic Episodes, Months 5-7
NCT00506662 (3) [back to overview]Mean Number of Total Hypoglycaemic Episodes, Months 2-4
NCT00509925 (18) [back to overview]Body Weight
NCT00509925 (18) [back to overview]Total Energy Expenditure, Double-labelled Water Method
NCT00509925 (18) [back to overview]Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)
NCT00509925 (18) [back to overview]Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)
NCT00509925 (18) [back to overview]Component of Total Energy Expenditure: Physical Activity Thermogenesis
NCT00509925 (18) [back to overview]Component of Total Energy Expenditure: Resting Energy Expenditure (REE)
NCT00509925 (18) [back to overview]Hypoglycaemic Episodes
NCT00509925 (18) [back to overview]Total Energy Expenditure, Dietary Record Method
NCT00509925 (18) [back to overview]Waist:Hip Ratio
NCT00509925 (18) [back to overview]Hypoglycaemic Episodes, Diurnal/Nocturnal
NCT00509925 (18) [back to overview]Hormonal Assessment: Resistin
NCT00509925 (18) [back to overview]Hormonal Assessment: Leptin
NCT00509925 (18) [back to overview]Hormonal Assessment: Insulin-like Growth Factor-1
NCT00509925 (18) [back to overview]Hormonal Assessment: Adiponectin
NCT00509925 (18) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00509925 (18) [back to overview]Lean Body Mass
NCT00509925 (18) [back to overview]Fat Mass
NCT00509925 (18) [back to overview]Fasting Plasma Glucose
NCT00510952 (11) [back to overview]Glycemic Variability at Endpoint
NCT00510952 (11) [back to overview]Total Daily Insulin Dose (Units) at Endpoint
NCT00510952 (11) [back to overview]Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
NCT00510952 (11) [back to overview]1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
NCT00510952 (11) [back to overview]30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
NCT00510952 (11) [back to overview]7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
NCT00510952 (11) [back to overview]Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
NCT00510952 (11) [back to overview]Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
NCT00510952 (11) [back to overview]Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint
NCT00510952 (11) [back to overview]Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall
NCT00510952 (11) [back to overview]Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value
NCT00519623 (2) [back to overview]Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)
NCT00519623 (2) [back to overview]Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)
NCT00524472 (6) [back to overview]a Composite of Minor Postoperative Complications
NCT00524472 (6) [back to overview]Any Major Morbidity/30-day Mortality
NCT00524472 (6) [back to overview]Duration of Hospitalization
NCT00524472 (6) [back to overview]Duration of Intensive Care Stay
NCT00524472 (6) [back to overview]Post Operative Atrial Fibrillation
NCT00524472 (6) [back to overview]All-cause Mortality
NCT00527397 (8) [back to overview]The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
NCT00527397 (8) [back to overview]The Value of Fasting Plasma Glucose:Change From Baseline
NCT00527397 (8) [back to overview]The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
NCT00527397 (8) [back to overview]Insulin Antibody Levels : Change From Baseline
NCT00527397 (8) [back to overview]The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
NCT00527397 (8) [back to overview]Daily Inhaled Insulin Dose
NCT00527397 (8) [back to overview]The Values of Hemoglobin A1c:Change From Baseline
NCT00527397 (8) [back to overview]The Values of Forced Vital Capacity:Change From Baseline
NCT00530023 (5) [back to overview]Change in A1C From Baseline to Week 15
NCT00530023 (5) [back to overview]Incidence of Severe Hypoglycemia Events Baseline to Week 15
NCT00530023 (5) [back to overview]Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15
NCT00530023 (5) [back to overview]Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15
NCT00530023 (5) [back to overview]Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15
NCT00537303 (6) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00537303 (6) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00537303 (6) [back to overview]Hypoglycaemic Episodes
NCT00537303 (6) [back to overview]Haematology: Haemoglobin Measured in Blood
NCT00537303 (6) [back to overview]Biochemistry: Serum Alanine Aminotransferase
NCT00537303 (6) [back to overview]Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin
NCT00542620 (30) [back to overview]Body Mass Index (BMI) Z Score
NCT00542620 (30) [back to overview]"Percentage of Children Assessing Insulin Therapy Injection Pain as Very Happy Face"
NCT00542620 (30) [back to overview]"Percentage of Children Assessing Insulin Therapy Injection Pain as Sad Face"
NCT00542620 (30) [back to overview]"Percentage of Children Assessing Insulin Therapy Injection Pain as Happy Face"
NCT00542620 (30) [back to overview]Incidence of Hypoglycaemic Episodes - All Episodes
NCT00542620 (30) [back to overview]Self-measured Plasma Glucose Profile (Before Breakfast)
NCT00542620 (30) [back to overview]Self-measured Plasma Glucose Profile (After Dinner)
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart
NCT00542620 (30) [back to overview]Pharmacokinetics: Cmax of Insulin Detemir
NCT00542620 (30) [back to overview]Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
NCT00542620 (30) [back to overview]Self-measured Plasma Glucose Profile (After Breakfast)
NCT00542620 (30) [back to overview]Fructosamine
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir
NCT00542620 (30) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00542620 (30) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00542620 (30) [back to overview]Self-measured Plasma Glucose Profile (Before Dinner)
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin
NCT00542620 (30) [back to overview]Pharmacokinetics: Cmax of Insulin Aspart
NCT00542620 (30) [back to overview]Weight Z Score
NCT00542620 (30) [back to overview]Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart
NCT00542620 (30) [back to overview]Pharmacokinetics: Tmax of Insulin Detemir
NCT00542620 (30) [back to overview]Pharmacokinetics: Tmax of Insulin Aspart
NCT00542620 (30) [back to overview]Pharmacokinetics: Tmax of Free Insulin
NCT00542620 (30) [back to overview]Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart
NCT00542620 (30) [back to overview]Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
NCT00542620 (30) [back to overview]Pharmacokinetics: Cmax of Free Insulin
NCT00542620 (30) [back to overview]Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir
NCT00548808 (9) [back to overview]Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
NCT00548808 (9) [back to overview]Change From Baseline in Postprandial Blood Glucose Over Time
NCT00548808 (9) [back to overview]Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)
NCT00548808 (9) [back to overview]Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks
NCT00548808 (9) [back to overview]Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks
NCT00548808 (9) [back to overview]Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
NCT00548808 (9) [back to overview]Safety: Number of Participants With Serious and Non-Serious Adverse Events
NCT00548808 (9) [back to overview]7-point Self-monitored Blood Glucose Profiles
NCT00548808 (9) [back to overview]Change in Hemoglobin A1c (HbA1c) Over Time
NCT00560417 (11) [back to overview]7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
NCT00560417 (11) [back to overview]Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
NCT00560417 (11) [back to overview]Total Daily Insulin Dose at Endpoint (LOCF)
NCT00560417 (11) [back to overview]Change From Baseline in Body Weight at Endpoint (LOCF)
NCT00560417 (11) [back to overview]Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
NCT00560417 (11) [back to overview]Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
NCT00560417 (11) [back to overview]Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
NCT00560417 (11) [back to overview]Glycemic Variability at Baseline and Endpoint (LOCF)
NCT00560417 (11) [back to overview]Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
NCT00560417 (11) [back to overview]Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
NCT00560417 (11) [back to overview]Actual Body Weight at Baseline and Endpoint (LOCF)
NCT00564395 (1) [back to overview]Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections
NCT00570687 (3) [back to overview]Minimum EGP - Meal Challenge
NCT00570687 (3) [back to overview]EGP AOC0-480 - Meal Challenge
NCT00570687 (3) [back to overview]Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge
NCT00574405 (1) [back to overview]Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
NCT00574912 (1) [back to overview]Maximum Glucose Infusion Rate
NCT00575666 (17) [back to overview]Cognitive Function- CPT D Prime Score
NCT00575666 (17) [back to overview]Psychopathology- PANSS Positive
NCT00575666 (17) [back to overview]Psychopathology- PANSS Total
NCT00575666 (17) [back to overview]Psychopathology- SANS Total
NCT00575666 (17) [back to overview]Cognitive Function- HVLT Delayed Recall Total
NCT00575666 (17) [back to overview]Cognitive Function- HVLT Immediate Recall Total
NCT00575666 (17) [back to overview]Cognitive Function- Trails A
NCT00575666 (17) [back to overview]Cognitive Function- Trails B
NCT00575666 (17) [back to overview]Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
NCT00575666 (17) [back to overview]Cognitive Function- Verbal Fluency
NCT00575666 (17) [back to overview]Psychopathology- CDSS Total
NCT00575666 (17) [back to overview]Psychopathology- PANSS General Psychopathology
NCT00575666 (17) [back to overview]Psychopathology- PANSS Negative
NCT00575666 (17) [back to overview]Cognitive Function- Digit Span Total
NCT00575666 (17) [back to overview]Cognitive Function- CPT Hits Rate (Proportion)
NCT00575666 (17) [back to overview]Cognitive Function- CPT False-alarm Rate (Proportion)
NCT00575666 (17) [back to overview]Psychopathology- QLS Total
NCT00581867 (2) [back to overview]fMRI Measure of Hippocampal Activation
NCT00581867 (2) [back to overview]Global Cognition
NCT00582309 (1) [back to overview]Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.
NCT00590044 (4) [back to overview]Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups
NCT00590044 (4) [back to overview]Difference in Time in Hours to Resolution of DKA Between the 2 Groups
NCT00590044 (4) [back to overview]Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin
NCT00590044 (4) [back to overview]Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups
NCT00590226 (2) [back to overview]Mean AM BG (mg/dl)
NCT00590226 (2) [back to overview]Number of Patients With Hypoglycemic Events
NCT00591227 (1) [back to overview]Hospital Length of Stay
NCT00593489 (10) [back to overview]Percent of Patients at Target (A1C ≤ 6.5%) Per FP
NCT00593489 (10) [back to overview]Mean Fasting Blood Glucose of Insulin-eligible Patients
NCT00593489 (10) [back to overview]Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop
NCT00593489 (10) [back to overview]Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop
NCT00593489 (10) [back to overview]Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation
NCT00593489 (10) [back to overview]Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice
NCT00593489 (10) [back to overview]Physician Score for Self-efficacy of Insulin Initiation & Titration
NCT00593489 (10) [back to overview]Physician Score for Knowledge of Insulin Initiation & Titration
NCT00593489 (10) [back to overview]Physician Score for Attitude Towards Insulin Initiation & Titration
NCT00593489 (10) [back to overview]Percentage of Patients at Target (A1C ≤ 7.0%) Per FP
NCT00596687 (2) [back to overview]# Participants With Hypoglycemic Events
NCT00596687 (2) [back to overview]Mean Blood Glucose Concentration
NCT00598663 (7) [back to overview]Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
NCT00598663 (7) [back to overview]Diabetic Ketoacidosis Events
NCT00598663 (7) [back to overview]Glycemic Variability
NCT00598663 (7) [back to overview]HbA1c at 6 Month
NCT00598663 (7) [back to overview]Number of Severe Hypoglycemia Events
NCT00598663 (7) [back to overview]Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
NCT00598663 (7) [back to overview]Postprandial Glycaemia
NCT00605696 (1) [back to overview]Murray Lung Injury Score
NCT00606034 (3) [back to overview]Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)
NCT00606034 (3) [back to overview]Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)
NCT00606034 (3) [back to overview]Percentage of Time Spent in Hypoglycemia
NCT00607087 (17) [back to overview]Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
NCT00607087 (17) [back to overview]Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site
NCT00607087 (17) [back to overview]Percentage of Patients With at Least One Confirmed Infusion Set Occlusion
NCT00607087 (17) [back to overview]Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
NCT00607087 (17) [back to overview]Percentage of Patients With at Least One Unexplained Hyperglycemia
NCT00607087 (17) [back to overview]Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
NCT00607087 (17) [back to overview]Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year
NCT00607087 (17) [back to overview]Rate of Severe Symptomatic Hypoglycemia Per Patient-year
NCT00607087 (17) [back to overview]Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year
NCT00607087 (17) [back to overview]Time Interval Between Infusion Set Changes in Routine
NCT00607087 (17) [back to overview]Time Interval Between Infusion Set Changes: All Changes
NCT00607087 (17) [back to overview]Glycosylated Hemoglobin: HbA1c
NCT00607087 (17) [back to overview]Total Daily Basal Insulin Infusion
NCT00607087 (17) [back to overview]Total Daily Bolus Insulin Dose
NCT00607087 (17) [back to overview]Monthly Rate of Confirmed Infusion Set Occlusion
NCT00607087 (17) [back to overview]Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
NCT00607087 (17) [back to overview]Monthly Rate of Unexplained Hyperglycemia
NCT00609986 (4) [back to overview]Acute/Active Rejection
NCT00609986 (4) [back to overview]Delayed Graft Function
NCT00609986 (4) [back to overview]Severe Hyperglycemia
NCT00609986 (4) [back to overview]Severe Hypoglycemia
NCT00611884 (11) [back to overview]Rate of Major and Minor Hypoglycaemic Episodes
NCT00611884 (11) [back to overview]Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
NCT00611884 (11) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT00611884 (11) [back to overview]Laboratory Safety Parameters (Biochemistry): Serum Creatinine
NCT00611884 (11) [back to overview]Vital Signs: Diastolic Blood Pressure (BP)
NCT00611884 (11) [back to overview]Vital Signs: Pulse
NCT00611884 (11) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT00611884 (11) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
NCT00611884 (11) [back to overview]Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
NCT00611884 (11) [back to overview]Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
NCT00611884 (11) [back to overview]Vital Signs: Systolic Blood Pressure (BP)
NCT00612040 (12) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT00612040 (12) [back to overview]Vital Signs: Diastolic BP (Blood Pressure)
NCT00612040 (12) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT00612040 (12) [back to overview]Vital Signs: Pulse
NCT00612040 (12) [back to overview]Vital Signs: Systolic BP (Blood Pressure)
NCT00612040 (12) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT00612040 (12) [back to overview]Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
NCT00612040 (12) [back to overview]Rate of Major and Minor Hypoglycaemic Episodes
NCT00612040 (12) [back to overview]Laboratory Safety Parameters (Biochemistry): Serum Creatinine
NCT00612040 (12) [back to overview]Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
NCT00612040 (12) [back to overview]Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
NCT00612040 (12) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
NCT00613951 (11) [back to overview]Laboratory Safety Parameters (Biochemistry): Serum Creatinine
NCT00613951 (11) [back to overview]Rate of Major and Minor Hypoglycaemic Episodes
NCT00613951 (11) [back to overview]Vital Signs: Pulse
NCT00613951 (11) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT00613951 (11) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
NCT00613951 (11) [back to overview]Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
NCT00613951 (11) [back to overview]Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
NCT00613951 (11) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT00613951 (11) [back to overview]Vital Signs: Diastolic Blood Pressure (BP)
NCT00613951 (11) [back to overview]Vital Signs: Systolic Blood Pressure (BP)
NCT00613951 (11) [back to overview]Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
NCT00614055 (12) [back to overview]Vital Signs: Systolic Blood Pressure (BP)
NCT00614055 (12) [back to overview]Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
NCT00614055 (12) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT00614055 (12) [back to overview]Laboratory Safety Parameters (Biochemistry): Serum Creatinine
NCT00614055 (12) [back to overview]Rate of Major and Minor Hypoglycaemic Episodes
NCT00614055 (12) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT00614055 (12) [back to overview]Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
NCT00614055 (12) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT00614055 (12) [back to overview]Vital Signs: Diastolic Blood Pressure (BP)
NCT00614055 (12) [back to overview]Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
NCT00614055 (12) [back to overview]Vital Signs: Pulse
NCT00614055 (12) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
NCT00623194 (17) [back to overview]Fasting Plasma Glucose Values
NCT00623194 (17) [back to overview]Diabetic Ketoacidosis
NCT00623194 (17) [back to overview]BMI (Body Mass Index)
NCT00623194 (17) [back to overview]Laboratory Values: Leukocytes and Thrombocytes
NCT00623194 (17) [back to overview]Vital Signs: Pulse
NCT00623194 (17) [back to overview]Vital Signs: Blood Pressure
NCT00623194 (17) [back to overview]Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)
NCT00623194 (17) [back to overview]Insulin Dose
NCT00623194 (17) [back to overview]Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)
NCT00623194 (17) [back to overview]Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)
NCT00623194 (17) [back to overview]Insulin Detemir-insulin Aspart Cross-reacting Antibodies
NCT00623194 (17) [back to overview]Hypoglycaemic Episodes
NCT00623194 (17) [back to overview]Fundoscopy/Fundus Photography
NCT00623194 (17) [back to overview]Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies
NCT00623194 (17) [back to overview]SD-score (Z-score) for Body Weight
NCT00623194 (17) [back to overview]Laboratory Values: Creatine Serum Umol/L
NCT00623194 (17) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00627445 (8) [back to overview]Change in Glycosylated Haemoglobin A1c (HbA1c)
NCT00627445 (8) [back to overview]Number of Nocturnal Hypoglycaemic Episodes
NCT00627445 (8) [back to overview]The Total Increase in Total Daily Insulin Dose Per Body Weight
NCT00627445 (8) [back to overview]Change and Daily Average in 8-point Plasma Glucose
NCT00627445 (8) [back to overview]Change and Daily Average in Prandial Plasma Glucose Increment
NCT00627445 (8) [back to overview]Number of Hypoglycaemic Episodes
NCT00627445 (8) [back to overview]Change in Body Weight
NCT00627445 (8) [back to overview]The Percentage of Subjects Achieving HbA1c Treatment Targets
NCT00634842 (4) [back to overview]Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
NCT00634842 (4) [back to overview]Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
NCT00634842 (4) [back to overview]Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
NCT00634842 (4) [back to overview]Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
NCT00635492 (21) [back to overview]Changes in Weight From Baseline to Month 24
NCT00635492 (21) [back to overview]Disinhibited Eating Associated With Treatment Choice at Baseline
NCT00635492 (21) [back to overview]Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
NCT00635492 (21) [back to overview]Percentage of Patients Hospitalized Between Baseline and 24 Months
NCT00635492 (21) [back to overview]Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline
NCT00635492 (21) [back to overview]Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
NCT00635492 (21) [back to overview]Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24
NCT00635492 (21) [back to overview]Older Age Associated With Treatment Choice at Baseline
NCT00635492 (21) [back to overview]Incidence of Hypoglycemia Between Baseline and 24 Months
NCT00635492 (21) [back to overview]Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
NCT00635492 (21) [back to overview]Higher Random Glucose Associated With Treatment Choice at Baseline
NCT00635492 (21) [back to overview]Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
NCT00635492 (21) [back to overview]Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
NCT00635492 (21) [back to overview]Reasons for Discontinuation of Baseline Regimen
NCT00635492 (21) [back to overview]Changes in HbA1c From Baseline to Month 24
NCT00635492 (21) [back to overview]Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
NCT00635492 (21) [back to overview]Factors Associated With Treatment Change in Insulin Cohort
NCT00635492 (21) [back to overview]Factors Associated With Treatment Change in Exenatide BID Cohort
NCT00635492 (21) [back to overview]Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
NCT00635492 (21) [back to overview]Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
NCT00635492 (21) [back to overview]Number of Contacts With Health Care Providers Between Baseline and 24 Months
NCT00642616 (2) [back to overview]Number of Participants With Asthma Exacerbation by Treatment Arm
NCT00642616 (2) [back to overview]Number of Participants With COPD Exacerbation by Treatment Arm
NCT00645528 (6) [back to overview]Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)
NCT00645528 (6) [back to overview]"Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes"
NCT00645528 (6) [back to overview]Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)
NCT00645528 (6) [back to overview]Percent of Patients Who Begin Insulin
NCT00645528 (6) [back to overview]Number of Subjects Experiencing Hypoglycemic Symptoms
NCT00645528 (6) [back to overview]Number of Patients Experiencing a Severe Hypoglycemic Event
NCT00646581 (6) [back to overview]Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
NCT00646581 (6) [back to overview]Improvement in Cognitive Function- HVLT-Delayed Recall (Number)
NCT00646581 (6) [back to overview]Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)
NCT00646581 (6) [back to overview]Improvement in Cognitive Function- CPT Hits Rate (Proportion)
NCT00646581 (6) [back to overview]Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)
NCT00646581 (6) [back to overview]CPT d Score
NCT00659165 (1) [back to overview]Calories Consumed After Fast.
NCT00662857 (4) [back to overview]Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360
NCT00662857 (4) [back to overview]Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.
NCT00662857 (4) [back to overview]Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax
NCT00662857 (4) [back to overview]Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro
NCT00664534 (11) [back to overview]Number of Participants With Adverse Events
NCT00664534 (11) [back to overview]Mean Postprandial Blood Glucose Values
NCT00664534 (11) [back to overview]7-point Self-monitored Blood Glucose Profiles
NCT00664534 (11) [back to overview]Percentage of Participants Using Each Possible Final Insulin Regimen
NCT00664534 (11) [back to overview]Mean Daily Total, Basal and Prandial Insulin Dose
NCT00664534 (11) [back to overview]HbA1c Over Time
NCT00664534 (11) [back to overview]Rate Per 30 Days of All Self-reported Hypoglycemic Episodes
NCT00664534 (11) [back to overview]Incidence of All Self-reported Hypoglycemic Episodes
NCT00664534 (11) [back to overview]Body Weight Change From Baseline to Endpoint
NCT00664534 (11) [back to overview]Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint
NCT00664534 (11) [back to overview]Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
NCT00666718 (11) [back to overview]Number of Participants With Adverse Events (AE)
NCT00666718 (11) [back to overview]Glycemic Variability at Endpoint
NCT00666718 (11) [back to overview]Change From Baseline in HbA1c at Week 12 and Week 24
NCT00666718 (11) [back to overview]7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
NCT00666718 (11) [back to overview]Total Daily Insulin Dose at Endpoint
NCT00666718 (11) [back to overview]Change in Body Weight From Baseline to Week 24
NCT00666718 (11) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
NCT00666718 (11) [back to overview]Number of Injections of Insulin at Week 24
NCT00666718 (11) [back to overview]Rate Of All Self-reported Hypoglycemic Episodes
NCT00666718 (11) [back to overview]Percentage of Participants With Self-Reported Hypoglycemic Episodes
NCT00666718 (11) [back to overview]Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint
NCT00670228 (4) [back to overview]Infarct Size Absolute Change From Baseline at Day 60
NCT00670228 (4) [back to overview]Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)
NCT00670228 (4) [back to overview]Occurrence of the Major Adverse Cardiovascular Events (MACE)
NCT00670228 (4) [back to overview]Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)
NCT00686712 (7) [back to overview]Any Adverse Event Other Than Hypoglycemia
NCT00686712 (7) [back to overview]Hemoglobin A1c Change From Baseline
NCT00686712 (7) [back to overview]Frequency of Total Hypoglycemic Reactions
NCT00686712 (7) [back to overview]Frequency of Severe Hypoglycemic Reactions
NCT00686712 (7) [back to overview]Frequency of Glucose Readings < 130 mg/dL
NCT00686712 (7) [back to overview]Body Mass Index Change From Baseline
NCT00686712 (7) [back to overview]Total Daily Insulin Dose
NCT00700622 (1) [back to overview]Change From Baseline in HbA1c to Week 16
NCT00705536 (14) [back to overview]Time to Late Half-Maximal Effect for Glucose Infusion Rate (tGIR[late50%])
NCT00705536 (14) [back to overview]Maximum Serum Insulin Concentration (Cmax)
NCT00705536 (14) [back to overview]Time to Early Half-Maximal Effect for Glucose Infusion Rate (tGIR[early50%])
NCT00705536 (14) [back to overview]Relative Bioavailability (Area Under the Curve [AUC] for Insulin + Recombinant Human Hyaluronidase [rHuPH20] / AUC for Insulin Alone)
NCT00705536 (14) [back to overview]Time to Maximum Serum Insulin Concentration (Tmax)
NCT00705536 (14) [back to overview]Time to Maximum Glucose Infusion Rate (tGIR[Max])
NCT00705536 (14) [back to overview]Area Under the Concentration-Time Curve From Time 0 to Time to Reach Maximum Concentration (Tmax) for Serum Insulin With Recombinant Human Hyaluronidase PH20 (rHuPH20) (AUC[0-tmaxPH20])
NCT00705536 (14) [back to overview]Maximum Glucose Infusion Rate (GIR[Max])
NCT00705536 (14) [back to overview]Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t'])
NCT00705536 (14) [back to overview]Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}])
NCT00705536 (14) [back to overview]Area Under the Glucose Infusion Rate Curve From 0 to 360 Minutes After Injection (AUC[GIR{0-360}])
NCT00705536 (14) [back to overview]Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}])
NCT00705536 (14) [back to overview]Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}])
NCT00705536 (14) [back to overview]Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}])
NCT00720122 (1) [back to overview]Change in Spine Bone Density (g/cm^2)
NCT00754624 (7) [back to overview]Annual Rate of Change in FEV1 From Baseline to End of Study
NCT00754624 (7) [back to overview]Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)
NCT00754624 (7) [back to overview]Annual Rate of Change in FVC From Baseline to End of Study
NCT00754624 (7) [back to overview]Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)
NCT00754624 (7) [back to overview]High Resolution Computerized Tomography Scans of the Chest
NCT00754624 (7) [back to overview]Change in Weight in kg From Baseline to End of Study
NCT00754624 (7) [back to overview]Annual Rate of Change in DLCo From Baseline to End of Study
NCT00757588 (14) [back to overview]Change From Baseline in Fasting Plasma Glucose Values
NCT00757588 (14) [back to overview]Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)
NCT00757588 (14) [back to overview]Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results
NCT00757588 (14) [back to overview]Percentage of Participants Achieving a Therapeutic Glycemic Response
NCT00757588 (14) [back to overview]Mean Changes From Baseline in Heart Rate
NCT00757588 (14) [back to overview]Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
NCT00757588 (14) [back to overview]Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs
NCT00757588 (14) [back to overview]Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)
NCT00757588 (14) [back to overview]Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
NCT00757588 (14) [back to overview]Percentage of Participants With Reported and Confirmed Hypoglycemia
NCT00757588 (14) [back to overview]Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
NCT00757588 (14) [back to overview]Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
NCT00757588 (14) [back to overview]Change From Baseline in 120-minute PPG Values During an MTT
NCT00757588 (14) [back to overview]Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])
NCT00774800 (4) [back to overview]Time to Maximum Serum Insulin Concentration (Tmax)
NCT00774800 (4) [back to overview]Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)
NCT00774800 (4) [back to overview]Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG])
NCT00774800 (4) [back to overview]Maximum Serum Insulin Concentration (Cmax)
NCT00779701 (1) [back to overview]Time to Achieve Glycemic Control
NCT00780026 (7) [back to overview]Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU
NCT00780026 (7) [back to overview]Number of Participants With Biliary Complications
NCT00780026 (7) [back to overview]Infection Rates
NCT00780026 (7) [back to overview]Hospital Length of Stay
NCT00780026 (7) [back to overview]Number of Participants With One Year Survival Post Transplant
NCT00780026 (7) [back to overview]Number of Participants With Venous Thrombotic Complications
NCT00780026 (7) [back to overview]Number of Participants With a Need for Hemodialysis
NCT00795600 (56) [back to overview]Absolute Change in High Density Lipoprotein (HDL) Cholesterol
NCT00795600 (56) [back to overview]Absolute Change in Neutrophils
NCT00795600 (56) [back to overview]Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
NCT00795600 (56) [back to overview]Absolute Change in Potassium
NCT00795600 (56) [back to overview]Absolute Change in Alkaline Phosphatase
NCT00795600 (56) [back to overview]Absolute Change in Albumin
NCT00795600 (56) [back to overview]Absolute Change in Alanine Aminotransferase (ALAT)
NCT00795600 (56) [back to overview]Absolute Change in Adiponectin
NCT00795600 (56) [back to overview]Absolute Change in Subcutaneous Adipose Tissue Area
NCT00795600 (56) [back to overview]Absolute Change in Liver/Spleen Attenuation Ratio
NCT00795600 (56) [back to overview]Absolute Change in Sodium
NCT00795600 (56) [back to overview]Percentage Change in Trunk Lean Mass
NCT00795600 (56) [back to overview]Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
NCT00795600 (56) [back to overview]Absolute Change in Aspartate Aminotransferase (ASAT)
NCT00795600 (56) [back to overview]Percentual Change in Calculated Whole Body Fat Percentage
NCT00795600 (56) [back to overview]Percentual Change in Calculated Trunk Fat Percentage
NCT00795600 (56) [back to overview]Percentage Change in Whole Body Lean Mass
NCT00795600 (56) [back to overview]Percentage Change in Whole Body Fat Mass
NCT00795600 (56) [back to overview]Percentage Change in Visceral Adipose Tissue Area
NCT00795600 (56) [back to overview]Absolute Change in Basophils
NCT00795600 (56) [back to overview]Absolute Change in Bilirubin Total
NCT00795600 (56) [back to overview]Absolute Change in Blood Volume (Haematocrit)
NCT00795600 (56) [back to overview]Absolute Change in Body Weight
NCT00795600 (56) [back to overview]Absolute Change in Trunk Fat Mass
NCT00795600 (56) [back to overview]Absolute Change in Trunk Lean Mass
NCT00795600 (56) [back to overview]Absolute Change in Urea
NCT00795600 (56) [back to overview]Absolute Change in Visceral Adipose Tissue Area
NCT00795600 (56) [back to overview]Absolute Change in Waist Circumference
NCT00795600 (56) [back to overview]Absolute Change in Whole Body Fat Mass
NCT00795600 (56) [back to overview]Absolute Change in Calculated Trunk Fat Percentage
NCT00795600 (56) [back to overview]Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
NCT00795600 (56) [back to overview]Absolute Change in HbA1c (Glycosylated Haemoglobin)
NCT00795600 (56) [back to overview]Absolute Change in Calculated Whole Body Fat Percentage
NCT00795600 (56) [back to overview]Absolute Change in Creatine Phosphokinase
NCT00795600 (56) [back to overview]Absolute Change in Creatinine
NCT00795600 (56) [back to overview]Absolute Change in Eosinophils
NCT00795600 (56) [back to overview]Absolute Change in Erythrocytes
NCT00795600 (56) [back to overview]Absolute Change in Fasting Plasma Glucose (FPG)
NCT00795600 (56) [back to overview]Absolute Change in Free Fatty Acids
NCT00795600 (56) [back to overview]Absolute Change in Haemoglobin
NCT00795600 (56) [back to overview]Absolute Change in Whole Body Lean Mass
NCT00795600 (56) [back to overview]Number of Hypoglycaemic Episodes
NCT00795600 (56) [back to overview]Number of Non-serious Adverse Events
NCT00795600 (56) [back to overview]Absolute Change in Monocytes
NCT00795600 (56) [back to overview]Absolute Change in Lymphocytes
NCT00795600 (56) [back to overview]Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
NCT00795600 (56) [back to overview]Absolute Change in Leucocytes
NCT00795600 (56) [back to overview]Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
NCT00795600 (56) [back to overview]Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
NCT00795600 (56) [back to overview]Percentage Change in Liver/Spleen Attenuation Ratio
NCT00795600 (56) [back to overview]Percentage Change in Subcutaneous Adipose Tissue Area
NCT00795600 (56) [back to overview]Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
NCT00795600 (56) [back to overview]Absolute Change in Hip Circumference
NCT00795600 (56) [back to overview]Absolute Change in Triglycerides
NCT00795600 (56) [back to overview]Absolute Change in Total Cholesterol
NCT00795600 (56) [back to overview]Absolute Change in Thrombocytes
NCT00797823 (2) [back to overview]Percent of Time Venous Blood Glucose <70 mg/dl
NCT00797823 (2) [back to overview]Effectiveness of Closed Loop Diabetes Control
NCT00807092 (12) [back to overview]Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS
NCT00807092 (12) [back to overview]Change in Prandial Blood Glucose Increment
NCT00807092 (12) [back to overview]Duration of Hypoglycaemic Events Based on CGMS
NCT00807092 (12) [back to overview]Hypoglycaemia Based on Self-reported Episodes
NCT00807092 (12) [back to overview]Change in GA (Glycated Albumin)
NCT00807092 (12) [back to overview]Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals
NCT00807092 (12) [back to overview]Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles
NCT00807092 (12) [back to overview]Mean FBG (Fasting Blood Glucose) Assessed by CGMS
NCT00807092 (12) [back to overview]Change in Mean FBG Assessed by CGMS
NCT00807092 (12) [back to overview]Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS
NCT00807092 (12) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT00807092 (12) [back to overview]Change in FPG (Fasting Plasma Glucose)
NCT00812253 (6) [back to overview]Hospital Readmission
NCT00812253 (6) [back to overview]Hospital Length of Stay
NCT00812253 (6) [back to overview]Heart Rate Variability
NCT00812253 (6) [back to overview]Brain Natriuretic Peptide (BNP)
NCT00812253 (6) [back to overview]Change in Quality of Life
NCT00812253 (6) [back to overview]Cardiac Output
NCT00812487 (10) [back to overview]Quality of Life
NCT00812487 (10) [back to overview]Coefficient of Variation (CV)
NCT00812487 (10) [back to overview]Brain Natriuretic Peptide (BNP)
NCT00812487 (10) [back to overview]Glycemic Lability Index (GLI)
NCT00812487 (10) [back to overview]High Frequency Heart Rate Variability
NCT00812487 (10) [back to overview]High Sensitivity C-reactive Protein (Hs-CRP)
NCT00812487 (10) [back to overview]Hospital Length of Stay
NCT00812487 (10) [back to overview]Hospital Readmission
NCT00812487 (10) [back to overview]Mean Glucose
NCT00812487 (10) [back to overview]Pre-ejection Period (PEP)
NCT00821795 (1) [back to overview]For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase.
NCT00824616 (2) [back to overview]Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
NCT00824616 (2) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) Level
NCT00835861 (9) [back to overview]Number of Babies With Adverse Neonatal Outcomes
NCT00835861 (9) [back to overview]Maternal Weight Gain
NCT00835861 (9) [back to overview]Number of Patients With Obstetric Complications
NCT00835861 (9) [back to overview]Blood Glucose Measurements
NCT00835861 (9) [back to overview]Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
NCT00835861 (9) [back to overview]Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
NCT00835861 (9) [back to overview]Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
NCT00835861 (9) [back to overview]Number of Episodes Maternal Hypoglycemia
NCT00835861 (9) [back to overview]Number of Babies With Neonatal Hypoglycemia
NCT00837512 (1) [back to overview]Onset Time (Tmax)
NCT00841087 (7) [back to overview]Change in Body Weight
NCT00841087 (7) [back to overview]Diastolic Blood Pressure (BP)
NCT00841087 (7) [back to overview]Number of Treatment Emergent Adverse Events (AEs)
NCT00841087 (7) [back to overview]Rate of Major and Minor Hypoglycaemic Episodes
NCT00841087 (7) [back to overview]Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
NCT00841087 (7) [back to overview]Systolic Blood Pressure (BP)
NCT00841087 (7) [back to overview]Electrocardiogram (ECG)
NCT00842361 (7) [back to overview]Number of Treatment Emergent Adverse Events (AEs)
NCT00842361 (7) [back to overview]Electrocardiogram (ECG) Worsening
NCT00842361 (7) [back to overview]Rate of Major and Minor Hypoglycaemic Episodes
NCT00842361 (7) [back to overview]Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
NCT00842361 (7) [back to overview]Systolic BP (Blood Pressure)
NCT00842361 (7) [back to overview]Change in Body Weight
NCT00842361 (7) [back to overview]Diastolic BP (Blood Pressure)
NCT00850096 (2) [back to overview]Continuous Glucose Monitoring (CGM)
NCT00850096 (2) [back to overview]Overall Glycemic Control
NCT00858273 (2) [back to overview]Glutathione Concentration
NCT00858273 (2) [back to overview]Plasma Protein Bound 3-nitrotyrosine
NCT00858897 (1) [back to overview]Glutathione Concentration
NCT00862849 (6) [back to overview]Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])
NCT00862849 (6) [back to overview]Percentage of Total Glucose Infused
NCT00862849 (6) [back to overview]Peak Serum Insulin Concentration (Cmax)
NCT00862849 (6) [back to overview]Number of Treatment Emergent Adverse Events (TEAEs) Related to Study Drug
NCT00862849 (6) [back to overview]Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T])
NCT00862849 (6) [back to overview]Time to Percentage of Total Glucose Infused
NCT00883558 (3) [back to overview]Number of Participants With Hypoglycemic Events
NCT00883558 (3) [back to overview]Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring
NCT00883558 (3) [back to overview]Postprandial Glucose Excursion
NCT00891995 (9) [back to overview]Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment
NCT00891995 (9) [back to overview]CGM Mean Glucose
NCT00891995 (9) [back to overview]Daily Insulin Dose
NCT00891995 (9) [back to overview]HbA1c
NCT00891995 (9) [back to overview]Adverse Events (Severe Hypoglycemia)
NCT00891995 (9) [back to overview]Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT
NCT00891995 (9) [back to overview]CGM Measured Glucose Outcomes
NCT00891995 (9) [back to overview]BMI Percentile
NCT00891995 (9) [back to overview]C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.
NCT00909480 (14) [back to overview]Hypoglycaemic Episodes, Nocturnal
NCT00909480 (14) [back to overview]Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
NCT00909480 (14) [back to overview]Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
NCT00909480 (14) [back to overview]Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
NCT00909480 (14) [back to overview]Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
NCT00909480 (14) [back to overview]Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
NCT00909480 (14) [back to overview]Fasting Plasma Glucose (FPG)
NCT00909480 (14) [back to overview]Incidence of Hypoglycaemic Episodes During the Trial
NCT00909480 (14) [back to overview]Change in HbA1c From Baseline
NCT00909480 (14) [back to overview]Change in Body Weight From Baseline
NCT00909480 (14) [back to overview]"Number of Subjects Having the Adverse Event Incorrect Dose Administered"
NCT00909480 (14) [back to overview]Hypoglycemic Episodes, Unclassifiable
NCT00909480 (14) [back to overview]Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
NCT00909480 (14) [back to overview]Hypoglycaemic Episodes, Diurnal
NCT00911625 (1) [back to overview]Average Blood Glucose Over 6 Days
NCT00913497 (2) [back to overview]Occurrence of Hypoglycemia;
NCT00913497 (2) [back to overview]Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days
NCT00916357 (11) [back to overview]Time to Percentage of Insulin Exposure (as Measured by Area Under the Curve [AUC])
NCT00916357 (11) [back to overview]Postprandial Glucose (PPG) Excursion Following a Liquid Meal
NCT00916357 (11) [back to overview]Area Under the Time-Concentration Curve for Blood Glucose (AUC[BG])
NCT00916357 (11) [back to overview]Time To Maximum Serum Insulin Concentration (Tmax)
NCT00916357 (11) [back to overview]Time to Late 50% Maximum Serum Insulin Concentration (Late[t50%])
NCT00916357 (11) [back to overview]Time to Early 50% Maximum Serum Insulin Concentration (Early[t50%])
NCT00916357 (11) [back to overview]Minimum Postprandial Glucose (PPG)
NCT00916357 (11) [back to overview]Area Under the Concentration Time-Curve for Serum Insulin From Time 0 to the End of Blood Sampling (AUC[Last])
NCT00916357 (11) [back to overview]Maximum Serum Insulin Concentration (Cmax)
NCT00916357 (11) [back to overview]Mean Residence Time From Time 0 to the End of Blood Sampling (MRT[Last])
NCT00916357 (11) [back to overview]Percentage of Participants Without Hypoglycemia
NCT00935532 (11) [back to overview]Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)
NCT00935532 (11) [back to overview]Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline
NCT00935532 (11) [back to overview]Change in Blood Pressure From Baseline to Endpoint (Week 26)
NCT00935532 (11) [back to overview]Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
NCT00935532 (11) [back to overview]Change in Body Weight From Baseline to Endpoint (Week 26)
NCT00935532 (11) [back to overview]Change in Total Cholesterol From Baseline to Endpoint (Week 26)
NCT00935532 (11) [back to overview]Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)
NCT00935532 (11) [back to overview]Percentage of Subjects Achieving HbA1c<=7%
NCT00935532 (11) [back to overview]Percentage of Subjects Achieving HbA1c<=6.5%
NCT00935532 (11) [back to overview]Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
NCT00935532 (11) [back to overview]Change in HbA1c From Baseline to Endpoint (Week 26)
NCT00960661 (13) [back to overview]Change in Total Cholesterol From Baseline to Week 30
NCT00960661 (13) [back to overview]Change in Low Density Lipoprotein (LDL) From Baseline to Week 30
NCT00960661 (13) [back to overview]Major Hypoglycemia Rate Per Year
NCT00960661 (13) [back to overview]Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
NCT00960661 (13) [back to overview]Change in High Density Lipoprotein (HDL) From Baseline to Week 30
NCT00960661 (13) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 30
NCT00960661 (13) [back to overview]Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.
NCT00960661 (13) [back to overview]Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30
NCT00960661 (13) [back to overview]Change in Body Weight From Baseline to Week 30.
NCT00960661 (13) [back to overview]Daily Insulin Glargine Dose at Baseline and at Week 30
NCT00960661 (13) [back to overview]Percentage of Participants Achieving HbA1C < 7.0%
NCT00960661 (13) [back to overview]Percent of Participants Achieving HbA1c ≤ 6.5%.
NCT00960661 (13) [back to overview]Minor Hypoglycemia Rate Per Year
NCT00972283 (9) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment
NCT00972283 (9) [back to overview]Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00972283 (9) [back to overview]Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78
NCT00972283 (9) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT00972283 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00972283 (9) [back to overview]Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00972283 (9) [back to overview]Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
NCT00972283 (9) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT00972283 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00974051 (4) [back to overview]Percent of Nighttime Glucose Levels >250 mg/dl
NCT00974051 (4) [back to overview]Blood Glucose Nadir
NCT00974051 (4) [back to overview]Percent of Nighttime Glucose Levels <70
NCT00974051 (4) [back to overview]Percent of Nighttime Glucose Levels <80
NCT00976391 (8) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
NCT00976391 (8) [back to overview]Change From Baseline in Body Weight at Week 26
NCT00976391 (8) [back to overview]Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26
NCT00976391 (8) [back to overview]Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26
NCT00976391 (8) [back to overview]Change From Baseline in HbA1c at Weeks 36, 48 and 52
NCT00976391 (8) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52
NCT00976391 (8) [back to overview]Change From Baseline in Body Weight at Weeks 36, 48 and 52
NCT00976391 (8) [back to overview]Time to Hyperglycemia Rescue
NCT00978627 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00978627 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
NCT00978627 (9) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT00978627 (9) [back to overview]Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
NCT00978627 (9) [back to overview]Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00978627 (9) [back to overview]Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00978627 (9) [back to overview]Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
NCT00978627 (9) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
NCT00978627 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00979628 (2) [back to overview]Number of Patients With Hypoglycemia Events (Blood Glucose Levels < 70 mg/dL) During Their Hospital Stay That Are Treated With Basal Plus, Basal-bolus and SSRI Treatments
NCT00979628 (2) [back to overview]Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments
NCT00979875 (6) [back to overview]Time to Maximum Glucose Infusion Rate (tGIR[Max])
NCT00979875 (6) [back to overview]Time to Percentage of Total Insulin Exposure
NCT00979875 (6) [back to overview]Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])
NCT00979875 (6) [back to overview]Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)
NCT00979875 (6) [back to overview]Time to Maximum Serum Insulin Concentration (Tmax)
NCT00979875 (6) [back to overview]Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)
NCT00982228 (10) [back to overview]Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin
NCT00982228 (10) [back to overview]Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
NCT00982228 (10) [back to overview]Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00982228 (10) [back to overview]Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00982228 (10) [back to overview]Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
NCT00982228 (10) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT00982228 (10) [back to overview]Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment
NCT00982228 (10) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
NCT00982228 (10) [back to overview]Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00982228 (10) [back to overview]Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00982644 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00982644 (9) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
NCT00982644 (9) [back to overview]Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104
NCT00982644 (9) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT00982644 (9) [back to overview]Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00982644 (9) [back to overview]Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00982644 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
NCT00982644 (9) [back to overview]Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
NCT00982644 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00993473 (16) [back to overview]Percent of Blood Glucose (BG) Within the Range of 70 - 180 mg/dL (3.9-10 mmol/L)
NCT00993473 (16) [back to overview]Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years
NCT00993473 (16) [back to overview]"Event Rate of All Confirmed Low CGMS Excursions (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"
NCT00993473 (16) [back to overview]Blood Glucose Variability Based on All On-treatment CGMS Values
NCT00993473 (16) [back to overview]Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years
NCT00993473 (16) [back to overview]Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)
NCT00993473 (16) [back to overview]Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values
NCT00993473 (16) [back to overview]Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit
NCT00993473 (16) [back to overview]Number of Patients With Different Types of Hypoglycemia Events
NCT00993473 (16) [back to overview]Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)
NCT00993473 (16) [back to overview]Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment
NCT00993473 (16) [back to overview]Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment
NCT00993473 (16) [back to overview]"Event Rate of All Confirmed Low FSBG (Individual Component of the Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"
NCT00993473 (16) [back to overview]"Event Rate of All Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"
NCT00993473 (16) [back to overview]"Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of All Hypoglycemia Episodes Divided by the Total Duration of the On-treatment Period in Years"
NCT00993473 (16) [back to overview]Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years
NCT00995501 (2) [back to overview]1 Year Mortality
NCT00995501 (2) [back to overview]Major Perioperative Morbidity
NCT00998335 (12) [back to overview]Number of Hypoglycemic Events
NCT00998335 (12) [back to overview]Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.
NCT00998335 (12) [back to overview]Metabolic Control as Measured by the Fasting Plasma Glucose Concentration
NCT00998335 (12) [back to overview]Change in Anthropometric Measure (Body Mass Index [BMI]).
NCT00998335 (12) [back to overview]Metabolic Control as Measured by the A1c
NCT00998335 (12) [back to overview]Change in Anthropometric Measure (Body Weight).
NCT00998335 (12) [back to overview]Change in Insulin Secretion
NCT00998335 (12) [back to overview]Advanced Lipid Testing
NCT00998335 (12) [back to overview]Plasma Lipid Concentration.
NCT00998335 (12) [back to overview]Hepatic Steatosis
NCT00998335 (12) [back to overview]Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).
NCT00998335 (12) [back to overview]Percent Change From Baseline in Vascular Inflammatory Markers
NCT01006291 (4) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
NCT01006291 (4) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01006291 (4) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01006291 (4) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01009580 (4) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01009580 (4) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
NCT01009580 (4) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01009580 (4) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01030341 (2) [back to overview]Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
NCT01030341 (2) [back to overview]Hypoglycemic Episodes
NCT01045447 (2) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
NCT01045447 (2) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01045707 (6) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
NCT01045707 (6) [back to overview]Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
NCT01045707 (6) [back to overview]Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
NCT01045707 (6) [back to overview]Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01045707 (6) [back to overview]Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT01045707 (6) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT01059799 (4) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01059799 (4) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
NCT01059799 (4) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01059799 (4) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01059812 (5) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01059812 (5) [back to overview]Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment
NCT01059812 (5) [back to overview]Change in Body Weight
NCT01059812 (5) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01059812 (5) [back to overview]Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
NCT01068652 (17) [back to overview]Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment
NCT01068652 (17) [back to overview]Glycosylated Haemoglobin (HbA1c)
NCT01068652 (17) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) at Week 50
NCT01068652 (17) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment
NCT01068652 (17) [back to overview]Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment
NCT01068652 (17) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
NCT01068652 (17) [back to overview]Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment
NCT01068652 (17) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment
NCT01068652 (17) [back to overview]Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
NCT01068652 (17) [back to overview]Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment
NCT01068665 (2) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT01068665 (2) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01068678 (2) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01068678 (2) [back to overview]Change in Body Weight
NCT01068860 (16) [back to overview]Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.
NCT01068860 (16) [back to overview]Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.
NCT01068860 (16) [back to overview]Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Fructosamine, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks
NCT01073566 (4) [back to overview]Glucose Profiles Per Day
NCT01073566 (4) [back to overview]Insulin Delivery System Rating
NCT01073566 (4) [back to overview]Mean Daily Blood Glucose
NCT01073566 (4) [back to overview]Self-reported Hypoglycemic Episodes
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
NCT01074268 (11) [back to overview]Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01074268 (11) [back to overview]Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
NCT01074268 (11) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
NCT01074268 (11) [back to overview]Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
NCT01074268 (11) [back to overview]Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
NCT01074268 (11) [back to overview]Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT01076647 (2) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01076647 (2) [back to overview]Change in Body Weight
NCT01079234 (6) [back to overview]Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
NCT01079234 (6) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
NCT01079234 (6) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT01079234 (6) [back to overview]Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
NCT01079234 (6) [back to overview]Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01079234 (6) [back to overview]Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT01109316 (13) [back to overview]Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values
NCT01109316 (13) [back to overview]Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight
NCT01109316 (13) [back to overview]Hyperglycemic Episode Rate Per 30 Days
NCT01109316 (13) [back to overview]Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure
NCT01109316 (13) [back to overview]Percentage of Participants With Hypoglycemia
NCT01109316 (13) [back to overview]Percentage of Participants With Hyperglycemia
NCT01109316 (13) [back to overview]Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%
NCT01109316 (13) [back to overview]Mean Daily Insulin Dose (Total, Basal, and Bolus)
NCT01109316 (13) [back to overview]Hypoglycemia Episode Rate Per 30 Days
NCT01109316 (13) [back to overview]Percentage of Participants With Pump Complications
NCT01109316 (13) [back to overview]Pump Complication Rate Per 30 Days
NCT01109316 (13) [back to overview]Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use
NCT01109316 (13) [back to overview]Mean SMBG
NCT01123980 (7) [back to overview]Number of Hypoglycaemic Episodes - Severe and Minor
NCT01123980 (7) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01123980 (7) [back to overview]9-point Plasma Glucose Profiles
NCT01123980 (7) [back to overview]Number of Hypoglycaemic Episodes
NCT01123980 (7) [back to overview]Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
NCT01123980 (7) [back to overview]Percentage of Subjects Achieving HbA1c Below 7.0%
NCT01123980 (7) [back to overview]Number of Hypoglycaemic Episodes - All
NCT01131052 (8) [back to overview]Mean of Glycosylated Hemoglobin (hbA1c)
NCT01131052 (8) [back to overview]Mean of Daily Blood Glucose Concentration
NCT01131052 (8) [back to overview]Mean Blood Glucose Concentration
NCT01131052 (8) [back to overview]Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL
NCT01131052 (8) [back to overview]Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL
NCT01131052 (8) [back to overview]Mean of Weekly Fasting Blood Glucose Concentration
NCT01131052 (8) [back to overview]Mean of Glycosylated Hemoglobin (hbA1c)
NCT01131052 (8) [back to overview]Mean of Glycosylated Hemoglobin (hbA1c)
NCT01133392 (5) [back to overview]Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]
NCT01133392 (5) [back to overview]Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)
NCT01133392 (5) [back to overview]Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
NCT01133392 (5) [back to overview]Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]
NCT01133392 (5) [back to overview]Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
NCT01134107 (14) [back to overview]Hyperglycemic Episode Rate Per 30 Days
NCT01134107 (14) [back to overview]Hypoglycemic Episode Rate Per 30 Days
NCT01134107 (14) [back to overview]Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use
NCT01134107 (14) [back to overview]Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure
NCT01134107 (14) [back to overview]Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)
NCT01134107 (14) [back to overview]Change From Baseline to 12 Week Endpoint for Each Treatment in Weight
NCT01134107 (14) [back to overview]Mean Daily Insulin Dose (Total, Basal, and Bolus)
NCT01134107 (14) [back to overview]Mean SMBG
NCT01134107 (14) [back to overview]Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%
NCT01134107 (14) [back to overview]Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values
NCT01134107 (14) [back to overview]Percentage of Participants Having a Hypoglycemic Episode
NCT01134107 (14) [back to overview]Percentage of Participants With Pump Complications
NCT01134107 (14) [back to overview]Percentage of Participants Having a Hyperglycemic Episode
NCT01134107 (14) [back to overview]Pump Complications Rate Per 30 Days
NCT01135992 (6) [back to overview]Fasting Plasma Glucose (FPG)
NCT01135992 (6) [back to overview]Change in Body Weight
NCT01135992 (6) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT01135992 (6) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01135992 (6) [back to overview]HbA1c (Glycosylated Haemoglobin)
NCT01135992 (6) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01136746 (5) [back to overview]Mean Plasma Glucose (MPG) by Hospital Day
NCT01136746 (5) [back to overview]Mean Plasma Glucose (MPG) Throughout Hospital Study Period
NCT01136746 (5) [back to overview]Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period
NCT01136746 (5) [back to overview]Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period
NCT01136746 (5) [back to overview]Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period
NCT01137773 (2) [back to overview]Blood Glucose Concentration
NCT01137773 (2) [back to overview]Karnovsky Performance Status Scale of Functional Impairment
NCT01145482 (2) [back to overview]Cerebral Glutamate Concentration
NCT01145482 (2) [back to overview]Memory
NCT01147627 (1) [back to overview]the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
NCT01165684 (15) [back to overview]Fasting Plasma Glucose (FPG) at Week 21
NCT01165684 (15) [back to overview]Fasting Plasma Glucose (FPG) at Week 10
NCT01165684 (15) [back to overview]Body Mass Index (BMI) at Week 32
NCT01165684 (15) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21
NCT01165684 (15) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32
NCT01165684 (15) [back to overview]Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32
NCT01165684 (15) [back to overview]Body Weight at Week 32
NCT01165684 (15) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10
NCT01165684 (15) [back to overview]Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32
NCT01165684 (15) [back to overview]Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21
NCT01165684 (15) [back to overview]Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10
NCT01165684 (15) [back to overview]Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21
NCT01165684 (15) [back to overview]Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10
NCT01165684 (15) [back to overview]Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)
NCT01165684 (15) [back to overview]Fasting Plasma Glucose (FPG) at Week 32
NCT01170208 (4) [back to overview]Change in Weekly Mean Blood Glucose From Week 4 to Week 16
NCT01170208 (4) [back to overview]Reduction in Fructosamine.
NCT01170208 (4) [back to overview]Reduction in HbA1c.
NCT01170208 (4) [back to overview]Incidence of Severe or Serious Hypoglycemia.
NCT01175811 (10) [back to overview]The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
NCT01175811 (10) [back to overview]Daily Dose of Insulin: Total, Basal, and Prandial
NCT01175811 (10) [back to overview]Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
NCT01175811 (10) [back to overview]Change in HbA1c From Baseline to 12 Week Endpoint
NCT01175811 (10) [back to overview]Percentage of Participants Experiencing a Severe Hypoglycemic Episode
NCT01175811 (10) [back to overview]Percentage of Participants With Hypoglycemic Episodes (Incidence)
NCT01175811 (10) [back to overview]The Rate of Hypoglycemic Episodes
NCT01175811 (10) [back to overview]Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks
NCT01175811 (10) [back to overview]Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
NCT01175811 (10) [back to overview]The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
NCT01175824 (14) [back to overview]Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
NCT01175824 (14) [back to overview]Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks
NCT01175824 (14) [back to overview]Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks
NCT01175824 (14) [back to overview]Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint
NCT01175824 (14) [back to overview]Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks
NCT01175824 (14) [back to overview]Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks
NCT01175824 (14) [back to overview]Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks
NCT01175824 (14) [back to overview]Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)
NCT01175824 (14) [back to overview]The Number of Participants With a Hypoglycemic Episodes (Incidence)
NCT01175824 (14) [back to overview]Change in Weight From Baseline to 12 Weeks and 24 Weeks
NCT01175824 (14) [back to overview]The Number of Participants With Severe Hypoglycemic Episodes
NCT01175824 (14) [back to overview]7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
NCT01175824 (14) [back to overview]The Rate of Hypoglycemic Episodes
NCT01175824 (14) [back to overview]Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)
NCT01181674 (12) [back to overview]Change in Fasting Plasma Glucose From Baseline
NCT01181674 (12) [back to overview]Percentage of Participants With Normal Fasting Plasma Glucose
NCT01181674 (12) [back to overview]Normoglycemia on Therapy
NCT01181674 (12) [back to overview]Normoglycemia on Therapy
NCT01181674 (12) [back to overview]Normoglycemia on Therapy
NCT01181674 (12) [back to overview]HbA1C
NCT01181674 (12) [back to overview]Change in Weight From Baseline
NCT01181674 (12) [back to overview]1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.
NCT01181674 (12) [back to overview]1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.
NCT01181674 (12) [back to overview]1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.
NCT01181674 (12) [back to overview]Number of Participants With Symptomatic Hypoglycemic Episodes
NCT01181674 (12) [back to overview]Number of Participants With Severe Hypoglycemic Episodes
NCT01182493 (7) [back to overview]Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)
NCT01182493 (7) [back to overview]Change in Body Weight
NCT01182493 (7) [back to overview]Between Group Difference in HbA1c When Comparing CSII to MDI
NCT01182493 (7) [back to overview]Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)
NCT01182493 (7) [back to overview]Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)
NCT01182493 (7) [back to overview]Safety - Severe Hypoglycemia Incidence
NCT01182493 (7) [back to overview]Safety - Diabetic Ketoacidosis Incidence
NCT01184014 (1) [back to overview]Mean Blood Glucose of All Readings
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)
NCT01191268 (30) [back to overview]Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia
NCT01191268 (30) [back to overview]Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)
NCT01191268 (30) [back to overview]Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)
NCT01191268 (30) [back to overview]Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52
NCT01191268 (30) [back to overview]Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes
NCT01191268 (30) [back to overview]Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Pulse Rate
NCT01191268 (30) [back to overview]Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Serum Calcitonin
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in the EQ-5D
NCT01191268 (30) [back to overview]Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
NCT01191268 (30) [back to overview]Rate of Self-reported Hypoglycemic Events up to 52 Weeks
NCT01191268 (30) [back to overview]Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose
NCT01191268 (30) [back to overview]Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)
NCT01191268 (30) [back to overview]Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)
NCT01191268 (30) [back to overview]Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Blood Pressure
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Body Weight
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
NCT01191268 (30) [back to overview]Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate
NCT01194245 (6) [back to overview]Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period
NCT01194245 (6) [back to overview]Change From Baseline in Body Weight at the End of Each Treatment Period
NCT01194245 (6) [back to overview]Mean Daily Postprandial Glucose (PPG) Excursions
NCT01194245 (6) [back to overview]Mean Daily Insulin Dose
NCT01194245 (6) [back to overview]Percentage of Participants Meeting Glucose Targets
NCT01194245 (6) [back to overview]Rates of Hypoglycemia at the End of Each Treatment Period
NCT01194258 (6) [back to overview]Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
NCT01194258 (6) [back to overview]Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period
NCT01194258 (6) [back to overview]Change From Baseline in Body Weight at the End of Each Treatment Period
NCT01194258 (6) [back to overview]Mean Daily PPG Excursions
NCT01194258 (6) [back to overview]Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring
NCT01194258 (6) [back to overview]Rates of Hypoglycemia at the End of Each Treatment Period
NCT01196104 (18) [back to overview]Week 20 (Follow-up) Forced Vital Capacity
NCT01196104 (18) [back to overview]Number of Single Coughing Episodes
NCT01196104 (18) [back to overview]Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation
NCT01196104 (18) [back to overview]Mild or Moderate Hypoglycemic Event Rate
NCT01196104 (18) [back to overview]Change in HbA1c (%) From Baseline to Week 16
NCT01196104 (18) [back to overview]Baseline Forced Vital Capacity (FVC)
NCT01196104 (18) [back to overview]Baseline Forced Expiratory Volume in 1 Second (FEV1)
NCT01196104 (18) [back to overview]Number of Subjects Reporting Cough Episodes
NCT01196104 (18) [back to overview]Number of Subjects Reporting Intermittent Coughing Episodes
NCT01196104 (18) [back to overview]Severe Hypoglycemic Event Rate
NCT01196104 (18) [back to overview]Week 20 (Follow-up) Forced Expiratory Volume in 1 Second
NCT01196104 (18) [back to overview]Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity
NCT01196104 (18) [back to overview]Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second
NCT01196104 (18) [back to overview]Week 16 Forced Vital Capacity
NCT01196104 (18) [back to overview]Week 16 Forced Expiratory Volume in 1 Second
NCT01196104 (18) [back to overview]Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second
NCT01196104 (18) [back to overview]Week 16 Change From Baseline Forced Vital Capacity
NCT01196104 (18) [back to overview]Total Number of Cough Episodes
NCT01206322 (2) [back to overview]Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg)
NCT01206322 (2) [back to overview]Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score)
NCT01211730 (6) [back to overview]Rehospitalization Rates
NCT01211730 (6) [back to overview]Rejection of Liver Transplant
NCT01211730 (6) [back to overview]Death Within 1 Year
NCT01211730 (6) [back to overview]Hypoglycemia
NCT01211730 (6) [back to overview]Infection Rates
NCT01211730 (6) [back to overview]Overall Graft Survival at 1 Year
NCT01215435 (3) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes
NCT01215435 (3) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
NCT01215435 (3) [back to overview]Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36
NCT01220557 (1) [back to overview]Changes in Glycemic Control Measured by A1c
NCT01232946 (3) [back to overview]Myocardial Fatty Acid Esterification Rate
NCT01232946 (3) [back to overview]Myocardial Fatty Acid Oxidation Rate
NCT01232946 (3) [back to overview]Myocardial Glucose Uptake
NCT01257087 (3) [back to overview]Number of Participants With Microvascular Events
NCT01257087 (3) [back to overview]Percentage of Type 2 Diabetes Mellitus Patients With a Reduction in the Doses/Number of Diabetes Medications Used Preoperatively
NCT01257087 (3) [back to overview]Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6%
NCT01267175 (2) [back to overview]Usability of the X54 Insulin Pump Meets Expectations
NCT01267175 (2) [back to overview]Usability of the Training Material Meets Expectations
NCT01272193 (6) [back to overview]Change in Body Weight
NCT01272193 (6) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01272193 (6) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01272193 (6) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01272193 (6) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT01272193 (6) [back to overview]Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
NCT01278160 (5) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes
NCT01278160 (5) [back to overview]9-point SMPG (Self Measured Plasma Glucose) Profile
NCT01278160 (5) [back to overview]Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline
NCT01278160 (5) [back to overview]Percentage of Subjects Achieving HbA1c Below 7.0%
NCT01278160 (5) [back to overview]Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
NCT01282164 (7) [back to overview]Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).
NCT01282164 (7) [back to overview]Peak Growth Hormone (GH) Level in Healthy Volunteers
NCT01282164 (7) [back to overview]Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test
NCT01282164 (7) [back to overview]Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).
NCT01282164 (7) [back to overview]Peak Cortisol Level in Healthy Volunteers.
NCT01282164 (7) [back to overview]Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).
NCT01282164 (7) [back to overview]Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).
NCT01293396 (6) [back to overview]Area Over Basal for Postprandial Triglycerides
NCT01293396 (6) [back to overview]Maximum Glucose Increase
NCT01293396 (6) [back to overview]Maximum Triglyceride Increase
NCT01293396 (6) [back to overview]Area Over Basal for Postprandial C-peptide
NCT01293396 (6) [back to overview]Area Over Basal for Postprandial Glucose From 0 to 600min
NCT01293396 (6) [back to overview]Area Over Basal for Postprandial Insulin
NCT01326026 (5) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT01326026 (5) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT01326026 (5) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01326026 (5) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01326026 (5) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01336023 (5) [back to overview]Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.
NCT01336023 (5) [back to overview]Mean Change From Baseline in Body Weight at Week 26
NCT01336023 (5) [back to overview]Mean Actual Daily Insulin Dose
NCT01336023 (5) [back to overview]Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test
NCT01336023 (5) [back to overview]Number of Hypoglycaemic Episodes
NCT01361594 (2) [back to overview]Number of Subjects That Were Diagnosed for Peri-operative Complications
NCT01361594 (2) [back to overview]Hospital Mortality
NCT01364428 (5) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01364428 (5) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT01364428 (5) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01364428 (5) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01364428 (5) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT01365507 (5) [back to overview]Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01365507 (5) [back to overview]Rate of Treatment Emergent Adverse Events (AEs)
NCT01365507 (5) [back to overview]Rate of Confirmed Hypoglycaemic Episodes
NCT01365507 (5) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01365507 (5) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT01369069 (6) [back to overview]Number of Participants With a Favorable Barthel Index
NCT01369069 (6) [back to overview]Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
NCT01369069 (6) [back to overview]Death
NCT01369069 (6) [back to overview]Number of Participants With a Favorable NIHSS
NCT01369069 (6) [back to overview]Stroke Specific Quality of Life (SSQOL)
NCT01369069 (6) [back to overview]Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)
NCT01388361 (4) [back to overview]Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
NCT01388361 (4) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01388361 (4) [back to overview]Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
NCT01388361 (4) [back to overview]Change From Baseline in Body Weight
NCT01392573 (2) [back to overview]Change in Body Weight
NCT01392573 (2) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01408628 (3) [back to overview]Frequency of Hypoglycemia
NCT01408628 (3) [back to overview]Change in HbA1c
NCT01408628 (3) [back to overview]Severity of Self-reported Hypoglycemia
NCT01409239 (1) [back to overview]Difference Between Heart Rate Variability Between Intravenous and Subcutaneous Group
NCT01421225 (4) [back to overview]Pre-lunch Blood Glucose Level
NCT01421225 (4) [back to overview]Nocturnal Glycemic Control
NCT01421225 (4) [back to overview]Number of Interventions for Hypoglycemia
NCT01421225 (4) [back to overview]Post-prandial Glycemic Control
NCT01432275 (2) [back to overview]Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.
NCT01432275 (2) [back to overview]Preference Questionnaire (Insulin Calculator Not Activated)
NCT01439672 (1) [back to overview]Insulin Sensitivity
NCT01445951 (11) [back to overview]Change in Body Weight From Baseline to Week 24
NCT01445951 (11) [back to overview]FEV1 Change From Baseline to Week 24
NCT01445951 (11) [back to overview]FPG Change From Baseline to Week 24
NCT01445951 (11) [back to overview]Incidence of Severe Hypoglycemia
NCT01445951 (11) [back to overview]Mean 7-point Glucose Week 24 Values
NCT01445951 (11) [back to overview]Severe Hypoglycemia Event Rate
NCT01445951 (11) [back to overview]Mean 7-point Glucose Baseline Values
NCT01445951 (11) [back to overview]Total Hypoglycemia Event Rate
NCT01445951 (11) [back to overview]Proportion of Responders Achieving HbA1c <= 7.0%
NCT01445951 (11) [back to overview]Incidence of Total Hypoglycemia
NCT01445951 (11) [back to overview]Change From Baseline to Week 24 in HbA1c
NCT01451398 (14) [back to overview]Change in Body Weight From Baseline to Week 24
NCT01451398 (14) [back to overview]Change From Baseline to Week 24 in HbA1c
NCT01451398 (14) [back to overview]Time to Rescue
NCT01451398 (14) [back to overview]Total Hypoglycemia Event Rate
NCT01451398 (14) [back to overview]Mean 7-point Glucose Baseline Values
NCT01451398 (14) [back to overview]Proportion of Responders Achieving HbA1c <= 6.5%
NCT01451398 (14) [back to overview]Proportion of Subjects Requiring Rescue Therapy
NCT01451398 (14) [back to overview]Incidence of Total Hypoglycemia
NCT01451398 (14) [back to overview]Incidence of Severe Hypoglycemia
NCT01451398 (14) [back to overview]Severe Hypoglycemia Event Rate
NCT01451398 (14) [back to overview]FEV1 Change From Baseline to Week 24
NCT01451398 (14) [back to overview]FPG Change From Baseline to Week 24
NCT01451398 (14) [back to overview]Proportion of Responders Achieving HbA1c <= 7.0%
NCT01451398 (14) [back to overview]Mean 7-point Glucose Week 24 Values
NCT01468987 (20) [back to overview]Low Blood Sugar Survey (LBSS) at 26 Weeks
NCT01468987 (20) [back to overview]HbA1c at 26 Weeks
NCT01468987 (20) [back to overview]Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks
NCT01468987 (20) [back to overview]Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks
NCT01468987 (20) [back to overview]Rapid Assessment of Physical Activity (RAPA) at 26 Weeks
NCT01468987 (20) [back to overview]Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks
NCT01468987 (20) [back to overview]Lipid Profile at 26 Weeks
NCT01468987 (20) [back to overview]Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks
NCT01468987 (20) [back to overview]0300-hour Blood Glucose to FBG Excursion at 26 Weeks
NCT01468987 (20) [back to overview]Body Weight Change From Baseline to 26 Weeks
NCT01468987 (20) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
NCT01468987 (20) [back to overview]EuroQoL-5D (EQ-5D) at 26 Weeks
NCT01468987 (20) [back to overview]Total Hypoglycemia Rates (Adjusted for 30 Days)
NCT01468987 (20) [back to overview]Percentage of Participants With Total Hypoglycemia Episodes
NCT01468987 (20) [back to overview]Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks
NCT01468987 (20) [back to overview]Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks
NCT01468987 (20) [back to overview]Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)
NCT01468987 (20) [back to overview]Percentage of Participants With Nocturnal Hypoglycemia Episodes
NCT01468987 (20) [back to overview]Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks
NCT01468987 (20) [back to overview]Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks
NCT01474538 (5) [back to overview]Total Daily Insulin Dose
NCT01474538 (5) [back to overview]Rate of Hypoglycemic Events Per 30 Days
NCT01474538 (5) [back to overview]Glycosylated Hemoglobin A1C (HbA1c) at Endpoint
NCT01474538 (5) [back to overview]Percentage of Participants With Hypoglycemic Events
NCT01474538 (5) [back to overview]Change From Baseline in Weight
NCT01476475 (14) [back to overview]Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia
NCT01476475 (14) [back to overview]Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24
NCT01476475 (14) [back to overview]Average Daily Insulin Glargine Dose at Week 24
NCT01476475 (14) [back to overview]Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24
NCT01476475 (14) [back to overview]Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24
NCT01476475 (14) [back to overview]Change in HbA1c From Baseline to Week 24
NCT01476475 (14) [back to overview]Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24
NCT01476475 (14) [back to overview]Change in Body Weight From Baseline to Week 24
NCT01476475 (14) [back to overview]Change in FPG From Baseline to Week 24
NCT01476475 (14) [back to overview]Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period
NCT01476475 (14) [back to overview]Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24
NCT01476475 (14) [back to overview]Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period
NCT01476475 (14) [back to overview]Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24
NCT01476475 (14) [back to overview]Change in 30-minute and 1-hour PPG From Baseline to Week 24
NCT01483651 (1) [back to overview]Area Under the Curve for Glucose Above Baseline
NCT01486966 (10) [back to overview]Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Change From Baseline in Fructosamine After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Incidence of Hypoglycaemic Episodes
NCT01486966 (10) [back to overview]Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment
NCT01497938 (2) [back to overview]The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)
NCT01497938 (2) [back to overview]Change in A1C From Baseline to End of Study Participation
NCT01499082 (12) [back to overview]Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
NCT01499082 (12) [back to overview]Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
NCT01499082 (12) [back to overview]Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
NCT01499082 (12) [back to overview]Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
NCT01499082 (12) [back to overview]Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
NCT01499082 (12) [back to overview]Change in HbA1c From Baseline to Month 6 Endpoint
NCT01499082 (12) [back to overview]Change in HbA1c From Month 6 to Month 9
NCT01499082 (12) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
NCT01499082 (12) [back to overview]Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
NCT01499082 (12) [back to overview]Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
NCT01499082 (12) [back to overview]Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
NCT01499082 (12) [back to overview]Percentage of Participants With HbA1c <7% at Month 6 Endpoint
NCT01499095 (12) [back to overview]Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
NCT01499095 (12) [back to overview]Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12
NCT01499095 (12) [back to overview]Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
NCT01499095 (12) [back to overview]Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
NCT01499095 (12) [back to overview]Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
NCT01499095 (12) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
NCT01499095 (12) [back to overview]Change in HbA1c From Baseline to Month 6 Endpoint
NCT01499095 (12) [back to overview]Change in HbA1c From Month 6 to Month 9
NCT01499095 (12) [back to overview]Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
NCT01499095 (12) [back to overview]Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
NCT01499095 (12) [back to overview]Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
NCT01499095 (12) [back to overview]Percentage of Participants With HbA1c <7% at Month 6 Endpoint
NCT01513473 (10) [back to overview]Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
NCT01513473 (10) [back to overview]Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
NCT01513473 (10) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
NCT01513473 (10) [back to overview]Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
NCT01513473 (10) [back to overview]Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))
NCT01513473 (10) [back to overview]Number of Hypoglycaemic Episodes
NCT01513473 (10) [back to overview]Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
NCT01513473 (10) [back to overview]Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))
NCT01513473 (10) [back to overview]Number of Treatment Emergent Adverse Events (TEAEs)
NCT01513473 (10) [back to overview]Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
NCT01513590 (7) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01513590 (7) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01513590 (7) [back to overview]Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
NCT01513590 (7) [back to overview]Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes
NCT01513590 (7) [back to overview]Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks
NCT01513590 (7) [back to overview]Number of Treatment Emergent AEs (Adverse Events)
NCT01513590 (7) [back to overview]Change From Baseline in Body Weight
NCT01519674 (11) [back to overview]Adverse Events (AEs)
NCT01519674 (11) [back to overview]Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)
NCT01519674 (11) [back to overview]Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
NCT01519674 (11) [back to overview]Prandial Plasma Glucose (PPG) Overall Mean Increment.
NCT01519674 (11) [back to overview]Prandial Plasma Glucose (PPG) Increments at Lunch.
NCT01519674 (11) [back to overview]Prandial Plasma Glucose (PPG) Increments at Dinner.
NCT01519674 (11) [back to overview]Prandial Plasma Glucose (PPG) Increments at Breakfast
NCT01519674 (11) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01519674 (11) [back to overview]Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.
NCT01519674 (11) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01519674 (11) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.
NCT01524705 (4) [back to overview]Weight Change During Trial
NCT01524705 (4) [back to overview]Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline
NCT01524705 (4) [back to overview]HbA1C Levels
NCT01524705 (4) [back to overview]Number of Participants With Hypoglycemia
NCT01526733 (7) [back to overview]Time to 50% Total Glucose Infused (50%Gtot)
NCT01526733 (7) [back to overview]Maximum Glucose Infusion Rate (GIRmax)
NCT01526733 (7) [back to overview]Early Insulin Exposure (%AUC[0-60])
NCT01526733 (7) [back to overview]Duration of Insulin Action (AUMC[0-360]/AUC[0-360])
NCT01526733 (7) [back to overview]Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max)
NCT01526733 (7) [back to overview]Area Under the Glucose Concentration Curve (AUC[0-360])
NCT01526733 (7) [back to overview]Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax)
NCT01534013 (1) [back to overview]Percentage Time in Euglycaemia
NCT01565941 (21) [back to overview]Insulin Algorithm Performance: Time to the Target Range
NCT01565941 (21) [back to overview]Participants With Any Hypoglycemia (<60 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)
NCT01565941 (21) [back to overview]Nursing Workload: SWAT (Subjective Workload Assessment Technique) Instrument
NCT01565941 (21) [back to overview]Insulin Algorithm Performance: Time in the Target Range
NCT01565941 (21) [back to overview]Insulin Algorithm Performance: Time-Weighted Glucose Average
NCT01565941 (21) [back to overview]Incidence of Wound Infection Incidence of Wound Infection
NCT01565941 (21) [back to overview]Nursing Workload: NASA-TLX (National Aeronautics and Space Administration - Task Load Index) Instrument
NCT01565941 (21) [back to overview]Ventilator-Free Days
NCT01565941 (21) [back to overview]Participants With Severe Hypoglycemia (<40 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)
NCT01565941 (21) [back to overview]Participants With Severe Hypoglycemia (<40 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)
NCT01565941 (21) [back to overview]Participants With Hypokalemia (<2.5 mmol/L)
NCT01565941 (21) [back to overview]Participants With Device-Related or Non-Device Related Nosocomial Infection
NCT01565941 (21) [back to overview]Participants With Any Hypoglycemia (<60 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)
NCT01565941 (21) [back to overview]Incidence of Ventilator-Associated Pneumonia
NCT01565941 (21) [back to overview]Incidence of Catheter-Associated Urinary Tract Infection
NCT01565941 (21) [back to overview]28-day Hospital Mortality
NCT01565941 (21) [back to overview]90-day Hospital Mortality
NCT01565941 (21) [back to overview]Accumulation of Multiple Organ Dysfunction Syndrome (MODS)
NCT01565941 (21) [back to overview]Developmental Neurobehavioral Outcomes: VABS-II Composite
NCT01565941 (21) [back to overview]ICU-Free Days
NCT01565941 (21) [back to overview]Incidence of Catheter-Associated Bloodstream Infection
NCT01569841 (6) [back to overview]Glycosylated Haemoglobin (HbA1c)
NCT01569841 (6) [back to overview]Number of Treatment Emergent Adverse Events (AEs)
NCT01569841 (6) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
NCT01569841 (6) [back to overview]Mean Interstitial Glucose (IG) Based on 14 Days of CGM
NCT01569841 (6) [back to overview]Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)
NCT01569841 (6) [back to overview]Fasting Plasma Glucose (FPG)
NCT01570751 (6) [back to overview]Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
NCT01570751 (6) [back to overview]Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period
NCT01570751 (6) [back to overview]Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period
NCT01570751 (6) [back to overview]Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
NCT01570751 (6) [back to overview]Number of Adverse Events (AEs)
NCT01570751 (6) [back to overview]Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
NCT01582451 (19) [back to overview]Number of Participants With Change in Anti-LY2605541 Antibodies
NCT01582451 (19) [back to overview]Number of Insulin Dose Adjustments to Steady-state
NCT01582451 (19) [back to overview]European Quality of Life - 5 Dimension (EuroQol-5D) Score
NCT01582451 (19) [back to overview]Change From Baseline to 52 Weeks in HbA1c
NCT01582451 (19) [back to overview]Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)
NCT01582451 (19) [back to overview]Adult Low Blood Sugar Survey (LBSS) Score
NCT01582451 (19) [back to overview]Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
NCT01582451 (19) [back to overview]Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)
NCT01582451 (19) [back to overview]Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%
NCT01582451 (19) [back to overview]Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
NCT01582451 (19) [back to overview]Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events
NCT01582451 (19) [back to overview]Intra-participant Variability in Fasting Blood Glucose (FBG)
NCT01582451 (19) [back to overview]Insulin Dose Per Kilogram of Body Weight
NCT01582451 (19) [back to overview]HbA1c
NCT01582451 (19) [back to overview]Fasting Serum Glucose (FSG) (by Laboratory)
NCT01582451 (19) [back to overview]Fasting Blood Glucose (FBG) (by Self Monitoring)
NCT01582451 (19) [back to overview]Change From Baseline in Lipid Profile
NCT01582451 (19) [back to overview]Change From Baseline in Body Weight
NCT01582451 (19) [back to overview]6-point Self-monitored Blood Glucose (SMBG)
NCT01589653 (5) [back to overview]Change in HbA1c From Baseline
NCT01589653 (5) [back to overview]Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden
NCT01589653 (5) [back to overview]Number of Hypoglycaemic Episodes During the Trial From Baseline
NCT01589653 (5) [back to overview]Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
NCT01589653 (5) [back to overview]Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline
NCT01595646 (5) [back to overview]Verbal Memory Composite
NCT01595646 (5) [back to overview]The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision
NCT01595646 (5) [back to overview]Cerebral Spinal Fluid (CSF) Biomarkers of AD
NCT01595646 (5) [back to overview]Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio
NCT01595646 (5) [back to overview]Functional Ability
NCT01613807 (2) [back to overview]Hemoglobin A1C
NCT01613807 (2) [back to overview]Birthweight of Infant
NCT01621178 (29) [back to overview]Change in Mean Daily Insulin Lispro Dose
NCT01621178 (29) [back to overview]Change From Baseline in Mean Daily Insulin Lispro Dose
NCT01621178 (29) [back to overview]Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)
NCT01621178 (29) [back to overview]Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)
NCT01621178 (29) [back to overview]Percentage of Participants With Estimated Average Glucose <154 mg/dL
NCT01621178 (29) [back to overview]Percentage of Participants Whose HbA1c Was <8.0%
NCT01621178 (29) [back to overview]Percentage of Participants Whose HbA1c Was <7.0%
NCT01621178 (29) [back to overview]Percentage of Participants With Self-Reported Hypoglycemic Events (HE)
NCT01621178 (29) [back to overview]Change From Baseline in UACR
NCT01621178 (29) [back to overview]Participants With Events of Allergic/Hypersensitivity Reactions
NCT01621178 (29) [back to overview]Percentage of Participants Whose HbA1c is <7.0%
NCT01621178 (29) [back to overview]Percentage of Participants Whose HbA1c is <8.0%
NCT01621178 (29) [back to overview]Change From Baseline in Serum Creatinine (sCr)
NCT01621178 (29) [back to overview]Change From Baseline in sCr
NCT01621178 (29) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c)
NCT01621178 (29) [back to overview]Change From Baseline in eGFR
NCT01621178 (29) [back to overview]Change From Baseline in HbA1c
NCT01621178 (29) [back to overview]Change From Baseline in FG
NCT01621178 (29) [back to overview]Change From Baseline in Fasting Glucose (FG)
NCT01621178 (29) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
NCT01621178 (29) [back to overview]Change From Baseline in Estimated Creatinine Clearance (eCrCl)
NCT01621178 (29) [back to overview]Change From Baseline in eCrCl
NCT01621178 (29) [back to overview]Change From Baseline in Body Weight
NCT01621178 (29) [back to overview]Change From Baseline in Body Weight
NCT01621178 (29) [back to overview]Change From Baseline in 8-Point SMPG
NCT01621178 (29) [back to overview]Rate of Hypoglycemic Events (HE)
NCT01621178 (29) [back to overview]Rate of Hypoglycemic Events
NCT01621178 (29) [back to overview]Percentage of Participants With Self-Reported Hypoglycemic Events (HE)
NCT01621178 (29) [back to overview]Percentage of Participants With Estimated Average Glucose <154 mg/dL
NCT01621776 (3) [back to overview]Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast
NCT01621776 (3) [back to overview]Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner
NCT01621776 (3) [back to overview]The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.
NCT01643382 (1) [back to overview]Incidence of Poor Graft Function After Kidney Transplant
NCT01658579 (10) [back to overview]Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])
NCT01658579 (10) [back to overview]Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])
NCT01658579 (10) [back to overview]Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
NCT01658579 (10) [back to overview]Evaluation of Diurnal Glucose Exposure, Variability, and Stability
NCT01658579 (10) [back to overview]Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B
NCT01658579 (10) [back to overview]Change in HbA1c From Baseline to Week 8 and 16
NCT01658579 (10) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16
NCT01658579 (10) [back to overview]Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16
NCT01658579 (10) [back to overview]Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16
NCT01658579 (10) [back to overview]Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16
NCT01676220 (13) [back to overview]Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint
NCT01676220 (13) [back to overview]Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
NCT01676220 (13) [back to overview]Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
NCT01676220 (13) [back to overview]Change in HbA1c From Baseline to Month 6 Endpoint
NCT01676220 (13) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
NCT01676220 (13) [back to overview]Change in Daily Basal Insulin Dose From Baseline to Month 6
NCT01676220 (13) [back to overview]Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint
NCT01676220 (13) [back to overview]Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
NCT01676220 (13) [back to overview]Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6
NCT01676220 (13) [back to overview]Variability of Preinjection SMPG at Month 6 Endpoint
NCT01676220 (13) [back to overview]Percentage of Participants With HbA1c <7% at Month 6
NCT01676220 (13) [back to overview]Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6
NCT01676220 (13) [back to overview]Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6
NCT01680341 (8) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
NCT01680341 (8) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
NCT01680341 (8) [back to overview]Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes
NCT01680341 (8) [back to overview]Incidence of Treatment Emergent Adverse Events (TEAEs)
NCT01680341 (8) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
NCT01680341 (8) [back to overview]Subjects With HbA1c Below 7.0%
NCT01680341 (8) [back to overview]Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia
NCT01680341 (8) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01683266 (12) [back to overview]Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12
NCT01683266 (12) [back to overview]Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
NCT01683266 (12) [back to overview]Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint
NCT01683266 (12) [back to overview]Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint
NCT01683266 (12) [back to overview]Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint
NCT01683266 (12) [back to overview]Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint
NCT01683266 (12) [back to overview]Percentage of Participants With HbA1c <7% at Month 6 Endpoint
NCT01683266 (12) [back to overview]Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint
NCT01683266 (12) [back to overview]Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6
NCT01683266 (12) [back to overview]Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint
NCT01683266 (12) [back to overview]Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
NCT01683266 (12) [back to overview]Change In HbA1c From Baseline to Month 6 Endpoint
NCT01683331 (2) [back to overview]The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation
NCT01683331 (2) [back to overview]The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation
NCT01684943 (6) [back to overview]Multiplex PK: Average Number of Hypoglycemia Events Over the Last Month at Baseline Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual
NCT01684943 (6) [back to overview]Multiplex PK: Count of Subjects With Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax That is > 25%
NCT01684943 (6) [back to overview]For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin
NCT01684943 (6) [back to overview]For Multiplex PK Profiling: Aggregate Mean Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax for Individuals
NCT01684943 (6) [back to overview]Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual
NCT01684943 (6) [back to overview]Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog With Tmax < 60 Minutes vs. Use of an Insulin Analog With Tmax > 60 Minutes for Each Individual
NCT01713530 (6) [back to overview]Change From Baseline in HbA1c (%)
NCT01713530 (6) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01713530 (6) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes
NCT01713530 (6) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes
NCT01713530 (6) [back to overview]Incidence of Treatment Emergent Adverse Events (TEAE)
NCT01713530 (6) [back to overview]Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
NCT01726621 (1) [back to overview]User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter
NCT01755416 (1) [back to overview]Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
NCT01767909 (6) [back to overview]Change in Hippocampal and Entorhinal Atrophy as Measured by Magnetic Resonance Imaging (MRI)
NCT01767909 (6) [back to overview]Change in Memory Composite as Measured by Story Recall (Immediate Paragraph Recall and Delayed Paragraph Recall) and Free and Cued Selective Reminding Test (FCSRT)
NCT01767909 (6) [back to overview]Change in Cognitive Deficit as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)
NCT01767909 (6) [back to overview]Change in CSF Biomarkers of AD
NCT01767909 (6) [back to overview]Change in Daily Functioning as Measured by the ADCS-MCI Activities of Daily Living (ADCS-ADL-MCI)
NCT01767909 (6) [back to overview]Change in Global Measure of Cognition as Measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12)
NCT01768559 (15) [back to overview]Change in Average 7-point SMPG Profiles From Baseline to Week 26
NCT01768559 (15) [back to overview]Change in Body Weight From Baseline to Week 26
NCT01768559 (15) [back to overview]Change in FPG From Baseline to Week 26
NCT01768559 (15) [back to overview]Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)
NCT01768559 (15) [back to overview]Change in Insulin Glargine Dose From Baseline to Week 26
NCT01768559 (15) [back to overview]Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)
NCT01768559 (15) [back to overview]Insulin Glulisine Dose at Week 26
NCT01768559 (15) [back to overview]Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26
NCT01768559 (15) [back to overview]Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period
NCT01768559 (15) [back to overview]Total Insulin Dose at Week 26
NCT01768559 (15) [back to overview]Percentage of Participants With no Weight Gain at Week 26
NCT01768559 (15) [back to overview]Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period
NCT01768559 (15) [back to overview]Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26
NCT01768559 (15) [back to overview]Change in HbA1c From Baseline to Week 26
NCT01768559 (15) [back to overview]Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia
NCT01771250 (4) [back to overview]VLDL-TG Oxidation Rate
NCT01771250 (4) [back to overview]VLDL-TG Secretion Rate
NCT01771250 (4) [back to overview]Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
NCT01771250 (4) [back to overview]VLDL-TG Clearance Rate
NCT01773473 (7) [back to overview]Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
NCT01773473 (7) [back to overview]Change From Baseline in Body Weight at Week 26
NCT01773473 (7) [back to overview]Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
NCT01773473 (7) [back to overview]Insulin Dose at Week 26
NCT01773473 (7) [back to overview]Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)
NCT01773473 (7) [back to overview]Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26
NCT01773473 (7) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
NCT01774968 (15) [back to overview]Percentage of Participants With Hypoglycemic Events
NCT01774968 (15) [back to overview]Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg
NCT01774968 (15) [back to overview]Time to Reach HbA1c Target Values
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in Body Weight
NCT01774968 (15) [back to overview]30-Day Adjusted Rate of Hypoglycemic Events
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in Number of Insulin Injections
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg
NCT01774968 (15) [back to overview]Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)
NCT01774968 (15) [back to overview]Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin
NCT01777542 (17) [back to overview]Parent Targeted Visual Analog Scale (PTSVAS) - Scale 3
NCT01777542 (17) [back to overview]Parental Global Impression - Improvement (PGI-I)
NCT01777542 (17) [back to overview]Parental Global Impression - Severity (PGI-S)
NCT01777542 (17) [back to overview]Quantitative Measures of Respiration: Apnea Index
NCT01777542 (17) [back to overview]Rett Syndrome Behavior Questionnaire (RSBQ) - Fear/Anxiety Subscale
NCT01777542 (17) [back to overview]Vineland Adaptive Behavior Scales, Second Edition (VABS-II)
NCT01777542 (17) [back to overview]Clinical Global Impression - Severity (CGI-S)
NCT01777542 (17) [back to overview]Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)
NCT01777542 (17) [back to overview]Aberrant Behavior Checklist - Community Edition (ABC-C)
NCT01777542 (17) [back to overview]Anxiety, Depression, and Mood Scale (ADAMS)
NCT01777542 (17) [back to overview]Anxiety, Depression, and Mood Scale (ADAMS) - Social Avoidance Subscale
NCT01777542 (17) [back to overview]Clinical Global Impression - Improvement (CGI-I)
NCT01777542 (17) [back to overview]Rett Syndrome Behavior Questionnaire (RSBQ)
NCT01777542 (17) [back to overview]Kerr Clinical Severity Scale
NCT01777542 (17) [back to overview]Mullen Scales of Early Learning (MSEL)
NCT01777542 (17) [back to overview]Parent Targeted Visual Analog Scale (PTSVAS) - Scale 1
NCT01777542 (17) [back to overview]Parent Targeted Visual Analog Scale (PTSVAS) - Scale 2
NCT01781234 (3) [back to overview]Salivary Cortisol
NCT01781234 (3) [back to overview]Nicotine Craving (Measured by Questionnaire of Smoking Urges)
NCT01781234 (3) [back to overview]Episodic Memory
NCT01790438 (23) [back to overview]Fasting Blood Glucose (FBG) (by Self Monitoring)
NCT01790438 (23) [back to overview]Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
NCT01790438 (23) [back to overview]Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores
NCT01790438 (23) [back to overview]Change From Baseline to 26 Weeks in Body Weight
NCT01790438 (23) [back to overview]Time to Steady-State (Stable Maximum Dose)
NCT01790438 (23) [back to overview]Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index
NCT01790438 (23) [back to overview]Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
NCT01790438 (23) [back to overview]HbA1c
NCT01790438 (23) [back to overview]Rate of Severe Hypoglycemic Events
NCT01790438 (23) [back to overview]Fasting Serum Glucose (FSG) (by Laboratory)
NCT01790438 (23) [back to overview]Insulin Dose Per Kilogram (kg) of Body Weight
NCT01790438 (23) [back to overview]Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
NCT01790438 (23) [back to overview]30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
NCT01790438 (23) [back to overview]6-Point Self-Monitored Blood Glucose (SMBG)
NCT01790438 (23) [back to overview]Intra-Participant Variability in FBG by Standard Deviation
NCT01790438 (23) [back to overview]Intra-Participant Variability in FBG by the Coefficient of Variation
NCT01790438 (23) [back to overview]Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
NCT01790438 (23) [back to overview]Percentage of Participants With Insulin Antibodies
NCT01790438 (23) [back to overview]Change From Baseline to 26 Weeks in Lipid Profile
NCT01790438 (23) [back to overview]Percentage of Participants With Severe Hypoglycemic Events
NCT01790438 (23) [back to overview]Percentage of Participants With HbA1c ≤6.5% and <7.0%
NCT01790438 (23) [back to overview]Percentage of Participants With Total and Nocturnal Hypoglycemic Events
NCT01790438 (23) [back to overview]Percentage of Participants With Injection Site Reactions
NCT01792284 (18) [back to overview]Self-Monitored Blood Glucose (SMBG) at 12 Weeks
NCT01792284 (18) [back to overview]Fasting Blood Glucose (FBG) Measured by Self-Monitored Blood Glucose
NCT01792284 (18) [back to overview]0300-Hour Blood Glucose to Fasting Blood Glucose Excursion
NCT01792284 (18) [back to overview]Change From Day 1 of Lead-In Period to 36 Weeks in Body Weight
NCT01792284 (18) [back to overview]Change From Randomization to 12 Weeks in Body Weight
NCT01792284 (18) [back to overview]Change From Randomization to 12 Weeks in HbA1c
NCT01792284 (18) [back to overview]Change From Day 1 of Lead-in to 36 Weeks in Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C)
NCT01792284 (18) [back to overview]Fasting Serum Glucose (FSG) at 12 Weeks
NCT01792284 (18) [back to overview]Hemoglobin A1c (HbA1c) at 12 Weeks
NCT01792284 (18) [back to overview]Intra-participant Variability in SMBG at 12 Weeks
NCT01792284 (18) [back to overview]Intra-Participant Variability of FBG at 12 Weeks
NCT01792284 (18) [back to overview]Basal, Bolus, and Total Insulin Doses at 12 Weeks
NCT01792284 (18) [back to overview]Participants With Treatment-Emergent Anti-LY2605541 Antibody Response
NCT01792284 (18) [back to overview]Proportion of Bolus to Total Insulin Doses at 12 Weeks
NCT01792284 (18) [back to overview]30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
NCT01792284 (18) [back to overview]Change From Randomization to 12 Weeks in 9-Point SMBG
NCT01792284 (18) [back to overview]Percentage of Participants With HbA1c <7.0% and ≤6.5% at 12 Weeks
NCT01792284 (18) [back to overview]Percentage of Participants With Total and Nocturnal Hypoglycemic Events
NCT01810952 (5) [back to overview]Glucose Values <70 mg/dL.
NCT01810952 (5) [back to overview]Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
NCT01810952 (5) [back to overview]Daily Insulin Dose/Kg Body Weight
NCT01810952 (5) [back to overview]Percent of Glucose Determinations >180 mg/dL
NCT01810952 (5) [back to overview]Percent of Participants With Average Glucose >70 and <180 mg/dL
NCT01814137 (5) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01814137 (5) [back to overview]Incidence of Treatment Emergent Adverse Events (TEAEs)
NCT01814137 (5) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes
NCT01814137 (5) [back to overview]Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes
NCT01814137 (5) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01819129 (4) [back to overview]Change From Baseline in HbA1c
NCT01819129 (4) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
NCT01819129 (4) [back to overview]Change From Baseline in 2-hour PPG Increment (Meal Test)
NCT01819129 (4) [back to overview]Change From Baseline in Body Weight
NCT01831765 (8) [back to overview]Change in HbA1c
NCT01831765 (8) [back to overview]Change From Baseline in HbA1c (Post Meal Arm)
NCT01831765 (8) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01831765 (8) [back to overview]Change in PPG (Postprandial Glucose)
NCT01831765 (8) [back to overview]Change From Baseline in Body Weight
NCT01831765 (8) [back to overview]Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)
NCT01831765 (8) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
NCT01831765 (8) [back to overview]Frequency of Adverse Events
NCT01835431 (7) [back to overview]Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill
NCT01835431 (7) [back to overview]Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)
NCT01835431 (7) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)
NCT01835431 (7) [back to overview]Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
NCT01835431 (7) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
NCT01835431 (7) [back to overview]Change From Baseline in Fasting Plasma Glucose
NCT01835431 (7) [back to overview]Incidence of Treatment Emergent Adverse Events (TEAEs)
NCT01837680 (12) [back to overview]Weight Gain
NCT01837680 (12) [back to overview]Time to Achieve Glycemic Control
NCT01837680 (12) [back to overview]Post-prandial Blood Glucose
NCT01837680 (12) [back to overview]Number of Patients Obtaining Glycemic Control
NCT01837680 (12) [back to overview]Neonatal Weight
NCT01837680 (12) [back to overview]Neonatal Hypoglycemia
NCT01837680 (12) [back to overview]Maternal Hypoglycemia
NCT01837680 (12) [back to overview]Intensive Care Admissions
NCT01837680 (12) [back to overview]Glycemic Control
NCT01837680 (12) [back to overview]Gestational Age at Delivery
NCT01837680 (12) [back to overview]Birth Rate
NCT01837680 (12) [back to overview]Average Fasting Glucose
NCT01848990 (27) [back to overview]Time Per Day <56 Milligrams Per Deciliter (mg/dL), ≤70 mg/dL, >70 mg/dL, <140 mg/dL, ≥140 mg/dL, Outside of 71 to 180 mg/dL, and Outside of 71 to 139 mg/dL
NCT01848990 (27) [back to overview]Average Carbohydrate Factor (CarbF) Values
NCT01848990 (27) [back to overview]Number of Participants With the Indicated Responses to the Question Regarding the Difficulty of Infusion Site Change
NCT01848990 (27) [back to overview]Change From Baseline in Average Weighted Impact ADDQoL Values at Month 12
NCT01848990 (27) [back to overview]Change From Baseline to 12 Months in HbA1c
NCT01848990 (27) [back to overview]Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c)
NCT01848990 (27) [back to overview]Mean Times Per Week Participants Said They Were Eating to Avoid Going Low Due to Late Insulin Action
NCT01848990 (27) [back to overview]Number of Participants Achieving HbA1c <7.0% and HbA1c ≤6.5% at Month 12
NCT01848990 (27) [back to overview]Rates of HEs to Month 12
NCT01848990 (27) [back to overview]Mean Time to Change Infusion Site
NCT01848990 (27) [back to overview]Rates of Hyperglycemia Events to Month 12
NCT01848990 (27) [back to overview]Rates of Hyperglycemia Events to Month 6
NCT01848990 (27) [back to overview]Rates of Hypoglycemia Events (HE) to Month 6
NCT01848990 (27) [back to overview]Mean Additional Time for Hylenex Pre-administration
NCT01848990 (27) [back to overview]Mean Glucose Excursions at 6 Months
NCT01848990 (27) [back to overview]Mean Glucose Excursions at 12 Months
NCT01848990 (27) [back to overview]Change From Baseline in Weighted Impact ADDQoL Values at Month 12
NCT01848990 (27) [back to overview]Change From Baseline in DTSQs and DTSQc at Month 12
NCT01848990 (27) [back to overview]Change From Baseline in Body Weight to Month 12
NCT01848990 (27) [back to overview]Average of Daily Insulin Doses (Bolus, Basal, and Total)
NCT01848990 (27) [back to overview]Average of Bolus Times Relative to Meal Times
NCT01848990 (27) [back to overview]Average Glucose, Median Glucose, and Average Daily Standard Deviation
NCT01848990 (27) [back to overview]Area Per Day <56 mg/dL, ≤70 mg/dL, ≥140 mg/dL, Outside of 71 to 180 mg/dL, and Outside of 71 to 139 mg/dL
NCT01848990 (27) [back to overview]Average Correction Factor (CorrF) Values
NCT01848990 (27) [back to overview]Number of Participants With the Indicated Responses to the Device Handling Questions
NCT01848990 (27) [back to overview]Standard Deviation of Self-Monitoring Blood Glucose Values at 6 Months
NCT01848990 (27) [back to overview]Standard Deviation of Self-Monitoring Blood Glucose Values at 12 Months
NCT01849289 (6) [back to overview]Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
NCT01849289 (6) [back to overview]Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
NCT01849289 (6) [back to overview]Number of Treatment Emergent AEs (Adverse Events)
NCT01849289 (6) [back to overview]Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes
NCT01849289 (6) [back to overview]Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)
NCT01849289 (6) [back to overview]Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)
NCT01850615 (6) [back to overview]Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
NCT01850615 (6) [back to overview]Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
NCT01850615 (6) [back to overview]Change From Baseline in HbA1c
NCT01850615 (6) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes
NCT01850615 (6) [back to overview]Number of Adverse Events
NCT01850615 (6) [back to overview]Change From Baseline in Body Weight
NCT01855243 (5) [back to overview]Number of Patients Developed Episodes of Severe Hyperglycemia
NCT01855243 (5) [back to overview]Mortality Rate
NCT01855243 (5) [back to overview]Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.
NCT01855243 (5) [back to overview]Mean BG After First Day of Hospitalization
NCT01855243 (5) [back to overview]Number of Patients Developed Hypoglycemic Events
NCT01874392 (7) [back to overview]Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.
NCT01874392 (7) [back to overview]Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.
NCT01874392 (7) [back to overview]Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System
NCT01874392 (7) [back to overview]Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System
NCT01874392 (7) [back to overview]Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.
NCT01874392 (7) [back to overview]Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting
NCT01874392 (7) [back to overview]Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting
NCT01879579 (14) [back to overview]Costs - Co-pays
NCT01879579 (14) [back to overview]Percentage of Text Message Responses
NCT01879579 (14) [back to overview]Baseline Treatment Satisfaction
NCT01879579 (14) [back to overview]Incidence of Hypoglycemia
NCT01879579 (14) [back to overview]Time to Reach Optimal Long-acting Insulin Dose
NCT01879579 (14) [back to overview]Patient Healthcare Utilization
NCT01879579 (14) [back to overview]Hemoglobin A1c
NCT01879579 (14) [back to overview]Costs - Provider Time Spent on Insulin Titration Visits
NCT01879579 (14) [back to overview]Costs - Titration Visit Information
NCT01879579 (14) [back to overview]Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose
NCT01879579 (14) [back to overview]Costs - Patient Travel Time
NCT01879579 (14) [back to overview]Percentage of Successful Phone Calls
NCT01879579 (14) [back to overview]Change in Treatment Satisfaction
NCT01879579 (14) [back to overview]Treatment Satisfaction After Initiation of Insulin Titration
NCT01880736 (9) [back to overview]Incidence of Treatment Emergent Adverse Events (TEAEs)
NCT01880736 (9) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))
NCT01880736 (9) [back to overview]Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period
NCT01880736 (9) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01880736 (9) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
NCT01880736 (9) [back to overview]Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial
NCT01880736 (9) [back to overview]Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
NCT01880736 (9) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
NCT01880736 (9) [back to overview]Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)
NCT01889667 (5) [back to overview]The Effect of ORMD-0801 on Morning Fasting Serum Insulin
NCT01889667 (5) [back to overview]The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo
NCT01889667 (5) [back to overview]Evaluate the Safety and Tolerability of ORMD-0801.
NCT01889667 (5) [back to overview]The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)
NCT01889667 (5) [back to overview]The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)
NCT01892020 (7) [back to overview]Incidence of AEs (Adverse Event)
NCT01892020 (7) [back to overview]The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile
NCT01892020 (7) [back to overview]2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test
NCT01892020 (7) [back to overview]-IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test
NCT01892020 (7) [back to overview]-1-hour PPG Increment Following a Standard Meal Test
NCT01892020 (7) [back to overview]Incidence of Hypoglycemic Episodes
NCT01892020 (7) [back to overview]2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile
NCT01894568 (18) [back to overview]Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])
NCT01894568 (18) [back to overview]Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)
NCT01894568 (18) [back to overview]Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
NCT01894568 (18) [back to overview]Fasting Serum Glucose (FSG)
NCT01894568 (18) [back to overview]Fasting Blood Glucose (FBG)
NCT01894568 (18) [back to overview]Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26
NCT01894568 (18) [back to overview]Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26
NCT01894568 (18) [back to overview]9-Point Self-Monitored Blood Glucose (SMBG)
NCT01894568 (18) [back to overview]30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
NCT01894568 (18) [back to overview]Percentage of Participants With HbA1c ≤6.5%
NCT01894568 (18) [back to overview]Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26
NCT01894568 (18) [back to overview]Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)
NCT01894568 (18) [back to overview]Percent Hemoglobin A1c at Week 26
NCT01894568 (18) [back to overview]Intra-Participant Variability of the Fasting Blood Glucose (FBG)
NCT01894568 (18) [back to overview]Insulin Dose Per Kilogram (kg) of Body Weight
NCT01894568 (18) [back to overview]Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)
NCT01894568 (18) [back to overview]Change From Baseline to Week 26 in Body Weight
NCT01894568 (18) [back to overview]Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
NCT01945138 (15) [back to overview]Day 14 Follow-Up: Average Serum BG
NCT01945138 (15) [back to overview]Study Period: Serum BG Standard Deviation
NCT01945138 (15) [back to overview]Study Period: Percent Time BG in Range 70-140 mg/dL
NCT01945138 (15) [back to overview]Study Period: Morning C-peptide
NCT01945138 (15) [back to overview]Study Period: Daily Insulin Needs
NCT01945138 (15) [back to overview]Study Period: Continuous Glucose Monitor Standard Deviation of BG
NCT01945138 (15) [back to overview]Study Period: Continuous Glucose Monitor (CGM) BG Average
NCT01945138 (15) [back to overview]Study Period: CGM AUC With Glucose> 140 mg/dL
NCT01945138 (15) [back to overview]Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL
NCT01945138 (15) [back to overview]Study Period: Average Serum BG
NCT01945138 (15) [back to overview]Study Period: % of Time CGM BG > 140 mg/dL
NCT01945138 (15) [back to overview]Study Period: % of Time CGM BG <70 mg/dL
NCT01945138 (15) [back to overview]Day 28 Follow-Up: C-Peptide
NCT01945138 (15) [back to overview]Day 28 Follow-Up: Average Serum BG
NCT01945138 (15) [back to overview]Day 14 Follow-Up: C-Peptide
NCT01952145 (3) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01952145 (3) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
NCT01952145 (3) [back to overview]Change From Baseline in Body Weight
NCT01957930 (1) [back to overview]Ischemic Foot Ulcer
NCT01959529 (4) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT01959529 (4) [back to overview]Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
NCT01959529 (4) [back to overview]Number of EAC-confirmed Severe Hypoglycaemic Episodes
NCT01959529 (4) [back to overview]Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no)
NCT01966978 (8) [back to overview]Mean Change From Randomization in A1c at Week 26
NCT01966978 (8) [back to overview]Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means
NCT01966978 (8) [back to overview]Change in Short Form-36 (SF-36) Questionnaire Score
NCT01966978 (8) [back to overview]Percentage of Participants Reaching Target A1c of <7% at Week 26
NCT01966978 (8) [back to overview]"Percentage of Participants Reaching Pre-specified Treatment Failure Outcome"
NCT01966978 (8) [back to overview]Composite End-point
NCT01966978 (8) [back to overview]Hypoglycemic Episodes
NCT01966978 (8) [back to overview]Mean Change From Randomization in Body Weight
NCT01970241 (18) [back to overview]Mean Point of Care (POC) Glucose Level in Both Groups.
NCT01970241 (18) [back to overview]Mean POC Glucose Level Between Groups
NCT01970241 (18) [back to overview]Mean Point of Care (POC) Glucose Level in Both Groups.
NCT01970241 (18) [back to overview]Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
NCT01970241 (18) [back to overview]Correlation of C-peptide With ALT
NCT01970241 (18) [back to overview]Correlation of C-peptide With Age
NCT01970241 (18) [back to overview]Correlation of C-peptide With Hemoglobin A1c
NCT01970241 (18) [back to overview]Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
NCT01970241 (18) [back to overview]Correlation of C-peptide With BMI
NCT01970241 (18) [back to overview]Correlation of C-peptide With Duration of Diabetes
NCT01970241 (18) [back to overview]Correlation of C-peptide With eGFR
NCT01970241 (18) [back to overview]Correlation of C-peptide With Length of Stay
NCT01970241 (18) [back to overview]Correlation of C-peptide With Plasma Glucose
NCT01970241 (18) [back to overview]Correlation of C-peptide With Serum Creatinine
NCT01970241 (18) [back to overview]Difference in Length of Stay Between NPH and Control Group
NCT01970241 (18) [back to overview]Episodes of Hypoglycemia Between NPH and Control Groups
NCT01970241 (18) [back to overview]Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
NCT01970241 (18) [back to overview]Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
NCT01973413 (3) [back to overview]Overnight Glucose
NCT01973413 (3) [back to overview]Percent Time Near Normoglycemia
NCT01973413 (3) [back to overview]Glycemic Events
NCT01991548 (1) [back to overview]User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter
NCT01995526 (5) [back to overview]Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro
NCT01995526 (5) [back to overview]Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro
NCT01995526 (5) [back to overview]Glucodynamics: Maximum Glucose Infusion Rate (Rmax)
NCT01995526 (5) [back to overview]Glucodynamics: Total Amount of Glucose Infused (Gtot)
NCT01995526 (5) [back to overview]Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro
NCT01999322 (4) [back to overview]Number of Premature Infusion Set Changes
NCT01999322 (4) [back to overview]Number of Microscopically Confirmed Episodes of Infusion Set Occlusions
NCT01999322 (4) [back to overview]Number of Episodes of Possible Infusion Set Occlusions
NCT01999322 (4) [back to overview]Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))
NCT02003898 (4) [back to overview]Mean Change in A1C From Baseline to 1 Year
NCT02003898 (4) [back to overview]Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%
NCT02003898 (4) [back to overview]Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%
NCT02003898 (4) [back to overview]Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%
NCT02006342 (5) [back to overview]Intensive Care Unit Length of Stay
NCT02006342 (5) [back to overview]Hospital Length of Stay
NCT02006342 (5) [back to overview]Number of Participants Who Developed Hypoglycemia
NCT02006342 (5) [back to overview]Number of Participants Admitted to the ICU
NCT02006342 (5) [back to overview]Time to Anion Gap Closure
NCT02006836 (5) [back to overview]∆g of Lunch With/Without Pomelo
NCT02006836 (5) [back to overview]∆g of Breakfast With/Without Pomelo
NCT02006836 (5) [back to overview]∆g of Dinner With/Without Pomelo
NCT02006836 (5) [back to overview]Glycemic Index
NCT02006836 (5) [back to overview]AUCs With/Without Pomelo
NCT02028871 (2) [back to overview]Nicotine Cravings Measured by Questionnaire of Smoking Urges
NCT02028871 (2) [back to overview]Amount Eaten in Taste Test
NCT02030600 (6) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT02030600 (6) [back to overview]Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period
NCT02030600 (6) [back to overview]Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period
NCT02030600 (6) [back to overview]Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
NCT02030600 (6) [back to overview]Incidence of Treatment Emergent Adverse Events
NCT02030600 (6) [back to overview]FPG (Fasting Plasma Glucose)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker Carboxy-Terminal Cross-Linking Telopeptides of Type I Collagen (CTX) at Week 26 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Time to Glycemic Rescue Therapy at Week 26
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 52
NCT02033889 (49) [back to overview]Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 26
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 104
NCT02033889 (49) [back to overview]Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From BMD at Week 104 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker PTH at Week 52 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker PTH at Week 104 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker Procollagen Type I N-terminal Propeptide (P1NP) at Week 26 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker Parathyroid Hormone (PTH) at Week 26 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker P1NP at Week 104 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in A1C at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in A1C at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in A1C at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Body Weight at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Body Weight at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker P1NP at Week 52 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Fasting Plasma Glucose at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Fasting Plasma Glucose at Week 52 (Excluding Rescue Therapy)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Diastolic Blood Pressure at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker CTX at Week 52 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker CTX at Week 104 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Diastolic Blood Pressure at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Systolic Blood Pressure at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Systolic Blood Pressure at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)
NCT02034513 (6) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT02034513 (6) [back to overview]Incidence of Treatment Emergent Adverse Events
NCT02034513 (6) [back to overview]FPG (Fasting Plasma Glucose)
NCT02034513 (6) [back to overview]Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
NCT02034513 (6) [back to overview]Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period
NCT02034513 (6) [back to overview]Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period
NCT02058147 (15) [back to overview]Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30
NCT02058147 (15) [back to overview]Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period
NCT02058147 (15) [back to overview]Change in Body Weight From Baseline to Week 30
NCT02058147 (15) [back to overview]Percentage of Participants With Documented Symptomatic Hypoglycemia
NCT02058147 (15) [back to overview]Percentage of Participants With Severe Symptomatic Hypoglycemia
NCT02058147 (15) [back to overview]Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30
NCT02058147 (15) [back to overview]Average Daily Insulin Glargine Dose at Week 30
NCT02058147 (15) [back to overview]Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30
NCT02058147 (15) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30
NCT02058147 (15) [back to overview]Change in HbA1c From Baseline to Week 30
NCT02058147 (15) [back to overview]Change in Plasma Glucose Excursion From Baseline to Week 30
NCT02058147 (15) [back to overview]Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year
NCT02058147 (15) [back to overview]Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
NCT02058147 (15) [back to overview]Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30
NCT02058147 (15) [back to overview]Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
NCT02058160 (15) [back to overview]Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period
NCT02058160 (15) [back to overview]Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year
NCT02058160 (15) [back to overview]Change in 2-hour PPG From Baseline to Week 30
NCT02058160 (15) [back to overview]Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30
NCT02058160 (15) [back to overview]Percentage of Participants With Severe Symptomatic Hypoglycemia
NCT02058160 (15) [back to overview]Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
NCT02058160 (15) [back to overview]Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30
NCT02058160 (15) [back to overview]Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30
NCT02058160 (15) [back to overview]Percentage of Participants With Documented Symptomatic Hypoglycemia
NCT02058160 (15) [back to overview]Change in Body Weight From Baseline to Week 30
NCT02058160 (15) [back to overview]Change in FPG From Baseline to Week 30
NCT02058160 (15) [back to overview]Change in Daily Insulin Glargine Dose From Baseline to Week 30
NCT02058160 (15) [back to overview]Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30
NCT02058160 (15) [back to overview]Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
NCT02058160 (15) [back to overview]Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30
NCT02059161 (28) [back to overview]Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24
NCT02059161 (28) [back to overview]Total Insulin Dose at Week 52
NCT02059161 (28) [back to overview]Total Insulin Dose at Week 24
NCT02059161 (28) [back to overview]Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24
NCT02059161 (28) [back to overview]Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52
NCT02059161 (28) [back to overview]Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24
NCT02059161 (28) [back to overview]Percentage of Participants With Confirmed Positive AIA Up Through Week 52
NCT02059161 (28) [back to overview]Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24
NCT02059161 (28) [back to overview]Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52
NCT02059161 (28) [back to overview]Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24
NCT02059161 (28) [back to overview]Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52
NCT02059161 (28) [back to overview]Basal Insulin Dose at Week 52
NCT02059161 (28) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
NCT02059161 (28) [back to overview]Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.
NCT02059161 (28) [back to overview]Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.
NCT02059161 (28) [back to overview]Bolus Insulin Dose Per kg of Body Weight at Week 52
NCT02059161 (28) [back to overview]Change From Baseline in FPG at Week 52
NCT02059161 (28) [back to overview]Change From Baseline in AIA Titer After 52 Weeks of Treatment
NCT02059161 (28) [back to overview]Change From Baseline in AIA Titer After 24 Weeks of Treatment
NCT02059161 (28) [back to overview]Change From Baseline in A1C at Week 52
NCT02059161 (28) [back to overview]Change From Baseline in 7-point SMBG at Week 52
NCT02059161 (28) [back to overview]Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24
NCT02059161 (28) [back to overview]Bolus Insulin Dose Per kg of Body Weight at Week 24
NCT02059161 (28) [back to overview]Bolus Insulin Dose at Week 52
NCT02059161 (28) [back to overview]Bolus Insulin Dose at Week 24
NCT02059161 (28) [back to overview]Basal Insulin Dose Per kg of Body Weight at Week 52
NCT02059161 (28) [back to overview]Basal Insulin Dose Per kg of Body Weight at Week 24
NCT02059161 (28) [back to overview]Basal Insulin Dose at Week 24
NCT02059187 (11) [back to overview]Percentage of Participants Experiencing an AE Over the 24-week Treatment Period
NCT02059187 (11) [back to overview]Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24
NCT02059187 (11) [back to overview]Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24
NCT02059187 (11) [back to overview]Change From Baseline in Participant Hemoglobin A1C Level at Week 24
NCT02059187 (11) [back to overview]Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24
NCT02059187 (11) [back to overview]Percentage of Participants With Hemoglobin A1C <6.5% at Week 24
NCT02059187 (11) [back to overview]Change From Baseline in Participant Body Weight at Week 24
NCT02059187 (11) [back to overview]Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24
NCT02059187 (11) [back to overview]Daily Basal Insulin Dose (Units) at Week 24
NCT02059187 (11) [back to overview]Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24
NCT02059187 (11) [back to overview]Percentage of Participants With Hemoglobin A1C <7% at Week 24
NCT02064166 (6) [back to overview]Gait Analysis (4-meter Test)
NCT02064166 (6) [back to overview]Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)
NCT02064166 (6) [back to overview]Change in Verbal Fluency FAS (F, A or S Words) Total Score
NCT02064166 (6) [back to overview]Beck Depression Inventory Score (BDI)
NCT02064166 (6) [back to overview]Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)
NCT02064166 (6) [back to overview]Modified Hoehn and Yahr Scale
NCT02081599 (4) [back to overview]Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose
NCT02081599 (4) [back to overview]Change From Baseline in 2-hour Postprandial Plasma Glucose
NCT02081599 (4) [back to overview]Change From Baseline in Fasting Plasma Glucose
NCT02081599 (4) [back to overview]Change From Baseline in HbA1c
NCT02094534 (2) [back to overview]Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements
NCT02094534 (2) [back to overview]Mean Nighttime, Daytime, and Fasting Glucose Levels
NCT02100475 (3) [back to overview]Change From Baseline in Body Weight
NCT02100475 (3) [back to overview]Number of Treatment-emergent Confirmed Hypoglycaemic Episodes
NCT02100475 (3) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT02104804 (6) [back to overview]Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test
NCT02104804 (6) [back to overview]The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)
NCT02104804 (6) [back to overview]Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test
NCT02104804 (6) [back to overview]Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24
NCT02104804 (6) [back to overview]Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%
NCT02104804 (6) [back to overview]Change in HbA1c From Baseline to Week 24
NCT02109029 (2) [back to overview]Part B: Pharmacokinetics: ISF-to-Serum Concentrations
NCT02109029 (2) [back to overview]Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)
NCT02120794 (4) [back to overview]Overall Mean Change in A1C
NCT02120794 (4) [back to overview]Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
NCT02120794 (4) [back to overview]Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
NCT02120794 (4) [back to overview]Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
NCT02130284 (8) [back to overview]Severe Hypoglycemia
NCT02130284 (8) [back to overview]Unanticipated Device Effect (UADE)
NCT02130284 (8) [back to overview]Sensor Performance: Accuracy
NCT02130284 (8) [back to overview]Rescue Events During In-clinic Procedues
NCT02130284 (8) [back to overview]PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.
NCT02130284 (8) [back to overview]Diabetic Ketoacidosis
NCT02130284 (8) [back to overview]Device Metric/Performance - All Device Deficiencies
NCT02130284 (8) [back to overview]Serious Adverse Events (SAE)
NCT02131272 (7) [back to overview]Change in Body Weight Standard Deviation Score (SDS)
NCT02131272 (7) [back to overview]Change in HbA1c (Glycosylated Haemoglobin)
NCT02131272 (7) [back to overview]Incidence of Adverse Events (AEs)
NCT02131272 (7) [back to overview]Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment.
NCT02131272 (7) [back to overview]Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02131272 (7) [back to overview]Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02131272 (7) [back to overview]Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment
NCT02132637 (10) [back to overview]Beta Cell Function
NCT02132637 (10) [back to overview]Duration of Glucose ≤70 mg/dL
NCT02132637 (10) [back to overview]Nadir Glucose
NCT02132637 (10) [back to overview]Percentage of Participants With Clinically Significant Hypoglycemia
NCT02132637 (10) [back to overview]Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose
NCT02132637 (10) [back to overview]Time to the Nadir Glucose
NCT02132637 (10) [back to overview]Fasting Blood Glucose
NCT02132637 (10) [back to overview]Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC)
NCT02132637 (10) [back to overview]Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion
NCT02132637 (10) [back to overview]Percentage of Participants With Hypoglycemia
NCT02138006 (2) [back to overview]Cardiovascular Mortality
NCT02138006 (2) [back to overview]Morbidity of Cardiovascular Complications
NCT02148250 (5) [back to overview]Duration (in Hours) of 20 % Dextrose Infusion Requirement
NCT02148250 (5) [back to overview]Peak Infusion Rate Achieved After U-500
NCT02148250 (5) [back to overview]Time Following Injection the Glucose Infusion Was Started to Maintain EU
NCT02148250 (5) [back to overview]Total Glucose Given After U-500 Dose
NCT02148250 (5) [back to overview]Total Glucose Required to Maintain Euglycaemia
NCT02152384 (7) [back to overview]Pharmacodynamics (PD): Area Under the Concentration Zero Through 5 Hours (AUC 0-5h) for Triglycerides
NCT02152384 (7) [back to overview]Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Last Time (AUC [0 Tlast]) for Paracetamol
NCT02152384 (7) [back to overview]Pharmacokinetics (PK): Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro
NCT02152384 (7) [back to overview]Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp
NCT02152384 (7) [back to overview]Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro
NCT02152384 (7) [back to overview]Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)
NCT02152384 (7) [back to overview]Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
NCT02154477 (1) [back to overview]LH
NCT02197520 (5) [back to overview]Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro
NCT02197520 (5) [back to overview]Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen
NCT02197520 (5) [back to overview]Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
NCT02197520 (5) [back to overview]Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)
NCT02197520 (5) [back to overview]Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro
NCT02229227 (40) [back to overview]Number of Participants With Hematology Values of Clinical Concern
NCT02229227 (40) [back to overview]Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)
NCT02229227 (40) [back to overview]Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication
NCT02229227 (40) [back to overview]Number of Participants With Other AE of Special Interest
NCT02229227 (40) [back to overview]Number of Participants With Vital Signs of Clinical Concern
NCT02229227 (40) [back to overview]Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26
NCT02229227 (40) [back to overview]Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits
NCT02229227 (40) [back to overview]Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits
NCT02229227 (40) [back to overview]Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms
NCT02229227 (40) [back to overview]Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26
NCT02229227 (40) [back to overview]Number of Participants Achieving a HbA1c <6.5% at Week 26
NCT02229227 (40) [back to overview]Change From Baseline in Body Weight at Week 26
NCT02229227 (40) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
NCT02229227 (40) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
NCT02229227 (40) [back to overview]Number of Participants Achieving HbA1c <7.0% at Week 26
NCT02229227 (40) [back to overview]Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26
NCT02229227 (40) [back to overview]Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26
NCT02229227 (40) [back to overview]Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26
NCT02229227 (40) [back to overview]Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26
NCT02229227 (40) [back to overview]Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26
NCT02229227 (40) [back to overview]Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26
NCT02229227 (40) [back to overview]Total Daily Insulin Dose at Week 26
NCT02229227 (40) [back to overview]Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26
NCT02229227 (40) [back to overview]Change From Baseline to Week 26 in Body Weight
NCT02229227 (40) [back to overview]Change From Baseline to Week 26 in FPG
NCT02229227 (40) [back to overview]Change From Baseline to Week 26 in HbA1c
NCT02229227 (40) [back to overview]Mean Albumin at Week 0 and Week 26
NCT02229227 (40) [back to overview]Mean Creatinine at Week 0 and Week 26
NCT02229227 (40) [back to overview]Mean Specific Gravity at Week 0 and Week 26
NCT02229227 (40) [back to overview]Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26
NCT02229227 (40) [back to overview]Number of Participants Achieving a HbA1c <6.5% up to Week 26
NCT02229227 (40) [back to overview]Number of Participants Achieving HbA1c <7.0% up to Week 26
NCT02229227 (40) [back to overview]Number of Participants With Clinical Chemistry Values of Clinical Concern
NCT02229227 (40) [back to overview]Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters
NCT02229227 (40) [back to overview]Number of Participants With Daytime and Nocturnal Hypoglycemia
NCT02229227 (40) [back to overview]Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26
NCT02229227 (40) [back to overview]Total Daily Insulin Dose at Week 4, Week 10 and Week 18
NCT02229227 (40) [back to overview]Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26
NCT02229227 (40) [back to overview]Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26
NCT02229227 (40) [back to overview]Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26
NCT02246582 (3) [back to overview]Retrospective Re-Analysis (MARD With 1 Additional Calibration)
NCT02246582 (3) [back to overview]Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)
NCT02246582 (3) [back to overview]Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
NCT02273180 (9) [back to overview]Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
NCT02273180 (9) [back to overview]Change in Daily Insulin Dose From Baseline to Week 26 and Week 52
NCT02273180 (9) [back to overview]Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26
NCT02273180 (9) [back to overview]Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year
NCT02273180 (9) [back to overview]Change in HbA1c From Baseline to Week 26
NCT02273180 (9) [back to overview]Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
NCT02273180 (9) [back to overview]Percentage of Participants With HbA1c <7.0% at Week 26
NCT02273180 (9) [back to overview]Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)
NCT02273180 (9) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT02294474 (9) [back to overview]Percentage of Participants With Treatment-Emergent Anti-insulin Antibodies (AIAs)
NCT02294474 (9) [back to overview]Change in Daily Insulin Dose From Baseline to Week 26
NCT02294474 (9) [back to overview]Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26
NCT02294474 (9) [back to overview]Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26
NCT02294474 (9) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT02294474 (9) [back to overview]Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
NCT02294474 (9) [back to overview]Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
NCT02294474 (9) [back to overview]Change in HbA1c From Baseline to Week 26
NCT02294474 (9) [back to overview]Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)
NCT02320721 (12) [back to overview]Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment
NCT02320721 (12) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT02320721 (12) [back to overview]Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period
NCT02320721 (12) [back to overview]Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period
NCT02320721 (12) [back to overview]Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period
NCT02320721 (12) [back to overview]Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period
NCT02320721 (12) [back to overview]Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment
NCT02320721 (12) [back to overview]Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment
NCT02320721 (12) [back to overview]Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period
NCT02320721 (12) [back to overview]Change in HbA1c From Baseline to Week 26
NCT02320721 (12) [back to overview]Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment
NCT02320721 (12) [back to overview]Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26
NCT02328040 (2) [back to overview]Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo
NCT02328040 (2) [back to overview]Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo
NCT02366767 (3) [back to overview]Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes
NCT02366767 (3) [back to overview]Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes
NCT02366767 (3) [back to overview]Efficacy of Hybrid Closed-loop System in Comparison With Control
NCT02397265 (1) [back to overview]Percentage of Time in Target Range Over 24 Hour
NCT02408120 (11) [back to overview]Mean Daily BG Levels
NCT02408120 (11) [back to overview]Average Number of Days of Hospital Stay
NCT02408120 (11) [back to overview]Incidence of Hyperglycemia
NCT02408120 (11) [back to overview]Mean Blood Glucose Levels at Bedtime
NCT02408120 (11) [back to overview]Mean Blood Glucose Levels Before Dinner
NCT02408120 (11) [back to overview]Mean Blood Glucose Levels Before Lunch
NCT02408120 (11) [back to overview]Mean Daily Dose of Insulin
NCT02408120 (11) [back to overview]Mortality
NCT02408120 (11) [back to overview]Number of Blood Glucose Readings Within 100-140 mg/dL Range
NCT02408120 (11) [back to overview]Number of Hypoglycemia Events
NCT02408120 (11) [back to overview]Number of Subjects That Experienced Hospital Complications
NCT02415556 (7) [back to overview]Weight (kg).
NCT02415556 (7) [back to overview]Gait Speed Normal Walk (cm/s).
NCT02415556 (7) [back to overview]Gait Speed Dual-task (cm/s).
NCT02415556 (7) [back to overview]Fasting Plasma Glucose (mg/dL).
NCT02415556 (7) [back to overview]Executive Function Composite z Score
NCT02415556 (7) [back to overview]Cerebral Blood Flow on Magnetic Resonance Imaging (MRI).
NCT02415556 (7) [back to overview]Verbal Memory Composite z Score
NCT02418676 (2) [back to overview]Efficacy Index (%EI)
NCT02418676 (2) [back to overview]Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients
NCT02420262 (5) [back to overview]Responder for HbA1c Below 7.0%
NCT02420262 (5) [back to overview]Change in HbA1c (Glycosylated Haemoglobin)
NCT02420262 (5) [back to overview]Change in Body Weight
NCT02420262 (5) [back to overview]Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.
NCT02420262 (5) [back to overview]Responder for HbA1c Below or Equal to 6.5 %
NCT02432716 (5) [back to overview]Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME)
NCT02432716 (5) [back to overview]Safety Measured by Adverse Events
NCT02432716 (5) [back to overview]Memory Retention Measured by Rivermead Behavioral Memory Test (RBMT-C).
NCT02432716 (5) [back to overview]Memory Retention Measured by Fuld Object-Memory Evaluation (FOME)
NCT02432716 (5) [back to overview]Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C)
NCT02443402 (28) [back to overview]Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration
NCT02443402 (28) [back to overview]Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)
NCT02443402 (28) [back to overview]Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay
NCT02443402 (28) [back to overview]Number of Participants With Infections Not Requiring Hospital Re-admission
NCT02443402 (28) [back to overview]Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
NCT02443402 (28) [back to overview]Duration of Continuous Intravenous Insulin (CII)
NCT02443402 (28) [back to overview]Mean Units Subcutaneous (SQ) Insulin Required
NCT02443402 (28) [back to overview]Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia
NCT02443402 (28) [back to overview]Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)
NCT02443402 (28) [back to overview]Number of Participants Re-admitted to the Hospital Due to Wound Infections
NCT02443402 (28) [back to overview]Number of Participants Re-admitted to the Hospital Not Due to Wound Infections
NCT02443402 (28) [back to overview]Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)
NCT02443402 (28) [back to overview]Number of Subject Requiring Surgical Re-Intervention
NCT02443402 (28) [back to overview]Number of Participants With Blood Glucose Less Than 40 mg/dl
NCT02443402 (28) [back to overview]Number of Participants With Cerebrovascular Events
NCT02443402 (28) [back to overview]Number of Participants With Emergency Room (ER) Visits
NCT02443402 (28) [back to overview]Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)
NCT02443402 (28) [back to overview]Total Insulin Therapy in the Intensive Care Unit (ICU)
NCT02443402 (28) [back to overview]Number of Subjects With Persistent Hyperglycemia
NCT02443402 (28) [back to overview]Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours
NCT02443402 (28) [back to overview]Number of Subjects Requiring Re-intubation Within 24 Hours
NCT02443402 (28) [back to overview]Number of Subjects Requiring Re-intubation
NCT02443402 (28) [back to overview]Hospital Complication Rate
NCT02443402 (28) [back to overview]Hospital Mortality Rate
NCT02443402 (28) [back to overview]Intensive Care Unit (ICU) Mortality Rate
NCT02443402 (28) [back to overview]Length of Hospital Stay After Study Randomization
NCT02443402 (28) [back to overview]Length of Stay: Intensive Care Unit (ICU)
NCT02443402 (28) [back to overview]Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)
NCT02451137 (13) [back to overview]Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12
NCT02451137 (13) [back to overview]Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12
NCT02451137 (13) [back to overview]"Percentage of Responders (Participants and Provider) Who Reported Excellent or Good Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12"
NCT02451137 (13) [back to overview]Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period
NCT02451137 (13) [back to overview]Treatment Persistence Measured by Medication Possession Ratio (MPR)
NCT02451137 (13) [back to overview]Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12
NCT02451137 (13) [back to overview]Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia
NCT02451137 (13) [back to overview]Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period
NCT02451137 (13) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12
NCT02451137 (13) [back to overview]Change From Baseline in Body Weight at Month 6 and Month 12
NCT02451137 (13) [back to overview]Change From Baseline in Basal Insulin Dose at Month 6 and Month 12
NCT02451137 (13) [back to overview]Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period
NCT02451137 (13) [back to overview]Change From Baseline in HbA1c at Month 6 and Month 12
NCT02451917 (7) [back to overview]Total Daily Insulin Dose
NCT02451917 (7) [back to overview]Serum Creatinine
NCT02451917 (7) [back to overview]Body Mass Index (BMI)
NCT02451917 (7) [back to overview]Difference in A1c Levels
NCT02451917 (7) [back to overview]Estimated Glomerular Filtration Rate (eGFR) Calculated by CKD-EPI
NCT02451917 (7) [back to overview]Glycemic Variability
NCT02451917 (7) [back to overview]Number of Hypoglycemic Events
NCT02453685 (4) [back to overview]HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes
NCT02453685 (4) [back to overview]Change in HbA1c (Glycosylated Haemoglobin)
NCT02453685 (4) [back to overview]Total Daily Insulin Dose
NCT02453685 (4) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions
NCT02463097 (3) [back to overview]Change in A1C
NCT02463097 (3) [back to overview]Number of Diabetic Ketoacidosis (DKA) Events
NCT02463097 (3) [back to overview]Number of Severe Hypoglycemia Events
NCT02496000 (5) [back to overview]The Effect of ORMD-0801 on Mean 24-hour Glucose
NCT02496000 (5) [back to overview]The Effect of ORMD-0801 on the Percent Change in HbA1c
NCT02496000 (5) [back to overview]Measure the Change From Baseline to End of the Study of Morning Fasting C-Peptide (Nmol/L)
NCT02496000 (5) [back to overview]Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.
NCT02496000 (5) [back to overview]Measure Percent Change in Continuous Glucose Monitoring Mean Fasting Glucose Between Treatment and Run-In
NCT02500706 (49) [back to overview]Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
NCT02500706 (49) [back to overview]Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal
NCT02500706 (49) [back to overview]Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L
NCT02500706 (49) [back to overview]Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia
NCT02500706 (49) [back to overview]Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Body Mass Index 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements
NCT02500706 (49) [back to overview]Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)
NCT02500706 (49) [back to overview]Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia
NCT02500706 (49) [back to overview]Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)
NCT02500706 (49) [back to overview]Change From Baseline in Blood Pressure 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)
NCT02500706 (49) [back to overview]Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)
NCT02500706 (49) [back to overview]Change From Baseline in Potassium 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Pulse 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Thrombocytes 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Total Bilirubin 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Total Protein 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Creatinine 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Body Weight 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall
NCT02500706 (49) [back to overview]Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Leukocytes 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile
NCT02500706 (49) [back to overview]Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile
NCT02500706 (49) [back to overview]Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Albumin 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in HbA1c 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Haemoglobin 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Haematocrit 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in Erythrocytes 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)
NCT02500706 (49) [back to overview]Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation
NCT02500706 (49) [back to overview]Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)
NCT02500979 (15) [back to overview]Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration
NCT02500979 (15) [back to overview]Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC)
NCT02500979 (15) [back to overview]Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration.
NCT02500979 (15) [back to overview]Fasting Plasma Glucose Concentration
NCT02500979 (15) [back to overview]Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM)
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM)
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)
NCT02500979 (15) [back to overview]Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM)
NCT02500979 (15) [back to overview]Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration
NCT02501161 (54) [back to overview]Change in Fasting C-peptide
NCT02501161 (54) [back to overview]Change in Fasting Free Fatty Acids
NCT02501161 (54) [back to overview]Change in Fasting HDL-cholesterol
NCT02501161 (54) [back to overview]Number of TEAEs During 26 Weeks of Treatment
NCT02501161 (54) [back to overview]Number of TEAEs During 104 Weeks of Treatment
NCT02501161 (54) [back to overview]Change in Urine Albumin/Creatinine Ratio
NCT02501161 (54) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment
NCT02501161 (54) [back to overview]Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
NCT02501161 (54) [back to overview]Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits
NCT02501161 (54) [back to overview]SMPG-9-point Profile (Individual Points in the Profile)
NCT02501161 (54) [back to overview]Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain
NCT02501161 (54) [back to overview]Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
NCT02501161 (54) [back to overview]Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02501161 (54) [back to overview]Participants Who Achieved (Yes/no): HbA1c ≤6.5%
NCT02501161 (54) [back to overview]Change in Fasting Human Insulin
NCT02501161 (54) [back to overview]Change in Fasting LDL-cholesterol
NCT02501161 (54) [back to overview]Change in Fasting Total Cholesterol
NCT02501161 (54) [back to overview]Change in Fasting Triglycerides
NCT02501161 (54) [back to overview]Change in Fasting VLDL-cholesterol
NCT02501161 (54) [back to overview]Change in FPG
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Basophils
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Eosinophils
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Erythrocytes
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Haematocrit
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Haemoglobin
NCT02501161 (54) [back to overview]Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Lymphocytes
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Monocytes
NCT02501161 (54) [back to overview]Change in HbA1c
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Neutrophils
NCT02501161 (54) [back to overview]Change in Haematological Parameter- Thrombocytes and Leukocytes
NCT02501161 (54) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment
NCT02501161 (54) [back to overview]Change in Pulse Rate
NCT02501161 (54) [back to overview]Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
NCT02501161 (54) [back to overview]Change in SMPG-mean 9-point Profile
NCT02501161 (54) [back to overview]Change in SMPG-mean Postprandial Increment Over All Meals
NCT02501161 (54) [back to overview]Change in TRIM-D
NCT02501161 (54) [back to overview]Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment
NCT02501161 (54) [back to overview]ECG Evaluation
NCT02501161 (54) [back to overview]Eye Examination Category
NCT02501161 (54) [back to overview]Insulin Dose
NCT02501161 (54) [back to overview]Change in Biochemistry Parameter- Creatinine, Total Bilirubin
NCT02501161 (54) [back to overview]Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain
NCT02501161 (54) [back to overview]Participants Who Achieved (Yes/no): HbA1c <7.0%
NCT02501161 (54) [back to overview]Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02501161 (54) [back to overview]Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment
NCT02501161 (54) [back to overview]Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment
NCT02501161 (54) [back to overview]Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment
NCT02501161 (54) [back to overview]Change in Biochemistry Parameter- Albumin
NCT02501161 (54) [back to overview]Change in Biochemistry Parameter- Sodium, Potassium and Calcium
NCT02501161 (54) [back to overview]Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
NCT02501161 (54) [back to overview]Change in Blood Pressure (Systolic and Diastolic)
NCT02501161 (54) [back to overview]Change in Body Weight
NCT02501161 (54) [back to overview]Change in Calcitonin
NCT02527265 (8) [back to overview]Insulin Maximum Observed Concentration (Cmax)
NCT02527265 (8) [back to overview]Insulin Time to Reach Cmax (Tmax)
NCT02527265 (8) [back to overview]Insulin Maximum Observed Concentration (Cmax)
NCT02527265 (8) [back to overview]Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2)
NCT02527265 (8) [back to overview]Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2)
NCT02527265 (8) [back to overview]Insulin Area Under Concentration Time Curve (AUC)
NCT02527265 (8) [back to overview]Insulin Area Under Concentration Time Curve (AUC)
NCT02527265 (8) [back to overview]Insulin Time to Reach Cmax (Tmax)
NCT02535715 (5) [back to overview]Plasma Insulin Concentrations
NCT02535715 (5) [back to overview]Plasma Glucose Concentrations
NCT02535715 (5) [back to overview]Plasma Glucagon Concentrations
NCT02535715 (5) [back to overview]Plasma Free Fatty Acid Concentrations
NCT02535715 (5) [back to overview]Hepatic Glucose Production (Co-primary Outcome)
NCT02542631 (9) [back to overview]Change in A1C From Baseline to Week 44
NCT02542631 (9) [back to overview]Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy
NCT02542631 (9) [back to overview]Change in Quality of Life From Baseline to Week 24
NCT02542631 (9) [back to overview]Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24
NCT02542631 (9) [back to overview]Change in Treatment Satisfaction From Baseline to Week 24
NCT02542631 (9) [back to overview]Number of Participants With Severe Hypoglycemic Event
NCT02542631 (9) [back to overview]Number of Patients With A1C ≤7.0% at Week 24
NCT02542631 (9) [back to overview]Number of Patients With A1C ≤7.0% at Week 44
NCT02542631 (9) [back to overview]Change in A1C From Week 24 to Week 44
NCT02556918 (26) [back to overview]Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU)
NCT02556918 (26) [back to overview]Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU)
NCT02556918 (26) [back to overview]Number of Subjects Readmitted to the Hospital
NCT02556918 (26) [back to overview]Number of Subjects Returning to the ER Within 30 Days
NCT02556918 (26) [back to overview]Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU
NCT02556918 (26) [back to overview]Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU)
NCT02556918 (26) [back to overview]Total IV Insulin in ICU
NCT02556918 (26) [back to overview]Total Length of Hospital Stay
NCT02556918 (26) [back to overview]Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours
NCT02556918 (26) [back to overview]Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)
NCT02556918 (26) [back to overview]Composite of Perioperative Complications
NCT02556918 (26) [back to overview]Duration of Continuous Intravenous Insulin Infusion (CII)
NCT02556918 (26) [back to overview]Duration of Intubation
NCT02556918 (26) [back to overview]Length of Intensive Care Unit (ICU) Stay
NCT02556918 (26) [back to overview]Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)
NCT02556918 (26) [back to overview]Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery
NCT02556918 (26) [back to overview]Mean Post-operative Blood Glucose (BG) Concentration
NCT02556918 (26) [back to overview]Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)
NCT02556918 (26) [back to overview]Number of Cerebrovascular Events
NCT02556918 (26) [back to overview]Number of Intensive Care Unit (ICU) Readmission
NCT02556918 (26) [back to overview]Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)
NCT02556918 (26) [back to overview]Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)
NCT02556918 (26) [back to overview]Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)
NCT02556918 (26) [back to overview]Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU)
NCT02556918 (26) [back to overview]Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU)
NCT02556918 (26) [back to overview]Number of Patients With Persistent Hyperglycemia
NCT02558829 (6) [back to overview]Co-primary Efficacy Variables: Percent Positive and Percent Negative Agreement of Macimorelin-GHST (MAC) With ITT
NCT02558829 (6) [back to overview]ECG: Change in Heart Rate From Baseline at 60 Minutes Post-dose
NCT02558829 (6) [back to overview]Agreement (Positive/Negative) for MAC Core Study Part and MAC Repeatability Extension (Amendment 1)
NCT02558829 (6) [back to overview]Sensitivity and Specificity of the MAC, GH: 2.8 ng/mL
NCT02558829 (6) [back to overview]Overall Agreements (Positive/ Negative) for MAC and ITT
NCT02558829 (6) [back to overview]Number of Participants With Any Test Emergent Adverse Event (TEAE), With Any TEAE Likely or Possibly Related, and With Any Test Emergent Severe AE
NCT02561078 (9) [back to overview]Percentage of Participants With HbA1c <7.0%
NCT02561078 (9) [back to overview]Change From Baseline in Body Weight
NCT02561078 (9) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT02561078 (9) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c)
NCT02561078 (9) [back to overview]Change From Baseline in Total Daily Dose (TDD)
NCT02561078 (9) [back to overview]Percentage of Participants With HbA1c <7.5%
NCT02561078 (9) [back to overview]Percentage of Participants With Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)
NCT02561078 (9) [back to overview]Rate of Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)
NCT02561078 (9) [back to overview]Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
NCT02563834 (3) [back to overview]Myocardial Fatty Acid Uptake Rate
NCT02563834 (3) [back to overview]Myocardial Oxidation Rate
NCT02563834 (3) [back to overview]Myocardial Perfusion Rate
NCT02580877 (2) [back to overview]Change in mIAA Autoantibody Titer From Baseline
NCT02580877 (2) [back to overview]Change in GAD65 Autoantibody Titer (DK Units/mL)
NCT02588950 (9) [back to overview]Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R
NCT02588950 (9) [back to overview]Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R
NCT02588950 (9) [back to overview]Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R
NCT02588950 (9) [back to overview]Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R
NCT02588950 (9) [back to overview]Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R
NCT02588950 (9) [back to overview]Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R
NCT02588950 (9) [back to overview]Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R
NCT02588950 (9) [back to overview]Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R
NCT02588950 (9) [back to overview]Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R
NCT02607306 (40) [back to overview]Change in Clinical Evaluation: Electrocardiogram (ECG)
NCT02607306 (40) [back to overview]Change in Clinical Evaluation: Fundoscopy or Fundus Photography
NCT02607306 (40) [back to overview]Plasma Concentrations of Liraglutide
NCT02607306 (40) [back to overview]Responder (Yes/no): HbA1c Less Than 6.5%
NCT02607306 (40) [back to overview]Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero
NCT02607306 (40) [back to overview]Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.
NCT02607306 (40) [back to overview]Total Cholesterol as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.
NCT02607306 (40) [back to overview]Responder (Yes/no): HbA1c Less Than 7.0%
NCT02607306 (40) [back to overview]Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero
NCT02607306 (40) [back to overview]Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02607306 (40) [back to overview]Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)
NCT02607306 (40) [back to overview]Serum Concentrations of Insulin Degludec
NCT02607306 (40) [back to overview]Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02607306 (40) [back to overview]Anti-drug Antibodies: Anti-insulin Degludec Antibodies
NCT02607306 (40) [back to overview]Change From Baseline in Body Weight (kg)
NCT02607306 (40) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT02607306 (40) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira
NCT02607306 (40) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg
NCT02607306 (40) [back to overview]Change in Clinical Evaluation: Pulse
NCT02607306 (40) [back to overview]Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)
NCT02607306 (40) [back to overview]Change in SMBG 9-point Profile - Mean of the 9-point Profile
NCT02607306 (40) [back to overview]Change in Waist Circumference
NCT02607306 (40) [back to overview]Fasting C-peptide as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Fasting Glucagon as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Fasting Human Insulin as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Free Fatty Acids as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Insulin Dose
NCT02607306 (40) [back to overview]Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Number of Treatment Emergent Adverse Events (TEAEs)
NCT02607306 (40) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition
NCT02607306 (40) [back to overview]Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02607306 (40) [back to overview]Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
NCT02607306 (40) [back to overview]Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02607306 (40) [back to overview]Proinsulin as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Triglycerides as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies
NCT02607306 (40) [back to overview]Change in Blood Pressure (Systolic and Diastolic)
NCT02648217 (7) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic
NCT02648217 (7) [back to overview]Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )
NCT02648217 (7) [back to overview]Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)
NCT02648217 (7) [back to overview]Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02648217 (7) [back to overview]Change in HbA1c (%) (Glycosylated Haemoglobin)
NCT02648217 (7) [back to overview]Change in Fructosamine
NCT02648217 (7) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT02653300 (3) [back to overview]Change in MRI-Proton Density Fat Fraction (MRI-PDFF)
NCT02653300 (3) [back to overview]Mean Fibrosis Score CAP™ (FibroMax)
NCT02653300 (3) [back to overview]Mean Transient Elastography Measurement (Fibroscan)
NCT02660827 (7) [back to overview]Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL)
NCT02660827 (7) [back to overview]Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL
NCT02660827 (7) [back to overview]Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event
NCT02660827 (7) [back to overview]Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL)
NCT02660827 (7) [back to overview]Age 2-13 Years Old Subjects Change in A1C
NCT02660827 (7) [back to overview]Age 2-13 Years Old - Number of Severe Hypoglycemic Event
NCT02660827 (7) [back to overview]Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL)
NCT02670915 (80) [back to overview]Change in FPG
NCT02670915 (80) [back to overview]Change in Haematology: Erythrocytes
NCT02670915 (80) [back to overview]Change in Haematology: Haematocrit
NCT02670915 (80) [back to overview]Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
NCT02670915 (80) [back to overview]Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
NCT02670915 (80) [back to overview]Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
NCT02670915 (80) [back to overview]Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
NCT02670915 (80) [back to overview]Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
NCT02670915 (80) [back to overview]Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
NCT02670915 (80) [back to overview]Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
NCT02670915 (80) [back to overview]Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
NCT02670915 (80) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total
NCT02670915 (80) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
NCT02670915 (80) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime
NCT02670915 (80) [back to overview]Change in Body Mass Index
NCT02670915 (80) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total
NCT02670915 (80) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
NCT02670915 (80) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime
NCT02670915 (80) [back to overview]Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose
NCT02670915 (80) [back to overview]Insulin Dose (Units/Day): Individual Meal Insulin Dose
NCT02670915 (80) [back to overview]Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
NCT02670915 (80) [back to overview]Change in Lipid Profile: High Density Lipoproteins (HDL)
NCT02670915 (80) [back to overview]Change in Lipid Profile: Low Density Lipoproteins (LDL)
NCT02670915 (80) [back to overview]Change in Lipid Profile: Total Cholesterol
NCT02670915 (80) [back to overview]Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])
NCT02670915 (80) [back to overview]Change in Vital Sign: Pulse
NCT02670915 (80) [back to overview]Change in Vital Sign: Blood Pressure
NCT02670915 (80) [back to overview]Change in Time to the IG Peak After Start of Meal
NCT02670915 (80) [back to overview]Change in the Percentage of HbA1c
NCT02670915 (80) [back to overview]Change in Body Weight
NCT02670915 (80) [back to overview]Change in SD Score of Body Weight
NCT02670915 (80) [back to overview]Change in SD Score of Body Mass Index
NCT02670915 (80) [back to overview]Change in Physical Examination
NCT02670915 (80) [back to overview]Change in Mean Time to the IG Peak After Meal
NCT02670915 (80) [back to overview]Change in Mean IG Peak After Start of Meal
NCT02670915 (80) [back to overview]Change in IG Peak After Start of Meal
NCT02670915 (80) [back to overview]Change in Height
NCT02670915 (80) [back to overview]Change in Haematology: Thrombocytes
NCT02670915 (80) [back to overview]Change in Haematology: Leukocytes
NCT02670915 (80) [back to overview]Change in Haematology: Haemoglobin
NCT02670915 (80) [back to overview]Change in Biochemistry: Total Bilirubin
NCT02670915 (80) [back to overview]Change in Biochemistry: Sodium
NCT02670915 (80) [back to overview]Change in Biochemistry: Potassium
NCT02670915 (80) [back to overview]Change in Biochemistry: Creatinine
NCT02670915 (80) [back to overview]Change in Biochemistry: Aspartate Aminotransferase (AST)
NCT02670915 (80) [back to overview]Change in Biochemistry: Alkaline Phosphatase (AP)
NCT02670915 (80) [back to overview]Change in Biochemistry: Albumin
NCT02670915 (80) [back to overview]Change in Biochemistry: Alanine Aminotransferase (ALT)
NCT02670915 (80) [back to overview]Change in AUCIG,0-4h
NCT02670915 (80) [back to overview]Change in AUCIG,0-30min
NCT02670915 (80) [back to overview]Change in AUCIG,0-15min
NCT02670915 (80) [back to overview]Change in Anti-insulin Aspart Antibody Development: Total
NCT02670915 (80) [back to overview]Change in Anti-insulin Aspart Antibody Development: Specific
NCT02670915 (80) [back to overview]Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin
NCT02670915 (80) [back to overview]Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)
NCT02670915 (80) [back to overview]Change in 8-point SMPG Profile: PPG Increment Over All Three Meals
NCT02670915 (80) [back to overview]Change in 8-point SMPG Profile: Mean PPG Over All Three Meals
NCT02670915 (80) [back to overview]Change in 8-point SMPG Profile: Mean of the 8-point Profile
NCT02670915 (80) [back to overview]Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment
NCT02670915 (80) [back to overview]Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG
NCT02670915 (80) [back to overview]Change in 30-minute PPG Increment
NCT02670915 (80) [back to overview]Change in 30-minute PPG
NCT02670915 (80) [back to overview]Change in 2-hour PPG Increment
NCT02670915 (80) [back to overview]Change in 2-hour PPG
NCT02670915 (80) [back to overview]Change in 1,5-anhydroglucitol
NCT02670915 (80) [back to overview]Change in 1-hour PPG Increment
NCT02670915 (80) [back to overview]Change in 1-hour PPG
NCT02670915 (80) [back to overview]Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included
NCT02670915 (80) [back to overview]Number of Treatment Emergent Injection Site Reactions
NCT02670915 (80) [back to overview]Number of Treatment Emergent Adverse Events (AEs)
NCT02670915 (80) [back to overview]Insulin Dose (Units/kg/Day): Total Bolus
NCT02670915 (80) [back to overview]Insulin Dose (Units/kg/Day): Total Basal
NCT02670915 (80) [back to overview]Insulin Dose (Units/Day): Total Bolus
NCT02670915 (80) [back to overview]Insulin Dose (Units/Day): Total Basal
NCT02670915 (80) [back to overview]Fluctuation in the 8-point SMPG Profile
NCT02670915 (80) [back to overview]Change in AUCIG,0-1h
NCT02670915 (80) [back to overview]Change in AUCIG,0-2h
NCT02670915 (80) [back to overview]Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
NCT02670915 (80) [back to overview]Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia
NCT02670915 (80) [back to overview]Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines
NCT02680054 (5) [back to overview]Acceptability of Giving Insulin at Different Times Related to Test Meal
NCT02680054 (5) [back to overview]Number of Participants With Hypoglycaemia Events Following the Insulin Dosing
NCT02680054 (5) [back to overview]Peak Glucose Excursion From Baseline Following Test Meal
NCT02680054 (5) [back to overview]Peak Glucose Level Following Test Meal
NCT02680054 (5) [back to overview]Time of Peak Glucose Level Following Test Meal
NCT02680457 (2) [back to overview]Glycemic Variability: Area Under the Curve of Glucose
NCT02680457 (2) [back to overview]Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE)
NCT02688933 (8) [back to overview]Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM
NCT02688933 (8) [back to overview]Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16
NCT02688933 (8) [back to overview]Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection
NCT02688933 (8) [back to overview]Change From Baseline in Daily Insulin Dose at Week 16
NCT02688933 (8) [back to overview]Change From Baseline in Time (Min) of Mean Glucose Concentration Within the Target Range of 70 to 180 mg/dL, by End of Study hbA1c Levels During Week 15 and/or Week 16
NCT02688933 (8) [back to overview]Coefficient of Variation (CV%) in Mean CGM Glucose
NCT02688933 (8) [back to overview]Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year
NCT02688933 (8) [back to overview]Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia
NCT02735044 (11) [back to overview]Percentage of Participants With HbA1c Values of <7.5% at Month 6
NCT02735044 (11) [back to overview]Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period
NCT02735044 (11) [back to overview]Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6
NCT02735044 (11) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6
NCT02735044 (11) [back to overview]Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6
NCT02735044 (11) [back to overview]Change From Baseline in HbA1c to Month 6
NCT02735044 (11) [back to overview]Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6
NCT02735044 (11) [back to overview]Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12
NCT02735044 (11) [back to overview]Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12
NCT02735044 (11) [back to overview]Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period
NCT02735044 (11) [back to overview]Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
NCT02738151 (19) [back to overview]Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period
NCT02738151 (19) [back to overview]Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24
NCT02738151 (19) [back to overview]Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point
NCT02738151 (19) [back to overview]Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point
NCT02738151 (19) [back to overview]Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24
NCT02738151 (19) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24
NCT02738151 (19) [back to overview]Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24
NCT02738151 (19) [back to overview]Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period
NCT02738151 (19) [back to overview]Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24
NCT02738151 (19) [back to overview]Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period
NCT02738151 (19) [back to overview]Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event
NCT02738151 (19) [back to overview]Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24
NCT02738151 (19) [back to overview]Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period
NCT02738151 (19) [back to overview]Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period
NCT02738151 (19) [back to overview]Change From Baseline in HbA1c to Week 12
NCT02738151 (19) [back to overview]Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24
NCT02738151 (19) [back to overview]Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24
NCT02738151 (19) [back to overview]Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period
NCT02738151 (19) [back to overview]Change From Baseline in HbA1c to Week 24
NCT02741687 (10) [back to overview]Number of Participants With Emergency Room Visits After Discharge
NCT02741687 (10) [back to overview]Number of Participants With Hospital Readmissions After Discharge
NCT02741687 (10) [back to overview]Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization
NCT02741687 (10) [back to overview]Number of Patients Requiring Supplemental, Subcutaneous Insulin
NCT02741687 (10) [back to overview]Length of Hospital Stay
NCT02741687 (10) [back to overview]Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin
NCT02741687 (10) [back to overview]Number of Days in the ICU
NCT02741687 (10) [back to overview]Number of Participants With Hypoglycemic Events
NCT02741687 (10) [back to overview]Number of Participants Experiencing Stress Hyperglycemia
NCT02741687 (10) [back to overview]Number of Participants Experiencing Complications
NCT02762578 (48) [back to overview]Incidence of Treatment Emergent Adverse Events (TEAEs)
NCT02762578 (48) [back to overview]Device Specific Questionnaires II (Would You Recommend the Pen?)
NCT02762578 (48) [back to overview]Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment
NCT02762578 (48) [back to overview]Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment
NCT02762578 (48) [back to overview]Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment
NCT02762578 (48) [back to overview]Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D])
NCT02762578 (48) [back to overview]Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?)
NCT02762578 (48) [back to overview]2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets
NCT02762578 (48) [back to overview]Change From Baseline in Body Weight
NCT02762578 (48) [back to overview]Change From Baseline in FPG (Fasting Plasma Glucose)
NCT02762578 (48) [back to overview]Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
NCT02762578 (48) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
NCT02762578 (48) [back to overview]Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0%
NCT02762578 (48) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment
NCT02762578 (48) [back to overview]Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period
NCT02762578 (48) [back to overview]Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
NCT02762578 (48) [back to overview]Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device])
NCT02762578 (48) [back to overview]2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment
NCT02762578 (48) [back to overview]9-point Profile (SMPG) After 26 Weeks of Treatment
NCT02762578 (48) [back to overview]Change in Health Related Quality of Life Questionnaire (SF -36)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?)
NCT02762578 (48) [back to overview]9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?)
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?)
NCT02762578 (48) [back to overview]Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes
NCT02762578 (48) [back to overview]Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?)
NCT02762578 (48) [back to overview]Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes
NCT02762578 (48) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
NCT02762578 (48) [back to overview]Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment
NCT02762578 (48) [back to overview]Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?)
NCT02772783 (6) [back to overview]Nucleus Accumbens Blood Flow
NCT02772783 (6) [back to overview]Functional Connectivity of Nucleus Accumbens, Hypothalamus and Other Brain Areas Involved in Intake Regulation
NCT02772783 (6) [back to overview]Blood Flow in Other Brain Areas Involved in Intake Regulation - Ventrolateral Striatum
NCT02772783 (6) [back to overview]Functional Connectivity of Nucleus Accumbens, Hypothalamus and Other Brain Areas Involved in Intake Regulation
NCT02772783 (6) [back to overview]Blood Flow in Other Brain Areas Involved in Intake Regulation - Dorsal Caudate
NCT02772783 (6) [back to overview]Nucleus Accumbens Blood Flow
NCT02773368 (33) [back to overview]Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
NCT02773368 (33) [back to overview]Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
NCT02773368 (33) [back to overview]Change From Baseline After 26 Weeks in Waist Circumference
NCT02773368 (33) [back to overview]Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02773368 (33) [back to overview]Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
NCT02773368 (33) [back to overview]Number of Treatment-emergent Adverse Events
NCT02773368 (33) [back to overview]Insulin Dose, Total Daily Dose (U)
NCT02773368 (33) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT02773368 (33) [back to overview]Change in Body Weight
NCT02773368 (33) [back to overview]Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
NCT02773368 (33) [back to overview]Change From Baseline in Systolic Blood Pressure
NCT02773368 (33) [back to overview]Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
NCT02773368 (33) [back to overview]Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
NCT02773368 (33) [back to overview]Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
NCT02773368 (33) [back to overview]Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
NCT02773368 (33) [back to overview]Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
NCT02773368 (33) [back to overview]Change From Baseline in Fasting Lipid Profile: Triglycerides
NCT02773368 (33) [back to overview]Change in HbA1c (Glycosylated Haemoglobin)
NCT02773368 (33) [back to overview]Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
NCT02773368 (33) [back to overview]Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
NCT02773368 (33) [back to overview]Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02773368 (33) [back to overview]Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
NCT02773368 (33) [back to overview]Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
NCT02773368 (33) [back to overview]Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
NCT02773368 (33) [back to overview]Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02773368 (33) [back to overview]Responder (Yes/No) for HbA1c Below 7.0%
NCT02773368 (33) [back to overview]Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
NCT02773368 (33) [back to overview]Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
NCT02773368 (33) [back to overview]Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
NCT02773368 (33) [back to overview]Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
NCT02773368 (33) [back to overview]Change From Baseline in Fasting Lipid Profile: Cholesterol
NCT02773368 (33) [back to overview]Change From Baseline in Diastolic Blood Pressure
NCT02773368 (33) [back to overview]Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
NCT02810392 (15) [back to overview]Story Memory Recall
NCT02810392 (15) [back to overview]Patient Health Questionnaire-9 Question (PHQ-9)
NCT02810392 (15) [back to overview]Montreal Cognitive Assessment (MoCA)
NCT02810392 (15) [back to overview]Modified Rankin Score (MRS)
NCT02810392 (15) [back to overview]Modified Caregiver Strain Index
NCT02810392 (15) [back to overview]Instrumental Activities of Daily Living Scale:
NCT02810392 (15) [back to overview]Verbal Fluency
NCT02810392 (15) [back to overview]Verbal Fluency
NCT02810392 (15) [back to overview]Verbal Fluency
NCT02810392 (15) [back to overview]Composite of Memory t Scores
NCT02810392 (15) [back to overview]Composite of Memory t Scores
NCT02810392 (15) [back to overview]Composite of Memory t Scores
NCT02810392 (15) [back to overview]Composite of Executive Function z Scores
NCT02810392 (15) [back to overview]Composite of Executive Function z Scores
NCT02810392 (15) [back to overview]Composite of Executive Function t Scores
NCT02825251 (89) [back to overview]Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck
NCT02825251 (89) [back to overview]Change From Baseline in Physical Examination: Musculoskeletal System
NCT02825251 (89) [back to overview]Change From Baseline in Physical Examination: Respiratory System
NCT02825251 (89) [back to overview]Change From Baseline in Physical Examination: Skin
NCT02825251 (89) [back to overview]Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM
NCT02825251 (89) [back to overview]Change From Baseline in Time to the IG Peak After Start of Meal
NCT02825251 (89) [back to overview]Change From Baseline in Urinalysis: Albumin/Creatine Ratio
NCT02825251 (89) [back to overview]Change From Baseline in Urinalysis: Erythrocytes
NCT02825251 (89) [back to overview]Change From Baseline in Urinalysis: Ketones
NCT02825251 (89) [back to overview]Change From Baseline in Urinalysis: Protein
NCT02825251 (89) [back to overview]Change From Baseline in Vital Sign: Blood Pressure
NCT02825251 (89) [back to overview]Change From Baseline in Vital Sign: Pulse
NCT02825251 (89) [back to overview]Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile
NCT02825251 (89) [back to overview]Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements
NCT02825251 (89) [back to overview]Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
NCT02825251 (89) [back to overview]Change From Baseline in Haematology: Leucocytes
NCT02825251 (89) [back to overview]Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
NCT02825251 (89) [back to overview]Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)
NCT02825251 (89) [back to overview]Change From Screening in Electrocardiogram (ECG)
NCT02825251 (89) [back to overview]Change From Screening in Fundus Photography/Fundoscopy
NCT02825251 (89) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT02825251 (89) [back to overview]Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
NCT02825251 (89) [back to overview]Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal
NCT02825251 (89) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
NCT02825251 (89) [back to overview]Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
NCT02825251 (89) [back to overview]Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)
NCT02825251 (89) [back to overview]Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]
NCT02825251 (89) [back to overview]Insulin Delivery Pump Parameter: Active Insulin Time
NCT02825251 (89) [back to overview]Insulin Delivery Pump Parameter: Glucose Sensitivity Factor
NCT02825251 (89) [back to overview]Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio
NCT02825251 (89) [back to overview]Insulin Dose in Units/Day: Total Basal
NCT02825251 (89) [back to overview]Insulin Dose in Units/Day: Total Bolus
NCT02825251 (89) [back to overview]Insulin Dose in Units/Day: Total Daily Insulin Dose
NCT02825251 (89) [back to overview]Insulin Dose in Units/kg/Day: Total Basal
NCT02825251 (89) [back to overview]Insulin Dose in Units/kg/Day: Total Bolus
NCT02825251 (89) [back to overview]Insulin Dose in Units/kg/Day: Total Daily Insulin Dose
NCT02825251 (89) [back to overview]Number of Change-of-infusion-sets Per Week
NCT02825251 (89) [back to overview]Number of Treatment Emergent Adverse Events (AEs)
NCT02825251 (89) [back to overview]Number of Treatment Emergent Infusion Site Reactions
NCT02825251 (89) [back to overview]Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)
NCT02825251 (89) [back to overview]Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)
NCT02825251 (89) [back to overview]Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes
NCT02825251 (89) [back to overview]Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]
NCT02825251 (89) [back to overview]Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia
NCT02825251 (89) [back to overview]Variation in the IG Profile
NCT02825251 (89) [back to overview]Change From Baseline in 1-hour PPG Increment
NCT02825251 (89) [back to overview]Change From Baseline in 1,5-anhydroglucitol
NCT02825251 (89) [back to overview]Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)
NCT02825251 (89) [back to overview]Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
NCT02825251 (89) [back to overview]Change From Baseline in AUCIG,0-15min
NCT02825251 (89) [back to overview]Change From Baseline in AUCIG,0-1h
NCT02825251 (89) [back to overview]Change From Baseline in AUCIG,0-2h
NCT02825251 (89) [back to overview]Change From Baseline in AUCIG,0-30min
NCT02825251 (89) [back to overview]Change From Baseline in AUCIG,0-4h
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Albumin
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Creatinine
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Potassium
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Sodium
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Total Bilirubin
NCT02825251 (89) [back to overview]Change From Baseline in Biochemistry: Total Protein
NCT02825251 (89) [back to overview]Change From Baseline in Body Mass Index (BMI)
NCT02825251 (89) [back to overview]Change From Baseline in Body Weight
NCT02825251 (89) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT02825251 (89) [back to overview]Change From Baseline in Haematology: Erythrocytes
NCT02825251 (89) [back to overview]Change From Baseline in Haematology: Haematocrit
NCT02825251 (89) [back to overview]Change From Baseline in Haematology: Haemoglobin
NCT02825251 (89) [back to overview]Change From Baseline in Haematology: Thrombocytes
NCT02825251 (89) [back to overview]Change From Baseline in IG Peak After Start of Meal
NCT02825251 (89) [back to overview]Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)
NCT02825251 (89) [back to overview]Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)
NCT02825251 (89) [back to overview]Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
NCT02825251 (89) [back to overview]Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile
NCT02825251 (89) [back to overview]Change From Baseline in Mean of the IG Profile
NCT02825251 (89) [back to overview]Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
NCT02825251 (89) [back to overview]Change From Baseline in Physical Examination: Cardiovascular System
NCT02825251 (89) [back to overview]Change From Baseline in Physical Examination: Central and Peripheral Nervous System
NCT02825251 (89) [back to overview]Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth
NCT02906709 (13) [back to overview]Constrained Longitudinal Data Analysis of Change From Baseline in 1,5-anhydroglucitol (1,5-AG) at Week 16 Excluding Data After Glycemic Rescue (Phase A)
NCT02906709 (13) [back to overview]Constrained Longitudinal Data Analysis of Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 Excluding Data After Glycemic Rescue (Phase A)
NCT02906709 (13) [back to overview]Percentage of Participants Achieving HbA1c Goals (<6.5%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A)
NCT02906709 (13) [back to overview]Percentage of Participants Achieving Hemoglobin A1c Goals (<6.5%) at Week 52 (Phase A+B)
NCT02906709 (13) [back to overview]Constrained Longitudinal Data Analysis of Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16 Excluding Data After Glycemic Rescue (Phase A)
NCT02906709 (13) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Phase A+B)
NCT02906709 (13) [back to overview]Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A)
NCT02906709 (13) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 (Phase A+B)
NCT02906709 (13) [back to overview]Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 52 (Phase A+B)
NCT02906709 (13) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an AE Excluding Data After Glycemic Rescue (Phase A)
NCT02906709 (13) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an AE Including Data After Glycemic Rescue (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only])
NCT02906709 (13) [back to overview]Percentage of Participants Who Experienced One or More Adverse Events (AE) Excluding Data After Glycemic Rescue (Phase A)
NCT02906709 (13) [back to overview]Percentage of Participants Who Experienced One or More AE (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only])
NCT02906917 (12) [back to overview]Total Insulin Dose
NCT02906917 (12) [back to overview]Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia
NCT02906917 (12) [back to overview]Responder (Yes/No) for HbA1c < 7%
NCT02906917 (12) [back to overview]Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02906917 (12) [back to overview]Incidence of TEAEs
NCT02906917 (12) [back to overview]Change in Body Weight
NCT02906917 (12) [back to overview]Change in FPG
NCT02906917 (12) [back to overview]Change in HbA1c (%) - Week 26
NCT02906917 (12) [back to overview]Change in HbA1c (%) - Week 38
NCT02906917 (12) [back to overview]Change in Postprandial SMPG Increment (From 9-point Profile)
NCT02906917 (12) [back to overview]Change in Pre-breakfast SMPG (Used for Titration)
NCT02906917 (12) [back to overview]Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02911948 (28) [back to overview]Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02911948 (28) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition
NCT02911948 (28) [back to overview]Number of Treatment Emergent Adverse Events (TEAE)
NCT02911948 (28) [back to overview]Daily Insulin Dose
NCT02911948 (28) [back to overview]Change in Waist Circumference
NCT02911948 (28) [back to overview]Change in SMBG 9-point Profile: Mean of the 9-point Profile
NCT02911948 (28) [back to overview]Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)
NCT02911948 (28) [back to overview]Change in Pulse
NCT02911948 (28) [back to overview]Change in Body Weight
NCT02911948 (28) [back to overview]Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain
NCT02911948 (28) [back to overview]Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire
NCT02911948 (28) [back to overview]Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile)
NCT02911948 (28) [back to overview]Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02911948 (28) [back to overview]Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02911948 (28) [back to overview]Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain
NCT02911948 (28) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT02911948 (28) [back to overview]Responder (Yes/no): HbA1c Less Than or Equal to 6.5%
NCT02911948 (28) [back to overview]Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02911948 (28) [back to overview]Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02911948 (28) [back to overview]Responder (Yes/no): HbA1c Less Than 7.0%
NCT02911948 (28) [back to overview]Fasting Lipid Profile
NCT02911948 (28) [back to overview]Change in Clinical Evaluation: Fundoscopy or Fundus Photography
NCT02911948 (28) [back to overview]Change in Clinical Evaluation: Electrocardiogram (ECG)
NCT02911948 (28) [back to overview]Change in Blood Pressure (Systolic and Diastolic)
NCT02911948 (28) [back to overview]Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire
NCT02911948 (28) [back to overview]Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
NCT02911948 (28) [back to overview]Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02911948 (28) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT02954601 (4) [back to overview]The Number Hypoglycemic Events for Single and Multiple Doses of ORMD-0801 vs Placebo
NCT02954601 (4) [back to overview]Change in Glucose Levels Between Pre-treatment and End of Treatment as Measured by 24-hour Continuous Glucose Monitoring (CGM)
NCT02954601 (4) [back to overview]Calculate the Difference Between Values of Pre-treatment and End-of-treatment Mean Daytime CGM Glucose
NCT02954601 (4) [back to overview]Calculate the C-peptide Ratio for Single and Multiple Doses of ORMD-0801 vs Placebo.
NCT02988401 (12) [back to overview]Fingerstick Blood Glucose (Subset)
NCT02988401 (12) [back to overview]Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT)
NCT02988401 (12) [back to overview]Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test
NCT02988401 (12) [back to overview]Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT)
NCT02988401 (12) [back to overview]Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT)
NCT02988401 (12) [back to overview]Evaluation of Impact of Study Products on Health Related Quality of Life Using the Functional Assessment of Multiple Sclerosis Questionnaire (FAMS)
NCT02988401 (12) [back to overview]Number of Participants With Adverse Events Leading to Study Discontinuation
NCT02988401 (12) [back to overview]Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index)
NCT02988401 (12) [back to overview]Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II)
NCT02988401 (12) [back to overview]Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO)
NCT02988401 (12) [back to overview]Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II)
NCT02988401 (12) [back to overview]Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall
NCT03018938 (15) [back to overview]Percentage of Participants Who Achieve HbA1c <7% at Week 24
NCT03018938 (15) [back to overview]Percentage of Participants Who Achieve HbA1c <7% at Week 48
NCT03018938 (15) [back to overview]Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
NCT03018938 (15) [back to overview]Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
NCT03018938 (15) [back to overview]Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
NCT03018938 (15) [back to overview]Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
NCT03018938 (15) [back to overview]Rate of Hypoglycemia at Week 24 and 48
NCT03018938 (15) [back to overview]Total Daily Insulin Dose at Week 24 and 48
NCT03018938 (15) [back to overview]Change From Baseline to Week 24 in Body Weight
NCT03018938 (15) [back to overview]Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
NCT03018938 (15) [back to overview]Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
NCT03018938 (15) [back to overview]Change From Baseline to Week 48 in Body Weight
NCT03018938 (15) [back to overview]Change From Baseline to Week 48 in HbA1c
NCT03018938 (15) [back to overview]Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
NCT03018938 (15) [back to overview]Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
NCT03042936 (1) [back to overview]Change From Baseline Hemoglobin A1c
NCT03078478 (16) [back to overview]Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
NCT03078478 (16) [back to overview]Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)
NCT03078478 (16) [back to overview]Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks)
NCT03078478 (16) [back to overview]Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)
NCT03078478 (16) [back to overview]Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)
NCT03078478 (16) [back to overview]Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)
NCT03078478 (16) [back to overview]Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)
NCT03078478 (16) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)
NCT03078478 (16) [back to overview]Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)
NCT03078478 (16) [back to overview]Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks)
NCT03078478 (16) [back to overview]Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)
NCT03078478 (16) [back to overview]Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks)
NCT03078478 (16) [back to overview]Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
NCT03078478 (16) [back to overview]Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)
NCT03078478 (16) [back to overview]Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
NCT03078478 (16) [back to overview]Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks)
NCT03081117 (12) [back to overview]Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
NCT03081117 (12) [back to overview]Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
NCT03081117 (12) [back to overview]Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value
NCT03081117 (12) [back to overview]Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value
NCT03081117 (12) [back to overview]Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score
NCT03081117 (12) [back to overview]Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score
NCT03081117 (12) [back to overview]Serious Adverse Event Frequency, Participant Count
NCT03081117 (12) [back to overview]Serious Adverse Event Frequency
NCT03081117 (12) [back to overview]Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
NCT03081117 (12) [back to overview]Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
NCT03081117 (12) [back to overview]Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
NCT03081117 (12) [back to overview]Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
NCT03104738 (11) [back to overview]Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip
NCT03104738 (11) [back to overview]Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.
NCT03104738 (11) [back to overview]Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively
NCT03104738 (11) [back to overview]Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively
NCT03104738 (11) [back to overview]Mean 24-hour Glucose Postoperatively
NCT03104738 (11) [back to overview]Incidence of Intraoperative Hyperglycemia
NCT03104738 (11) [back to overview]Incidence of Surgical Delay or Cancellation Due to Hyperglycemia
NCT03104738 (11) [back to overview]Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital
NCT03104738 (11) [back to overview]Incidence of Preoperative Hypoglycemia
NCT03104738 (11) [back to overview]Incidence of Preoperative Hyperglycemia
NCT03104738 (11) [back to overview]Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively
NCT03106870 (3) [back to overview]Number of Participants With a Macrosomic Baby
NCT03106870 (3) [back to overview]Number of Participants With Neonates Who Were Hypoglycemic
NCT03106870 (3) [back to overview]Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
NCT03143816 (7) [back to overview]Change in Above the Target Time (%) (>180 mg/dl) on CGM
NCT03143816 (7) [back to overview]Change in Glucose Variability (GV) (mg/dl) (Standard Deviation and/or Coefficient Variation)
NCT03143816 (7) [back to overview]Change in HbA1c (%) in One-month Treatment
NCT03143816 (7) [back to overview]The Area Under the Curve Calculation (AUC) (Min*mg/dl) in the PPBG and PPGE,
NCT03143816 (7) [back to overview]Hypoglycemia Frequency (%) (Below the Target <70mg/dl) on CGM
NCT03143816 (7) [back to overview]Change in Time in Range (%) (70-180 mg/dl) With TI on CGM
NCT03143816 (7) [back to overview]Change in Post-prandial Glucose Excursion (mg/dl) (1-4 Hours After Meals) With TI
NCT03172494 (53) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT03172494 (53) [back to overview]Change in Fasting Total Cholesterol - Ratio to Baseline
NCT03172494 (53) [back to overview]Change in Fasting Triglycerides - Ratio to Baseline.
NCT03172494 (53) [back to overview]Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
NCT03172494 (53) [back to overview]Change in Haematologcal Parameter: Leukocytes
NCT03172494 (53) [back to overview]Change in Haematological Parameter - Lymphocytes
NCT03172494 (53) [back to overview]Change in Haematological Parameter - Neutrophils
NCT03172494 (53) [back to overview]Change in Haematological Parameter: Basophils
NCT03172494 (53) [back to overview]Change in Haematological Parameter: Erythrocytes Blood
NCT03172494 (53) [back to overview]Change in Haematological Parameter: Haematocrits
NCT03172494 (53) [back to overview]Change in Haematological Parameter: Thrombocytes
NCT03172494 (53) [back to overview]Change in Haematology: Haemoglobin Blood
NCT03172494 (53) [back to overview]Change in Haemotological Parameter- Eosinophils
NCT03172494 (53) [back to overview]Change in Haemotological Parameter- Monocytes
NCT03172494 (53) [back to overview]Change in HbA1c
NCT03172494 (53) [back to overview]Change in HOMA-B (Beta Cell Function)- Ratio to Baseline
NCT03172494 (53) [back to overview]Change in Mean Post-prandial Plasma Glucose (PG) Increments
NCT03172494 (53) [back to overview]Change in Pulse
NCT03172494 (53) [back to overview]Change in Electrocardiogram (ECG)
NCT03172494 (53) [back to overview]Change in Mean of 9-point SMPG Profile
NCT03172494 (53) [back to overview]Change in Calcitonin
NCT03172494 (53) [back to overview]Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
NCT03172494 (53) [back to overview]Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum
NCT03172494 (53) [back to overview]Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum
NCT03172494 (53) [back to overview]Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum
NCT03172494 (53) [back to overview]Change in Biochemistry Parameters (Albumin Serum, Total Protein)
NCT03172494 (53) [back to overview]9-point SMPG Profile
NCT03172494 (53) [back to overview]Serum Concentrations of Insulin Degludec
NCT03172494 (53) [back to overview]Plasma Concentration of Liraglutide
NCT03172494 (53) [back to overview]Occurence of Total Insulin Antibodies
NCT03172494 (53) [back to overview]Occurence of Neutralising Liraglutide Antibodies
NCT03172494 (53) [back to overview]Change in Waist Circumferance
NCT03172494 (53) [back to overview]Insulin Dose
NCT03172494 (53) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
NCT03172494 (53) [back to overview]Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.
NCT03172494 (53) [back to overview]Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT03172494 (53) [back to overview]Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes
NCT03172494 (53) [back to overview]Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.
NCT03172494 (53) [back to overview]Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
NCT03172494 (53) [back to overview]Change in Body Weight
NCT03172494 (53) [back to overview]Change in Fasting C-peptide - Ratio to Baseline
NCT03172494 (53) [back to overview]Change in Fasting Free Fatty Acid - Ratio to Baseline
NCT03172494 (53) [back to overview]Change in Fasting Glucagon - Ratio to Baseline
NCT03172494 (53) [back to overview]Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
NCT03172494 (53) [back to overview]Change in Fasting Human Insulin - Ratio to Baseline
NCT03172494 (53) [back to overview]Number of Treatment-emergent Adverse Events (TEAE)
NCT03172494 (53) [back to overview]Occurence of Antibodies Cross-reacting to Human Insulin
NCT03172494 (53) [back to overview]Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)
NCT03172494 (53) [back to overview]Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1
NCT03172494 (53) [back to overview]Urinalysis (Protein, Glucose, Erythrocytes and Ketones)
NCT03172494 (53) [back to overview]Eye Examination
NCT03172494 (53) [back to overview]Change in Physical Examination
NCT03172494 (53) [back to overview]Occurence of Anti-insulin Degludec Specific Antibodies
NCT03175120 (49) [back to overview]Eye Examination
NCT03175120 (49) [back to overview]Change in Physical Examination
NCT03175120 (49) [back to overview]Change in Electrocardiogram (ECG)
NCT03175120 (49) [back to overview]Change in Calcitonin
NCT03175120 (49) [back to overview]SMPG-9-point Profile (Individual Points in the Profile)
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Leukocytes and Thrombocytes
NCT03175120 (49) [back to overview]Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
NCT03175120 (49) [back to overview]Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea
NCT03175120 (49) [back to overview]Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
NCT03175120 (49) [back to overview]Total Insulin Antibodies
NCT03175120 (49) [back to overview]Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
NCT03175120 (49) [back to overview]Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT03175120 (49) [back to overview]Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT03175120 (49) [back to overview]Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes
NCT03175120 (49) [back to overview]Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition
NCT03175120 (49) [back to overview]Number of Treatment-emergent Adverse Events (TEAEs)
NCT03175120 (49) [back to overview]Insulin Dose
NCT03175120 (49) [back to overview]Change in Waist Circumference
NCT03175120 (49) [back to overview]Change in Total Protein
NCT03175120 (49) [back to overview]Change in Total Bilirubin
NCT03175120 (49) [back to overview]Change in SMPG-mean Post Prandial Increments
NCT03175120 (49) [back to overview]Change in Pulse
NCT03175120 (49) [back to overview]Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile
NCT03175120 (49) [back to overview]Change in HOMA-B (Beta-cell Function)- Ratio to Baseline
NCT03175120 (49) [back to overview]Change in HbA1c
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Monocytes
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Lymphocytes
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Haemoglobin
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Haematocrit
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Erythrocytes
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Eosinophils
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Basophils
NCT03175120 (49) [back to overview]Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
NCT03175120 (49) [back to overview]Change in Fasting Triglycerides- Ratio to Baseline
NCT03175120 (49) [back to overview]Change in Fasting Total Cholesterol- Ratio to Baseline
NCT03175120 (49) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT03175120 (49) [back to overview]Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
NCT03175120 (49) [back to overview]Antibodies Cross-reacting to Human Insulin
NCT03175120 (49) [back to overview]Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
NCT03175120 (49) [back to overview]Change in Fasting Glucagon- Ratio to Baseline
NCT03175120 (49) [back to overview]Change in Fasting Free Fatty Acids- Ratio to Baseline
NCT03175120 (49) [back to overview]Change in Fasting C-peptide- Ratio to Baseline
NCT03175120 (49) [back to overview]Change in Creatinine
NCT03175120 (49) [back to overview]Change in Body Weight
NCT03175120 (49) [back to overview]Change in Haematological Parameter- Neutrophils
NCT03175120 (49) [back to overview]Change in Albumin
NCT03175120 (49) [back to overview]Change in Fasting Insulin- Ratio to Baseline
NCT03175120 (49) [back to overview]Urinalysis (Erythrocytes, Protein, Glucose and Ketones)
NCT03175120 (49) [back to overview]Anti-insulin Degludec Specific Antibodies
NCT03211858 (18) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52
NCT03211858 (18) [back to overview]Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52
NCT03211858 (18) [back to overview]Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52
NCT03211858 (18) [back to overview]Change in Glycated Hemoglobin A1c From Baseline to Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog
NCT03211858 (18) [back to overview]Number of Hypoglycemia Events Per Participant-Year
NCT03211858 (18) [back to overview]Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52
NCT03211858 (18) [back to overview]Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog
NCT03211858 (18) [back to overview]Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point
NCT03211858 (18) [back to overview]Change in HbA1c From Baseline to Week 52
NCT03211858 (18) [back to overview]Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26
NCT03211858 (18) [back to overview]Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample
NCT03211858 (18) [back to overview]Percentage of Participants With HbA1c <7% at Week 26 and Week 52
NCT03211858 (18) [back to overview]Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
NCT03211858 (18) [back to overview]Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)
NCT03211858 (18) [back to overview]Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs): Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog
NCT03211858 (18) [back to overview]Number of Participants With at Least One Hypoglycemic Event: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog
NCT03211858 (18) [back to overview]Number of Participants With at Least One Hypoglycemic Event
NCT03211858 (18) [back to overview]Number of Participants With Adverse Events: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog
NCT03214367 (12) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
NCT03214367 (12) [back to overview]Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
NCT03214367 (12) [back to overview]Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
NCT03214367 (12) [back to overview]Percentage of Participants With HbA1c <7%
NCT03214367 (12) [back to overview]Rate of Documented Symptomatic Hypoglycemia at Week 26
NCT03214367 (12) [back to overview]Change From Baseline in Insulin Dose at Week 26
NCT03214367 (12) [back to overview]Rate of Severe Hypoglycemia at Week 26
NCT03214367 (12) [back to overview]Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
NCT03214367 (12) [back to overview]Change From Baseline in HbA1c at Week 52
NCT03214367 (12) [back to overview]Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26
NCT03214367 (12) [back to overview]Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
NCT03214367 (12) [back to overview]Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26
NCT03214380 (11) [back to overview]Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
NCT03214380 (11) [back to overview]Change From Baseline in Insulin Dose at Week 26
NCT03214380 (11) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
NCT03214380 (11) [back to overview]1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
NCT03214380 (11) [back to overview]2-hour PPG Excursion During MMTT Efficacy Estimand
NCT03214380 (11) [back to overview]Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
NCT03214380 (11) [back to overview]Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
NCT03214380 (11) [back to overview]Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
NCT03214380 (11) [back to overview]Number of Participants With HbA1c <7%
NCT03214380 (11) [back to overview]Rate of Documented Symptomatic Hypoglycemia
NCT03214380 (11) [back to overview]Rate of Severe Hypoglycemia
NCT03260868 (4) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24
NCT03260868 (4) [back to overview]Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period
NCT03260868 (4) [back to overview]Change From Baseline in Glycated Hemoglobin A1c to Week 16
NCT03260868 (4) [back to overview]Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24
NCT03262116 (8) [back to overview]Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day
NCT03262116 (8) [back to overview]Mean Post Prandial Excursion
NCT03262116 (8) [back to overview]Number of Symptomatic Hypoglycemic Events Per Day
NCT03262116 (8) [back to overview]Percentage of Time Spent With CGM Glucose < 54 mg/dl
NCT03262116 (8) [back to overview]Percentage of Time Spent Within Each of the Following Ranges:
NCT03262116 (8) [back to overview]Within Day Coefficient of Variation
NCT03262116 (8) [back to overview]Total Daily Dose of Insulin
NCT03262116 (8) [back to overview]Average Continuous Glucose Monitor (CGM) Glucose
NCT03268005 (48) [back to overview]Change From Baseline in Fundoscopy/Fundus Photography
NCT03268005 (48) [back to overview]Change From Baseline in Haematology - Haemoglobin
NCT03268005 (48) [back to overview]Change From Baseline in Haematology - Haematocrit
NCT03268005 (48) [back to overview]Change From Baseline in 1-hour PPG Increment
NCT03268005 (48) [back to overview]Individual Meal Insulin Dose: in Units/kg
NCT03268005 (48) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
NCT03268005 (48) [back to overview]Change From Baseline in Physical Examination
NCT03268005 (48) [back to overview]Change From Baseline in Haematology - Erythrocytes
NCT03268005 (48) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT03268005 (48) [back to overview]Change From Baseline in Body Weight
NCT03268005 (48) [back to overview]Change From Baseline in Body Mass Index (BMI)
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Total Protein
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Total Bilirubin
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Sodium
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Potassium
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Creatinine
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Alkaline Phosphatase
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Albumin
NCT03268005 (48) [back to overview]Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)
NCT03268005 (48) [back to overview]Change From Baseline in 1,5-anhydroglucitol
NCT03268005 (48) [back to overview]Individual Meal Insulin Dose: in Units
NCT03268005 (48) [back to overview]Change From Baseline in Electrocardiogram (ECG)
NCT03268005 (48) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
NCT03268005 (48) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal
NCT03268005 (48) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal
NCT03268005 (48) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal
NCT03268005 (48) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)
NCT03268005 (48) [back to overview]Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal
NCT03268005 (48) [back to overview]Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
NCT03268005 (48) [back to overview]Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
NCT03268005 (48) [back to overview]Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements
NCT03268005 (48) [back to overview]Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure
NCT03268005 (48) [back to overview]Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline
NCT03268005 (48) [back to overview]Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
NCT03268005 (48) [back to overview]Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])
NCT03268005 (48) [back to overview]Total Bolus Insulin Dose: in Units/kg/Day
NCT03268005 (48) [back to overview]Total Bolus Insulin Dose: in Units/Day
NCT03268005 (48) [back to overview]Total Basal Insulin Dose: in Units/kg/Day
NCT03268005 (48) [back to overview]Total Basal Insulin Dose: in Units/Day
NCT03268005 (48) [back to overview]Number of Treatment Emergent Injection Site Reactions
NCT03268005 (48) [back to overview]Number of Treatment Emergent Adverse Events
NCT03268005 (48) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT03268005 (48) [back to overview]Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile
NCT03268005 (48) [back to overview]Change From Baseline in Vital Signs: Pulse
NCT03268005 (48) [back to overview]Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile
NCT03268005 (48) [back to overview]Change From Baseline in Haematology - Thrombocytes
NCT03268005 (48) [back to overview]Change From Baseline in Haematology - Leukocytes
NCT03324451 (5) [back to overview]Change in Quality of Life
NCT03324451 (5) [back to overview]Change in Glycosylated Hemoglobin (HbA1c) Levels
NCT03324451 (5) [back to overview]Change in Diabetes Empowerment Process
NCT03324451 (5) [back to overview]Change in Diabetes Distress
NCT03324451 (5) [back to overview]Change in Body Mass Index
NCT03337477 (7) [back to overview]Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo
NCT03337477 (7) [back to overview]The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo
NCT03337477 (7) [back to overview]Fraction of Patients Responding to Therapy Defined as: S-K <6.0mmol/L Between 1 and 4h and S-K <5.0mmol/L at 4h; and no Additional Potassium Lowering Therapy From 0 to 4h With Exception of the Initial Insulin Treatment
NCT03337477 (7) [back to overview]Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo
NCT03337477 (7) [back to overview]The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.
NCT03337477 (7) [back to overview]The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
NCT03337477 (7) [back to overview]The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
NCT03350984 (3) [back to overview]the Number of Participants With Mild and Severe Hypoglycemic Events
NCT03350984 (3) [back to overview]Number of Participants With Sustained Glycemic Control During Hospital Stay
NCT03350984 (3) [back to overview]Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.
NCT03377699 (24) [back to overview]Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]
NCT03377699 (24) [back to overview]Birth Weight for Live Birth Infants
NCT03377699 (24) [back to overview]Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)
NCT03377699 (24) [back to overview]Birth Weight Standard Deviation (SD) Score for Live Birth Infants
NCT03377699 (24) [back to overview]Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)
NCT03377699 (24) [back to overview]Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)
NCT03377699 (24) [back to overview]Last Planned Fasting Plasma Glucose Prior to Delivery
NCT03377699 (24) [back to overview]Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
NCT03377699 (24) [back to overview]Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants With Live Born Infants (Yes/no)
NCT03377699 (24) [back to overview]Number of Adverse Events During Pregnancy Period
NCT03377699 (24) [back to overview]Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)
NCT03377699 (24) [back to overview]Number of Adverse Events in the Infant
NCT03377699 (24) [back to overview]Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants With Pre-term Delivery
NCT03377699 (24) [back to overview]Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants
NCT03377699 (24) [back to overview]Number of Hypoglycaemic Episodes During the Pregnancy Period
NCT03377699 (24) [back to overview]Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
NCT03377699 (24) [back to overview]Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)
NCT03377699 (24) [back to overview]Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery
NCT03377699 (24) [back to overview]Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
NCT03430856 (8) [back to overview]Participants Achieving HbA1c < 7% (Part 1)
NCT03430856 (8) [back to overview]Post-prandial Glucose (PPG) Excursion (Part 1)
NCT03430856 (8) [back to overview]Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24
NCT03430856 (8) [back to overview]Change From Baseline in HbA1c at 24 Weeks (Part 1)
NCT03430856 (8) [back to overview]Weight (Kgs) (Part 1)
NCT03430856 (8) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (Part 1)
NCT03430856 (8) [back to overview]Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1)
NCT03430856 (8) [back to overview]Change From Baseline in HbA1c at Week 12 (Part 1)
NCT03434119 (5) [back to overview]Change From Baseline in Daily Insulin Glargine Dose at Week 26
NCT03434119 (5) [back to overview]Percentage of Participants Achieving HbA1c Target of <7% at Week 26
NCT03434119 (5) [back to overview]Change From Baseline in Body Weight at Week 26
NCT03434119 (5) [back to overview]Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period
NCT03434119 (5) [back to overview]Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
NCT03449433 (2) [back to overview]Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
NCT03449433 (2) [back to overview]Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm
NCT03467932 (3) [back to overview]Change From Baseline of HbA1C (Glycated Hemoglobin)
NCT03467932 (3) [back to overview]Mean Change From Baseline Over Time for HbA1C
NCT03467932 (3) [back to overview]Change Over Time in Hb1Ac
NCT03469492 (6) [back to overview]Plasma Insulin
NCT03469492 (6) [back to overview]Plasma Glucose
NCT03469492 (6) [back to overview]Change in HbA1c Levels
NCT03469492 (6) [back to overview]Optional Hyperglycemic Clamp
NCT03469492 (6) [back to overview]Plasma Glucose
NCT03469492 (6) [back to overview]Plasma Insulin
NCT03478969 (18) [back to overview]Device Satisfaction and Treatment Preference
NCT03478969 (18) [back to overview]Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5
NCT03478969 (18) [back to overview]Number of Participants With Skin Reactions (Including Type and Intensity)
NCT03478969 (18) [back to overview]Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
NCT03478969 (18) [back to overview]Therapy Success Indicated by Change in Weight
NCT03478969 (18) [back to overview]Therapy Success Indicated by Change in Body Mass Index (BMI)
NCT03478969 (18) [back to overview]Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
NCT03478969 (18) [back to overview]Change in Therapy Parameters Based on Type of Insulin Used
NCT03478969 (18) [back to overview]Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)
NCT03478969 (18) [back to overview]Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges
NCT03478969 (18) [back to overview]Change in Glycemic Index
NCT03478969 (18) [back to overview]Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
NCT03478969 (18) [back to overview]Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
NCT03478969 (18) [back to overview]Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day
NCT03478969 (18) [back to overview]Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
NCT03478969 (18) [back to overview]Device Satisfaction and Treatment Preference
NCT03478969 (18) [back to overview]Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges
NCT03478969 (18) [back to overview]Change in Therapy Parameters Based on Type of Insulin Used
NCT03511521 (3) [back to overview]Percentage of Glucose Values Within Therapeutic Range
NCT03511521 (3) [back to overview]Percentage of Glucose Values Within the Hypoglycemic Range
NCT03511521 (3) [back to overview]Glycemic Control
NCT03554486 (3) [back to overview]Mean Sensor Glucose in mg/dl
NCT03554486 (3) [back to overview]Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl
NCT03554486 (3) [back to overview]Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
NCT03555305 (4) [back to overview]PD: Maximum Glucose Infusion Rate (Rmax)
NCT03555305 (4) [back to overview]Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
NCT03555305 (4) [back to overview]PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus
NCT03555305 (4) [back to overview]Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus
NCT03565666 (12) [back to overview]Percentage of Time Where Glucose is Less Than 54 mg/dL
NCT03565666 (12) [back to overview]Percentage of Time Where Glucose is Greater Than 250 mg/dL
NCT03565666 (12) [back to overview]Percentage of Time Where Glucose is Greater Than 180 mg/dL
NCT03565666 (12) [back to overview]Episodes of Diabetic Ketoacidosis (DKA)
NCT03565666 (12) [back to overview]Episodes of Severe Hypoglycemia
NCT03565666 (12) [back to overview]Mean Absolute Relative Difference Between Dexcom G5 CGM and Contour Next One Glucose Meter
NCT03565666 (12) [back to overview]Mean Absolute Relative Difference Between Senseonics Eversense CGM and Contour Next One Glucose Meter
NCT03565666 (12) [back to overview]Mean CGM Glucose
NCT03565666 (12) [back to overview]Percentage of Time in the Glucose Target Range of 70-180 mg/dl
NCT03565666 (12) [back to overview]Percentage Time in the Glucose Target Range of 70-120mg/dL
NCT03565666 (12) [back to overview]Percentage of Time Where Glucose is Less Than 70 mg/dL
NCT03565666 (12) [back to overview]Percentage of Time Where Glucose is Less Than 60 mg/dL
NCT03660553 (3) [back to overview]Hemoglobin A1c (HbA1c)
NCT03660553 (3) [back to overview]Incidence of Any Hypoglycemia
NCT03660553 (3) [back to overview]Incidence of Severe Hypoglycemia
NCT03668808 (11) [back to overview]Continuous Glucose Monitoring - Time in Range (70-180 mg/dl)
NCT03668808 (11) [back to overview]Continuous Glucose Monitoring - Time in Range (70-140 mg/dl)
NCT03668808 (11) [back to overview]CGM % Time 70-180 mg/dl
NCT03668808 (11) [back to overview]CGM % Time >180 mg/dl
NCT03668808 (11) [back to overview]CGM % Time <70 mg/dl
NCT03668808 (11) [back to overview]CGM - Coefficient of Variation (CV)
NCT03668808 (11) [back to overview]Sleep Quantity Measured by ActiGraph
NCT03668808 (11) [back to overview]Sleep Efficiency Measured by ActiGraph
NCT03668808 (11) [back to overview]Mean ± SD CGM Glucose (mg/dl)
NCT03668808 (11) [back to overview]Liverpool Jet-Lag Questionnaire
NCT03668808 (11) [back to overview]CGM Fasting Blood Glucose (FBG)
NCT03687827 (6) [back to overview]Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring
NCT03687827 (6) [back to overview]Time Spent in Nocturnal Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, in the Nocturnal Period (00:01 am - 05:59 am Both Inclusive) Using Flash Glucose Monitoring
NCT03687827 (6) [back to overview]Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM)
NCT03687827 (6) [back to overview]Mean Glucose Levels Using Flash Glucose Monitoring (FGM)
NCT03687827 (6) [back to overview]Level of Glycated Haemoglobin (HbA1c) - Percentage
NCT03687827 (6) [back to overview]Level of Glycated Haemoglobin (HbA1c) - mmol/Mol
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Pulse Rate
NCT03689374 (25) [back to overview]Daily Basal Insulin Dose at Week 52
NCT03689374 (25) [back to overview]Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52
NCT03689374 (25) [back to overview]Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52
NCT03689374 (25) [back to overview]Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52
NCT03689374 (25) [back to overview]Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52
NCT03689374 (25) [back to overview]Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)
NCT03689374 (25) [back to overview]Change From Baseline in Glycated Haemoglobin (HbA1c)
NCT03689374 (25) [back to overview]Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52
NCT03689374 (25) [back to overview]Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52
NCT03689374 (25) [back to overview]Total Daily Insulin Dose at Week 52
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Waist Circumference
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Body Mass Index (BMI)
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Body Weight (Kilogram (kg))
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
NCT03689374 (25) [back to overview]Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
NCT03736785 (8) [back to overview]Change From Baseline in Insulin Dose (LY3209590)
NCT03736785 (8) [back to overview]Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
NCT03736785 (8) [back to overview]Change From Baseline in Insulin Dose (Insulin Degludec)
NCT03736785 (8) [back to overview]Change From Baseline in HbA1c Compared to Insulin Degludec
NCT03736785 (8) [back to overview]Change From Baseline in HbA1c
NCT03736785 (8) [back to overview]Change From Baseline in Body Weight
NCT03736785 (8) [back to overview]Change From Baseline in Fasting Glucose
NCT03736785 (8) [back to overview]Rate of Total Documented Symptomatic Hypoglycemia
NCT03737240 (26) [back to overview]Average Daily Blood Glucose
NCT03737240 (26) [back to overview]Percentage of Time With Interstitial Glucose <54 mg/dL
NCT03737240 (26) [back to overview]Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score
NCT03737240 (26) [back to overview]Number of Participants With Documented Symptomatic Hypoglycemic Events
NCT03737240 (26) [back to overview]Change in Hemoglobin A1c (HbA1c)
NCT03737240 (26) [back to overview]Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score
NCT03737240 (26) [back to overview]Nocturnal Asymptomatic Hypoglycemic Events
NCT03737240 (26) [back to overview]Nocturnal Symptomatic Hypoglycemic Events
NCT03737240 (26) [back to overview]Number of Emergency Room (ER) Visits
NCT03737240 (26) [back to overview]Number of Hospital Readmissions
NCT03737240 (26) [back to overview]Number of Participants With Severe Hypoglycemic Events
NCT03737240 (26) [back to overview]Participants With HbA1c <7.0% and no Hypoglycemia
NCT03737240 (26) [back to overview]Participants With HbA1c <7.0% and no Hypoglycemia
NCT03737240 (26) [back to overview]Participants With HbA1c <7.0% and no Weight Gain
NCT03737240 (26) [back to overview]Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia
NCT03737240 (26) [back to overview]Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia
NCT03737240 (26) [back to overview]Participants With HbA1c >10% Achieving HbA1c <7.5%
NCT03737240 (26) [back to overview]Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL
NCT03737240 (26) [back to overview]Percentage of Time With Interstitial Glucose <70 mg/dL
NCT03737240 (26) [back to overview]Total Daily Insulin Dose
NCT03737240 (26) [back to overview]Participants With HbA1c >11% Achieving HbA1c <8.0%
NCT03737240 (26) [back to overview]Participants With HbA1c >11% Achieving HbA1c <7.5%
NCT03737240 (26) [back to overview]Average Fasting Blood Glucose
NCT03737240 (26) [back to overview]Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score
NCT03737240 (26) [back to overview]Participants With HbA1c >10% Achieving HbA1c <8.0%
NCT03737240 (26) [back to overview]Glycemic Variability
NCT03740919 (10) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
NCT03740919 (10) [back to overview]Change From Baseline in HbA1c (Postprandial) at Week 26
NCT03740919 (10) [back to overview]Percentage of Participants With Documented Hypoglycemic Events
NCT03740919 (10) [back to overview]Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
NCT03740919 (10) [back to overview]Rate of Documented Hypoglycemia Events
NCT03740919 (10) [back to overview]Percentage of Participants With HbA1c < 7.0% and <7.5%
NCT03740919 (10) [back to overview]Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
NCT03740919 (10) [back to overview]Change From Baseline in Insulin Dose at Week 26
NCT03740919 (10) [back to overview]Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26
NCT03740919 (10) [back to overview]Rate of Severe Hypoglycemia
NCT03751657 (15) [back to overview]Change in Anti-insulin 287 Antibody Titres
NCT03751657 (15) [back to overview]Change in Body Weight
NCT03751657 (15) [back to overview]Number of Hypoglycaemic Alert Episodes (Level 1) (≥3.0 and <3.9 mmol/L (≥54 and <70 mg/dL), Confirmed by BG Meter)
NCT03751657 (15) [back to overview]Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
NCT03751657 (15) [back to overview]Fluctuations of the 9-point Profile (Defined as the Integrated Absolute Distance From the Mean Profile Value Divided by Measurement Time).
NCT03751657 (15) [back to overview]Fasting C-peptide
NCT03751657 (15) [back to overview]Change in Mean of the 9-point Profile, Defined as the Area Under the Profile Divided by Measurement Time
NCT03751657 (15) [back to overview]Change in HbA1c [Millimoles/Mole (mmol/Mol)]
NCT03751657 (15) [back to overview]Change in Glycated Haemoglobin (HbA1c) [Percentage Point (%-Point)]
NCT03751657 (15) [back to overview]Change in Fasting Plasma Glucose
NCT03751657 (15) [back to overview]Change in Cross-reactive Anti-human Insulin Antibody Status (Positive/Negative)
NCT03751657 (15) [back to overview]9-point Profile (Individual SMPG Values)
NCT03751657 (15) [back to overview]Weekly Dose of Insulin 287 and Weekly Dose of Insulin Glargine
NCT03751657 (15) [back to overview]Number of Treatment Emergent Adverse Events (TEAEs)
NCT03751657 (15) [back to overview]Number of Severe Hypoglycaemic Episodes (Level 3)
NCT03811951 (1) [back to overview]Go/No-Go Accuracy
NCT03830281 (13) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16
NCT03830281 (13) [back to overview]Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change
NCT03830281 (13) [back to overview]Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change
NCT03830281 (13) [back to overview]Rate of Documented Symptomatic Hypoglycemia at Week 16
NCT03830281 (13) [back to overview]Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16
NCT03830281 (13) [back to overview]Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16
NCT03830281 (13) [back to overview]Percentage of Participants With HbA1c <7%
NCT03830281 (13) [back to overview]Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16
NCT03830281 (13) [back to overview]Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16
NCT03830281 (13) [back to overview]Rate of Severe Hypoglycemia at Week 16
NCT03830281 (13) [back to overview]Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
NCT03830281 (13) [back to overview]Change From Baseline in Insulin Dose at Week 16
NCT03830281 (13) [back to overview]Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16
NCT03841526 (17) [back to overview]Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline
NCT03841526 (17) [back to overview]Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline
NCT03841526 (17) [back to overview]Outpatient Phase: Insulin Use Change From Baseline
NCT03841526 (17) [back to overview]Outpatient Phase: Insulin Use Change From Baseline
NCT03841526 (17) [back to overview]Outpatient Phase: Insulin Use Change From Baseline
NCT03841526 (17) [back to overview]Outpatient Phase: Interstitial Glucose Levels Below Target Range
NCT03841526 (17) [back to overview]CRC Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise Exercise.
NCT03841526 (17) [back to overview]CRC Phase: Mean Number of Hypoglycemic Events Exercise.
NCT03841526 (17) [back to overview]CRC Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions
NCT03841526 (17) [back to overview]Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise.
NCT03841526 (17) [back to overview]Outpatient Phase: Mean Number of Hypoglycemic Events
NCT03841526 (17) [back to overview]Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions
NCT03841526 (17) [back to overview]CRC Phase: Interstitial Glucose Below Target Range
NCT03841526 (17) [back to overview]Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline
NCT03841526 (17) [back to overview]Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline
NCT03841526 (17) [back to overview]Outpatient Phase: HFS-II Overall Score Change From Baseline
NCT03841526 (17) [back to overview]Outpatient Phase: HFS-II Overall Score Change From Baseline
NCT03859960 (6) [back to overview]Correlation Between Penn Spasm Frequency Scale and Insulin Resistance
NCT03859960 (6) [back to overview]Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass%
NCT03859960 (6) [back to overview]Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity
NCT03859960 (6) [back to overview]Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance
NCT03859960 (6) [back to overview]Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass%
NCT03859960 (6) [back to overview]Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity
NCT03874715 (8) [back to overview]Number of Participants With at Least One Hypoglycemic Event
NCT03874715 (8) [back to overview]Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
NCT03874715 (8) [back to overview]Number of Hypoglycemic Events Per Participant-year
NCT03874715 (8) [back to overview]Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
NCT03874715 (8) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
NCT03874715 (8) [back to overview]Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
NCT03874715 (8) [back to overview]Number of Participants With Treatment-emergent Anti-Insulin Aspart Antibodies (AIAs)
NCT03874715 (8) [back to overview]Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
NCT03922750 (9) [back to overview]Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring)
NCT03922750 (9) [back to overview]Number of Treatment-emergent Adverse Events (TEAEs)
NCT03922750 (9) [back to overview]Number of Severe Hypoglycaemic Episodes (Level 3)
NCT03922750 (9) [back to overview]Change in Body Weight
NCT03922750 (9) [back to overview]Number of Hypoglycaemic Alert Episodes(Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by BG Meter)
NCT03922750 (9) [back to overview]Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
NCT03922750 (9) [back to overview]Change in Glycosylated Haemoglobin (HbA1c)
NCT03922750 (9) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT03922750 (9) [back to overview]Weekly Insulin Dose
NCT03951805 (9) [back to overview]Change in HbA1c (Glycated Haemoglobin)
NCT03951805 (9) [back to overview]Number of Hypoglycaemic Alert Episodes (Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by Blood Glucose (BG) Meter)
NCT03951805 (9) [back to overview]Weekly Insulin Dose
NCT03951805 (9) [back to overview]Number of Treatment Emergent Adverse Events (TEAEs)
NCT03951805 (9) [back to overview]Number of Severe Hypoglycaemic Episodes (Level 3)
NCT03951805 (9) [back to overview]Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter) or Severe Hypoglycaemic Episodes (Level 3)
NCT03951805 (9) [back to overview]Percentage of Time in Target Range (TIR) 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter (mg/dL) Measured Using CGM (Continuous Glucose Monitoring)
NCT03951805 (9) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT03951805 (9) [back to overview]Change in Body Weight
NCT03952130 (9) [back to overview]1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
NCT03952130 (9) [back to overview]2-hour PPG Excursion During MMTT
NCT03952130 (9) [back to overview]Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
NCT03952130 (9) [back to overview]Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
NCT03952130 (9) [back to overview]Change From Baseline in Daily Insulin Dose
NCT03952130 (9) [back to overview]Percentage of Participants With HbA1c <7% and ≤6.5%
NCT03952130 (9) [back to overview]Rate of Documented Symptomatic Post Meal Hypoglycemia
NCT03952130 (9) [back to overview]Rate of Severe Hypoglycemia
NCT03952130 (9) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c)
NCT03952143 (9) [back to overview]Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
NCT03952143 (9) [back to overview]2-hour PPG Excursion During MMTT
NCT03952143 (9) [back to overview]Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
NCT03952143 (9) [back to overview]1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
NCT03952143 (9) [back to overview]Rate of Documented Symptomatic Postmeal Hypoglycemia
NCT03952143 (9) [back to overview]Percentage of Participants With HbA1c <7% and ≤6.5%
NCT03952143 (9) [back to overview]Change From Baseline in Insulin Dose
NCT03952143 (9) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c)
NCT03952143 (9) [back to overview]Rate of Severe Hypoglycemia
NCT03959423 (5) [back to overview]Change in Percentage of Euglycemia
NCT03959423 (5) [back to overview]Number of Severe Hypoglycemic Event
NCT03959423 (5) [back to overview]Number of Diabetic Ketoacidosis (DKA) Event
NCT03959423 (5) [back to overview]Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)
NCT03959423 (5) [back to overview]Change in HbA1c
NCT03987191 (7) [back to overview]Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups
NCT03987191 (7) [back to overview]Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization
NCT03987191 (7) [back to overview]"Time Spent in CGM-measured Time-in-range(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups"
NCT03987191 (7) [back to overview]Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups
NCT03987191 (7) [back to overview]Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups
NCT03987191 (7) [back to overview]Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups
NCT03987191 (7) [back to overview]Number of Participants With Severe Hypoglycemia as Defined by the ADA (Severe Cognitive Impairment Requiring External Assistance for Recovery) and Severe Hyperglycemia (BG≥250 Needing Hospitalization) Between Two Groups
NCT04028960 (9) [back to overview]Mean Glucose From the Study Participants
NCT04028960 (9) [back to overview]Percent of Time With Blood Glucose 70-180 mg/dL
NCT04028960 (9) [back to overview]Percentage of Time Blood Glucose >180 mg/dL
NCT04028960 (9) [back to overview]Percentage of Time Participant Had Active Sensor Wear
NCT04028960 (9) [back to overview]Percentage of Time With Dangerous Hypoglycemia
NCT04028960 (9) [back to overview]Percentage of Time With Blood Glucose >250 mg/dL
NCT04028960 (9) [back to overview]Coefficient of Variation (%CV) of Blood Glucose Values From CGM Data
NCT04028960 (9) [back to overview]Percentage of Time With Blood Glucose <70 mg/dL
NCT04028960 (9) [back to overview]Glucose Management Indicator (GMI)
NCT04075513 (12) [back to overview]Number of Hypoglycemic Events Per Participant Year During the On-treatment Period
NCT04075513 (12) [back to overview]Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)
NCT04075513 (12) [back to overview]Percentage of Time With Glucose Level >180 Milligrams Per Deciliter
NCT04075513 (12) [back to overview]Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period
NCT04075513 (12) [back to overview]Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)
NCT04075513 (12) [back to overview]Glucose Within-day CV% and Between-day CV%
NCT04075513 (12) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
NCT04075513 (12) [back to overview]Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis
NCT04075513 (12) [back to overview]Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis
NCT04075513 (12) [back to overview]Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter
NCT04075513 (12) [back to overview]Glucose Total Coefficient of Variation (CV%)
NCT04075513 (12) [back to overview]Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12
NCT04079881 (1) [back to overview]AUC Postprandial Glucose
NCT04084171 (15) [back to overview]Above 250mg/dl.
NCT04084171 (15) [back to overview]Above 180 mg/dl.
NCT04084171 (15) [back to overview]Percent of Time Spent in Closed Loop
NCT04084171 (15) [back to overview]Average of Carbohydrate Treatments (g).
NCT04084171 (15) [back to overview]Average Number of Treatments.
NCT04084171 (15) [back to overview]Below 54 mg/dl.
NCT04084171 (15) [back to overview]Below 50mg/dl.
NCT04084171 (15) [back to overview]Above 300 mg/dl.
NCT04084171 (15) [back to overview]Below 60 mg/dl.
NCT04084171 (15) [back to overview]Below 70 mg/dl.
NCT04084171 (15) [back to overview]Primary Outcome
NCT04084171 (15) [back to overview]Number of Hypoglycemia Below 70 mg/dL
NCT04084171 (15) [back to overview]CGM Consensus Goal
NCT04084171 (15) [back to overview]Between 70-180mg/dl
NCT04084171 (15) [back to overview]Between 70-140mg/dl.
NCT04115384 (15) [back to overview]Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Eating Habits Subscore
NCT04115384 (15) [back to overview]Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Food Preference Subscore
NCT04115384 (15) [back to overview]Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Other Oral Behaviors Subscore
NCT04115384 (15) [back to overview]Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Swallowing Subscore
NCT04115384 (15) [back to overview]Pre to Post Inhibition by EXAMINER - Flanker
NCT04115384 (15) [back to overview]Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency
NCT04115384 (15) [back to overview]Pre to Post Inhibition by EXAMINER - Set Shifting
NCT04115384 (15) [back to overview]Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs)
NCT04115384 (15) [back to overview]Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs)
NCT04115384 (15) [back to overview]Pre to Post Working Memory Measured by EXAMINER - Dot Counting
NCT04115384 (15) [back to overview]Feasibility Measured by Completion of Study
NCT04115384 (15) [back to overview]Feasibility Measured by Recruitment
NCT04115384 (15) [back to overview]Feasibility Measured by Screen Fails
NCT04115384 (15) [back to overview]Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Appetite Subscore
NCT04115384 (15) [back to overview]Feasibility Measured by EXAMINER Battery
NCT04150107 (6) [back to overview]Average Exogenous Bolus Insulin Compared to Baseline (Placebo)
NCT04150107 (6) [back to overview]Daytime Low Blood Glucose Index (LBGI) Compared to Baseline
NCT04150107 (6) [back to overview]Daytime Glucose Coefficient of Variation Compared to Baseline
NCT04150107 (6) [back to overview]Average Exogenous Total Insulin Compared to Baseline
NCT04150107 (6) [back to overview]Daytime Average Mean Glucose Compared to Baseline
NCT04150107 (6) [back to overview]Average Exogenous Basal Insulin Compared to Baseline (Placebo)
NCT04157738 (5) [back to overview]Number of All Consented Participants
NCT04157738 (5) [back to overview]Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
NCT04157738 (5) [back to overview]Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention
NCT04157738 (5) [back to overview]Caregiver Anxiety
NCT04157738 (5) [back to overview]Number of Participants That Completed All Visits
NCT04267770 (1) [back to overview]Change in Basal Insulin Rate
NCT04292535 (10) [back to overview]Number of Participants With Manifestation of Any Symptom Following the Protocol
NCT04292535 (10) [back to overview]Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
NCT04292535 (10) [back to overview]Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task
NCT04292535 (10) [back to overview]Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task
NCT04292535 (10) [back to overview]Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task
NCT04292535 (10) [back to overview]Effect Size of Change in Behavioral Index of Sustained Attention - RT
NCT04292535 (10) [back to overview]Effect Size for Change in Behavioral Index of Inhibitory Control - RT
NCT04292535 (10) [back to overview]Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy
NCT04292535 (10) [back to overview]Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task
NCT04292535 (10) [back to overview]Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy
NCT04450394 (4) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c)
NCT04450394 (4) [back to overview]Change From Baseline in Fasting Serum Glucose
NCT04450394 (4) [back to overview]Rate of Documented Hypoglycemia
NCT04450394 (4) [back to overview]Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
NCT04450407 (5) [back to overview]Change From Baseline in Hemoglobin A1c (HbA1c)
NCT04450407 (5) [back to overview]Rate of Documented Hypoglycemia
NCT04450407 (5) [back to overview]Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
NCT04450407 (5) [back to overview]Change From Baseline in Bolus Insulin Dose
NCT04450407 (5) [back to overview]Change From Baseline in Fasting Serum Glucose
NCT04461015 (1) [back to overview]Endogenous Glucose Production (EGP)
NCT04585776 (4) [back to overview]Insulin to Carbohydrate Ratio (ICR)
NCT04585776 (4) [back to overview]Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
NCT04585776 (4) [back to overview]Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
NCT04585776 (4) [back to overview]Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
NCT04784637 (4) [back to overview]INSPIRE Questionnaire
NCT04784637 (4) [back to overview]Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.
NCT04784637 (4) [back to overview]Time in Hypoglycemia
NCT04784637 (4) [back to overview]Time in Range
NCT04834362 (4) [back to overview]Mortality
NCT04834362 (4) [back to overview]Length of Hospital Stay
NCT04834362 (4) [back to overview]Glycemic Control
NCT04834362 (4) [back to overview]Total Daily Dose of Insulin
NCT04849845 (7) [back to overview]Percent of Level 2 Hypoglycemia
NCT04849845 (7) [back to overview]Percent of Level 1 Hypoglycemia
NCT04849845 (7) [back to overview]Number of Subjects With At Least 1 Event of Severe Hypoglycemia
NCT04849845 (7) [back to overview]Number of Subjects With at Least 1 Event of Level 2 Hypoglycemia
NCT04849845 (7) [back to overview]Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Between Two Points, Baseline and 120 Minutes Post-Afrezza Dose
NCT04849845 (7) [back to overview]Number of Subjects With at Least 1 Event of Level 1 Hypoglycemia
NCT04849845 (7) [back to overview]Post-prandial Glucose Excursion
NCT04857320 (3) [back to overview]Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin
NCT04857320 (3) [back to overview]OECD Acute Dermal Irritation/Corrosion Score According to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404
NCT04857320 (3) [back to overview]Postprandial Serum Glucose in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin Averaged Per Subject
NCT04964128 (2) [back to overview]Percentage of Time in Range (Phase 1, Software Release Tag 1.0)
NCT04964128 (2) [back to overview]Percentage of Time in Range (Phase 2, Software Release Tag 2.0)

First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.

"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).~In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion." (NCT00000620)
Timeframe: 4.9 years

Interventionparticipants (Number)
Glycemia Trial: Intensive Control503
Glycemia Trial: Standard Control543

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First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants. (NCT00000620)
Timeframe: 4.7 years

Interventionparticipants (Number)
Lipid Trial: Fenofibrate291
Lipid Trial: Placebo310

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First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants. (NCT00000620)
Timeframe: 4.7 years

Interventionparticipants (Number)
Lipid Trial: Fenofibrate641
Lipid Trial: Placebo667

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First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial. (NCT00000620)
Timeframe: 4.7 years

Interventionparticipants (Number)
BP Trial: Intensive Control208
BP Trial: Standard Control237

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Death From Any Cause in the Glycemia Trial.

"Time to death from any cause. Secondary measure for Glycemia Trial.~A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid)." (NCT00000620)
Timeframe: 4.9 years

Interventionparticipants (Number)
Glycemia Trial: Intensive Control391
Glycemia Trial: Standard Control327

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Stroke in the Blood Pressure Trial.

Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial. (NCT00000620)
Timeframe: 4.7 years

Interventionparticipants (Number)
BP Trial: Intensive Control36
BP Trial: Standard Control62

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Total Mortality (All Causes)

Number of deaths due to any cause (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)

Interventionparticipants (Number)
Insulin Glargine951
Standard Care965

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Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)

"Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease).~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table." (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)

,
Interventionparticipants (Number)
Participants with a composite endpointEndpoint's composition: CV deathEndpoint's composition: nonfatal MIEndpoint's composition: nonfatal strokeEndpoint's composition: revascularizationEndpoint's composition: hospitalization for HF
Insulin Glargine1792350257231763249
Standard Care1727339238227717259

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Number of Patients With Various Types of Symptomatic Hypoglycemia Events

"Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia, based on data recorded in the participant's diary. These were further categorized as confirmed (ie, with a concomitant home glucose reading ≤54 mg/dL [≤3.0 mmol/L]) or unconfirmed.~Severe hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following:~the event was associated with a documented self-measured or laboratory plasma glucose level ≤36 mg/dL (≤2.0 mmol/L), or~the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration." (NCT00069784)
Timeframe: on-treatment period (median duration of follow-up: 6.2 years)

,
Interventionparticipants (Number)
Patients with hypoglycemia eventsPatients with non-severe hypoglycemiaPatients with confirmed non-severe hypoglycemiaPatients with severe hypoglycemia
Insulin Glargine359735332581352
Standard Care16241582904113

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Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG

The incidence was determined by calculating the proportion of randomized participants without diabetes at randomization who either developed diabetes during the study or who were classified as having possible diabetes based on results of two oral glucose tolerance tests (OGTT) performed after the last follow-up visit (within 21-28 days for OGTT#1 and within 10-14 weeks for OGTT#2). (NCT00069784)
Timeframe: from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years)

Interventionpercentage of patients (Number)
Insulin Glargine24.7
Standard Care31.2

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Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke

"Number of participants with a first occurrence of one of the above events.~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table." (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)

,
Interventionparticipants (Number)
Participants with a composite endpointEndpoint's composition: CV deathEndpoint's composition: nonfatal MIEndpoint's composition: nonfatal stroke
Insulin Glargine1041484297261
Standard Care1013476282256

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Number of Patients With First Occurrence of Any Type of Cancer

Data on cancers that occurred in association with hospitalizations were collected systematically in both groups from the start of the study. All reported cancers occurring during the trial (new or recurrent) were adjudicated by the Event Adjudication Committee. (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)

Interventionparticipants (Number)
Insulin Glargine559
Standard Care561

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Composite Diabetic Microvascular Outcome (Kidney or Eye Disease)

"The composite outcome used to analyze microvascular disease progression contained components of clinical events:~the occurrence of laser surgery or vitrectomy for diabetic retinopathy (DR);~the development of blindness due to DR;~the occurrence of renal death or renal replacement therapy; as well as the following laboratory-based events:~doubling of serum creatinine; or~progression of albuminuria (from none to microalbuminuria [at least 30 mg/g creatinine], to macroalbuminuria [at least 300 mg/g creatinine])." (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)

,
Interventionparticipants (Number)
Participants with a composite endpointEndpoint's composition: vitrectomyEndpoint's composition: laser therapy for DREndpoint's composition: dialysisEndpoint's composition: renal transplantEndpoint's composition: serum creatinine doubledEndpoint's composition: death due to renal failureEndpoint's composition: albuminuria progression
Insulin Glargine132324571808241153
Standard Care136325672808831171

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Progression of Acute Coronary Syndrome to Myocardial Infarction

Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results. (NCT00091507)
Timeframe: 24 hours

Interventionparticipants (Number)
GIK --200
Placebo242

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Mortality

Outcome for all participants (mortality at 30 days). (NCT00091507)
Timeframe: 30 days

Interventionparticipants (Number)
GIK --18
Placebo28

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Heart Failure or Death

Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days) (NCT00091507)
Timeframe: 30 days

Interventionparticipants (Number)
GIK --23
Placebo35

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Cardiac Arrest or Acute Mortality

Outcome for all participants (composite of cardiac arrest or acute mortality) (NCT00091507)
Timeframe: Prehospital setting through hospitalization

Interventionparticipants (Number)
GIK --18
Placebo40

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Cardiac Arrest

Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization. (NCT00091507)
Timeframe: 1 to 18 hours (From prehospital setting through hospitalization.)

Interventionparticipants (Number)
GIK --15
Placebo29

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Change From Baseline in Body Weight

Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3

,
Interventionkg (Mean)
Baseline (n=314, 302)W4 (n=280, 270)W8 (n=289, 281)M3 (n=288, 290)W18(n=280, 285)M6 (n=276, 277)M9 (n=269, 274)M12 (n=259, 264)M15(n=247, 249)M18(n=237, 235)M21(n=232, 232)M24 (n=223, 226)FU M3 (n=249, 231)FU M6 (n=243, 218)Ext M1 (n=161, 162)Ext M3 (n=157, 157)Ext M6 (n=148, 159)Ext M9 (n=144, 156)Ext M12 (n=144, 156)Ext M15 (n=142, 145)Ext M18 (n=135, 139)Ext M21(n=132, 143)Ext M24 (n=126, 131)Ext M27(n=125, 125)Ext M30 (n=125, 126)Ext M33(n=99, 113)Ext M36 (n=54, 60)Ext FU M3 (n=119, 115)
Inhaled Insulin (Exubera®)87.180.631.071.081.331.151.501.751.881.791.992.042.322.382.872.833.152.952.963.123.332.792.942.993.392.772.482.74
Subcutaneous Insulin88.310.831.001.131.761.892.152.372.622.933.043.363.634.093.754.144.013.894.194.544.465.014.575.584.785.225.284.44

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Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)

Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3

,
Interventionml/min/mmHg (Mean)
Baseline (n=308, 303)M3 (n=289, 290)M6 (n=278, 280)M9 (n=266, 272)M12 (n=258, 263)M15 (n=246, 248)M18 (n=237, 232)M21 (n=231, 231)M24 (n=221, 223)FU M1 (n=247, 220)FU M3 (n=247, 231)FU M6 (n=241, 219)Ext M1 (n=159, 161)Ext M3 (n=157, 157)Ext M6 (n=148, 157)Ext M9 (n=143, 155)Ext M12 (n=141, 155)Ext M15 (n=141, 142)Ext M18 (n=132, 138)Ext M21 (n=129, 142)Ext M24 (n=124, 130)Ext M27 (n=123, 124)Ext M30 (n=124, 125)Ext M33 (n=98, 113)Ext M36 (n=52, 60)Ext M36 [LOCF] (n=171, 169)Ext FU M3 (n=118, 114)
Inhaled Insulin (Exubera®)24.13-0.57-0.56-0.67-0.72-0.81-0.86-0.89-0.74-0.46-0.58-0.64-1.01-1.07-1.48-1.15-1.49-1.49-1.54-1.33-1.39-1.35-1.75-1.47-1.22-1.39-1.12
Subcutaneous Insulin23.97-0.32-0.44-0.72-0.41-0.56-0.65-0.67-0.81-1.02-0.90-0.95-1.09-1.16-1.26-1.36-1.59-1.46-1.63-1.64-1.46-1.44-1.62-1.61-1.87-1.77-1.69

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3

,
Interventionmg/dL (Mean)
Baseline (n=315, 303)W6 (n=282, 276)M3 (n=294, 290)M6 (n=281, 285)M9 (n=267, 279)M12 (n=260, 263)M15(n=253, 255)M18(n=242, 238)M21(n=232, 237)M24 (n=226, 232)FU M3 (n=5, 4)FU M6 (n=161, 156)Ext M1 (n=165, 162)Ext M3 (n=162, 159)Ext M6 (n=152, 161)Ext M9 (n=149, 155)Ext M12 (n=148, 155)Ext M15(n=143, 143)Ext M18 (n=136, 138)Ext M21(n=132, 144)Ext M24 (n=129, 136)Ext M27 (n=128, 129)Ext M30 (n=127, 130)Ext M33(n=103, 115)Ext M36 (n=55, 64)Ext FU M3 (n=115, 118)
Inhaled Insulin (Exubera®)158.13-23.36-26.38-25.21-26.68-20.55-21.37-24.52-25.95-24.02-22.60-2.85-17.91-18.16-15.65-13.99-12.53-6.88-17.23-12.86-14.45-21.68-11.80-16.26-28.61-2.87
Subcutaneous Insulin154.53-12.55-12.77-9.05-10.41-7.60-8.82-7.69-13.14-8.91-4.08-1.56-7.34-9.29-4.34-6.06-4.98-4.23-10.32-6.53-3.47-3.76-6.40-7.35-13.351.88

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Change From Baseline in FEV1

Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3

,
InterventionL (Mean)
Baseline (n=311, 304)Month 3 (M3) (n=290, 291)M6 (n=281, 280)M9 (n=266, 276)M12 (n=259, 263)M15 (n=247, 250)M18 (n=237, 236)M21 (n=232, 233)M24 (n=223, 226)Follow-up (FU) M1 (n=249, 221)FU M3 (n=248, 231)FU M6 (n=242, 220)Extension (Ext) M1 (n=161, 163)Ext M3 (n=157, 158)Ext M6 (n=148, 159)Ext M9 (n=144, 157)Ext M12 (n=144, 157)Ext M15 (n=141, 145)Ext M18 (n=135, 139)Ext M21 (n=132, 143)Ext M24 (n=125, 131)Ext M27 (n=124, 125)Ext M30 (n=125, 126)Ext M33 (n=98, 113)Ext M36 (n=54, 60)Ext M36 [LOCF] (n=171, 169)Ext FU M3 (n=119, 115)
Inhaled Insulin (Exubera®)2.91-0.06-0.05-0.08-0.09-0.12-0.12-0.13-0.15-0.14-0.13-0.12-0.16-0.19-0.20-0.19-0.20-0.22-0.22-0.23-0.24-0.25-0.24-0.24-0.25-0.24-0.24
Subcutaneous Insulin2.93-0.01-0.05-0.07-0.07-0.09-0.10-0.11-0.13-0.14-0.14-0.15-0.16-0.16-0.17-0.16-0.18-0.21-0.21-0.21-0.23-0.24-0.23-0.24-0.28-0.24-0.25

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Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)

Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine. (NCT00136916)
Timeframe: Month 3 through extension Month 36

,
Interventionunits (Mean)
M3 (n=301, 298)M6 (n=289, 291)M9 (n=275, 284)M12 (n=266, 270)M15 (n=258, 260)M18 (n=243, 242)M21 (n=240, 240)M24 (n=229, 237)Ext M1 (n=167, 164)Ext M3 (n=165, 162)Ext M6 (n=159, 164)Ext M9 (n=156, 158)Ext M12 (n=151, 158)Ext M15 (n=148, 149)Ext M18 (n=145, 145)Ext M21 (n=137, 148)Ext M24 (n=131, 137)Ext M27 (n=132, 133)Ext M30 (n=131, 130)Ext M33 (n=104, 116)Ext M36 (n=56, 65)
Inhaled Insulin (Exubera®)44.1044.0343.6444.6245.0246.0746.6746.6245.2945.7645.8946.5146.5246.3946.3146.4947.2148.1348.1348.3846.42
Subcutaneous Insulin47.9847.3148.1148.0148.3748.9349.8450.3451.2951.6252.1852.3251.7252.9252.3752.6852.1852.4253.2251.9353.47

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Insulin Antibodies

Observed values for insulin antibodies measured as micro units per milliliter (microU/mL). (NCT00136916)
Timeframe: Baseline through extension Month 36

,
InterventionmicroU/mL (Median)
Baseline (n=312, 300)W3 (n=270, 264)W6 (n=289, 282)M3 (n=293, 289)W18 (n=275, 280)M6 (n=276, 279)M9 (n=267, 277)M12 (n=263, 263)M15 (n=252, 253)M18 (n=241, 239)M21 (n=234, 233)M24 (n=226, 233)FU M1 (n=247, 226)FU M3 (n=249, 229)FU M6 (n=250, 227)Ext M1 (n=165, 160)Ext M3 (n=159, 158)Ext M6 (n=157, 156)Ext M9 (n=150, 157)Ext M12 (n=148, 154)Ext M15 (n=144, 147)Ext M18 (n=140, 144)Ext M21 (n=136, 145)Ext M24 (n=130, 135)Ext M27 (n=129, 131)Ext M30 (n=125, 127)Ext M33 (n=103, 114)Ext M36 (n=56, 63)
Inhaled Insulin (Exubera®)1.051.054.4012.0018.0020.0022.0019.0020.0020.0019.0020.0014.008.506.5513.0015.0012.0011.5013.0010.5013.0012.0010.5012.008.409.205.75
Subcutaneous Insulin1.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.051.052.501.051.051.05

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Hypoglycemic Event Rates

Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval). (NCT00136916)
Timeframe: Month 1 through extension Month 36

,
Interventionevent rate (events/subject months) (Number)
M1 (n=315, 303)M2 (n=307, 302)M3 (n=297, 298)M4 (n=289, 295)M5 (n=284, 293)M6 (n=283, 290)M7 (n=280, 289)M8 (n=276, 288)M9 (n=275, 287)M10 (n=273, 285)M11 (n=267, 274)M12 (n=264, 274)M13 (n=263, 269)M14 (n=260, 265)M15 (n=256, 265)M16 (n=254, 261)M17 (n=252, 257)M18 (n=246, 253)M19 (n=245, 252)M20 (n=242, 249)M21 (n=241, 246)M22 (n=236, 244)M23 (n=236, 241)M24 (n=229, 232)Ext M1 (n=172, 169)Ext M2 (n=171, 169)Ext M3 (n=169, 169)Ext M4 (n=167, 169)Ext M5 (n=165, 168)Ext M6 (n=162, 167)Ext M7 (n=161, 167)Ext M8 (n=158, 164)Ext M9 (n=158, 164)Ext M10 (n=156, 164)Ext M11 (n=153, 164)Ext M12 (n=152, 162)Ext M13 (n=152, 160)Ext M14 (n=151, 159)Ext M15 (n=149, 156)Ext M16 (n=149, 156)Ext M17 (n=148, 154)Ext M18 (n=146, 154)Ext M19 (n=143, 152)Ext M20 (n=142, 152)Ext M21 (n=141, 151)Ext M22 (n=141, 149)Ext M23 (n=139, 149)Ext M24 (n=138, 147)Ext M25 (n=137, 146)Ext M26 (n=137, 145)Ext M27 (n=137, 141)Ext M28 (n=135, 137)Ext M29 (n=135, 137)Ext M30 (n=133, 137)Ext M31 (n=124, 133)Ext M32 (n=117, 125)Ext M33 (n=100, 117)Ext M34 (n=84, 90)Ext M35 (n=66, 78)Ext M36 (n=51, 60)Overall comparative (n=315, 303)Overall extension (n=172, 169)
Inhaled Insulin (Exubera®)1.631.401.221.100.950.980.800.820.710.720.680.720.710.620.640.680.530.610.590.620.570.440.410.451.161.101.020.870.910.871.100.820.560.990.701.261.070.950.860.991.201.081.251.200.780.790.820.880.730.680.620.680.810.640.670.820.550.640.630.720.950.89
Subcutaneous Insulin1.801.601.651.641.281.091.120.940.860.930.790.940.820.870.780.970.820.950.780.730.650.720.820.661.161.331.121.441.181.201.411.341.251.110.921.251.141.011.251.231.011.051.211.081.151.081.061.111.221.251.040.870.910.871.320.810.890.570.800.471.191.10

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Summary of ≥ 20 % Decliners in DLco

Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed. (NCT00136916)
Timeframe: Month 3 through extension follow up Month 3

,
Interventionparticipants (Number)
M3 (n=289, 290)M6 (n=278, 280)M9 (n=266, 272)M12 (n=258, 263)M15 (n=246, 248)M18(n=237, 232)M21 (n=231, 231)M24 (n=221, 223)FU M1 (n=247, 220)FU M3 (n=247, 231)FU M6 (n=241, 219)Ext M1 (n=159, 161)Ext M3 (n=157, 157)Ext M6 (n=148, 157)Ext M9 (n=143, 155)Ext M12 (n=141, 155)Ext M15(n=141, 142)Ext M18 (n=132, 138)Ext M21(n=129, 142)Ext M24 (n=124, 130)Ext M27(n=123, 124)Ext M30 (n=124, 125)Ext M33(n=98, 113)Ext M36 (n=52, 60)Ext FU M3 (n=118, 114)
Inhaled Insulin (Exubera®)0104120423533448464577126
Subcutaneous Insulin223325354653867967878114310

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Total Daily Long-acting Insulin (Adjusted for Body Weight)

Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine. (NCT00136916)
Timeframe: Month 3 through extension Month 36

,
Interventionunits/kg (Mean)
M3 (n=301, 298)M6 (n=289, 291)M9 (n=275, 284)M12 (n=266, 270)M15 (n=258, 260)M18 (n=243, 242)M21 (n=240, 240)M24 (n=229, 237)Ext M1 (n=167, 164)Ext M3 (n=165, 162)Ext M6 (n=159, 164)Ext M9 (n=156, 158)Ext M12 (n=151, 158)Ext M15 (n=148, 149)Ext M18 (n=145, 145)Ext M21 (n=137, 148)Ext M24 (n=131, 137)Ext M27 (n=132, 133)Ext M30 (n=131, 130)Ext M33 (n=104, 116)Ext M36 (n=56, 65)
Inhaled Insulin (Exubera®)0.510.500.500.510.520.530.530.540.530.530.540.540.540.540.540.540.550.560.560.560.53
Subcutaneous Insulin0.540.540.550.550.560.570.570.580.590.590.600.600.600.610.610.610.610.610.620.610.61

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Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)

Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg). (NCT00136916)
Timeframe: Month 3 through extension Month 36

,
Interventionmg/kg, units/kg (Mean)
M3 (n=302, 299)M6 (n=290, 292)M9 (n=275, 285)M12 (n=266, 270)M15 (n=258, 261)M18 (n=245, 242)M21 (n=240, 242)M24 (n=229, 238)Ext M1 (n=167, 164)Ext M3 (n=165, 163)Ext M6 (n=159, 165)Ext M9 (n=156, 161)Ext M12 (n=151, 160)Ext M15 (n=148, 151)Ext M18 (n=145, 146)Ext M21 (n=138, 149)Ext M24 (n=131, 138)Ext M27 (n=132, 134)Ext M30 (n=131, 131)Ext M33 (n=105, 117)Ext M36 (n=56, 66)
Inhaled Insulin (Exubera®) (mg)0.150.150.160.170.170.170.170.180.160.170.170.170.180.180.180.180.180.190.190.190.19
Subcutaneous Insulin (Units)0.360.360.360.370.370.380.390.400.400.410.410.420.430.420.440.430.450.450.460.470.48

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Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)

Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin. (NCT00136916)
Timeframe: Month 3 through extension Month 36

,
Interventionmg, units (Mean)
M3 (n=302, 299)M6 (n=290, 292)M9 (n=275, 285)M12 (n=266, 270)M15 (n=258, 261)M18 (n=245, 242)M21 (n=240, 242)M24 (n=229, 238)Ext M1 (n=167, 164)Ext M3 (n=165, 163)Ext M6 (n=159, 165)Ext M9 (n=156, 161)Ext M12 (n=151, 160)Ext M15 (n=148, 151)Ext M18 (n=145, 146)Ext M21 (n=138, 149)Ext M24 (n=131, 138)Ext M27 (n=132, 134)Ext M30 (n=131, 131)Ext M33 (n=105, 117)Ext M36 (n=56, 66)
Inhaled Insulin (Exubera®) (mg)12.6613.1813.5714.4014.7014.9115.0915.4313.8914.6214.6214.8215.4215.4815.5715.9415.4616.2516.5616.5117.25
Subcutaneous Insulin (Units)31.1531.7331.5831.9431.8832.7933.1834.0434.5235.2935.4335.6836.5636.2737.3736.8038.5138.5439.0140.3342.34

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High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits

"Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. No response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn)." (NCT00136916)
Timeframe: Baseline, M12, M24, Ext M6, Ext M18, Ext M36

,
Interventionparticipants (Number)
M12 = YesM12 = NoM12 = No (NSC)M12 = No (> Abn)M12 = No (< Abn)M24 = YesM24 = NoM24 = No (NSC)M24 = No (> Abn)M24 = No (< Abn)Ext M6 = YesExt M6 = NoExt M6 = No (NSC)Ext M6 = No (> Abn)Ext M6 = No (< Abn)Ext M18 = YesExt M18 = NoExt M18 = No (NSC)Ext M18 = No (> Abn)Ext M18 = No (< Abn)Ext M24 = YesExt M24 = NoExt M24 = No (NSC)Ext M24 = No (> Abn)Ext M24 = No (< Abn)
Inhaled Insulin (Exubera®)620190141717003161510314121159810
Subcutaneous Insulin516112369810398102770028800

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High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits

Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline. (NCT00136916)
Timeframe: Baseline, M12, M24, Ext M6, Ext M18, Ext M36

,
Interventionparticipants (Number)
M12 = YesM12 = NoM24 = YesM24 = NoExt M6 = YesExt M6 = NoExt M18 = YesExt M18 = NoExt M36 = YesExt M36 = No
Inhaled Insulin (Exubera®)674388328288226
Subcutaneous Insulin64125110378336274

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Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3

,
Interventionpercent (Mean)
Baseline (n=315, 303)Week 6 (W6) (n=291, 280)M3 (n=296, 291)M6 (n=284, 287)M9 (n=270, 280)M12 (n=261, 263)M15(n=252, 258)M18(n=244, 241)M21 (n=236, 238)M24 (n=226, 234)FU M3 (n=225, 226)FU M6 (n=230, 230)Ext M1 (n=167, 162)Ext M3 (n=164, 162)Ext M6 (n=157, 163)Ext M9 (n=152, 157)Ext M12 (n=150, 157)Ext M15(n=146, 151)Ext M18 (n=145, 145)Ext M21(n=137, 147)Ext M24 (n=131, 137)Ext M27(n=129, 132)Ext M30 (n=129, 129)Ext M33(n=104, 116)Ext M36 (n=55, 64)Ext FU M3 (n=117, 116)
Inhaled Insulin (Exubera®)7.66-0.64-0.80-0.67-0.56-0.45-0.43-0.42-0.43-0.35-0.41-0.27-0.41-0.33-0.26-0.11-0.08-0.17-0.20-0.13-0.18-0.18-0.208.54-0.20-0.11
Subcutaneous Insulin7.77-0.60-0.73-0.68-0.61-0.58-0.51-0.53-0.52-0.48-0.44-0.31-0.40-0.42-0.40-0.26-0.17-0.25-0.29-0.20-0.23-0.28-0.30-0.18-0.30-0.17

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Summary of ≥ 15 % Decliners in FEV1

Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed. (NCT00136916)
Timeframe: Month 3 through extension follow up Month 3

,
Interventionparticipants (Number)
M3 (n=290, 291)M6 (n=281, 280)M9 (n=266, 276)M12 (n=259, 263)M15 (n=247, 250)M18 (n=237, 236)M21 (n=232, 233)M24 (n=223, 226)FU M1 (n=249, 221)FU M3 (n=248, 231)FU M6 (n=242, 220)Ext M1 (n=161, 163)Ext M3 (n=157, 158)Ext M6 (n=148, 159)Ext M9 (n=144, 157)Ext M12 (n=144, 157)Ext M15 (n=141, 145)Ext M18 (n=135, 139)Ext M21 (n=132, 143)Ext M24 (n=125, 131)Ext M27 (n=124, 125)Ext M30 (n=125, 126)Ext M33 (n=98, 113)Ext M36 (n=54, 60)Ext FU M3 (n=119, 115)
Inhaled Insulin (Exubera®)237713101214111613121214111915172222182010514
Subcutaneous Insulin24546881371511658101311181116141812619

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Severe Hypoglycemic Event Rates

Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval. (NCT00136916)
Timeframe: Month 1 through extension Month 36

,
Interventionevent rate (events/subject months*100) (Number)
M1 (n=315, 303)M2 (n=307, 302)M3 (n=297, 298)M4 (n=289, 295)M5 (n=284, 293)M6 (n=283, 290)M7 (n=280, 289)M8 (n=276, 288)M9 (n=275, 287)M10 (n=273, 285)M11 (n=267, 274)M12 (n=264, 274)M13 (n=263, 269)M14 (n=260, 265)M15 (n=256, 265)M16 (n=254, 261)M17 (n=252, 257)M18 (n=246, 253)M19 (n=245, 252)M20 (n=242, 249)M21 (n=241, 246)M22 (n=236, 244)M23 (n=236, 241)M24 (n=229, 232)Ext M1 (n=172, 169Ext M2 (n=171, 169)Ext M3 (n=169, 169)Ext M4 (n=167, 169)Ext M5 (n=165, 168)Ext M6 (n=162, 167)Ext M7 (n=161, 167)Ext M8 (n=158, 164)Ext M9 (n=158, 164)Ext M10 (n=156, 164)Ext M11 (n=153, 164)Ext M12 (n=152, 162)Ext M13 (n=152, 160)Ext M14 (n=151, 159)Ext M15 (n=149, 156)Ext M16 (n=149, 156)Ext M17 (n=148, 154)Ext M18 (n=146, 154)Ext M19 (n=143, 152)Ext M20 (n=142, 152)Ext M21 (n=141, 151)Ext M22 (n=141, 149)Ext M23 (n=139, 149)Ext M24 (n=138, 147)Ext M25 (n=137, 146)Ext M26 (n=137, 145)Ext M27 (n=137, 141)Ext M28 (n=135, 137)Ext M29 (n=135, 137)Ext M30 (n=133, 137)Ext M31 (n=124, 133)Ext M32 (n=117, 125)Ext M33 (n=100, 117)Ext M34 (n=84, 90)Ext M35 (n=66, 78)Ext M36 (n=51, 60)Overall comparative (n=315, 303)Overall extension (n=172, 169)
Inhaled Insulin (Exubera®)0.980.340.690.350.360.720.000.370.740.000.380.760.770.780.790.000.000.000.410.420.000.000.000.000.950.001.921.920.000.000.000.000.000.000.000.980.000.001.001.001.001.011.034.160.000.000.001.060.000.001.070.000.000.000.000.000.000.000.000.000.450.50
Subcutaneous Insulin0.670.340.341.381.742.100.700.700.350.360.370.370.760.380.770.000.400.400.000.000.000.000.850.000.931.870.940.000.000.941.900.002.863.813.863.910.981.960.001.960.990.000.990.990.001.000.002.021.010.000.000.001.060.001.153.580.001.890.000.820.651.17

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Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).

Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat DLco was performed. (NCT00137046)
Timeframe: Month 3 through Extension Follow-up Month 3

,
Interventionparticipants (Number)
Month 3 (n=277, 264)Month 6 (n=262, 273)Month 9 (n=250, 266)Month 12 (n=241, 258)Month 15 (n=235, 249)Month 18 (n=227, 232)Month 21 (n=218, 224)Month 24 (n=208, 219)Follow-up Month 1 (n=242, 208)Follow-up Month 3 (n=247, 225)Follow-up Month 6 (n=240, 218)Extension Month 1 (n=166, 175)Extension Month 3 (n=161, 173)Extension Month 6 (n=158, 169)Extension Month 9 (n=151, 163)Extension Month 12 (n=152, 161)Extension Month 15 (n=143, 160)Extension Month 18 (n=148, 159)Extension Month 21 (n=144, 156)Extension Month 24 (n=140, 152)Extension Month 27 (n=136, 144)Extension Month 30 (n=135, 146)Extension Month 33 (n=127, 139)Extension Month 36 (n=105, 122)Extension Month 39 (n=52, 64)Extension Follow Up Month 3 (n=115, 101)
Inhaled Insulin01221542311544253155443433
Subcutaneous Insulin10112422312012222431242712

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Change From Baseline Body Weight

Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus mean baseline body weight. (NCT00137046)
Timeframe: Baseline through Extension Follow-up Month 3

,
Interventionkilograms (Mean)
Baseline (n=288, 286)Week 4 (n=257, 247)Week 8 (n=263, 262)Month 3 (n=273, 269)Week 18 (n=248, 260)Month 6 (n=259, 272)Month 9 (n=251, 266)Month 12 (n=242, 259)Month 15 (n=236, 250)Month 18 (n=227, 233)Month 21 (n=220, 224)Month 24 (n=211, 220)Follow-up Month 3 (n=248, 225)Follow-up Month 6 (n=239, 219)Extension Month 1 (n=166, 175)Extension Month 3 (n=161, 175)Extension Month 6 (n=158, 170)Extension Month 9 (n=153, 164)Extension Month 12 (n=152, 162)Extension Month 15 (n=153, 162)Extension Month 18 (n=149, 160)Extension Month 21 (n=144, 158)Extension Month 24 (n=141, 153)Extension Month 27 (n=136, 146)Extension Month 30 (n=136, 147)Extension Month 33 (n=127, 139)Extension Month 36 (n=105, 126)Extension Month 39 (n=52, 64)Extension Follow-Up Month 3 (n=116, 103)
Inhaled Insulin75.120.300.460.130.150.110.050.370.440.571.070.991.501.682.441.731.671.612.112.012.312.142.492.122.422.302.111.582.49
Subcutaneous Insulin73.720.630.670.671.001.251.411.551.842.262.352.232.312.172.503.083.053.173.083.163.303.724.233.964.805.283.874.834.09

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Change From Baseline in Fasting Plasma Glucose

Change from Baseline: mean of (value of fasting plasma glucose [milligrams per deciliter (mg/dL)] at observation minus Baseline value). (NCT00137046)
Timeframe: Baseline through Extension Follow-up Month 3

,
Interventionmg/dL (Mean)
Baseline (n=286, 286)Week 6 (n=263, 250)Month 3 (n=267, 276)Month 6 (n=258, 271)Month 9 (n=243, 262)Month 12 (n=232, 256)Month 15 (n=230, 251)Month 18 (n=226, 236)Month 21 (n=216, 230)Month 24 (n=208, 222)Follow-up Month 3 (n=2, 2)Follow-up Month 6 (n=159, 164)Extension Month 1 (n=164, 171)Extension Month 3 (n=167, 172)Extension Month 6 (n=164, 177)Extension Month 9 (n=152, 170)Extension Month 12 (n=155, 167)Extension Month 15 (n=148, 163)Extension Month 18 (n=148, 163)Extension Month 21 (n=152, 157)Extension Month 24 (n=142, 148)Extension Month 27 (n=140, 148)Extension Month 30 (n=138, 147)Extension Month 33 (n=129, 141)Extension Month 36 (n=107, 132)Extension Month 39 (n=55, 64)Extension Follow-Up Month 3 (n=118, 105)
Inhaled Insulin171.24-26.04-21.84-31.48-25.34-24.25-34.75-24.13-26.77-18.36-43.503.45-25.52-25.02-13.47-16.19-22.53-26.11-12.42-24.75-20.46-14.91-17.16-22.77-20.00-38.471.97
Subcutaneous Insulin170.06-14.02-6.15-6.291.28-4.955.96-8.13-11.621.2546.671.46-2.720.43-12.56-4.46-5.15-10.64-2.324.86-10.36-2.86-3.77-12.12-2.49-1.573.25

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Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value). (NCT00137046)
Timeframe: Baseline through Extension Follow-up Month 3

,
Interventionliters (Mean)
Baseline (n=283, 281)Month 3 (n=277, 263)Month 6 (n=262, 273)Month 9 (n=251, 264)Month 12 (n=242, 259)Month 15 (n=236, 250)Month 18 (n=227, 232)Month 21 (n=218, 224)Month 24 (n=211, 219)Follow-up Month 1 (n=242, 209)Follow-up Month 3 (n=249, 225)Follow-up Month 6 (n=240, 218)Extension Month 1 (n=166, 175)Extension Month 3 (n=161, 175)Extension Month 6 (n=158, 170)Extension Month 9 (n=151, 164)Extension Month 12 (n=152,161)Extension Month 15 (n=153,162)Extension Month 18 (n=148,160)Extension Month 21 (n=144,158)Extension Month 24 (n=141,153)Extension Month 27 (n=136,146)Extension Month 30 (n=136,147)Extension Month 33 (n=127,139)Extension Month 36 (n=105,126)Extension Month 39 (n=52, 64)Extension Month 39 (LOCF) (n=177, 187)Extension Follow Up Month 3 (n=115,102)
Inhaled Insulin3.51-0.04-0.05-0.06-0.08-0.09-0.09-0.11-0.12-0.11-0.10-0.10-0.14-0.14-0.15-0.16-0.17-0.16-0.18-0.17-0.18-0.19-0.20-0.20-0.23-0.21-0.22-0.20
Subcutaneous Insulin3.47-0.01-0.03-0.04-004-0.05-0.06-0.06-0.08-0.09-0.09-0.09-0.10-0.10-0.11-0.12-0.11-0.12-0.14-0.15-0.14-0.13-0.16-0.17-0.16-0.17-0.15-0.17

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Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Change from Baseline: mean of (value of Glycosylated Hemoglobin [HbA1c] at observation minus Baseline value). (NCT00137046)
Timeframe: Baseline through Extension Follow-up Month 3

,
Interventionpercent (Mean)
Baseline (n=288, 286)Week 6 (n=269, 256)Month 3 (n=276, 280)Month 6 (n=263, 274)Month 9 (n=253, 266)Month 12 (n=240, 262)Month 15 (n=236, 253)Month 18 (n=231, 237)Month 21 (n=223, 231)Month 24 (n=214, 225)Follow-up Month 3 (n=205, 195)Follow-up Month 6 (n=219, 221)Extension Month 1 (n=171, 177)Extension Month 3 (n=170, 177)Extension Month 6 (n=166, 178)Extension Month 9 (n=159, 171)Extension Month 12 (n=158, 169)Extension Month 15 (n=156, 167)Extension Month 18 (n=153, 166)Extension Month 21 (n=154, 161)Extension Month 24 (n=149, 154)Extension Month 27 (n=141, 151)Extension Month 30 (n=140, 150)Extension Month 33 (n=131, 143)Extension Month 36 (n=108, 132)Extension Month 39 (n=55, 66)Extension Follow-Up Month 3 (n=120, 107)
Inhaled Insulin7.41-0.40-0.36-0.21-0.10-0.04-0.12-0.11-0.050.05-0.13-0.10-0.090.120.210.260.390.400.320.270.290.330.330.400.300.300.14
Subcutaneous Insulin7.46-0.43-0.41-0.36-0.23-0.32-0.29-0.30-0.25-0.27-0.22-0.14-0.23-0.17-0.19-0.060.080.170.050.000.060.10-0.01-0.08-0.03-0.090.12

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Hypoglycemic Event Rates

A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment. (NCT00137046)
Timeframe: Month 1 through Extension Month 39

,
Interventiontotal events/subject months (Number)
Month 1 (n=288, 286)Month 2 (n=282, 286)Month 3 (n=279, 285)Month 4 (n=273, 282)Month 5 (n=266, 280)Month 6 (n=263, 277)Month 7 (n=259, 275)Month 8 (n=257, 273)Month 9 (n=254, 272)Month 10 (n=249, 270)Month 11 (n=245, 269)Month 12 (n=243, 267)Month 13 (n=239, 265)Month 14 (n=237, 260)Month 15 (n=236, 258)Month 16 (n=236, 256)Month 17 (n=235, 252)Month 18 (n=233, 250)Month 19 (n=232, 250)Month 20 (n=227, 245)Month 21 (n=226, 244)Month 22 (n=226, 243)Month 23 (n=224, 238)Month 24 (n=222, 229)Extension Month 1 (n=177, 187)Extension Month 2 (n=177, 187)Extension Month 3 (n=172, 185)Extension Month 4 (n=169, 182)Extension Month 5 (n=169, 182)Extension Month 6 (n=168, 182)Extension Month 7 (n=167, 181)Extension Month 8 (n=167, 178)Extension Month 9 (n=165, 177)Extension Month 10 (n=165, 176)Extension Month 11 (n=162, 175)Extension Month 12 (n=160, 175)Extension Month 13 (n=158, 174)Extension Month 14 (n=156, 173)Extension Month 15 (n=156, 173)Extension Month 16 (n=156, 172)Extension Month 17 (n=156, 172)Extension Month 18 (n=156, 172)Extension Month 19 (n=155, 172)Extension Month 20 (n=155, 170)Extension Month 21 (n=155, 169)Extension Month 22 (n=155, 165)Extension Month 23 (n=152, 164)Extension Month 24 (n=152, 163)Extension Month 25 (n=150, 162)Extension Month 26 (n=149, 160)Extension Month 27 (n=147, 159)Extension Month 28 (n=146, 158)Extension Month 29 (n=145, 155)Extension Month 30 (n=143, 153)Extension Month 31 (n=141, 153)Extension Month 32 (n=138, 152)Extension Month 33 (n=136, 150)Extension Month 34 (n=131, 148)Extension Month 35 (n=122, 147)Extension Month 36 (n=113, 138)Extension Month 37 (n=88, 104)Extension Month 38 (n=66, 73)Extension Month 39 (n=53, 64)Overall Comparative (n=288, 286)Overall Extension (n=177, 187)
Inhaled Insulin7.65.95.84.84.74.54.54.23.84.23.93.83.63.63.23.43.03.03.23.03.02.82.52.63.53.64.13.23.22.83.12.62.13.13.23.32.82.93.03.43.03.03.22.92.82.83.32.93.22.72.72.72.72.52.62.82.32.01.81.91.51.81.74.12.8
Subcutaneous Insulin6.35.55.34.64.44.24.33.83.73.93.43.83.53.63.33.53.13.13.03.23.03.12.92.52.92.72.92.62.82.52.52.82.62.62.22.52.62.72.32.42.32.22.62.12.32.22.32.12.12.11.92.32.01.92.22.12.12.12.12.42.01.71.43.92.4

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Insulin Antibodies

Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL). (NCT00137046)
Timeframe: Baseline through Extension Month 39

,
InterventionmicroU/mL (Median)
Baseline (n=284, 283)Week 3 (n=262, 260)Week 6 (n=267, 260)Month 3 (n=271, 274)Week 18 (n=263, 271)Month 6 (n=254, 268)Month 9 (n=244, 262)Month 12 (n=234, 258)Month 15 (n=230, 250)Month 18 (n=226, 233)Month 21 (n=216, 228)Month 24 (n=212, 224)Follow-up Month 1 (n=234, 209)Follow-up Month 3 (n=245, 226)Follow-up Month 6 (n=239, 223)Extension Month 1 (n=164, 176)Extension Month 3 (165, 177)Extension Month 6 (n=162, 176)Extension Month 9 (n=154, 167)Extension Month 12 (n=155, 167)Extension Month 15 (n=149, 163)Extension Month 18 (n=149, 160)Extension Month 21 (n=151, 157)Extension Month 24 (n=146, 153)Extension Month 27 (n=138, 148)Extension Month 30 (n=139, 150)Extension Month 33 (n=129, 142)Extension Month 36 (n=104, 132)Extension Month 39 (n=54, 66)
Inhaled Insulin4.507.5015.0031.0049.0088.50134.50142.50109.5091.0059.5067.0041.5028.0022.0037.5045.0042.5041.0049.0043.0045.0044.0042.5035.0036.0035.0030.5025.50
Subcutaneous Insulin4.103.604.004.254.405.104.954.904.704.403.854.404.204.204.404.504.403.554.704.304.503.603.604.406.355.254.303.651.58

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Severe Hypoglycemic Event Rates

Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months * 100. (NCT00137046)
Timeframe: Month 1 through Extension Month 39

,
Interventionevents / subject months * 100 (Number)
Month 1 (n=288, 286)Month 2 (n=282, 286)Month 3 (n=279, 285)Month 4 (n=273, 282)Month 5 (n=266, 280)Month 6 (n=263, 277)Month 7 (n=259, 275)Month 8 (n=257, 273)Month 9 (n=254, 272)Month 10 (n=249, 270)Month 11 (n=245, 269)Month 12 (n=243, 267)Month 13 (n=239, 265)Month 14 (n=237, 260)Month 15 (n=236, 258)Month 16 (n=236, 256)Month 17 (n=235, 252)Month 18 (n=233, 250)Month 19 (n=232, 250)Month 20 (n=227, 245)Month 21 (n=226, 244)Month 22 (n=226, 243)Month 23 (n=224, 238)Month 24 (n=222, 239)Extension Month 1 (n=177, 187)Extension Month 2 (n=177, 187)Extension Month 3 (n=172, 185)Extension Month 4 (n=169, 182)Extension Month 5 (n=169, 182)Extension Month 6 (n=168, 182)Extension Month 7 (n=167, 181)Extension Month 8 (n=167, 178)Extension Month 9 (n=165, 177)Extension Month 10 (n=165, 176)Extension Month 11 (n=162, 175)Extension Month 12 (n=160, 175)Extension Month 13 (n=158, 174)Extension Month 14 (n=156, 173)Extension Month 15 (n=156, 173)Extension Month 16 (n=156, 172)Extension Month 17 (n=156, 172)Extension Month 18 (n=156, 172)Extension Month 19 (n=155, 172)Extension Month 20 (n=155, 170)Extension Month 21 (n=155, 169)Extension Month 22 (n=155, 165)Extension Month 23 (n=152, 164)Extension Month 24 (n=152, 163)Extension Month 25 (n=150, 162)Extension Month 26 (n=149, 160)Extension Month 27 (n=147, 159)Extension Month 28 (n=146, 158)Extension Month 29 (n=145, 155)Extension Month 30 (n=143, 153)Extension Month 31 (n=141, 153)Extension Month 32 (n=138, 152)Extension Month 33 (n=136, 150)Extension Month 34 (n=131, 148)Extension Month 35 (n=122, 147)Extension Month 36 (n=113, 138)Extension Month 37 (n=88, 104)Extension Month 38 (n=66, 73)Extension Month 39 (n=53, 64)Overall Comparative (n=288, 286)Overall Extension (n=177, 187)
Inhaled Insulin10.27.96.53.40.03.82.32.04.00.82.12.51.31.31.72.63.92.60.40.41.80.90.90.83.94.04.01.42.70.00.70.02.10.02.81.40.71.41.40.70.70.01.42.11.42.11.40.71.52.20.70.00.00.83.10.02.40.80.01.00.00.00.82.81.4
Subcutaneous Insulin9.17.46.04.34.36.54.04.05.23.33.03.82.73.53.12.01.65.62.44.92.92.12.62.61.27.02.41.24.23.02.42.44.93.01.24.31.83.111.113.75.67.56.92.53.81.33.23.20.00.70.03.40.70.70.01.41.41.45.90.93.80.01.74.13.3

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Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)

Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed. (NCT00137046)
Timeframe: Month 3 through Extension Follow-up 3

,
Interventionparticipants (Number)
Month 3 (n=277, 263)Month 6 (n=262, 273)Month 9 (n=251, 264)Month 12 (n=242, 259)Month 15 (n=236, 250)Month 18 (n=227, 232)Month 21 (n=218, 224)Month 24 (n=211, 219)Follow-up Month 1 (n=242, 209)Follow-up Month 3 (n=249, 225)Follow-up Month 6 (n=240, 218)Extension Month 1 (n=166, 175)Extension Month 3 (n=161, 175)Extension Month 6 (n=158, 170)Extension Month 9 (n=151, 164)Extension Month 12 (n=152, 161)Extension Month 15 (n=153, 162)Extension Month 18 (n=148, 160)Extension Month 21 (n=144, 158)Extension Month 24 (n=141, 153)Extension Month 27 (n=136, 146)Extension Month 30 (n=136, 147)Extension Month 33 (n=127, 139)Extension Month 36 (n=105, 126)Extension Month 39 (n=52, 64)Extension Follow Up Month 3 (n=115, 102)
Inhaled Insulin00013023235242321443664725
Subcutaneous Insulin00101332231222200355423311

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Total Daily Short-Acting Insulin Dose Adjusted for Body Weight

Total Daily Short-Acting Insulin Dose adjusted for body weight (milligrams [mg] or units divided by kilograms [kg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. (NCT00137046)
Timeframe: Month 3 through Extension Month 39

,
Interventionmg/kg, units/kg (Mean)
Month 3 (n=280, 285)Month 6 (n=271, 281)Month 9 (n=257, 271)Month 12 (n=243, 266)Month 15 (n=237, 255)Month 18 (n=234, 241)Month 21 (n=224, 235)Month 24 (n=219, 232)Extension Month 1 (n=170, 179)Extension Month 3 (n=170, 178)Extension Month 6 (n=166, 179)Extension Month 9 (n=160, 174)Extension Month 12 (n=159, 169)Extension Month 15 (n=156, 167)Extension Month 18 (n=153, 167)Extension Month 21 (n=154, 166)Extension Month 24 (n=150, 156)Extension Month 27 (n=142, 153)Extension Month 30 (n=141, 149)Extension Month 33 (n=133, 144)Extension Month 36 (n=113, 136)Extension Month 39 (n=57, 67)
Inhaled Insulin (mg/kg)0.140.150.160.170.170.180.190.190.150.170.180.190.200.190.190.190.200.200.200.200.210.23
Subcutaneous Insulin (Units/kg)0.340.340.340.340.340.340.340.340.350.350.340.350.340.350.350.350.360.360.370.360.360.39

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Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)

Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. (NCT00137046)
Timeframe: Month 3 through Extension Month 39

,
Interventionmg, units (Mean)
Month 3 (n=280, 285)Month 6 (n=271, 281)Month 9 (n=257, 271)Month 12 (n=243, 266)Month 15 (n=237, 255)Month 18 (n=234, 241)Month 21 (n=224, 235)Month 24 (n=219, 232)Extension Month 1 (n=170, 179)Extension Month 3 (n=170, 178)Extension Month 6 (n=166, 179)Extension Month 9 (n=160, 174)Extension Month 12 (n=159, 169)Extension Month 15 (n=156, 167)Extension Month 18 (n=153, 167)Extension Month 21 (n=154, 166)Extension Month 24 (n=150, 156)Extension Month 27 (n=142, 153)Extension Month 30 (n=141, 149)Extension Month 33 (n=133, 144)Extension Month 36 (n=113, 136)Extension Month 39 (n=57, 67)
Inhaled Insulin (mg)10.4511.5011.9712.6913.1213.6014.4214.6111.4912.5013.6414.0614.7413.9313.9714.5314.4814.8214.9215.2815.7217.92
Subcutaneous Insulin (Units)25.0525.1424.9025.3225.1125.2025.4525.2325.8425.9425.3926.1925.4925.8026.0425.9527.2626.6327.2226.7127.0429.75

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Total Daily Long-Acting Insulin Dose Adjusted for Body Weight

Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups. (NCT00137046)
Timeframe: Month 3 through Extension Month 39

,
Interventionunits/kg (Mean)
Month 3 (n=280, 285)Month 6 (n=271, 280)Month9 (n=256, 269)Month 12 (n=243, 262)Month 15 (n=237, 255)Month 18 (n=234, 242)Month 21 (n=224, 233)Month 24 (n=218, 229)Extension Month 1 (n=171, 178)Extension Month 3 (n=170, 177)Extension Month 6 (n=166, 179)Extension Month 9 (n=160, 174)Extension Month 12 (n=159, 169)Extension Month 15 (n=156, 164)Extension Month 18 (n=152, 166)Extension Month 21 (n=154, 165)Extension Month 24 (n=150, 153)Extension Month 27 (n=142, 153)Extension Month 30 (n=141, 148)Extension Month 33 (n=133, 144)Extension Month 36 (n=113, 136)Extension Month 39 (n=57, 67)
Inhaled Insulin0.410.410.410.410.420.420.420.430.450.440.430.440.440.440.440.440.440.430.420.420.400.39
Subcutaneous Insulin0.480.490.490.490.490.500.510.500.490.490.480.490.470.490.480.480.490.490.490.480.460.45

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Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)

Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight; long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups. (NCT00137046)
Timeframe: Month 3 through Extension Month 39

,
Interventionunits (Mean)
Month 3 (n=280, 285)Month 6 (n=271, 280)Month 9 (n=256, 269)Month 12 (n=243, 262)Month 15 (n=237, 255)Month 18 (n=234, 242)Month 21 (n=224, 233)Month 24 (n=218, 229)Extension Month 1 (n=171, 178)Extension Month 3 (n=170, 177)Extension Month 6 (n=166, 179)Extension Month 9 (n=160, 174)Extension Month 12 (n=159, 169)Extension Month 15 (n=156, 164)Extension Month 18 (n=152, 166)Extension Month 21 (n=154, 165)Extension Month 24 (n=150, 153)Extension Month 27 (n=142, 153)Extension Month 30 (n=141, 148)Extension Month 33 (n=133, 144)Extension Month 36 (n=113, 136)Extension Month 39 (n=57, 67)
Inhaled Insulin30.5230.5730.6930.6530.9930.9731.3031.8232.8432.4531.9632.7332.2932.0232.3731.8331.9931.2531.0630.7129.6229.07
Subcutaneous Insulin34.9735.3735.3535.4235.7536.3536.7536.2135.6735.1034.7535.2233.8235.5234.8835.1435.6135.5835.3434.8333.5833.63

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Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)

Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity [DLco] measured in milliters/minutes/millimeters of mercury [mL/min/mmHg] at observation minus Baseline value). (NCT00137046)
Timeframe: Baseline through Extension Follow-up Month 3

,
InterventionmL/min/mmHg (Mean)
Baseline (n=283, 281)Month 3 (n=277, 264)Month 6 (n=262, 273)Month 9 (n=250, 266)Month 12 (n=241, 258)Month 15 (n=235, 249)Month 18 (n=227, 232)Month 21 (n=218, 224)Month 24 (n=208, 219)Follow-up Month 1 (n=242,208)Follow-up Month 3 (n=247,225)Follow-up Month 6 (n=240,218)Extension Month 1 (n=166,175)Extension Month 3 (n=161,173)Extension Month 6 (n=158,169)Extension Month 9 (n=151,163)Extension Month 12 (n=152,161)Extension Month 15 (n=143,160)Extension Month 18 (n=148,159)Extension Month 21 (n=144,156)Extension Month 24 (n=140,152)Extension Month 27 (n=136,144)Extension Month 30 (n=135,146)Extension Month 33 (n=127,139)Extension Month 36 (n=105,122)Extension Month 39 (n=52, 64)Extension Month 39 (LOCF) (n=177, 187)Extension Follow Up Month 3 (n=115, 101)
Inhaled Insulin28.09-1.09-1.17-1.16-1.40-1.16-1.21-1.29-1.28-0.81-0.77-0.77-1.15-1.43-1.38-1.17-1.70-1.70-1.67-1.51-1.63-1.25-1.36-1.31-1.53-2.02-1.66-0.89
Subcutaneous Insulin27.18-0.29-0.26-0.41-0.41-0.42-0.45-0.56-0.71-0.81-0.80-0.67-0.55-0.73-0.78-0.74-0.70-0.72-1.02-0.88-0.70-0.76-0.75-0.81-0.96-0.93-0.90-1.11

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Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)

Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. (NCT00138671)
Timeframe: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

,
Interventionmg, Units (Mean)
Week 1 (n=54, 40)Week 2 (n=51, 41)Week 3 (n=52, 39)Week 4 (n=53, 41)Week 6 (n=55, 40)Week 9 (n=48, 35)Week 12 (n=52, 41)Week 18 (n=52, 40)Week 26 (n=52, 38)Week 39 (n=49, 35)Week 52 (n=48, 34)
Inhaled Insulin12.3413.0314.1014.1715.1715.8215.6416.4716.7117.2216.85
Subcutaneous Insulin32.7432.0832.8831.8533.4236.6533.5835.3637.7337.4739.28

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Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)

Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. Dose was adjusted for body weight (mg divided by kg or units divided by kg). (NCT00138671)
Timeframe: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

,
Interventionmg/kg, Units/kg (Mean)
Week 1 (n=52, 40)Week 2 (n=51, 40)Week 3 (n=49, 39)Week 4 (n=51, 41)Week 6 (n=54, 39)Week 9 (n=47, 34)Week 12 (n=49, 41)Week 18 (n=52, 37)Week 26 (n=52, 38)Week 39 (n=47, 34)Week 52 (n=43, 27)
Inhaled Insulin0.130.140.150.150.160.170.170.170.180.180.18
Subcutaneous Insulin0.330.330.330.320.340.360.340.370.380.380.40

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Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)

Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. (NCT00138671)
Timeframe: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

,
InterventionUnits (Mean)
Week 1 (n=53, 40)Week 2 (n=50, 41)Week 3 (n=51, 39)Week 4 (n=52, 41)Week 6 (n=54, 40)Week 9 (n=47, 35)Week 12 (n=51, 41)Week 18 (n=51, 40)Week 26 (n=51, 38)Week 39 (n=49, 35)Week 52 (n=48, 34)
Inhaled Insulin43.7844.9647.0447.5049.5648.6849.2350.8750.4749.9950.66
Subcutaneous Insulin48.1848.0450.5350.3051.3456.7252.3253.8355.7853.1053.39

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Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)

Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg). (NCT00138671)
Timeframe: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

,
InterventionUnits/kg (Mean)
Week 1 (n=51, 40)Week 2 (n=50, 40)Week 3 (n=49, 39)Week 4 (n=50, 41)Week 6 (n=53, 39)Week 9 (n=46, 34)Week 12 (n=49, 41)Week 18 (n=51, 37)Week 26 (n=51, 38)Week 39 (n=47, 34)Week 52, (n=43, 27)
Inhaled Insulin0.460.470.500.490.520.500.510.530.520.510.52
Subcutaneous Insulin0.480.480.500.500.510.570.520.550.550.540.56

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Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval. (NCT00138671)
Timeframe: 0 to 1 week to > 9 months

,
Interventionevents/subject-month (crude event rate) (Number)
0 to 1 week (n=59, 43)> 1 to 2 weeks (n=59, 43)> 2 to 3 weeks (n=59, 43)> 3 to 4 weeks (n=59, 42)> 4 to 6 weeks (n=57, 42)> 6 to 9 weeks (n=56, 42)> 9 to 12 weeks (n=55, 41)> 3 to 6 months (n=52, 41)> 6 to 9 months (n=52, 37)> 9 months (n=50, 35)Overall (n=59, 43)
Inhaled Insulin0.000.070.000.070.080.050.050.020.010.010.02
Subcutaneous Insulin0.000.000.000.100.050.030.070.010.010.020.02

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Insulin Dose Responsiveness for FEV1

FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value). (NCT00138671)
Timeframe: Baseline, Week 9, Week 51

,
InterventionL (Mean)
Baseline, 10 minutes (n=50, 39)Baseline, 60 minutes (n=50, 39)Week 9, 10 minutes (n=42, 31)Week 9, 60 minutes (n=42, 30)Week 51, 10 minutes (n=46, 31)Week 51, 60 minutes (n=45, 31)
Inhaled Insulin0.009-0.004-0.0040.011-0.0210.005
Subcutaneous Insulin0.0220.0200.0160.030-0.002-0.020

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Severe Hypoglcyemic Event Rates

An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval. (NCT00138671)
Timeframe: 0 to 1 month to > 11 months

,
Interventionevents / 100 subject-months (Number)
0 to 1 month (n=57, 43)> 1 to 2 months (n=56, 42)> 2 to 3 months (n=55, 42)> 3 to 4 months (n=52, 41)> 4 to 5 months (n=52, 40)> 5 to 6 months (n=52, 38)> 6 to 7 months (n=52, 37)> 7 to 8 months (n=51, 36)> 8 to 9 months (n=51, 36)> 9 to 10 months (n=51, 36)> 10 to 11 months (n=49, 34)> 11 months (n=47, 33)Overall (n=57, 43)
Inhaled Insulin1.711.790.000.000.000.000.000.001.962.010.000.000.64
Subcutaneous Insulin2.350.000.000.000.000.000.000.000.000.000.000.000.22

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Insulin Dose Responsiveness for DLco

DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value). (NCT00138671)
Timeframe: Baseline, Week 9, Week 51

,
InterventionmL/min/mmHg (Mean)
Baseline, 10 minutes (n=48, 39)Baseline, 60 minutes (n=49, 39)Week 9, 10 minutes (n=41, 30)Week 9, 60 minutes (n=42, 29)Week 51, 10 minutes (n=44, 31)Week 51, 60 minutes (n=44, 31)
Inhaled Insulin-0.461-0.597-0.1820.013-0.465-0.395
Subcutaneous Insulin-0.195-0.160-0.238-0.3730.054-0.163

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Incidence of Severe COPD Exacerbations

Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval. (NCT00138671)
Timeframe: 0 to 1 week to > 9 months

,
Interventionevents/subject-month (crude event rate) (Number)
0 to 1 week (n=59, 43)> 1 to 2 weeks (n=59, 43)> 2 to 3 weeks (n=59, 43)> 3 to 4 weeks (n=59, 42)> 4 to 6 weeks (n=57, 42)> 6 to 9 weeks (n=56, 42)> 9 to 12 weeks (n=55, 41)> 3 to 6 months (n=52, 41)> 6 to 9 months (n=52, 37)> 9 months (n=50, 35)Overall (n= 59, 43)
Inhaled Insulin0.000.000.000.000.000.000.000.000.010.000.00
Subcutaneous Insulin0.000.000.000.000.000.000.000.000.000.000.00

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Hypoglycemic Event Rates

A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval. (NCT00138671)
Timeframe: 0 to1 month to > 11 months

,
Interventionevents / subject-month (Number)
0 to 1 month (n=57, 43)> 1 to 2 months (n=56, 42)> 2 to 3 months (n=55, 42)> 3 to 4 months (n=52, 41)> 4 to 5 months (n=52, 40)> 5 to 6 months (n=52, 38)> 6 to 7 months (n=52, 37)> 7 to 8 months (n=51, 36)> 8 to 9 months (n=51, 36)> 9 to 10 months (n=51, 36)> 10 to 11 months (n=49, 34)> 11 months (n=47, 33)Overall (n=57, 43)
Inhaled Insulin1.761.251.210.870.960.690.620.670.590.500.750.620.89
Subcutaneous Insulin1.360.980.970.671.011.130.920.750.780.520.510.260.84

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Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value). (NCT00138671)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

,
InterventionL (Mean)
Week 1 (n=52, 39)Week 2 (n=51, 40)Week 3 (n=47, 40)Week 4 (n=50, 38)Week 6 (n=53, 38)Week 12 (n=48, 41)Week 18 (n=52, 37)Week 26 (n=52, 38)Week 39, (n=47, 34)Week 52 (n=45, 30)
Inhaled Insulin-0.021-0.039-0.026-0.050-0.045-0.056-0.049-0.067-0.053-0.068
Subcutaneous Insulin-0.018-0.042-0.048-0.039-0.070-0.007-0.071-0.096-0.092-0.128

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Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)

DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value). (NCT00138671)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

,
InterventionmL/min/mmHg (Mean)
Week 1 (n=51, 40)Week 2 (n=51, 40)Week 3 (n=47, 40)Week 4 (n=50, 39)Week 6 (n=52, 38)Week 12 (n=47, 40)Week 18 (n=51, 36)Week 26 (n=52, 38)Week 39 (n=47, 33)Week 52 (n=45, 29)
Inhaled Insulin-0.263-0.491-0.494-0.640-0.625-0.379-0.287-0.287-0.611-0.614
Subcutaneous Insulin-0.319-0.0310.169-0.482-0.576-0.534-0.286-0.947-0.891-0.882

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Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value). (NCT00138671)
Timeframe: Baseline, Weeks 6, 12, 26, 39, and 52

,
Interventionpercent (Mean)
Week 6 (n=56, 40)Week 12 (n=50, 41)Week 26 (n=52, 38)Week 39 (n=48, 35)Week 52 (n=46, 32)Week 52 LOCF (n=57, 43)
Inhaled Insulin-0.40-0.53-0.39-0.34-0.30-0.28
Subcutaneous Insulin-0.48-0.42-0.32-0.20-0.23-0.26

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Bronchodilator Responsiveness as Determined by the Change in FEV1

Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100. (NCT00138671)
Timeframe: Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

,
Interventionpercent change (Mean)
Week 1 (n=52, 39)Week 2 (n=51, 40)Week 3 (n=47, 40)Week 4 (n=50, 38)Week 6 (n=53, 38)Week 12 (n=48, 41)Week 18 (n=52, 37)Week 26 (n=52, 38)Week 39 (n=47, 34)Week 52 (n=45, 30)
Inhaled Insulin4.8906.1326.3465.1775.9886.4736.7005.5856.6346.030
Subcutaneous Insulin5.6935.2455.8206.3827.7365.5425.1525.8566.0985.445

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Change From Baseline in Body Weight

Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value). (NCT00138671)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52

,
Interventionkg (Mean)
Week 1 (n=52, 40)Week 2 (n=51, 40)Week 3 (n=49, 41)Week 4 (n=53, 41)Week 6 (n=54, 39)Week 9 (n=47, 34)Week 11 (n=8, 8)Week 12 (n=49, 41)Week 18 (n=52, 37)Week 26 (n=52, 38)Week 39 (n=47, 34)Week 50 (n=8, 6)Week 51 (n=23, 17)Week 52 (n=43, 27)Week 52 LOCF (n=59, 43)
Inhaled Insulin0.250.260.190.190.420.310.030.420.400.850.611.751.210.970.99
Subcutaneous Insulin0.020.150.130.240.260.25-0.140.340.901.992.436.332.673.322.40

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Change From Baseline in Fasting Plasma Glucose

Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value). (NCT00138671)
Timeframe: Baseline, Weeks 6, 12, 26, 39, 52

,
Interventionmg/dL (Mean)
Week 6 (n=52, 39)Week 12 (n=48, 39)Week 26 (n=47, 38)Week 39 (n=47, 33)Week 52 (n=45, 31)Week 52 (LOCF) (n=57, 43)
Inhaled Insulin-24.67-30.73-34.92-20.45-23.40-28.55
Subcutaneous Insulin2.89-0.1810.4510.4312.372.36

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Body Weight: Mean Baseline and Change From Baseline

Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus baseline value. (NCT00139659)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF)

,
Interventionkilograms (Mean)
Baseline (n=113, 124)Week 1: Change from Baseline (n=102, 113)Week 2: Change from Baseline (n=104, 105)Week 3: Change from Baseline (n=103, 113)Week 4: Change from Baseline (n=101, 119)Week 6: Change from Baseline (n=106, 122)Week 9: Change from Baseline (n=101, 104)Week 11: Change from Baseline (n=14, 17)Week 12: Change from Baseline (n=106, 118)Week 18: Change from Baseline (n=110, 116)Week 26: Change from Baseline (n=111, 121)Week 39: Change from Baseline (n=107, 121)Week 50: Change from Baseline (n=19, 13)Week 51: Change from Baseline (n=49, 60)Week 52: Change from Baseline (n=90, 109)Week 52 LOCF: Change from Baseline (n=113, 124)
Inhaled Insulin87.41-0.020.120.180.310.130.140.710.010.350.720.770.040.241.341.13
Subcutaneous Insulin87.131.000.570.340.440.680.910.690.841.271.291.331.980.631.261.44

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Number of Systemic Corticosteroid Rescues

Number of subjects who used a systemic corticosteroid at any time during the study, and the total number of systemic corticosteroid rescues. New rescue event = >=2 consecutive days between the end of one event and the start of another event. (NCT00139659)
Timeframe: Baseline through Week 52

Interventionsystemic corticosteriod rescues (Number)
Inhaled Insulin14
Subcutaneous Insulin16

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Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)

Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline. (NCT00139659)
Timeframe: Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)

,
Interventionml/min/mmHg (Mean)
Baseline (n=128, 131)Week 9 (n=109, 106)Week 51 (n=102, 116)Week 51 LOCF (n=128, 131)
Inhaled Insulin22.836-1.130-1.156-1.185
Subcutaneous Insulin22.718-0.663-0.630-0.533

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Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)

Annualized rates of change (slope throughout time from baseline to end of study[visit]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol. (NCT00139659)
Timeframe: Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52

Interventionml/min/mmHg/yr (Mean)
Inhaled Insulin-0.776
Subcutaneous Insulin-0.273

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Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)

Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline. (NCT00139659)
Timeframe: Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward

,
Interventionliters (Mean)
Baseline (n=130, 133)Week 9 (n=111, 108)Week 51 (n=103, 119)Week 51 LOCF (n=130, 133)
Inhaled Insulin2.449-0.038-0.078-0.068
Subcutaneous Insulin2.403-0.028-0.017-0.018

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Fasting Plasma Glucose

Fasting plasma glucose (milligrams per deciliter [mg/dL]) at Baseline, and change from Baseline. Change from baseline: mean of value of fasting plasma glucose in mg/dL at observation minus baseline value. (NCT00139659)
Timeframe: Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

,
Interventionmg/dL (Mean)
Baseline (n=112, 123)Week 6: Observed Value (n=103, 112)Week 6: Change from Baseline (n=103, 112)Week 12: Observed Value (n=106, 113)Week 12: Change from Baseline (n=106, 113)Week 26: Observed Value (n=102, 114)Week 26: Change from Baseline (n=102, 114)Week 39: Observed Value (n=102, 115)Week 39: Change from Baseline (n=102, 115)Week 52: Observed Value (n=98, 115)Week 52: Change from Baseline (n=98, 115)Week 52 LOCF: Observed Value (n=112, 123)Week 52 LOCF: Change from Baseline (n=112, 123)
Inhaled Insulin149.22143.02-3.34136.32-12.16139.05-11.86143.64-5.67146.32-3.86148.28-0.95
Subcutaneous Insulin149.03136.54-15.19144.47-5.40143.54-4.63142.91-7.47145.43-2.53144.96-4.07

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Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)

Annualized rates of change (slope throughout time from baseline to end of study[visit]) for forced expiratory volume in 1 second (FEV1) (liters per year [L/yr]) measured 30 minutes following the administration of albuterol. (NCT00139659)
Timeframe: Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52

InterventionL/yr (Mean)
Inhaled Insulin-0.070
Subcutaneous Insulin-0.035

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Baseline Dyspnea Index (BDI)

Total score = the sum of the numeric grades from the three dyspnea index questions. Functional Impairment rating scale: Grade 4 (no impairment) to Grade 0 (very severe impairment); Magnitude of Task rating scale: Grade 4 (extraordinary) to Grade 0 (no task); and Magnitude of Effort rating scale: Grade 4 (extraordinary) to grade 0 (no effort). (NCT00139659)
Timeframe: run-in period

,
Interventionscores on scale (Mean)
Functional ImpairmentMagnitude of TaskMagnitude of EffortTotal Score
Inhaled Insulin3.372.292.498.15
Subcutaneous Insulin3.362.292.347.97

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Glycosylated Hemoglobin (HbA1c)

Glycosylated Hemoglobin (HbA1c): observed mean values at Baseline and each observation, and change from Baseline. Change from Baseline = mean HbA1c at observation minus mean HbA1c at Baseline. (NCT00139659)
Timeframe: Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

,
Interventionpercent (Mean)
Baseline (n=135, 135)Week 6: Observed Value (n=127, 126)Week 6: Change from Baseline (n=127, 126)Week 12: Observed Value (n=122, 127)Week 12: Change from Baseline (n=122, 127)Week 26: Observed Value (n=118, 120)Week 26: Change from Baseline (n=118, 120)Week 39: Observed Value (n=108, 123)Week 39: Change from Baseline (n=108, 123)Week 52: Observed Value (n=101, 118)Week 52: Change from Baseline (n=101, 118)Week 52 (LOCF): Observed Value (n=135, 135)Week 52 (LOCF): Change from Baseline (n=135, 135)
Inhaled Insulin7.627.22-0.387.28-0.327.38-0.127.44-0.087.510.007.58-0.04
Subcutaneous Insulin7.436.97-0.436.98-0.487.19-0.257.20-0.217.35-0.057.40-0.03

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Hypoglycemic Event Rates

A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate = total events divided by subject months. Subject months = elapsed number of months a subject was in the study in each time interval. (NCT00139659)
Timeframe: 0 to 1 month to 11 to 12 months, and Overall

,
Interventionevents / subject-months (Number)
0 to 1 month (n=135, 135)> 1 to 2 months (n=135, 135)> 2 to 3 months (n=131, 134)> 3 to 4 months (n=128, 134)> 4 to 5 months (n=126, 134)> 5 to 6 months (n=121, 131)> 6 to 7 months (n=119, 131)> 7 to 8 months (n=115, 129)> 8 to 9 months (n=111, 129)> 9 to 10 months (n=110, 129)> 10 to 11 months (n=109, 125)> 11 to 12 months (n=104, 123)Overall (n=135, 135)
Inhaled Insulin2.992.522.121.841.941.511.501.451.621.261.121.181.79
Subcutaneous Insulin2.482.341.841.611.691.841.671.261.261.551.371.231.68

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Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)

Percent predicted change from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in post-bronchdilator FEV1 measured in liters (L): (observed value minus Baseline value) divided by Baseline value *100%. (NCT00139659)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

,
Interventionpercentage of FEV1 (Mean)
Baseline (n=141, 139)Week 1: % of Predicted Value (n=123, 125)Week 2: % of Predicted Value (n=126, 115)Week 3: % of Predicted Value (n=131, 119)Week 4: % of Predicted Value (n=121, 129)Week 6: % of Predicted Value (n=130, 135)Week 12: % of Predicted Value (n=125, 129)Week 18: % of Predicted Value (n=124, 125)Week 26: % of Predicted Value (n=120, 128)Week 39: % of Predicted Value (n=107, 124)Week 52: % of Predicted Value (n=106, 112)Week 52 LOCF: % of Predicted Value (n=141, 139)Week 1: % Change from Baseline (n=123, 125)Week 2: % Change from Baseline (n=126, 115)Week 3: % Change from Baseline (n=131, 119)Week 4: % Change from Baseline (n=121, 129)Week 6: % Change from Baseline (n=130, 135)Week 12: % Change from Baseline (n=125, 129)Week 18: % Change from Baseline (n=124, 125)Week 26: % Change from Baseline (n=120, 128)Week 39: % Change from Baseline (n=107, 124)Week 52: % Change from Baseline (n=106, 112)Week 52 LOCF: % Change from Baseline (n=141, 139)
Inhaled Insulin83.69881.98781.65580.71181.09381.61182.14582.18782.94182.85180.86980.136-2.682-2.355-2.943-3.063-2.559-1.975-2.437-2.006-3.144-4.777-4.129
Subcutaneous Insulin82.83382.87881.88182.03682.02982.01681.64081.72382.22781.84781.13880.687-1.238-1.142-1.057-0.833-0.957-1.226-1.247-1.189-1.466-2.002-2.108

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Severe Hypoglycemic Event Rates

Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); blood glucose measurement was ≤ 49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Crude event rate = number of events divided by 100 subject-months. Subject months = elapsed number of months subject was in study in each time interval. (NCT00139659)
Timeframe: 0 to 1 month to 11 to 12 months, and Overall

,
InterventionNumber of events/100 subject-months. (Number)
0 to 1 month (n=135, 135)> 1 to 2 months (n=135, 135)> 2 to 3 months (n=131, 134)> 3 to 4 months (n=128, 134)> 4 to 5 months (n=126, 134)> 5 to 6 months (n=121, 131)> 6 to 7 months (n=119, 131)> 7 to 8 months (n=115, 129)> 8 to 9 months (n=111, 129)> 9 to 10 months (n=110, 129)> 10 to 11 months (n=109, 125)> 11 to 12 months (n=104, 123)Overall (n=135, 135)
Inhaled Insulin2.915.224.640.784.053.330.000.895.420.911.883.952.89
Subcutaneous Insulin1.481.492.992.241.512.290.772.331.553.182.413.102.13

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Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin

Carbon Monoxide Diffusing Capacity (DLco) dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin was defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value. (NCT00139659)
Timeframe: Baseline, Week 9, Week 51

,
Interventionml/min/mmHg (Mean)
Baseline: 10 minutes (n=122, 129)Week 9: 10 minutes (n=102, 104)Week 51: 10 minutes (n=95, 109)Baseline: 60 minutes (n=135, 133)Week 9: 60 minutes (n=104, 108)Week 51: 60 minutes (n=101, 110)
Inhaled Insulin-0.163-0.241-0.139-0.446-0.338-0.216
Subcutaneous Insulin-0.184-0.131-0.171-0.451-0.159-0.383

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Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin

Change from Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in one second (FEV1) measured 10 and 60 minutes after the first daily dose of insulin. Insulin dose responsiveness = the difference between FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post dose FEV1 value minus predose FEV1 value. (NCT00139659)
Timeframe: Baseline, Week 9, Week 51

,
Interventionliters (Mean)
Baseline: 10 minutes (n=124, 131)Week 9: 10 minutes (n=105, 106)Week 51: 10 minutes (n=96, 113)Baseline: 60 minutes (n=125, 131)Week 9: 60 minutes (n=105, 105)Week 51: 60 minutes (n=99, 112)
Inhaled Insulin-0.004-0.0080.000-0.0040.0130.029
Subcutaneous Insulin0.0030.0050.0130.0160.0280.020

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Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)

Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value. (NCT00139659)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

,
InterventionmL/min/mmHg (Mean)
Baseline (n=141, 139)Week 1 (n=122, 124)Week 2 (n=126, 112)Week 3 (n=129, 118)Week 4 (n=120, 128)Week 6 (n=129, 135)Week 12 (n=125, 125)Week 18 (n=124, 123)Week 26 (n=119, 127)Week 39 (n=107, 123)Week 52 (n=105, 110)Week 52 LOCF (n=141, 139)
Inhaled Insulin23.023-0.574-0.777-0.811-1.075-1.017-0.961-1.024-0.849-1.016-1.483-1.426
Subcutaneous Insulin22.883-0.333-0.481-0.506-0.576-0.602-0.477-0.549-0.477-0.395-0.798-0.682

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Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)

Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value. (NCT00139659)
Timeframe: Baseline through Week 52 Last Observation Carried Forward (LOCF)

,
Interventionliters (Mean)
Baseline (n=141, 139)Week 1 (n=123, 125)Week 2 (n=126, 115)Week 3 (n=131, 119)Week 4 (n=121, 129)Week 6 (n=130, 135)Week 12 (n=125, 129)Week 18 (n=124, 125)Week 26 (n=120, 128)Week 39 (n=107, 124)Week 52 (n=106, 112)Week 52 LOCF (n=141, 139)
Inhaled Insulin2.559-0.066-0.056-0.077-0.074-0.070-0.053-0.066-0.056-0.088-0.131-0.113
Subcutaneous Insulin2.524-0.027-0.031-0.030-0.022-0.025-0.031-0.040-0.038-0.039-0.059-0.062

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Incidence of Non-severe Asthma Exacerbations

Non-severe asthma exacerbation = one of the following: any home monitored morning (4:45 am - 10:15 am) forced expiratory volume in 1 second (FEV1) <80% of the morning baseline for 2 or more consecutive days; or home monitored FEV1 <60% of Baseline at any time. Percent of Baseline = 100*(daily FEV1)/Baseline weekly FEV1. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months. (NCT00139659)
Timeframe: 0 to 1 week to > 12 months

,
Interventionevents/subject-months (Number)
0 to 1 Week (n=141, 139)>1 to 2 Weeks (n=141, 139)>2 to 3 Weeks (n=141, 139)>3 to 4 Weeks (n=141, 139)>4 to 6 Weeks (n=141, 139)>6 to 9 Weeks (n=138, 139)>9 to 12 Weeks (n=134, 138)>3 Months (n=133, 137)>6 to 9 Months (n=121, 133)>9 to 12 Months (n=114, 131)>12 Months (n=67, 81)Overall (n=141, 139)
Inhaled Insulin0.430.280.220.370.520.530.350.400.300.270.340.35
Subcutaneous Insulin0.410.380.310.410.360.510.460.400.490.430.210.43

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Incidence of Severe Asthma Exacerbations

Severe asthma exacerbation was defined as one of the following: subject received oral (systemic) corticosteriods for the treatment of asthma; or subject had an unscheduled visit to a physician, emergency room, or hospital for the treatment of asthma. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months * 100. (NCT00139659)
Timeframe: 0 to 1 Week to > 12 Months

,
Interventionevents/subject months*100 (Number)
0 to 1 Week (n=141, 139)>1 to 2 Weeks (n=141, 139)>2 to 3 Weeks (n=141, 139)>3 to 4 Weeks (n=141, 139)>4 to 6 Weeks (n=141, 139)>6 to 9 Weeks (n=138, 139)>9 to 12 Weeks (n=134, 138)>3 Months (n=133, 137)>6 to 9 Months (n=121, 133)>9 to 12 Months (n=114, 131)>12 Months (n=67, 81)Overall (n=141, 139)
Inhaled Insulin0.000.000.003.084.631.061.091.201.431.533.391.46
Subcutaneous Insulin0.003.139.390.001.560.000.002.271.011.330.001.47

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Asthma Control as Measured by the Asthma Control Questionnaire©

Asthma Control Questionnaire©: 6 self-administered questions that assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; 7-point ordinal rating scale from 0 (good control) to 6 (poor control). A seventh question was completed by a health professional on forced expiratory volume in 1 second (FEV1) % predicted using a one-week recall period; scale: 0 (>95% predicted) to 6 (<50% predicted). Overall score = mean of questions 1 - 7. (NCT00139659)
Timeframe: Baseline, Weeks 4, 12, 26, 39, 52

,
Interventionscores on scale (Mean)
Baseline: Subject Evaluation (n=138, 138)Baseline: Clinical Evaluation (n=138, 138)Baseline: Overall Evaluation (n=138, 138)Week 4: Subject Evaluation (n=123, 121)Week 4: Clinical Evaluation (n=123, 121)Week 4: Overall Evaluation (n=123, 121)Week 12: Subject Evaluation (n=129, 134)Week 12: Clinical Evaluation (n=129, 134)Week 12: Overall Evaluation (n=129, 134)Week 26: Subject Evaluation (n=121, 131)Week 26: Clinical Evaluation (n=121, 131)Week 26: Overall Evaluation (n=121, 131)Week 39: Subject Evaluation (n=110, 125)Week 39: Clinical Evaluation (n=110, 125)Week 39: Overall Evaluation (n=110, 125)Week 52: Subject Evaluation (n=107, 120)Week 52: Clinical Evaluation (n=107, 120)Week 52: Overall Evaluation (n=107, 120)Week 4: Subject Eval: Change from BL (n=122, 120)Week 4: Clinical Eval: Change from BL (n=122, 120)Week 4: Overall Eval: Change from BL (n=122, 120)Week 12: Subject Eval: Change from BL (n=129, 134)Week 12 Clinical Eval: Change from BL (n=129, 134)Week 12: Overall Eval: Change from BL (n=129, 134)Week 26: Subject Eval: Change from BL (n=121, 130)Week 26 Clinical Eval: Change from BL (n=121, 130)Week 26: Overall Eval: Change from BL (n=121, 130)Week 39: Subject Eval: Change from BL (n=110, 124)Week 39 Clinical Eval: Change from BL (n=110, 124)Week 39: Overall Eval: Change from BL (n=110, 124)Week 52: Subject Eval: Change from BL (n=106, 119)Week 52 Clinical Eval: Change from BL (n=106, 119)Week 52: Overall Eval: Change from BL (n=106, 119)
Inhaled Insulin1.042.501.251.082.681.311.042.551.251.062.481.270.942.541.171.082.771.320.020.170.04-0.020.120.000.050.090.05-0.090.14-0.060.060.380.11
Subcutaneous Insulin1.212.541.401.152.651.361.172.611.371.072.611.291.002.631.230.982.641.21-0.070.14-0.04-0.040.09-0.02-0.120.09-0.09-0.190.11-0.15-0.190.10-0.15

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Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)

Percent predicted change from Baseline in 10 Minute and 60 Minute post-insulin forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in FEV1 measured in liters (L) 10 and 60 Minutes post-insulin. Percent change = (value at observation minus Baseline value) divided by Baseline value *100%. (NCT00139659)
Timeframe: Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)

,
Interventionpercent (Mean)
Baseline: 10 minutes (n=124, 131)Week 9: 10 min.; % of Predicted Value (n=105, 106)Week 9: 10 min;% Change from Baseline (n=105, 106)Week 51: 10 min.;% of Predicted Value (n=96, 113)Week 51:10 min;% Change from Baseline (n=96, 113)Week 51 LOCF:10 min;% Predicted Value (n=124, 131)Week 51 LOCF:10 min;% Change from BL (n=124, 131)Baseline: 60 minutes (n=125, 131)Week 9: 60 min.; % of Predicted Value (n=105, 105)Week 9: 60 min;% Change from Baseline (n=105, 105)Week 51: 60 min.; % of Predicted Value (n=99, 112)Week 51:60 min.;% Change from Baseline (n=99, 112)Week 51 LOCF:60 min;% Predicted Value (n=125, 131)Week 51 LOCF:60 min;% Change from BL (n=125, 131)
Inhaled Insulin94.40292.698-1.86491.668-2.76091.196-3.17694.28493.586-0.45092.302-1.69992.418-1.714
Subcutaneous Insulin94.39194.190-0.45693.7170.22893.882-0.02994.68894.950-0.03194.084-0.24794.300-0.222

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Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)

Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline. (NCT00139659)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

,
Interventionliters (Mean)
Baseline (n=141, 139)Week 1 (n=123, 125)Week 2 (n=126, 115)Week 3 (n=131, 119)Week 4 (n=121, 129)Week 6 (n=130, 135)Week 12 (n=125, 129)Week 18 (n=124, 125)Week 26 (n=120, 128)Week 39 (n=107, 124)Week 52 (n=106, 112)Week 52 LOCF (n=141, 139)
Inhaled Insulin3.355-0.068-0.057-0.078-0.065-0.092-0.045-0.053-0.061-0.080-0.105-0.097
Subcutaneous Insulin3.341-0.046-0.053-0.068-0.051-0.043-0.056-0.069-0.052-0.057-0.088-0.083

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Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)

Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline. (NCT00139659)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)

,
Interventionml/min/mmHg (Mean)
Baseline (n=141, 139)Week 1 (n=123, 125)Week 2 (n=126, 114)Week 3 (n=128, 119)Week 4 (n=122, 127)Week 6 (n=129, 135)Week 12 (n=124, 128)Week 18 (n=123, 125)Week 26 (n=117, 127)Week 39 (n=106, 125)Week 52 (n=105, 111)Week 52 LOCF (n=141, 139)
Inhaled Insulin23.034-0.749-0.835-0.855-1.120-1.169-1.018-0.906-0.945-0.821-1.699-1.557
Subcutaneous Insulin22.911-0.452-0.456-0.556-0.648-0.669-0.725-0.646-0.561-0.550-0.911-0.785

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Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)

Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value. (NCT00139659)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

,
Interventionliters (Mean)
Baseline (141, 139)Week 1 (123, 125)Week 2 (n=127, 117)Week 3 (n=130, 121)Week 4 (n=123, 130)Week 6 (n=130, 135)Week 12 (n=125, 130)Week 18 (n=125, 125)Week 26 (n=120, 129)Week 39 (n=108, 124)Week 52 (n=106, 112)Week 52 LOCF (n=141, 139)
Inhaled Insulin2.435-0.057-0.065-0.067-0.076-0.059-0.067-0.063-0.058-0.076-0.136-0.119
Subcutaneous Insulin2.412-0.035-0.034-0.044-0.037-0.034-0.032-0.042-0.043-0.044-0.056-0.058

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Transition Dyspnea Index (TDI): Change in Total Score

Transition Dyspnea Index total score = sum of the numeric grades from the three dyspnea index questions: Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort. Rating scale: -3 (major deterioration), -2 (moderate deterioration), -1 (minor deterioration, 0 (no change), +1 (minor improvement), +2 (moderate improvement), +3 (major improvement). (NCT00139659)
Timeframe: Week 4, Week 12, Week 26, Week 39, Week 52

,
Interventionscores on scale (Mean)
Week 4 (n=121, 122)Week 12 (n=131, 135)Week 26 (n=124, 131)Week 39 (n=112, 127)Week 52 (n=105, 121)
Inhaled Insulin0.360.510.140.260.13
Subcutaneous Insulin0.500.470.130.290.67

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Total Daily Short-Acting Insulin Dose Adjusted for Body Weight

Total Daily Short-Acting Insulin Dose adjusted for body weight (units divided by kg). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. (NCT00139659)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52

,
Interventionmg/kg, units/kg (Mean)
Baseline (n=109, 122)Week 1 (n=102, 113)Week 2 (n=104, 104)Week 3 (n=103, 112)Week 4 (n=101, 118)Week 6 (n=106, 121)Week 9 (n=101, 104)Week 12 (n=106, 117)Week 18 (n=110, 116)Week 26 (n=111, 121)Week 39 (n=107, 120)Week 52 (n=90, 108)
Inhaled Insulin (mg/kg)0.350.120.140.150.150.160.160.160.180.190.190.19
Subcutaneous Insulin (Units/kg)0.360.340.360.350.370.360.360.380.370.380.380.36

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Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)

Average Total Daily Insulin Dose: short-acting insulin (milligrams [mg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. (NCT00139659)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52

,
Interventionmg, units (Mean)
Baseline (n=109, 122)Week 1 (n=106, 118)Week 2 (n=108, 111)Week 3 (n=106, 116)Week 4 (n=106, 120)Week 6 (n=108, 122)Week 9 (n=106, 110)Week 12 (n=112, 122)Week 18 (n=112, 120)Week 26 (n=113, 122)Week 39 (n=109, 121)Week 52 (n= 103, 119)
Inhaled Insulin (mg)30.5611.0312.1312.9613.4414.0414.0314.4215.1115.9516.1717.20
Subcutaneous Insulin (Units)30.7429.5231.2430.5831.8731.8131.5532.7133.4933.8033.1233.04

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Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol

Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100. (NCT00139659)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52

,
Interventionpercent change in FEV1 (Mean)
Baseline (n=141, 139)Week 1 (n=123, 125)Week 2 (n=126, 115)Week 3 (n=130, 119)Week 4 (n=121, 129)Week 6 (n=130, 135)Week 12 (n=124, 129)Week 18 (n=124, 125)Week 26 (n=120, 128)Week 39 (n=107, 124)Week 52 (n=106, 112)
Inhaled Insulin5.487-0.0150.683-0.0550.056-0.4600.721-0.095-0.186-0.2830.640
Subcutaneous Insulin5.1020.3470.3470.8230.5590.504-0.1000.1540.2110.133-0.035

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Total Daily Long-Acting Insulin Dose Adjusted for Body Weight

"Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.~Inhaled Insulin reported in mg/kg. Subcutaneous Insulin reported in units/kg." (NCT00139659)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52

,
Interventionmg/kg, units/kg (Mean)
Baseline (n=105, 121)Week 1 (n=100, 112)Week 2 (n=103, 104)Week 3 (n=101, 113)Week 4 (n=99, 118)Week 6 (n=104, 121)Week 9 (n=99, 103)Week 12 (n=104, 117)Week 18 (n=108, 115)Week 26 (n=109, 120)Week 39 (n=105, 120)Week 52 (n=88, 108)
Inhaled Insulin (mg/kg)0.470.470.490.490.490.520.510.520.530.520.540.53
Subcutaneous Insulin (Units/kg)0.520.530.520.540.540.550.540.550.550.550.560.55

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Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)

"Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight: long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.~Inhaled Insulin reported in mg. Subcutaneous Insulin reported in units." (NCT00139659)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52

,
Interventionmg, units (Mean)
Baseline (n=105, 121)Week 1 (n=104, 117)Week 2 (n=106, 111)Week 3 (n=104, 117)Week 4 (n=104, 120)Week 6 (n=106, 122)Week 9 (n=104, 109)Week 12 (n=110, 122)Week 18 (n=110, 120)Week 26 (n=111, 122)Week 39 (n=107, 121)Week 52 (n=101, 119)
Inhaled Insulin (mg)41.7041.7543.4843.7544.7045.8946.0146.0547.1547.6548.9750.17
Subcutaneous Insulin (Units)45.5045.4647.1947.6148.5448.5947.6849.0449.9449.9850.3250.07

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Lipids: Median Change From Baseline to Last Observation

Lipids: median changes (milligrams per deciliter [mg/dL]) from Baseline median to last observation in cholesterol (random), triglycerides (random), high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. Normalized data was used in the computations. Last observation = last observation while on study drug or during the lag. Measures of dispersion for median changes in lipids were not determined. (NCT00139659)
Timeframe: Baseline to Last Observation

,
Interventionmg/dL (Number)
Cholesterol (random) (n=110, 121)Triglycerides (random) (n=105, 121)HDL Cholesterol (n=110, 121)LDL Cholesterol (n=97, 110)
Inhaled Insulin-0.59-30
Subcutaneous Insulin0-810

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Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment

Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements. (NCT00143247)
Timeframe: Baseline to 126 months

Interventionliters (Mean)
3 months (n=154)6 months (n=149)12 months (n=138)18 months (n=123)24 months (n=116)30 months (n=108)36 months (n=101)42 months (n=92)48 months (n=88)54 months (n=83)60 months (n=75)66 months (n=70)72 months (n=67)78 months (n=61)84 months (n=57)90 months (n=56)96 months (n=54)102 months (n=50)108 months (n=42)114 months (n=35)120 months (n=23)126 months (n=11)
Inhaled Insulin-0.077-0.101-0.137-0.141-0.184-0.210-0.253-0.288-0.307-0.291-0.312-0.344-0.363-0.376-0.421-0.446-0.455-0.469-0.496-0.510-0.490-0.634

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Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment

Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements. (NCT00143247)
Timeframe: baseline to 126 months

InterventionmL/min/mm Hg (Mean)
6 months (n=149)12 months (n=130)18 months (n=115)24 months (n=113)30 months (n=100)36 months (n=95)42 months (n=86)48 months (n=82)54 months (n=80)60 months (n=70)66 months (n=64)72 months (n=62)78 months (n=59)84 months (n=57)90 months (n=50)96 months (n=52)102 months (n=42)108 months (n=40)114 months (n=35)120 months (n=26)126 months (n=22)
Inhaled Insulin-1.200-1.262-1.883-2.012-1.601-2.122-2.550-1.827-2.118-2.037-2.377-1.401-1.532-1.111-0.919-0.609-1.504-2.397-2.450-2.028-2.126

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Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment

Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity. (NCT00143247)
Timeframe: 3 to >=108 months

Interventionparticipants (Number)
3 months (n=154)6 months (n=151)12 months (n=138)18 months (n=123)24 months (n=116)30 months (n=108)36 months (n=101)42 months (n=92)48 months (n=88)54 months (n=83)60 months (n=75)66 months (n=70)72 months (n=67)78 months (n=61)84 months (n=57)90 months (n=56)96 months (n=54)102 months (n=50)>=108 months (n=42)
Inhaled Insulin2191415262630302422282519212625212529

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Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment

Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity. (NCT00143247)
Timeframe: 6 to >=108 months

Interventionparticipants (Number)
6 months (n=149)12 months (n=130)18 months (n=115)24 months (n=113)30 months (n=100)36 months (n=95)42 months (n=86)48 months (n=82)54 months (n=80)60 months (n=70)66 months (n=64)72 months (n=62)78 months (n=59)84 months (n=57)90 months (n=50)96 months (n=52)102 months (n=42)>=108 months (n=41)
Inhaled Insulin1681321141413111110118111054413

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Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)

observed values by duration of treatment. (NCT00143247)
Timeframe: 36 to 126 months

Interventionpercent binding (Median)
36 months (n=22)42 months (n=9)48 months (n=21)54 months (n=20)60 months (n=17)66 months (n=16)72 months (n=14)78 months (n=14)84 months (n=14)90 months (n=12)96 months (n=12)102 months (n=11)108 months (n=11)114 months (n=11)120 months (n=10)126 months (n=8)
Inhaled Insulin2.751.501.501.501.501.501.501.501.501.501.501.504.004.001.501.50

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Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)

Observed values by duration of treatment. (NCT00143247)
Timeframe: 6 to 120 months

Interventionpercent binding (Median)
6 months (n=58)12 months (n=48)18 months (n=5)24 months (n=41)30 months (n=4)36 months (n=37)42 months (n=33)48 months (n=32)54 months (n=30)60 months (n=25)66 months (n=30)72 months (n=24)78 months (n=23)84 months (n=20)90 months (n=18)96 months (n=18)102 months (n=14)108 months (n=13)114 months (n=9)120 months (n=6)
Inhaled Insulin1.502.2510.001.507.251.501.501.501.501.501.501.501.501.501.501.501.501.501.501.50

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Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes

Observed values by duration of treatment. (NCT00143247)
Timeframe: 36 months to 126 months

Interventionpercent binding (Median)
36 months (n=31)42 months (n=4)48 months (n=28)54 months (n=27)60 months (n=26)66 months (n=23)72 months (n=22)78 months (n=24)84 months (n=23)90 months (n=21)96 months (n=23)102 months (n=21)108 months (n=17)114 months (n=15)120 months (n=14)126 months (n=14)
Inhaled Insulin26.0027.0019.0016.0014.0016.0013.0014.0016.0013.0018.0014.0018.0011.008.509.00

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Hypoglycemic Event Rates by Interval of Exubera Treatment

Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled & uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms. (NCT00143247)
Timeframe: 0 to 132 months

Interventionevents / subject-month (Number)
0 to 4 weeks (n=159)>4 to 8 weeks (n=158)>8 to 12 weeks (n=157)>12 weeks to 6 months (n=155)>6 to12 months (n=149)>12 to18 months (n=134)>18 to 24 months (n=122)>24 to 30 months (n=112)>30 to 36 months (n=107)>36 to 42 months (n=98)>42 to 48 months (n=91)>48 to 54 months (n=85)>54 to 60 months (n=80)>60 to 66 months (n=74)>66 to 72 months (n=70)>72 to 78 months (n=64)>78 to 84 months (n=59)>84 to 90 months (n=58)>90 to 96 months (n=56)>96 to 102 months (n=52)>102 to 108 months (n=48)>108 to 114 months (n=40)>114 to 120 months (n=37)>120 to 126 months (n=25)>126 to 132 months (n=18)Overall (n=159)
Inhaled Insulin2.382.101.921.881.911.631.961.991.781.541.471.361.381.321.421.471.741.631.671.521.161.511.411.130.921.65

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Change in Glycosylated Hemoglobin by Duration of Exubera Treatment

Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements. (NCT00143247)
Timeframe: Baseline to 126 months

Interventionpercent HbA1C (Mean)
3 months (n=155)6 months (n=146)12 months (n=136)18 months (n=121)24 months (n=115)30 months (n=107)36 months (n=99)42 months (n=93)48 months (n=88)54 months (n=83)60 months (n=75)66 months (n=70)72 months (n=67)78 months (n=62)84 months (n=57)90 months (n=56)96 months (n=54)102 months (n=50)108 months (n=42)114 months (n=37)120 months (n=31)126 months (n=23)
Inhaled Insulin-0.99-0.90-0.60-0.66-0.65-0.67-0.60-0.61-0.48-0.50-0.48-0.56-0.61-0.80-0.71-0.75-0.58-0.77-0.68-0.78-0.39-0.08

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Severe Hypoglycemic Event Rates by Interval of Exubera Treatment

Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled & uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose. (NCT00143247)
Timeframe: 0-132 months

Interventionsevere events / 100 subject-months (Number)
0-4 weeks (n=159)>4-8 weeks (n=158)>8-12 weeks (n=157)>12 weeks-6months (n=155)>6-12 months (n=149)>12-18 months (n=134)>18-24 months (n=122)>24-30 months (n=112)>30-36 months (n=107)>36-42 months (n=98)>42-48 months (n=91)>48-54 months (n=85)>54-60 months (n=80)>60-66 months (n=74)>66-72 months (n=70)>72-78 months (n=64)>78-84 months (n=59)>84-90 months (n=58)>90-96 months (n=56)>96-102 months (n=52)>102-108 months (n=48)>108-114 months (n=40)>114-120 months (n=37)>120-126 months (n=25)>126-132 months (n=18)Overall (n=159)
Inhaled Insulin1.372.760.702.641.070.930.851.070.970.180.190.600.870.470.750.271.141.470.311.320.390.440.54000.88

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Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment

Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume. (NCT00143247)
Timeframe: 3 to >=108 months

Interventionparticipants (Number)
3 months (n=154)6 months (n=149)12 months (n=138)18 months (n=123)24 months (n=116)30 months (n=108)36 months (n=101)42 months (n=92)48 months (n=88)54 months (n=83)60 months (n=75)66 months (n=70)72 months (n=67)78 months (n=61)84 months (n=57)90 months (n=56)96 months (n=54)102 months (n=50)>=108 months (n=42)
Inhaled Insulin256591418181914211917172124192427

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Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months

For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group. (NCT00184600)
Timeframe: Baseline, month 12

,,
Interventionmg/dL (Mean)
All timepoints excluding 3amFastingPostprandial3am
Biphasic Insulin Aspart 30 (Biphasic Insulin)-59-45-68-52
Insulin Aspart (Prandial Insulin)-65-23-83-34
Insulin Detemir (Basal Insulin)-43-59-47-40

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HbA1c (Glycosylated Haemoglobin) at Month 12

HbA1c values offer evidence of the efficacy and durability of the insulin regimens. (NCT00184600)
Timeframe: Baseline, Month 12

,,
Interventionpercentage (%) of total haemoglobin (Mean)
BaselineMonth 12
Biphasic Insulin Aspart 30 (Biphasic Insulin)8.637.33
Insulin Aspart (Prandial Insulin)8.557.20
Insulin Detemir (Basal Insulin)8.457.64

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Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%

Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36 (NCT00184600)
Timeframe: Month 36

Interventionpercentage of participants (Number)
Insulin Detemir (Basal Insulin)43.2
Insulin Aspart (Prandial Insulin)44.8
Biphasic Insulin Aspart 30 (Biphasic Insulin)31.9

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Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%

Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%. (NCT00184600)
Timeframe: Month 36

,,
Interventionhypoglycaemic events/participant/year (Median)
All participants, Grade 1All participants, Grade 2All participants, Grade 3All participants, Grade 2 or 3Achieved HbA1c target, Grade 1, n=73, 70, 55Achieved HbA1c target, Grade 2, n=73, 70, 55Achieved HbA1c target, Grade 3, n=73, 70, 55Achieved HbA1c target, Grade 2 or 3, n=73, 70, 55
Biphasic Insulin Aspart 30 (Biphasic Insulin)3.83.003.03.02.703.0
Insulin Aspart (Prandial Insulin)5.75.505.75.75.305.5
Insulin Detemir (Basal Insulin)2.71.701.73.02.002.0

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Change From Baseline in Body Weight at Month 12

(NCT00184600)
Timeframe: Week 0 (baseline), month 12

Interventionkilogram (Mean)
Insulin Detemir (Basal Insulin)1.9
Insulin Aspart (Prandial Insulin)5.7
Biphasic Insulin Aspart 30 (Biphasic Insulin)4.7

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Change From Baseline in Body Weight at Month 36

(NCT00184600)
Timeframe: Week 0 (baseline), month 36

Interventionkilograms (Mean)
Insulin Detemir (Basal Insulin)3.6
Insulin Aspart (Prandial Insulin)6.4
Biphasic Insulin Aspart 30 (Biphasic Insulin)5.7

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Number of Participants Having an 'Other' Adverse Event

(NCT00184600)
Timeframe: Up to month 37 (36 months of treatment plus 1 month follow-up)

Interventionparticipants (Number)
Insulin Detemir (Basal Insulin)227
Insulin Aspart (Prandial Insulin)235
Biphasic Insulin Aspart 30 (Biphasic Insulin)228

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Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%

Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%. (NCT00184600)
Timeframe: Month 12

,,
Interventionhypoglycaemic events/participant/year (Median)
All participants, Grade 1All participants, Grade 2All participants, Grade 3All participants, Grade 2 or 3Achieved HbA1c target, Grade 1, n=18, 50, 39Achieved HbA1c target, Grade 2, n=18, 50, 39Achieved HbA1c target, Grade 3, n=18, 50, 39Achieved HbA1c target, Grade 2 or 3, n=18, 50, 39
Biphasic Insulin Aspart 30 (Biphasic Insulin)5.03.903.95.44.004.0
Insulin Aspart (Prandial Insulin)8.08.008.07.88.008.7
Insulin Detemir (Basal Insulin)2.00003.93.003.0

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Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months

For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group. (NCT00184600)
Timeframe: Baseline, month 36

,,
Interventionmg/dL (Mean)
All timepoints excluding 3amFastingPostprandial3am
Biphasic Insulin Aspart 30 (Biphasic Insulin)-56-50-61-38
Insulin Aspart (Prandial Insulin)-67-49-85-27
Insulin Detemir (Basal Insulin)-58-47-67-45

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Percentage of Participants Who Required A Second Insulin Therapy by Month 12

Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens. (NCT00184600)
Timeframe: Month 12

Interventionpercentage of participants (Number)
Insulin Detemir (Basal Insulin)17.9
Insulin Aspart (Prandial Insulin)4.2
Biphasic Insulin Aspart 30 (Biphasic Insulin)8.9

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HbA1c (Glycosylated Haemoglobin) at Month 36

HbA1c values offer evidence of the efficacy and durability of the insulin regimens. (NCT00184600)
Timeframe: Baseline, Month 36

,,
Interventionpercentage (%) of total haemoglobin (Mean)
BaselineMonth 36
Biphasic Insulin Aspart 30 (Biphasic Insulin)8.637.22
Insulin Aspart (Prandial Insulin)8.557.04
Insulin Detemir (Basal Insulin)8.457.11

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Percentage of Participants Who Required A Second Insulin Therapy by Month 36

Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens. (NCT00184600)
Timeframe: Month 36

Interventionpercentage of participants (Number)
Insulin Detemir (Basal Insulin)89
Insulin Aspart (Prandial Insulin)82
Biphasic Insulin Aspart 30 (Biphasic Insulin)88

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Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%

Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself. (NCT00184600)
Timeframe: Month 12

,,
Interventionpercentage of participants (Number)
Total participants who achieved targetSubset who achieved target, n=18, 50, 39
Biphasic Insulin Aspart 30 (Biphasic Insulin)17.052.5
Insulin Aspart (Prandial Insulin)23.943.9
Insulin Detemir (Basal Insulin)8.178.9

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Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months

The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death. (NCT00184600)
Timeframe: Month 12

Interventionunits on a scale (Mean)
Insulin Detemir (Basal Insulin)0.78
Insulin Aspart (Prandial Insulin)0.76
Biphasic Insulin Aspart 30 (Biphasic Insulin)0.76

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Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months

The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death. (NCT00184600)
Timeframe: Month 36

Interventionunits on a scale (Mean)
Insulin Detemir (Basal Insulin)0.80
Insulin Aspart (Prandial Insulin)0.77
Biphasic Insulin Aspart 30 (Biphasic Insulin)0.76

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Number of Participants Who Experienced Coronary Angiography Planned After Randomization

(NCT00191282)
Timeframe: Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial75
Fasting86

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Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 4 (Month 3)

Interventionepisodes of hypoglycemia (Number)
Postprandial567
Fasting524

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Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 5 (Month 6)

Interventionepisodes of hypoglycemia (Number)
Postprandial770
Fasting576

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Number of Participants Who Experienced a Primary Combined Outcome

The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization. (NCT00191282)
Timeframe: Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial174
Fasting181

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Number of Participants With Self-Reported Hypoglycemia During Month 12

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 7 (Month 12)

Interventionparticipants (Number)
Postprandial146
Fasting130

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Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization

(NCT00191282)
Timeframe: Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial9
Fasting8

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Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control

Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations. (NCT00191282)
Timeframe: Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial174
Fasting181

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Number of Participants With Self-Reported Hypoglycemia During Month 18

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 8 (Month 18)

Interventionparticipants (Number)
Postprandial143
Fasting129

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Number of Participants With Self-Reported Hypoglycemia During Month 3

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 4 (Month 3)

Interventionparticipants (Number)
Postprandial160
Fasting139

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Number of Participants With Self-Reported Hypoglycemia During Month 9

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 6 (Month 9)

Interventionparticipants (Number)
Postprandial155
Fasting138

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Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 6 (Month 9)

,
Interventionepisodes of hypoglycemia (Number)
Number of Episodes
Fasting569
Postprandial747

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Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 8 (Month 18)

Interventionepisodes of hypoglycemia (Number)
Postprandial945
Fasting669

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Summary of Reasons for Deaths

(NCT00191282)
Timeframe: Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

,
Interventionparticipants (Number)
Fatal MIFatal StrokeCV Death other than Stroke/MINon-CV DeathUnknown
Fasting1222881
Postprandial1232970

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Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 7 (Month 12)

Interventionepisodes of hypoglycemia (Number)
Postprandial710
Fasting486

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Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 3 (Month 1)

Interventionepisodes of hypoglycemia (Number)
Postprandial353
Fasting302

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Number of Participants With Self-Reported Hypoglycemia During Month 6

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 5 (Month 6)

Interventionparticipants (Number)
Postprandial163
Fasting145

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Number of Participants Who Experienced Cardiovascular (CV) Death

(NCT00191282)
Timeframe: Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial44
Fasting42

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Number of Participants Who Experienced Myocardial Infarction (MI)

Occurrence of myocardial infarction (MI) (fatal, nonfatal, any). (NCT00191282)
Timeframe: Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial63
Fasting63

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Number of Participants Who Experienced Coronary Revascularization Procedures

Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization. (NCT00191282)
Timeframe: Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial84
Fasting94

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Number of Participants Who Experienced Death From Any Cause

(NCT00191282)
Timeframe: Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial51
Fasting51

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Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes

Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization. (NCT00191282)
Timeframe: Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial178
Fasting189

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Number of Participants Who Experienced Congestive Heart Failure

Occurrence of congestive heart failure (newly diagnosed after Visit 2). (NCT00191282)
Timeframe: Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial33
Fasting37

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Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)

(NCT00191282)
Timeframe: Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial58
Fasting54

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Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors

Primary outcomes adjusted for major cardiovascular (CV) risk factors (blood pressure, cholesterol [total, high density lipoprotein (HDL), and low density lipoprotein (LDL)], triglycerides, smoking, albuminuria, age, gender, and body mass index (BMI). (NCT00191282)
Timeframe: Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial174
Fasting181

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Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization

(NCT00191282)
Timeframe: Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial11
Fasting12

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Number of Participants Who Experienced Stroke

Occurrence of stroke (fatal, nonfatal, any). (NCT00191282)
Timeframe: Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Interventionparticipants (Number)
Postprandial20
Fasting17

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Number of Participants With Self-Reported Hypoglycemia During Month 1

Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL). (NCT00191282)
Timeframe: Visit 3 (Month 1)

Interventionparticipants (Number)
Postprandial124
Fasting119

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Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26

Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26 (NCT00211510)
Timeframe: Baseline and 26 weeks

Interventionmmol/dl*min (Mean)
Paradigm 722 Sensor Augmented Pump-10.2
Paradigm 715 Insulin Pump-9.2

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Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26

Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26 (NCT00211510)
Timeframe: Baseline and 26 weeks

Interventionmmol/dl*min (Mean)
Paradigm 722 Sensor Augmented Pump-0.07
Paradigm 715 Insulin Pump0.281

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Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26

Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26. (NCT00211510)
Timeframe: Baseline and 26 weeks

Interventionhypoglycemic events (Number)
Paradigm 722 Sensor Augmented Pump11
Paradigm 715 Insulin Pump3

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Glucose Sensor Accuracy as Measured in the 722 Group

Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B). (NCT00211510)
Timeframe: Baseline and 26 weeks

Interventionpercent of agreement (Number)
Paradigm 722 Sensor Augmented Pump95.9
Paradigm 715 Insulin PumpNA

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Change in A1c From Baseline to 26 Weeks

Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects. (NCT00211510)
Timeframe: Baseline and 26 weeks

InterventionPercent glycated hemoglobin (Mean)
Paradigm 722 Sensor Augmented Pump-0.72
Paradigm 715 Insulin Pump-0.58

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Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups

Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem. (NCT00211510)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Mean)
Paradigm 722 Sensor Augmented Pump-0.07
Paradigm 715 Insulin Pump-0.22

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Average Daily Blood Glucose

For each subject, a minimum of two blood glucose readings per day was required for calculation of the average daily mean. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months. (NCT00211536)
Timeframe: average from baseline to 12 months

Interventionmg/dL (Mean)
MiniMed Implantable Insulin Pump (MIP)186.77
Subcutaneous Insulin Arm (SC)195.8

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Change in HbA1c and Compared Between Groups

To determine whether Intra Peritoneal insulin delivery via MIP results in glycemic control that is equal to or superior (i.e. not inferior to) control with SC therapy (Ho : μ (IP) -μ (SC) ≥ 0.50% A1C), a repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed was used to compare average A1C trends over time between the two treatment groups (19). Type 3 Least Square (LS) means for each group were assessed. The Estimate statement within SAS proc mixed was used to estimate contrasts among the LS means and confidence intervals for the contrasts. (NCT00211536)
Timeframe: Baseline and 12 months

Interventionpercent HbA1c (Mean)
MiniMed Implantable Insulin Pump (MIP)-0.3122449
Subcutaneous Insulin Arm (SC)0.1191489

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Low Blood Glucose Index (LBGI);

4 to 10 daily blood glucose readings (BG) were required for this measure. LBGI was calculated from BG values collected for 30 days prior to Visit 2 and 30 days following Visits 5 and 7. The continuous measure was compared between the two treatment groups for the three periods with a repeated measures ANOVA using proc mixed. Type 3 least square means for each group were assessed and estimate statements used to make comparisons among the LS means and create confidence intervals on the contrasts. (NCT00211536)
Timeframe: average from baseline to 12 months

Interventionmg/dL (Mean)
MiniMed Implantable Insulin Pump (MIP)2.14
Subcutaneous Insulin Arm (SC)2.27

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Incidence of Severe Hypoglycemia Events

The total number of severe hypoglycemia events, defined as a clinical episode of hypoglycemia (resulting in seizure or coma, requiring hospitalization, intravenous glucose or glucagon administration), or any hypoglycemia that requires assistance from another person, compared between the two study arms from Baseline to 12 months. (NCT00211536)
Timeframe: 12 months

Interventionevents (Number)
MiniMed Implantable Insulin Pump (MIP)2
Subcutaneous Insulin Arm (SC)4

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Mean Amplitude of Glycemic Excursions (MAGE)

MAGE was calculated by taking the arithmetic mean of BG excursions when both ascending and descending segments of the curve exceed one Standard Deviation of the average 24-hour BG value. MAGE was calculated for each subject using SMBG data from periods in which subjects had a minimum of 4 and maximum of 10 readings daily. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months. (NCT00211536)
Timeframe: average from baseline to 12 months

Interventionmg/dL (Mean)
MiniMed Implantable Insulin Pump (MIP)136.27
Subcutaneous Insulin Arm (SC)149.2

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Cerebral Activation During Hypoglycaemia

To compare the high RAS activity vs low RAS activity a Z score was used. (NCT00264641)
Timeframe: After 4 scans on day 1

InterventionZ score (Number)
Low RAS>High RAS Right sup frontal gyrusHigh RAS>Low RAS post entorhinal cortex
All Study Participants4.854.55

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Symptomatic Hypoglycemia

symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period (NCT00282867)
Timeframe: up to 5 days

Interventionparticipants (Number)
Tight Control Group0
Loose Control Group1
Usual Care Group0

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Hypoglycemic Events

hypoglycemic events (NCT00282867)
Timeframe: up to 5 days

Interventionparticipants (Number)
Tight Control Group7
Loose Control Group1
Usual Care Group1

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Favorable 3 Month Modified Rankin

3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap. (NCT00282867)
Timeframe: 3 months

Interventionpercentage of participants (Number)
Tight Control Group42
Loose Control Group25
Usual Care Group33

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Target Glucose Concentration

glucose in target range in first 24 hours (NCT00282867)
Timeframe: first 24 hours after initiation of treatment

Interventionparticipants (Number)
Tight Control Group10
Loose Control Group22

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Percentage of Participants Achieving Glycemic Control by Visit

2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0% (NCT00282971)
Timeframe: 4, 12 and 24 weeks

,
InterventionPercentage of participants (Number)
HbA1c<=7% at week 4 (n=165 and 158 respectively)HbA1c<=7% at week 12 (n=160 and 150 respectively)HbA1c<=7% at week 24 (n=143 and 150 respectively)HbA1c<=7% at wk-24 LOCF (n=178 & 170 respectively)HbA1c<=6.5% at week 4 (n=165 and 158 respectively)HbA1c<=6.5% at week 12 (n=160 &150 respectively)HbA1c<=6.5% at week 24 (n=143 &150 respectively)HbA1c<=6.5% at wk-24 LOCF(n=178 &170 respectively)
Inhaled Insulin6.138.134.332.00.615.618.215.2
Standard of Care0.011.312.012.90.04.76.05.9

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Change From Baseline in FEV1 at Week 24 LOCF

(NCT00282971)
Timeframe: 24 weeks

InterventionLiter (Mean)
Inhaled Insulin-0.27
Standard of Care-0.08

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Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

[(week 24 value - baseline value)/baseline value]*100% (NCT00282971)
Timeframe: 4, 12 and 24 weeks

,
Interventionpercentage change (Mean)
week 4 (n=164 and 158, respectively)week 12 (n=159 and 150, respectively)week 24 (n=142 and 150, respectively)week 24 (LOCF, n=175 and 170, respectively)
Inhaled Insulin-1.08-2.03-2.02-1.94
Standard of Care-0.62-1.37-1.44-1.42

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Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia

"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.~Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL~Severe hypoglycemia: assistance of another party is required & either:~SMBG of <36 mg/dL, or~with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.~Serious hypoglycemia:~Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion." (NCT00283049)
Timeframe: 60 weeks from Baseline

,,
InterventionParticipants (Number)
Any reported symptomatic Hypoglycemic eventSymptomatic events with Self-monitored BG (SMBG)SMBG <70 mg/dL with symptomSMBG <50mg/dL with symptomSMBG <36 mg/dL with symptomSevere HypoglycemiasSevere only due to SMBG <36mg/dLSevere: Prompt response to CHO countermeasureSevere:SMBG<36mg/dL, prompt response to CHOSerious hypoglycemiaComa/Loss of Consciousness
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)1121121128535504200
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)10710610271241015411
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)1101091077423814333

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Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12

(NCT00283049)
Timeframe: 12 weeks from Baseline

InterventionPercentage (Mean)
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)-1.2
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)-1.2
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)-1.2

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Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia

"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.~Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL~Severe hypoglycemia: assistance of another party is required & either:~SMBG of <36 mg/dL, or~with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.~Serious hypoglycemia:~Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion." (NCT00283049)
Timeframe: 60 Weeks from Baseline

,,
Interventionevents/ patient-year (Mean)
Exposure (Patient-years)Hypoglycemic (HE) event with SMBG <70mg/dLHE with SMBG <50mg/dLHE with SMBG <36mg/dLSevere HE (BG<36mg/dL or prompt response to CHOSerious HE (coma/loss of consciousness,seizure)
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)0.96725.35.60.60.10.0
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)0.94316.53.30.30.10.0
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)0.94130.14.90.30.10.0

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Change From Baseline in C-peptide (Week 8).

The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 8.

Interventionng/mL (Least Squares Mean)
Placebo-0.024
Alogliptin 12.5 mg QD0.178
Alogliptin 25 mg QD0.348

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Change From Baseline in C-peptide (Week 4).

The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 4.

Interventionng/mL (Least Squares Mean)
Placebo-0.023
Alogliptin 12.5 mg QD0.132
Alogliptin 25 mg QD0.453

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Change From Baseline in C-peptide (Week 26).

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionng/mL (Least Squares Mean)
Placebo-0.083
Alogliptin 12.5 mg QD0.199
Alogliptin 25 mg QD0.042

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Change From Baseline in Body Weight (Week 12).

The change between Body Weight measured at week 12 and Body Weight measured at baseline. (NCT00286429)
Timeframe: Baseline and Week 12.

Interventionkg (Least Squares Mean)
Placebo0.50
Alogliptin 12.5 mg QD0.44
Alogliptin 25 mg QD0.31

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Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionparticipants (Number)
Placebo17
Alogliptin 12.5 mg QD41
Alogliptin 25 mg QD47

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Change From Baseline in C-peptide (Week 16).

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 16.

Interventionng/mL (Least Squares Mean)
Placebo0.241
Alogliptin 12.5 mg QD0.319
Alogliptin 25 mg QD0.396

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Change From Baseline in C-peptide (Week 12).

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 12.

Interventionng/mL (Least Squares Mean)
Placebo0.207
Alogliptin 12.5 mg QD0.333
Alogliptin 25 mg QD0.390

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Change From Baseline in Body Weight (Week 8).

The change between Body Weight measured at week 8 and Body Weight measured at baseline. (NCT00286429)
Timeframe: Baseline and Week 8.

Interventionkg (Least Squares Mean)
Placebo0.39
Alogliptin 12.5 mg QD0.10
Alogliptin 25 mg QD0.18

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Change From Baseline in Body Weight (Week 26).

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionkg (Least Squares Mean)
Placebo0.63
Alogliptin 12.5 mg QD0.68
Alogliptin 25 mg QD0.60

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Change From Baseline in Body Weight (Week 20).

The change between Body Weight measured at week 20 and Body Weight measured at baseline. (NCT00286429)
Timeframe: Baseline and Week 20.

Interventionkg (Least Squares Mean)
Placebo0.73
Alogliptin 12.5 mg QD0.55
Alogliptin 25 mg QD0.45

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Change From Baseline in Glycosylated Hemoglobin (Week 20).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 20.

Interventionpercentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo-0.17
Alogliptin 12.5 mg QD-0.76
Alogliptin 25 mg QD-0.74

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Change From Baseline in Glycosylated Hemoglobin (Week 4).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 4.

Interventionpercentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo-0.26
Alogliptin 12.5 mg QD-0.47
Alogliptin 25 mg QD-0.58

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Number of Participants Requiring Rescue.

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study. (NCT00286429)
Timeframe: 26 Weeks.

Interventionparticipants (Number)
Placebo52
Alogliptin 12.5 mg QD27
Alogliptin 25 mg QD25

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Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionparticipants (Number)
Placebo0
Alogliptin 12.5 mg QD3
Alogliptin 25 mg QD3

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Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionparticipants (Number)
Placebo1
Alogliptin 12.5 mg QD11
Alogliptin 25 mg QD10

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Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionparticipants (Number)
Placebo5
Alogliptin 12.5 mg QD22
Alogliptin 25 mg QD33

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Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionparticipants (Number)
Placebo40
Alogliptin 12.5 mg QD70
Alogliptin 25 mg QD70

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Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionparticipants (Number)
Placebo6
Alogliptin 12.5 mg QD22
Alogliptin 25 mg QD23

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Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionparticipants (Number)
Placebo0
Alogliptin 12.5 mg QD11
Alogliptin 25 mg QD11

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Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study. (NCT00286429)
Timeframe: 26 Weeks.

Interventionparticipants (Number)
Placebo105
Alogliptin 12.5 mg QD99
Alogliptin 25 mg QD86

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Change From Baseline in Glycosylated Hemoglobin (Week 8).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 8.

Interventionpercentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo-0.27
Alogliptin 12.5 mg QD-0.76
Alogliptin 25 mg QD-0.84

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Change From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 20.

Interventionmg/dL (Least Squares Mean)
Placebo8.6
Alogliptin 12.5 mg QD-4.2
Alogliptin 25 mg QD-11.3

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Change From Baseline in Fasting Plasma Glucose (Week 2).

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 2.

Interventionmg/dL (Least Squares Mean)
Placebo1.0
Alogliptin 12.5 mg QD-3.1
Alogliptin 25 mg QD-11.4

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Change From Baseline in Fasting Plasma Glucose (Week 16).

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 16.

Interventionmg/dL (Least Squares Mean)
Placebo4.6
Alogliptin 12.5 mg QD-5.3
Alogliptin 25 mg QD-6.3

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Change From Baseline in Fasting Plasma Glucose (Week 26).

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionmg/dL (Least Squares Mean)
Placebo5.8
Alogliptin 12.5 mg QD2.3
Alogliptin 25 mg QD-11.7

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Change From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 4.

Interventionmg/dL (Least Squares Mean)
Placebo5.3
Alogliptin 12.5 mg QD-5.0
Alogliptin 25 mg QD-12.1

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Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 8.

Interventionmg/dL (Least Squares Mean)
Placebo5.4
Alogliptin 12.5 mg QD-13.5
Alogliptin 25 mg QD-14.1

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Change From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 12.

Interventionmg/dL (Least Squares Mean)
Placebo-1.4
Alogliptin 12.5 mg QD-5.2
Alogliptin 25 mg QD-2.9

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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 26.

Interventionpercentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo-0.13
Alogliptin 12.5 mg QD-0.63
Alogliptin 25 mg QD-0.71

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Change From Baseline in Glycosylated Hemoglobin (Week 12).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 12.

Interventionpercentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo-0.27
Alogliptin 12.5 mg QD-0.84
Alogliptin 25 mg QD-0.81

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Change From Baseline in Glycosylated Hemoglobin (Week 16).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 16.

Interventionpercentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo-0.22
Alogliptin 12.5 mg QD-0.80
Alogliptin 25 mg QD-0.76

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Change From Baseline in Fasting Plasma Glucose (Week 1).

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 1.

Interventionmg/dL (Least Squares Mean)
Placebo6.3
Alogliptin 12.5 mg QD-5.0
Alogliptin 25 mg QD-9.9

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Change From Baseline in C-peptide (Week 20).

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 20.

Interventionng/mL (Least Squares Mean)
Placebo0.239
Alogliptin 12.5 mg QD0.318
Alogliptin 25 mg QD0.281

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Change From Baseline in Weight to Week 52

Change from baseline in weight at Week 52 (NCT00308308)
Timeframe: Baseline to Week 52

Interventionkilogram (Least Squares Mean)
TI + Insulin Glargine-0.5
Insulin Aspart + Insulin Glargine1.4

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Change From Baseline in Fasting Plasma Glucose to Week 52

Change from baseline in fasting plasma glucose at Week 52 (NCT00308308)
Timeframe: Baseline to Week 52

Interventionmg/dl (Least Squares Mean)
TI + Insulin Glargine-46.5
Insulin Aspart + Insulin Glargine-25.7

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Incidence of Severe Hypoglycemia

"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:~Subject requires the assistance of another person;~Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);~Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,~Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms." (NCT00308308)
Timeframe: Baseline to Week 52

Interventionpercentage of participants (Number)
TI + Insulin Glargine32.08
Insulin Aspart + Insulin Glargine36.40

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Severe Hypoglycemia Event Rate

Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months) (NCT00308308)
Timeframe: Baseline to Week 52

InterventionNumber of events/subject-month (Number)
TI + Insulin Glargine0.08
Insulin Aspart + Insulin Glargine0.10

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Incidence of Total Hypoglycemia

Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms. (NCT00308308)
Timeframe: Baseline to Week 52

Interventionpercentage of participants (Number)
TI + Insulin Glargine85.67
Insulin Aspart + Insulin Glargine92.28

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Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%

Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0% (NCT00308308)
Timeframe: Baseline to Week 52

InterventionParticipants (Number)
TI + Insulin Glargine33
Insulin Aspart + Insulin Glargine35

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Total Hypoglycemia Event Rate

Number of Hypoglycemic Events/Total Subject Exposure Time (in months) (NCT00308308)
Timeframe: Baseline to Week 52

InterventionNumber of events/subject-month (Number)
TI + Insulin Glargine1.81
Insulin Aspart + Insulin Glargine1.86

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Compare the Mean Change From Baseline to Week 52 in HbA1c

(NCT00308308)
Timeframe: Baseline to Week 52

InterventionPercentage (Least Squares Mean)
TI + Insulin Glargine-0.13
Insulin Aspart + Insulin Glargine-0.37

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Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement

Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement (NCT00308737)
Timeframe: Baseline to Month 24

InterventionParticipants (Number)
Technosphere® Insulin181
Usual Care181
Non-diabetes40

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FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care

FEV1 decrease of ≥ 15% from Baseline value at last measurement (NCT00308737)
Timeframe: Baseline to Month 24

InterventionParticipants (Number)
Technosphere® Insulin42
Usual Care27

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Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement

FVC Decrease of ≥15% from Baseline Value at Last Measurement (NCT00308737)
Timeframe: Baseline to Month 24

Interventionparticipants (Number)
Technosphere® Insulin23
Usual Care17
Non-diabetes2

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Change in Weight From Baseline at Month 24

Change from baseline in weight at Month 24 (NCT00308737)
Timeframe: Baseline to Month 24

Interventionkilograms (Mean)
Technosphere® Insulin1.0
Usual Care1.64
Non-diabetes1.19

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Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care

Change from baseline in HbA1c at last measurement (NCT00308737)
Timeframe: Baseline to Month 24

Interventionpercentage (Mean)
Technosphere® Insulin-0.42
Usual Care-0.49

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Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM

Change from Baseline to Month 24 in FVC by MMRM (NCT00308737)
Timeframe: Baseline to Month 24

Interventionliters (Mean)
Technosphere® Insulin-0.14
Usual Care-0.11
Non-diabetes-0.09

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Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care

Change from Baseline to End of Study in FEV1 by MMRM (NCT00308737)
Timeframe: Baseline to Month 24

Interventionliters (Mean)
Technosphere® Insulin-0.16
Usual Care-0.12

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Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care

Change from Baseline to last measurement(Month 24) in FEV1 (NCT00308737)
Timeframe: Baseline to Month 24

Interventionliters (Least Squares Mean)
Technosphere® Insulin-0.128
Usual Care-0.092

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Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement

TLC Decrease of ≥ 15% from Baseline Value at Last Measurement (NCT00308737)
Timeframe: Baseline to Month 24

InterventionParticipants (Number)
Technosphere® Insulin7
Usual Care6
Non-diabetes1

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Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement

Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement (NCT00308737)
Timeframe: Baseline to Month 24

InterventionParticipants (Number)
Technosphere® Insulin105
Usual Care108
Non-diabetes20

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Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM

Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM (NCT00308737)
Timeframe: Baseline to Month 24

InterventionmL/min/mmHg (Mean)
Technosphere® Insulin-1.60
Usual Care-1.36
Non-diabetes-1.33

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Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM

Change from baseline to Month 24 in TLC by MMRM (NCT00308737)
Timeframe: Baseline to Month 24

Interventionliters (Mean)
Technosphere® Insulin-0.05
Usual Care-0.07
Non-diabetes-0.02

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Severe Hypoglycemia Event Rate

Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months) (NCT00309244)
Timeframe: 52 Weeks

InterventionNumber of events/100 subject-months (Number)
TI + Insulin Glargine0.73
BPR 70/302.20

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Total Hypoglycemia Event Rate

Number of Hypoglycemic Events/Total Subject Exposure Time (in months) (NCT00309244)
Timeframe: 52 Weeks

InterventionNumber of events/subject-month (Number)
TI + Insulin Glargine0.41
BPR 70/300.61

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Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%

(NCT00309244)
Timeframe: Week 52

Interventionparticipants (Number)
TI + Insulin Glargine47
BPR 70/3065

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Change From Baseline in Fasting Plasma Glucose to Week 52

(NCT00309244)
Timeframe: Baseline to Week 52

Interventionmilligrams per deciliter (Least Squares Mean)
TI + Insulin Glargine-35.7
BPR 70/30-17.9

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Change From Baseline in HbA1c to Week 52

(NCT00309244)
Timeframe: Baseline to Week 52

Interventionpercent (Least Squares Mean)
TI + Insulin Glargine-0.59
BPR 70/30-0.71

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Change From Baseline in Weight to Week 52

(NCT00309244)
Timeframe: Baseline to Week 52

Interventionkilogram (Least Squares Mean)
TI + Insulin Glargine0.9
BPR 70/302.5

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Incidence of Severe Hypoglycemia

"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:~Subject requires the assistance of another person;~Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);~Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,~Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms." (NCT00309244)
Timeframe: 52 Weeks

Interventionpercentage of participants (Number)
TI + Insulin Glargine4.33
BPR 70/309.97

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Incidence of Total Hypoglycemia

Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms. (NCT00309244)
Timeframe: 52 Weeks

Interventionpercentage of participants (Number)
TI + Insulin Glargine47.99
BPR 70/3068.58

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Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery

Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat. (NCT00309465)
Timeframe: Day 1

,,,,,
InterventionPercentage of subjects (Number)
Achievement of 100-179 mg/dlAchievement of 80-249 mg/dl
Call Physician (Insulin Glargine Only Group)72.489.7
Call Physician (Insulin Glargine Plus Bolus Group52.681.6
Dose Table (Insulin Glargine Only Group)74.198.3
Dose Table (Insulin Glargine Plus Bolus Group)63.293.4
Take 80% (Insulin Glargine Only Group)58.689.7
Take 80% (Insulin Glargine Plus Bolus Group)58.781.3

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Incidence of Wound Infections

(NCT00328094)
Timeframe: postoperative

Interventionparticipants (Number)
Continuous Insulin Infusion35
Intermittent Insulin Bolus29

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Composite (Myocardial Infarction and CHF)

(NCT00328094)
Timeframe: hospital length of stay

InterventionNumber of patients (Number)
Continuous Insulin Infusion4
Intermittent Insulin Bolus15

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Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)

(NCT00332488)
Timeframe: Week 24

Interventionpercentage of total hemoglobin (Mean)
TI Inhalation Powder Alone-1.82
Metformin & Secretagogues-1.23
TI Inhalation Powder + Metformin-1.68

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Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue

(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue) (NCT00332488)
Timeframe: Baseline to Week 12

InterventionPercentage of total hemoglobin (Mean)
TI Inhalation Powder Alone0.12
Metformin & Secretagogues-0.76

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Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue

(NCT00332488)
Timeframe: Baseline to Week 12

InterventionPercentage of total hemoglobin (Least Squares Mean)
Metformin & Secretagogues-0.78
TI Inhalation Powder + Metformin-0.70

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Percentage of Glucose Values < 50 mg/dL

Percentage of blood glucose values < 50 mg/dL (NCT00338104)
Timeframe: First 24 hours after conversion

Interventionpercentage of blood glucose values (Number)
40% Group1
60% Group0
80% Group0

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Percentage of Blood Glucose Values Between 80 - 140

Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL (NCT00338104)
Timeframe: First 24 hours after conversion

Interventionpercentage of blood glucose values (Number)
40% Group43
60% Group35
80% Group48

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Percentage of Glucose Levels > 180 mg/dL

Percentage of blood glucose levels > 180 mg/dL (NCT00338104)
Timeframe: First 24 hours after conversion

Interventionpercentage of blood glucose values (Number)
40% Group19
60% Group34
80% Group18

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First Will be the Changes in TNG Stimulated Arterial Dilation (Endothelial-independent) in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements

Trinitroglycerin (TNG) response evaluates endothelium independent vasodilation. The brachial artery was scanned before and 5 minutes after sublingual administration of 400 ug of trinitroglycerin. This was performed only at 4 hours following the test meal and fifteen minutes after completion of the FMD study to allow for the brachial artery to return to baseline. This was performed at both the baseline and 3 month visits. (NCT00353834)
Timeframe: Baseline and end of study

InterventionPercentage dilation (Mean)
Glargine Insulin10.7
Exenatide11.3

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The Primary Endpoint Was the Change in FMD at the End of the Study Compared to Baseline Measurements in Subjects Treated With Exenatide Compared to Subjects Treated With Lantus.

Flow mediated dilation (FMD) of the brachial artery was measured at rest and during reactive hyperemia using a high-resolution 10.0 MHz linear array transducer and an HOI Ultramark 9 system. Reactive hyperemia was produced by inflating a pneumatic tourniquet on the forearm distal to the brachial artery to 50 mmHg above the systolic BP for 5 minutes, then deflating it . Brachial artery diameter was measured before inflation of the cuff and 1-2 minutes after cuff deflation and expressed as the percentage change. This protocol is described in detail elsewhere. This was performed fasting, 2, and 4 hours after the meal challenge at baseline and 3 months. (NCT00353834)
Timeframe: Baseline and End of Study

InterventionPercentage dilation (Mean)
Glargine Insulin5.0
Exenatide4.7

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Insulin Sensitivity

Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity. (NCT00357890)
Timeframe: 24 months

,
Interventionmg/kg/min (Mean)
Baseline24 month
Multiple Daily Injections (MDI)6.24.8
Pump Therapy (CSII)8.65.8

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Percent Body Fat

Percent body fat based on DEXA scan (%BF) (NCT00357890)
Timeframe: 24 months

,
Interventionpercentage of body fat (Mean)
Baseline12 months24 months
Multiple Daily Injections (MDI)21.620.320.5
Pump Therapy (CSII)2018.517.4

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Beta Cell Function

Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing (NCT00357890)
Timeframe: 24 months

,
Interventionng/mL (Mean)
Baseline24 months
Multiple Daily Injections (MDI)1.71.6
Pump Therapy (CSII)2.11.1

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Hemoglobin A1c

Hemoglobin A1c (HbA1c) (%) (NCT00357890)
Timeframe: 24 months

,
Interventionpercentage of glycosylated hemoglobin (Mean)
Baseline12 months24 months
Multiple Daily Injections (MDI)10.27.07.5
Pump Therapy (CSII)106.16.8

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All-cause Mortality: Number of Deaths

Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria (confirmation of deaths by blinded adjudicator(s) through medical records or death certificates). Patients meeting the endpoint All Cause Mortality after adjudication by the endpoint committee. (NCT00359801)
Timeframe: Baseline through End of Study

Interventionparticipants (Number)
Exubera®12
Non-Exubera®9

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Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm

Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite or possible: anaphylaxis, angioedema/urticaria, bronchospasm or possible allergic reaction not otherwise specified (NOS); Insufficient: insufficient data. (NCT00359801)
Timeframe: Baseline through End of Study

,
Interventionevents (Number)
Definite or PossibleInsufficient
Exubera®23
Non-Exubera®00

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Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke

Endpoint committee adjudicated based on review of medical/hospital records; results classified using standard criteria. Definite: definite MI or stroke; Possible: possible MI or stroke; Other (non-MI, non-stroke): other cardiovascular event (non-MI, non-stroke); Definite or possible: either definite or possible or both; Insufficient: insufficient data; Death from cardiovascular or cerebrovascular: cardiovascular or cerebrovascular event; Definite or possible or death from cardiovascular or cerebrovascular: either definite or possible or both or cardiovascular or cerebrovascular event. (NCT00359801)
Timeframe: Baseline through End of Study

,
Interventionevents (Number)
DefinitePossibleOther (non-myocardial infarction, non-stroke)Definite or PossibleInsufficientDeath from Cardiovascular or CerebrovascularDefinite or Possible, or Death from Cardiovascular
Exubera®5515109212
Non-Exubera®36997411

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Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

Change from Baseline: mean of value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value. Index Visit: date subject had final scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment. (NCT00359801)
Timeframe: Baseline, Week 26, Week 52, Week 104, Index Visit

,
Interventionliters (Mean)
Baseline (n=985, 987)Week 26 (n=813, 852)Week 52 (n=470, 482)Week 104 (n=3, 1)Index Visit (n=729, 803)
Exubera®2.661-0.009-0.032-0.103-0.000
Non-Exubera®2.684-0.035-0.056-1.270-0.018

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Change in Glycosylated Hemoglobin (HbA1c) From Baseline

Baseline HbA1c: the latest determination prior to beginning study participation. Change from Baseline: HbA1c at observation (falling within the time window associated with a given analysis set) minus the baseline value. (NCT00359801)
Timeframe: Baseline, Month 6, Year 1, Year 2, Index Visit

,
Interventionpercent (Mean)
Baseline (n=978, 985)Week 26: Observed Value (804, 849)Week 26: Change from Baseline (n=800, 848)Week 52: Observed Value (n=468, 489)Week 52: Change from Baseline (n=467, 489)Week 104: Observed Value (n=3, 1)Week 104: Change from Baseline (n=3, 1)Index Visit: Observed Value (n=673, 754)Index Visit: Change from Baseline (n=669, 754)
Exubera®8.68.0-0.57.8-0.46.6-1.08.1-0.3
Non-Exubera®8.58.0-0.57.7-0.66.0-2.78.0-0.5

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Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline

Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment. (NCT00359801)
Timeframe: Baseline, Month 6, Year 1, Year 2, Index Visit

,
Interventionparticipants (Number)
Initial FEV1 DeclineInitial FEV1 Decline but not a Confirmed DeclineConfirmed FEV1 DeclineConfirmed FEV1 Decline but not Persistent DeclinePersistent FEV1 Decline
Exubera®1008119118
Non-Exubera®112105770

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Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis

Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite: definite pneumonia, definite COPD, or definite asthma; possible: possible pneumonia, possible COPD, possible asthma, probable obstructive lung disease not otherwise specified or probable acute bronchitis; definite or possible: either definite or possible; insufficient: insufficient data. (NCT00359801)
Timeframe: Baseline through End of Study

,
Interventionevents (Number)
DefinitePossibleDefinite or PossibleInsufficient
Exubera®4374
Non-Exubera®1232

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Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects

Confirmed FEV1 decline: any two consecutive declines that are >= 14 days apart. The pulmonary function test that established persistence occured >= 60 days after the initial decline. A confirmed decline: any two consecutive declines ≥ 14 days apart. The third PFT that established persistence was to occur ≥ 60 days after the initial decline. Index Visit: date the subject had his/her final scheduled spirometry was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment. (NCT00359801)
Timeframe: Baseline, Month 6, Year 1, Year 2, Index Visit

,
Interventionparticipants (Number)
Initial FEV1 DeclineInitial FEV1 Decline but not a Confirmed DeclineConfirmed FEV1 DeclineConfirmed FEV1 Decline but not Persistent DeclinePersistent FEV1 Decline
Exubera®10062381127
Non-Exubera®11274381424

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Change in Glycosylated Haemoglobin (HbA1c) Value

(NCT00360698)
Timeframe: from baseline to the end of treatment (week 24)

Interventionpercent (Least Squares Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride-0.37
Insulin Glargine+Metformin+Glimepiride-0.11

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Change in Daily Mean Plasma Glucose

(NCT00360698)
Timeframe: from baseline to the end of treatment (week 24)

Interventionmg/dL (Least Squares Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride-15.01
Insulin Glargine+Metformin+Glimepiride-2.07

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Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL

(NCT00360698)
Timeframe: during treatment period (12 weeks)

InterventionNumber of hypoglycemia per patient-year (Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride8.19
Insulin Glargine+Metformin+Glimepiride7.68

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Rate of Severe Symptomatic Hypoglycemia

(NCT00360698)
Timeframe: during treatment period (12 weeks)

InterventionNumber of hypoglycemia per patient-year (Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride0.00
Insulin Glargine+Metformin+Glimepiride0.20

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Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL

(NCT00360698)
Timeframe: during treatment period (12 weeks)

InterventionNumber of hypoglycemia per patient-year (Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride1.62
Insulin Glargine+Metformin+Glimepiride3.95

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Daily Mean Plasma Glucose

(NCT00360698)
Timeframe: at the end of treatment (week 24)

Interventionmg/dL (Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride154.7
Insulin Glargine+Metformin+Glimepiride165.8

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Daily Dose of Insulin Glulisine

Mean of 3 daily doses reported during the week prior to the final visit (NCT00360698)
Timeframe: at the end of treatment (week 24)

Interventionunits of insulin glulisine per day (Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride12.8

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Daily Dose of Insulin Glargine

Mean of 3 daily doses reported during the week prior to the final visit (NCT00360698)
Timeframe: at the end of treatment (week 24)

Interventionunits of insulin glargine per day (Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride54.7
Insulin Glargine+Metformin+Glimepiride62.2

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Change in Weight

(NCT00360698)
Timeframe: from baseline to the end of treatment (week 24)

Interventionkg (Least Squares Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride0.46
Insulin Glargine+Metformin+Glimepiride0.22

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Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%

Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7% (NCT00360698)
Timeframe: at the end of treatment (week 24)

Interventionpercentage of participants (Number)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride22.4
Insulin Glargine+Metformin+Glimepiride8.8

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Glycosylated Haemoglobin (HbA1c) Value

(NCT00360698)
Timeframe: at the end of treatment (week 24)

Interventionpercent (Mean)
Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride7.5
Insulin Glargine+Metformin+Glimepiride7.8

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Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial

Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF. (NCT00377858)
Timeframe: 36 Weeks

,
InterventionU/kg/day (Least Squares Mean)
Daily Basal (n=239, n=240)Daily Prandial (n=239, n=130)Daily Total (n=239, n=240)
Insulin Glargine0.350.290.51
Insulin Lispro Mid Mixture0.270.360.57

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Hemoglobin A1c (HbA1c) at 36 Week Endpoint

Level of hemoglobin A1c at endpoint. (NCT00377858)
Timeframe: 36 weeks

Interventionpercent HbA1c (Least Squares Mean)
Insulin Lispro Mid Mixture7.66
Insulin Glargine7.49

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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)

Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF. (NCT00377858)
Timeframe: Baseline to 36 Weeks

,
Interventionhypoglycemic event per 30 days (Mean)
Endpoint Hypoglycemic RateOverall Hypoglycemic RateEndpoint Nocturnal Hypoglycemic RateOverall Nocturnal Hypoglycemic RateEndpoint Non-Nocturnal Hypoglycemic RateOverall Non-Nocturnal Hypoglycemic Rate
Insulin Glargine2.192.210.320.281.871.93
Insulin Lispro Mid Mixture1.571.880.260.261.311.63

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Number of Insulin Injections Per Day

(NCT00377858)
Timeframe: Weeks 12, 24, 30, 36

,
Interventioninsulin injections (Least Squares Mean)
Week 12Week 24Week 30Week 36Endpoint
Insulin Glargine1.001.761.811.801.79
Insulin Lispro Mid Mixture1.331.972.052.031.98

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Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia

Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF. (NCT00377858)
Timeframe: Baseline to 36 Weeks

,
Interventionparticipants (Number)
Endpoint Hypoglycemic EpisodesOverall Hypoglycemic EpisodesEndpoint Nocturnal Hypoglycemic EpisodesOverall Nocturnal Hypoglycemic EpisodesEndpoint Non-Nocturnal Hypoglycemic EpisodesOverall Non-Nocturnal Hypoglycemic Episodes
Insulin Glargine1061793711298179
Insulin Lispro Mid Mixture871783011271175

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Hemoglobin A1c (HbA1c) at Interval Visits

Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks. (NCT00377858)
Timeframe: 12, 24, and 36 weeks

,
Interventionpercent HbA1c (Least Squares Mean)
12 Week Interval (n=222, n=222)24 Week Interval (n=206, n=217)36 Week Interval (n=202, n=208)
Insulin Glargine7.857.367.44
Insulin Lispro Mid Mixture8.027.537.53

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Glycemic Variability

Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values. (NCT00377858)
Timeframe: Baseline, 12-24-36 weeks

,
Interventionmillimoles per liter (mmol/L) (Least Squares Mean)
Baseline MODD (n=226, n=229)Baseline M-Value (n=228, n=231)12 Week MODD (n=214, n=221)12 Week M-Value (n=218, n=226)24 Week MODD (n=208, n=211)24 Week M-Value (n=210, n=213)36 Week MODD (n=198, n=206)36 Week M-Value (n=200, n=210)Endpoint MODD (n=226, n=229)Endpoint M-Value (n=228, n=231)
Insulin Glargine2.0746.751.5428.491.6620.141.6027.411.6127.99
Insulin Lispro Mid Mixture2.0948.021.5130.071.5722.671.5526.461.5126.27

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Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint

(NCT00377858)
Timeframe: 12-24-36 weeks

,
Interventionpercentage of participants (Number)
Week 12: HbA1c ≤7.0% (n=222, n=222)Week 12: HbA1c >7.0% (n=222, n=222)Week 12: HbA1c <7.0% (n=222, n=222)Week 12: HbA1c ≥7.0% (n=222, n=222)Week 12: HbA1c ≤6.5% (n=222, n=222)Week 12: HbA1c >6.5% (n=222, n=222)Week 24: HbA1c ≤7.0% (n=206, n=217)Week 24: HbA1c >7.0% (n=206, n=217)Week 24: HbA1c <7.0% (n=206, n=217)Week 24: HbA1c ≥7.0% (n=206, n=217)Week 24: HbA1c ≤6.5% (n=206, n=217)Week 24: HbA1c >6.5% (n=206, n=217)Week 36: HbA1c ≤7.0% (n=202, n=208)Week 36: HbA1c >7.0% (n=202, n=208)Week 36: HbA1c <7.0% (n=202, n=208)Week 36: HbA1c ≥7.0% (n=202, n=208)Week 36: HbA1c ≤6.5% (n=202, n=208)Week 36: HbA1c >6.5% (n=202, n=208)Endpoint (LOCF): HbA1c ≤7.0% (n=234, n=235)Endpoint (LOCF): HbA1c >7.0% (n=234, n=235)Endpoint (LOCF): HbA1c <7.0% (n=234, n=235)Endpoint (LOCF): HbA1c ≥7.0% (n=234, n=235)Endpoint (LOCF): HbA1c ≤6.5% (n=234, n=235)Endpoint (LOCF): HbA1c >6.5% (n=234, n=235)
Insulin Glargine25.274.821.678.410.889.247.053.038.761.321.778.344.755.340.459.619.280.843.057.039.160.919.180.9
Insulin Lispro Mid Mixture21.278.818.981.18.191.939.860.235.464.616.084.039.660.437.662.415.384.736.863.235.065.013.286.8

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Number of Patients With at Least One Severe Hypoglycemia Episode

Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF. (NCT00377858)
Timeframe: Baseline to 36 Weeks

,
Interventionparticipants (Number)
Endpoint Severe Hypoglycemic EpisodesOverall Severe Hypoglycemic Episodes
Insulin Glargine15
Insulin Lispro Mid Mixture18

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Endpoint Insulin Dose; Total, Basal, and Prandial

Total daily insulin dose (Units of insulin per day [U/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF. (NCT00377858)
Timeframe: 36 Weeks

,
InterventionU/day (Least Squares Mean)
Daily Basal (n=239, n=240)Daily Prandial (n=239, n=130)Daily Total (n=239, n=240)
Insulin Glargine26.8621.6838.25
Insulin Lispro Mid Mixture19.9027.7343.44

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7-point Self-monitored Blood Glucose Profiles

Actual daily mean blood glucose levels at specified time points. (NCT00377858)
Timeframe: Baseline, 12-24-36 weeks

,
Interventionmillimoles per Liter (mmol/L) (Least Squares Mean)
Baseline: Morning Pre-Meal (n=228, n=231)Baseline: Morning Postprandial Meal (n=213, n=222)Baseline: Midday Pre-Meal (n=227, n=230)Baseline: Midday Postprandial Meal (n=215, n=223)Baseline: Evening Pre-Meal (n=227, n=229)Baseline: Evening Postprandial Meal (n=226,n= 229)Baseline: 0300 Hours (n=205, n=202)12 Week: Morning Pre-Meal (n=218, n=226)12 Week: Morning Postprandial Meal (n=192, n=206)12 Week: Midday Pre-Meal (n=215, n=220)12 Week: Midday Postprandial Meal (n=196, n=209)12 Week: Evening Pre-Meal (n=216, n=221)12 Week: Evening Postprandial Meal (n=213, n= 223)12 Week: 0300 Hours (n=185, n=187)24 Week: Morning Pre-Meal (n=210, n=213)24 Week: Morning Postprandial Meal (n=193, n=201)24 Week: Midday Pre-Meal (n=209, n=213)24 Week: Midday Postprandial Meal (n=196, n=203)24 Week: Evening Pre-Meal (n=209, n=211)24 Week: Evening Postprandial Meal (n=207, n= 207)24 Week: 0300 Hours (n=181, n=184)36 Week: Morning Pre-Meal (n=200, n=210)36 Week: Morning Postprandial Meal (n=179, n=194)36 Week: Midday Pre-Meal (n=199, n=210)36 Week: Midday Postprandial Meal (n=182, n=195)36 Week: Evening Pre-Meal (n=199, n=207)36 Week: Evening Postprandial Meal (n=195, n= 225)36 Week: 0300 Hours (n=167, n=177)Endpoint: Morning Pre-Meal (n=228, n=231)Endpoint: Morning Postprandial Meal (n=213, n=222)Endpoint: Midday Pre-Meal (n=227, n=230)Endpoint: Midday Postprandial Meal (n=215, n=223)Endpoint: Evening Pre-Meal (n=227, n=229)Endpoint: Evening Postprandial Meal (n=226,n= 229)Endpoint: 0300 Hours (n=205, n=202)
Insulin Glargine9.6412.399.6211.2210.3111.769.176.6811.288.109.437.989.407.126.079.457.829.156.948.697.186.4810.297.4610.307.979.858.256.5310.297.5210.347.989.847.89
Insulin Lispro Mid Mixture10.2212.4910.1511.4010.3811.879.377.2611.568.639.928.758.236.976.729.877.999.387.508.217.146.9610.097.3310.318.139.468.186.989.987.3610.288.159.277.78

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Change From Baseline in Absolute Body Weight at 36 Week Endpoint

Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline. (NCT00377858)
Timeframe: Baseline, 36 Weeks

,
Interventionkilograms (Least Squares Mean)
BaselineChange from Baseline
Insulin Glargine77.003.19
Insulin Lispro Mid Mixture76.713.09

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Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis)

Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders. (NCT00384085)
Timeframe: At week 60

,
Interventionpercentage of participants (Number)
HbA1c < 7.0%HbA1c ≥ 7.0%Missing data
Lantus/Apidra-344.134.421.5
Novolog Mix 70/3038.132.029.9

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Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl

"Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration.~A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of <50 mg/dL with reported symptoms." (NCT00384085)
Timeframe: At week 60

,,
Interventionpercentage of participants (Number)
HbA1c < 7.0%HbA1c ≥ 7.0%Missing data
Lantus/Apidra-125.052.222.8
Lantus/Apidra-323.055.721.3
Novolog Mix 70/3014.158.427.6

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Adjusted Hypoglycemic Event Rates (Event/Patient-year)

"Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study.~An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to & including 1 day after the date of last dose of study drug)." (NCT00384085)
Timeframe: Week 60

,,
Interventionevent per patient year (Mean)
Self-Monitored Blood Glucose (SMBG) < 70 mg/dlSMBG< 70 mg/dl with symptomsSMBG< 70 mg/dl, nocturnalSMBG< 70 mg/dl with symptoms, nocturnalSMBG< 50 mg/dlSMBG< 50 mg/dl with symptomsSMBG< 50 mg/dl, nocturnalSMBG< 50 mg/dl with symptoms, nocturnalSMBG< 36 mg/dlSevere hypoglycemiasSerious hypoglycemias
Lantus/Apidra-112.857.111.841.101.170.830.180.090.100.10NA
Lantus/Apidra-314.507.231.901.161.380.890.200.100.150.17NA
Novolog Mix 70/3020.4212.231.681.162.421.910.270.180.230.17NA

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Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)

Absolute Change in HbA1c from Baseline to Week 60. (NCT00384085)
Timeframe: From baseline to week 60

Interventionpercent HbA1c (Least Squares Mean)
Lantus/Apidra-3-2.45
Novolog Mix 70/30-2.13

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Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)

Patients who achieved an HbA1c value <7.0% were defined as responders. Patients who did not achieve HbA1c values <7.0% and patients with missing HbA1c values were considered nonresponders. (NCT00384085)
Timeframe: At week 60

Interventionpercentage of participants (Number)
Lantus/Apidra-151.1
Novolog Mix 70/3039.5

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Adjusted Incidence Rate of Hypoglycemia

"Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia.~A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) <36 mg/dL during or soon after the event.~A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion.~Nocturnal = events occurring between 00:00 & 06:00 based on a 24-hour clock.~An event is included if the HE start date is within the treatment period." (NCT00384085)
Timeframe: Week 60

,,
Interventionestimated percentage per patient (Mean)
Self-Monitored Blood Glucose (SMBG) < 70 mg/dlSMBG< 70 mg/dl with symptomsSMBG< 70 mg/dl, nocturnalSMBG< 70 mg/dl with symptoms, nocturnalSMBG< 50 mg/dlSMBG< 50 mg/dl with symptomsSMBG< 50 mg/dl, nocturnalSMBG< 50 mg/dl with symptoms, nocturnalSMBG< 36 mg/dlSevere hypoglycemiasSerious hypoglycemias
Lantus/Apidra-174.7862.5040.3133.5539.5532.5611.297.498.637.190.00
Lantus/Apidra-374.4060.1446.3037.0339.7731.5112.056.9310.8910.100.41
Novolog Mix 70/3083.1571.9842.5335.6853.1445.9212.588.8814.328.232.29

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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population

Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol. (NCT00384085)
Timeframe: At week 60

,
Interventionpercent HbA1c (Least Squares Mean)
baseline HbA1cAbsolute change in HbA1c from baseline
Lantus/Apidra-19.30-2.30
Novolog Mix 70/309.06-1.97

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Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)

Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders. (NCT00384085)
Timeframe: At week 60

,
Interventionpercentage of participants (Number)
HbA1c < 7.0%HbA1c ≥ 7.0%Missing data
Lantus/Apidra-343.335.321.4
Novolog Mix 70/3038.632.329.1

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Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)

Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline. (NCT00391027)
Timeframe: Baseline, Week 26

Interventionmg/dl (Mean)
Inhaled Human Insulin (Exubera®)0.2
Insulin Glargine (Lantus®)-0.1

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Number of Subjects With HbA1c < 7.0 %

Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation. (NCT00391027)
Timeframe: Week 26

Interventionparticipants (Number)
Inhaled Human Insulin (Exubera®)84
Insulin Glargine (Lantus®)67

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Number of Subjects With HbA1c < 6.5 %

Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation. (NCT00391027)
Timeframe: Week 26

Interventionparticipants (Number)
Inhaled Human Insulin (Exubera®)37
Insulin Glargine (Lantus®)23

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Number of Subjects Discontinued Due to Insufficient Clinical Response

Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12. (NCT00391027)
Timeframe: Week 26

Interventionparticipants (Number)
Inhaled Human Insulin (Exubera®)3
Insulin Glargine (Lantus®)0

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Number of Events of Nocturnal Hypoglycemia

Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized. (NCT00391027)
Timeframe: Week 26

Interventionevents (Number)
Inhaled Human Insulin (Exubera®)159
Insulin Glargine (Lantus®)81

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Number of Subjects With HbA1c < 8.0 %

Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation. (NCT00391027)
Timeframe: Week 26

Interventionparticipants (Number)
Inhaled Human Insulin (Exubera®)121
Insulin Glargine (Lantus®)108

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Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)

Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline. (NCT00391027)
Timeframe: Baseline, Week 26

Interventionpg/ml (Mean)
Inhaled Human Insulin (Exubera®)-1.1
Insulin Glargine (Lantus®)-2.4

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Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients

The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3. (NCT00391027)
Timeframe: Baseline, Week 26

,
Interventionmg/dl (Mean)
Week 26: 24-hour mean (n=14, 12)Week 26: 24-hour SD (n=14, 12)
Inhaled Human Insulin (Exubera®)107.633.7
Insulin Glargine (Lantus®)102.130.7

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Change From Baseline in HbA1c Prior to Week 26

Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline. (NCT00391027)
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18

,
Interventionpercent (Mean)
Week 2 (n = 128, 108)Week 4 (n = 134, 121)Week 8 (n = 134, 121)Week 12 (n = 134, 121)Week 18 (n = 134, 121)
Inhaled Human Insulin (Exubera®)-0.4-0.8-1.3-1.6-1.7
Insulin Glargine (Lantus®)-0.3-0.6-1.1-1.3-1.5

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Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)

Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal. (NCT00391027)
Timeframe: Baseline, Week 26

,
Interventionmg/dl (Mean)
Average overall absolute BG (n=101, 95)Average pre-meal BG (n=101, 95)Average post-meal BG (n=99, 91)Change from pre-meal to post-meal BG (n=99, 91)
Inhaled Human Insulin (Exubera®)-45.0-38.1-64.5-24.5
Insulin Glargine (Lantus®)-43.7-50.7-49.61.6

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Change From Baseline in Fasting Plasma Glucose (FPG) Level

FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline. (NCT00391027)
Timeframe: Baseline, Week 26

Interventionmg/dl (Mean)
Inhaled Human Insulin (Exubera®)-30.6
Insulin Glargine (Lantus®)-60.1

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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical. (NCT00391027)
Timeframe: Baseline, Week 26

Interventionpercent (Mean)
Inhaled Human Insulin (Exubera®)-1.7
Insulin Glargine (Lantus®)-1.4

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Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)

Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline. (NCT00391027)
Timeframe: Baseline, Week 26

Interventionpg/ml (Mean)
Inhaled Human Insulin (Exubera®)230.2
Insulin Glargine (Lantus®)170.4

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Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)

Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline. (NCT00391027)
Timeframe: Baseline, Week 26

Interventionng/ml (Mean)
Inhaled Human Insulin (Exubera®)-3.4
Insulin Glargine (Lantus®)-40.4

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Change From Baseline in Body Mass Index (BMI)

BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline. (NCT00391027)
Timeframe: Baseline, Week 26

Interventionkg/m2 (Mean)
Inhaled Human Insulin (Exubera®)0.7
Insulin Glargine (Lantus®)0.4

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Number of Subjects With Hypoglycemic Events by Severity

Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate. (NCT00391027)
Timeframe: Week 26

,
Interventionparticipants (Number)
Week 26 Mild, ModerateWeek 26 Severe
Inhaled Human Insulin (Exubera®)261
Insulin Glargine (Lantus®)321

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Change From Baseline in Body Weight

Change from baseline calculated as body weight at observation minus body weight at baseline. (NCT00391027)
Timeframe: Baseline, Week 26

Interventionkilograms (kg) (Mean)
Inhaled Human Insulin (Exubera®)2.2
Insulin Glargine (Lantus®)1.1

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2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint

Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16. (NCT00393705)
Timeframe: 16 weeks

Interventionmilligrams per deciliter (mg/dL) (Mean)
Insulin Lispro LM + Insulin Lispro MM163.4
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM178.2

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Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint

(NCT00393705)
Timeframe: Baseline, 16 Weeks

Interventionpercent HbA1c (Mean)
Insulin Lispro LM + Insulin Lispro MM-1.00
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM-0.82

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Change From Baseline in Weight at 16 Week Endpoint

(NCT00393705)
Timeframe: Baseline, 16 weeks

Interventionkilograms (kg) (Mean)
Insulin Lispro LM + Insulin Lispro MM1.3
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM0.4

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Hemoglobin A1c (HbA1c) at 16 Week Endpoint

(NCT00393705)
Timeframe: 16 weeks

Interventionpercent HbA1c (Mean)
Insulin Lispro LM + Insulin Lispro MM7.71
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM7.84

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Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint

Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16. (NCT00393705)
Timeframe: 16 weeks

Interventionmilligrams per deciliter (mg/dL) (Mean)
Insulin Lispro LM + Insulin Lispro MM17.0
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM36.1

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30-Day Adjusted Rate of Hypoglycemic Events

Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. (NCT00393705)
Timeframe: Baseline through 16 weeks

,
Interventionnumber of events per 30 days (Mean)
Total Hypoglycemic Episodes/30 DaysNocturnal Hypoglycemic Episodes/30 DaysSevere Hypoglycemic Episodes/30 Days
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM0.640.120
Insulin Lispro LM + Insulin Lispro MM0.520.040.01

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Total Daily Insulin Dose at 4 Weeks and 12 Weeks

(NCT00393705)
Timeframe: 4 weeks and 12 weeks

,
InterventionInternational Units (IU) (Mean)
4 Weeks (n=134, n=135)12 Weeks (n=130, n=131)
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM51.458.0
Insulin Lispro LM + Insulin Lispro MM57.164.4

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Mean Daily Blood Glucose Values at 16 Week Endpoint

(NCT00393705)
Timeframe: 16 weeks

,
Interventionmilligrams per deciliter (mg/dL) (Mean)
Fasting2-Hours After BreakfastPre-Lunch2-Hours After LunchPre-Dinner2-Hours After Dinner3:00 A.M.
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM153.9160.9141.7178.2165.7171.4141.0
Insulin Lispro LM + Insulin Lispro MM161.1179.0146.3163.4157.5166.4141.2

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Number of Patients With Self-reported Hypoglycemic Episodes

Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. (NCT00393705)
Timeframe: Baseline through 16 weeks

,
Interventionparticipants (Number)
1 Hypoglycemic Event2 Hypoglycemic Events≥3 Hypoglycemic Events1 Nocturnal Hypoglycemic Event2 Nocturnal Hypoglycemic Events≥3 Nocturnal Hypoglycemic Events1 Severe Hypoglycemic Event2 Severe Hypoglycemic Events
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM141133143801
Insulin Lispro LM + Insulin Lispro MM24924103211

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Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint

(NCT00393705)
Timeframe: 16 weeks

,
Interventionpercentage of participants (Number)
HbA1c <7%HbA1c ≤6.5%
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM18.56.7
Insulin Lispro LM + Insulin Lispro MM21.411.5

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Number of Patients With Severe Hypoglycemia Episodes Among the Glucommander Group Compared to Standard Algorithm

Severe hypoglycemia is defined as the blood glucose (BG) levels lower than 40 mg/dL. The number of patients enrolled among both groups with the reports of having the BG levels lower than 40 mg/dL are recorded for duration of 10 days (NCT00394524)
Timeframe: First 10 days of ICU stay

InterventionParticipants (Count of Participants)
Computer Assisted IV Insulin Infusion3
Standard Insulin Infusion Algorithm4

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Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion

Daily mean blood glucose concentrations during insulin infusion with the Glucommander and a standard paper form insulin infusion algorithm are measured every day up until 10 days and a mean values of these levels are calculated. The Mean blood glucose concentrations are measured once the target blood glucose levels are achieved after admission (NCT00394524)
Timeframe: First 10 days of ICU stay

Interventionmg/dl (Mean)
Glucommander103.3
Standard Insulin Infusion117.3

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Mean Hospital Length of Stay in Days Among the Glucommander Group Compared to Standard Insulin Infusion

mean number of days the patients stayed in the hospital are measured among the Glucommander group and standard insulin infusion and compared (NCT00394524)
Timeframe: During the complete length of hospitalization, up to 60 days

Interventiondays (Mean)
Glucommander23.9
Standard Insulin Infusion17.5

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Mean Length of Intensive Care Unit (ICU) in Days Stay Among Glucommander Group Compared to Standard Insulin Infusion Group

Mean number of days, the patients stayed in the intensive care unit are measured among glucommander group and standard insulin infusion group. (NCT00394524)
Timeframe: During ICU hospitalization, up to 30 days

Interventiondays (Mean)
Glucommander8.5
Standard Insulin Infusion13.4

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Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26

CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

,
Interventionmg/mL (Mean)
Adiponectin, Week 26 (n=195, 184)ApoB, Week 26 (n=198, 187)
Inhaled Human Insulin0.23-0.06
Insulin Glargine-0.32-0.06

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Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26

CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

,
Interventionmg/L (Mean)
hs-CRP, Week 26 (n=198, 187)Leptin, Week 26 (n=193, 186)Spot Urine Microalbumin, Week 26 (n=183, 169)
Inhaled Human Insulin0.613.683.47
Insulin Glargine0.324.413.70

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Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26

Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%. (NCT00418522)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Inhaled Human Insulin62.6
Insulin Glargine47.6

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Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26

Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%. (NCT00418522)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Inhaled Human Insulin35.5
Insulin Glargine22.2

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Number of Nocturnal Hypoglycemic Events

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am. (NCT00418522)
Timeframe: Months 1 to 7

Interventionevents (Number)
Inhaled Human Insulin187
Insulin Glargine114

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Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26

SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

Interventionmg/dL (Mean)
Inhaled Human Insulin-12.50
Insulin Glargine4.46

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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population

HbA1c lab value: Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

Interventionpercent (Mean)
Inhaled Human Insulin-2.01
Insulin Glargine-1.75

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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS

HbA1c lab value: Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

Interventionpercent (Mean)
Inhaled Human Insulin-1.91
Insulin Glargine-1.67

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Change From Baseline in Fasting Plasma Glucose at Week 26

Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

Interventionmg/dL (Mean)
Inhaled Human Insulin-52.77
Insulin Glargine-53.50

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Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26

Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

,
Interventionmg/dL (Mean)
Time 0 at Week 26 (n=105, 119)Time 30 at Week 26 (n=95, 107)Time 60 at Week 26 (n=110, 118)Time 90 at Week 26 (n=114, 120)Time 120 at Week 26 (n=113, 124)Time 180 at Week 26 (n=114, 122)
Inhaled Human Insulin-35.22-49.91-56.83-64.94-66.59-66.99
Insulin Glargine-61.16-66.02-64.77-58.85-54.89-51.27

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Number of Subjects With Hypoglycemic Events

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. (NCT00418522)
Timeframe: Months 1 to 7

,
Interventionparticipants (Number)
Overall at Month 1 (n=147, 83)Mild/Moderate at Month 1 (n=147, 83)Severe at Month 1 (n=147, 83)Overall at Month 2 (n=141, 81)Mild/Moderate at Month 2 (n=141, 81)Severe at Month 2 (n=141, 81)Overall at Month 3 (n=135, 81)Mild/Moderate at Month 3 (n=135, 81)Severe at Month 3 (n=135, 81)Overall at Month 4 (n=120, 80)Mild/Moderate at Month 4 (n=120, 80)Severe at Month 4 (n=120, 80)Overall at Month 5 (n=117, 79)Mild/Moderate at Month 5 (n=117, 79)Severe at Month 5 (n=117, 79)Overall at Month 6 (n=109, 77)Mild/Moderate at Month 6 (n=109, 77)Severe at Month 6 (n=109, 77)Overall at Month 7 (n=77, 60)Mild/Moderate at Month 7 (n=77, 60)Severe at Month 7 (n=77, 60)
Inhaled Human Insulin706909898184833616105555042420880
Insulin Glargine242403838035350252503030031310440

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Number of Total Hypoglycemic Events

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study. (NCT00418522)
Timeframe: Months 1 to 7

,
Interventionevents (Number)
Overall at Month 1 (n=147, 83)Mild/Moderate at Month 1 (n=147, 83)Severe at Month 1 (n=147, 83)Overall at Month 2 (n=141, 81)Mild/Moderate at Month 2 (n=141, 81)Severe at Month 2 (n=141, 81)Overall at Month 3 (n=135, 81)Mild/Moderate at Month 3 (n=135, 81)Severe at Month 3 (n=135, 81)Overall at Month 4 (n=120, 80)Mild/Moderate at Month 4 (n=120, 80)Severe at Month 4 (n=120, 80)Overall at Month 5 (n=117, 79)Mild/Moderate at Month 5 (n=117, 79)Severe at Month 5 (n=117, 79)Overall at Month 6 (n=109, 77)Mild/Moderate at Month 6 (n=109, 77)Severe at Month 6 (n=109, 77)Overall at Month 7 (n=77, 60)Mild/Moderate at Month 7 (n=77, 60)Severe at Month 7 (n=77, 60)
Inhaled Human Insulin19519403653641292289316616601571570119119012120
Insulin Glargine414106666084840515106464063630550

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Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26

24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

Interventionmg/dL (Mean)
Inhaled Human Insulin-36.53
Insulin Glargine-35.63

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Change From Baseline in Body Mass Index (BMI) at Week 26

BMI value (kg/m2): Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

Interventionkg/m2 (Mean)
Inhaled Human Insulin1.22
Insulin Glargine0.80

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Number of Total Subject Months of Treatment

Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. (NCT00418522)
Timeframe: Months 1 to 7

,
Interventionsubject months (Number)
Overall at Month 1 (n=147, 83)Mild/Moderate at Month 1 (n=147, 83)Severe at Month 1 (n=147, 83)Overall at Month 2 (n=141, 81)Mild/Moderate at Month 2 (n=141, 81)Severe at Month 2 (n=141, 81)Overall at Month 3 (n=135, 81)Mild/Moderate at Month 3 (n=135, 81)Severe at Month 3 (n=135, 81)Overall at Month 4 (n=120, 80)Mild/Moderate at Month 4 (n=120, 80)Severe at Month 4 (n=120, 80)Overall at Month 5 (n=117, 79)Mild/Moderate at Month 5 (n=117, 79)Severe at Month 5 (n=117, 79)Overall at Month 6 (n=109, 77)Mild/Moderate at Month 6 (n=109, 77)Severe at Month 6 (n=109, 77)Overall at Month 7 (n=77, 60)Mild/Moderate at Month 7 (n=77, 60)Severe at Month 7 (n=77, 60)
Inhaled Human Insulin145.8145.8145.8138.3138.3138.3128.8128.8128.8117.7117.7117.7112.2112.2112.2103.5103.5103.512.812.812.8
Insulin Glargine82.482.482.481.081.081.080.480.480.479.779.779.777.977.977.975.775.775.76.66.66.6

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Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26

Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%. (NCT00418522)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Inhaled Human Insulin79.8
Insulin Glargine83.6

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Change From Baseline in Lipids at Week 26

Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

,
Interventionmg/dL (Mean)
Total cholesterol, Week 26 (n=197, 186)HDL-c, Week 26 (n=197, 186)LDL-c, Week 26 (n=197, 186)Triglycerides, Week 26 (n=197, 187)
Inhaled Human Insulin-2.802.97-2.09-42.65
Insulin Glargine-6.190.69-3.71-46.23

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Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26

Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

,
Interventionmg/dL (Mean)
Post-Breakfast, Week 26 (n=185,171)Post-Lunch, Week 26 (n=184, 172)Post-Dinner, Week 26 (n=187,166)
Inhaled Human Insulin-86.61-86.66-81.86
Insulin Glargine-75.36-58.51-59.20

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Crude Hypoglycemic Event Rate

crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. (NCT00418522)
Timeframe: Months 1 to 7

,
Interventionevents / subject-months (Number)
Overall at Month 1 (n=147, 83)Mild/Moderate at Month 1 (n=147, 83)Severe at Month 1 (n=147, 83)Overall at Month 2 (n=141, 81)Mild/Moderate at Month 2 (n=141, 81)Severe at Month 2 (n=141, 81)Overall at Month 3 (n=135, 81)Mild/Moderate at Month 3 (n=135, 81)Severe at Month 3 (n=135, 81)Overall at Month 4 (n=120, 80)Mild/Moderate at Month 4 (n=120, 80)Severe at Month 4 (n=120, 80)Overall at Month 5 (n=117, 79)Mild/Moderate at Month 5 (n=117, 79)Severe at Month 5 (n=117, 79)Overall at Month 6 (n=109, 77)Mild/Moderate at Month 6 (n=109, 77)Severe at Month 6 (n=109, 77)Overall at Month 7 (n=77, 60)Mild/Moderate at Month 7 (n=77, 60)Severe at Month 7 (n=77, 60)
Inhaled Human Insulin1.31.302.62.60.72.32.22.31.41.401.41.401.21.200.90.90
Insulin Glargine0.50.500.80.801.01.000.60.600.80.800.80.800.80.80

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Change From Baseline in Body Weight at Week 26

Body weight value: Change = value at Week 26 minus value at Baseline. (NCT00418522)
Timeframe: Baseline, Week 26

Interventionkg (Mean)
Inhaled Human Insulin3.55
Insulin Glargine2.33

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Rate of Type 1 Diabetes Per Year in Secondary Stratum (Stratum 2) When Treated With Oral Insulin Versus Placebo

Secondary outcome is reported as the rate of type 1 diabetes per year among secondary stratum 2; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up. (NCT00419562)
Timeframe: Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years

InterventionProportion with diabetes/year (Number)
Oral Insulin0.181
Placebo0.341

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Rate of Type 1 Diabetes Per Year Among Individuals in the Primary Stratum When Treated With Oral Inulin Versus Placebo

Primary outcome is reported as the rate of type 1 diabetes per year among the primary stratum; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up. (NCT00419562)
Timeframe: Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years

InterventionProportion with diabetes/year (Number)
Oral Insulin0.088
Placebo0.102

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Rate of Type 1 Diabetes in Secondary Stratum (Stratum 3+4) When Treated With Oral Insulin Versus Placebo

Secondary outcome is reported as the rate of type 1 diabetes per year among secondary stratum 3+4; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up. (NCT00419562)
Timeframe: Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years

InterventionProportion with diabetes/year (Number)
Oral Insulin0.051
Placebo0.047

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Number of Participants With Laboratory Parameters Significantly Different From Baseline

Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment. (NCT00420095)
Timeframe: Baseline and 12 weeks of each treatment

,
Interventionparticipants (Number)
Hematology - Significantly Different from BaselineChemistry - Significantly Different from BaselineUrinalysis - Significantly Different from Baseline
Human Insulin Mix 30/70000
Insulin Lispro Low Mix000

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Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment

Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint. (NCT00420095)
Timeframe: Baseline and at 12 weeks of each treatment

Interventionpercent of glycosylated hemoglobin (Mean)
Human Insulin Mix 30/700.68
Insulin Lispro Low Mix0.63

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Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment

Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint (NCT00420095)
Timeframe: Baseline and 12 weeks of each treatment

Interventionmillimoles/Liter (Mean)
Human Insulin Mix 30/701.04
Insulin Lispro Low Mix1.18

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Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment

Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint (NCT00420095)
Timeframe: Baseline and 12 weeks of each treatment

Interventionunits of insulin (Mean)
Human Insulin Mix 30/70-4.72
Insulin Lispro Low Mix-4.56

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Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint

Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment. (NCT00420095)
Timeframe: Baseline and 12 weeks of each treatment

Interventionpercent of glycosylated hemoglobin (Mean)
Human Insulin Mix 30/707.91
Insulin Lispro Low Mix7.96

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Hypoglycemia Rate Per Participant Per 30 Days

Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment. (NCT00420095)
Timeframe: over 12 weeks of each treatment period

Interventionevents/30 days (Mean)
Human Insulin Mix 30/700.34
Insulin Lispro Low Mix0.37

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Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%

Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment. (NCT00420095)
Timeframe: 12 weeks of each treatment

,
Interventionparticipants (Number)
HbA1c <=7%HbA1c <=6.5%
Human Insulin Mix 30/702611
Insulin Lispro Low Mix3014

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Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory. (NCT00435019)
Timeframe: after 52 weeks of treatment

InterventionPercent (%) glycosylated haemoglobin (Mean)
Insulin Detemir8.75
NPH Insulin8.64

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Observed Insulin Antibody Values

Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies. (NCT00435019)
Timeframe: at 0 and 52 weeks

,
InterventionPercent bound of total (Mean)
Insulin detemir specific, week 0 (n=127, 112)Insulin detemir specific, week 52 (n=125, 128)Cross-reacting insulin, week 0 (n=130, 113)Cross-reacting insulin, week 52 (n=132, 135)Insulin aspart specific, week 0 (n=126, 111)Insulin aspart specific, week 52 (n=128, 133)
Insulin Detemir3.235.1527.0643.702.264.20
NPH Insulin2.953.0127.2630.192.242.68

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Number of Subjects Reporting Adverse Events

"Number of subjects reporting adverse events during the trial (from week -2 to week 52).~For details, please refer to the adverse events section." (NCT00435019)
Timeframe: from week -2 to week 52

Interventionparticipants (Number)
Insulin Detemir132
NPH Insulin135

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Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)

Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values. (NCT00437489)
Timeframe: From baseline to week 16

,
Interventionmmol/l (Mean)
Fasting plasma glucoseOverall absolute blood glucosePre-meal blood glucosePost-meal blood glucoseChange from pre-meal to post-meal blood glucose
Exubera Dose (mg) as Per Weight Based Formula TID-2.9-4.3-3.3-5.5-2.1
Exubera Dose of 1mg Three Times Daily (TID)-1.8-2.5-1.7-4.1-2.5

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Hypoglycemia Event Rate Per Month

Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16). (NCT00437489)
Timeframe: up to week 4 or 16

,
Interventionevent rate per month (Mean)
up to week 4 (GrpA:n=8, GrpB:n=4)up to week 16 (GrpA:n=12, GrpB:n=5)
Exubera Dose (mg) as Per Weight Based Formula TID8.32.5
Exubera Dose of 1mg Three Times Daily (TID)3.32.4

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Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia

Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms. (NCT00437489)
Timeframe: week 16

,
Interventionparticipants (Number)
HypoglycemiaNocturnal hypoglycemia
Exubera Dose (mg) as Per Weight Based Formula TID52
Exubera Dose of 1mg Three Times Daily (TID)122

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Change in HbA1c From Baseline

Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16 (NCT00437489)
Timeframe: From baseline to week 16

InterventionPercent (Mean)
Exubera Dose of 1mg Three Times Daily (TID)-1.9
Exubera Dose (mg) as Per Weight Based Formula TID-2.0

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Difference in HbA1C From Baseline and 6 Months

Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline (NCT00441129)
Timeframe: Baseline and 6 months

Interventionpercentage of HbA1C (Mean)
Conventional Insulin Pump Therapy-0.57
Minimed Paradigm Real Time Sytem-0.81

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Change From Baseline in Total Daily Dose (TDD)

Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline (NCT00441129)
Timeframe: Baseline and 6 months

Interventionunits/day (Mean)
Conventional Insulin Pump Therapy6.8
Minimed Paradigm Real Time Sytem1.5

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Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.

Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline (NCT00441129)
Timeframe: Baseline and 6 months

Interventionmg/dL (Mean)
Conventional Insulin Pump Therapy-10.8
Minimed Paradigm Real Time Sytem-30.6

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Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.

Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone (NCT00442767)
Timeframe: 0 to 120 minutes post-dose

Interventionng*L/min (Mean)
Rapid Acting Insulin Therapy - Before Meal6060
Pre-meal Pramlintide and Post-meal Insulin Therapy7575

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Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone

Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone (NCT00442767)
Timeframe: 0 to 240 minutes post-dose

Interventionmmol*L/min (Mean)
Rapid Acting Insulin Therapy - Before Meal205
Pre-meal Pramlintide and Post-meal Insulin Therapy993

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Incidence of Nosocomial Infections in the Cardiac ICU

Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria. These definitions are extensive and cannot be accurately condensed to fit within this space. Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf. (NCT00443599)
Timeframe: Measured during participant's ICU stay, a median duration of 3 days.

Interventioninfections / 1000 pt days (Number)
Tight Glycemic Control8.6
Standard Care9.9

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Mortality at 30 Days.

Mortality is assessed at hospital discharge and at 30 days. If the participant is discharged from the hospital prior to 30 days, status is determined by a follow-up phone call to the family. (NCT00443599)
Timeframe: Measured at 30 days.

InterventionParticipants (Number)
Tight Glycemic Control5
Standard Care6

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Mortality at Hospital Discharge.

Mortality is assessed at hospital discharge and at 30 days. (NCT00443599)
Timeframe: Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit).

InterventionParticipants (Number)
Tight Glycemic Control11
Standard Care11

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Neurodevelopmental Evaluation, Cognitive

"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature." (NCT00443599)
Timeframe: Measured at one year of age.

InterventionScores on a scale (Mean)
Tight Glycemic Control100.2
Standard Care100.8

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Neurodevelopmental Evaluation, Language

"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature." (NCT00443599)
Timeframe: Measured at one year of age.

InterventionScores on a scale (Mean)
Tight Glycemic Control94.7
Standard Care94.7

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Neurodevelopmental Evaluation, Motor

"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature." (NCT00443599)
Timeframe: Measured at one year of age.

InterventionScores on a scale (Mean)
Tight Glycemic Control87.2
Standard Care88.9

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Nutritional Status

Nutritional status assessed by percentage of total caloric intake as enteral nutrition during critical illness period. (NCT00443599)
Timeframe: The percentage of total caloric intake was evaluated from the day of postoperative cardiac ICU admission until the last day of the critical illness period, as defined by the presence of the arterial catheter, assessed up to 30 days.

InterventionPercent of total caloric intake (Median)
Tight Glycemic Control41
Standard Care38

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Immune Function

Immune function is assessed by C-reactive protein (CRP) on post-operative day 7. (NCT00443599)
Timeframe: Post-operative day 7.

Interventionmg/dL (Median)
Tight Glycemic Control3.1
Standard Care4.3

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Cardiac Function

Cardiac function is assessed by duration of vasoactive support. (NCT00443599)
Timeframe: The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days.

InterventionDays (Median)
Tight Glycemic Control2
Standard Care2

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Cardiac Index (CI)

Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area. It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry. (NCT00443599)
Timeframe: Day 2 (day after cardiopulmonary bypass surgery).

Interventionliters/min/m^2 (Median)
Tight Glycemic Control2.0
Standard Care1.8

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Duration of Endotracheal Intubation

Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation. (NCT00443599)
Timeframe: The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days.

InterventionDays (Median)
Tight Glycemic Control3
Standard Care2

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Duration of Hospital Stay

Duration of hospital stay spans from post-operative cardiac ICU admission to hospital discharge. (NCT00443599)
Timeframe: The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days.

InterventionDays (Median)
Tight Glycemic Control8
Standard Care7

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Duration of ICU Stay

Duration of ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge. (NCT00443599)
Timeframe: The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days.

InterventionDays (Median)
Tight Glycemic Control3
Standard Care3

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Endocrine Function

Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7. (NCT00443599)
Timeframe: Measured during participant's ICU stay on Day 7.

Interventionng/dL (Median)
Tight Glycemic Control84
Standard Care75

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Clinical Laboratory Values (Change in Haematology - Lymphocytes)

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30433.8028.12-3.25
NN72937.4536.675.33

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Clinical Laboratory Values (Change in Haematology - Leucocytes)

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3046.226.240.03
NN7296.35.96-0.32

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Clinical Laboratory Values (Change in Haematology - Haemoglobin)

Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (NCT00447382)
Timeframe: Week 0, week 52

,
Interventionmmol/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3048.858.54-0.30
NN7298.808.47-0.31

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Clinical Laboratory Values (Change in Haematology - Eosinophils)

Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3042.502.47-0.25
NN7291.822.080.00

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Clinical Laboratory Values (Change in Haematology - Basophilis)

"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3040.300.24-0.25
NN7290.360.330.00

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Clinical Laboratory Values (Change in Biochemistry - Total Protein)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
Interventiong/dL (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3047.237.13-0.11
NN7297.247.19-0.06

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Clinical Laboratory Values (Change in Biochemistry - Sodium)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
Interventionmmol/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN304138.9140.31.4
NN729139.2140.00.8

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Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase) (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionU/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN304161.1164.93.2
NN729159.4162.72.6

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Clinical Laboratory Values (Change in Biochemistry - Creatinine)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionUmol/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30473.172.5-0.5
NN72972.373.10.8

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Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALP = alkaline phosphatase)" (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionU/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30475.4082.356.77
NN72975.5580.424.53

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Clinical Laboratory Values (Change in Biochemistry - Albumin)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
Interventiong/dL (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3044.304.28-0.02
NN7294.274.300.02

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Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALAT = alanine aminotransferase)" (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionU/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30429.2130.721.34
NN72925.9827.811.76

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Adverse Events

(NCT00447382)
Timeframe: Weeks 0-52

,
Interventionevents (Number)
Serious Adverse EventsNon-Serious Adverse Events
NN30425259
NN72910346

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Change From Baseline in Total Antibodies

Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir - human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. (NCT00447382)
Timeframe: Week 0, week 52

Interventionratio (Mean)
NN3041.55
NN7291.55

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Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies

Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. (NCT00447382)
Timeframe: week 0, week 52

Interventionratio (Mean)
NN3041.81
NN7291.89

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Change From Baseline in Detemir Specific Antibodies

Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. (NCT00447382)
Timeframe: Week 0, week 52

Interventionratio (Mean)
NN3041.14
NN7291.06

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Clinical Laboratory Values (Change in Biochemistry - Potassium)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
Interventionmmol/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3044.464.490.02
NN7294.374.430.06

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Hypoglycaemic Episodes

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal. (NCT00447382)
Timeframe: Weeks 0-52

,
Interventionepisodes (Number)
All events - MajorAll events - MinorAll events - Symptoms OnlyDaytime - MajorDaytime - MinorDaytime - Symptoms OnlyNocturnal - MajorNocturnal - MinorNocturnal - Symptoms OnlyUnclassified - Minor
NN3042132154459274138112472642
NN7292129963181525902586404602

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Glycaemic Control Parameters (Change in HbA1c)

HbA1c (Glycosylated haemoglobin). (NCT00447382)
Timeframe: week 0, week 52

,
InterventionPercent (%) glycosylated haemoglobin (Mean)
Week 52Change from Baseline to week 52
NN3047.88-0.08
NN7297.85-0.11

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Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])

(NCT00447382)
Timeframe: week 0, week 52

,
Interventionmmol/L (Mean)
Week 52Change from Baseline to week 52
NN3049.730.07
NN7299.64-0.02

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Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])

"point is Before Breakfast~point is 120 minutes after Breakfast~point is Before Lunch~point is 120 minutes after Lunch~point is Before Dinner~point is 120 minutes after Dinner~point is at Bedtime~point is At 03:00 A.M.~point is Before Breakfast the Following Day" (NCT00447382)
Timeframe: week 0, 26 and 52

,
Interventionmmol/L (Mean)
Baseline 1. pointBaseline 2. pointBaseline 3. pointBaseline 4. pointBaseline 5. pointBaseline 6. pointBaseline 7. pointBaseline 8. pointBaseline 9. pointWeek 26 change. 1. pointWeek 26 change. 2. pointWeek 26 change. 3. pointWeek 26 change. 4. pointWeek 26 change. 5. pointWeek 26 change. 6. pointWeek 26 change. 7. pointWeek 26 change. 8. pointWeek 26 change. 9. pointWeek 52 change. 1. pointWeek 52 change. 2. pointWeek 52 change. 3. pointWeek 52 change. 4. pointWeek 52 change. 5. pointWeek 52 change. 6. pointWeek 52 change. 7. pointWeek 52 change. 8. pointWeek 52 change. 9. point
NN3048.178.957.668.608.298.438.697.978.05-0.64-0.61-0.49-0.34-0.36-0.35-0.350.18-0.64-0.60-0.54-0.36-0.78-0.41-0.31-0.34-0.24-0.44
NN7298.179.037.348.188.168.608.607.727.56-0.44-0.610.08-0.22-0.000.070.200.080.24-0.67-0.99-0.28-0.29-0.59-0.51-0.47-0.31-0.09

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Clinical Laboratory Values (Change in Haematology - Thrombocytes)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (NCT00447382)
Timeframe: Week 0, week 52

,
Intervention10^9/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN304254.0242.2-12.8
NN729267.1247.2-18.6

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Clinical Laboratory Values (Change in Haematology - Neutrophils)

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30460.0065.596.25
NN72956.3657.50-6.00

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Clinical Laboratory Values (Change in Haematology - Monocytes)

"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3043.403.59-2.50
NN7294.003.420.67

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Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change

For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level >300 mg/dL. (NCT00461331)
Timeframe: 24 to 100 hours after last pump infusion line change

InterventionParticipants (Number)
Insulin Aspart17
Insulin Lispro16

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Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place

Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods. (NCT00461331)
Timeframe: Between 48, 72 and 96 hours after the last pump infusion line change

Interventionpg/ml (Mean)
Insulin Aspart6.9
Insulin Lispro6.5

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Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place

Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods. (NCT00461331)
Timeframe: 48 to 100 hours after keeping the same pump infusion line in place

Interventionµg/ml (Mean)
Insulin Aspart5.1
Insulin Lispro5.6

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Percentage of Patients Achieving HbA1c <=7% at Week 24

This is a component of the primary endpoint (NCT00467649)
Timeframe: 24 Weeks

InterventionPercent (Number)
Group A (Phase 1 SYMLIN)44.6
Group B (Phase 1 RA Insulin)55.4

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Percentage of Patients With a Severe Hypoglycemia Adverse Event

This is a component of the primary endpoint. (NCT00467649)
Timeframe: 24 Weeks

InterventionPercent (Number)
Group A (Phase 1 SYMLIN)0.0
Group B (Phase 1 RA Insulin)0.0

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Percentage of Patients With no Weight Gain at Week 24

This is a component of the primary endpoint (NCT00467649)
Timeframe: 24 Weeks

InterventionPercent (Number)
Group A (Phase 1 SYMLIN)46.4
Group B (Phase 1 RA Insulin)14.3

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The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia

A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention. (NCT00467649)
Timeframe: 24 Weeks

InterventionPercent (Number)
Group A (Phase 1 SYMLIN)30.4
Group B (Phase 1 RA Insulin)10.7

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Fasting Serum Lipids Change From Baseline to Week 24

(NCT00467649)
Timeframe: Baseline, week 24

,
Interventionmg/dL (Mean)
Total CholesterolHDLLDLTriglycerides
Group A (Phase 1 SYMLIN)-1.811.112.36-28.96
Group B (Phase 1 RA Insulin)5.271.659.12-31.98

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Hypoglycemia Adverse Events

"MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating.~MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion).~SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention." (NCT00467649)
Timeframe: 36 weeks

,,,,,
Interventionparticipants (Number)
MildModerateSevere
Group A (Phase 1 SYMLIN)31120
Group B (Phase 1 RA Insulin)46130
Group C (Phase 2 SYMLIN)700
Group D (Phase 2 SYMLIN+RA)1810
Group E (Phase 2 RA Insulin)920
Group F (Phase 2 RA Insulin + SYMLIN)1930

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Phase 2: Change in HbA1c at Week 36

Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only). (NCT00467649)
Timeframe: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

,,,
InterventionPercent (Mean)
Phase 1 BaselineChange From Phase 1 Baseline to Week 36Phase 2 Baseline at Week 24Change From Phase 2 Baseline to Week 36
Group C (Phase 2 SYMLIN)8.35-1.966.260.14
Group D (Phase 2 SYMLIN+RA)8.03-0.687.57-0.23
Group E (Phase 2 RA Insulin)7.85-1.496.140.22
Group F (Phase 2 RA Insulin + SYMLIN)8.38-0.997.320.07

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Phase 2: Change in Body Weight at Week 36

Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only). (NCT00467649)
Timeframe: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

,,,
Interventionkg (Mean)
Phase 1 BaselineChange From Phase 1 Baseline to Week 36Phase 2 Baseline at Week 24Change From Phase 2 Baseline to Week 36
Group C (Phase 2 SYMLIN)109.98-0.80108.500.69
Group D (Phase 2 SYMLIN+RA)104.831.34105.670.50
Group E (Phase 2 RA Insulin)104.423.90107.870.44
Group F (Phase 2 RA Insulin + SYMLIN)105.304.51110.68-0.86

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Change in Body Weight From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section (NCT00467649)
Timeframe: From Baseline to Week 24

Interventionkg (Least Squares Mean)
Group A (Phase 1 SYMLIN)0.02
Group B (Phase 1 RA Insulin)4.65

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Change in Fasting Plasma Glucose From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section (NCT00467649)
Timeframe: From Baseline to Week 24

Interventionmg/dL (Mean)
Group A (Phase 1 SYMLIN)-29.0
Group B (Phase 1 RA Insulin)-37.8

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Change in HbA1c From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section (NCT00467649)
Timeframe: From Baseline to Week 24

InterventionPercent (Least Squares Mean)
Group A (Phase 1 SYMLIN)-1.11
Group B (Phase 1 RA Insulin)-1.27

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Change in Waist Circumference From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section (NCT00467649)
Timeframe: From Baseline to Week 24

Interventioncm (Least Squares Mean)
Group A (Phase 1 SYMLIN)-0.63
Group B (Phase 1 RA Insulin)2.17

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Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment. (NCT00469092)
Timeframe: After 26 weeks of treatment

Interventionpercentage of total haemoglobin (Least Squares Mean)
BIAsp 307.08
Glargine7.23

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9-point Self-measured Plasma Glucose Profiles

Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. (NCT00469092)
Timeframe: After 26 weeks of treatment

,
Interventionmmol/L (Mean)
Before breakfast2 hours after breakfastBefore lunch2 hours after lunchBefore dinner2 hours after dinnerBefore bedtime02:00-04:00 AMBefore breakfast following day
BIAsp 306.739.407.248.907.908.667.776.566.65
Glargine6.569.077.288.987.809.188.546.696.40

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Number of Subjects Reporting Treatment Emergent Adverse Events

Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration. (NCT00469092)
Timeframe: Weeks 0-26

Interventionparticipants (Number)
BIAsp 30117
Glargine115

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Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)

Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. (NCT00469092)
Timeframe: After 26 weeks of treatment

,
Interventionscores on a scale (Mean)
Burden ScoreEfficacy ScoreSymptoms ScoreOverall Score
BIAsp 3083.1073.2572.4276.53
Glargine83.0673.4772.8176.64

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Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)

The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin. (NCT00469092)
Timeframe: After 26 weeks of treatment

,
Interventionparticipants (Number)
HbA1c <= 6.5% of haemoglobinHbA1c < 7.0% of haemoglobinReduction > 1% point from baselineHbA1c < 7% no nocturnal hypoglycemiaHbA1c < 7%, no daytime hypoglycemiaHbA1c < 7%, no hypoglycemia
BIAsp 3054101134825245
Glargine60106132925045

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Number of Hypoglycaemic Episodes

Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. (NCT00469092)
Timeframe: Weeks 0-26

,
Interventionevents (Number)
MinorSymptom onlyMajorUnclassified
BIAsp 3044326531
Glargine31822430

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Insulin Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.

Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first. (NCT00469833)
Timeframe: 180 minutes

,
Interventionpmol/L (Mean)
Insulin at baselineInsulin at 8 weeks
IV Glucose316.4395.6
Oral Glucose546.9934.6

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HbA1c Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.

Type 2 diabetic subjects had HbA1c measured before and after 2 months of basal insulin glargine treatment. (NCT00469833)
Timeframe: 2 months

Intervention% glycosylated hemoglobin (Mean)
HbA1c at baselineHbA1c at 8 weeks
Uncontrolled Type 2 Diabetic Subjects8.67.1

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ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.

Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first. (NCT00469833)
Timeframe: 180 minutes

,
Interventionpmol/min (Mean)
Insulin secretion at baselineInsulin secretion at 8 weeks
IV Glucose0.750.76
Oral Glucose0.671.11

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C-peptide Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.

Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first. (NCT00469833)
Timeframe: 180 minutes

,
Interventionnmol/L (Mean)
C-peptide at baselineC-peptide at 8 weeks
IV Glucose5.636.02
Oral Glucose7.1010.89

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Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36

(NCT00474045)
Timeframe: At gestational week (GW) 36

InterventionPercent (%) glycosylated haemoglobin (Least Squares Mean)
Insulin Detemir6.22
Neutral Protamine Hagedorn (NPH) Insulin6.37

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Maternal Safety - Acceleration of Nephropathy

Acceleration of nephropathy was defined as a change from a low U-albumin:U-creatinine ratio ≤33.93 mg/mmol to a high U-albumin:U-creatinine ratio > 33.93 mg/mmol from GW 8-12 (Visit P1) to the follow-up visit. (NCT00474045)
Timeframe: From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)

Interventionparticipants (Number)
Insulin Detemir2
Neutral Protamine Hagedorn (NPH) Insulin1

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Maternal Safety - Electrocardiogram (ECG)

The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' (at Visit 1, 3 weeks before randomisation) to 'Abnormal, clinically significant' (at Follow-Up). 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. (NCT00474045)
Timeframe: Follow-Up (6 weeks after delivery)

Interventionparticipants (Number)
Insulin Detemir0
Neutral Protamine Hagedorn (NPH) Insulin0

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Maternal Safety - Nocturnal Hypoglycaemic Episodes

A nocturnal episode is any episode occurring between 0.01 - 5.59, both including. It includes major, minor and symptoms only episodes. Major: unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. (NCT00474045)
Timeframe: Participants were followed during the pregnancy period, an average of 9.6 months

Interventionepisodes (Number)
Insulin Detemir1451
Neutral Protamine Hagedorn (NPH) Insulin1643

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Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T) (NCT00474045)
Timeframe: At Delivery (End of Pregnancy)

Intervention%B/T (Median)
Insulin Detemir0.38
Neutral Protamine Hagedorn (NPH) Insulin0.32

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Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T). (NCT00474045)
Timeframe: At Delivery (End of Pregnancy)

Intervention%B/T (Median)
Insulin Detemir5.99
Neutral Protamine Hagedorn (NPH) Insulin4.12

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Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T). (NCT00474045)
Timeframe: At Delivery (End of Pregnancy)

Intervention%B/T (Median)
Insulin Detemir1.31
Neutral Protamine Hagedorn (NPH) Insulin0.90

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Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood

(NCT00474045)
Timeframe: At Delivery

Interventionpmol/L (Median)
Insulin Detemir25.00

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Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36) (NCT00474045)
Timeframe: At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

Interventionratio (Median)
Insulin Detemir0.84
Neutral Protamine Hagedorn (NPH) Insulin0.64

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Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36) (NCT00474045)
Timeframe: At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

Interventionratio (Median)
Insulin Detemir1.29
Neutral Protamine Hagedorn (NPH) Insulin0.90

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Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36) (NCT00474045)
Timeframe: At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

Interventionratio (Median)
Insulin Detemir1.10
Neutral Protamine Hagedorn (NPH) Insulin0.77

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Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36

(NCT00474045)
Timeframe: At both Visit P3 (GW 24) and Visit P4 (GW 36)

Interventionparticipants (Number)
Insulin Detemir57
Neutral Protamine Hagedorn (NPH) Insulin46

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8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36

8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit. (NCT00474045)
Timeframe: Visit P4 (GW 36)

,
Interventionmmol/L (Mean)
Before Breakfast (N=131,141)120 mins after breakfast (N=130,139)Before Lunch (N=131,141)120 mins after lunch (N=130,140)Before Dinner (N=131,140)120 mins after Dinner (N=117,132)Bedtime (N=126,137)At 2.00 A.M. (N=122,135)
Insulin Detemir67.45.96.96.57.476
Neutral Protamine Hagedorn (NPH) Insulin6.37.56.17.16.57.47.26.4

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8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24

8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit. (NCT00474045)
Timeframe: Visit P3 (GW 24)

,
Interventionmmol/L (Mean)
Before Breakfast (N=131,141)120 mins after breakfast (N=130,141)Before Lunch (N=131,141)120 mins after lunch (N=130,140)Before Dinner (N=130,140)120 mins after Dinner (N=117,133)Bedtime (N=125,137)At 2.00 A.M. (N=125,134)
Insulin Detemir6.47.76.17.26.87.27.66.7
Neutral Protamine Hagedorn (NPH) Insulin7.38.06.77.47.07.87.86.9

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Fasting Plasma Glucose (FPG)

(NCT00474045)
Timeframe: During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]

,
Interventionmmol/L (Mean)
GW 8-12 IDet (N)=130, NPH (N)=141GW 14 IDet (N)=125, NPH (N)=135GW 24 IDet (N)=129, NPH (N)=141GW 36 IDet (N)=129, NPH (N)=142
Insulin Detemir5.05.05.24.7
Neutral Protamine Hagedorn (NPH) Insulin5.85.76.35.4

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Glycosylated Haemoglobin (HbA1c) During Pregnancy

(NCT00474045)
Timeframe: During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Delivery Visit (end of pregnancy)] and Follow-Up Visit ( 6 weeks after delivery)

,
InterventionPercent (%) glycosylated haemoglobin (Mean)
GW 8-12 IDet (N)=140, NPH (N)=146GW 14 IDet (N)=136, NPH (N)=146GW 24 IDet (N)=138, NPH (N)=146GW 36 IDet (N)=138, NPH (N)=146Delivery IDet (N)=138, NPH (N)=146Follow-up IDet (N)=138, NPH (N)=146
Insulin Detemir6.66.366.26.36.5
Neutral Protamine Hagedorn (NPH) Insulin6.86.56.16.36.56.6

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Maternal Safety - Acceleration of Retinopathy in Any Eye

Acceleration of Retinopathy is defined as worsening of fundoscopy/fundusphotography findings from GW 8-12 (Visit P1) to follow-up on one or both eyes. (NCT00474045)
Timeframe: From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)

,
Interventionparticipants (Number)
Acceleration in Any EyeNo Acceleration in Any EyeMissing Data
Insulin Detemir1212020
Neutral Protamine Hagedorn (NPH) Insulin1412024

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Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit

Change in the body weight was summarised by treatment. (NCT00474045)
Timeframe: Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)

,
Interventionkg (Mean)
GW (8-12) IDet(N)=139,NPH(N)=145Change from GW(8-12)-GW 14 (N=128,139)Change from GW(8-12)-GW 24 (N=130,139)Change from GW(8-12)-GW 36(N=130,139)
Insulin Detemir67.81.05.611.5
Neutral Protamine Hagedorn (NPH) Insulin69.21.46.011.0

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Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit

Change in the diastolic blood pressure was summarised by treatment. (NCT00474045)
Timeframe: Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionmmHg (Mean)
GW (8-12) IDet(N)=140,NPH(N)=146Change from GW(8-12)-GW 14 (N=137,145)Change from GW(8-12)-GW 24(N=138,145)Change from GW(8-12)-GW 36(N=138,145)Change from GW(8-12)-FU(N=138,145)
Insulin Detemir70.5-0.2-1.63.21.3
Neutral Protamine Hagedorn (NPH) Insulin70.7-0.5-1.22.61.8

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Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up

Change in the pulse was summarised by treatment. (NCT00474045)
Timeframe: Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up Visit (6 weeks after delivery)

,
Interventionbeats/minute (Mean)
GW (8-12) IDet(N)=136,NPH(N)=142Change from GW(8-12)-GW 14 (N=133,139)Change from GW(8-12)-GW 24(N=134,141)Change from GW(8-12)-GW 36(N=134,141)Change from GW(8-12)-FU(N=134,141)
Insulin Detemir77.41.53.55.2-3
Neutral Protamine Hagedorn (NPH) Insulin76.82.24.54.9-2.3

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Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit

Change in the systolic blood pressure was summarised by treatment. (NCT00474045)
Timeframe: Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionmmHg (Mean)
GW (8-12) IDet(N)=140,NPH(N)=146Change from GW(8-12)-GW 14 (N=137,145)Change from GW(8-12)-GW 24(N=138,145)Change from GW(8-12)-GW 36(N=138,145)Change from GW(8-12)-FU(N=138,145)
Insulin Detemir114.10.8-0.73.12.6
Neutral Protamine Hagedorn (NPH) Insulin116.2-2.8-1.62.3-0

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Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alanine aminotransferase level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionU/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir16.1227.0610.88
Neutral Protamine Hagedorn (NPH) Insulin17.9726.168.16

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Maternal Safety - Change in Albumin Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in albumin level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventiong/dL (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir4.054.190.13
Neutral Protamine Hagedorn (NPH) Insulin4.044.120.09

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Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in albumin/creatinine ratio at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmg/mmol (Mean)
Visit P1 IDet (N)=135, NPH (N)=143FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=133, 142)
Insulin Detemir0.822.651.88
Neutral Protamine Hagedorn (NPH) Insulin0.854.814.07

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Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alkaline phosphatase level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionU/L (Mean)
Visit P1 IDet (N)=137, NPH (N)=144FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=135, 144)
Insulin Detemir52.6490.1737.39
Neutral Protamine Hagedorn (NPH) Insulin53.8892.9639.51

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Maternal Safety - Change in Creatinine Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in creatinine serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmcmol/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir52.0462.9811.18
Neutral Protamine Hagedorn (NPH) Insulin54.0166.5712.52

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Maternal Safety - Change in Haemoglobin Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in haemoglobin level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmmol/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=146FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir7.647.810.16
Neutral Protamine Hagedorn (NPH) Insulin7.647.690.05

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Maternal Safety - Change in Insulin Aspart Specific Antibodies

Change in concentrations values for insulin aspart specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing. (NCT00474045)
Timeframe: Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.

,
Intervention%B/T (Median)
Baseline IDet (N)=145, NPH (N)=154Visit P4 IDet (N)=109, NPH (N)=110Change from Baseline-Visit P4(N=104,109)
Insulin Detemir0.440.43-0.12
Neutral Protamine Hagedorn (NPH) Insulin0.460.36-0.21

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Maternal Safety - Change in Insulin Detemir Specific Antibodies

Change in concentrations of values for insulin detemir specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing. (NCT00474045)
Timeframe: Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.

,
Intervention%B/T (Median)
Baseline IDet (N)=145, NPH (N)=155Visit P4 IDet (N)=110, NPH (N)=110Change from Baseline-Visit P4(N=105,109)
Insulin Detemir1.131.360.04
Neutral Protamine Hagedorn (NPH) Insulin1.091.250.09

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Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies

Change in concentrations values for insulin detemir/aspart cross-reacting antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing (NCT00474045)
Timeframe: Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.

,
Intervention%B/T (Median)
Baseline IDet (N)=146, NPH (N)=155Visit P4 IDet (N)=110, NPH (N)=110Change from Baseline-Visit P4(N=106,109)
Insulin Detemir5.215.40-0.43
Neutral Protamine Hagedorn (NPH) Insulin5.364.28-1.12

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Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in lactate dehydrogenase serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionU/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir145.1167.521.82
Neutral Protamine Hagedorn (NPH) Insulin144.1169.525.46

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Maternal Safety - Change in Leukocytes Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in leukocytes level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Intervention10^9 cells/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=146FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir8.016.68-1.36
Neutral Protamine Hagedorn (NPH) Insulin8.26.55-1.65

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Maternal Safety - Change in Potassium Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in potassium serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmmol/L (Mean)
Visit P1 IDet (N)=137, NPH (N)=144FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=135, 144)
Insulin Detemir4.134.300.15
Neutral Protamine Hagedorn (NPH) Insulin4.124.310.20

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Maternal Safety - Change in Sodium Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in sodium serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmmol/L (Mean)
Visit P1 IDet (N)=137, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=135, 145)
Insulin Detemir138.0141.63.59
Neutral Protamine Hagedorn (NPH) Insulin137.8141.23.36

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Maternal Safety - Change in Thrombocytes Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in thrombocytes level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Intervention10^9 cells/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=146FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir245.3270.624.25
Neutral Protamine Hagedorn (NPH) Insulin247.2263.116.16

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Maternal Safety - Change in Total Protein Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in total protein serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventiong/dL (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir6.847.080.24
Neutral Protamine Hagedorn (NPH) Insulin6.897.110.22

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Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in Urine-N (creatinine) level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmg/dL (Mean)
Visit P1 IDet (N)=135, NPH (N)=144FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=133, 143)
Insulin Detemir114.8106.2-6.62
Neutral Protamine Hagedorn (NPH) Insulin103.198.61-6.34

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Maternal Safety - Hypoglycaemic Episodes

All episodes include major, minor and symptoms only. Major episode : unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. Diurnal: Episode occurring between 06.00 - 00.00, both including. (NCT00474045)
Timeframe: Participants were followed during the pregnancy period, an average of 9.6 months

,
Interventionepisodes (Number)
All EpisodesDiurnal
Insulin Detemir94968045
Neutral Protamine Hagedorn (NPH) Insulin94537810

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Maternal Safety - Mode of Delivery

Non-Planned Caesarean Section is a procedure which takes place ≤8h prior to delivery. Planned Caesarean Section takes place >8h prior to delivery. (NCT00474045)
Timeframe: At Delivery Visit

,
Interventionpercentage (%) of subjects (Number)
Spontaneous onset of labour (N)=130,136Induction of labour (N)=130,136Normal Vaginal Delivery(N)=54,50Instrumental Vaginal Delivery(N)=54,50Non-Planned Caesarean Section(N)=76,86Planned Caesarean Section(N)=76,86
Insulin Detemir193976243665
Neutral Protamine Hagedorn (NPH) Insulin283680204357

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Maternal Safety - Number of Subjects With Adverse Events (AEs)

AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. Serious adverse event (SAE) =any undesirable serious medical event as defined in protocol. (NCT00474045)
Timeframe: Participants were followed during the pregnancy period, an average of 9.6 months

,
Interventionparticipants (Number)
Subjects with (w.) adverse eventsSubjects with serious adverse eventsSubjects with severe adverse eventsSubjects w. AEs related to basal insulinSubjects w. AEs related to bolus insulinSubjects with AEs leading to withdrawal
Insulin Detemir1386138181213
Neutral Protamine Hagedorn (NPH) Insulin141493216146

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Pregnancy Outcome at Delivery

Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Stillbirth indicates death between at or after 22 GW and at or before delivery. (NCT00474045)
Timeframe: Delivery Visit

,
Interventionparticipants (Number)
Live BirthEarly Foetal Death (Spont. Abortion)Early Foetal Death (Ectopic Pregnancy)Induced AbortionStillbirth
Insulin Detemir12810112
Neutral Protamine Hagedorn (NPH) Insulin1368100

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Pregnancy Outcome at Follow-Up

Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Perinatal Death means death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal Death means death between at or after 7 completed days and before 28 completed days after delivery. Death During Follow-Up means death between at or after 28 days after delivery and at or before Follow-Up. (NCT00474045)
Timeframe: Follow-Up (6 weeks after delivery)

,
Interventionparticipants (Number)
Live ChildrenEarly Foetal Death (Spont. Abortion)Early Foetal Death (Ectopic Pregnancy)Induced AbortionPerinatal DeathNeonatal DeathDeath During Follow-Up
Insulin Detemir1281011200
Neutral Protamine Hagedorn (NPH) Insulin135810100

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Safety - Composite Pregnancy Outcome

Wt. corresponds to weight of live-born infants. Pre-term delivery: delivery before 37 completed GWs including abortions. Early foetal death: death before 22 completed GWs. Perinatal mortality: death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal mortality: post-partum after 7 completed days and before 28 completed days after delivery. Major-malformation: a life threatening structural anomaly or one likely to cause significant impairment of health or functional capacity and needs medical or surgical treatment. (NCT00474045)
Timeframe: End of Pregnancy

,
Interventionparticipants (Number)
Wt. below the 10th percentile(N)=128,136Wt. above the 90th percentile(N)=128,136Pre-term delivery (N)=142,145Major malformations (N)=142,145Early foetal death (N)=142,145Perinatal mortality (N)=130,136Neonatal mortality (N)=126,135Compiled(at least 1 of above)(N)=142,145
Insulin Detemir359395112089
Neutral Protamine Hagedorn (NPH) Insulin17345191096

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Safety - Total Daily Insulin Dose During Pregnancy

(NCT00474045)
Timeframe: Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (6 weeks after delivery)

,
InterventionU/kg (Mean)
GW 14 IDet (N)=129, NPH (N)=141GW 24 IDet (N)=128, NPH (N)=137GW 36 IDet (N)=119, NPH (N)=121Follow-Up IDet (N)=124, NPH (N)=133
Insulin Detemir0.730.851.170.53
Neutral Protamine Hagedorn (NPH) Insulin0.740.841.050.57

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Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events

AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. SAE=any undesirable serious medical event as defined in protocol. (NCT00474045)
Timeframe: Foetuses/Newborns were followed during the pregnancy period, an average of 9.6 months and Follow-Up period (6 weeks after delivery)

,
InterventionFoetus/Newborns (1 per pregnant woman) (Number)
Subjects with adverse eventsSubjects with serious adverse eventsSubjects with severe adverse eventsSubjects w. AEs related to Basal insulinSubjects w. AEs related to Bolus insulinSubjects with AEs leading to withdrawal
Insulin Detemir563615110
Neutral Protamine Hagedorn (NPH) Insulin553212001

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Maternal Safety - Change in Urine Albumin Level (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in urine albumin level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventiong/dL (Mean)
Visit P1 IDet (N)=135, NPH (N)=143FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=133, 142)
Insulin Detemir0.010.020.01
Neutral Protamine Hagedorn (NPH) Insulin0.010.030.02

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Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36

(NCT00474045)
Timeframe: At gestational week (GW) 36

InterventionPercent (%) glycosylated haemoglobin (Least Squares Mean)
Insulin Detemir6.27
Neutral Protamine Hagedorn (NPH) Insulin6.33

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Number of Reported Adverse Events

adverse events are defined as a change from baseline (NCT00476788)
Timeframe: 6.9 months (average)

Interventionevents (Number)
Omnipod Device0

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Mean Glycated Hemoglobin (A1c)

Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%. (NCT00476788)
Timeframe: 6.9 months (average)

Interventionpercentage of glycated hemoglobin (Mean)
Omnipod Device7.6

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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint

(NCT00487240)
Timeframe: baseline to 32 weeks

,
Interventionhypoglycemic events per 30 days (Mean)
Endpoint Hypogylcemic RateOverall Hypoglycemic RateEndpoint Nocturnal Hypoglycemic RateOverall Nocturnal Hypoglycemic RateEndpoint Non-Nocturnal Hypoglycemic RateOverall Non-Nocturnal Hypoglycemic RateEndpoint Severe Hypoglycemic RateOverall Severe Hypoglycemic Rate
Detemir4.325.030.460.493.854.500.010.02
Insulin Lispro Protamine Suspension5.456.280.730.794.695.470.050.03

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7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint

Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals. (NCT00487240)
Timeframe: 32 Weeks

,
Interventionmillimoles per Liter (mmol/L) (Mean)
Daily Mean 7-Point SMBG (N=164,N=172)Daily Mean Pre-Meal (N=174,N=181)Daily Mean Postprandial Meal (N=168,N=176)Daily Mean Morning+Evening Pre-Meal (N=174,N=181)Actual Morning Pre-Meal (N=175,N=182)Actual Morning Postprandial Meal (N=171,N=178)Actual Midday Pre-Meal (N=175,N=181)Actual Midday Postprandial Meal (N=170,N=177)Actual Evening Pre-Meal (N=174,N=181)Actual Evening Postprandial Meal (N=172,N=181)Actual 0300 Hours (N=167,N=173)Actual Morning SMBG Excursion (N=171,N=178)Actual Midday SMBG Excursion (N=170,N=176)Actual Evening SMBG Excursion (N=172,N=181)Actual Daily Mean SMBG Excursion (N=168,N=176)
Detemir8.488.568.588.758.628.568.198.618.878.608.29-0.120.46-0.240.01
Insulin Lispro Protamine Suspension8.678.778.709.009.098.688.298.548.929.058.49-0.340.380.120.06

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Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values

"The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the mean change from baseline is calculated by averaging out for all subjects. [Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline." (NCT00487240)
Timeframe: Baseline, 8,16, 24, 32 Weeks

,
Interventionpercent of HbA1c (Least Squares Mean)
Baseline8 Week HbA1c (n=184, n=179)8 Week Change from Baseline16 Week HbA1c (n=174, n=173)16 Week Change from Baseline24 Week HbA1c (n=171, n=174)24 Week Change from Baseline32 Week HbA1c (n=165, n=165)32 Week Change from Baseline
Detemir8.688.11-0.648.08-0.678.11-0.658.14-0.62
Insulin Lispro Protamine Suspension8.888.08-0.687.94-0.818.07-0.698.09-0.68

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Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%

(NCT00487240)
Timeframe: 32 Weeks

,
Interventionpercentage of participants (Number)
With HbA1c ≤7.0%With HbA1c >7.0%With HbA1c <7.0%With HbA1c ≥7.0%With HbA1c ≤6.5%With HbA1c >6.5%With HbA1c <6.5%With HbA1c ≥6.5%
Detemir18.781.315.484.69.990.18.291.8
Insulin Lispro Protamine Suspension18.581.515.284.88.791.37.192.9

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Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint

Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. (NCT00487240)
Timeframe: Baseline to 32 Weeks

,
Interventionepisodes of hypoglycemia (Number)
Endpoint Hypoglycemic EpisodesOverall Hypoglycemic EpisodesEndpoint Nocturnal Hypoglycemic EpisodesOverall Nocturnal Episodes (N=191,N=186)Endpoint Non-Nocturnal Hypoglycemic EpisodesOverall Non-Nocturnal Hypoglycemic EpisodesEndpoint Severe Hypoglycemic EpisodesOverall Severe Hypoglycemic Episodes (N=171,N=170)
Detemir13517355111129172313
Insulin Lispro Protamine Suspension134173691251271721124

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Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])

Total daily insulin dose adjusted for body weight (U/kg/day) was assessed. (NCT00487240)
Timeframe: 32 Weeks

,
Interventionunits of insulin per kilogram per day (Mean)
Total Insulin (N=192, N=188)Total Bolus Insulin (N=191, N=187)Total Basal Insulin (N=192, N=188)
Detemir0.990.450.55
Insulin Lispro Protamine Suspension0.910.390.53

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Change From Baseline in Absolute Body Weight at 32 Week Endpoint

(NCT00487240)
Timeframe: Baseline, 32 Weeks

,
Interventionkilograms (Mean)
BaselineChange from Baseline
Detemir72.690.58
Insulin Lispro Protamine Suspension72.761.54

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Insulin Dose (Total and By Component [Basal and Bolus])

Total daily insulin dose (U/day) was assessed. (NCT00487240)
Timeframe: 32 weeks

,
Interventionunits of insulin per day (U/day) (Mean)
Total Insulin (N=192, N=188)Total Bolus Insulin (N=191, N=187)Total Basal Insulin (N=192, N=188)
Detemir73.8433.3240.70
Insulin Lispro Protamine Suspension67.7828.9438.99

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Glycemic Variability at Endpoint

Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose [SMBG] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values. (NCT00487240)
Timeframe: 32 Weeks

,
Interventionmillimoles per Liter (mmol/L) (Mean)
Standard Deviation (SD) Value (N=172, N=180)Mean Value (M-Value) (N=175, N=182)Mean Daily Difference (MODD) Value (N=172, N=180)
Detemir2.3032.192.78
Insulin Lispro Protamine Suspension2.6436.393.04

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Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

(NCT00487240)
Timeframe: baseline and 32 weeks

,
Interventionpercent of HbA1c (Least Squares Mean)
BaselineChange from Baseline
Detemir8.68-0.59
Insulin Lispro Protamine Suspension8.88-0.69

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1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint

Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. (NCT00487240)
Timeframe: baseline to 32 weeks

,
Interventionhypoglycemic events per 1 year (Mean)
Endpoint Hypoglycemic RateOverall Hypoglycemic RateEndpoint Nocturnal Hypoglcemic RateOverall Nocturnal Hypoglycemic RateEndpoint Non-Nocturnal Hypoglycemic RateOverall Non-Nocturnal Hypoglycemic RateEndpoint Severe Hypoglycemic RateOverall Severe Hypoglycemic Rate
Detemir52.6061.215.606.0146.8854.830.100.25
Insulin Lispro Protamine Suspension66.4176.458.909.6557.0866.580.630.42

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1-Year Overall Survival Rate

The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months. (NCT00500240)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Conventional Care80.8
Intensive Insulin63.5

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Overall Survival

Overall survival (OS) defined as the interval between the date of randomization and the date of death. Calculation of period was from baseline (date of randomization) to the death or last follow-up. (NCT00500240)
Timeframe: Baseline (date of randomization) to date of death or last follow-up (weekly during treatment then every 2 months post study treatment) up to 6 years

InterventionMonths (Median)
Conventional Care44
Intervention Group62.2

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Progression Free Survival (PFS)

PFS was defined as the time interval between the date of complete remission and the date of relapse detection or death. Complete Remission (CR) defined as granulocyte count >1.0 × 10^9/L, platelet count >100 × 10^9/L, no abnormal peripheral blasts, and <5% blasts in normocellular or hypercellular bone marrow. (NCT00500240)
Timeframe: Date of complete remission to disease progression, assessed for approximately 6 years

InterventionMonths (Median)
Conventional Care38.8
Intensive Insulin24

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Mean Number of Total Hypoglycaemic Episodes, Month 1

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. (NCT00506662)
Timeframe: weeks -2-0, month 1

,
Interventionepisodes per week by visit (Mean)
Screening (week -2 to week 0)Month 1 (weeks 1-4)Difference (month 1-screening)
Insulin Detemir0.0390.026-0.013
Insulin NPH0.0730.1200.047

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Mean Number of Total Hypoglycaemic Episodes, Months 5-7

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. (NCT00506662)
Timeframe: weeks -2-0, months 5-7

,
Interventionepisodes per week by visit (Mean)
Screening (week -2 to week 0)Months 5-7 (weeks 17-28)Difference (months 5-7 - screening)
Insulin Detemir0.0390.018-0.022
Insulin NPH0.0580.041-0.017

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Mean Number of Total Hypoglycaemic Episodes, Months 2-4

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. (NCT00506662)
Timeframe: weeks -2-0, months 2-4

,
Interventionepisodes per week by visit (Mean)
Screening (week -2 to week 0)Months 2-4 (weeks 5-16)Difference (months 2-4 - screening)
Insulin Detemir0.0390.015-0.024
Insulin NPH0.0760.072-0.004

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Body Weight

Body weight after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionkg (Mean)
Treatment period 1, N= 12, 10Treatment period 2, N= 10, 12
Insulin Detemir First, Then Insulin NPH80.682.9
Insulin NPH First, Then Insulin Detemir86.084.8

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Total Energy Expenditure, Double-labelled Water Method

Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure. (NCT00509925)
Timeframe: Weeks 14-16, weeks 30-32

Interventionkcal/day (Mean)
Insulin Detemir2942.2
Insulin NPH3007.2

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Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)

Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual's average daily food intake. (NCT00509925)
Timeframe: Week 14, week 30

Interventionkcal/day (Mean)
Insulin Detemir73.0
Insulin NPH74.3

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Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)

Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT. (NCT00509925)
Timeframe: Week 16, week 32

Interventionkcal/day (Mean)
Insulin Detemir1163.7
Insulin NPH1170.0

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Component of Total Energy Expenditure: Physical Activity Thermogenesis

Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32). (NCT00509925)
Timeframe: Week 16, week 32

Interventionkcal/day (Mean)
Insulin Detemir588.5
Insulin NPH542.7

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Component of Total Energy Expenditure: Resting Energy Expenditure (REE)

Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation. (NCT00509925)
Timeframe: Week 14, week 30

Interventionkcal/day (Mean)
Insulin Detemir1932.5
Insulin NPH2034.5

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Hypoglycaemic Episodes

Total number of hypoglycaemic episodes experienced in the study. (NCT00509925)
Timeframe: Weeks 0-32

Interventionepisodes (Number)
Insulin Detemir90
Insulin NPH109

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Total Energy Expenditure, Dietary Record Method

The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE. (NCT00509925)
Timeframe: Weeks 14-16, weeks 30-32

Interventionkcal/day (Mean)
Insulin Detemir2017.9
Insulin NPH2181.0

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Waist:Hip Ratio

At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionpercentage of hip circumference (Mean)
Treatment period 1, N= 12, 10Treatment period 2, N= 10, 12
Insulin Detemir First, Then Insulin NPH92.492.4
Insulin NPH First, Then Insulin Detemir94.494.8

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Hypoglycaemic Episodes, Diurnal/Nocturnal

Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study. (NCT00509925)
Timeframe: Weeks 0-32

,
Interventionepisodes (Number)
DiurnalNocturnalTime of event not recorded
Insulin Detemir62262
Insulin NPH601534

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Hormonal Assessment: Resistin

Resistin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30

,
Interventionng/ml (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 11
Insulin Detemir First, Then Insulin NPH8.28.4
Insulin NPH First, Then Insulin Detemir10.216.2

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Hormonal Assessment: Leptin

Leptin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30

,
Interventionng/ml (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 11
Insulin Detemir First, Then Insulin NPH9.49.9
Insulin NPH First, Then Insulin Detemir10.56.6

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Hormonal Assessment: Insulin-like Growth Factor-1

Insulin-like growth factor-1 (IGF-1) levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30

,
Interventionng/ml (Mean)
Treatment period 1, N=12, 9Treatment period 2, N=9, 10
Insulin Detemir First, Then Insulin NPH212.3179.8
Insulin NPH First, Then Insulin Detemir206.8168.4

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Hormonal Assessment: Adiponectin

Adiponectin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30

,
Interventionng/ml (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 11
Insulin Detemir First, Then Insulin NPH15978.315189.5
Insulin NPH First, Then Insulin Detemir11361.011053.3

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Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated haemoglobin A1c (HbA1c) after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionpercentage of total haemoglobin (Mean)
Treatment period 1, N=11, 10Treatment period 2, N=10, 12
Insulin Detemir First, Then Insulin NPH7.87.6
Insulin NPH First, Then Insulin Detemir7.48.0

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Lean Body Mass

Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionkg (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 12
Insulin Detemir First, Then Insulin NPH58.959.9
Insulin NPH First, Then Insulin Detemir63.764.3

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Fat Mass

Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionkg (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 12
Insulin Detemir First, Then Insulin NPH21.723.0
Insulin NPH First, Then Insulin Detemir22.319.2

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Fasting Plasma Glucose

Fasting plasma glucose (FPG) after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionmmol/L (Mean)
Treatment period 1, N=12, 9Treatment period 2, N=10, 12
Insulin Detemir First, Then Insulin NPH13.39.1
Insulin NPH First, Then Insulin Detemir10.513.3

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Glycemic Variability at Endpoint

Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose. (NCT00510952)
Timeframe: 24 weeks

Interventionmillimoles per liter (mmol/L) (Mean)
Lispro1.01
Glargine0.94

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Total Daily Insulin Dose (Units) at Endpoint

Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units). (NCT00510952)
Timeframe: 24 weeks

InterventionUnits of insulin (Mean)
Lispro33.28
Glargine30.85

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Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint

Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms). (NCT00510952)
Timeframe: 24 Weeks

InterventionUnits of insulin/kilograms (U/kg) (Mean)
Lispro0.39
Glargine0.35

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1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall

Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days. (NCT00510952)
Timeframe: Baseline to 24 weeks

,
Interventionhypoglycemic event per 1 year (Mean)
Hypoglycemic RateNocturnal Hypoglycemic RateSevere Hypoglycemic Rate
Glargine22.954.080.02
Lispro24.166.080.11

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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall

Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. (NCT00510952)
Timeframe: Baseline to 24 Weeks

,
Interventionhypoglycemic events per 30 days (Mean)
Hypoglycemic RateNocturnal Hypoglycemic RateSevere Hypoglycemic Rate
Glargine1.880.340.00
Lispro1.980.500.01

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7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint

Actual measurements and daily mean blood glucose levels at endpoint. (NCT00510952)
Timeframe: 24 weeks

,
Interventionmillimoles per liter (mmol/L) (Mean)
Actual Morning Pre-MealActual Morning Postprandial MealActual Midday Pre-MealActual Midday Postprandial MealActual Evening Pre-MealActual Evening Postprandial MealActual 0300 HoursDaily Mean 7-Point SMBGDaily Mean Pre-MealDaily Mean Postprandial MealDaily Mean Morning+Evening Pre-Meal
Glargine6.339.007.169.177.549.297.007.967.049.186.93
Lispro6.478.646.939.097.509.196.797.796.998.966.99

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Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)

(NCT00510952)
Timeframe: Baseline, 24 Weeks

,
Interventionpercent of HbA1c (Least Squares Mean)
BaselineChange from Baseline
Glargine8.69-1.41
Lispro8.70-1.46

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Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint

(NCT00510952)
Timeframe: Baseline, 24 weeks

,
Interventionkilograms (kg) (Mean)
BaselineChange from Baseline
Glargine86.051.07
Lispro84.231.04

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Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint

Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint. (NCT00510952)
Timeframe: 24 weeks

,
Interventionpercentage of participants (Number)
HbA1c <7.0%HbA1c ≤6.5%
Glargine41.221.7
Lispro43.824.8

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Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall

Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value <2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. (NCT00510952)
Timeframe: Baseline to 24 weeks

,
Interventionparticipants (Number)
All Hypoglycemic EpisodesNocturnal Hypoglycemic EpisodesSevere Hypoglycemic Episodes
Glargine160872
Lispro1681149

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Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value

(NCT00510952)
Timeframe: Baseline, 12 Weeks, 24 Weeks

,
Interventionpercent hemoglobin (Least Squares Mean)
Baseline (n= 225, n= 226)Week 12 HbA1c (n=213, n=220)Week 12 Change from Baseline (n=213, n=220)Week 24 HbA1c (n=206, n=218)Week 24 Change from Baseline (n=206, n=218)
Glargine8.697.36-1.307.24-1.43
Lispro8.707.30-1.367.15-1.52

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Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)

Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported. (NCT00519623)
Timeframe: Glucose infusion rates were adjusted every 10 minutes as necessary

Interventionmg/kg/min (Mean)
Transdermal Patch4.9

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Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)

Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported. (NCT00519623)
Timeframe: Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours

InterventionuU/mL (Mean)
Transdermal Patch33.0

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a Composite of Minor Postoperative Complications

a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days. (NCT00524472)
Timeframe: within 30 days after surgery

InterventionParticipants (Count of Participants)
Hyperinsulinemic-normoglycemic Clamp200
Insulin at the Standard of Care Levels237

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Any Major Morbidity/30-day Mortality

"a composite (any versus none) of the following major postoperative complications occurring:~all-cause postoperative mortality~failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation~serious postoperative infection~acute postoperative kidney injury requiring renal replacement therapy;~new postoperative focal or global neurologic deficit." (NCT00524472)
Timeframe: within 30 days post surgery

InterventionParticipants (Count of Participants)
Hyperinsulinemic-normoglycemic Clamp46
Insulin at the Standard of Care Levels82

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Duration of Hospitalization

Days from date of surgery to hospital discharge (NCT00524472)
Timeframe: starting post operative day one to discharge from hospital, on an average of 8 days

Interventiondays (Median)
Hyperinsulinemic-normoglycemic Clamp8
Insulin at the Standard of Care Levels8

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Duration of Intensive Care Stay

Hours from date of surgery to discharge from intensive care unit (NCT00524472)
Timeframe: ICU stay hours during hospital stay after surgery, on average of 25 hours

Interventionhours (Median)
Hyperinsulinemic-normoglycemic Clamp25
Insulin at the Standard of Care Levels27

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Post Operative Atrial Fibrillation

Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery (NCT00524472)
Timeframe: 15 - 30 days post operative

InterventionParticipants (Count of Participants)
Hyperinsulinemic-normoglycemic Clamp209
Insulin at the Standard of Care Levels235

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All-cause Mortality

All-cause mortality identified during one-year follow-up. (NCT00524472)
Timeframe: one year post operative

InterventionParticipants (Count of Participants)
Hyperinsulinemic-normoglycemic Clamp32
Insulin at the Standard of Care Levels22

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The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline

Pulmonary function test(forced expiratory volume at 1 second/forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks. (NCT00527397)
Timeframe: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment

Interventionliter/liter (Mean)
Week 1 (n=23)Week 2 (n=22)Week 6 (n=21)Week 12 (n=13)Week 26 (n=4)End of treatment (n=24)
All Subjects-0.003-0.023-0.022-0.0120.013-0.012

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The Value of Fasting Plasma Glucose:Change From Baseline

Fasting plasma glucose levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks. (NCT00527397)
Timeframe: Baseline, Week 6, Week 12, Week 26

,,
Interventionmilligram/millilitre (Mean)
Week 6 (n=4, 10, 6)Week 12 (n=3, 6, 3)End of treatment (n=4, 12, 6)
Type 1 Diabetes Mellitus50.327.787.3
Type 2 Diabetes Mellitus Not Using Insulin-3.0-5.0-8.8
Type 2 Diabetes Mellitus Using Insulin-1.611.318.3

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The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin

Number of hypoglycemic events per subject-month. Subject-month=(number of days from the first day of study treatment to the last day of active treatment + 1 day lag)/30.44 (NCT00527397)
Timeframe: 0 month to 12 months

,,
Interventionevents / subject-month (Number)
0 to 3 months (n=6, 12, 6)>3 to 6 months (n=3, 6, 4)overall (n=6, 12, 6)
Type 1 Diabetes Mellitus3.50.11.9
Type 2 Diabetes Mellitus Not Using Insulin0.10.30.2
Type 2 Diabetes Mellitus Using Insulin3.20.21.9

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Insulin Antibody Levels : Change From Baseline

Insulin antibody levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks. (NCT00527397)
Timeframe: Baseline, Week 6, Week 12, End of treatment

,,
Interventionmicrounit/milliliter (Mean)
Week 6 (n=5, 10, 6)Week 12 (n=4, 6, 3)End of treatment (n=6, 12, 6)
Type 1 Diabetes Mellitus1.689.7810.52
Type 2 Diabetes Mellitus Not Using Insulin-0.4211.0011.42
Type 2 Diabetes Mellitus Using Insulin3630.63131.733220.95

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The Values of Forced Expiratory Volume at 1 Second:Change From Baseline

Pulmonary function test(forced expiratory volume at 1 second) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks. (NCT00527397)
Timeframe: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26

Interventionliter (Mean)
Week 1 (n=23)Week 2 (n=22)Week 6 (n=21)Week 12 (n=13)Week 26 (n=4)End of treatment (n=24)
All Subjects-0.055-0.070-0.0650.012-0.030-0.034

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Daily Inhaled Insulin Dose

The mean of daily inhaled insulin dose. The dose of inhaled insulin was adjusted based on the results of self-monitoring of blood glucose before each meal.The end of treatment values were calculated each subject's last observed value up to 26 weeks. (NCT00527397)
Timeframe: Up to 26 weeks

,,
Interventionmilligram (Mean)
Day 1 (n=6, 12, 6)Day 2 (n=6, 12, 6)Day 3 (n=6, 12, 6)Day 4 (n=6, 12, 6)Day 5 (n=6, 12, 6)Week 1 (n=6, 12, 6)Week 2 (n=6, 11, 6)Week 4 (n=5, 11, 6)Week 6 (n=5, 9, 6)Week 8 (n=5, 8, 6)Week 12 (n=4, 7, 5)Week 16 (n=3, 6, 3)Week 20 (n=3, 5, 3)Week 26 (n=3, 5, 3)End of treatment (n=6, 12, 6)
Type 1 Diabetes Mellitus8.89.79.810.07.79.89.38.48.88.05.56.05.06.07.7
Type 2 Diabetes Mellitus Not Using Insulin5.55.55.85.55.55.85.55.25.85.75.45.06.36.36.8
Type 2 Diabetes Mellitus Using Insulin7.27.67.87.87.88.58.98.48.19.09.911.512.412.49.1

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The Values of Hemoglobin A1c:Change From Baseline

Hemoglobin A1c levels obtained each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks. (NCT00527397)
Timeframe: Baseline, Week 6, Week 12, Week 26, End of treatment

,,
Interventionpercent (Mean)
Week 6 (n=5, 10, 6)Week 12 (n=4, 6, 3)End of treatment (n=6, 12, 6)
Type 1 Diabetes Mellitus-0.42-0.35-0.22
Type 2 Diabetes Mellitus Not Using Insulin-0.72-0.93-0.48
Type 2 Diabetes Mellitus Using Insulin-0.39-0.480.01

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The Values of Forced Vital Capacity:Change From Baseline

pulmonary function test(forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks. (NCT00527397)
Timeframe: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment

Interventionliter (Mean)
Week 1 (n=23)Week 2 (n=22)Week 6 (n=21)Week 12 (n=13)Week 26 (n=4)End of treatment (n=24)
All Subjects-0.0530.000-0.0030.065-0.105-0.001

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Change in A1C From Baseline to Week 15

Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects. (NCT00530023)
Timeframe: Baseline and 15 weeks

Interventionpercent glycated hemoglobin (Mean)
722 Sensor Augmented Insulin Pump-1.7
Multiple Daily Injections (MDI)-1.0

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Incidence of Severe Hypoglycemia Events Baseline to Week 15

The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15. (NCT00530023)
Timeframe: Baseline and 15 weeks

Interventionnumber of events (Number)
722 Sensor Augmented Insulin Pump0
Multiple Daily Injections (MDI)1

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Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15

Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response. (NCT00530023)
Timeframe: Baseline and 15 weeks

InterventionScores on a scale (Mean)
722 Sensor Augmented Insulin Pump83.3
Multiple Daily Injections (MDI)33.3

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Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15

Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response. (NCT00530023)
Timeframe: Baseline and 15 weeks

InterventionScores on a scale (Mean)
722 Sensor Augmented Insulin Pump73.8
Multiple Daily Injections (MDI)41.0

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Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15

Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result. (NCT00530023)
Timeframe: Baseline and 15 weeks

InterventionScores on a scale (Mean)
722 Sensor Augmented Insulin Pump-10.57
Multiple Daily Injections (MDI)-17.79

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Glycosylated Haemoglobin A1c (HbA1c)

Analysed for the full analysis set. (NCT00537303)
Timeframe: week 36

Interventionpercentage (%) of total haemoglobin (Least Squares Mean)
Advanced7.67
Basic7.61

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Glycosylated Haemoglobin A1c (HbA1c)

Measured for the Per Protocol analysis set. (NCT00537303)
Timeframe: week 36

Interventionpercentage (%) of total haemoglobin (Least Squares Mean)
Advanced7.55
Basic7.52

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Hypoglycaemic Episodes

Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00537303)
Timeframe: Weeks 0-36

,
Interventionepisodes (Number)
MajorMinorSymptoms Only
Advanced1531283
Basic4567344

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Haematology: Haemoglobin Measured in Blood

Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory. (NCT00537303)
Timeframe: week 36

Interventionmmol/L (Mean)
Advanced8.57
Basic8.58

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Biochemistry: Serum Alanine Aminotransferase

Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory. (NCT00537303)
Timeframe: week 36

InterventionU/L (Mean)
Advanced30.09
Basic27.04

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Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide

High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory. (NCT00537303)
Timeframe: week 36

Interventionmg/L (Mean)
Advanced3.76
Basic4.67

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0, n=8, 9Week 8, n=11, 11
Mixed Injection1441.31981.1
Separate Injection752.1672.8

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Body Mass Index (BMI) Z Score

Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex (NCT00542620)
Timeframe: Week 0 and Week 8

,
InterventionZ-score (Mean)
Week 0, n=13, 12Week 8, n=11, 12
Mixed Injection-0.32-0.07
Separate Injection0.040.26

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"Percentage of Children Assessing Insulin Therapy Injection Pain as Very Happy Face"

Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face. (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpercentage of subjects (Number)
Week 0Week 8
Mixed Injection27.318.2
Separate Injection16.77.7

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"Percentage of Children Assessing Insulin Therapy Injection Pain as Sad Face"

Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face. (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpercentage of subjects (Number)
Week 0Week 8
Mixed Injection450
Separate Injection3323

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"Percentage of Children Assessing Insulin Therapy Injection Pain as Happy Face"

Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face. (NCT00542620)
Timeframe: Week 0 and week 8

,
Interventionpercentage of subjects (Number)
Week 0Week 8
Mixed Injection2781
Separate Injection5069

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Incidence of Hypoglycaemic Episodes - All Episodes

Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator's judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00542620)
Timeframe: Weeks 0-8

Interventionepisodes (Number)
Mixed Injection351
Separate Injection293

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Self-measured Plasma Glucose Profile (Before Breakfast)

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmg/dL (Mean)
Week 0Week 8
Mixed Injection190.31162.96
Separate Injection165.39204.75

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Self-measured Plasma Glucose Profile (After Dinner)

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmg/dL (Mean)
Week 0, n=8, 5Week 8, n=7, 6
Mixed Injection175.38198.00
Separate Injection201.80187.67

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0, n=4, 3Week 8, n=3, 6
Mixed Injection230728.2123555.7
Separate Injection68509.6362313.5

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0, n=10, 11Week 8, n=13, 12
Mixed Injection3008.15674.3
Separate Injection3006.33019.9

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Pharmacokinetics: Cmax of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol/L (Median)
Week 0Week 8
Mixed Injection1070012000
Separate Injection1050012600

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Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L

Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself. (NCT00542620)
Timeframe: Weeks 0-8

,
Interventionepisodes (Number)
With symptomsWithout (w/o) symptomsW/o info on presence of symptoms
Mixed Injection687523
Separate Injection159486

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Self-measured Plasma Glucose Profile (After Breakfast)

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmg/dL (Mean)
Week 0, n=5, 6Week 8, n=4, 7
Mixed Injection123.00208.08
Separate Injection164.89167.98

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Fructosamine

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmmol/L (Mean)
Week 0, n=13, 12Week 8, n=12, 12
Mixed Injection334.8316.4
Separate Injection319.8334.8

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0Week 8
Mixed Injection36591.236055.0
Separate Injection34653.439757.0

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Glycosylated Haemoglobin A1c (HbA1c)

Measured for the Per Protocol (PP) set (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpercentage of total haemoglobin (Mean)
Week 0Week 8
Mixed Injection8.007.63
Separate Injection7.778.15

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Glycosylated Haemoglobin A1c (HbA1c)

Measured for the ITT (Intention-to-Treat) set (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpercentage of total haemoglobin (Mean)
Week 0Week 8
Mixed Injection7.937.65
Separate Injection7.778.15

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Self-measured Plasma Glucose Profile (Before Dinner)

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmg/dL (Mean)
Week 0Week 8
Mixed Injection199.14185.23
Separate Injection201.44181.03

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0Week 8
Mixed Injection638.4819.6
Separate Injection398.9466.2

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Pharmacokinetics: Cmax of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol/L (Median)
Week 0Week 8
Mixed Injection557662
Separate Injection762601

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Weight Z Score

Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex (NCT00542620)
Timeframe: Week 0 and Week 8

,
InterventionZ-score (Mean)
Week 0, n=13, 12Week 8, n=11, 12
Mixed Injection-0.42-0.29
Separate Injection0.190.26

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Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0, n=8, 9Week 8, n=11, 11
Mixed Injection3.62.9
Separate Injection2.32.0

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0Week 8
Mixed Injection1546.32102.4
Separate Injection1510.91540

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Pharmacokinetics: Tmax of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0Week 8
Mixed Injection3.53.5
Separate Injection3.53.3

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Pharmacokinetics: Tmax of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0Week 8
Mixed Injection22
Separate Injection21.5

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Pharmacokinetics: Tmax of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0Week 8
Mixed Injection2.52.5
Separate Injection3.01.8

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Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0, n=10, 11Week 8, n=13, 12
Mixed Injection2.23.5
Separate Injection21.7

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Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L

"Number of symptoms only hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself." (NCT00542620)
Timeframe: Weeks 0-8

,
Interventionepisodes (Number)
With symptomsWithout (w/o) symptomsW/o information on presence of symptoms
Mixed Injection491315
Separate Injection46331

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Pharmacokinetics: Cmax of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol/L (Median)
Week 0Week 8
Mixed Injection216274
Separate Injection167186

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Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0, n=4, 3Week 8, n=3, 6
Mixed Injection16.25.6
Separate Injection8.220.8

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Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles

(NCT00548808)
Timeframe: baseline, 48 weeks

,
Interventionmillimoles/Liter (mmol/L) (Least Squares Mean)
Cholesterol (n=195, n=203)Triglycerides (n=195, n=203)Low Density Lipoprotein (n=178, n=191)High Density Lipoprotein (n=195, n=203)
Insulin Glargine-0.080.03-0.060.04
Insulin Lispro LM-0.18-0.09-0.110.06

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Change From Baseline in Postprandial Blood Glucose Over Time

The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase. (NCT00548808)
Timeframe: Baseline, 16 weeks, 32 weeks, 48 weeks

,
Interventionmillimoles per liter (Least Squares Mean)
Week 16 Change from BaselineWeek 32 Change from BaselineWeek 48 Change from Baseline
Insulin Glargine3.554.564.89
Insulin Lispro LM3.324.695.24

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Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)

(NCT00548808)
Timeframe: Baseline, 48 weeks

Interventionpercent (%) glycated hemoglobin (Least Squares Mean)
Insulin Lispro LM-1.91
Insulin Glargine-1.87

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Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks

(NCT00548808)
Timeframe: 16 weeks, 32 weeks, 48 weeks

,
InterventionUnits of insulin per day (U/day) (Mean)
Week 16Week 32Week 48
Insulin Glargine35.8748.1654.03
Insulin Lispro LM36.4250.3854.97

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Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks

(NCT00548808)
Timeframe: 16 weeks, 32 weeks, 48 weeks

,
InterventionUnits of insulin/kilogram/day (U/kg/day) (Mean)
Week 16Week 32Week 48
Insulin Glargine0.490.650.71
Insulin Lispro LM0.490.650.71

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Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time

(NCT00548808)
Timeframe: 16 weeks, 32 weeks, 48 weeks

,
Interventionpercentage of participants (Number)
Percent achieving HbA1c < 6.5 % at 16 weeksPercent achieving HbA1c < 7.0 % at 16 weeksPercent achieving HbA1c < 6.5 % at 32 weeksPercent achieving HbA1c < 7.0 % at 32 weeksPercent achieving HbA1c < 6.5 % at 48 weeksPercent achieving HbA1c < 7.0 % at 48 weeks
Insulin Glargine12.532.617.538.819.039.1
Insulin Lispro LM10.228.219.440.621.240.0

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Safety: Number of Participants With Serious and Non-Serious Adverse Events

Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section. (NCT00548808)
Timeframe: baseline through 48 weeks

,
Interventionparticipants (Number)
Serious Adverse EventsNon-Serious Adverse Events
Insulin Glargine13116
Insulin Lispro LM19107

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7-point Self-monitored Blood Glucose Profiles

(NCT00548808)
Timeframe: Baseline, 16 weeks, 32 weeks, 48 weeks

,
Interventionmillimoles per liter (mmol/L) (Mean)
Morning Pre-Meal BaselineMorning Postprandial Meal BaselineMidday Pre-Meal BaselineMidday Postprandial Meal BaselineEvening Pre-Meal BaselineEvening Postprandial Meal Baseline0300 Hours BaselineMorning Pre-Meal Week 16Morning Postprandial Meal Week 16Midday Pre-Meal Week 16Midday Postprandial Meal Week 16Evening Pre-Meal Week 16Evening Postprandial Meal Week 160300 Hours Week 16Morning Pre-Meal Week 32Morning Postprandial Meal Week 32Midday Pre-Meal Week 32Midday Postprandial Meal Week 32Evening Pre-Meal Week 32Evening Postprandial Meal Week 320300 Hours Week 32Morning Pre-Meal Week 48Morning Postprandial Meal Week 48Midday Pre-Meal Week 48Midday Postprandial Meal Week 48Evening Pre-Meal Week 48Evening Postprandial Meal Week 480300 Hours Week 48
Insulin Glargine10.0413.7010.6212.7010.6512.8010.126.559.557.649.587.819.807.016.218.736.908.867.508.966.756.378.856.998.887.338.906.56
Insulin Lispro LM9.9213.6410.3612.7710.3912.5910.097.049.797.9410.138.529.357.156.628.806.939.337.718.626.636.748.797.019.257.338.746.53

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Change in Hemoglobin A1c (HbA1c) Over Time

(NCT00548808)
Timeframe: Baseline, 16 Weeks, 32 Weeks, 48 Weeks

,
Interventionpercent (%) glycated hemoglobin (Least Squares Mean)
16 Week Change from Baseline32 Week Change from Baseline48 Week Change from Baseline
Insulin Glargine-1.76-1.90-1.87
Insulin Lispro LM-1.65-1.92-1.91

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7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal. (NCT00560417)
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeks

,
Interventionmilligrams per deciliter (mg/dL) (Mean)
Baseline Morning Pre-MealBaseline Morning PostprandialBaseline Midday Pre-MealBaseline Midday PostprandialBaseline Evening Pre-MealBaseline Evening PostprandialBaseline 0300 HoursBaseline Daily Mean 7-Point Blood GlucoseBaseline Daily Mean Pre-MealBaseline Daily Mean PostprandialEndpoint Morning Pre-MealEndpoint Morning PostprandialEndpoint Midday Pre-MealEndpoint Midday PostprandialEndpoint Evening Pre-MealEndpoint Evening PostprandialEndpoint 0300 HoursEndpoint Daily Mean 7-Point Blood GlucoseEndpoint Daily Mean Pre-MealEndpoint Daily Mean Postprandial
Glargine180.86190.84166.34200.25175.14184.92172.00180.72172.66191.27127.01137.39129.71155.26135.93144.25127.53136.17129.32146.12
ILPS175.41195.31165.18193.22173.33189.00170.51180.19170.60192.37129.63152.32132.84161.77146.03159.14123.96143.06135.51158.10

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Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100. (NCT00560417)
Timeframe: Baseline to Endpoint (LOCF) up to 24 weeks

,
Interventionpercentage of participants (Number)
All Reported - EndpointAll Reported - OverallNon-Nocturnal - EndpointNon-Nocturnal - OverallNocturnal - EndpointNocturnal - OverallSevere - EndpointSevere - Overall
Glargine43.174.940.170.711.437.100
ILPS41.870.630.662.421.847.601.8

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Total Daily Insulin Dose at Endpoint (LOCF)

(NCT00560417)
Timeframe: Endpoint (LOCF) up to 24 weeks

InterventionUnits of Insulin (Mean)
ILPS31.11
Glargine37.93

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Change From Baseline in Body Weight at Endpoint (LOCF)

(NCT00560417)
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeks

Interventionkilograms (Mean)
ILPS0.27
Glargine0.66

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Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group. (NCT00560417)
Timeframe: 24 weeks, Endpoint (LOCF) up to 24 weeks

,
Interventionpercent of glycosylated hemoglobin (Least Squares Mean)
24 weeksEndpoint (LOCF)
Glargine6.706.78
ILPS6.947.00

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Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime. (NCT00560417)
Timeframe: Baseline to Endpoint (LOCF) up to 24 weeks

,
Interventionepisodes/participant/365 days (Mean)
All reported episodes rate - EndpointAll reported episodes rate - OverallNon-Nocturnal reported episodes rate - EndpointNon-Nocturnal reported episodes rate - OverallNocturnal reported episodes rate - EndpointNocturnal reported episodes rate - Overall
Glargine15.2918.0513.2014.831.733.01
ILPS14.5116.2710.4011.364.014.88

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Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

(NCT00560417)
Timeframe: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks

,
Interventionpercent of participants (Number)
Week 12: HbA1c <7.0%Week 12: HbA1c <=6.5%Week 18: HbA1c <7.0%Week 18: HbA1c <=6.5%Week 24: HbA1c <7.0%Week 24: HbA1c <=6.5%Endpoint (LOCF): HbA1c <7.0%Endpoint (LOCF): HbA1c <=6.5%
Glargine50.728.769.137.663.439.961.738.9
ILPS46.924.854.830.855.429.753.728.4

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Glycemic Variability at Baseline and Endpoint (LOCF)

Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study. (NCT00560417)
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeks

,
Interventionmg/dL (Mean)
BaselineEndpoint
Glargine39.0230.96
ILPS41.1536.78

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Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group. (NCT00560417)
Timeframe: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks

,
Interventionpercent of glycosylated hemoglobin (Least Squares Mean)
Baseline24 Weeks ChangeEndpoint (LOCF) Change
Glargine8.47-1.49-1.43
ILPS8.48-1.25-1.21

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Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group. (NCT00560417)
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeks

,
Interventionpercent of glycosylated hemoglobin (Least Squares Mean)
BaselineEndpoint (LOCF) Change
Glargine8.47-1.43
ILPS8.48-1.21

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Actual Body Weight at Baseline and Endpoint (LOCF)

(NCT00560417)
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeks

,
Interventionkilograms (Mean)
BaselineEndpoint
Glargine102.62103.28
ILPS101.57101.85

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Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections

Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections. (NCT00564395)
Timeframe: 0-48 hours post-dose

Interventionmmol*hr/L (Mean)
Insulin Detemir Mixed With RAI Injection457
Insulin Detemir and RAI Injection Separately469

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Minimum EGP - Meal Challenge

Minimum calculated EGP per subject as change from baseline (NCT00570687)
Timeframe: 0-480 minutes

Interventionµmol/kg/min (Mean)
Amendment 1 - TI Inhalation Powder 90 U-10.29
Amendment 1 - TI Inhalation Powder 60U-6.92
Amendment 1 - Insulin Lispro 10 U-7.11
Original Protocol - TI Inhalation Powder 45 U-7.59
Original Protocol - Exubera 4 mg-7.86
Original Protocol - Insulin Lispro 12 U-7.63

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EGP AOC0-480 - Meal Challenge

EGP area over the curve from 0 to 480 minutes postdose (NCT00570687)
Timeframe: 0-480 minutes

Interventionµmol/kg (Mean)
Amendment 1 - TI Inhalation Powder 90 U2272.8
Amendment 1 - TI Inhalation Powder 60U2108.7
Amendment 1 - Insulin Lispro 10 U2190.9
Original Protocol - TI Inhalation Powder 45 U2129.4
Original Protocol - Exubera 4 mg2488.3
Original Protocol - Insulin Lispro 12 U1985.9

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Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge

Time to minimum EGP post dose (NCT00570687)
Timeframe: 0-480 minutes

InterventionMinutes (Median)
Amendment 1 - TI Inhalation Powder 90 U75.0
Amendment 1 - TI Inhalation Powder 60U75.0
Amendment 1 - Insulin Lispro 10 U125.0
Original Protocol - TI Inhalation Powder 45 U60
Original Protocol - Exubera 4 mg160
Original Protocol - Insulin Lispro 12 U130

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Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.

(NCT00574405)
Timeframe: 12 months

Interventionng/mL (Mean)
Multiple Daily Injection Therapy1.8
Insulin Pump Therapy, Started at Diagnosis.3.1

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Maximum Glucose Infusion Rate

measuring the changes in glucose infusion rate during the 24 hour experimental period. (NCT00574912)
Timeframe: 24 hours

Interventionumol/kg/min (Mean)
Placebo0.3
0.5 Units of Glargine/kg2.6
1.0 Units of Glargine/kg5.5
1.5 Units of Glargine/kg6.8
2.0 Units of Glargine/kg9.5

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Cognitive Function- CPT D Prime Score

"Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance. Higher scores represent less advanced psychopathology. Week 8 values are displayed below." (NCT00575666)
Timeframe: Week 8

InterventionD prime score (Mean)
Humulin1.9
Placebo2.1

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Psychopathology- PANSS Positive

Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Humulin17.2
Placebo16.8

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Psychopathology- PANSS Total

Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Humulin74.3
Placebo74.1

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Psychopathology- SANS Total

Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Humulin30.8
Placebo33.5

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Cognitive Function- HVLT Delayed Recall Total

Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

InterventionWords correct (Mean)
Humulin6.8
Placebo7.8

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Cognitive Function- HVLT Immediate Recall Total

Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

InterventionWords correct (Mean)
Humulin21.4
Placebo23.6

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Cognitive Function- Trails A

"Subjects completed a timed trails (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below." (NCT00575666)
Timeframe: Week 8

InterventionSeconds (Mean)
Humulin60.6
Placebo52.3

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Cognitive Function- Trails B

"Subjects completed a timed trails (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below." (NCT00575666)
Timeframe: Week 8

InterventionSeconds (Mean)
Humulin131.5
Placebo118.6

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Cognitive Function- CPT Reaction Time of Hits (Milliseconds)

"Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure (CPT d prime score). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below." (NCT00575666)
Timeframe: Week 8

InterventionMilliseconds (Mean)
Humulin554.1
Placebo552.9

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Cognitive Function- Verbal Fluency

Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

InterventionWords correct (Mean)
Humulin27.9
Placebo28.0

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Psychopathology- CDSS Total

Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Humulin2.1
Placebo2.7

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Psychopathology- PANSS General Psychopathology

General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Humulin36.3
Placebo36.6

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Psychopathology- PANSS Negative

Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Humulin20.8
Placebo20.7

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Cognitive Function- Digit Span Total

Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

InterventionItems correct (Mean)
Humulin13.3
Placebo14.1

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Cognitive Function- CPT Hits Rate (Proportion)

"Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure (CPT d prime score). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below." (NCT00575666)
Timeframe: Week 8

InterventionProportion of total hits (Mean)
Humulin0.7
Placebo0.7

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Cognitive Function- CPT False-alarm Rate (Proportion)

Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

InterventionProportion of total hits (Mean)
Humulin0.1
Placebo0.1

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Psychopathology- QLS Total

Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below. (NCT00575666)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Humulin70.9
Placebo67

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fMRI Measure of Hippocampal Activation

Percentage active voxels of total hippocampal volume of interest (NCT00581867)
Timeframe: 30 minutes After Intervention Administration

Interventionpercentage of active voxels (Mean)
Intranasal Insulin Aspart36.4
Placebo41.3

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Global Cognition

Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale [WMS]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale [WAIS] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination [MMSE]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average. (NCT00581867)
Timeframe: 90 mins

Interventionz-scores (Mean)
Intranasal Insulin Aspart-.05
Placebo-.02

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Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.

The protocol were compared by measuring in each patient time to acquire the Blood Glucose (BG) target range (80-120 mg/dl) defined by reaching a BG < 120, and maintaining the target range thereafter. (NCT00582309)
Timeframe: 24 hours

InterventionTime to reach glycemic control in hours (Mean)
Glucommander-Guided Intravenous Insulin Infusion5
Standard Intravenous Insulin Infusion Algorithm10.1
Simple Calculated Intravenous Insulin Infusion7.7

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Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups

To determine the safety of the two treatments the number of hypoglycemia episodes that occurred between the 2 groups are measured from the time of transitioning to subcutaneous insulin to day 5. The hypoglycemia events are defined as blood glucose levels <70 mg/dL. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972. (NCT00590044)
Timeframe: 5 days after transitioning to subcutaneous insulin

Interventionnumber of hypoglycemia episodes (Number)
Insulin Glargine+Glulisine8
Split-mixed NPH + Regular Insulin26

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Difference in Time in Hours to Resolution of DKA Between the 2 Groups

The mean duration of treatment until resolution of ketoacidosis is measured and compared between the 2 groups. The DKA was considered resolved when blood glucose was 250 mg/dl, the serum bicarbonate level was <18 mmol/l, and venous phenol hydroxylase (pH) was 7.30. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972. (NCT00590044)
Timeframe: up to 20 hours

Interventionhours (Mean)
Glargine (Lantus) + Glulisine8.9
NPH + Regular10.5

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Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin

The primary outcome during the subcutaneous (SC) period (the primary outcome measurement) was to determine differences in glycemic control as measured by mean daily blood glucose(BG) concentration between treatment groups. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed Identification (ID): 19366972. (NCT00590044)
Timeframe: Day1 - Day5 after the resolution of ketoacidosis and transition to subcutaneous insulin

,
Interventionmg/dl (Mean)
Day 1Day 2Day 3Day 4Day 5
Glargine (Lantus) + Glulisine213220180158124
NPH + Regular188206207211190

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Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups

To determine the differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA) before transitioning to subcutaneous insulin. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972. (NCT00590044)
Timeframe: up to 20 hours

Interventionmg/dL (Mean)
Glargine (Lantus) + Glulisine153
NPH + Regular185

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Mean AM BG (mg/dl)

average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2 (NCT00590226)
Timeframe: during hospitalization

Interventionmg/dl (Mean)
Detemir + Aspart144
NPH+Regular155

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Number of Patients With Hypoglycemic Events

number of patients with hypoglycemic events as defined as BG 40-59 mg/dl (NCT00590226)
Timeframe: during hospitalization

Interventionparticipants (Number)
Detemir + Aspart15
NPH+Regular13

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Hospital Length of Stay

hospital length of stay in days (NCT00591227)
Timeframe: from hospital admission to hospital discharge

Interventiondays (Mean)
Aspart Detemir2.7
Usual Care3.1

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Percent of Patients at Target (A1C ≤ 6.5%) Per FP

Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop (NCT00593489)
Timeframe: 15 months

,
Interventionpercent of patients per physician (Mean)
At time of Workshop15 months post Workshop
Basal Insulin Strategy36.7636.13
Usual Care36.6236.61

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Mean Fasting Blood Glucose of Insulin-eligible Patients

mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop (NCT00593489)
Timeframe: 15 months

,
Interventionmean mmol/L per physician (Mean)
WorkshopEnd of Study
Basal Insulin Strategy7.867.78
Usual Care7.897.82

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Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop

mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period (NCT00593489)
Timeframe: 15 months

,
InterventionMean % glycolyslated hemoglobin per FP (Mean)
WorkshopEnd of Study
Basal Insulin Strategy7.127.09
Usual Care7.207.15

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Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop

Percent of insulin-eligible patients with intensification of diabetes management (increase dose of oral anti-diabetes drug (OAD) or insulin, OAD score, the addition of insulin) per FP post - Workshop (NCT00593489)
Timeframe: 12 months

Intervention% of pts with intensification per FP (Mean)
Basal Insulin Strategy31.59
Usual Care32.80

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Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation

Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician (NCT00593489)
Timeframe: 15 months

,
InterventionMean % glycosylated hemoglobin per FP (Mean)
Initiation3 months post initiation6 months post initiation
Basal Insulin Initiation Strategy8.828.327.97
Usual Practice9.379.058.57

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Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice

Insulin Prescription Rate (IPR) - the number of insulin-eligible patients per 12 months who are prescribed insulin in each family physician (FP) practice (Number of patients per year per FP). The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate. (NCT00593489)
Timeframe: 12 months

Interventionpatients per year (Mean)
Basal Insulin Strategy2.28
Usual Care2.29

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Physician Score for Self-efficacy of Insulin Initiation & Titration

physician score for self-efficacy of insulin initiation & titration where the minimum value was 10 and the maximum was 50. A value of 50 indicated complete self efficacy to initiate and titrate insulin (NCT00593489)
Timeframe: 12 months

,
Interventionscore on a scale (Mean)
Pre WorkshopPost Workshop
Basal Insulin Initiation Strategy35.840.6
Usual Practice35.739.6

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Physician Score for Knowledge of Insulin Initiation & Titration

physician score for knowledge of insulin initiation & titration minimum score of 0 maximum score of 17. The greater the score the greater the knowledge. (NCT00593489)
Timeframe: 12 months

,
Interventionunits on a scale (Mean)
Pre-WorkshopPost-Workshop
Basal Insulin Initiation Strategy15.516.3
Usual Practice15.516.9

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Physician Score for Attitude Towards Insulin Initiation & Titration

physician score for attitude towards insulin initiation & titration The minimum score is 11 and the maximum is 55 with a lower score indicating the ideal attitude. (NCT00593489)
Timeframe: 12 months

,
Interventionunits on a scale (Mean)
Pre-WorkshopPost-Workshop
Basal Insulin Initiation Strategy28.926.1
Usual Practice29.727.3

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Percentage of Patients at Target (A1C ≤ 7.0%) Per FP

Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop (NCT00593489)
Timeframe: 15 months

,
Interventionpercentage of patients per physician (Mean)
WorkshopEnd of Study
Basal Insulin Strategy58.458.68
Usual Care55.9557.58

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# Participants With Hypoglycemic Events

number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl) (NCT00596687)
Timeframe: hospital stay days 2-10

Interventionparticipants (Number)
Basal Bolus24
SSRI5

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Mean Blood Glucose Concentration

blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment (NCT00596687)
Timeframe: hospital stay days 2-10

Interventionmg/dl (Mean)
Basal Bolus145
SSRI172

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Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)

(NCT00598663)
Timeframe: 6 months

Interventionminutes (Mean)
Sensor Off Arm669
Sensor ON Arm774

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Diabetic Ketoacidosis Events

A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose >250 mg/dL) with either low serum bicarbonate (<15 mEq/L) and/or low pH (<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility. (NCT00598663)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Sensor Off3
Sensor On2

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Glycemic Variability

24 h SD of glucose values (mg/dl) (NCT00598663)
Timeframe: 6 months

Interventionmg/dl (Mean)
Sensor Off Arm77.16
Sensor On Arm71.58

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HbA1c at 6 Month

The end of period difference in HbA1c after 6 months of treatment (NCT00598663)
Timeframe: 6 months

Interventionpercentage of glycosylated hemoglobin (Mean)
Sensor Off Arm8.47
Sensor ON Arm8.04

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Number of Severe Hypoglycemia Events

(NCT00598663)
Timeframe: 6 months

Interventionparticipants (Number)
Sensor Off2
Sensor On4

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Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)

"This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998).~Scores are transformed on a scale from 0 to 100. higher values represent a better outcome" (NCT00598663)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Sensor Off85.11
Sensor On84.75

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Postprandial Glycaemia

Breakfast Postprandial glycaemia (NCT00598663)
Timeframe: 6 months

Interventionmg/dl (Mean)
Sensor Off Arm157.7
Sensor ON Arm160.4

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Murray Lung Injury Score

Murray Lung Injury Score is a continuous score that quantifies the severity of lung injury and consist of components related to severity of hypoxia, pulmonary compliance, peep, and radiologic abnormalities. The scores range between 0 - 4. The higher the score, the greater the degree and severity of lung injury. The scale runs from 0-4, with 0 being the minimum and 4 the maximum score. (NCT00605696)
Timeframe: Measured at Day 3

Interventionunits on a scale (Mean)
Early Insulin Group0.333
Control Group0.323

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Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)

HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline. (NCT00606034)
Timeframe: 1 year

InterventionHbA1c percentage (Mean)
All Subjects Using U-500 Regular Insulin Via Omnipod-1.23

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Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)

Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method. (NCT00606034)
Timeframe: Baseline versus 1 year

Interventionpercent satisfaction (Mean)
All Subjects90.68

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Percentage of Time Spent in Hypoglycemia

For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM. (NCT00606034)
Timeframe: baseline versus 12 months

Interventionpercent of time spent in hypoglycemia (Mean)
All Subjects-3.7

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Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion

"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.~Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value." (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionevents per patient per month (Mean)
Insulin Glulisine2.02
Insulin Aspart1.32
Insulin Lispro1.54

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Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site

"Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment.~Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment.~Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection.~Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection." (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionpatients (Number)
Insulin Glulisine110
Insulin Aspart110
Insulin Lispro107

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Percentage of Patients With at Least One Confirmed Infusion Set Occlusion

"Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value." (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionpercentage of patients (Number)
Insulin Glulisine32.8
Insulin Aspart27.0
Insulin Lispro27.0

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Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis

"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).~Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l" (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionpercentage of patients (Number)
Insulin Glulisine17.6
Insulin Aspart10.9
Insulin Lispro11.7

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Percentage of Patients With at Least One Unexplained Hyperglycemia

Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason. (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionpercentage of patients (Number)
Insulin Glulisine61.3
Insulin Aspart55.9
Insulin Lispro56.3

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Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion

"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.~Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value." (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionpercentage of patients (Number)
Insulin Glulisine68.4
Insulin Aspart62.1
Insulin Lispro61.3

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Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year

Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning. (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionevents in patient-year (Mean)
Insulin Glulisine12.80
Insulin Aspart9.66
Insulin Lispro9.48

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Rate of Severe Symptomatic Hypoglycemia Per Patient-year

"Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following:~the event was associated with a measured blood glucose level below 36 mg/dL~or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration." (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionevents in patient-year (Mean)
Insulin Glulisine1.63
Insulin Aspart1.39
Insulin Lispro1.07

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Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year

Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration. (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionevents in patient-year (Mean)
Insulin Glulisine73.88
Insulin Aspart65.06
Insulin Lispro62.74

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Time Interval Between Infusion Set Changes in Routine

"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).~Changes in routine correspond to interval between changes according to patient use." (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionhours (Mean)
Insulin Glulisine70.72
Insulin Aspart71.00
Insulin Lispro71.07

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Time Interval Between Infusion Set Changes: All Changes

"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).~All changes include all the changes whatever the reason such as routine or requested by occurrence of events." (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionhours (Mean)
Insulin Glulisine69.1
Insulin Aspart69.44
Insulin Lispro69.98

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Glycosylated Hemoglobin: HbA1c

Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7% (NCT00607087)
Timeframe: over 13 weeks of each treatment period

,,
Interventionpercentage (Mean)
First week (week 1) (n=253, n=254, n=255)Last week (week 13) (n=252, n=255, n=251)
Insulin Aspart7.337.25
Insulin Glulisine7.317.32
Insulin Lispro7.287.33

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Total Daily Basal Insulin Infusion

dose of the basal insulin regimen administered throughout the 24-hour period (NCT00607087)
Timeframe: over 13 weeks of each treatment period

,,
InterventionUnits (Mean)
First week (week 1) (n=251, n=249, n=250)Last week (week 13) (n=251, n=249, n=251)
Insulin Aspart20.9320.81
Insulin Glulisine20.8320.86
Insulin Lispro20.8521.11

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Total Daily Bolus Insulin Dose

dose of every increment administered for example before meals (NCT00607087)
Timeframe: over 13 weeks of each treatment period

,,
InterventionUnits (Mean)
First week (week 1) (n=249, n=247, n=250)Last week (week 13) (n=248, n=244, n=249)
Insulin Aspart18.4918.64
Insulin Glulisine18.6318.58
Insulin Lispro18.4019.19

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Monthly Rate of Confirmed Infusion Set Occlusion

(NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionevents per patient per month (Mean)
Insulin Glulisine0.41
Insulin Aspart0.28
Insulin Lispro0.31

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Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis

"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).~Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l" (NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionevents per patient per month (Mean)
Insulin Glulisine0.14
Insulin Aspart0.06
Insulin Lispro0.06

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Monthly Rate of Unexplained Hyperglycemia

(NCT00607087)
Timeframe: over 13 weeks of each treatment period

Interventionevents per patient per month (Mean)
Insulin Glulisine1.61
Insulin Aspart1.04
Insulin Lispro1.23

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Acute/Active Rejection

Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology. (NCT00609986)
Timeframe: 30 months

Interventionparticipants (Number)
Intensive9
Control2

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Delayed Graft Function

Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl. (NCT00609986)
Timeframe: 10 days

Interventionparticipants (Number)
Intensive8
Control12

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Severe Hyperglycemia

Blood glucose greater than 350 mg/dl. (NCT00609986)
Timeframe: 30 months

Interventionparticipants (Number)
Intensive5
Control12

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Severe Hypoglycemia

Blood glucose less than 40 mg/dl (NCT00609986)
Timeframe: 30 months

Interventionparticipants (Number)
Intensive7
Control2

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Rate of Major and Minor Hypoglycaemic Episodes

Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00611884)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,,
InterventionEpisodes/100 years of patient exposure (Number)
MajorMinor
IGlar0113
SIBA (D)089
SIBA (D) M, W, F6221
SIBA (E)060

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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included). (NCT00611884)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,,
InterventionEpisodes/100 years of patient exposure (Number)
MajorMinor
IGlar00
SIBA (D)06
SIBA (D) M, W, F617
SIBA (E)012

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00611884)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEsFatal
IGlar6220281414520
SIBA (D)5946121144680
SIBA (D) M, W, F488501103790
SIBA (E)430061023230

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Laboratory Safety Parameters (Biochemistry): Serum Creatinine

Mean values at Week -4 and at Week 16 (NCT00611884)
Timeframe: Week -4, Week 16

,,,
Interventionumol/L (Mean)
Creatinine, Week -4, N=56, 59, 62, 60Creatinine, Week 16, N=53, 53, 58, 56
IGlar72.474.2
SIBA (D)74.576.1
SIBA (D) M, W, F73.271.5
SIBA (E)75.476.6

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Vital Signs: Diastolic Blood Pressure (BP)

Mean values at baseline (Week 0) and at Week 16 (NCT00611884)
Timeframe: Week 0, Week 16

,,,
InterventionmmHg (Mean)
Week 0 (Baseline), N=57, 59, 62, 61Week 16, N=55, 55, 60, 56
IGlar7977
SIBA (D)8179
SIBA (D) M, W, F8078
SIBA (E)8282

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Vital Signs: Pulse

Mean values at baseline (Week 0) and at Week 16 (NCT00611884)
Timeframe: Week 0, Week 16

,,,
Interventionbeats/minute (Mean)
Week 0 (Baseline), N=57, 59, 62, 61Week 16, N=55, 55, 60, 56
IGlar7674
SIBA (D)7977
SIBA (D) M, W, F7979
SIBA (E)7978

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 16 weeks of treatment (NCT00611884)
Timeframe: Week 0, Week 16

Interventionpercentage of glycosylated haemoglobin (Mean)
SIBA (D)-1.26
SIBA (E)-1.28
SIBA (D) M, W, F-1.46
IGlar-1.49

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast. (NCT00611884)
Timeframe: Week 16

Interventionmmol/L (Least Squares Mean)
SIBA (D)8.30
SIBA (E)8.55
SIBA (D) M, W, F8.45
IGlar8.42

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Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

Mean values at Week -4 and at Week 16 (NCT00611884)
Timeframe: Week -4, Week 16

,,,
InterventionIU/L (Mean)
ALAT, Week -4, N=56, 59, 62, 60ALAT, Week 16, N=53, 53, 58, 56
IGlar32.930.0
SIBA (D)34.625.7
SIBA (D) M, W, F30.924.3
SIBA (E)29.224.7

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Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

Mean values at Week -4 and at Week 16 (NCT00611884)
Timeframe: Week -4, Week 16

,,,
InterventionIU/L (Mean)
ASAT, Week -4, N=56, 59, 62, 60ASAT, Week 16, N=53, 53, 58, 56
IGlar24.224.1
SIBA (D)26.723.3
SIBA (D) M, W, F23.921.7
SIBA (E)22.521.8

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Vital Signs: Systolic Blood Pressure (BP)

Mean values at baseline (Week 0) and at Week 16 (NCT00611884)
Timeframe: Week 0, Week 16

,,,
InterventionmmHg (Mean)
Week 0 (Baseline), N=57, 59, 62, 61Week 16, N=55, 55, 60, 56
IGlar127128
SIBA (D)129126
SIBA (D) M, W, F129126
SIBA (E)131131

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 16 weeks of treatment (NCT00612040)
Timeframe: Week 0, Week 16

Interventionpercentage of glycosylated haemoglobin (Mean)
SIBA (D)-0.54
SIBA (E)-0.57
IGlar-0.62

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Vital Signs: Diastolic BP (Blood Pressure)

Values at baseline (Week 0) and at Week 16 (NCT00612040)
Timeframe: Week 0, Week 16

,,
InterventionmmHg (Mean)
Week 0 (Baseline), N=60, 59, 59Week 16, N=60, 57, 57
IGlar7474
SIBA (D)7676
SIBA (E)7575

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Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment (NCT00612040)
Timeframe: Week 0, Week 16

Interventionmmol/L (Mean)
SIBA (D)-2.06
SIBA (E)-1.60
IGlar-0.54

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Vital Signs: Pulse

Values at baseline (Week 0) and at Week 16 (NCT00612040)
Timeframe: Week 0, Week 16

,,
Interventionbeats/minute (Mean)
Week 0 (Baseline), N=60, 59, 59Week 16, N=60, 57, 57
IGlar7372
SIBA (D)7474
SIBA (E)7272

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Vital Signs: Systolic BP (Blood Pressure)

Values at baseline (Week 0) and at Week 16 (NCT00612040)
Timeframe: Week 0, Week 16

,,
InterventionmmHg (Mean)
Week 0 (Baseline), N=60, 59, 59Week 16, N=60, 57, 57
IGlar124123
SIBA (D)124122
SIBA (E)126125

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00612040)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEsFatal AEs
IGlar914663975110
SIBA (D)653662024450
SIBA (E)87412292465990

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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded). (NCT00612040)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEpisodes/100 years of patient exposure (Number)
MajorMinor
IGlar181082
SIBA (D)17769
SIBA (E)12546

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Rate of Major and Minor Hypoglycaemic Episodes

Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00612040)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEpisodes/100 years of patient exposure (Number)
MajorMinor
IGlar366637
SIBA (D)465838
SIBA (E)415305

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Laboratory Safety Parameters (Biochemistry): Serum Creatinine

Laboratory values at screening (Week -1) and at Week 16 (NCT00612040)
Timeframe: Week -1, Week 16

,,
Interventionumol/L (Mean)
Week -1 , N=60, 59, 59Week 16 , N=55, 53, 54
IGlar77.677.9
SIBA (D)77.277.2
SIBA (E)76.675.9

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Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

Laboratory values at screening (Week -1) and at Week 16 (NCT00612040)
Timeframe: Week -1, Week 16

,,
InterventionIU/L (Mean)
Week -1 , N=60, 59, 59Week 16 , N=55, 53, 54
IGlar23.123.1
SIBA (D)25.525.0
SIBA (E)22.721.2

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Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

Laboratory values at screening (Week -1) and at Week 16 (NCT00612040)
Timeframe: Week -1, Week 16

,,
InterventionIU/L (Mean)
Week -1, N=60, 59, 59Week 16, N=55, 53, 54
IGlar23.323.9
SIBA (D)22.823.3
SIBA (E)21.721.6

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00612040)
Timeframe: Week 16

Interventionmmol/L (Least Squares Mean)
SIBA (D)9.27
SIBA (E)9.56
IGlar9.04

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Laboratory Safety Parameters (Biochemistry): Serum Creatinine

Laboratory values at screening (Week -4) and at Week 16 (NCT00613951)
Timeframe: Week -4, Week 16

,,
Interventionumol/L (Mean)
Week -4, N=60, 57, 62Week 16, N=56, 57, 56
BIAsp 3074.878.1
SIAC 30 (B)72.773.6
SIAC 45 (B)75.876.3

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Rate of Major and Minor Hypoglycaemic Episodes

Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00613951)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEpisodes/100 years of patient exposure (Number)
MajorMinor
BIAsp 300730
SIAC 30 (B)0287
SIAC 45 (B)0679

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Vital Signs: Pulse

Values at baseline (Week 0) and at Week 16 (NCT00613951)
Timeframe: Week 0, Week 16

,,
Interventionbeats/minute (Mean)
Week 0 (Baseline), N=60, 59, 62Week 16, N=58, 56, 58
BIAsp 307577
SIAC 30 (B)7473
SIAC 45 (B)7673

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 16 weeks of treatment (NCT00613951)
Timeframe: Week 0, Week 16

Interventionpercentage of glycosylated haemoglobin (Mean)
SIAC 30 (B)-1.79
SIAC 45 (B)-1.87
BIAsp 30-1.84

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast. (NCT00613951)
Timeframe: Week 16

Interventionmmol/L (Least Squares Mean)
SIAC 30 (B)7.52
SIAC 45 (B)7.44
BIAsp 307.52

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Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

Laboratory values at screening (Week -4) and at Week 16 (NCT00613951)
Timeframe: Week -4, Week 16

,,
InterventionIU/L (Mean)
Week -4, N=60, 57, 62Week 16, N=54, 57, 53
BIAsp 3036.923.6
SIAC 30 (B)33.022.9
SIAC 45 (B)31.422.5

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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included). (NCT00613951)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEpisodes/100 years of patient exposure (Number)
MajorMinor
BIAsp 300108
SIAC 30 (B)039
SIAC 45 (B)079

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00613951)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEsFatal AEs
BIAsp 30379115383355
SIAC 30 (B)29800562420
SIAC 45 (B)54500674770

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Vital Signs: Diastolic Blood Pressure (BP)

Values at baseline (Week 0) and at Week 16 (NCT00613951)
Timeframe: Week 0, Week 16

,,
InterventionmmHg (Mean)
Week 0 (Baseline), N=60, 59, 62Week 16, N=58, 56, 58
BIAsp 308176
SIAC 30 (B)8078
SIAC 45 (B)8179

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Vital Signs: Systolic Blood Pressure (BP)

Values at baseline (Week 0) and at Week 16 (NCT00613951)
Timeframe: Week 0, Week 16

,,
InterventionmmHg (Mean)
Week 0 (Baseline), N=60, 59, 62Week 16, N=58, 56, 58
BIAsp 30137133
SIAC 30 (B)134128
SIAC 45 (B)138135

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Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

Laboratory values at screening (Week -4) and at Week 16 (NCT00613951)
Timeframe: Week -4, Week 16

,,
InterventionIU/L (Mean)
Week -4, N=60, 56, 62Week 16, N=54, 57, 53
BIAsp 3026.423.1
SIAC 30 (B)23.622.6
SIAC 45 (B)25.222.9

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Vital Signs: Systolic Blood Pressure (BP)

Values at baseline (Week 0) and at Week 16 (NCT00614055)
Timeframe: Week 0, Week 16

,,
InterventionmmHg (Mean)
Week 0 (Baseline), N=59, 59, 60Week 16, N=56, 53, 58
Insulin Glargine135129
SIAC 30 (B)135129
SIAC 45 (B)133133

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Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

Values at screening (Week -4) and at Week 16 (NCT00614055)
Timeframe: Week -4, Week 16

,,
InterventionIU/L (Mean)
Week -4 , N=58, 59, 60Week 16 , N=54, 54, 57
Insulin Glargine33.722.3
SIAC 30 (B)31.923.9
SIAC 45 (B)29.723.2

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Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 16 weeks of treatment (NCT00614055)
Timeframe: Week 0, Week 16

Interventionmmol/L (Mean)
SIAC 30 (B)-4.30
SIAC 45 (B)-4.10
Insulin Glargine-5.07

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Laboratory Safety Parameters (Biochemistry): Serum Creatinine

Values at screening (Week -4) and at Week 16 (NCT00614055)
Timeframe: Week -4, Week 16

,,
Interventionumol/L (Mean)
Week -4 , N=58, 59, 60Week 16 , N=54, 54, 57
Insulin Glargine77.476.8
SIAC 30 (B)76.475.7
SIAC 45 (B)75.874.9

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Rate of Major and Minor Hypoglycaemic Episodes

Rate of Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00614055)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEpisodes/100 years of patient exposure (Number)
MajorMinor
Insulin Glargine067
SIAC 30 (B)0115
SIAC 45 (B)0240

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 16 weeks of treatment (NCT00614055)
Timeframe: Week 0, Week 16

Interventionpercentage of glycosylated haemoglobin (Mean)
SIAC 30 (B)-1.31
SIAC 45 (B)-1.46
Insulin Glargine-1.29

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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Rate of nocturnal Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded). (NCT00614055)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEpisodes/100 years of patient exposure (Number)
MajorMinor
Insulin Glargine017
SIAC 30 (B)06
SIAC 45 (B)0158

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00614055)
Timeframe: Week 0 to Week 16 + 5 days follow up

,,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEsFatal AEs
Insulin Glargine29500612340
SIAC 30 (B)4411161382980
SIAC 45 (B)310601231870

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Vital Signs: Diastolic Blood Pressure (BP)

Values at baseline (Week 0) and at Week 16 (NCT00614055)
Timeframe: Week 0, Week 16

,,
InterventionmmHg (Mean)
Week 0 (Baseline), N=59, 59, 60Week 16, N=56, 53, 58
Insulin Glargine7977
SIAC 30 (B)7876
SIAC 45 (B)7877

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Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

Values at screening (Week -4) and at Week 16 (NCT00614055)
Timeframe: Week -4, Week 16

,,
InterventionIU/L (Mean)
Week -4, N=58, 59, 60Week 16, N=54, 54, 57
Insulin Glargine24.019.2
SIAC 30 (B)24.821.1
SIAC 45 (B)22.020.0

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Vital Signs: Pulse

Values at baseline (Week 0) and at Week 16 (NCT00614055)
Timeframe: Week 0, Week 16

,,
Interventionbeats/minute (Mean)
Week 0 (Baseline), N=59, 59, 60Week 16, N=56, 53, 58
Insulin Glargine7571
SIAC 30 (B)7371
SIAC 45 (B)7569

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00614055)
Timeframe: Week 16

Interventionmmol/L (Mean)
SIAC 30 (B)8.34
SIAC 45 (B)8.31
Insulin Glargine8.42

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Fasting Plasma Glucose Values

FPG (Fasting Plasma Glucose) values after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Interventionmmol/L (Mean)
Insulin Detemir7.71

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Diabetic Ketoacidosis

Diabetic ketoacidosis requiring hospitalisation (NCT00623194)
Timeframe: At 104 weeks

Interventionevents (Number)
Insulin Detemir3

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BMI (Body Mass Index)

BMI (Body Mass Index) after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Interventionkg/m^2 (Mean)
Insulin Detemir18.88

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Laboratory Values: Leukocytes and Thrombocytes

Leukocytes and Thrombocytes after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Intervention10^9/L (Mean)
Leukocytes (n=144)Thrombocytes (n=144)
Insulin Detemir6.72301.90

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Vital Signs: Pulse

Pulse at week 104 (NCT00623194)
Timeframe: At 104 weeks

Interventionbeats/minute (Mean)
Insulin Detemir82.6

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Vital Signs: Blood Pressure

Blood pressure (Systolic and Diastolic) after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

InterventionmmHg (Mean)
Systolic Blood PressureDiastolic Blood Pressure
Insulin Detemir109.566.6

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Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)

Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Interventionmmol/L (Mean)
Sodium Serum (n=144)Potassium serum (n=137)Haemoglobin (n=144)
Insulin Detemir141.64.388.28

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Insulin Dose

Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104. (NCT00623194)
Timeframe: At 104 weeks

InterventionU/kg (Mean)
Insulin Detemir dose (Basal)Insulin Aspart dose (Bolus)
Insulin Detemir0.660.51

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Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)

Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

InterventionU/L (Mean)
Alkaline phosphatase serum (n=144)Alanine Aminotransferase serum (n=144)Lactate Dehydrogenase serum (n=137)
Insulin Detemir226.719.0199.6

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Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)

Albumin Serum and Total Protein Serum after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Interventiong/dL (Mean)
Albumin serum (n=144)Total Protein serum (n=144)
Insulin Detemir4.327.09

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Insulin Detemir-insulin Aspart Cross-reacting Antibodies

Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection. (NCT00623194)
Timeframe: week 0, 52 and 104

InterventionPercent bound of total (Mean)
Week 0 (3 hours)Week 52 (3 hours)Week 104 (3 hours)Week 0 (2.5 hours)Week 52 (2.5 hours)Week 104 (2.5 hours)
Insulin Detemir31.1143.9935.9631.2244.0935.92

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Hypoglycaemic Episodes

"Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.~Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment." (NCT00623194)
Timeframe: Weeks 0-104

Interventionevents (Number)
Overall, MildOverall, ModerateOverall, SevereOverall, BiochemicalOverall, UnclassifiedDaytime, MildDaytime, ModerateDaytime, SevereDaytime, BiochemicalDaytime, UnclassifiedNight-time, MildNight-time, ModerateNight-time, SevereNight-time, BiochemicalNight-time, UnclassifiedTotal hypoglycaemic episodesTotal hypoglycaemic episodes, daytimeTotal hypoglycaemic episodes, night-time
Insulin Detemir1053045075080790803963412241450544958316074136052469

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Fundoscopy/Fundus Photography

"Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant~Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant" (NCT00623194)
Timeframe: at 52 weeks and at 104 weeks

Interventionparticipants (Number)
Abnormal, clinically significantAbnormal, not clinically significantNormalMissingAbn CS baseline and 104 weeks
Insulin Detemir1813161

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Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies

Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks. (NCT00623194)
Timeframe: At 0, 52 and 104 weeks

InterventionPercent bound of total (Mean)
Insulin Detemir specific, week 0Insulin Detemir specific, week 52Insulin Detemir specific, week 104Insulin Aspart specific, week 0Insulin Aspart specific, week 52Insulin Aspart specific, week 104
Insulin Detemir2.814.403.051.322.791.99

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SD-score (Z-score) for Body Weight

Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. (NCT00623194)
Timeframe: At 104 weeks

InterventionSD-scores (Mean)
Insulin Detemir0.13

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Laboratory Values: Creatine Serum Umol/L

Creatine serum after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

InterventionUmol/L (Mean)
Insulin Detemir51.08

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Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

InterventionPercent (%) glycosylated haemoglobin (Mean)
Insulin Detemir8.74

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Change in Glycosylated Haemoglobin A1c (HbA1c)

Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16) (NCT00627445)
Timeframe: week 0, week 16

Interventionpercentage (%) of total haemoglobin (Least Squares Mean)
BIAsp 50-50-30-1.790
BIAsp 30-30-1.517

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Number of Nocturnal Hypoglycaemic Episodes

Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. (NCT00627445)
Timeframe: weeks 0-16

,
Interventionepisodes (Number)
AllMajor or MinorMinorSymptons Only
BIAsp 30-3081303051
BIAsp 50-50-301343131103

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The Total Increase in Total Daily Insulin Dose Per Body Weight

The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16). (NCT00627445)
Timeframe: week 0, week 16

InterventionU/kg (Least Squares Mean)
BIAsp 50-50-300.963
BIAsp 30-300.820

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Change and Daily Average in 8-point Plasma Glucose

Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment. (NCT00627445)
Timeframe: week 0, week 16

,
Interventionmmol/L (Least Squares Mean)
Before Breakfast, N= 213, 2132 hours After Breakfast, N= 213, 210Before Lunch, N= 213, 2102 hours After Lunch, N= 213, 211Before Dinner, N= 212, 2122 hours After Dinner, N= 211, 209Bedtime, N= 207, 2073:00 AM, N= 211, 210Average, N= 213, 212
BIAsp 30-30-2.43-4.00-2.71-3.15-2.83-3.37-3.09-1.89-2.94
BIAsp 50-50-30-2.52-3.92-2.80-4.37-3.83-3.46-2.93-1.99-3.23

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Change and Daily Average in Prandial Plasma Glucose Increment

Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment. (NCT00627445)
Timeframe: week 0, week 16

,
Interventionmmol/L (Least Squares Mean)
At Breakfast, N= 213, 210At Lunch, N= 213, 210At Dinner, N= 210, 209Average, N= 213, 211
BIAsp 30-30-1.58-0.44-0.53-0.84
BIAsp 50-50-30-1.41-1.570.40-0.88

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Number of Hypoglycaemic Episodes

Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. (NCT00627445)
Timeframe: weeks 0-16

,
Interventionepisodes (Number)
AllMajor or MinorMinorSymptoms Only
BIAsp 30-30679198198481
BIAsp 50-50-30728158157570

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Change in Body Weight

Change in body weight from baseline (week 0) to end of treatment (week 16) (NCT00627445)
Timeframe: week 0, week 16

Interventionkg (Least Squares Mean)
BIAsp 50-50-301.188
BIAsp 30-300.817

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The Percentage of Subjects Achieving HbA1c Treatment Targets

The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%. (NCT00627445)
Timeframe: week 16

,
Interventionpercentage (%) of subjects (Number)
Achieving HbA1c <7.0%Achieving HbA1c <=6.5%
BIAsp 30-305229
BIAsp 50-50-306547

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Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%

Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment (NCT00634842)
Timeframe: week 20

Interventionpercentage of participants (Number)
FPG 70-90 mg/dL64.3
FPG 80-110 mg/dL54.5

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Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline

Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20 (NCT00634842)
Timeframe: week -2, week 20

Interventionpercentage point change (Least Squares Mean)
FPG 70-90 mg/dL-1.229
FPG 80-110 mg/dL-0.958

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Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%

Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment (NCT00634842)
Timeframe: week 20

Interventionpercentage of participants (Number)
FPG 70-90 mg/dL41.1
FPG 80-110 mg/dL26.8

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Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)

"Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:~If subject was unable to treat himself: Major incidence.~If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.~If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only." (NCT00634842)
Timeframe: weeks 0-20

,
Interventionnumber of events (Number)
AllMajorMinorSymptoms only
FPG 70-90 mg/dL3331225107
FPG 80-110 mg/dL227013691

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Changes in Weight From Baseline to Month 24

Changes in Weight From Baseline to Month 24 (NCT00635492)
Timeframe: Baseline, Month 24

Interventionkg (Mean)
Exenatide BID-3.22
Insulin2.16

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Disinhibited Eating Associated With Treatment Choice at Baseline

Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Exenatide BID43.52
Insulin34.38

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Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline

Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: 4 weeks prior to Baseline

Interventiontests/week (Mean)
Exenatide BID9.28
Insulin9.91

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Percentage of Patients Hospitalized Between Baseline and 24 Months

Percentage of Patients Hospitalized Between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

,
Interventionpercentage of patients (Number)
Last 6 months prior to baselineBaseline to 24 months
Exenatide BID4.74.3
Insulin6.47.8

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Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline

Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

Interventionmmol/L (Mean)
Exenatide BID2.82
Insulin3.00

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Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24

Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis (NCT00635492)
Timeframe: Month 24

Interventionpercentage of patients (Number)
Exenatide BID26.9
Insulin28.5

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Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis. (NCT00635492)
Timeframe: Month 24

Interventionpercentage of patients (Number)
Exenatide BID12.5
Insulin10.7

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Older Age Associated With Treatment Choice at Baseline

Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

Interventionyears (Mean)
Exenatide BID58.1
Insulin63.7

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Incidence of Hypoglycemia Between Baseline and 24 Months

Incidence of Hypoglycemia between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

Interventionpercentage of patients (Number)
Exenatide BID17.5
Insulin35.2

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Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months

Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

Interventionpercentage of patients (Number)
Exenatide BID29.4
Insulin5.0

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Higher Random Glucose Associated With Treatment Choice at Baseline

Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: 6 months prior to Baseline

Interventionmmol/L (Mean)
Exenatide BID10.37
Insulin12.13

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Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline

Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

Interventionkg/m^2 (Mean)
Exenatide BID35.3
Insulin29.7

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Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline

Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher. (NCT00635492)
Timeframe: Baseline

Interventionpercent of hemoglobin (Mean)
Exenatide BID8.4
Insulin9.2

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Reasons for Discontinuation of Baseline Regimen

Reasons for Discontinuation of Baseline Regimen (NCT00635492)
Timeframe: Baseline to Month 24

,
Interventionnumber of patients (Number)
Inadequate responseAdverse eventPatient decisionNon complianceCannot afford medicationOther
Exenatide BID17091699450
Insulin8711153138

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Changes in HbA1c From Baseline to Month 24

Changes in HbA1c From Baseline to Month 24 (NCT00635492)
Timeframe: Baseline, Month 24

Interventionpercentage of total hemoglobin (Mean)
Exenatide BID-1.03
Insulin-1.71

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Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months

Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

,
Interventionpercentage of patients (Number)
Last 6 months prior to baselineBaseline to 24 months
Exenatide BID94.490.4
Insulin94.192.3

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Factors Associated With Treatment Change in Insulin Cohort

Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort (NCT00635492)
Timeframe: Baseline to Month 24

Interventionhazard ratio (Number)
HbA1c (%) at baselineDHP barriers to activity subscale at baselineGastrointestinal symptoms: yes vs. no at baselineInsulin regimen: basal/bolus vs. long-acting onlyInsulin regimen: mixtures vs. long-acting onlyInsulin regimen: other vs. long-acting onlyInsulin regimen: short-acting only vs. long-actin
Insulin Cohort1.1180.9602.5320.4370.6760.5492.164

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Factors Associated With Treatment Change in Exenatide BID Cohort

Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998). (NCT00635492)
Timeframe: Baseline to Month 24

Interventionhazard ratio (Number)
Gastro intestinal symptoms: yes vs no at baselineEQ-5D index value at baseline
Exenatide BID1.4630.601

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Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.

"The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.~Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.~Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:~Insulin:~Addition of a new medication for the treatment of type 2 diabetes~A change in the number of times insulin is administered per day~Discontinuation of any insulin initiated at baseline~Substitution of a human insulin for an analogue insulin or vice-versa.~Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.~Exenatide:~Addition of a new medication for the treatment of type 2 diabetes~Discontinuation of exenatide." (NCT00635492)
Timeframe: Month 24

,
Interventionprobability (%) (Number)
Estimate at 24 monthsEstimate at 12 months
Exenatide BID53.967.8
Insulin60.670.6

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Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline

Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

,
Interventionparticipants (Number)
MissingNoYesUnknown
Exenatide BID12131910124
Insulin1237905172

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Number of Contacts With Health Care Providers Between Baseline and 24 Months

Number of contacts with Health Care Providers Between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

,
Interventionnumber of contacts (Mean)
Last 6 months prior to baselineBaseline to 24 months
Exenatide BID7.1719.00
Insulin7.6424.58

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Number of Participants With Asthma Exacerbation by Treatment Arm

Number of participants who experienced worsening of asthma symptoms (NCT00642616)
Timeframe: Baseline to Week 52

,
Interventionparticipants (Number)
Exacerbation of AsthmaNo Exacerbation of Asthma
Technosphere® Insulin (Asthma)18
Usual Care With Anti-diabetic Agents (Asthma)17

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Number of Participants With COPD Exacerbation by Treatment Arm

Number of participants who experienced worsening of COPD symptoms (NCT00642616)
Timeframe: Baseline to Week 52

,
Interventionparticipants (Number)
COPD ExacerbationNo Exacerbation
Technosphere® Insulin (COPD)36
Usual Care With Anti-diabetic Agents (COPD)17

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Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)

"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here." (NCT00645528)
Timeframe: Visit 1 (week 0)

Interventionunits on a scale (Mean)
Total Sum ScoreFear of injections and self-testingExpectations regarding positive insulin-related ouExpected hardship from insulin therapyStigmatization by insulin injectionsFear of hypoglycemia
Insulin Education Class Participants4.273.065.594.164.144.69

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"Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes"

"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test." (NCT00645528)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
Change in Total Sum ScoreChange in Fear of Injections and Self-TestingChange in Expectations regarding positive insulinChange in Expected hardship from insulin therapyChange in Stigmatization by insulin injectionsChange in Fear of hypoglycemia
Insulin Education Class Participants-0.76-0.420.88-0.55-1.1-1.02

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Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)

"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here." (NCT00645528)
Timeframe: Visit 2 (week 2)

Interventionunits on a scale (Mean)
Total Sum ScoreFear of injections and self-testingExpectations regarding positive insulin-related ouExpected hardship from insulin therapyStigmatization by insulin injectionsFear of hypoglycemia
Insulin Education Class Participants3.512.646.473.613.133.79

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Percent of Patients Who Begin Insulin

(NCT00645528)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Insulin Education Class Participants78

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Number of Subjects Experiencing Hypoglycemic Symptoms

Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits (NCT00645528)
Timeframe: 2 weeks

Interventionparticipants (Number)
Insulin Education Class Participants15

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Number of Patients Experiencing a Severe Hypoglycemic Event

Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia (NCT00645528)
Timeframe: 2 weeks

Interventionparticipants (Number)
Insulin Education Class Participants0

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Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)

"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). Reaction time of hits refers to the average time each participant took to correctly respond to a stimuli in milliseconds. Values below represent posttreatment performance minus pretreatment performance." (NCT00646581)
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration

InterventionMilliseconds (Mean)
Placebo (1)8.5
Single-Dose Intranasal Insulin-13.8

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Improvement in Cognitive Function- HVLT-Delayed Recall (Number)

Subjects performed the HVLT word recall task after a 20-minute delay before and after intranasal treatment. In the HVLT delayed recall task, participants were asked to recall the same list of 12 words dictated in the immediate recall task 20 minutes after the completion of the immediate recall task. Words successfully recalled after the 20-minute delay were measured. Values below represent posttreatment performance minus pretreatment performance. (NCT00646581)
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration

InterventionWords successfully recalled (Mean)
Placebo (1)1.1
Single-Dose Intranasal Insulin1.4

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Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)

Subjects performed the HVLT Immediate Recall Task. For this task, participants were read aloud a list of 12 words from three taxonomic categories. Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could. The number of words recalled successfully was measured before and after intranasal treatment. Values below represent posttreatment performance minus pretreatment performance. (NCT00646581)
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration

InterventionWords successfully recalled (Mean)
Placebo (1)4.9
Single-Dose Intranasal Insulin5.3

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Improvement in Cognitive Function- CPT Hits Rate (Proportion)

"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in the previous outcome measure (CPT d score). Hits rate refers to each participant's ability to correctly respond to two consecutive target presentations (i.e. correct responses). Hits rate was measured as a proportion of overall attempts (0= no hits, 1.0= 100% accuracy on hits). Values below represent posttreatment performance minus pretreatment performance." (NCT00646581)
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration

InterventionProportion of overall attempts (Mean)
Placebo (1)0.03
Single-Dose Intranasal Insulin0.09

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Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)

"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). False alarm rate refers to the proportion of overall attempts that were characterized as incorrect responses (responses to two non-identical targets). Values below represent posttreatment performance minus pretreatment performance." (NCT00646581)
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration

InterventionProportion of overall attempts (Mean)
Placebo (1)-0.03
Single-Dose Intranasal Insulin0.02

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CPT d Score

"Subjects performed a computer-based test designed to measure sustained attention (attention to a specific stimuli over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance." (NCT00646581)
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration

Interventionunits on a scale (Mean)
Placebo (1)0.12
Single-Dose Intranasal Insulin0.29

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Calories Consumed After Fast.

Total energy ingested following the 24 hour fast. (NCT00659165)
Timeframe: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks

Interventionkcal (Mean)
Insulin Detemir1418
Insulin Glargine1357

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Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360

Dose-normalized baseline-corrected area under the serum insulin vs. time curve (NCT00662857)
Timeframe: 0 to 360 minutes post-dose

Intervention(micro U)*min/mL (Least Squares Mean)
Techosphere Insulin - A (2 x 15 U)3337.2
Techosphere Insulin - B (1 x 30 U)3396.6

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Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.

Maximum observed baseline-corrected serum insulin concentration (NCT00662857)
Timeframe: 0 to 360 minutes post-dose

Intervention(micro U)/mL (Least Squares Mean)
Techosphere Insulin - A (2 x 15 U)65.72
Techosphere Insulin - B (1 x 30 U)69.08

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Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax

(NCT00662857)
Timeframe: 0 to 360 minutes post-dose

Interventionmin (Median)
Techosphere Insulin - A (2 x 15 U)10
Techosphere Insulin - B (1 x 30 U)10

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Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro

Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose) (NCT00662857)
Timeframe: 0 to 360 minutes post-dose

Intervention(micro U)*min/mL (Least Squares Mean)
Techosphere Insulin - B (1 x 30 U)3406.8
10 U Subcutaneous (sc) Insulin Lispro7404.0

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Number of Participants With Adverse Events

"A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.~TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline." (NCT00664534)
Timeframe: Baseline to 48 weeks

,
Interventionparticipants (Number)
SAETEAE
Glargine353
Premix Insulin Lispro752

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Mean Postprandial Blood Glucose Values

Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase. (NCT00664534)
Timeframe: Baseline, 16 weeks, 32 weeks and 48 weeks

,
Interventionmicrogram per milliliter (µg/mL) (Mean)
Baseline (N=160, N=158)Week 16 (N=143, N=141)Week 32 (N=125, N=123)Week 48 (N=119, N=125)
Glargine6.259.6910.5410.90
Premix Insulin Lispro5.699.5210.8111.41

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7-point Self-monitored Blood Glucose Profiles

(NCT00664534)
Timeframe: 16 weeks, 32 weeks and 48 weeks

,
Interventionmillimoles per Liter (mmol/L) (Least Squares Mean)
Week 16 Before Breakfast (n=142, n=145)Week 32 Before Breakfast (n=126, n=130)Week 48 Before Breakfast (n=123, n=130)Week 16 After Breakfast (n=136, n=138)Week 32 After Breakfast (n=123, n=127)Week 48 After Breakfast (n=120, n=129)Week 16 Before Lunch (n=143, n=145)Week 32 Before Lunch (n=128, n=132)Week 48 Before Lunch (n=121, n=129)Week 16 After Lunch (n=138, n=140)Week 32 After Lunch (n=127, n=130)Week 48 After Lunch (n=120, n=126)Week 16 Before Dinner (n=143, n=145)Week 32 Before Dinner (n=129, n=132)Week 48 Before Dinner (n=120, n=129)Week 16 After Dinner (n=140, n=141)Week 32 After Dinner (n=128, n=131)Week 48 After Dinner (n=120, n=126)Week 16 at 0300 Hours (n=114, n=120)Week 32 at 0300 Hours (n=105, n=106)Week 48 at 0300 Hours (n=104, n=107)
Glargine6.946.656.799.128.658.887.337.007.149.328.348.587.847.317.559.688.648.877.346.946.94
Premix Insulin Lispro7.367.206.949.929.168.947.667.256.869.378.698.347.927.397.199.038.508.097.226.806.57

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Percentage of Participants Using Each Possible Final Insulin Regimen

"Insulin Regimens:~Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro." (NCT00664534)
Timeframe: 48 weeks

,
Interventionpercentage of participants (Number)
MM before noonLM before PMMM before noon+LM before PMLM before AM+MM before noon+LM before PMMM before AM+MM before noon+LM before PMGlargine QDGlargine QD+1 Lispro (noon or PM)Glargine QD+2 Lispro (noon and PM)Glargine QD+3 LisproOther (not specified)
Glargine00000592730140
Premix Insulin Lispro15334236700004

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Mean Daily Total, Basal and Prandial Insulin Dose

(NCT00664534)
Timeframe: 16 weeks, 32 weeks and 48 weeks

,
InterventionInternational Units per day (IU/day) (Mean)
Week 16 Total Daily Insulin (N=156, N=155)Week 32 Total Daily Insulin (N=135, N=140)Week 48 Total Daily Insulin (N=130, N=137)Week 16 Basal Insulin (N=156, N=155)Week 32 Basal Insulin (N=135, N=140)Week 48 Basal Insulin (N=130, N=137)Week 16 Prandial Insulin (N=156, N=155)Week 32 Prandial Insulin (N=135, N=140)Week 48 Prandial Insulin (N=130, N=137)
Glargine29.9440.8046.4525.5330.0531.524.4110.7514.94
Premix Insulin Lispro26.9438.4546.2017.9725.0630.128.9713.3916.07

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HbA1c Over Time

Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit*treatment in Full Analysis Set (FAS) Population. (NCT00664534)
Timeframe: 16 weeks, 32 weeks, and 48 weeks

,
Interventionpercent glycosylated hemoglobin (Least Squares Mean)
16 weeks (n=142,n=140)32 weeks (n=119, n=121)48 weeks (n=115,n=125)
Glargine7.577.437.40
Premix Insulin Lispro7.627.467.33

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Rate Per 30 Days of All Self-reported Hypoglycemic Episodes

The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days). (NCT00664534)
Timeframe: Baseline to 48 weeks

Interventionepisodes per 30 days (Mean)
Glargine0.67
Premix Insulin Lispro0.79

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Incidence of All Self-reported Hypoglycemic Episodes

Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). (NCT00664534)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
Glargine60.1
Premix Insulin Lispro64.5

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Body Weight Change From Baseline to Endpoint

(NCT00664534)
Timeframe: baseline, 48 weeks

Interventionkilograms (kg) (Least Squares Mean)
Glargine2.70
Premix Insulin Lispro2.61

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Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint

Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population. (NCT00664534)
Timeframe: 48 weeks

Interventionpercent glycosylated hemoglobin (Least Squares Mean)
Glargine7.55
Premix Insulin Lispro7.40

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Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time

(NCT00664534)
Timeframe: 16 weeks, 32 weeks and 48 weeks

,
Interventionpercentage of participants (Number)
Week 16 HbA1c <=7.0% (n=157, n=155)Week 16 HbA1c <=6.5% (n=157, n=155)Week 32 HbA1c <=7.0% (n=137, n=141)Week 32 HbA1c <=6.5% (n=137, n=141)Week 48 HbA1c <=7.0% (n=130, n=137)Week 48 HbA1c <=6.5% (n=130, n=137)
Glargine24.214.632.119.036.218.5
Premix Insulin Lispro30.318.737.620.648.224.8

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Number of Participants With Adverse Events (AE)

A listing of adverse events is located in the Reported Adverse Event module. (NCT00666718)
Timeframe: Baseline through Week 24

,
Interventionparticipants (Number)
AEsSerious adverse events (SAE)
Glargine819
ILPS6514

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Glycemic Variability at Endpoint

LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements. (NCT00666718)
Timeframe: Week 24

,
Interventionmmol/L (Least Squares Mean)
FastingPost-breakfastPost-lunchPost-dinner
Glargine0.861.561.611.43
ILPS0.951.641.511.40

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Change From Baseline in HbA1c at Week 12 and Week 24

LSMean values presented were controlled for treatment, country, baseline HbA1C value and week. (NCT00666718)
Timeframe: Baseline, Week 12, Week 24

,
InterventionPercent of Glycosylated Hemoglobin (Least Squares Mean)
Week 12 Change (n=172, n=168)Week 24 Change (n=170, n=166)
Glargine-0.99-1.29
ILPS-0.90-1.07

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7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint

LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal. (NCT00666718)
Timeframe: 24 weeks

,
Interventionmillimoles per liter (mmol/L) (Least Squares Mean)
Morning Pre-MealMorning PostprandialMidday Pre-MealMidday PostprandialEvening Pre-MealEvening Postprandial0300 Hours
Glargine8.268.938.199.118.809.278.16
ILPS8.639.197.909.588.759.738.30

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Total Daily Insulin Dose at Endpoint

LSMean values presented were controlled for treatment, country, and baseline HbA1C value. (NCT00666718)
Timeframe: Week 24

InterventionUnits (Least Squares Mean)
Glargine78.05
ILPS80.23

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Change in Body Weight From Baseline to Week 24

LSMean values presented were controlled for treatment, country, and baseline HbA1C value. (NCT00666718)
Timeframe: Baseline, Week 24

InterventionKilograms (kg) (Least Squares Mean)
Glargine1.19
ILPS1.03

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Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24

Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value. (NCT00666718)
Timeframe: Baseline, Week 24

InterventionPercent of Glycosylated Hemoglobin (Least Squares Mean)
Glargine-1.28
ILPS-1.18

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Number of Injections of Insulin at Week 24

(NCT00666718)
Timeframe: Week 24

,
InterventionParticipants (Number)
2 to <3 per day3 to <4 per day≥4 per day
Glargine81294
ILPS101021

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Rate Of All Self-reported Hypoglycemic Episodes

Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose. (NCT00666718)
Timeframe: Baseline through Week 24

,
Interventionepisode/30 days/participant (Least Squares Mean)
All reported episodes rateNocturnal reported episodes rateNon-Nocturnal reported episodes rateSevere reported episodes rateDocumented <=3.9 millimoles per liter(mmol/L) rateDocumented <=3.0 mmol/L rate
Glargine1.380.191.1600.890.13
ILPS0.840.150.7100.490.12

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Percentage of Participants With Self-Reported Hypoglycemic Episodes

Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. (NCT00666718)
Timeframe: Baseline through Week 24

,
Interventionpercentage of participants (Number)
>=1 hypoglycemic episode>=1 nocturnal hypoglycemic episode>=1 non-nocturnal hypoglycemic episode>=1 severe hypoglycemic episode
Glargine63.619.361.00.5
ILPS56.125.754.01.6

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Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint

(NCT00666718)
Timeframe: Week 24

,
InterventionPercent of Participants (Number)
HbA1c < 7.0%HbA1c <= 6.5%
Glargine5024
ILPS3614

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Infarct Size Absolute Change From Baseline at Day 60

Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass. (NCT00670228)
Timeframe: From baseline at Day 60

Interventionpercentage of LV mass change (Mean)
Intensive Insulin Therapy (IIT)-7.84
Standard Glycemic Care (SGC)-15.72

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Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)

Due to study early termination and the limited number of randomized subjects, descriptive statistics for the Day 3 Ejection Fraction were selected for presentation instead of for Day 60 as initially planned. (NCT00670228)
Timeframe: At Day 3

Interventionpercentage of Ejection Fraction (Mean)
Intensive Insulin Therapy (IIT)43.08
Standard Glycemic Care (SGC)43.43

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Occurrence of the Major Adverse Cardiovascular Events (MACE)

"MACE:~Cardiac death, New onset or worsening congestive heart failure (>24 h post-admission) event evaluating using New York Heart Association (NYHA) Class II or greater Non-fatal Myocardial Infarction, Severe arrhythmia, Stroke/TIA (Transient Ischemic Attack), Cardiogenic shock, Catheterization/revascularization, Unstable angina leading to hospitalisation" (NCT00670228)
Timeframe: At Day 60

,
Interventionevents (Number)
Severe arrhythmiaShockRevascularizationNew onset or worsening of congestive heart failureMyocardial Infarction (MI)Death
Intensive Insulin Therapy (IIT)701111
Standard Glycemic Care (SGC)210001

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Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)

(NCT00670228)
Timeframe: At Day 60

Interventionmg/L (Mean)
Intensive Insulin Therapy (IIT)2.52
Standard Glycemic Care (SGC)2.96

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Any Adverse Event Other Than Hypoglycemia

Any reported adverse event that is not hypoglycemia (NCT00686712)
Timeframe: 6 months

InterventionEvents (Number)
1 - Insulin Glargine QHS1
2 - Insulin Glargine QAM2
3 - NPH Insulin QHS1

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Hemoglobin A1c Change From Baseline

(NCT00686712)
Timeframe: Baseline to 6 months

InterventionPercent (Mean)
Insulin Glargine at Bedtime-1.3
Insulin Glargine in AM-1.9
NPH Insulin-1.4

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Frequency of Total Hypoglycemic Reactions

Frequency of hypoglycemic reactions without regard to time of occurrence (NCT00686712)
Timeframe: 6 months

InterventionHypoglycemic events per patient (Mean)
1 - Insulin Glargine QHS6.7
2 - Insulin Glargine QAM9.6
3 - NPH Insulin QHS8.2

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Frequency of Severe Hypoglycemic Reactions

Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person (NCT00686712)
Timeframe: 6 months

InterventionSevere hypoglycemic events (Number)
1 - Insulin Glargine QHS0
2 - Insulin Glargine QAM0
3 - NPH Insulin QHS0

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Frequency of Glucose Readings < 130 mg/dL

Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL (NCT00686712)
Timeframe: 6 months

Interventionpercentage of readings (Mean)
1 - Insulin Glargine QHS61.7
2 - Insulin Glargine QAM73.0
3 - NPH Insulin QHS72.6

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Body Mass Index Change From Baseline

Change in body mass index from baseline BMI measurement (NCT00686712)
Timeframe: 6 months

Interventionkg per square meter (Mean)
1 - Insulin Glargine QHS0.7
2 - Insulin Glargine QAM1.1
3 - NPH Insulin QHS0.0

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Total Daily Insulin Dose

Total daily number of units of insulin used (NCT00686712)
Timeframe: 6 months

InterventionUnits of insulin per day (Mean)
1 - Insulin Glargine QHS17.7
2 - Insulin Glargine QAM17.9
3 - NPH Insulin QHS14.6

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Change From Baseline in HbA1c to Week 16

Change from Baseline in glycosylated hemoglobin at Week 16 (NCT00700622)
Timeframe: Baseline to Week 16

Interventionpercentage of total hemoglobin (Least Squares Mean)
TI + Insulin Glargine-0.10
Insulin Lispro + Insulin Glargine-0.03

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Time to Late Half-Maximal Effect for Glucose Infusion Rate (tGIR[late50%])

"Time to late half-maximal effect for glucose infusion rate (tGIR[late50%]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.~Because the study was only 360 minutes in duration, there was not sufficient time for regular human insulin to show an effect and therefore tGIR(late50%) could not be calculated for participants receiving Humulin-R alone." (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionMinutes (Mean)
Stage 1: Humalog Alone324
Stage 1: Humalog + rHuPH20275
Stage 2: Humulin-R + rHuPH20282

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Maximum Serum Insulin Concentration (Cmax)

Maximum serum insulin concentration (Cmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionPicomoles per liter (Mean)
Stage 1: Humalog Alone680
Stage 1: Humalog + rHuPH201290
Stage 2: Humulin-R Alone390
Stage 2: Humulin-R + rHuPH20944

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Time to Early Half-Maximal Effect for Glucose Infusion Rate (tGIR[early50%])

Time to early half-maximal effect for glucose infusion rate (tGIR[early50%]) for participants who were randomized to Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionMinutes (Mean)
Stage 1. Humalog Alone72.3
Stage 1: Humalog + rHuPH2043.8
Stage 2: Humulin-R Alone104
Stage 2: Humulin-R + rHuPH2047.4

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Relative Bioavailability (Area Under the Curve [AUC] for Insulin + Recombinant Human Hyaluronidase [rHuPH20] / AUC for Insulin Alone)

"Relative bioavailability was determined by dividing the baseline-corrected geometric mean of the area under the curve (AUC) for insulin (ins) (Humalog or Humulin-R) with recombinant human hyaluronidase PH20 (rHuPH20) by the baseline-corrected geometric mean of the AUC for insulin alone (AUC[insulin+rHuPH20]/AUC[insulin]).~Bioavailability values for participants who received Humalog or Humulin-R and rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period." (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionRatio of AUC(ins+rHuPH20)/AUC(ins alone) (Mean)
Stage 1: Humalog + rHuPH201.18
Stage 2: Humulin-R + rHuPH201.57

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Time to Maximum Serum Insulin Concentration (Tmax)

Time to maximum serum insulin concentration (tmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionMinutes (Mean)
Stage 1: Humalog Alone97.5
Stage 1: Humalog + rHuPH2048.0
Stage 2: Humulin-R Alone163
Stage 2: Humulin-R + rHuPH2067.8

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Time to Maximum Glucose Infusion Rate (tGIR[Max])

Time to maximal effect for glucose infusion rate (tGIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained every 3 minutes during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionMinutes (Mean)
Stage 1: Humalog Alone193
Stage 1: Humalog + rHuPH20114
Stage 2: Humulin-R Alone253
Stage 2: Humulin-R + rHuPH20165

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Area Under the Concentration-Time Curve From Time 0 to Time to Reach Maximum Concentration (Tmax) for Serum Insulin With Recombinant Human Hyaluronidase PH20 (rHuPH20) (AUC[0-tmaxPH20])

Area under the concentration-time curve from time 0 to time to reach maximum concentration (tmax) for serum insulin (Humalog or Humulin-R) with recombinant human hyaluronidase (rHuPH20) (AUC[0-tmaxPH20]) for participants who received Humalog or Humulin-R and with rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment and every 3 min from min 0 through 48 for Stage 1 and, and every 3 min from min 0 through 68 for Stage 2 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 48 minutes postdose during Stage 1, or up to 68 minutes postdose during Stage 2

InterventionPicomoles per liter times minutes (Mean)
Stage 1: Humalog Alone9530
Stage 1: Humalog + rHuPH2027900
Stage 2: Humulin-R Alone8780
Stage 2: Humulin-R + rHuPH2034800

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Maximum Glucose Infusion Rate (GIR[Max])

Maximum glucose infusion rate (GIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionMilligrams per kilogram per minute (Mean)
Stage 1: Humalog Alone8.11
Stage 1: Humalog + rHuPH208.57
Stage 2: Humulin-R Alone7.82
Stage 2: Humulin-R + rHuPH2010.5

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Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t'])

Area under the serum concentration-time curve from time zero to the time required to reach endogenous plasma glucose levels (AUC[0-t']) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionPicomoles per liter times minutes (Mean)
Stage 1: Humalog Alone116000
Stage 1: Humalog + rHuPH20133000
Stage 2: Humulin-R Alone91400
Stage 2: Humulin-R + rHuPH20137000

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Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}])

The area under the curve for the glucose infusion rate from minutes (min) 0 to 60 after injection (AUC[GIR{0-60}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment and every 3 min from min 0 through 60 during the clamp procedure. Means were calculated using analysis of variance with fixed of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 60 minutes postdose during Stage 1 or Stage 2

InterventionGrams per kilogram (Mean)
Stage 1: Humalog Alone82.8
Stage 1: Humalog + rHuPH20167
Stage 2: Humulin-R Alone74.3
Stage 2: Humulin-R + rHuPH20180

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Area Under the Glucose Infusion Rate Curve From 0 to 360 Minutes After Injection (AUC[GIR{0-360}])

The area under glucose infusion rate curve from minutes (min) 0 to 360 after injection (AUC[GIR{0-360}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 360 during the clamp. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 360 minutes postdose during Stage 1 or Stage 2

InterventionGrams per kilogram (Mean)
Stage 1: Humalog Alone1940
Stage 1: Humalog + rHuPH201930
Stage 2: Humulin-R Alone1860
Stage 2: Humulin-R + rHuPH202260

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Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}])

The area the glucose infusion rate curve from minutes (min) 0 to 240 after injection (AUC[GIR{0-240}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 240 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose up to 240 minutes postdose during Stage 1 or Stage 2

InterventionGrams per kilogram (Mean)
Stage 1: Humalog Alone1240
Stage 1: Humalog + rHuPH201430
Stage 2: Humulin-R Alone1010
Stage 2: Humulin-R + rHuPH201630

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Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}])

The area under the curve for the glucose infusion rate from minutes (min) 0 to 180 after injection (AUC[GIR{0-180}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 180 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 180 minutes postdose during Stage 1 or Stage 2

InterventionGrams per kilogram (Mean)
Stage 1: Humalog Alone801
Stage 1: Humalog + rHuPH201040
Stage 2: Humulin-R Alone604
Stage 2: Humulin-R + rHuPH201150

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Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}])

The area under the glucose infusion rate curve from minutes 0 to 120 after injection (AUC[GIR{0-120}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 120 during the clamp. Means were calculated using analysis of variance with fixed effects of participant, sequence within participant, treatment, and period. (NCT00705536)
Timeframe: Predose and up to 120 minutes postdose during Stage 1 or Stage 2

InterventionGrams per kilogram (Mean)
Stage 1: Humalog Alone393
Stage 1: Humalog + rHuPH20597
Stage 2: Humulin Alone281
Stage 2: Humulin-R + rHuPH20637

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Change in Spine Bone Density (g/cm^2)

Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated. (NCT00720122)
Timeframe: Baseline and 6 months

Interventiongm/cm^2 (Mean)
Anorexia Nervosa Females-0.00558

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Annual Rate of Change in FEV1 From Baseline to End of Study

(NCT00754624)
Timeframe: Baseline to 48 months

InterventionLiters per year (Mean)
TI Inhalation Powder-0.048

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Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)

Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months) (NCT00754624)
Timeframe: Baseline to last measurement on study drug (maximum of 48 months

Interventionpercentage (Mean)
TI Inhalation Powder0.20

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Annual Rate of Change in FVC From Baseline to End of Study

(NCT00754624)
Timeframe: Baseline to 48 months

InterventionLiters per year (Mean)
TI Inhalation Powder-0.058

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Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)

Change from Baseline to last study measurement on treatment (maximum of 48 months) (NCT00754624)
Timeframe: Baseline to last study measurement on treatment (maximum of 48 months)

Interventionmilligrams per deciliter (Mean)
TI Inhalation Powder-5.34

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High Resolution Computerized Tomography Scans of the Chest

(NCT00754624)
Timeframe: End of study

Interventionparticipants (Number)
"Normal HRCT subjects""Abnormal, clinically not significant subjects""Abnormal, Clinically Significant HRCT subjects"
TI Inhalation Powder4714712

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Change in Weight in kg From Baseline to End of Study

Baseline to last measurement on study drug (maximum of 48 months) (NCT00754624)
Timeframe: Baseline to last measurement on study drug (maximum of 48 months)

Interventionkilograms (Mean)
TI Inhalation Powder1.42

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Annual Rate of Change in DLCo From Baseline to End of Study

(NCT00754624)
Timeframe: Baseline to 48 months

InterventionmL/min/mmHg per year (Mean)
TI Inhalation Powder-0.311

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Change From Baseline in Fasting Plasma Glucose Values

(NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Saxagliptin, 5 mg + Insulin-10.1
Placebo + Insulin-6.1

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Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)

Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. (NCT00757588)
Timeframe: Baseline to Week 24

InterventionUnits (Mean)
Saxagliptin, 5 mg + Insulin1.71
Placebo + Insulin5.01

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Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results

"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions." (NCT00757588)
Timeframe: Baseline to Week 52

InterventionParticipants (Number)
Saxagliptin, 5 mg + Insulin15
Placebo + Insulin11

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Percentage of Participants Achieving a Therapeutic Glycemic Response

Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. (NCT00757588)
Timeframe: Baseline to Week 24

InterventionPercentage of participants (Number)
Saxagliptin, 5 mg + Insulin17.3
Placebo + Insulin6.7

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Mean Changes From Baseline in Heart Rate

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

,
InterventionBeats per minute (Number)
Week 2 (n=294, 147)Week 4 (n=293, 144)Week 6 (n=280, 141)Week 8 (n=290, 142)Week 12 (n=286, 144)Week 16 (n=278, 139)Week 20 (n=276, 137)Week 24 (n=273, 134)Week 28 (n=264, 132)Week 36 (n=261, 129)Week 44 (n=250, 125)Week 52 (n=246, 125)
Placebo + Insulin-0.7-1.0-0.9-0.70.2-0.60.4-1.0-0.6-0.0-0.70.2
Saxagliptin, 5 mg + Insulin-0.5-0.5-0.5-0.00.3-1.0-0.50.0-1.00.00.2-0.3

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Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

,
Interventionmm Hg (Number)
Systolic blood pressure (Week 2) (n=294, 147)Systolic blood pressure (Week 4) (n=293, 144)Systolic blood pressure (Week 6) (n=280, 141)Systolic blood pressure (Week 8) (n=290, 142)Systolic blood pressure (Week 12) (n=286, 144)Systolic blood pressure (Week 16) (n=278, 139)Systolic blood pressure (Week 20) (n=276, 137)Systolic blood pressure (Week 24) (n=273, 134)Systolic blood pressure (Week 28) (n=264, 132)Systolic blood pressure (Week 36) (n=261, 129)Systolic blood pressure (Week 44) (n=250, 125)Systolic blood pressure (Week 52) (n=246, 125)Diastolic blood pressure (Week 2) (n=294, 147)Diastolic blood pressure (Week 4) (n=293, 144)Diastolic blood pressure (Week 6) (n=280, 141)Diastolic blood pressure (Week 8) (n=290, 142)Diastolic blood pressure (Week 12) (n=286, 144)Diastolic blood pressure (Week 16) (n=278, 139)Diastolic blood pressure (Week 20) (n=276, 137)Diastolic blood pressure (Week 24) (n=273, 134)Diastolic blood pressure (Week 28) (n=264, 132)Diastolic blood pressure (Week 36) (n=261, 129)Diastolic blood pressure (Week 44) (n=250, 125)Diastolic blood pressure (Week 52) (n=246, 125)
Placebo + Insulin2.30.01.02.42.21.11.3-0.11.83.62.61.01.41.80.32.11.01.31.10.50.20.20.40.1
Saxagliptin, 5 mg + Insulin-1.0-1.2-0.8-0.8-1.7-1.2-0.6-1.5-1.4-0.7-0.60.00.10.00.0-0.5-0.8-1.1-0.7-1.7-1.6-1.2-0.3-0.5

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Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal (NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg*min/dL (Mean)
Saxagliptin, 5 mg + Insulin-4548.5
Placebo + Insulin-718.8

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Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period

"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4." (NCT00757588)
Timeframe: Baseline and during and up to 14 days after last dose of study drug (in Week 52)

,
InterventionParticipants (Number)
Hemoglobin <8 g/dL (n=300; 150)Hematocrit <0.75*prx (n=300; 150)Platelets <50*10^9 c/L (n=297; 145)Platelets >1.5*ULN (n=297; 145)Leukocytes <2*1000 c/uL (n=300; 150)Neutrophils <1*1000 c/uL (n=296; 150)Eosinophils >0.9*1000 c/uL (n=296; 150)Lymphocytes <=0.75*1000 c/uL (n=296; 150)Alkaline phosphatase >3*prx & >ULN (n=302; 150)Alkaline phosphatase >1.5 ULN (n=302; 150)Aspartate aminotransferase >3* ULN (n=298; 148)Aspartate aminotransferase>5* ULN (n=298; 148)Aspartate aminotransferase >10*ULN (n=298; 148)Aspartate aminotransferase >20*ULN (n=298; 148)Alanine transaminase >3*ULN (n=300; 148)Alanine transaminase >5*ULN (n=300; 148)Alanine transaminase >10*ULN (n=300; 148)Alanine transaminase >20*ULN (n=300; 148)Bilirubin, total >2 mg/dL (n=301; 150)Bilirubin, total >1.5*ULN (n=301; 150)Bilirubin, total >2*ULN (n=301; 150)Blood urea nitrogen >2*prx & >ULN (n=302; 150)Creatinine >2.5 mg/dL (n=303; 150)Glucose, serum fasting <50 mg/dL (n=0; 0)Glucose, serum fasting >500 mg/dL (n=0; 0)Glucose, serum unspecified <50 mg/dL (n=0; 0)Glucose, serum unspecified >500 mg/dL (n=0; 0)Glucose, plasma fasting <50 mg/dL (n=301;150)Glucose, plasma fasting >500 mg/dL (n=301;150)Glucose, plasma unspecified <50 mg/dL (n=272; 133)Glucose, plasma unspecified >500 mg/d (n=272; 133)Sodium, serum <0.9*prx & <=130 mEq/L (n=302; 150)Sodium, serum >1.1*prx & >=150 mEq/L (n=302; 150)Potassium, serum <0.8 prx &<=3.2 mEq/L(n=300; 148)Potassium, serum >1.2*prx&>= 6.0 mEq/L(n=300; 148)Chloride, serum <90 mEq/L (n=302; 150)Chloride, serum >120 mEq/L (n=302; 150)Albumin <0.9*LLN; if prxCreatine kinase >5*ULN (n=301, 148)Uric acid >1.5*ULN; if prx >ULN, >2 (n=0,0)Protein urine (see criteria 1) (n=297,146)Blood urine (see criteria 1) (n=297; 146)Red blood cells urine (see criteria 1) (n=53; 31)White blood cells urine (see criteria 1)(n=115;53)
Placebo + Insulin020010721500003000010700000011100180002032310
Saxagliptin, 5 mg + Insulin22000193210210051000005000005051103810160814835

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Percentage of Participants With Reported and Confirmed Hypoglycemia

Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ (NCT00757588)
Timeframe: Baseline to Week 52

,
InterventionPercentage of Participants (Number)
ReportedConfirmed
Placebo + Insulin24.56.6
Saxagliptin, 5 mg + Insulin19.47.6

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Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)

Absolute lymphocyte count=value*10^3 c/uL (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

,
InterventionParticipants (Number)
Baseline <= 0.75; Week 24 <= 0.75Baseline <= 0.75; Week 24 >0.75- <= 5.00Baseline <= 0.75; Week 24 >5.00Baseline >0.75- <= 5.00; Week 24 <= 0.75Baseline >0.75- <= 5.00; Week 24 >0.75- <= 5.00Baseline >0.75- <= 5.00; Week 24 >5.00Baseline >5.00; Week 24 <= 0.75Baseline >5.00; Week 24 >0.75- <= 5.00Baseline >5.00; Week 24 >5.00Baseline <= 0.75; Week 52 <= 0.75Baseline <= 0.75; Week 52 >0.75- <= 5.00Baseline <= 0.75; Week 52 >5.00Baseline >0.75- <= 5.00; Week 52 <= 0.75Baseline >0.75- <= 5.00; Week 52 >0.75- <= 5.00Baseline >0.75- <= 5.00; Week 52 >5.00Baseline >5.00; Week 52 <= 0.75Baseline >5.00; Week 52 >0.75- <= 5.00Baseline >5.00; Week 52 >5.00
Placebo + Insulin0200148000002001471000
Saxagliptin, 5 mg + Insulin0001293100100002950001

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Shift in Platelet Counts From Baseline to Selected Visits (LOCF)

Platelet count=value*10^9 c/L (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

,
InterventionParticipants (Number)
Baseline <= 100; Week 24 <= 100Baseline <= 100; Week 24 >100 - <= 600Baseline <= 100; Week 24 >600Baseline >100 - <= 600; Week 24 <= 100Baseline >100 - <= 600; Week 24 >100 - <= 600Baseline >100 - <= 600; Week 24 >600Baseline >600; Week 24 <= 100Baseline >600; Week 24 >100 - <= 600Baseline >600; Week 24 >600Baseline <= 100; Week 52 <= 100Baseline <= 100; Week 52 >100 - <= 600Baseline <= 100; Week 52 >600Baseline >100 - <= 600; Week 52 <= 100Baseline >100 - <= 600; Week 52 >100 - <= 600Baseline >100 - <= 600; Week 52 >600Baseline >600; Week 52 <= 100Baseline >600; Week 52 >100 - <= 600Baseline >600; Week 52 >600
Placebo + Insulin0001143000001001440000
Saxagliptin, 5 mg + Insulin0001296000000022950000

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Change From Baseline in 120-minute PPG Values During an MTT

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. (NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Saxagliptin, 5 mg + Insulin-27.2
Placebo + Insulin-4.2

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Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])

Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use (NCT00757588)
Timeframe: Baseline to Week 24

InterventionPercentage of change (Mean)
Saxagliptin, 5 mg + Insulin-0.73
Placebo + Insulin-0.32

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Time to Maximum Serum Insulin Concentration (Tmax)

Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose. (NCT00774800)
Timeframe: Predose up to 480 minutes postdose

Interventionminutes (Mean)
Humalog + rHuPH2030.24
Humalog Alone48.57
Humulin-R + rHuPH2057.06
Humulin-R Alone116.76

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Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)

"AUC was derived as the area under the serum insulin concentration profile from 0 to time t. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose." (NCT00774800)
Timeframe: Predose up to 60 minutes postdose

Interventionnanomole*minute per liter (nmol*min/L) (Mean)
Humalog + rHuPH2012346.67
Humalog Alone8297.62
Humulin-R + rHuPH2011607.65
Humulin-R Alone4331.76

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Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG])

AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 140 milligrams per deciliter (mg/dL) within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before; at 3, 6, 9, 12, 15, 20, 25 minutes; and every 10 minutes from minute 30 to 240 postdose. (NCT00774800)
Timeframe: Predose up to 4 hours after injection of study drug

Interventionminutes*milligrams per deciliter (Geometric Mean)
Humalog + rHuPH20111
Humalog Alone526
Humulin-R + rHuPH20181
Humulin-R Alone1,238

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Maximum Serum Insulin Concentration (Cmax)

Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose. (NCT00774800)
Timeframe: Predose up to 480 minutes postdose

InterventionPicomoles per liter (pmol/L) (Mean)
Humalog + rHuPH20307.67
Humalog Alone226.38
Humulin-R + rHuPH20285.88
Humulin-R Alone165.05

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Time to Achieve Glycemic Control

(NCT00779701)
Timeframe: Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.

InterventionMinutes (Mean)
Insulin Infusion225

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Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU

Requirements for blood transfusion counted as a binary variable yes/no per participant (NCT00780026)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Strict Glycemic Control0
Standard of Care Control0

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Number of Participants With Biliary Complications

Number of participants who experienced bile leak or biliary Stricture (NCT00780026)
Timeframe: 12 months

,
InterventionParticipants (Count of Participants)
bile leakBiliary Stricture
Standard of Care Control1520
Strict Glycemic Control1413

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Infection Rates

Number of participants who sustained an infection after surgery (NCT00780026)
Timeframe: 30 days

,
InterventionParticipants (Count of Participants)
Bacterial InfectionFungal InfectionTransplant Incision woundViral
Standard of Care Control26776
Strict Glycemic Control271194

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Hospital Length of Stay

(NCT00780026)
Timeframe: 12 months

Interventiondays (Median)
Strict Glycemic Control12.5
Standard of Care Control11

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Number of Participants With One Year Survival Post Transplant

(NCT00780026)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Strict Glycemic Control44
Standard of Care Control44

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Number of Participants With Venous Thrombotic Complications

Number of participants who were diagnosed with portal vein thrombosis post surgery (NCT00780026)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Strict Glycemic Control3
Standard of Care Control3

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Number of Participants With a Need for Hemodialysis

Number of people who had renal failure in the year following liver transplant and needing hemodialysis to support it; (NCT00780026)
Timeframe: 12 months post surgery

InterventionParticipants (Count of Participants)
Strict Glycemic Control6
Standard of Care Control9

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Absolute Change in High Density Lipoprotein (HDL) Cholesterol

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-0.95
Insulin NPH2.87

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Absolute Change in Neutrophils

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir-0.29
Insulin NPH0.01

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Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)

(NCT00795600)
Timeframe: Week 0, week 26

Interventionng/L (Least Squares Mean)
Insulin Detemir-10.77
Insulin NPH-12.50

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Absolute Change in Potassium

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Detemir-0.20
Insulin NPH0.21

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Absolute Change in Alkaline Phosphatase

(NCT00795600)
Timeframe: Week 0, week 26

InterventionIU/L (Mean)
Insulin Detemir-7.10
Insulin NPH-12.55

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Absolute Change in Albumin

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-0.02
Insulin NPH0.01

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Absolute Change in Alanine Aminotransferase (ALAT)

(NCT00795600)
Timeframe: Week 0, week 26

InterventionIU/L (Mean)
Insulin Detemir-3.59
Insulin NPH-4.55

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Absolute Change in Adiponectin

Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionmcg/dL (Least Squares Mean)
Insulin Detemir0.926
Insulin NPH2.844

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Absolute Change in Subcutaneous Adipose Tissue Area

Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventioncm^2 (Least Squares Mean)
Insulin Detemir7.654
Insulin NPH12.616

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Absolute Change in Liver/Spleen Attenuation Ratio

Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionratio (Least Squares Mean)
Insulin Detemir-0.044
Insulin NPH-0.023

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Absolute Change in Sodium

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Detemir1.12
Insulin NPH0.69

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Percentage Change in Trunk Lean Mass

Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir1.480
Insulin NPH2.090

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Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir1.05
Insulin NPH1.54

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Absolute Change in Aspartate Aminotransferase (ASAT)

(NCT00795600)
Timeframe: Week 0, week 26

InterventionIU/L (Mean)
Insulin Detemir0.23
Insulin NPH-0.48

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Percentual Change in Calculated Whole Body Fat Percentage

Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir1.607
Insulin NPH1.491

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Percentual Change in Calculated Trunk Fat Percentage

Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir-1.543
Insulin NPH0.042

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Percentage Change in Whole Body Lean Mass

Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir0.051
Insulin NPH2.798

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Percentage Change in Whole Body Fat Mass

Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir3.870
Insulin NPH4.047

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Percentage Change in Visceral Adipose Tissue Area

Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir-0.535
Insulin NPH4.526

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Absolute Change in Basophils

(NCT00795600)
Timeframe: Week 0, week 26

Intervention10^9 cells/L (Mean)
Insulin Detemir0.00
Insulin NPH-0.01

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Absolute Change in Bilirubin Total

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-0.07
Insulin NPH-0.07

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Absolute Change in Blood Volume (Haematocrit)

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir-1.17
Insulin NPH-1.06

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Absolute Change in Body Weight

Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable. (NCT00795600)
Timeframe: Week 0, week 26

Interventionkg (Least Squares Mean)
Insulin Detemir1.663
Insulin NPH2.293

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Absolute Change in Trunk Fat Mass

Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate. (NCT00795600)
Timeframe: week 0, week 26

Interventiongrams (g) (Least Squares Mean)
Insulin Detemir133.99
Insulin NPH-62.37
Insulin Detemir153.38
Insulin NPH39.43

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Absolute Change in Trunk Lean Mass

Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventiongrams (g) (Least Squares Mean)
Insulin Detemir359.43
Insulin NPH469.84

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Absolute Change in Urea

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir2.45
Insulin NPH0.50

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Absolute Change in Visceral Adipose Tissue Area

Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventioncm^2 (Least Squares Mean)
Insulin Detemir-3.258
Insulin NPH5.658

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Absolute Change in Waist Circumference

Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventioncm (Least Squares Mean)
Insulin Detemir0.064
Insulin NPH0.609

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Absolute Change in Whole Body Fat Mass

Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventiongrams (g) (Least Squares Mean)
Insulin Detemir1147.1
Insulin NPH858.88

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Absolute Change in Calculated Trunk Fat Percentage

Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent of trunk fat (%) (Least Squares Mean)
Insulin Detemir-0.600
Insulin NPH-0.321

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Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio

Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionratio (Least Squares Mean)
Insulin Detemir-0.032
Insulin NPH-0.036

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Absolute Change in HbA1c (Glycosylated Haemoglobin)

Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Least Squares Mean)
Insulin Detemir-0.922
Insulin NPH-0.792

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Absolute Change in Calculated Whole Body Fat Percentage

Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent of whole body fat (%) (Least Squares Mean)
Insulin Detemir0.782
Insulin NPH0.291

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Absolute Change in Creatine Phosphokinase

(NCT00795600)
Timeframe: Week 0, week 26

InterventionIU/L (Mean)
Insulin Detemir-19.86
Insulin NPH21.56

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Absolute Change in Creatinine

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir0.03
Insulin NPH-0.00

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Absolute Change in Eosinophils

(NCT00795600)
Timeframe: Week 0, week 26

Intervention10^9 cells/L (Mean)
Insulin Detemir0.01
Insulin NPH0.01

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Absolute Change in Erythrocytes

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir4.64
Insulin NPH4.38

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Absolute Change in Fasting Plasma Glucose (FPG)

Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Least Squares Mean)
Insulin Detemir-48.29
Insulin NPH-37.36

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Absolute Change in Free Fatty Acids

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-0.03
Insulin NPH-0.05

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Absolute Change in Haemoglobin

(NCT00795600)
Timeframe: Week 0, week 26

Interventiong/dL (Mean)
Insulin Detemir-0.38
Insulin NPH-0.35

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Absolute Change in Whole Body Lean Mass

Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventiongrams (g) (Least Squares Mean)
Insulin Detemir-54.20
Insulin NPH1097.2

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Number of Hypoglycaemic Episodes

Number of episodes reported during the trial. (NCT00795600)
Timeframe: Weeks 0-26

Interventionepisodes (Number)
Insulin Detemir17
Insulin NPH32

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Number of Non-serious Adverse Events

Number of episodes reported during the trial. (NCT00795600)
Timeframe: Weeks 0-26

Interventionevents (Number)
Insulin Detemir64
Insulin NPH103

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Absolute Change in Monocytes

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir0.10

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Absolute Change in Lymphocytes

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir-0.10

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Absolute Change in Low Density Lipoprotein (LDL) Cholesterol

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir2.39
Insulin NPH6.14

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Absolute Change in Leucocytes

(NCT00795600)
Timeframe: Week 0, week 26

Intervention10^9 cells/L (Mean)
Insulin Detemir-0.01
Insulin NPH-0.07

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Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)

Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/L (Least Squares Mean)
Insulin Detemir1.200
Insulin NPH-0.862

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Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio

Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir-4.092
Insulin NPH-3.303

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Percentage Change in Liver/Spleen Attenuation Ratio

Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir-2.632
Insulin NPH-0.855

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Percentage Change in Subcutaneous Adipose Tissue Area

Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir1.153
Insulin NPH5.743

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Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)

Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor. (NCT00795600)
Timeframe: week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir0.366
Insulin NPH1.011
Insulin Detemir0.535
Insulin NPH1.126

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Absolute Change in Hip Circumference

Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventioncm (Least Squares Mean)
Insulin Detemir0.577
Insulin NPH0.112

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Absolute Change in Triglycerides

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-14.71
Insulin NPH-20.97

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Absolute Change in Total Cholesterol

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-8.96
Insulin NPH7.77

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Absolute Change in Thrombocytes

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir0.10

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Percent of Time Venous Blood Glucose <70 mg/dl

(NCT00797823)
Timeframe: 1 year

Interventionpercent of time (Mean)
Placebo Comparator: Insulin Alone2.8
Active Comparator: Insulin Plus Glucagon1.15

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Effectiveness of Closed Loop Diabetes Control

Effectiveness of closed loop diabetes control will be measured by mean glucose. (NCT00797823)
Timeframe: 1 year

Interventionmg/dl (Mean)
Placebo Comparator: Insulin Alone136.9
Active Comparator: Insulin Plus Glucagon149.5

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Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS

The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC (0-4 hours) after each meal at 6 weeks and change in IAUC (0-4 hours) from baseline (week 0) after each meal were to be assessed. The arithmetic mean of day 1 and day 2 for each meal-specific incremental area (breakfast, lunch, dinner) was calculated. (NCT00807092)
Timeframe: Week 0, Week 6

,
Interventionmmol/L (Least Squares Mean)
Breakfast, N=68, 64Lunch, N=69, 66Dinner, N=69, 65
BHI 30-4.2721.969-4.026
BIAsp 30-3.0941.651-4.775

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Change in Prandial Blood Glucose Increment

Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6 respectively. Prandial increment was the difference between the blood glucose (BG) value measured 120 minutes after meal and the BG value measured before meal. (NCT00807092)
Timeframe: Week 0, Week 6

,
Interventionmmol/L (Least Squares Mean)
Breakfast, N=69, 68Lunch, N=70, 68Dinner, N=69, 69Average, N=70, 68
BHI 30-2.821.27-1.85-1.1
BIAsp 30-1.821.32-1.91-0.81

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Duration of Hypoglycaemic Events Based on CGMS

The CGMS device recorded blood glucose levels every 10 seconds then stored a smoothed average over 5 minutes. The range of blood glucose detection was 2.2-22 mmol/l. Hypoglycaemia was defined as blood glucose readings below 3.5 mmol/l or below 2.5 mmol/l, respectively. The duration of the hypoglycaemic episodes was quantified by accumulating the total time the CGMS profiles stays below the defined threshold (i.e. below 3.5 mmol/l or below 2.5 mmol/l, respectively). (NCT00807092)
Timeframe: 72-hour monitoring period at Week 0 and Week 6

,
InterventionHours (Least Squares Mean)
Blood glucose < 3.5 mmol/L, N=70, 68Blood glucose < 2.5 mmol/L, N=70, 68
BHI 300.3580.06
BIAsp 300.3040.048

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Hypoglycaemia Based on Self-reported Episodes

Total number of hypoglycaemic episodes occurring in the trial after baseline (week 0) until the end of treatment (week 6). Hypoglycaemic episodes are classified as major, minor or symptoms only: Major if the subject was unable to treat her/himself; minor if subject was able to treat her/himself and self monitored blood glucose (SMBG) was below 2.8 mmol/L; symptoms only if subject was able to treat her/himself and with no blood glucose measurement or SMBG higher than or equal to 2.8 mmol/L. (NCT00807092)
Timeframe: Weeks 0-6

,
Interventionepisodes (Number)
AllMajorMinorSymptoms only
BHI 305531042
BIAsp 30633951

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Change in GA (Glycated Albumin)

Glycated Albumin is used as a general glycaemic control parameter. Analysed by laboratory. GA was measured at baseline (week 0) and end of treatment (week 6). Change in GA at end of treatment (week 6) from baseline (week 0) was assessed. (NCT00807092)
Timeframe: Week -2, week 6

Interventionpercentage point change (Least Squares Mean)
BIAsp 30-6.147
BHI 30-6.474

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Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals

The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period (NCT00807092)
Timeframe: Week 0, week 6

Interventionmmol/L (Least Squares Mean)
BIAsp 30-1.99
BHI 30-1.977

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Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles

Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6. Change in blood glucose level at end of treatment (week 6) from baseline (week 0) at each time point was to be assessed respectively. Blood glucose levels were measured at the following 8 time points: Before each meal (breakfast, lunch and dinner), 120 minutes after the start of each meal, at bedtime and at 3 am in the morning. (NCT00807092)
Timeframe: Week 0, Week 6

,
Interventionmmol/L (Least Squares Mean)
Before Breakfast, N=71, 682 hours after Breakfast, N=69, 69Before Lunch, N=71, 682 hours after Lunch, N=70, 69Before dinner, N=70, 692 hours after Dinner, N=70, 69Bedtime, N=71, 683AM, N=68, 66Average, N=71, 69
BHI 30-2.38-5.22-3.73-2.41-2.32-4.1-4.03-3.39-3.43
BIAsp 30-2.27-3.99-3.46-2.24-2.59-4.57-3.84-2.62-3.16

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Mean FBG (Fasting Blood Glucose) Assessed by CGMS

The blood glucose profiles were monitored by CGMS for 72 hours at end of treatment (week 6). Mean FBG assessed by CGMS at 6 weeks. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period. (NCT00807092)
Timeframe: Week 6

Interventionmmol/L (Least Squares Mean)
BIAsp 306.861
BHI 306.414

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Change in Mean FBG Assessed by CGMS

The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and at end of treatment (week 6). Change in mean FBG from baseline (week 0) was assessed. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period. (NCT00807092)
Timeframe: Week 0, week 6

Interventionmmol/L (Least Squares Mean)
BIAsp 30-2.114
BHI 30-2.561

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Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS

MAGE is a parameter to monitor the intraday blood glucose excursions. It was calculated using CGMS data and as the arithmetic mean of glycaemic excursion with the criterion that both segments (ascending and descending parts) of the glycaemic excursion exceed of the value of one standard deviation of respective 24-hour blood glucose value. The direction of calculation (peak-to-nadir or nadir-to-peak) was established by the direction of the first excursion. The arithmetic mean of the glycaemic excursion of day 1 and day 2 was the value of MAGE for each CGMS (NCT00807092)
Timeframe: Week 0, Week 6

Interventionmmol/L (Least Squares Mean)
BIAsp 30-0.499
BHI 30-0.686

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Change in Glycosylated Haemoglobin (HbA1c)

(NCT00807092)
Timeframe: Week -2, week 6

Interventionpercentage point change (Least Squares Mean)
BIAsp 30-1.647
BHI 30-1.667

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Change in FPG (Fasting Plasma Glucose)

FPG was analysed by local laboratories at baseline (week 0) and end of treatment (week 6). Change in FPG at end of treatment (week 6) from baseline (week 0) was to be assessed. (NCT00807092)
Timeframe: Week 0, Week 6

Interventionmmol/L (Least Squares Mean)
BIAsp 30-2.961
BHI 30-3.456

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Hospital Readmission

All-cause hospital readmission at 30 days after discharge (NCT00812253)
Timeframe: 30 days

,
Interventionparticipants (Number)
ReadmittedNot readmitted
Intravenous (IV) Insulin719
Subcutaneous (SQ) Insulin1524

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Hospital Length of Stay

Duration of hospitalization in days (NCT00812253)
Timeframe: Days

Interventiondays (Median)
Intravenous (IV) Insulin7
Subcutaneous (SQ) Insulin8

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Heart Rate Variability

High frequency (HF) Heart rate variability (HRV). HRV was assessed with a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration and impedance cardiography was performed using a standard tetrapolar arrangement. Measures were performed at baseline and each morning (0800-1000 hour) during and following the intervention for 7 minutes each. Software (Mindware, Gahanna, OH) was used to derive HF HRV. The middle five minutes of the recordings were scored minute by minute and the first suitable1 minute period was used for calculation. Five minute epochs were not feasible due to an unexpectedly high frequency of ectopy. One minute intervals allow calculation of HF (parasympathetic tone) but not low frequency (combination of sympathetic and parasympathetic tone). (NCT00812253)
Timeframe: 72 hours

Interventionms^2 (Median)
Intravenous (IV) Insulin5.1
Subcutaneous (SQ) Insulin20.7

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Brain Natriuretic Peptide (BNP)

Brain natriuretic peptide (BNP) was measured at day 3 (NCT00812253)
Timeframe: 72 hours

Interventionpg/ml (Median)
Intravenous (IV) Insulin794
Subcutaneous (SQ) Insulin356

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Change in Quality of Life

Change in Quality of Life questionnaire measured from baseline (enrollment) to 30 days following discharge. The questionnaire is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on health related quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), (NCT00812253)
Timeframe: 30 day

Interventionunits on a scale (Mean)
Intravenous (IV) Insulin-22.4
Subcutaneous (SQ) Insulin-22.6

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Cardiac Output

Cardiac output measured using impedance cardiography at 72 hours. (NCT00812253)
Timeframe: 72 hours

Interventionliter/min (Mean)
Intravenous (IV) Insulin10.3
Subcutaneous (SQ) Insulin8.6

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Quality of Life

Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105). (NCT00812487)
Timeframe: 30 days

Interventionunits on a scale (Median)
Intravenous Insulin50.5
Subcutaneous Insulin45

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Coefficient of Variation (CV)

CV is a measure of glycemic variability (NCT00812487)
Timeframe: 24 hours

Interventionpercentage (mean glucose/SD) (Mean)
Intravenous Insulin24.5
Subcutaneous Insulin18.6

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Brain Natriuretic Peptide (BNP)

Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits (NCT00812487)
Timeframe: 72 hours

Interventionpg/ml (Median)
Intravenous Insulin360
Subcutaneous Insulin299

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Glycemic Lability Index (GLI)

GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements (NCT00812487)
Timeframe: 24 hours

Intervention(mg/dl)^2/hr*day-1 (Median)
Intravenous Insulin0.83
Subcutaneous Insulin0.66

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High Frequency Heart Rate Variability

High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis. (NCT00812487)
Timeframe: 24 hours

Interventionms^2 (Median)
Intravenous Insulin15.5
Subcutaneous Insulin13.9

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High Sensitivity C-reactive Protein (Hs-CRP)

High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany). (NCT00812487)
Timeframe: 72 hours

Interventionmg/dl (Median)
Intravenous Insulin10.5
Subcutaneous Insulin15.9

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Hospital Length of Stay

Duration of hospitalization (NCT00812487)
Timeframe: participants were followed for the duration of hospital stay, median hospital stay 8 day

Interventiondays (Median)
Intravenous Insulin7
Subcutaneous Insulin8

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Hospital Readmission

All-cause hospital readmission within 30 days (NCT00812487)
Timeframe: 30 days

Interventionparticipants (Number)
Intravenous Insulin7
Subcutaneous Insulin15

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Mean Glucose

mean sensor glucose (NCT00812487)
Timeframe: 24 hours

Interventionmg/dl (Mean)
Intravenous Insulin139
Subcutaneous Insulin169

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Pre-ejection Period (PEP)

Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone. (NCT00812487)
Timeframe: 24 hours

Interventionms (Mean)
Intravenous Insulin120
Subcutaneous Insulin117

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For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase.

Hemoglobin A1c (NCT00821795)
Timeframe: 16 weeks

Intervention% hemoglobin A1c (Mean)
NPH/Regular 70/30 Mix8.32
Aspart Insulin Analog Biphasic Mix8.35

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Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)

Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy. (NCT00824616)
Timeframe: From first dose of study drug (Week 0) to last dose of study drug (Week 20)

Interventionparticipants (Number)
Placebo6
MK-09418

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Change From Baseline in Hemoglobin A1c (HbA1c) Level

HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels. (NCT00824616)
Timeframe: Baseline (Day 1) and End of Treatment (Week 20)

Intervention% HbA1c (Least Squares Mean)
Placebo-0.15
MK-0941-0.26

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Number of Babies With Adverse Neonatal Outcomes

Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy. (NCT00835861)
Timeframe: Delivery until hospital discharge

Interventionnumber of babies (Number)
Metformin4
Insulin7

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Maternal Weight Gain

(NCT00835861)
Timeframe: Baseline throughout pregnancy until last prenatal visit.

Interventionkg/week (Median)
Metformin0.28
Insulin0.30

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Number of Patients With Obstetric Complications

Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion. (NCT00835861)
Timeframe: Throughout pregnancy until hospital discharge following delivery.

Interventionparticipants (Number)
Metformin0
Insulin0

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Blood Glucose Measurements

Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner. (NCT00835861)
Timeframe: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery

,
Interventionmg/dL (Median)
Fasting throughout enrollmentFasting 18-20 weeksFasting 28-30 weeksFasting 36-38 weeksPostprandial throughout enrollmentPostprandial 18-20 weeksPostprandial 28-30 weeksPostprandial 36-38 weeks
Insulin95.0492.3890.6485.18128.62120.46126.45125.25
Metformin97.3897.0092.4389.49120.40118.40119.00122.59

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Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)

NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130 (NCT00835861)
Timeframe: Baseline throughout pregnancy until time of delivery

,
Interventionpercent of glucose values (Number)
Throughout enrollment; n=4195, 379618-20 weeks; n=368, 42828-30 weeks; n=652, 55936-38 weeks; n=272,228
Insulin61675865
Metformin69727166

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Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)

NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95 (NCT00835861)
Timeframe: Baseline throughout pregnancy until time of delivery

,
Interventionpercent of glucose values (Number)
Throughout enrollment; n=1634, 143218-20 weeks; n=148, 25928-30 weeks; n=253, 20136-38 weeks; n=115, 83
Insulin58646296
Metformin48426476

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Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester

(NCT00835861)
Timeframe: 1st, 2nd, and 3rd trimester

,
Interventionpercentage of glycosolated hemoglobin (Median)
1st trimester2nd trimester3rd trimester
Insulin6.25.55.6
Metformin5.85.65.9

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Number of Episodes Maternal Hypoglycemia

Maternal glucose < 60 mg/dL (NCT00835861)
Timeframe: Baseline throughout pregnancy until time of delivery

InterventionNumber of episodes (Number)
Metformin1
Insulin7

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Number of Babies With Neonatal Hypoglycemia

Initial neonatal glucose < 40 mg/dL (NCT00835861)
Timeframe: Time of delivery through hospital discharge

InterventionNumber of babies (Number)
Metformin2
Insulin0

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Onset Time (Tmax)

Average time to peak insulin concentration (NCT00837512)
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours

InterventionMinutes (Mean)
Microneedle30
Subcutaneous Insulin Catheter52

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Change in Body Weight

Observed change from baseline in body weight after 6 weeks of treatment (NCT00841087)
Timeframe: Week 0, Week 6

Interventionkg (Mean)
SIBA0.22
Insulin Detemir-0.20

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Diastolic Blood Pressure (BP)

Mean values at baseline (Week 0) and at Week 6 (NCT00841087)
Timeframe: Week 0, Week 6

,
InterventionmmHg (Mean)
Week 0 (Baseline)Week 6
Insulin Detemir73.873.0
SIBA73.974.7

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Number of Treatment Emergent Adverse Events (AEs)

Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00841087)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
Interventionevents (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEs
Insulin Detemir1500213
SIBA1300013

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Rate of Major and Minor Hypoglycaemic Episodes

Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. (NCT00841087)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
InterventionEpisodes /year of patient exposure (Number)
MajorMinor
Insulin Detemir080.84
SIBA062.97

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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00-05:59 (both inclusive). (NCT00841087)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
InterventionEpisodes /year of patient exposure (Number)
MajorMinor
Insulin Detemir015.83
SIBA04.97

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Systolic Blood Pressure (BP)

Mean values at baseline (Week 0) and at Week 6 (NCT00841087)
Timeframe: Week 0, Week 6

,
InterventionmmHg (Mean)
Week 0 (Baseline)Week 6
Insulin Detemir125.3120.2
SIBA125.0125.5

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Electrocardiogram (ECG)

The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. (NCT00841087)
Timeframe: Week 0, Week 6

Interventionparticipants (Number)
SIBA0
Insulin Detemir0

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Number of Treatment Emergent Adverse Events (AEs)

Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00842361)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
Interventionevents (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEs
Mix3080008
SIAC1310112

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Electrocardiogram (ECG) Worsening

The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. (NCT00842361)
Timeframe: Week 0, Week 6

Interventionparticipants (Number)
SIAC2
Mix300

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Rate of Major and Minor Hypoglycaemic Episodes

Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. (NCT00842361)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
InterventionEpisodes /year of patient exposure (Number)
MajorMinor
Mix30021.83
SIAC013.63

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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive). (NCT00842361)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
InterventionEpisodes /year of patient exposure (Number)
MajorMinor
Mix3002.03
SIAC00.99

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Systolic BP (Blood Pressure)

Values at baseline (Week 0) and at Week 6 (NCT00842361)
Timeframe: Week 0, Week 6.

,
InterventionmmHg (Mean)
Week 0 (Baseline)Week 6
Mix30130.8130.9
SIAC137.5137.0

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Change in Body Weight

Change from baseline in body weight after 6 weeks of treatment (NCT00842361)
Timeframe: Week 0, Week 6

Interventionkg (Mean)
SIAC0.09
Mix30-0.10

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Diastolic BP (Blood Pressure)

Values at baseline (Week 0) and at Week 6 (NCT00842361)
Timeframe: Week 0, Week 6

,
InterventionmmHg (Mean)
Week 0 (Baseline)Week 6
Mix3075.476.7
SIAC77.376.8

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Continuous Glucose Monitoring (CGM)

Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6. (NCT00850096)
Timeframe: Baseline and 5-6 weeks

InterventionPercentage of day (24h) in euglycemia (Mean)
Placebo for Nasulin-6.23
Nasulin-0.72

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Overall Glycemic Control

Continuous glucose monitoring (CGM) data from patients at the last weeks of study (week 5-6) were averaged for assessment of glycemic control under the treatment of either Nasulin or placebo. (NCT00850096)
Timeframe: 5-6 weeks

Interventionmg/dl (Mean)
Placebo for Nasulin174.64
Nasulin163.34

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Glutathione Concentration

While at near normoglycemia (NCT00858273)
Timeframe: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

Interventionumol/L (Mean)
Antioxidant Supplement706
Placebo734

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Plasma Protein Bound 3-nitrotyrosine

Marker of oxidative stress (NCT00858273)
Timeframe: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

Interventionng/mL (Median)
Antioxidant Supplement4.26
Placebo7.13

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Glutathione Concentration

umol/L (NCT00858897)
Timeframe: Up to 30 minutes post- 5 hour infusion on Day 1 (First Intervention) and up to 30 minutes post- 5 hour infusion on Day 14 (Second Intervention)

Interventionumol/L (Mean)
Normoglycemia (80-140 mg/dL)541
Hyperglycemia (200-250 mg/dL)551

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Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])

Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. (NCT00862849)
Timeframe: predose up to 480 minutes postdose

,,
Interventionminutes (Mean)
early t(50%max)late t(50%max)
Insulin Lispro + rHuPH2014.1488.14
Insulin Lispro Alone24.73144.43
Regular Human Insulin + rHuPH2021.52136.67

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Percentage of Total Glucose Infused

Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and every 30 mins (from 90 to 240 mins) after each injection. Percentage of total glucose infused from 0 to 4 hours is summarized. (NCT00862849)
Timeframe: predose up to 240 minutes postdose

Interventionpercentage of total glucose infused (Mean)
Insulin Lispro + rHuPH2088.70
Regular Human Insulin + rHuPH2085.17
Insulin Lispro Alone79.81

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Peak Serum Insulin Concentration (Cmax)

Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. (NCT00862849)
Timeframe: predose up to 480 minutes postdose

Interventionpicomoles per liter (pmol/L) (Mean)
Insulin Lispro + rHuPH20782.85
Regular Human Insulin + rHuPH20561.93
Insulin Lispro Alone482.40

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Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T])

Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes. (NCT00862849)
Timeframe: predose up to 30 minutes postdose

Interventionpercentage of coefficient of variance (Mean)
Insulin Lispro + rHuPH2014.04
Regular Human Insulin + rHuPH2023.81
Insulin Lispro Alone40.51

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Time to Percentage of Total Glucose Infused

Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. Time to 25%, 50%, and 75% of total glucose infused are summarized. (NCT00862849)
Timeframe: predose up to 480 minutes postdose

,,
Interventionminutes (Mean)
25%50%75%
Insulin Lispro + rHuPH2072.38118.95179.23
Insulin Lispro Alone99.13156.83222.48
Regular Human Insulin + rHuPH2091.58142.55203.15

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Number of Participants With Hypoglycemic Events

The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT00883558)
Timeframe: Baseline through Week 29

,
Interventionparticipants (Number)
OverallSevere HE
Insulin Lispro430
INSULIN-PH20 NP452

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Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring

Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented. (NCT00883558)
Timeframe: Week 14 and Week 26

Interventionhours (Mean)
INSULIN-PH20 NP14.58
Insulin Lispro13.37

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Postprandial Glucose Excursion

A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented. (NCT00883558)
Timeframe: Week 14 and Week 26

Interventionmilligrams per deciliter (mg/dL) (Mean)
INSULIN-PH20 NP17.23
Insulin Lispro14.47

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Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment

(NCT00891995)
Timeframe: 0 to 240 min post meal at 1 year MMTT

Interventionpmol/ml (Geometric Mean)
Intensive Treatment0.53
Standard Treatment0.65

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CGM Mean Glucose

(NCT00891995)
Timeframe: 1 year

Interventionmg/dL (Median)
Intensive Treatment150
Standard Treatment152

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Daily Insulin Dose

(NCT00891995)
Timeframe: 1 year

Interventionu/day/kg (Mean)
Intensive Treatment0.6
Standard Treatment0.6

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HbA1c

(NCT00891995)
Timeframe: 1 year

Interventionpercent (Mean)
Intensive Treatment7.4
Standard Treatment7.3

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Adverse Events (Severe Hypoglycemia)

(NCT00891995)
Timeframe: 1 year

Interventionparticipants (Number)
Intensive Treatment1
Standard Treatment0

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Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT

Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported. (NCT00891995)
Timeframe: 0 to 240 min post meal at 1 year MMTT

Interventionparticipants (Number)
Intensive Treatment37
Standard Treatment16

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CGM Measured Glucose Outcomes

Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices. (NCT00891995)
Timeframe: 1 year

,
Interventionpercent (Median)
%Glucose 71-180 mg/dL%Glucose <=70 mg/dL%Glucose >180 mg/dL%Coefficient of variation
Intensive Treatment692.52735
Standard Treatment700.72235

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BMI Percentile

(NCT00891995)
Timeframe: 1 year

Interventionpercent (Median)
Intensive Treatment58
Standard Treatment62

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C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.

In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49). (NCT00891995)
Timeframe: At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal

Interventionpmol/ml (Geometric Mean)
Intensive Treatment0.43
Standard Treatment0.52

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Hypoglycaemic Episodes, Nocturnal

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
MajorMinorSymptoms only
IDet03976
IGlar03061

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Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%

The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less (NCT00909480)
Timeframe: Week 26

,
Interventionpercentage (%) of subjects (Number)
Metformin monotherapyMetformin+TZDMetformin+2nd OAD other than TZDAll
IDet2213511
IGlar30131721

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Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%

The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% (NCT00909480)
Timeframe: Week 26

,
Interventionpercentage of subjects (Number)
Metformin monotherapyMetformin+TZDMetformin+2nd OAD other than TZDAll
IDet55403138
IGlar70404753

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Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia

The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. (NCT00909480)
Timeframe: Week 26

,
Interventionpercentage (%) of subjects (Number)
Metformin monotherapyMetformin+TZDMetformin+2nd OAD other than TZDAll
IDet22739
IGlar21131315

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Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia

The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. (NCT00909480)
Timeframe: Week 26

,
Interventionpercentage (%) of subjects (Number)
Metformin monotherapyMetformin+TZDMetformin+2nd OAD other than TZDAll
IDet48332532
IGlar52333338

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Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast

The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. (NCT00909480)
Timeframe: Week 26

,
Interventionmmol/L (Median)
Metformin MonotherapyMetformin+TZDMetformin+2nd OAD other than TZDOverall
IDet0.480.720.60.57
IGlar0.670.840.710.71

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Fasting Plasma Glucose (FPG)

(NCT00909480)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDet6.22
IGlar6.09

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Incidence of Hypoglycaemic Episodes During the Trial

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
All EventsMajorMinorSymptoms only
IDet3290119210
IGlar4572156299

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Change in HbA1c From Baseline

(NCT00909480)
Timeframe: Week 0, Week 26

Interventionpercentage point change (Mean)
IDet-0.48
IGlar-0.74

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Change in Body Weight From Baseline

(NCT00909480)
Timeframe: Week 0, Week 26

Interventionkg (Mean)
IDet-0.49
IGlar1

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"Number of Subjects Having the Adverse Event Incorrect Dose Administered"

"Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications" (NCT00909480)
Timeframe: Weeks 0-26

InterventionSubjects (Number)
IDet12
IGlar24

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Hypoglycemic Episodes, Unclassifiable

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
MajorMinorSymptoms only
IDet056
IGlar0816

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Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)

Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am. (NCT00909480)
Timeframe: Week 26

,
Interventionmmol/L (Mean)
Before breakfast (N=200, N=197)2 hours after breakfast (N=192, N=188)Before Lunch (N=193, N=189)2 hours After Lunch (N=194, N=186)Before Dinner (N=194, N=186)2 hours after dinner (N=192, N=190)Bedtime (N=190, N=183)At 3AM (N=193, N=186)Before Breakfast Next Day (N=197, N=195)
IDet5.89.17.29.78.210.39.56.65.7
IGlar5.98.76.68.87.59.896.35.6

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Hypoglycaemic Episodes, Diurnal

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
MajorMinorSymptoms only
IDet075128
IGlar2118222

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Average Blood Glucose Over 6 Days

Participants have their blood glucose measured daily for six days. The average blood glucose measure over all six days is compared between the two treatment cohorts. (NCT00911625)
Timeframe: 6 Days

Interventionmilligrams per deciliter (Mean)
0.5 Units/kg174
0.25 Units/kg174.5

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Occurrence of Hypoglycemia;

(NCT00913497)
Timeframe: measured daily at 2 and 4 hours postprandial for 20 days

,
Interventionnumber of events (Number)
2 hour post prandial hypoglycemia4 hour post prandial hypoglycemia
Insulin Aspart926
Insulin Glulisine819

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Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days

Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating) (NCT00913497)
Timeframe: measured daily at baseline, 2 and 4 hours post prandial for 20 days

,
Interventionmg/dL (Mean)
Baseline blood sugar (prior to eating)2 hour postprandial Blood Glucose excursion (2h measurement minus baseline)4 hour postprandial blood glucose excursion (4h measurement minus baseline)
Insulin Aspart133.498.64.4
Insulin Glulisine136.4113.55.5

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Time to Percentage of Insulin Exposure (as Measured by Area Under the Curve [AUC])

Time to percentage of exposure to insulin, as measured by area under the curve (AUC), following a liquid meal for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. (NCT00916357)
Timeframe: Predose up to 480 minutes following after injection of study drug

,,
InterventionMinutes (min) (Mean)
Time to 10% Insulin ExposureTime to 50% Insulin Exposure
Humalog + rHuPH2030.4994.49
Humalog Alone46.05135.73
Humulin-R + rHuPH2043.41137.52

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Postprandial Glucose (PPG) Excursion Following a Liquid Meal

Postprandial glucose (PPG) values in participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal are reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least square mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

,,
InterventionMilligrams per deciliter (mg/dL) (Least Squares Mean)
60-minute PPG90-minute PPG120-minute PPGCBGMax(0-4hr)
Humalog + rHuPH20144.67143.62138.24165.38
Humalog Alone162.71166.05159.10177.81
Humulin-R + rHuPH20169.38166.71159.90181.62

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Area Under the Time-Concentration Curve for Blood Glucose (AUC[BG])

Area under the time-concentration curve for blood glucose (AUC[BG]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 following a liquid meal is reported. AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 160 milligrams per deciliter (mg/dL) or 140 mg/dL, or lower than 70 mg/dL within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

,,
InterventionMilligrams per deciliter * minutes (Least Squares Mean)
AUC(BG) >160 mg/dLAUC(BG) >140 mg/dLAUC(BG) <70 mg/dL
Humalog + rHuPH20722.822696.54197.00
Humalog Alone2017.464233.71571.20
Humulin-R + rHuPH202509.654905.92408.50

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Time To Maximum Serum Insulin Concentration (Tmax)

Time to maximum serum insulin concentration (Tmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

InterventionMinutes (min) (Mean)
Humalog Alone74.29
Humalog + rHuPH2043.10
Humulin-R + rHuPH2081.67

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Time to Late 50% Maximum Serum Insulin Concentration (Late[t50%])

Time to late 50% maximum serum insulin concentration (late[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

InterventionMinutes (min) (Mean)
Humalog Alone206.86
Humalog + rHuPH20123.93
Humulin-R + rHuPH20220.33

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Time to Early 50% Maximum Serum Insulin Concentration (Early[t50%])

Time to early 50% maximum serum insulin concentration (early[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, and 120 minutes after injection of each study drug. (NCT00916357)
Timeframe: Predose up to 120 minutes after study drug injection

InterventionMinutes (min) (Mean)
Humalog Alone27.02
Humalog + rHuPH2018.71
Humulin-R + rHuPH2021.46

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Minimum Postprandial Glucose (PPG)

Minimum postprandial glucose (PPG) in participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

InterventionMilligrams per deciliter (mg/dL) (Mean)
Humalog Alone76.38
Humalog + rHuPH2088.52
Humulin-R + rHuPH2075.62

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Area Under the Concentration Time-Curve for Serum Insulin From Time 0 to the End of Blood Sampling (AUC[Last])

Area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

InterventionMinutes * picomoles /1000 (min*pm/1000) (Least Squares Mean)
Humalog Alone578.67
Humalog + rHuPH20668.33
Humulin-R + rHuPH20571.42

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Maximum Serum Insulin Concentration (Cmax)

Maximum serum insulin concentration (Cmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

InterventionPicomoles per liter (pm/L) (Mean)
Humalog Alone3329.49
Humalog + rHuPH205661.92
Humulin-R + rHuPH203011.56

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Mean Residence Time From Time 0 to the End of Blood Sampling (MRT[Last])

Mean residence time from time 0 to the end of blood sampling (MRT[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

InterventionMinutes (min) (Mean)
Humalog Alone148.79
Humalog + rHuPH20108.23
Humulin-R + rHuPH20150.24

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Percentage of Participants Without Hypoglycemia

Percentage of participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 who did not experience hypoglycemia following a liquid meal is reported. Hypoglycemia was defined as any blood glucose values lower than 70 milligrams per deciliter (mg/dL) or symptoms of hypoglycemia responding to treatment with glucose. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. (NCT00916357)
Timeframe: Predose up to 480 minutes after study drug injection

InterventionPercentage of participants (Number)
Humalog Alone81.0
Humalog + rHuPH2071.4
Humulin-R + rHuPH2071.4

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Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)

Change in FSG (centralized measurement) from baseline to endpoint (Week 26) (NCT00935532)
Timeframe: Baseline, Week 26

Interventionmg/dL (Least Squares Mean)
Exenatide Once Weekly-46.09
Insulin Glargine-40.82

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Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline

Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline. (NCT00935532)
Timeframe: Baseline, Week 26

Interventionratio (Least Squares Mean)
Exenatide Once Weekly1.00
Insulin Glargine1.00

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Change in Blood Pressure From Baseline to Endpoint (Week 26)

Change in Blood Pressure from baseline to endpoint (Week 26) (NCT00935532)
Timeframe: Baseline, Week 26

,
InterventionmmHg (Mean)
Systolic Blood PressureDiastolic Blood Pressure
Exenatide Once Weekly-4.5-1.1
Insulin Glargine-2.6-2.5

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Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events

Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS. (NCT00935532)
Timeframe: Baseline to Week 26

Interventionevents per subject-year (Mean)
Exenatide Once Weekly0.01
Insulin Glargine0.16

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Change in Body Weight From Baseline to Endpoint (Week 26)

Change in Body Weight from baseline to endpoint (Week 26) (NCT00935532)
Timeframe: Baseline, Week 26

Interventionkg (Least Squares Mean)
Exenatide Once Weekly-1.67
Insulin Glargine0.34

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Change in Total Cholesterol From Baseline to Endpoint (Week 26)

Change in Total Cholesterol from baseline to endpoint (Week 26) (NCT00935532)
Timeframe: Baseline, Week 26

Interventionmg/dL (Least Squares Mean)
Exenatide Once Weekly-14.21
Insulin Glargine-6.32

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Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)

Change in HDL-C from baseline to endpoint (Week 26) (NCT00935532)
Timeframe: Baseline, Week 26

Interventionmg/dL (Least Squares Mean)
Exenatide Once Weekly-0.99
Insulin Glargine-0.71

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Percentage of Subjects Achieving HbA1c<=7%

Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline) (NCT00935532)
Timeframe: Baseline, Week 26

Interventionpercentage of subjects (Number)
Exenatide Once Weekly42.2
Insulin Glargine21.0

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Percentage of Subjects Achieving HbA1c<=6.5%

Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline) (NCT00935532)
Timeframe: Baseline, Week 26

Interventionpercentage of subjects (Number)
Exenatide Once Weekly20.6
Insulin Glargine4.2

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Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events

Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS. (NCT00935532)
Timeframe: Baseline to Week 26

Interventionevents per subject-year (Mean)
Exenatide Once Weekly0.00
Insulin Glargine0.00

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Change in HbA1c From Baseline to Endpoint (Week 26)

Change in HbA1c from baseline to endpoint (Week 26). (NCT00935532)
Timeframe: Baseline, Week 26

Interventionpercentage of total hemoglobin (Least Squares Mean)
Exenatide Once Weekly-1.11
Insulin Glargine-0.68

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Change in Total Cholesterol From Baseline to Week 30

Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, week 30

Interventionmmol/L (Least Squares Mean)
Exenatide (BET)-0.14
Insulin Lispro (BBT)-0.03

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Change in Low Density Lipoprotein (LDL) From Baseline to Week 30

Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Exenatide (BET)-0.12
Insulin Lispro (BBT)-0.03

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Major Hypoglycemia Rate Per Year

Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior. (NCT00960661)
Timeframe: 30 weeks

Interventionrate per year (Mean)
Exenatide (BET)0.0
Insulin Lispro (BBT)0.1

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Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30

Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline). (NCT00960661)
Timeframe: Baseline, 30 weeks

Interventionpercent of hemoglobin (Least Squares Mean)
Exenatide (BET)-1.13
Insulin Lispro (BBT)-1.10

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Change in High Density Lipoprotein (HDL) From Baseline to Week 30

Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, week 30

Interventionmmol/L (Least Squares Mean)
Exenatide (BET)-0.04
Insulin Lispro (BBT)0.03

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Change in Systolic Blood Pressure (SBP) From Baseline to Week 30

Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: Baseline, Week 30

InterventionmmHg (Least Squares Mean)
Exenatide (BET)-4.13
Insulin Lispro (BBT)0.37

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Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.

Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Exenatide (BET)-0.46
Insulin Lispro (BBT)0.18

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Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30

Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: baseline, Week 30

InterventionmmHg (Least Squares Mean)
Exenatide (BET)-0.64
Insulin Lispro (BBT)-0.14

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Change in Body Weight From Baseline to Week 30.

Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: baseline, week 30

Interventionkg (Least Squares Mean)
Exenatide (BET)-2.45
Insulin Lispro (BBT)2.11

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Daily Insulin Glargine Dose at Baseline and at Week 30

Daily Insulin Glargine Dose at baseline and at Week 30 (NCT00960661)
Timeframe: Baseline, week 30

,
InterventionIU/day (Mean)
BaselineWeek 30
Exenatide (BET)61.556.9
Insulin Lispro (BBT)61.151.5

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Percentage of Participants Achieving HbA1C < 7.0%

Percentage of participants achieving HbA1C < 7.0% (NCT00960661)
Timeframe: Week 30

InterventionPercentage of participants (Number)
Exenatide (BET)46.7
Insulin Lispro (BBT)42.6

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Percent of Participants Achieving HbA1c ≤ 6.5%.

Percent of participants achieving HbA1c ≤ 6.5%. (NCT00960661)
Timeframe: Week 30

Interventionpercentage of participants (Number)
Exenatide (BET)26.2
Insulin Lispro (BBT)25.5

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Minor Hypoglycemia Rate Per Year

Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) (NCT00960661)
Timeframe: 30 weeks

Interventionrate per year (Mean)
Exenatide (BET)2.1
Insulin Lispro (BBT)5.0

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment

Change from baseline in HbA1c after 78 weeks of treatment (NCT00972283)
Timeframe: Week 0, Week 78

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-0.95
IGlar OD-1.15

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Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT00972283)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD139
IGlar OD184

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Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78

Mean of the SMPG at 78 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am, before breakfast. (NCT00972283)
Timeframe: Week 78

Interventionmmol/L (Mean)
IDeg OD7.2
IGlar OD6.8

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00972283)
Timeframe: Week 0 to Week 78 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AESevere AEModerate AEMild AEFatal AE
IDeg OD41120241132741
IGlar OD40320201182661

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Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT00972283)
Timeframe: Week 0 to Week 78 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD134
IGlar OD176

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Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00972283)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD1109
IGlar OD1363

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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00972283)
Timeframe: Week 52

Interventionmmol/L (Mean)
IDeg OD7.3
IGlar OD6.9

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment (NCT00972283)
Timeframe: Week 0, Week 52

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-1.17
IGlar OD-1.29

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Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00972283)
Timeframe: Week 0 to Week 78 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD1039
IGlar OD1271

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Percent of Nighttime Glucose Levels >250 mg/dl

(NCT00974051)
Timeframe: 10:00pm to 6:00am

Interventionpercentage of overnght glucose values (Number)
Control Arm30.2
Terbutaline Arm63.5
20% Basal Reduction Arm41.7

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Blood Glucose Nadir

BG nadir overnight after intervention (NCT00974051)
Timeframe: overnight hours

Interventionmg/dl (Mean)
Control Arm128
Terbutaline Arm189
20% Basal Reduction Arm162

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Percent of Nighttime Glucose Levels <70

(NCT00974051)
Timeframe: 10:00pm to 6:00am

Interventionpercentage of nighttime glucose values (Number)
Control Arm1.7
Terbutaline Arm0
20% Basal Reduction Arm0.3

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Percent of Nighttime Glucose Levels <80

(NCT00974051)
Timeframe: 9:00pm to 6:00am

Interventionpercentage of overnight glucose levels (Number)
Control Arm6.6
Terbutaline Arm0
20% Basal Reduction Arm4.9

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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + region (NCT00976391)
Timeframe: Baseline and Week 26

InterventionMillimoles per liter (mmol/L) (Least Squares Mean)
Albiglutide 30 mg With Insulin Glargine-0.99
Preprandial Lispro Insulin With Insulin Glargine-0.71

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Change From Baseline in Body Weight at Week 26

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current oral antidiabetic therapy. (NCT00976391)
Timeframe: Baseline and Week 26

InterventionKilograms (Least Squares Mean)
Albiglutide 30 mg With Insulin Glargine-0.73
Preprandial Lispro Insulin With Insulin Glargine0.81

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Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. (NCT00976391)
Timeframe: Baseline and Week 26

InterventionPercentage of HbA1c in the blood (Least Squares Mean)
Albiglutide 30 mg With Insulin Glargine-0.82
Preprandial Lispro Insulin With Insulin Glargine-0.66

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Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26

The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7.0% at Week 26) were assessed. (NCT00976391)
Timeframe: Week 26

,
InterventionParticipants (Number)
HbA1c <6.5 %HbA1c <7.0 %
Albiglutide 30 mg With Insulin Glargine3183
Preprandial Lispro Insulin With Insulin Glargine2370

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Change From Baseline in HbA1c at Weeks 36, 48 and 52

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline is defined as the last available assessment on or prior to the first dose of study drug. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00976391)
Timeframe: Baseline and Weeks 36, 48 and 52

,
InterventionPercentage of HbA1c in the blood (Mean)
Week 36, n=173, 182Week 48, n=140, 153Week 52, n=121, 141
Albiglutide 30 mg With Insulin Glargine-1.04-0.97-1.01
Preprandial Lispro Insulin With Insulin Glargine-0.88-0.81-0.84

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Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00976391)
Timeframe: Baseline and Weeks 36, 48 and 52

,
InterventionMillimoles per liter (mmol/L) (Mean)
Week 36, n=171, 182Week 48, n=131, 151Week 52, n=121, 139
Albiglutide 30 mg With Insulin Glargine-1.41-1.13-1.36
Preprandial Lispro Insulin With Insulin Glargine-0.91-1.07-0.97

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Change From Baseline in Body Weight at Weeks 36, 48 and 52

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00976391)
Timeframe: Baseline and Weeks 36, 48 and 52

,
InterventionKilograms (Mean)
Week 36, n=172, 182Week 48, n=142, 153Week 52, n=122, 141
Albiglutide 30 mg With Insulin Glargine-0.42-0.60-0.70
Preprandial Lispro Insulin With Insulin Glargine1.311.561.44

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Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 4 and 9.0% and <0.5% decrease from Baseline between >=Week 8 and 8.5% and >=4 weeks since uptitration between >=Week 12 and 8.0% and >=4 weeks since uptitration; HbA1c >7.5% and >=4 weeks between >Week 26 and >=Week 48 since uptitration. Participants could have been rescued at any time after Week 4. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks. (NCT00976391)
Timeframe: From the start of study medication until the end of the treatment (up to Week 52)

InterventionWeeks (Median)
Albiglutide 30 mg With Insulin GlargineNA
Preprandial Lispro Insulin With Insulin GlargineNA

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Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L. (NCT00978627)
Timeframe: Week 0 to Week 53 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD3183
IDet3673

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Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00978627)
Timeframe: Week 0 to Week 53 + 7 days of follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse event (AE)Serious AESevere AEModerate AEMild AEFatal AE
IDegAsp OD4082433932820
IDet4421948833110

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment (NCT00978627)
Timeframe: Week 0, Week 53

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp OD-0.65
IDet-0.56

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Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

Change from baseline in FPG after 52 weeks of treatment. (NCT00978627)
Timeframe: Week 0, Week 53

Interventionmmol/L (Mean)
IDegAsp OD-1.83
IDet-2.40

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Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. (NCT00978627)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD371
IDet572

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Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00978627)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD3917
IDet4434

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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Overall mean of 9-point SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00978627)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDegAsp OD8.0
IDet8.4

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment (NCT00978627)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp OD-0.73
IDet-0.68

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Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. (NCT00978627)
Timeframe: Week 0 to Week 53 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD309
IDet541

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Number of Patients With Hypoglycemia Events (Blood Glucose Levels < 70 mg/dL) During Their Hospital Stay That Are Treated With Basal Plus, Basal-bolus and SSRI Treatments

Effective Glycemic control is also assessed by number of hypoglycemia events among the patients treated with Basal plus, basal-bolus and SSRI treatments. Hypoglycemia event is defined as blood glucose levels <70 mg/dL. Number of patients with hypoglycemia episodes that are treated with Basal plus, basal-bolus and SSRI treatment regimens during their hospital stay are examined and compared. (NCT00979628)
Timeframe: During hospital stay, up to 12 days

Interventionparticipants (Number)
Basal Bolus23
Basal Plus Regimen17
Sliding Scale Regular Insulin (SSRI)2

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Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments

The primary outcome is to determine the effective glycemic control among the subjects that received Basal Plus (glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus corrective doses of glulisine before meals and Sliding Scale Regular Insulin (SSRI). Glycemic control is measured by mean blood glucose(BG) levels in mg/dL after first day of treatment and are compared to mean BG levels at randomization among subjects treated with Basal Plus, Basal -bolus and SSRI treatments. The optimal glycemic control is achieved when BG levels are between 70 mg/dL -140 mg/dL. The BG levels levels below 70 mg/dL are regarded as hypoglycemic events. The BG levels levels above 140 mg/dl are considered elevated and Hyperglycemia defined as a fasting BG >126 mg/dl or random BG >200 mg/dl on two or more occasions). (NCT00979628)
Timeframe: Randomization and 24 hrs after treatment

,,
Interventionmg/dL (Mean)
RandomizationAfter first day of therapy
Basal Bolus200156
Basal Plus Regimen194163
Sliding Scale Regular Insulin (SSRI)187172

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Time to Maximum Glucose Infusion Rate (tGIR[Max])

Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. (NCT00979875)
Timeframe: Predose up to 480 minutes postdose

Interventionminutes (Mean)
Glulisine Alone141.93
Glulisine + rHuPH20113.36
Lispro Alone160.14
Lispro + rHuPH20103.57
Aspart Alone158.79
Aspart + rHuPH2096.93

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Time to Percentage of Total Insulin Exposure

Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. (NCT00979875)
Timeframe: Predose up to 480 minutes postdose

,,,,,
Interventionminutes (Mean)
Time to 10% of total insulin exposureTime to 50% of total insulin exposure
Aspart + rHuPH2026.9972.53
Aspart Alone48.42130.86
Glulisine + rHuPH2023.3978.64
Glulisine Alone39.59123.65
Lispro + rHuPH2026.3570.97
Lispro Alone46.56123.39

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Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])

Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. (NCT00979875)
Timeframe: Predose up to 480 minutes postdose

,,,,,
Interventionminutes (Mean)
early t(50%max)late t(50%max)
Aspart + rHuPH2017.98102.82
Aspart Alone31.93193.50
Glulisine + rHuPH2010.16118.92
Glulisine Alone21.06195.43
Lispro + rHuPH2018.9689.59
Lispro Alone30.69176.79

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Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)

Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection. (NCT00979875)
Timeframe: Predose up to 120 minutes postdose

,,,,,
Interventionpercentage of total AUC (Mean)
AUC0-15AUC0-30AUC0-60AUC0-120
Aspart + rHuPH202.9213.6641.5177.37
Aspart Alone0.563.5416.8547.97
Glulisine + rHuPH205.2915.8239.4571.70
Glulisine Alone2.027.0920.6850.35
Lispro + rHuPH202.3813.8142.8877.00
Lispro Alone0.683.8818.7250.14

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Time to Maximum Serum Insulin Concentration (Tmax)

Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. (NCT00979875)
Timeframe: Predose up to 480 minutes postdose

Interventionminutes (Mean)
Glulisine Alone80.36
Glulisine + rHuPH2041.43
Lispro Alone67.50
Lispro + rHuPH2041.07
Aspart Alone85.71
Aspart + rHuPH2043.57

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Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)

Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection. (NCT00979875)
Timeframe: Predose up to 60 minutes postdose

Interventionminutes*nanomolars (min*nM) (Mean)
Glulisine Alone11667.14
Glulisine + rHuPH2023807.14
Lispro Alone10687.14
Lispro + rHuPH2027850.00
Aspart Alone8065.00
Aspart + rHuPH2020778.57

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Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin

The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period. (NCT00982228)
Timeframe: Week 0, Week 106

Intervention%B/T (Mean)
IDeg OD11.3
IGlar OD11.0

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Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00982228)
Timeframe: Week 0 to Week 104 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AE)Serious AESevere AEModerate AEMild AEFatal AE
IDeg OD38314221052561
IGlar OD37417261062421

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Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT00982228)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD441
IGlar OD586

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Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00982228)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD4254
IGlar OD4018

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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00982228)
Timeframe: Week 52

Interventionmmol/L (Mean)
IDeg OD8.1
IGlar OD8.3

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment (NCT00982228)
Timeframe: Week 0, Week 52

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-0.40
IGlar OD-0.39

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Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment

Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00982228)
Timeframe: Treatment week 104

Interventionmmol/L (Mean)
IDeg OD8.0
IGlar OD8.1

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment

Change from baseline in HbA1c after 104 weeks of treatment (NCT00982228)
Timeframe: Week 0, Week 104

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-0.27
IGlar OD-0.24

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Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT00982228)
Timeframe: Week 0 to Week 104 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD390
IGlar OD532

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Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00982228)
Timeframe: Week 0 to Week 104 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD3750
IGlar OD3743

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Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT00982644)
Timeframe: Week 0 to Week 104 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD27
IGlar OD46

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment

Change from baseline in HbA1c after 104 weeks of treatment (NCT00982644)
Timeframe: Week 0, Week 104

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-0.95
IGlar OD-1.11

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Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104

Mean of 9-point SMPG at 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00982644)
Timeframe: Week 104

Interventionmmol/L (Mean)
IDeg OD7.6
IGlar OD7.6

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment (NCT00982644)
Timeframe: Week 0, Week 52

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-1.06
IGlar OD-1.19

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Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00982644)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD152
IGlar OD185

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Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT00982644)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD25
IGlar OD39

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Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00982644)
Timeframe: Week 0 to Week 104 + 7 days of follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse event (AE)Serious AESevere AEModerate AEMild AEFatal AE
IDeg OD3621514932540
IGlar OD3391717872341

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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00982644)
Timeframe: Week 52

Interventionmmol/L (Mean)
IDeg OD7.7
IGlar OD7.7

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Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00982644)
Timeframe: Week 0 to Week 104 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD172
IGlar OD205

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Percent of Blood Glucose (BG) Within the Range of 70 - 180 mg/dL (3.9-10 mmol/L)

Calculated for each patient as the percent of all on-treatment CGMS values falling within the range of 70 - 180 mg/dL (3.9 - 10 mmol/L) inclusive. (NCT00993473)
Timeframe: 6 months

Interventionpercent of CGMS values within the range (Mean)
Lantus (Insulin Glargine)41.667
NPH Insulin38.158

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Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours. (NCT00993473)
Timeframe: 6 months

Interventionnumber of events per patient-year (Mean)
Lantus (Insulin Glargine)0.04
NPH Insulin0.00

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"Event Rate of All Confirmed Low CGMS Excursions (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"

"All confirmed low CGMS excursions consisted of all low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL." (NCT00993473)
Timeframe: 6 months

Interventionevents per patient-year (Mean)
Lantus (Insulin Glargine)74.61
NPH Insulin71.60

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Blood Glucose Variability Based on All On-treatment CGMS Values

Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded over all CGMS placements. (NCT00993473)
Timeframe: 6 months

Interventionmmol/L (Mean)
Lantus (Insulin Glargine)4.954
NPH Insulin5.089

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Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Severe symptomatic hypoglycemia: any event with clinical symptoms considered to result from a hypoglycemic episode for which the patients required the assistance of a third party (ie, other than the patient, or a parent/usual caregiver; eg, from emergency personnel), because the patients/parents could not treat the event with acute neurological impairment directly resulting from the hypoglycemic event. The occurrence of seizure, coma, unconsciousness, or the use of glucagon, were also to qualify a hypoglycemic episode as severe. (NCT00993473)
Timeframe: 6 months

Interventionnumber of events per patient-year (Mean)
Lantus (Insulin Glargine)0.14
NPH Insulin0.07

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Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)

Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries. (NCT00993473)
Timeframe: 6 months

Interventionevents per patient-year (Mean)
Lantus (Insulin Glargine)25.54
NPH Insulin33.02

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Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values

Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded during the nocturnal time period (between 23:00 and 07:00 hours). (NCT00993473)
Timeframe: 6 months

Interventionmmol/L (Mean)
Lantus (Insulin Glargine)4.747
NPH Insulin4.837

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Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit

Percentage of patients reaching International Society for Pediatric and Adolescent Diabetes (ISPAD)-recommended goals of Glycosylated Hemoglobin A1c <7.5% at the end of treatment visit. (NCT00993473)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Lantus (Insulin Glargine)22.0
NPH Insulin22.8

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Number of Patients With Different Types of Hypoglycemia Events

Definitions of the different types of hypoglycemia events provided in the outcome measure description of the corresponding event rates. (NCT00993473)
Timeframe: 6 months

,
Interventionparticipants (Number)
"Patients with All hypoglycemia"Patients with symptomatic hypoglycemiaPatients with severe symptomatic hypoglycemiaPatients with nocturnal hypoglycemiaPatients with nocturnal symptomatic hypoglycemiaPatients with severe noct. sympto. hypoglycemia"Patients with All confirmed low CGMS excursions""Patients with All confirmed low FSBG"
Lantus (Insulin Glargine)61404591716061
NPH Insulin63442602806163

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Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)

Assessed using an analysis of covariance (ANCOVA) model with treatment, and randomization strata (baseline number of CGM hypoglycemic excursions <0.5 events/24hours or ≥0.5 events/24 hours, and baseline HbA1c <8.5% or ≥8.5%) as fixed effects, and using the baseline value as covariate. (NCT00993473)
Timeframe: baseline, 6 months

,
Interventionpercent HbA1c (Least Squares Mean)
End of treatment HbA1c (ANCOVA)Absolute change from baseline HbA1c (ANCOVA)
Lantus (Insulin Glargine)8.139-0.048
NPH Insulin8.2320.045

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Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment

(NCT00993473)
Timeframe: baseline, 6 months

,
Interventionpercent HbA1c (Mean)
Baseline HbA1cEnd of treatment HbA1c (N = 59 & 57)Absolute change from baseline (N = 59 & 57)
Lantus (Insulin Glargine)8.0238.0710.036
NPH Insulin8.2488.3440.000

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Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment

(NCT00993473)
Timeframe: baseline, 6 months

,
Interventionmmol/L (Mean)
Baseline daily BG (N= 61 & 63)End of treatment daily BG (N= 60 & 63)Absolute change from baseline (N= 60 & 62)
Lantus (Insulin Glargine)11.26311.085-0.218
NPH Insulin11.17011.7120.501

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"Event Rate of All Confirmed Low FSBG (Individual Component of the Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"

"All confirmed low FSBG consisted of all low FSBG readings (values <70 mg/dL) performed at other times." (NCT00993473)
Timeframe: 6 months

Interventionevents per patient-year (Mean)
Lantus (Insulin Glargine)192.69
NPH Insulin168.24

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"Event Rate of All Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"

"The rate of all hypoglycemia was calculated from all hypoglycemia episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients' diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL, - low FSBG readings (values <70 mg/dL) performed at other times." (NCT00993473)
Timeframe: 6 months

Interventionnumber of events per patient-year (Mean)
Lantus (Insulin Glargine)192.75
NPH Insulin168.91

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"Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of All Hypoglycemia Episodes Divided by the Total Duration of the On-treatment Period in Years"

"Nocturnal hypoglycemia: any event from the all hypoglycemia total that occurred between 23:00 and 07:00 hours." (NCT00993473)
Timeframe: 6 months

Interventionnumber of events per patient-year (Mean)
Lantus (Insulin Glargine)33.50
NPH Insulin30.92

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Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours. (NCT00993473)
Timeframe: 6 months

Interventionnumber of events per patient-year (Mean)
Lantus (Insulin Glargine)2.38
NPH Insulin3.65

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1 Year Mortality

All-cause mortality (NCT00995501)
Timeframe: 1 year after surgery

InterventionParticipants (Count of Participants)
Intensive Glucose Control, Dexamethasone, Light Anesthesia1
Intensive Glucose Control, Dexamethasone, Deep Anesthesia7
Intensive Glucose Control, Placebo, Light Anesthesia9
Conventional Glucose Control, Dexamethasone, Light Anesthesia7
Intensive Glucose Control, Placebo, Deep Anesthesia7
Conventional Glucose Control, Dexamethasone, Deep Anesthesia7
Conventional Glucose Control, Placebo, Light Anesthesia5
Conventional Glucose Control, Placebo, Deep Anesthesia2

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Major Perioperative Morbidity

Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality. (NCT00995501)
Timeframe: 30 day after surgery

InterventionParticipants (Count of Participants)
Intensive Glucose Control, Dexamethasone, Light Anesthesia10
Intensive Glucose Control, Dexamethasone, Deep Anesthesia10
Intensive Glucose Control, Placebo, Light Anesthesia8
Conventional Glucose Control, Dexamethasone, Light Anesthesia9
Intensive Glucose Control, Placebo, Deep Anesthesia10
Conventional Glucose Control, Dexamethasone, Deep Anesthesia8
Conventional Glucose Control, Placebo, Light Anesthesia11
Conventional Glucose Control, Placebo, Deep Anesthesia9

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Number of Hypoglycemic Events

Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial. (NCT00998335)
Timeframe: 3 and 6 months

,
InterventionNumber of events (Number)
3-month rate of severe hypoglycemia6-month rate of severe hypoglycemia
Insulin Detemir Only00
Insulin Detemir Plus AspartNA0

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Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.

(NCT00998335)
Timeframe: 3 and 6 months

,
Interventionmg/dL (Mean)
3-month - Day-long plasma glucose profile6-month - Day-long plasma glucose profile
Insulin Detemir Only (3 and 6 Months)168153
Insulin Detemir Plus AspartNA170

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Metabolic Control as Measured by the Fasting Plasma Glucose Concentration

(NCT00998335)
Timeframe: 3 and 6 months

,
Interventionmg/dL (Mean)
3-month - Fasting plasma glucose6-month - Fasting plasma glucose
Insulin Detemir Only (3 and 6 Months)10589
Insulin Detemir Plus AspartNA116

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Change in Anthropometric Measure (Body Mass Index [BMI]).

Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months. (NCT00998335)
Timeframe: 3 and 6 months.

,
InterventionChange from baseline (Kg/m2) (Mean)
3-month body mass index6-month body mass index
Insulin Detemir Only-0.40.3
Insulin Detemir Plus AspartNA0.2

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Metabolic Control as Measured by the A1c

(NCT00998335)
Timeframe: 3 and 6 months

,
Interventionpercentage of A1c (Mean)
3-month - A1c6-month - A1c
Insulin Detemir Only (3 and 6 Months)7.46.9
Insulin Detemir Plus AspartNA6.7

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Change in Anthropometric Measure (Body Weight).

Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months. (NCT00998335)
Timeframe: 3 and 6 months.

,
InterventionChange from baseline (Kg) (Mean)
3-month total body weight6-month total body weight
Insulin Detemir Only-0.80.8
Insulin Detemir Plus AspartNA0.3

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Change in Insulin Secretion

Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase). (NCT00998335)
Timeframe: 3 and 6 months.

,
Interventionng/ml (Mean)
3-month C-peptide level increase in first phase3-month C-peptide level increase in second phase6-month C-peptide level increase in first phase6-month C-peptide level increase in second phase
Insulin Detemir Only (3 and 6 Months)0.51.6-0.10.6
Insulin Detemir Plus AspartNANA0.20.2

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Advanced Lipid Testing

Change in lipoprotein particle number was determined using NMR. (NCT00998335)
Timeframe: 3 and 6 months

,
InterventionChange in number of particles (nmol/L) (Mean)
VLDL particles (3 months)VLDL particles (6 months)LDL particles (3 months)LDL particles (6 months)HDL particles (3 months)HDL particles (6 months)
Insulin Detemir Only (3 and 6 Months)-15-5-10012802
Insulin Detemir Plus AspartNA-2NA85NA1

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Plasma Lipid Concentration.

Fasting plasma lipid concentration on day of admission at 3 and 6 months. (NCT00998335)
Timeframe: 3 and 6 months.

,
Interventionmg/dL (Mean)
3-month total cholesterol3-month LDL-cholesterol3-month triglycerides3-month HDL-C6-month total cholesterol6-month LDL-cholesterol6-month triglycerides6-month HDL-C
Insulin Detemir Only13676154331478615031
Insulin Detemir Plus AspartNANANANA1458014433

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Hepatic Steatosis

Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS). (NCT00998335)
Timeframe: 3 and 6 months

,
Interventionpercentage of liver fat (Mean)
Month 3Month 6
Insulin Detemir Plus AspartNA5.9
Insulin Detemir x 3 Months (All Pts Had Liver MRS)6.78.4

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Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).

Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS). (NCT00998335)
Timeframe: 3 and 6 months.

,
Intervention% of intramyocellular triglyceride (Mean)
3-month intramyocellular triglycerides6-month intramyocellular triglycerides
Insulin Detemir Only0.631.05
Insulin Detemir Plus AspartNA0.49

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Percent Change From Baseline in Vascular Inflammatory Markers

Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM (NCT00998335)
Timeframe: 3 and 6 months

,
InterventionPercentage of change (Mean)
Adiponectin (3 months)Adiponectin (6 months)MMP-9 (3 months)MMP-9 (6 months)E-selectin (3 months)E-selectin (6 months)sICAM (3 months)sICAM (6 months)sVCAM (3 months)sVCAM (6 months)
Insulin Detemir Only18653230-634-42114
Insulin Detemir Plus AspartNA5NA49NA19NA-1NA7

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast. (NCT01006291)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDeg OD FF7.9
IDeg OD8.0
IGlar OD7.8

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment (NCT01006291)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD FF-1.28
IDeg OD-1.07
IGlar OD-1.26

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Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01006291)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD FF364
IDeg OD363
IGlar OD348

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT01006291)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD FF63
IDeg OD56
IGlar OD75

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01009580)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp BID-1.28
BIAsp 30 BID-1.30

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT01009580)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDegAsp BID7.0
BIAsp 30 BID7.3

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Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01009580)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp BID972
BIAsp 30 BID1396

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. (NCT01009580)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp BID74
BIAsp 30 BID253

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Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score

"To determine the efficacy of CGMS guided insulin pump therapy on symptoms of gastroparesis as assessed by GCSI total score and mean score and quality of life as assessed by PAGI-QOL score in diabetics with gastroparesis.~The outcome is assessed using the self-reported total GCSI score, which is computed as the average of the 3 subscores on the GCSI survey: 3-item postprandial fullness/early satiety subscore, the nausea/vomiting subscore (average of 3-items: nausea, retching, vomiting), and bloating subscore (average of 2-items: bloating, stomach visibly larger). Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the total score ranges from 0 to 5.~The self-reported PAGI-QOL total score which comprises 30 items scored from 0 (none of the time) to 5 (all of the time) the participant's QOL has been affected in the last 2 weeks.The total score is the mean of the 5 subscale scores and ranges from 0 (lowest QOL) to 5 (highest QOL) in past 2-weeks." (NCT01030341)
Timeframe: Change from baseline (screening) vs 24 weeks of follow-up

Interventionscore on a scale (Mean)
Change in total GCSI score, screening to 12 weeksChange in total GCSI score, screening to 24 weeksChange in GCSI composite, screening to 12 weeksChange in GCSI composite, screening to 24 weeksChange in PAGI-QOL score, screening to 12 weeksChange in PAGI-QOL score, screening to 24 weeks
All Participants-7.2-7.1-0.6-0.80.70.7

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Hypoglycemic Episodes

The incidence rate (events / person-week) of mild/moderate (glucose level < 70 mg/dL) and severe (glucose < 50 mg/dL) hypoglycemic episodes during screening vs 24 week of follow-up visits while using a combination of continuous glucose monitoring system (CGMS) and insulin pump therapy. (NCT01030341)
Timeframe: 4 weeks screening vs 24 weeks follow-up

Interventionevent rate per person-week (Number)
Screening phase, hypoglycemia / person-weekTreatment phase, hypoglycemia / person-week
All Participants1.92.2

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT01045447)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDegAsp OD8.1
IGlar OD8.4

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01045447)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp OD-0.98
IGlar OD-1.00

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01045707)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp OD-1.65
IGlar OD-1.72

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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT01045707)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDegAsp OD7.9
IGlar OD7.9

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Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect (NCT01045707)
Timeframe: Week 0 to Week 53 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AE)Serious AESevere AEModerate AEMild AEFatal AE
IDegAsp OD313179772272
IGlar OD238910661621

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Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT01045707)
Timeframe: Week 0 to Week 53 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD19
IGlar OD53

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Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01045707)
Timeframe: Week 0 to Week 53 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD419
IGlar OD211

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment. (NCT01045707)
Timeframe: Week 0, Week 53

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp OD-1.39
IGlar OD-1.34

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment (NCT01059799)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-1.24
IGlar OD-1.35

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast. (NCT01059799)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDeg OD8.2
IGlar OD8.0

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Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01059799)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD298
IGlar OD370

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT01059799)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD78
IGlar OD124

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT01059812)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp BID111
BIAsp 30 BID155

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Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01059812)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp BID-1.38
BIAsp 30 BID-1.42

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Change in Body Weight

Change from baseline in body weight after 26 weeks of treatment. (NCT01059812)
Timeframe: Week 0, Week 26

Interventionkg (Mean)
IDegAsp BID1.1
BIAsp 30 BID1.4

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Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol. (NCT01059812)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp BID956
BIAsp 30 BID952

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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT01059812)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDegAsp BID7.6
BIAsp 30 BID7.9

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Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment

Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)} (NCT01068652)
Timeframe: Week 14

Interventionmg/dL (Mean)
Detemir + Met43.19
BIAsp 30 + Met32.61

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Glycosylated Haemoglobin (HbA1c)

Estimated mean difference in HbA1c after 50 weeks of treatment (NCT01068652)
Timeframe: Week 50

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met7.34
BIAsp 30 + Met7.23

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Change in Glycosylated Haemoglobin (HbA1c) at Week 50

Observed mean change from baseline in HbA1c at Week 50 (visit 32) (NCT01068652)
Timeframe: Week 0, Week 50

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met-1.16
BIAsp 30 + Met-1.34

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Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment

Observed mean change from baseline in HbA1c at Week 38 (visit 25) (NCT01068652)
Timeframe: Week 0, Week 38

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met-1.35
BIAsp 30 + Met-1.56

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Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment

Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25) (NCT01068652)
Timeframe: Week 38

InterventionSubjects (Number)
Detemir + Met84
BIAsp 30 + Met103

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Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment

Observed mean change from baseline in HbA1c at Week 14 (visit 11) (NCT01068652)
Timeframe: Week 0, Week 14

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met-0.18
BIAsp 30 + Met-0.64

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Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment

Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11) (NCT01068652)
Timeframe: Week 14

,
Interventionmg/dL (Mean)
Before Breakfast (n=193, 194)120 min After Breakfast (n=187, 184)Before Lunch (n=192, 193)120 min After Lunch (n=186, 185)Before Dinner (n=191, 192)120 min After Dinner (n=183, 185)Bedtime (n=187, 192)At 2 AM - 3 AM (n=172, 177)
BIAsp 30 + Met128.31176.31156.12199.75168.09173.95156.65139.93
Detemir + Met136.44181.89157.61199.40169.69212.23200.15158.69

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Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment

Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18) (NCT01068652)
Timeframe: Week 26

,
Interventionmg/dL (Mean)
Before Breakfast (n=193, 194)120 min After Breakfast (n=191, 191)Before Lunch (n=193, 194)120 min After Lunch (n=191, 191)Before Dinner (n=192, 194)120 min After Dinner (n=188, 191)Bedtime (n=190, 194)At 2 AM - 3 AM (n=181, 187)
BIAsp 30 + Met115.79153.85131.27178.92143.29152.44140.39123.29
Detemir + Met116.57163.52140.97166.00147.58172.21164.70133.59

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Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment

Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25) (NCT01068652)
Timeframe: Week 38

,
Interventionmg/dL (Mean)
Before Breakfast (n=193, 194)120 min After Breakfast (n=191, 192)Before Lunch (n=193, 194)120 min After Lunch (n=191, 192)Before Dinner (n=193, 194)120 min After Dinner (n=192,192)Bedtime (n=193, 194)At 2 AM - 3 AM (n=187, 190)
BIAsp 30 + Met110.86139.38118.30158.45129.10142.82132.45117.42
Detemir + Met110.14146.70130.63145.91132.26155.47146.37124.57

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Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment

Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32) (NCT01068652)
Timeframe: Week 50

,
Interventionmg/dL (Mean)
Before Breakfast (n=193, 194)120 min After Breakfast (n=191, 192)Before Lunch (n=193, 194)120 min After Lunch (n=191, 192)Before Dinner (n=193, 194)120 min After Dinner (n=192, 192)Bedtime (n=193, 194)At 2 AM - 3 AM (n=187, 190)
BIAsp 30 + Met110.76132.45115.02149.90126.76138.08130.10113.14
Detemir + Met108.78140.05120.43139.48128.28144.19137.13118.60

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Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment

Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32) (NCT01068652)
Timeframe: Week 50

InterventionSubjects (Number)
Detemir + Met73
BIAsp 30 + Met84

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Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Observed mean change in from baseline in HbA1c at Week 26 (visit 18) (NCT01068652)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met-1.05
BIAsp 30 + Met-1.30

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Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment

Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}. (NCT01068652)
Timeframe: Week 38

Interventionmg/dL (Mean)
Detemir + Met25.44
BIAsp 30 + Met28.32

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Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment

Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}. (NCT01068652)
Timeframe: Week 50

Interventionmg/dL (Mean)
Detemir + Met22.45
BIAsp 30 + Met23.66

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Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment

Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11) (NCT01068652)
Timeframe: Week 14

InterventionSubjects (Number)
Detemir + Met15
BIAsp 30 + Met26

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Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment

Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)} (NCT01068652)
Timeframe: Week 26

Interventionmg/dL (Mean)
Detemir + Met32.95
BIAsp 30 + Met31.71

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Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment

Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18) (NCT01068652)
Timeframe: Week 26

InterventionSubjects (Number)
Detemir + Met67
BIAsp 30 + Met77

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Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 26 weeks of treatment (NCT01068665)
Timeframe: Week 0, Week 26

Interventionmmol/L (Mean)
IDeg 200 U/mL OD-3.70
IGlar OD-3.38

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment (NCT01068665)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg 200 U/mL OD-1.30
IGlar OD-1.32

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after week 26 (NCT01068678)
Timeframe: Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg 3TW-1.00
IGlar OD-1.40

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Change in Body Weight

Change from baseline in body weight after week 26 (NCT01068678)
Timeframe: Week 26

Interventionkg (Mean)
IDeg 3TW0.8
IGlar OD1.0

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Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks

"Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population." (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionmmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-0.53
Placebo + Metformin0.13
Canakinumab 150 mg + Metformin + Sulfonylurea-0.60
Placebo + Metformin + Sulfonylurea0.18
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-1.08
Placebo + Met + Sulfonyl + Thiaz-0.56
Canakinumab 150 mg + Insulin-0.56
Placebo + Insulin-0.16
Canakinumab 150 mg in Participants With IGT-0.26
Placebo in Participants With IGT-0.25

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Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks

An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit. (NCT01068860)
Timeframe: Baseline, 4 weeks

,,,,,,,,,
Interventionparticipants (Number)
Number of Participants with Serious Adverse EventsNumber of Participants with Non-serious AEs > 5%
Canakinumab 150 mg + Insulin06
Canakinumab 150 mg + Metformin00
Canakinumab 150 mg + Metformin + Sulfonylurea06
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia04
Canakinumab 150 mg in Participants With IGT00
Placebo + Insulin03
Placebo + Met + Sulfonyl + Thiaz03
Placebo + Metformin04
Placebo + Metformin + Sulfonylurea03
Placebo in Participants With IGT00

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Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks

GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group. (NCT01068860)
Timeframe: Baseline, 4 weeks

,,,,,,,,,
Interventionnumber (Least Squares Mean)
Index 1Index 2 (n= 32,15, 29,15, 30,13, 25, 15, 20, 26)
Canakinumab 150 mg + Insulin0.25-0.21
Canakinumab 150 mg + Metformin0.060.14
Canakinumab 150 mg + Metformin + Sulfonylurea0.06-0.94
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia0.240.62
Canakinumab 150 mg in Participants With IGT-0.51-0.16
Placebo + Insulin-0.27-0.25
Placebo + Met + Sulfonyl + Thiaz0.330.49
Placebo + Metformin-0.29-0.81
Placebo + Metformin + Sulfonylurea0.370.81
Placebo in Participants With IGT-0.64-0.31

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Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks

"The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population." (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionnumber (Least Squares Mean)
Canakinumab 150 mg + Metformin0.004
Placebo + Metformin-0.000
Canakinumab 150 mg + Metformin + Sulfonylurea0.002
Placebo + Metformin + Sulfonylurea0.009
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia0.018
Placebo + Met + Sulfonyl + Thiaz-0.001
Canakinumab 150 mg + Insulin-0.003
Placebo + Insulin0.005
Canakinumab 150 mg in Participants With IGT-0.001
Placebo in Participants With IGT0.001

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Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks

Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group. (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionmmol*hr/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-0.59
Placebo + Metformin0.46
Canakinumab 150 mg + Metformin + Sulfonylurea-1.37
Placebo + Metformin + Sulfonylurea-1.24
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-3.58
Placebo + Met + Sulfonyl + Thiaz-2.88
Canakinumab 150 mg + Insulin-1.49
Placebo + Insulin-1.76
Canakinumab 150 mg in Participants With IGT-0.71
Placebo in Participants With IGT-0.10

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Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks

Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population. (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionpmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin8.09
Placebo + Metformin44.56
Canakinumab 150 mg + Metformin + Sulfonylurea-55.07
Placebo + Metformin + Sulfonylurea11.33
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia5.13
Placebo + Met + Sulfonyl + Thiaz-5.15
Canakinumab 150 mg + Insulin91.74
Placebo + Insulin36.87
Canakinumab 150 mg in Participants With IGT56.21
Placebo in Participants With IGT-26.43

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Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks

"Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population." (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionmmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-0.41
Placebo + Metformin0.21
Canakinumab 150 mg + Metformin + Sulfonylurea-0.43
Placebo + Metformin + Sulfonylurea-0.03
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-0.82
Placebo + Met + Sulfonyl + Thiaz-0.77
Canakinumab 150 mg + Insulin-0.15
Placebo + Insulin-0.60
Canakinumab 150 mg in Participants With IGT-0.34
Placebo in Participants With IGT-0.04

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Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks

"Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population." (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionnmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-0.04
Placebo + Metformin-0.04
Canakinumab 150 mg + Metformin + Sulfonylurea-0.10
Placebo + Metformin + Sulfonylurea0.16
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-0.21
Placebo + Met + Sulfonyl + Thiaz0.05
Canakinumab 150 mg + Insulin0.07
Placebo + Insulin-0.14
Canakinumab 150 mg in Participants With IGT-0.18
Placebo in Participants With IGT-0.18

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Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks

Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionpmol/min/m^2/mmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin0.21
Placebo + Metformin-2.15
Canakinumab 150 mg + Metformin + Sulfonylurea-2.98
Placebo + Metformin + Sulfonylurea2.02
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia0.15
Placebo + Met + Sulfonyl + Thiaz1.19
Canakinumab 150 mg + Insulin-0.43
Placebo + Insulin-0.51
Canakinumab 150 mg in Participants With IGT-0.71
Placebo in Participants With IGT-1.00

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Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.

Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population. (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionpmol/min/m^2/mmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin0.44
Placebo + Metformin-0.99
Canakinumab 150 mg + Metformin + Sulfonylurea-0.32
Placebo + Metformin + Sulfonylurea1.22
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-0.63
Placebo + Met + Sulfonyl + Thiaz1.24
Canakinumab 150 mg + Insulin0.53
Placebo + Insulin-0.49
Canakinumab 150 mg in Participants With IGT-1.38
Placebo in Participants With IGT-1.35

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Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.

Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionpmol/min/m^2/mmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-0.06
Placebo + Metformin-0.23
Canakinumab 150 mg + Metformin + Sulfonylurea0.04
Placebo + Metformin + Sulfonylurea0.45
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-0.79
Placebo + Met + Sulfonyl + Thiaz1.16
Canakinumab 150 mg + Insulin1.23
Placebo + Insulin-0.49
Canakinumab 150 mg in Participants With IGT-1.50
Placebo in Participants With IGT-1.93

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Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks

Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group. (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionpmol*hour/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-9.37
Placebo + Metformin1.21
Canakinumab 150 mg + Metformin + Sulfonylurea-73.25
Placebo + Metformin + Sulfonylurea-38.32
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-36.96
Placebo + Met + Sulfonyl + Thiaz8.46
Canakinumab 150 mg + Insulin163.87
Placebo + Insulin139.24
Canakinumab 150 mg in Participants With IGT44.27
Placebo in Participants With IGT-106.68

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Mean Change in Fructosamine, From Baseline to 4 Weeks

"Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population" (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionmmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-5.30
Placebo + Metformin-0.75
Canakinumab 150 mg + Metformin + Sulfonylurea-3.45
Placebo + Metformin + Sulfonylurea-7.50
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-1.81
Placebo + Met + Sulfonyl + Thiaz-3.07
Canakinumab 150 mg + Insulin-3.00
Placebo + Insulin-19.73
Canakinumab 150 mg in Participants With IGT-6.36
Placebo in Participants With IGT1.39

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Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks

"Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population" (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionpmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-3.58
Placebo + Metformin10.73
Canakinumab 150 mg + Metformin + Sulfonylurea-16.07
Placebo + Metformin + Sulfonylurea-9.40
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-0.77
Placebo + Met + Sulfonyl + Thiaz2.31
Canakinumab 150 mg + Insulin21.27
Placebo + Insulin25.67
Canakinumab 150 mg in Participants With IGT-.021
Placebo in Participants With IGT-3.43

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Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks

"Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population" (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionmmol/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-0.32
Placebo + Metformin0.33
Canakinumab 150 mg + Metformin + Sulfonylurea-0.20
Placebo + Metformin + Sulfonylurea-0.23
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-0.33
Placebo + Met + Sulfonyl + Thiaz-0.36
Canakinumab 150 mg + Insulin-0.26
Placebo + Insulin-0.80
Canakinumab 150 mg in Participants With IGT-0.06
Placebo in Participants With IGT0.10

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Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks

Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group. (NCT01068860)
Timeframe: Baseline, 4 weeks

Interventionnmol*hour/L (Least Squares Mean)
Canakinumab 150 mg + Metformin-0.18
Placebo + Metformin-0.18
Canakinumab 150 mg + Metformin + Sulfonylurea-0.21
Placebo + Metformin + Sulfonylurea0.12
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia-0.61
Placebo + Met + Sulfonyl + Thiaz0.02
Canakinumab 150 mg + Insulin0.16
Placebo + Insulin-0.29
Canakinumab 150 mg in Participants With IGT-0.43
Placebo in Participants With IGT-0.40

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Glucose Profiles Per Day

Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days (NCT01073566)
Timeframe: 6 weeks

Interventionmmol/L (Least Squares Mean)
Finesse3.18
Usual Injection Device3.63

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Insulin Delivery System Rating

Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better. (NCT01073566)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Finesse82.9
Usual Injection Device54.9

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Mean Daily Blood Glucose

Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose (NCT01073566)
Timeframe: 6 weeks

Interventionmmol/L (Least Squares Mean)
Finesse8.61
Usual Injection Device9.02

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Self-reported Hypoglycemic Episodes

Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose. (NCT01073566)
Timeframe: 6 weeks

Interventionepisodes (Number)
Finesse0
Usual Injection Device0

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Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day. (NCT01074268)
Timeframe: Week 52

Interventionmmol/L (Mean)
IDeg OD7.8
IDet OD7.8

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Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT01074268)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD414
IDet OD593

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Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

Change from baseline in FPG after 52 weeks of treatment (NCT01074268)
Timeframe: Week 0, Week 52

Interventionmmol/L (Mean)
IDeg OD-2.19
IDet OD-0.82

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment (NCT01074268)
Timeframe: Week 0, Week 52

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-0.46
IDet OD-0.47

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Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms (NCT01074268)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD3778
IDet OD3926

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Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT01074268)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD338
IDet OD481

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Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect or important medical issues (NCT01074268)
Timeframe: Week 0 to Week 52 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AESevere AEModerate AEMild AEFatal AE
IDeg OD4592023483880
IDet OD4201735453410

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment (NCT01074268)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-0.73
IDet OD-0.65

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Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment

Change from baseline in FPG after 26 weeks of treatment (NCT01074268)
Timeframe: Week 0, Week 26

Interventionmmol/L (Mean)
IDeg OD-2.60
IDet OD-0.62

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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day. (NCT01074268)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDeg OD7.9
IDet OD7.8

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Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. (NCT01074268)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD4583
IDet OD4569

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment (NCT01076647)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg 3TW-1.05
IGlar OD-1.36

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Change in Body Weight

Change from baseline in body weight after 26 weeks of treatment (NCT01076647)
Timeframe: Week 0, Week 26

Interventionkg (Mean)
IDeg 3TW0.8
IGlar OD0.5

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Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment

Change from baseline in FPG after 26 weeks of treatment (NCT01079234)
Timeframe: Week 0, Week 26

Interventionmmol/L (Mean)
IDeg OD FF-1.28
IDeg OD-2.54
IGlar OD-1.33

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment (NCT01079234)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD FF-0.40
IDeg OD-0.41
IGlar OD-0.58

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment. (NCT01079234)
Timeframe: Week 0, Week 52

Interventionpercentage of glycosylated haemoglobin (Mean)
IGlar OD-0.21
IDeg OD F-0.13

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Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

Change from baseline in FPG after 52 weeks of treatment. (NCT01079234)
Timeframe: Week 0, Week 52

Interventionmmol/L (Mean)
IGlar OD-0.61
IDeg OD F-1.73

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Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT01079234)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IGlar OD848
IDeg OD F640

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Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01079234)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IGlar OD6341
IDeg OD F6811

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Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values

(NCT01109316)
Timeframe: Baseline, 8 weeks for each treatment

Interventionpercentage of glycosylated hemoglobin (Mean)
Insulin Lispro 2 Day-0.04
Insulin Lispro 6 Day0.06
Insulin Aspart 6 Day0.00

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Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight

(NCT01109316)
Timeframe: Baseline, 8 weeks for each treatment

Interventionkilograms (kg) (Mean)
Insulin Lispro 2 Day0.44
Insulin Lispro 6 Day0.34
Insulin Aspart 6 Day0.65

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Hyperglycemic Episode Rate Per 30 Days

Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days. (NCT01109316)
Timeframe: 8 weeks for each treatment

Interventionhyperglycemic episodes per 30 days (Mean)
Insulin Lispro 2 Day15.91
Insulin Lispro 6 Day16.91
Insulin Aspart 6 Day15.76

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Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure

(NCT01109316)
Timeframe: Baseline, 8 weeks for each treatment

,,
InterventionmmHg (Mean)
Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)
Insulin Aspart 6 Day-1.07-0.33
Insulin Lispro 2 Day0.80-0.14
Insulin Lispro 6 Day0.801.37

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Percentage of Participants With Hypoglycemia

"Hypoglycemia was defined as an event which was associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L)." (NCT01109316)
Timeframe: 8 weeks for each treatment

Interventionpercentage of participants (Number)
Insulin Lispro 2 Day100.0
Insulin Lispro 6 Day100.0
Insulin Aspart 6 Day99.2

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Percentage of Participants With Hyperglycemia

Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. (NCT01109316)
Timeframe: 8 weeks for each treatment

Interventionpercentage of participants (Number)
Insulin Lispro 2 Day99.2
Insulin Lispro 6 Day98.4
Insulin Aspart 6 Day98.4

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Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%

(NCT01109316)
Timeframe: 8 weeks for each treatment

,,
Interventionparticipants (Number)
HbA1c ≤6.5%HbA1c <7%
Insulin Aspart 6 Day1844
Insulin Lispro 2 Day2140
Insulin Lispro 6 Day1638

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Mean Daily Insulin Dose (Total, Basal, and Bolus)

(NCT01109316)
Timeframe: 8 weeks for each treatment

,,
InterventionUnits (U) of insulin (Mean)
Daily Bolus InsulinDaily Basal InsulinDaily Total Insulin
Insulin Aspart 6 Day14.4418.3431.99
Insulin Lispro 2 Day14.3318.6232.36
Insulin Lispro 6 Day14.5118.7732.37

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Hypoglycemia Episode Rate Per 30 Days

"Hypoglycemia was defined as an event which was associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days." (NCT01109316)
Timeframe: 8 weeks for each treatment

Interventionhypoglycemic episodes per 30 days (Mean)
Insulin Lispro 2 Day17.90
Insulin Lispro 6 Day15.66
Insulin Aspart 6 Day17.52

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Percentage of Participants With Pump Complications

Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change. (NCT01109316)
Timeframe: 8 weeks for each treatment

,,
Interventionpercentage of participants (Number)
Pump Complication: Premature Reservoir ChangePump Complication: Premature Infusion Set Change
Insulin Aspart 6 Day36.356.5
Insulin Lispro 2 Day23.842.6
Insulin Lispro 6 Day38.659.1

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Pump Complication Rate Per 30 Days

Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change. (NCT01109316)
Timeframe: 8 weeks for each treatment

,,
Interventionpump complications per 30 days (Mean)
Pump Complication: Premature Reservoir ChangePump Complication: Premature Infusion Set Change
Insulin Aspart 6 Day0.510.94
Insulin Lispro 2 Day0.160.44
Insulin Lispro 6 Day0.400.84

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Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use

(NCT01109316)
Timeframe: 8 weeks of each treatment

Interventionmillimoles per liter (mmol/L) (Mean)
Insulin Lispro 2 Day9.03
Insulin Lispro 6 Day9.33
Insulin Aspart 6 Day8.72

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Mean SMBG

Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day. (NCT01109316)
Timeframe: 8 weeks for each treatment

Interventionmmol/L (Mean)
Insulin Lispro 2 Day8.79
Insulin Lispro 6 Day9.01
Insulin Aspart 6 Day8.83

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Number of Hypoglycaemic Episodes - Severe and Minor

Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L. (NCT01123980)
Timeframe: Weeks 0-24

,
Interventionepisodes (Number)
SevereMinor
BIAsp 300154
Insulin Glargine1125

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Change in Glycosylated Haemoglobin (HbA1c)

(NCT01123980)
Timeframe: Week 0, week 24

Interventionpercentage of glycosylated haemoglobin (Least Squares Mean)
BIAsp 30-0.68
Insulin Glargine-0.56

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9-point Plasma Glucose Profiles

Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day. (NCT01123980)
Timeframe: Week 24

,
Interventionmmol/L (Mean)
Before breakfast2 hours after breakfastBefore lunch2 hours after lunchBefore dinner2 hours after dinnerBefore bedtimeAt 2-4 a.m.Before breakfast the following day
BIAsp 306.4610.187.3510.507.679.368.146.586.51
Insulin Glargine6.4910.117.2210.227.0310.889.397.066.35

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Number of Hypoglycaemic Episodes

All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)). (NCT01123980)
Timeframe: Weeks 0-24

Interventionepisodes (Number)
BIAsp 3097
Insulin Glargine63

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Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%

The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment (NCT01123980)
Timeframe: Week 24

Interventionpercentage (%) of subjects (Number)
BIAsp 3014.9
Insulin Glargine14.2

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Percentage of Subjects Achieving HbA1c Below 7.0%

The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment (NCT01123980)
Timeframe: Week 24

Interventionpercentage (%) of subjects (Number)
BIAsp 3029.1
Insulin Glargine30.0

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Number of Hypoglycaemic Episodes - All

(NCT01123980)
Timeframe: Weeks 0-24

Interventionepisodes (Number)
BIAsp 30745
Insulin Glargine605

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Mean of Glycosylated Hemoglobin (hbA1c)

Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. (NCT01131052)
Timeframe: 3 months

Interventionpercent of glycosylated hemoglobin (Mean)
Basal Plus7.0
Sliding Scale Regular Insulin (SSRI)6.3

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Mean of Daily Blood Glucose Concentration

Mean of daily blood glucose concentration at baseline (NCT01131052)
Timeframe: Baseline

Interventionmg/dL (Mean)
Basal Plus163.0
Sliding Scale Regular Insulin (SSRI)137.7

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Mean Blood Glucose Concentration

Mean blood glucose concentration at baseline (NCT01131052)
Timeframe: Baseline

Interventionmg/dL (Mean)
Basal Plus198.2
Sliding Scale Regular Insulin (SSRI)191.8

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Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL

Mean weekly blood glucose concentration less than 70 mg/dL at 3 months (NCT01131052)
Timeframe: 3 months

Interventionpercentage of participants (Number)
Basal Plus28
Sliding Scale Regular Insulin (SSRI)31

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Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL

Mean weekly blood glucose concentration less than 40 mg/dL at 3 months (NCT01131052)
Timeframe: 3 months

Interventionpercentage of participants (Number)
Basal Plus0
Sliding Scale Regular Insulin (SSRI)1

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Mean of Weekly Fasting Blood Glucose Concentration

Mean weekly blood glucose concentration at 3 months (NCT01131052)
Timeframe: 3 months

Interventionmg/dL (Mean)
Basal Plus130
Sliding Scale Regular Insulin (SSRI)123

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Mean of Glycosylated Hemoglobin (hbA1c)

Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. (NCT01131052)
Timeframe: Baseline

Interventionpercent of glycosylated hemoglobin (Mean)
Basal Plus6.8
Sliding Scale Regular Insulin (SSRI)6.5

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Mean of Glycosylated Hemoglobin (hbA1c)

Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. (NCT01131052)
Timeframe: 6 months

Interventionpercent of glycosylated hemoglobin (Mean)
Basal Plus6.7
Sliding Scale Regular Insulin (SSRI)6.3

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Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]

Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration. (NCT01133392)
Timeframe: 0 up to 8 hours post dose

Interventionpicomole*hour/liter (pmol*h/L) (Geometric Mean)
Insulin Lispro A1920
Insulin Lispro B1940

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Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)

The total amount of glucose infused during the euglycemic clamp procedure. (NCT01133392)
Timeframe: 0 to 8 hours post dose

Interventiongrams (g) (Geometric Mean)
Insulin Lispro A125
Insulin Lispro B123

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Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)

Time of maximal glucose infusion rate. (NCT01133392)
Timeframe: 0 to 8 hours post dose

Interventionhours (Geometric Mean)
Insulin Lispro A2.11
Insulin Lispro B2.00

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Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]

The maximum observed insulin lispro concentration following dosing. (NCT01133392)
Timeframe: 0 to 8 hours post dose

Interventionpicomole/liter (pmol/L) (Geometric Mean)
Insulin Lispro A819
Insulin Lispro B887

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Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)

The maximum observed glucose infusion rate during the euglycemic clamp procedure. (NCT01133392)
Timeframe: 0 to 8 hours post dose

Interventionmilligrams per minute (mg/min) (Geometric Mean)
Insulin Lispro A544
Insulin Lispro B539

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Hyperglycemic Episode Rate Per 30 Days

Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days. (NCT01134107)
Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Interventionhyperglycemic episodes per 30 days (Mean)
Insulin Lispro 6D15.47
Insulin Aspart 6D14.23

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Hypoglycemic Episode Rate Per 30 Days

"All Reported Hypoglycemic Episodes are defined as an event which is associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)" (NCT01134107)
Timeframe: All days for each reservoir cycle throughout each 12-week treatment period

Interventionhypoglycemic episodes per 30 days (Mean)
Insulin Lispro 6D16.94
Insulin Aspart 6D18.90

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Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use

(NCT01134107)
Timeframe: Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)

Interventionmillimoles per liter (mmol/L) (Mean)
Insulin Lispro 6D8.83
Insulin Aspart 6D8.43

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Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure

(NCT01134107)
Timeframe: Baseline, endpoint for each 12-week treatment period

,
Interventionmillimeters of mercury (mmHg) (Mean)
Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)
Insulin Aspart 6D-1.36-1.57
Insulin Lispro 6D-2.25-1.61

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Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)

(NCT01134107)
Timeframe: Baseline, endpoint for each 12-week treatment period

,
InterventionUnits (U) of insulin (Mean)
Total Insulin DoseBasal Insulin DoseBolus Insulin Dose (N=112, 112)
Insulin Aspart 6D4.971.911.80
Insulin Lispro 6D5.212.342.19

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Change From Baseline to 12 Week Endpoint for Each Treatment in Weight

(NCT01134107)
Timeframe: Baseline, endpoint for each 12-week treatment period

Interventionkilograms (kg) (Mean)
Insulin Lispro 6D-0.04
Insulin Aspart 6D0.56

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Mean Daily Insulin Dose (Total, Basal, and Bolus)

(NCT01134107)
Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

,
InterventionUnits (U) of insulin (Mean)
Daily Total InsulinDaily Basal InsulinDaily Bolus Insulin (N=116, 117)
Insulin Aspart 6D32.4817.7116.09
Insulin Lispro 6D32.9017.8316.26

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Mean SMBG

Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D. (NCT01134107)
Timeframe: Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period

,
Interventionmillimoles per liter (mmol/L) (Mean)
SMBG Days 1-6 (N=124, 124)SMBG Day 2SMBG Day 6 (N=124, 124)
Insulin Aspart 6D8.478.408.57
Insulin Lispro 6D8.708.568.93

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Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%

(NCT01134107)
Timeframe: Endpoint for each 12-week treatment period

,
Interventionparticipants (Number)
HbA1c ≤6.5%HbA1c <7%
Insulin Aspart 6D2156
Insulin Lispro 6D1838

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Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values

(NCT01134107)
Timeframe: Baseline, endpoint for each 12-week treatment period

Interventionpercentage of HbA1c (Mean)
Insulin Lispro 6D-0.16
Insulin Aspart 6D-0.31

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Percentage of Participants Having a Hypoglycemic Episode

"A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).~All Reported Hypoglycemic Episodes are defined as an event which is associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)" (NCT01134107)
Timeframe: All days for each reservoir cycle throughout each 12-week treatment period

,
Interventionpercentage of participants (Number)
Documented Hypoglycemic EpisodesAll Reported Hypoglycemic Episodes
Insulin Aspart 6D93.799.2
Insulin Lispro 6D91.399.2

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Percentage of Participants With Pump Complications

Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change. (NCT01134107)
Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

,
Interventionpercentage of participants (Number)
Pump Complication: Premature Reservoir ChangePump Complication: Premature Infusion Set Change
Insulin Aspart 6D44.170.9
Insulin Lispro 6D42.574.8

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Percentage of Participants Having a Hyperglycemic Episode

A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating (NCT01134107)
Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Interventionpercentage of participants (Number)
Insulin Lispro 6D97.6
Insulin Aspart 6D98.4

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Pump Complications Rate Per 30 Days

Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change. (NCT01134107)
Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

,
Interventionpump complications per 30 days (Mean)
Pump Complication: Premature Reservoir ChangePump Complication: Premature Infusion Set Change
Insulin Aspart 6D0.451.10
Insulin Lispro 6D0.421.01

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Fasting Plasma Glucose (FPG)

FPG at week 4 and 16 (NCT01135992)
Timeframe: Week 4 and Week 16

Interventionmmol/L (Mean)
Week 4 (N=128) (IGlar)Week 16 (N=122) (IDeg)
IGlar/IDeg7.06.3

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Change in Body Weight

Change from baseline in body weight after week 4 and after week 16 (NCT01135992)
Timeframe: Week 0, Week 4, Week 16

Interventionkg (Mean)
Week 4(N= 142) (IGlar)Week 16 (N=129) (IDeg)
IGlar/IDeg0.10.6

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect (NCT01135992)
Timeframe: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)

Interventionevents per 100 patient years (Number)
Adverse events (N=142)(week 4)(IGlar)Serious AEs (N=142 ) (week 4)(IGlar)Severe AEs (N=142)(week 4) (IGlar)Moderate AEs (N=142) (week 4)(IGlar)Mild AEs (N=142)(week 4) (IGlar)Fatal AEs (N=142) (week 4) (IGlar)Adverse events (N=129) (week 16) (IDeg)Serious AEs (n=129) (week 16) (IDeg)Severe AEs (N=129) (week 16) (IDeg)Moderate AEs (N=129) (week 16) (IDeg)Mild AEs (N=129) (week 16) (IDeg)Fatal AEs (N=129) (week 16) (IDeg)Adverse Events (N=142) (Total)Serious AEs (N=142) (Total)Severe AEs (N=142) (Total)Moderate AEs (N=142) (Total)Mild AEs (N=142) (Total)Fatal AEs (N=142)(Total)
IGlar/IDeg370919102250042471013228004098131242730

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT01135992)
Timeframe: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)

Interventionepisodes per 100 patient years (Number)
IGlar (week 4) (N=142)IDeg (week 16) (N=129)
IGlar/IDeg11183

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HbA1c (Glycosylated Haemoglobin)

HbA1C at week 4 and 16 (NCT01135992)
Timeframe: Week 4 and Week 16

Interventionpercentage of glycosylated haemoglobin (Mean)
Week 4 (N=128) (IGlar)Week 16 (N=122)(IDeg)
IGlar/IDeg7.47.2

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Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. (NCT01135992)
Timeframe: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)

Interventionepisodes per 100 patient years (Number)
IGlar (N=142) (week 4)IDeg (N=129) (week 16)
IGlar/IDeg453424

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Mean Plasma Glucose (MPG) by Hospital Day

The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7. (NCT01136746)
Timeframe: Day 1 up to day 7 of hospital study period

,
Interventionmg/dL (Mean)
Day 1 (n=6, n=6)Day 2 (n=8, n=5)Day 3 (n=6, n=3)Day 4 (n=2, n=1)Day 5 (n=1, n=1)Day 6 (n=1, n=1)Day 7 (n=0, n=1)
Basal-bolus Therapy149.9124.0128.596.3104.6111.0108.0
Sliding Scale Regular Insulin178.1175.2151.0132.5154.8138.0NA

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Mean Plasma Glucose (MPG) Throughout Hospital Study Period

Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10. (NCT01136746)
Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Interventionmilligrams per deciliter (mg/dL) (Mean)
Sliding Scale Regular Insulin167.6
Basal-bolus Therapy128.4

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Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period

Treatment-emergent adverse event - any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module. (NCT01136746)
Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Interventionparticipants (Number)
Sliding Scale Regular Insulin1
Basal-bolus Therapy2

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Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period

Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm. (NCT01136746)
Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Interventionpercentage of capillary PG measurements (Number)
Sliding Scale Regular Insulin81.4
Basal-bolus Therapy84.3

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Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period

Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. (NCT01136746)
Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

,
Interventionhypoglycemic episodes (Number)
Hypoglycemic EpisodesSevere Hypoglycemic Episodes
Basal-bolus Therapy30
Sliding Scale Regular Insulin10

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Blood Glucose Concentration

average blood glucose concentration while the patients received insulin drip (NCT01137773)
Timeframe: 24 h

Interventionmg/dl blood (Mean)
Intensive IV Insulin99
Conventional Insulin Treatment138

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Karnovsky Performance Status Scale of Functional Impairment

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Patients are assigned a value from 0 to 100 based on the following definitions: Normal no complaints; no evidence of disease - 100. Normal activity with effort; some signs or symptoms of disease - 80. Requires occasional assistance, but is able to care for most of his personal needs - 60. Disabled; requires special care and assistance - 40. Very sick; hospital admission necessary; active supportive treatment necessary- 20. Dead- 0 (NCT01137773)
Timeframe: 3 months

Interventionunits on a scale (Mean)
Intensive IV Insulin53
Convention Insulin Treatment60

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Cerebral Glutamate Concentration

Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance. (NCT01145482)
Timeframe: 15 minutes post insulin or placebo administration

Interventionratio (Mean)
Insulin1.34
Saline1.34

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Memory

Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance (NCT01145482)
Timeframe: 15 minutes post insulin or placebo administration

Interventionunits on a scale (Mean)
Insulin6.73
Saline5.36

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the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks

(NCT01147627)
Timeframe: 48 weeks

Interventionpercentage of HbA1c (Mean)
Exenatide-1.8
Premixed Insulin Analog-1.74
Thiazolidinedione-1.47

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Fasting Plasma Glucose (FPG) at Week 21

Mean FPG at Week 21 (NCT01165684)
Timeframe: Week 21

Interventionmmol/L (Mean)
Step-wise7.1
Basal-bolus7.0

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Fasting Plasma Glucose (FPG) at Week 10

Mean FPG at Week 10 (NCT01165684)
Timeframe: Week 10

Interventionmmol/L (Mean)
Step-wise7.1
Basal-bolus6.7

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Body Mass Index (BMI) at Week 32

Estimated mean BMI after 32 Weeks of treatment (NCT01165684)
Timeframe: Week 32

Interventionkg/m^2 (Mean)
Step-wise31.86
Basal-bolus32.03

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21

Estimated mean change from baseline in HbA1c after 21 Weeks of treatment (NCT01165684)
Timeframe: Week 0, Week 21

Interventionpercentage of glycosylated haemoglobin (Mean)
Step-wise-0.78
Basal-bolus-1.15

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32

Estimated mean change from baseline in HbA1c after 32 Weeks of treatment (NCT01165684)
Timeframe: Week 0, Week 32

Interventionpercentage of glycosylated haemoglobin (Mean)
Step-wise-0.98
Basal-bolus-1.12

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Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32

Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32 (NCT01165684)
Timeframe: Week 32

Interventionmmol/L (Mean)
Step-wise1.64
Basal-bolus1.28

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Body Weight at Week 32

Estimated mean body weight after 32 Weeks of treatment (NCT01165684)
Timeframe: Week 32

Interventionkg (Mean)
Step-wise89.32
Basal-bolus89.80

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10

Estimated mean change from baseline in HbA1c after 10 Weeks of treatment (NCT01165684)
Timeframe: Week 0, Week 10

Interventionpercentage of glycosylated haemoglobin (Mean)
Step-wise-0.45
Basal-bolus-1.00

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Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32

Proportion of subjects reaching HbA1c below 7.0% at Week 32 (NCT01165684)
Timeframe: Week 32

Interventionpercentage (%) of subjects (Number)
Step-wise55.9
Basal-bolus63.3

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Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21

Proportion of subjects reaching HbA1c below 7.0% at Week 21 (NCT01165684)
Timeframe: Week 21

Interventionpercentage (%) of subjects (Number)
Step-wise45.1
Basal-bolus65.4

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Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10

Proportion of subjects reaching HbA1c below 7.0% at Week 10 (NCT01165684)
Timeframe: Week 10

Interventionpercentage (%) of subjects (Number)
Step-wise19.2
Basal-bolus56.3

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Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21

Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21 (NCT01165684)
Timeframe: Week 21

Interventionmmol/L (Mean)
Step-wise1.9
Basal-bolus1.5

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Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10

Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10 (NCT01165684)
Timeframe: Week 10

Interventionmmol/L (Mean)
Step-wise2.3
Basal-bolus1.4

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Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. (NCT01165684)
Timeframe: Week 0 to Week 32

InterventionEpisodes /year of patient exposure (Number)
Step-wise33.47
Basal-bolus57.56

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Fasting Plasma Glucose (FPG) at Week 32

Estimated Mean FPG at Week 32 (NCT01165684)
Timeframe: Week 32

Interventionmmol/L (Mean)
Step-wise7.12
Basal-bolus7.01

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Change in Weekly Mean Blood Glucose From Week 4 to Week 16

(NCT01170208)
Timeframe: Twelve week period from week 4 to week 16

Interventionmg/dL (Mean)
Group I4.6
Group II8.1
Group III29.5

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Reduction in Fructosamine.

(NCT01170208)
Timeframe: 12 week period from Week 4 to Week 16

InterventionµM (Mean)
Group I-4.2
Group II10.2
Group III37.0

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Reduction in HbA1c.

(NCT01170208)
Timeframe: Twelve week period from week 4 to week 16

Interventionpercentage of A1c (Mean)
Group I0.1
Group II0.6
Group III1.3

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Incidence of Severe or Serious Hypoglycemia.

(NCT01170208)
Timeframe: January 2011

InterventionParticipants (Count of Participants)
Group I0
Group II0
Group III0

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The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks

The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal. (NCT01175811)
Timeframe: 12 weeks, 24 weeks

,
InterventionPercentage of participants (Number)
<=6.5 Percent HbA1c at 12 weeks<=7.0 Percent HbA1c at 12 weeks<=6.5 Percent HbA1c at 24 weeks<=7.0 Percent HbA1c at 24 weeks
Basal-Bolus8.927.711.934.2
Premixed Insulin6.126.49.129.9

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Daily Dose of Insulin: Total, Basal, and Prandial

(NCT01175811)
Timeframe: 24 weeks

,
InterventionInternational Units (IU) (Mean)
Total Daily DoseDaily Insulin Dose BasalDaily Insulin Dose Bolus (prandial)
Basal-Bolus54.024.71729.269
Premixed Insulin52.931.53921.385

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Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint

Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect. (NCT01175811)
Timeframe: Baseline, 24 weeks

Interventionpercent HbA1c (Least Squares Mean)
Premixed Insulin-1.05
Basal-Bolus-1.06

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Change in HbA1c From Baseline to 12 Week Endpoint

Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect. (NCT01175811)
Timeframe: Baseline, 12 weeks

Interventionpercent HbA1c (Least Squares Mean)
Premixed Insulin-0.96
Basal-Bolus-0.96

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Percentage of Participants Experiencing a Severe Hypoglycemic Episode

Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug. (NCT01175811)
Timeframe: baseline through 24 weeks

InterventionPercentage of participants (Number)
Premixed Insulin0.0
Basal-Bolus0.0

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Percentage of Participants With Hypoglycemic Episodes (Incidence)

Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L). (NCT01175811)
Timeframe: baseline through 24 weeks

Interventionpercentage of participants (Number)
Premixed Insulin54.8
Basal-Bolus55.0

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The Rate of Hypoglycemic Episodes

The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L). (NCT01175811)
Timeframe: baseline through 24 weeks

Interventionhypoglycemic episode/30 days/participant (Mean)
Premixed Insulin0.468
Basal-Bolus0.409

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Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks

Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect. (NCT01175811)
Timeframe: Baseline, 12 weeks, and 24 weeks

,
Interventionkilogram per square meter (kg/m^2) (Least Squares Mean)
Change at 12 weeksChange at 24 weeks
Basal-Bolus0.200.29
Premixed Insulin0.260.31

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Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial

(NCT01175811)
Timeframe: 24 weeks

,
InterventionInternational Units per kilogram (IU/kg) (Mean)
Total Daily DoseDaily Insulin Dose BasalDaily Insulin Dose Bolus (prandial)
Basal-Bolus0.7600.3480.412
Premixed Insulin0.7380.4400.298

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The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.

7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. (NCT01175811)
Timeframe: Baseline, 12 weeks, and 24 weeks

,
Interventionmilligrams per deciliter (mg/dL) (Mean)
Morning Pre-meal (Week 0) (n=195, 201)Morning Pre-meal (Week 12) (n=187, 191)Morning Pre-meal (Week 24) (n=177, 186)Morning 2 hours Post-meal (Week 0) (n=194, 201)Morning 2 hours Post-meal (Week 12) (n=187, 190)Morning 2 hours Post-meal (Week 24) (n=176, 184)Midday Pre-meal (Week 0) (n=195, 200)Midday Pre-meal (Week 12) (n=187, 190)Midday Pre-meal (Week 24) (n=177, 186)Midday 2 hours Post-meal (Week 0) (n=194, 201)Midday 2 hours Post-meal (Week 12) (n=186, 189)Midday 2 hours Post-meal (Week 24) (n=175, 184)Evening Pre-meal (Week 0) (n=195, 200)Evening Pre-meal (Week 12) (n=187, 190)Evening Pre-meal (Week 24) (n=177, 186)Evening 2 hours Post-meal (Week 0) (n=194, 201)Evening 2 hours Post-meal (Week 12) (n=186, 190)Evening 2 hours Post-meal (Week 24)(n=176, 185)0300 Hours (3 am) (Week 0) (n=185, 193)0300 Hours (3 am) (Week 12) (n=177, 185)0300 Hours (3 am) (Week 24) (n=171, 179)
Basal-Bolus157.7136.5132.4213.6176.5165.8164.9149.4142.1227.5177.2171.1190.0157.6151.1209.9176.2165.6180.0163.6155.8
Premixed Insulin155.0141.8137.4207.1179.6169.7160.7142.5139.5219.7162.5161.9186.6148.1145.0204.8177.1172.0175.9150.3145.1

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Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks

The 7-point SMBG profile was calculated as the average blood glucose concentration across the 7 pre-specified time points in a day that was then averaged over 3 non-consecutive days in the 2 weeks prior to the 12 week visit and 24 week visit. Glycemic variability was calculated as the standard deviation of the 7-point SMBG profiles. Standard deviation was first calculated for each day and then averaged over 3 non-consecutive days for each visit. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: 12 weeks, 24 weeks

,
Interventionmillimoles/liter (mmol/L) (Least Squares Mean)
SMBG glycemic variability, 12 weeks (n=220, 221)SMBG glycemic variability, 24 weeks (n=216, 216)
Insulin Glargine+Insulin Lispro2.131.99
Insulin Lispro Low Mixture2.122.03

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Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks

PAM-D21 is a validated questionnaire consisting of 21 items to assess a participant's perceptions about their diabetes treatment regimens and perceived emotional and physical side-effects. The PAM-D21 consists of 4 subscales: Convenience/Flexibility (items 1 to 3); Perceived Effectiveness (items 4 to 6); Emotional Effects (items 7 to 11); and Physical Effects (items 12 to 21). Item scores range from 1 (none of the time) to 4 (all of the time). Subscale scores were linearly transformed to a 0-100, with higher score corresponds to better perceptions about diabetes medications. The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included baseline score as a covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects. (NCT01175824)
Timeframe: 24 weeks

,
Interventionunits on a scale (Least Squares Mean)
Convenience/Flexibility (n= 231, 230)Perceived Effectiveness (n=231, 230)Emotional Effects (n=231, 230)Physical Effects (n=231, 228)
Insulin Glargine+Insulin Lispro84.1378.7681.8689.04
Insulin Lispro Low Mixture83.9076.7881.8487.89

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Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks

(NCT01175824)
Timeframe: 24 weeks

,
Interventionparticipants (Number)
HbA1c <7%HbA1c <=6.5%
Insulin Glargine+Insulin Lispro6631
Insulin Lispro Low Mixture7636

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Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint

The change from baseline to 12 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Lispro Low Mixture-1.12
Insulin Glargine+Insulin Lispro-1.01

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Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks

(NCT01175824)
Timeframe: 12 weeks, 24 weeks

,
Interventioninternational units (IU) (Mean)
Total Insulin Dose at 12 Weeks (n=224, 224)Total Insulin Dose at 24 Weeks LOCF (n=236, 240)Basal Insulin Dose at 12 Weeks (n=224, 224)Basal Insulin Dose at 24 Weeks LOCF (n=236, 240)Prandial Insulin Dose at 12 Weeks (n=224, 224)Prandial Insulin Dose at 24 Weeks LOCF(n=236, 240)
Insulin Glargine+Insulin Lispro49.250.837.137.412.113.5
Insulin Lispro Low Mixture51.253.138.439.812.813.3

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Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks

ITSQ: validated instrument containing 22 items which are measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother) used to assess insulin treatment satisfaction. Items are divided into 5 domains: Inconvenience of Regimen (5 items: domain score range 5 to 35), Lifestyle Flexibility (3 items: domain score range 3 to 21), Glycemic Control (3 items: domain score range 3 to 21), Hypoglycemic Control (5 items: domain score range 5 to 35), Insulin Delivery Device (6 items: domain score range 6 to 42) lower scores reflect better outcome. ITSQ Total Overall Score ranged from 22 to 154. Raw domain scores transformed on 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better treatment satisfaction. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects. (NCT01175824)
Timeframe: 24 weeks

Interventionunits on a scale (Least Squares Mean)
Insulin Lispro Low Mixture80.91
Insulin Glargine+Insulin Lispro81.84

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Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks

The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline fasting plasma glucose value as a covariate, treatment, country, baseline HbA1c stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks, and 24 weeks

,
Interventionmillimoles per liter (mmol/L) (Least Squares Mean)
Change at 12 Weeks (n= 222, 222)Change at 24 Weeks (n=219, 217)
Insulin Glargine+Insulin Lispro0.640.75
Insulin Lispro Low Mixture1.040.89

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Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)

The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 24 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Lispro Low Mixture-1.30
Insulin Glargine+Insulin Lispro-1.08

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The Number of Participants With a Hypoglycemic Episodes (Incidence)

A hypoglycemic episode was defined as an event associated with 1) reported signs and symptoms of hypoglycemia, and/or 2) a documented blood glucose (BG) concentration of <= 70 milligrams per deciliter [mg/dL, 3.9 millimoles per liter (mmol/L)]. (NCT01175824)
Timeframe: Baseline through 24 weeks

Interventionparticipants (Number)
Insulin Lispro Low Mixture144
Insulin Glargine+Insulin Lispro150

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Change in Weight From Baseline to 12 Weeks and 24 Weeks

The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline weight as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c) stratification level, week of visit, and the treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks, 24 weeks

,
Interventionkilograms (kg) (Least Squares Mean)
Change at 12 weeks (n=224, 225)Change at 24 weeks (n=219, 217)
Insulin Glargine+Insulin Lispro0.340.50
Insulin Lispro Low Mixture0.541.13

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The Number of Participants With Severe Hypoglycemic Episodes

The number of participants who had a severe hypoglycemic episode anytime during the study. Severe hypoglycemia was defined as any event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. (NCT01175824)
Timeframe: Baseline through 24 weeks

Interventionparticipants (Number)
Insulin Lispro Low Mixture2
Insulin Glargine+Insulin Lispro0

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7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks

7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: 12 weeks, 24 weeks

,
Interventionmillimoles per liter (mmol/L) (Least Squares Mean)
pre-morning meal (Week 12) (n=223, 222)2 hour post-morning meal (Week 12) (n=220, 221)pre-midday meal (Week 12) (n=220, 221)2 hours post-midday meal (Week 12) (n=220, 221)pre-evening meal (Week 12) (n=221, 221)2 hours post-evening meal (Week 12) (n=217, 220)3 am - during the night (Week 12)(n=197, 201)pre-morning meal (Week 24) (n=217, 216)2 hours post-morning meal (Week 24) (n=216, 215)pre-midday meal (Week 24) (n=215, 216)2 hours post-midday meal (Week 24) (n=216, 216)pre-evening meal (Week 24) (n=216, 216)2 hours post-evening meal (Week 24) (n=212, 216)3 am - during the night (Week 24)(n=198, 195)
Insulin Glargine+Insulin Lispro6.209.017.449.148.259.108.526.268.867.448.997.958.958.26
Insulin Lispro Low Mixture6.878.826.969.467.989.158.216.608.526.829.087.709.118.05

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The Rate of Hypoglycemic Episodes

The hypoglycemia rate per 30 days was calculated as the number of episodes reported for the interval between visits and during the study divided by the number of days in the given interval and multiplied by 30. (NCT01175824)
Timeframe: Baseline through 24 weeks

Interventionhypoglycemic episodes per 30 day period (Mean)
Insulin Lispro Low Mixture1.07
Insulin Glargine+Insulin Lispro1.36

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Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)

The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 24 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Lispro Low Mixture-1.30
Insulin Glargine+Insulin Lispro-1.09

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Change in Fasting Plasma Glucose From Baseline

(NCT01181674)
Timeframe: Baseline and 52 weeks

Interventionmmol/L (Mean)
Group 1 (Short)-0.23
Group 2 (Long)-0.64
Standard Care0.05

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Percentage of Participants With Normal Fasting Plasma Glucose

Normal fasting plasma glucose is defined as <6.1 mmol/L. (NCT01181674)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Group 1 (Short)5
Group 2 (Long)5
Standard Care3

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Normoglycemia on Therapy

"Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group.~Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group.~Normoglycemia on therapy is defined as a mean fasting capillary blood glucose NCT01181674)
Timeframe: (1) 8 weeks and (2) 16 weeks

InterventionParticipants (Count of Participants)
Group 1 and Standard care at 8 weeksGroup 2 and Standard care at 16 weeks
Standard Care11

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Normoglycemia on Therapy

"Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group.~Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group.~Normoglycemia on therapy is defined as a mean fasting capillary blood glucose NCT01181674)
Timeframe: (1) 8 weeks and (2) 16 weeks

InterventionParticipants (Count of Participants)
Group 2 and Standard care at 16 weeks
Group 2 (Long)19

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Normoglycemia on Therapy

"Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group.~Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group.~Normoglycemia on therapy is defined as a mean fasting capillary blood glucose NCT01181674)
Timeframe: (1) 8 weeks and (2) 16 weeks

InterventionParticipants (Count of Participants)
Group 1 and Standard care at 8 weeks
Group 1 (Short)14

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HbA1C

(NCT01181674)
Timeframe: 8, 20, 28 and 52 weeks

,,
Interventionpercent (Mean)
8 weeks20 weeks28 weeks52 weeks
Group 1 (Short)6.16.26.56.4
Group 2 (Long)6.06.16.46.7
Standard Care6.66.66.66.5

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Change in Weight From Baseline

(NCT01181674)
Timeframe: Baseline, 8, 20, 28 and 52 weeks

,,
Interventionkg (Mean)
Baseline8 weeks20 weeks28 weeks52 weeks
Group 1 (Short)99.595.392.893.396.6
Group 2 (Long)95.392.490.591.793.8
Standard Care89.387.186.386.186.5

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1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.

Normal glucose tolerance is defined as a fasting plasma glucose <6.1 mmol/L and a 2-hour pc plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs. (NCT01181674)
Timeframe: (1) 20 weeks and (2) 28 weeks

InterventionParticipants (Count of Participants)
Group 1 and Standard care at 20 weeksGroup 2 and Standard care at 28 weeks
Standard Care21

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1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.

Normal glucose tolerance is defined as a fasting plasma glucose <6.1 mmol/L and a 2-hour pc plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs. (NCT01181674)
Timeframe: (1) 20 weeks and (2) 28 weeks

InterventionParticipants (Count of Participants)
Group 2 and Standard care at 28 weeks
Group 2 (Long)2

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1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.

Normal glucose tolerance is defined as a fasting plasma glucose <6.1 mmol/L and a 2-hour pc plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs. (NCT01181674)
Timeframe: (1) 20 weeks and (2) 28 weeks

InterventionParticipants (Count of Participants)
Group 1 and Standard care at 20 weeks
Group 1 (Short)2

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Number of Participants With Symptomatic Hypoglycemic Episodes

(NCT01181674)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Group 1 (Short)9
Group 2 (Long)10
Standard Care1

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Number of Participants With Severe Hypoglycemic Episodes

(NCT01181674)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Group 1 (Short)0
Group 2 (Long)0
Standard Care0

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Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)

Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (≤70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline (NCT01182493)
Timeframe: 6 months

Interventionmg/dL/min (Mean)
Insulin Pump Treatment0
Insulin Treatment With MDI-0.1

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Change in Body Weight

Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight (NCT01182493)
Timeframe: 6 months

Interventionkg (Mean)
Insulin Pump Treatment1.52
Insulin Treatment With MDI1.12

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Between Group Difference in HbA1c When Comparing CSII to MDI

To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline (NCT01182493)
Timeframe: baseline and 6 months

InterventionChange in % HbA1c (Mean)
Insulin Pump Treatment-1.1
Insulin Treatment With MDI-0.4

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Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)

Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (≥180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline (NCT01182493)
Timeframe: 6 months

Interventionmg/dL/min (Mean)
Insulin Pump Treatment-11
Insulin Treatment With MDI-2.6

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Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores (NCT01182493)
Timeframe: 6 months

Interventionscore (Mean)
Insulin Pump Treatment4.75
Insulin Treatment With MDI-0.26

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Safety - Severe Hypoglycemia Incidence

Severe hypoglycemia incidence during the study (NCT01182493)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Insulin Pump Treatment0
Insulin Treatment With MDI1

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Safety - Diabetic Ketoacidosis Incidence

Diabetic Ketoacidosis incidence during the study (NCT01182493)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
Insulin Pump Treatment0
Insulin Treatment With MDI0

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Mean Blood Glucose of All Readings

Starting 3 hours after the initial index blood glucose (BG) >180 measure, across the entire hospital stay or up through 5 days if hospital length of stay (LOS) is > 5 days (NCT01184014)
Timeframe: starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days

Interventionmg/dL (Mean)
Experimental Group157.2
Control Group181.8

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Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)

The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionunits on a scale (Least Squares Mean)
26 weeks (n=277, 274, 274)52 weeks (n=278, 277, 281)
0.75 mg LY21892650.340.22
1.5 mg LY21892650.600.86
Insulin Glargine0.180.06

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Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01191268)
Timeframe: Baseline through 26 weeks and 52 weeks

,,
Interventionparticipants (Number)
Severe HE, 26 weeksSevere HE, 52 weeksSevere HE, 4 weeks after last doseDocumented Symptomatic HE, 26 weeksDocumented Symptomatic HE, 52 weeksDocumented Symptomatic HE, 4 weeks after last doseAsymptomatic HE, 26 weeksAsymptomatic HE, 52 weeksAsymptomatic HE, 4 weeks after last doseTotal HE, 26 weeksTotal HE, 52 weeksTotal HE, 4 weeks after last dose
0.75 mg LY218926557NA242250NA179196NA258263NA
1.5 mg LY218926548NA228235NA174191NA250252NA
Insulin Glargine914NA243247NA198207NA264266NA

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Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)

The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionunits on a scale (Least Squares Mean)
26 weeks (n=251, 256, 250)52 weeks (n=234, 238, 244)
0.75 mg LY21892652.910.92
1.5 mg LY21892653.752.51
Insulin Glargine2.832.38

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Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia

The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionpercentage of participants (Number)
26 weeks52 weeks
0.75 mg LY218926554.544.0
1.5 mg LY218926553.844.0
Insulin Glargine28.226.8

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Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)

Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionkilograms per meter squared (kg/m^2) (Least Squares Mean)
26 weeks (n=248, 251, 250)52 weeks (n=225, 224, 232)4 weeks after last dose
0.75 mg LY21892650.210.57NA
1.5 mg LY2189265-0.200.09NA
Insulin Glargine1.011.33NA

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Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01191268)
Timeframe: Baseline through 52 weeks

,,
Interventionevents (Number)
26 weeks52 weeks4 weeks after last dose
0.75 mg LY2189265NA0NA
1.5 mg LY2189265NA0NA
Insulin GlargineNA0NA

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Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)

"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate." (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionunits on a scale (Least Squares Mean)
26 weeks (n=274, 270, 270)52 weeks (n=277, 275, 279)
0.75 mg LY2189265-0.60-1.05
1.5 mg LY2189265-0.50-0.50
Insulin Glargine-0.93-1.28

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Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52

The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model. (NCT01191268)
Timeframe: 26 weeks and 52 weeks

,,
Interventionpercentage of participants (Number)
HbA1c less than 7.0%, 26 weeksHbA1c less than 7.0%, 52 weeksHbA1c less than or equal to 6.5%, 26 weeksHbA1c less than or equal to 6.5%, 52 weeks
0.75 mg LY218926569.056.343.034.7
1.5 mg LY218926567.658.548.036.7
Insulin Glargine56.849.337.530.4

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Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)

Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks. (NCT01191268)
Timeframe: Baseline and 26 weeks and 52 weeks

,,
Interventionunits (Mean)
TDI, BaselineTDI, 26 weeks (n=244, 251, 254)TDI, 52 weeks (n=224, 227, 238)Insulin Lispro, 26 weeks (n=244, 251, 254)Insulin Lispro, 52 weeks (n=224, 227, 238)Insulin Glargine, 26 weeks (n=244, 251, 254)Insulin Glargine, 52 weeks (n=224, 227, 238)
0.75 mg LY218926559.1196.6995.0096.6995.00NANA
1.5 mg LY218926555.2093.2488.1593.2488.15NANA
Insulin Glargine53.93132.00133.1967.7969.1264.4864.07

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Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes

Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionunits per liter (U/L) (Median)
Amylase (total), 26 weeks (n=284, 282, 287)Amylase (total), 52 weeks (n=284, 283, 287)Amylase (PD), 26 weeks (n=284, 282, 287)Amylase (PD), 52 weeks (n=284, 283, 287)Lipase, 26 weeks (n=284, 282, 287)Lipase, 52 weeks (n=284, 283, 287)
0.75 mg LY21892654.002.002.502.004.003.00
1.5 mg LY21892655.002.004.003.007.006.00
Insulin Glargine1.000.001.000.00-2.00-2.00

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Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks

Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01191268)
Timeframe: Baseline through 52 weeks

,,
Interventionparticipants (Number)
Any cardiovascular eventAny fatal cardiovascular eventAny non-fatal cardiovascular event
0.75 mg LY2189265606
1.5 mg LY2189265505
Insulin Glargine12211

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Change From Baseline to 26 and 52 Weeks in Pulse Rate

Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionbeats per minute (bpm) (Least Squares Mean)
26 weeks (n=255, 261, 258)52 weeks (n=239, 240, 246)
0.75 mg LY21892652.792.27
1.5 mg LY21892652.842.38
Insulin Glargine0.900.93

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Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01191268)
Timeframe: Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose

,,
Interventionparticipants (Number)
26 weeks52 weeks4 weeks after last dose
0.75 mg LY2189265216230235
1.5 mg LY2189265203217223
Insulin Glargine178206211

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Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose

A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. (NCT01191268)
Timeframe: Baseline through 4 weeks after last dose

Interventionparticipants (Number)
26 weeks52 weeks4 weeks after last dose
1.5 mg or 0.75 mg LY2189265NANA9

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Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD). (NCT01191268)
Timeframe: Baseline and 52 weeks and 4 weeks after last dose

,,
Interventionunits per liter (U/L) (Mean)
Amylase (total), BaselineAmylase (total), 52 weeks (n=284, 283, 287)Amylase (total), 4 weeks ALD (n=251, 259, 251)Amylase (PD), BaselineAmylase (PD), 52 weeks (n=284, 283, 287)Amylase (PD), 4 weeks ALD (n=251, 260, 251)Lipase, BaselineLipase, 52 weeks (n=284, 283, 287)Lipase, 4 weeks ALD (n=252, 260, 251)
0.75 mg LY218926558.5960.9759.2125.1027.8625.7741.0845.3441.86
1.5 mg LY218926561.2166.0861.6926.5631.3827.5041.4250.5744.19
Insulin Glargine61.1861.9362.1326.4326.9126.8443.2039.3943.02

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Change From Baseline to 26 and 52 Weeks in Serum Calcitonin

(NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionpicogram per milliliter (pcg/mL) (Median)
26 weeks (n=283, 282, 285)52 weeks (n=283, 283, 285)
0.75 mg LY21892650.000.00
1.5 mg LY21892650.000.00
Insulin Glargine0.000.00

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Change From Baseline to 26 and 52 Weeks in the EQ-5D

The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionunits on a scale (Least Squares Mean)
EQ-5D UK, 26 weeks (n=272, 271, 274)EQ-5D UK, 52 weeks (n=274, 274, 281)VAS, 26 weeks (n=278, 275, 275)VAS, 52 weeks (n=279, 278, 282)
0.75 mg LY2189265-0.03-0.04-2.30-2.54
1.5 mg LY2189265-0.03-0.04-1.69-0.46
Insulin Glargine-0.03-0.03-0.60-0.18

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Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Seated pulse rate was measured. (NCT01191268)
Timeframe: Baseline and 52 weeks and 4 weeks after last dose

,,
Interventionbeats per minute (bpm) (Mean)
Baseline52 weeks (n=290, 290, 295)4 weeks after last dose (n=260, 260, 255)
0.75 mg LY218926575.0877.8374.99
1.5 mg LY218926575.2678.3074.52
Insulin Glargine74.5476.0275.27

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Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose

(NCT01191268)
Timeframe: Baseline and 52 weeks and 4 weeks after last dose

,,
Interventionpicomole per liter (Mean)
Baseline52 weeks (n=284, 283, 285)4 weeks after last dose (n=245, 254, 246)
0.75 mg LY21892650.730.780.73
1.5 mg LY21892650.750.790.76
Insulin Glargine0.780.800.87

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Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles

The self-monitored plasma glucose (SMPG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionmillimoles per liter (mmol/L)] (Least Squares Mean)
Pre-morning meal, 26 weeks (n=228, 231, 232)Post-morning meal, 26 weeks (n=220, 227, 229)Pre-midday meal, 26 weeks (n=227, 231, 233)Post-midday meal, 26 weeks (n=219, 227, 228)Pre-evening meal, 26 weeks (n=226, 231, 232)Post-evening meal, 26 weeks (n=220, 228, 227)Bedtime, 26 weeks (n=220, 221, 226)After bedtime, 26 weeks (n=208, 216, 208)Daily Mean, 26 weeks (n=202, 206, 199)Pre-morning meal, 52 weeks (n=207, 213, 218)Post-morning meal, 52 weeks (n=200, 211, 211)Pre-midday meal, 52 weeks (n=207, 213, 218)Post-midday meal, 52 weeks (n=202, 210, 212)Pre-evening meal, 52 weeks (n=207, 214, 217)Post-evening meal, 52 weeks (n=200, 210, 212)Bedtime, 52 weeks (n=195, 205, 213)After bedtime, 52 weeks (n=192, 192 197)Daily Mean, 52 weeks (n=182, 185, 189)
0.75 mg LY2189265-0.06-3.29-2.38-4.53-3.06-4.54-3.89-1.50-2.970.05-3.23-2.52-4.29-3.07-4.54-3.96-1.36-2.95
1.5 mg LY2189265-0.36-3.70-2.80-4.51-3.24-4.61-4.00-1.48-3.170.03-3.38-2.53-4.333.00-4.22-3.62-1.17-2.84
Insulin Glargine-2.01-4.03-2.65-3.70-2.74-3.90-3.40-1.96-3.10-2.02-3.76-2.63-3.83-2.67-3.71-3.27-1.80-2.97

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Rate of Self-reported Hypoglycemic Events up to 52 Weeks

Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01191268)
Timeframe: Baseline through 52 weeks

,,
Interventionevents per participant per year (Mean)
Severe HEDocumented Symptomatic HEAsymptomatic HETotal HE
0.75 mg LY21892650.0535.0311.5647.42
1.5 mg LY21892650.0330.989.5541.52
Insulin Glargine0.0839.9014.2055.93

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Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose

Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. (NCT01191268)
Timeframe: Baseline and 52 weeks and 4 weeks after last dose

,,
Interventionmilliliters of mercury (mmHg) (Mean)
SBP, BaselineSBP, 52 weeks (n=290, 290, 295)SBP, 4 weeks after last dose (n=260, 260, 255)DBP, BaselineDBP, 52 weeks (n=290, 290, 295)DBP, 4 weeks after last dose (n=260, 260, 255)
0.75 mg LY2189265134.03134.31134.7277.5777.5977.04
1.5 mg LY2189265133.26132.67133.7777.3377.3376.58
Insulin Glargine133.26134.90132.7577.1877.0776.94

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Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose

Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionmillimoles per liter (mmol/L) (Least Squares Mean)
26 weeks (n=253, 256, 255)52 weeks (n=237, 238, 246)
0.75 mg LY21892650.220.41
1.5 mg LY2189265-0.270.08
Insulin Glargine-1.58-1.01

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Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c. (NCT01191268)
Timeframe: Baseline, 26 weeks

Interventionpercentage of glycosylated hemoglobin (Least Squares Mean)
1.5 mg LY2189265-1.64
0.75 mg LY2189265-1.59
Insulin Glargine-1.41

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Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c. (NCT01191268)
Timeframe: Baseline, 52 weeks

Interventionpercentage of glycosylated hemoglobin (Least Squares Mean)
1.5 mg LY2189265-1.48
0.75 mg LY2189265-1.42
Insulin Glargine-1.23

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Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose

(NCT01191268)
Timeframe: Baseline and 52 weeks and 4 weeks after last dose

,,
Interventionkilograms (kg) (Mean)
Baseline52 weeks (n=290, 290, 295)4 weeks after last dose (n=259, 260, 253)
0.75 mg LY218926591.6993.2193.14
1.5 mg LY218926591.0091.5891.69
Insulin Glargine90.7594.1494.27

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Change From Baseline to 26 and 52 Weeks in Blood Pressure

Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionmilliliters of mercury (mmHg) (Least Squares Mean)
SBP, 26 weeks (n=255, 261, 258)SBP, 52 weeks (n=239, 240, 246)DBP, 26 weeks (n=255, 261, 258)DBP, 52 weeks (n=239, 240, 246)
0.75 mg LY2189265-0.651.04-0.080.15
1.5 mg LY2189265-0.97-0.260.02-0.01
Insulin Glargine2.231.98-0.23-0.34

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Change From Baseline to 26 and 52 Weeks in Body Weight

Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionkilograms (kg) (Least Squares Mean)
26 weeks52 weeks
0.75 mg LY21892650.180.86
1.5 mg LY2189265-0.87-0.35
Insulin Glargine2.332.89

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Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionmilliseconds (msec) (Least Squares Mean)
QTcF interval, 26 weeks (n=241, 242, 236)QTcF interval, 52 weeks (n= 222, 221, 221)PR interval, 26 weeks (n=238, 243, 236)PR interval, 52 weeks (n=220, 222, 221)
0.75 mg LY21892650.301.48-1.750.05
1.5 mg LY21892650.291.890.820.85
Insulin Glargine1.591.80-1.13-0.43

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Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate

Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate. (NCT01191268)
Timeframe: Baseline, 26 weeks, and 52 weeks

,,
Interventionbeats per minute (bpm) (Least Squares Mean)
26 weeks (n=244, 246, 243)52 weeks (n=230, 226, 230)
0.75 mg LY21892654.183.83
1.5 mg LY21892653.953.02
Insulin Glargine1.371.03

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Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period

Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect. (NCT01194245)
Timeframe: Baseline, Week 12 and Week 24

Interventionpercentage of hemoglobin A1C (Mean)
Analog-PH20-0.14
Insulin Lispro-0.19

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Change From Baseline in Body Weight at the End of Each Treatment Period

Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). (NCT01194245)
Timeframe: Baseline, Week 12 and Week 24

Interventionpounds (lbs) (Mean)
Analog-PH20-0.25
Insulin Lispro0.10

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Mean Daily Postprandial Glucose (PPG) Excursions

Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented. (NCT01194245)
Timeframe: Week 10 and Week 22

,
Interventionmilligrams per deciliter (mg/dL) (Mean)
1-hr breakfast excursion2-hr breakfast excursion1-hr lunch excursion2-hr lunch excursion1-hr dinner excursion2-hr dinner excursion
Analog-PH2018.85-5.6316.2610.68-0.31-5.13
Insulin Lispro27.467.0826.2520.774.47-5.16

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Mean Daily Insulin Dose

Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). (NCT01194245)
Timeframe: Week 10 and Week 22

Interventionunits (U) (Mean)
Analog-PH2054.28
Insulin Lispro56.05

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Percentage of Participants Meeting Glucose Targets

Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). (NCT01194245)
Timeframe: Baseline through Week 24, excluding 10-point glucose monitoring days

,
Interventionpercentage of participants (Number)
PPG <140 mg/dL for all mealsPPG <140 mg/dL for breakfastPPG <180 mg/dL for all mealsPPG <180 mg/dL for breakfast
Analog-PH2015.021.469.970.5
Insulin Lispro8.810.659.354.0

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Rates of Hypoglycemia at the End of Each Treatment Period

Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01194245)
Timeframe: Week 12 and Week 24

,
Interventionevents per participant per month (Number)
≤70 mg/dL<56 mg/dL
Analog-PH2018.967.50
Insulin Lispro19.918.05

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Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time

Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). (NCT01194258)
Timeframe: Baseline through Week 24, excluding 10-point glucose monitoring days

,
InterventionPercentage of participants (Number)
Overall 90-minute PPG <140 mg/dLPPG <140 mg/dL for breakfastPPG <140 mg/dL for lunchPPG <140 mg/dL for dinnerOverall 90 minute PPG <180 mg/dLPPG <180 mg/dL for breakfastPPG <180 mg/dL for lunchPPG <180 mg/dL for dinner
Analog-PH2013.924.328.713.071.370.483.567.0
Insulin Lispro14.817.426.115.774.865.280.070.4

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Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period

Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect. (NCT01194258)
Timeframe: Baseline, Week 12 and Week 24

Interventionpercentage of HbA1C (Mean)
Analog-PH20-0.48
Insulin Lispro-0.46

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Change From Baseline in Body Weight at the End of Each Treatment Period

Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both cohorts). (NCT01194258)
Timeframe: Baseline, Week 12 and Week 24

Interventionpounds (Mean)
Analog-PH203.35
Insulin-lispro3.44

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Mean Daily PPG Excursions

Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (insulin lispro from both cohorts). (NCT01194258)
Timeframe: Week 10 and Week 22

,
Interventionmg/dL (Mean)
1 hr after breakfast excursion (n=105, n=107)2 hr after breakfast excursion (n=105, n=107)1 hr after lunch excursion (n=105, n=106)2 hr after lunch excursion (n=104, n=106)1 hr after dinner excursion (n=104, n=107)2 hr after dinner excursion (n=104, n=107)
Analog-PH2033.6716.6418.4720.7621.2412.72
Insulin Lispro40.3822.9427.2825.2718.0915.75

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Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring

Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). (NCT01194258)
Timeframe: Week 10 and Week 22

Interventionunits of Insulin (Mean)
Analog-PH20122.99
Insulin Lispro127.47

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Rates of Hypoglycemia at the End of Each Treatment Period

The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and <56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. (NCT01194258)
Timeframe: Week 12 and Week 24

,
InterventionEvents per participant per month (Number)
Blood glucose <70 mg/dL (n=111, n=113)Blood glucose <56 mg/dL (n=91, n=86)
Analog-PH207.921.99
Insulin Lispro7.661.78

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Week 20 (Follow-up) Forced Vital Capacity

Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC (NCT01196104)
Timeframe: Week 20

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine3.77
Insulin Aspart + Insulin Glargine3.57

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Number of Single Coughing Episodes

Total number of times patients coughed only once (NCT01196104)
Timeframe: Baseline to Week 16

InterventionCough episodes (Number)
Technosphere Insulin + Insulin Glargine1
Insulin Aspart + Insulin Glargine0

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Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation

(NCT01196104)
Timeframe: Baseline to Week 16

InterventionCough episodes (Number)
Technosphere Insulin + Insulin Glargine5
Insulin Aspart + Insulin Glargine0

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Mild or Moderate Hypoglycemic Event Rate

"Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation~Nonsevere hypoglycemia is defined as a subject:~SMBG levels < 70 mg/dL AND/OR~Symptoms that are relieved by the self-administration of carbohydrates" (NCT01196104)
Timeframe: Baseline to Week 16

InterventionEvents / subject-month (Number)
Technosphere® Insulin Inhalation Powder (TI)4.47
Comparator4.41

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Change in HbA1c (%) From Baseline to Week 16

Change from Baseline in glycated hemoglobin at Week 16 (NCT01196104)
Timeframe: Baseline to Week 16

InterventionPercentage of total hemoglobin (Least Squares Mean)
Technosphere Insulin + Insulin Glargine-1.2179
Insulin Aspart + Insulin Glargine-1.2652

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Baseline Forced Vital Capacity (FVC)

Baseline FVC (NCT01196104)
Timeframe: Baseline

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine3.63
Insulin Aspart + Insulin Glargine3.48

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Baseline Forced Expiratory Volume in 1 Second (FEV1)

Baseline FEV1 (NCT01196104)
Timeframe: Baseline

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine2.97
Insulin Aspart + Insulin Glargine2.83

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Number of Subjects Reporting Cough Episodes

Number of Subjects Reporting Cough Episodes (NCT01196104)
Timeframe: Baseline to Week 16

InterventionNumber of participants (Number)
Technosphere Insulin + Insulin Glargine4
Insulin Aspart + Insulin Glargine0

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Number of Subjects Reporting Intermittent Coughing Episodes

Number of subjects reporting Intermittent Coughing Episodes (NCT01196104)
Timeframe: Baseline to Week 16

InterventionNumber of participants (Number)
Technosphere Insulin + Insulin Glargine4
Insulin Aspart + Insulin Glargine0

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Severe Hypoglycemic Event Rate

"Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation~Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:~SMBG levels ≤ 36 mg/dL OR~There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures" (NCT01196104)
Timeframe: Baseline to Week 16

InterventionEvents / subject-month (Number)
Technosphere Insulin + Insulin Glargine0.01
Insulin Aspart + Insulin Glargine0.34

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Week 20 (Follow-up) Forced Expiratory Volume in 1 Second

Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment (NCT01196104)
Timeframe: Week 20 (Follow-up)

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine3.07
Insulin Aspart + Insulin Glargine2.86

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Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity

Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC (NCT01196104)
Timeframe: Baseline to Week 20

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine-0.05
Insulin Aspart + Insulin Glargine-0.06

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Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second

Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1 (NCT01196104)
Timeframe: Baseline to Week 20

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine-0.07
Insulin Aspart + Insulin Glargine-0.05

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Week 16 Forced Vital Capacity

Week 16 FVC (NCT01196104)
Timeframe: Week 16

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine3.61
Insulin Aspart + Insulin Glargine3.33

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Week 16 Forced Expiratory Volume in 1 Second

Week 16 FEV1 (NCT01196104)
Timeframe: Week 16

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine2.91
Insulin Aspart + Insulin Glargine2.66

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Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second

Week 16 Change from Baseline in FEV1 (NCT01196104)
Timeframe: Baseline to Week 16

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine-0.14
Insulin Aspart + Insulin Glargine-0.07

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Week 16 Change From Baseline Forced Vital Capacity

Week 16 Change from Baseline FVC (NCT01196104)
Timeframe: Baseline to Week 16

InterventionL (Mean)
Technosphere Insulin + Insulin Glargine-0.13
Insulin Aspart + Insulin Glargine-0.07

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Total Number of Cough Episodes

Total number of times patients coughed once, intermittently or continuously (inclusive) (NCT01196104)
Timeframe: Baseline to Week 16

InterventionCough episodes (Number)
Technosphere Insulin + Insulin Glargine5
Insulin Aspart + Insulin Glargine0

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Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg)

"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.~Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).~Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg)." (NCT01206322)
Timeframe: Acute changes within 2 hours

Interventionml/100g/min/mmHg (Mean)
Diabetes Group: Placebo39.2
Diabetes Group: Insulin46.4
Control Group: Placebo40.3
Control Group: Insulin36.9

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Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score)

"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.~Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).~Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg).~Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order.~Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo." (NCT01206322)
Timeframe: Acute changes within 2 hours

InterventionT-score (Mean)
Diabetes Group: Placebo39.46
Diabetes Group: Insulin41.23
Control Group: Placebo43.1
Control Group: Insulin50.9

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Rehospitalization Rates

(NCT01211730)
Timeframe: Within 1 year following transplantation

Interventionparticipants (Number)
140 Group48
180 Group51

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Rejection of Liver Transplant

Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications (NCT01211730)
Timeframe: within 1 year of transplantation

Interventionparticipants (Number)
140 Group17
180 Group20

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Death Within 1 Year

Death following liver transplant between 1 day and 1 year (NCT01211730)
Timeframe: 1 year

Interventionparticipants (Number)
140 Group5
180 Group7

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Hypoglycemia

Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation (NCT01211730)
Timeframe: Within first 3 days following transplantation

Interventionparticipants (Number)
140 Group27
180 Group10

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Infection Rates

(NCT01211730)
Timeframe: Within 1 year following transplantation

Interventionparticipants (Number)
140 Group35
180 Group54

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Overall Graft Survival at 1 Year

(NCT01211730)
Timeframe: 1 year following transplantation

Interventionparticipants (Number)
140 Group77
180 Group74

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Number of Treatment Emergent Hypoglycaemic Episodes

A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product. (NCT01215435)
Timeframe: Week 0 to Week 36

Interventionepisodes (Number)
Pre-breakfast BIAsp 301181
Pre-dinner BIAsp 30953

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11

Estimated mean change from baseline in HbA1c after 11 weeks of treatment (NCT01215435)
Timeframe: Week 0, Week 11

Interventionpercentage of glycosylated haemoglobin (Mean)
Pre-breakfast BIAsp 30-1.04
Pre-dinner BIAsp 30-0.90

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Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36

Estimated mean change from baseline in FPG after 36 weeks of treatment (NCT01215435)
Timeframe: Week 0, Week 36

Interventionmg/dL (Mean)
Pre-breakfast BIAsp 30-61.57
Pre-dinner BIAsp 30-58.43

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Changes in Glycemic Control Measured by A1c

Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority. (NCT01220557)
Timeframe: Baseline and 6 months

InterventionChanges in A1c in percentage points (Mean)
PRIMAS Group-0.4
Control Group0.0

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Myocardial Fatty Acid Esterification Rate

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Interventionumol/g/min (Median)
Iiraglutide0.00274
Insulin Detemir0.00358
Liraglutide Plus Insulin Detemir0.00146

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Myocardial Fatty Acid Oxidation Rate

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Interventionumol/g/min (Median)
Iiraglutide0.1019
Insulin Detemir0.1234
Liraglutide Plus Insulin Detemir0.0992

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Myocardial Glucose Uptake

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Interventionumol/g/min (Median)
Iiraglutide0.055
Insulin Detemir0.0399
Liraglutide Plus Insulin Detemir0.0373

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Number of Participants With Microvascular Events

Composite of microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy. (NCT01257087)
Timeframe: 1 year after surgery

InterventionParticipants (Count of Participants)
Intensive Glycaemic Control0
Conservative Glycaemic Control0

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Percentage of Type 2 Diabetes Mellitus Patients With a Reduction in the Doses/Number of Diabetes Medications Used Preoperatively

A list of patients medication will be collected to assess the percentage of Type 2 Diabetes Mellitus patients with a reduction in the doses/number of diabetes medications used preoperatively (NCT01257087)
Timeframe: 1 year after surgery

InterventionParticipants (Count of Participants)
Intensive Glycaemic Control18
Conservative Glycaemic Control17

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Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6%

Patients will be tested off all anti-diabetes medications if safe to do so to assess the percentage of patients with Type 2 Diabetes Mellitus who achieve fasting blood glucose of less than 5.6 mmol/l and/or HbA1c of less than 6% (NCT01257087)
Timeframe: 1 year after surgery

InterventionParticipants (Count of Participants)
Intensive Glycaemic Control4
Conservative Glycaemic Control4

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Usability of the X54 Insulin Pump Meets Expectations

Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use. (NCT01267175)
Timeframe: 5 weeks

InterventionScores on a scale (Mean)
X54 Pump5.9

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Usability of the Training Material Meets Expectations

Questionnaire completed at the end of the study, measuring usability of the device training manual. Results scored on a Likert scale of 1 - 7, 1 being the least user friendly and 7 being the most user friendly. (NCT01267175)
Timeframe: 5 weeks

InterventionScores on a scale (Mean)
X54 Pump6.1

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Change in Body Weight

Observed change from baseline in body weight after 26 weeks of treatment (NCT01272193)
Timeframe: Week 0, Week 26

Interventionkg (Mean)
IDegAsp OD0.7
IGlar OD0.7

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Change in Glycosylated Haemoglobin (HbA1c)

Observed change from baseline in HbA1c after 26 weeks of treatment (NCT01272193)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp OD-1.35
IGlar OD-1.22

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Rate of Confirmed Hypoglycaemic Episodes

Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01272193)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD191
IGlar OD271

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. (NCT01272193)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD39
IGlar OD53

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT01272193)
Timeframe: Week 0 to Week 26 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEsFatal AEs
IDegAsp OD33471173160
IGlar OD36840143530

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Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal

Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal (NCT01272193)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDegAsp OD1.4
IGlar OD4.7

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Number of Treatment Emergent Hypoglycaemic Episodes

Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included). (NCT01278160)
Timeframe: Weeks 0-16

,
Interventionepisodes (Number)
All episodesNocturnalDiurnalSevereMinor
BIAsp 30 (1:1)14311127035
BIAsp 30 (2:1)1081884020

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9-point SMPG (Self Measured Plasma Glucose) Profile

A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day (NCT01278160)
Timeframe: Week 16

,
Interventionmmol/L (Least Squares Mean)
Before breakfast2 hours after breakfastBefore lunch2 hours after lunchBefore dinner2 hours after dinnerBedtime2:00 - 4:00 a.m.Before breakfast the following day
BIAsp 30 (1:1)6.238.616.799.177.077.947.036.346.22
BIAsp 30 (2:1)6.028.566.428.916.647.927.296.056.30

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Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline

(NCT01278160)
Timeframe: Week 0, week 16

Interventionpercentage of glycosylated haemoglobin (Least Squares Mean)
BIAsp 30 (2:1)-0.13
BIAsp 30 (1:1)-0.12

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Percentage of Subjects Achieving HbA1c Below 7.0%

The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment (NCT01278160)
Timeframe: Week 16

Interventionpercentage of subjects (Number)
BIAsp 30 (2:1)12.4
BIAsp 30 (1:1)14.4

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Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%

The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment (NCT01278160)
Timeframe: Week 16

Interventionpercentage of subjects (Number)
BIAsp 30 (2:1)2.2
BIAsp 30 (1:1)7.8

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Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).

The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency. (NCT01282164)
Timeframe: one year

Interventionug/dL (Median)
Patients With 1-2 PHD- Insulin Tolerance Test22.2
Patients With 1-2 PHD- Fixed Dose GST19.5
Patients With 1-2 PHD- Weight Based GST22.7

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Peak Growth Hormone (GH) Level in Healthy Volunteers

The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers (NCT01282164)
Timeframe: one year

Interventionng/mL (Median)
Control Group- ITT14.0
Control Group- Fixed-dose GST4.5
Control Group- Weight-based GST5.8

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Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test

The peak cortisol level during ACTH stimulation test in 3 patients with adult onset hypothalamic-pituitary disease who were older than 65 years of age and could not under go insulin tolerance test (ITT). (NCT01282164)
Timeframe: one year

Interventionug/dL (Median)
Patients Older Than 6510

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Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).

The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency. (NCT01282164)
Timeframe: one year

Interventionug/dL (Median)
Patients With 3 or More PHD- Insulin Tolerance Test6.3
Patients With 3 or More PHD- Fixed Dose GST2.3
Patients With 3 or More PHD- Weight Based GST2.5

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Peak Cortisol Level in Healthy Volunteers.

The peak cortisol levels during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers. (NCT01282164)
Timeframe: one year

Interventionug/dL (Median)
Control Group- ITT22.1
Control Group- Fixed-dose GST18.0
Control Group- Weight-based GST22.7

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Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).

The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency. (NCT01282164)
Timeframe: one year

Interventionng/mL (Median)
Patients With 1-2 PHD- Insulin Tolerance Test0.9
Patients With 1-2 PHD- Fixed Dose GST0.6
Patients With 1-2 PHD- Weight Based GST0.7

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Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).

The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease with three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency. (NCT01282164)
Timeframe: one year

Interventionng/mL (Median)
Patients With 3 or More PHD- Insulin Tolerance Test0.1
Patients With 3 or More PHD- Fixed Dose GST0.1
Patients With 3 or More PHD- Weight Based GST0.1

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Area Over Basal for Postprandial Triglycerides

Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. (NCT01293396)
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

Interventionmg*min/dL (Mean)
Biphasic Insulin Aspart 30484
Biphasic Insulin Aspart 70358
Insulin Aspart412

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Maximum Glucose Increase

Maximum glucose increase from baseline to 600min after baseline (NCT01293396)
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

Interventionmg/dL (Mean)
Biphasic Insulin Aspart 3089.25
Biphasic Insulin Aspart 7055.95
Insulin Aspart60.25

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Maximum Triglyceride Increase

Maximum trigylceride increase from Baseline to 600min after Baseline (NCT01293396)
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

Interventionmg/dL (Mean)
Biphasic Insulin Aspart 30484
Biphasic Insulin Aspart 70358
Insulin Aspart412

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Area Over Basal for Postprandial C-peptide

Area over basal for postprandial c-peptide from 0 (Fasting c-peptide, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. (NCT01293396)
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

Interventionmg*min/mL (Mean)
Biphasic Insulin Aspart 3021.6
Biphasic Insulin Aspart 7012.8
Insulin Aspart13.4

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Area Over Basal for Postprandial Glucose From 0 to 600min

Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. (NCT01293396)
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

Interventionmg*/min/dL (Mean)
Biphasic Insulin Aspart 30591
Biphasic Insulin Aspart 70220
Insulin Aspart197

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Area Over Basal for Postprandial Insulin

Area over basal for postprandial insulin from 0 (Fasting insulin, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. (NCT01293396)
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

InterventionµU*min/L (Mean)
Biphasic Insulin Aspart 30211.2
Biphasic Insulin Aspart 70141.2
Insulin Aspart128.6

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT01326026)
Timeframe: Week 0 to Week 26 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEsFatal AEs
IDeg Simple3461515692620
IDeg Step Wise3791510792912

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Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 26 weeks of treatment. (NCT01326026)
Timeframe: Week 0, Week 26

Interventionmmol/L (Mean)
IDeg Simple-3.27
IDeg Step Wise-2.68

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01326026)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg Simple-1.09
IDeg Step Wise-0.93

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Rate of Confirmed Hypoglycaemic Episodes

Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01326026)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg Simple160
IDeg Step Wise117

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Observed rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT01326026)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg Simple21
IDeg Step Wise10

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Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.

Values of mean change in HbA1c. (NCT01336023)
Timeframe: Week 0, week 26

InterventionPercentage of glycosylated haemoglobin (Mean)
IDeg-1.44
IDegLira-1.91
Liraglutide-1.28

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Mean Change From Baseline in Body Weight at Week 26

Values of mean change in body weight. (NCT01336023)
Timeframe: Week 0, Week 26

Interventionkg (Mean)
IDeg1.6
IDegLira-0.5
Liraglutide-3.0

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Mean Actual Daily Insulin Dose

Mean of the actual doses recorded at visit 28 (Week 26). (NCT01336023)
Timeframe: Week 26

Interventionunits (Mean)
IDeg53
IDegLira38

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Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test

Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point. (NCT01336023)
Timeframe: Week 0, Week 26

Interventionmmol/L (Mean)
IDeg-0.17
IDegLira-0.87
Liraglutide-0.78

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Number of Hypoglycaemic Episodes

Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure. (NCT01336023)
Timeframe: Weeks 0-26

InterventionEvents per 100 patient years of exposure (Number)
IDeg256.7
IDegLira180.2
Liraglutide22.0

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Number of Subjects That Were Diagnosed for Peri-operative Complications

Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization (NCT01361594)
Timeframe: Within 6 months of hospitalization

Interventionparticipants (Number)
Intensive Insulin Treatment58
Conventional Insulin Treatment70

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Hospital Mortality

Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission. (NCT01361594)
Timeframe: average 1 month during the hospitalization

Interventionparticipants (Number)
Intensive Insulin Treatment5
Conventional Insulin Treatment2

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. (NCT01364428)
Timeframe: Week 0 to Week 22 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg 200 U/mL127
IDeg170

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Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 22 weeks of treatment. (NCT01364428)
Timeframe: Week 0, Week 22

Interventionmmol/L (Mean)
IDeg 200 U/mL-2.26
IDeg-2.40

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 22 weeks of treatment (NCT01364428)
Timeframe: Week 0, Week 22

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg 200 U/mL-0.79
IDeg-0.70

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Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01364428)
Timeframe: Week 0 to Week 22 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg 200 U/mL517
IDeg566

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT01364428)
Timeframe: Week 0 to Week 22 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEsFatal AEs
IDeg30016211071720
IDeg 200 U/mL41620271302590

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Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. (NCT01365507)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp Simple52
IDegAsp Step Wise41

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Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT01365507)
Timeframe: Week 0 to Week 26 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEsFatal AEs
IDegAsp Simple22623681550
IDegAsp Step Wise3421331122280

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Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01365507)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp Simple326
IDegAsp Step Wise207

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01365507)
Timeframe: Week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp Simple-1.33
IDegAsp Step Wise-1.09

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Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 26 weeks of treatment. (NCT01365507)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
IDegAsp Simple-2.99
IDegAsp Step Wise-2.73

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Number of Participants With a Favorable Barthel Index

Favorable outcomes for the Barthel Index was defined as a score of 95-100 on the BI at 90 days post randomization. Barthel - Barthel Index for Activities of Daily Living (ADL) assesses functional independence, generally in stroke patients. Scores range from 0-100 with higher scores indicating greater ability to perform activities of daily living. (NCT01369069)
Timeframe: Follow up (Max 164 days)

InterventionParticipants (Count of Participants)
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL271
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL261

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Number of Participants With a Favorable Modified Rankin Scale (Yes/No)

Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment. (NCT01369069)
Timeframe: 90 days (-14/+30 days)

InterventionParticipants (Count of Participants)
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL119
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL123

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Death

Death from any cause (NCT01369069)
Timeframe: 90 days (+30 days)

InterventionParticipants (Count of Participants)
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL54
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL65

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Number of Participants With a Favorable NIHSS

The NIHSS (National Institutes of Health Stroke Scale) score ranges from 0 to 42, with higher scores indicating greater neurological deficits. A favorable NIHSS was defined as a score of 0 or 1 on the NIHSS at 90 days post randomization. (NCT01369069)
Timeframe: Follow up (Max 164 days)

InterventionParticipants (Count of Participants)
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL152
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL166

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Stroke Specific Quality of Life (SSQOL)

Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life (NCT01369069)
Timeframe: Follow up (Max 164 days)

Interventionscore on a scale (Median)
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL3.75
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL3.69

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Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)

Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period. (NCT01369069)
Timeframe: 72 hours

InterventionParticipants (Count of Participants)
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL15
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL0

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Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL). (NCT01388361)
Timeframe: Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.

,,
Interventionevents (Number)
Confirmed(severe+minor)Severe
IDeg3131
IDeg + IAsp OD3300
IDeg + Liraglutide400

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Change From Baseline in Fasting Plasma Glucose (FPG)

Values for change in FPG in mmol/L from baseline to week 26 of randomised period. (NCT01388361)
Timeframe: week 0, week 26

Interventionmmol/L (Mean)
IDeg-1.23
IDeg + Liraglutide-0.14
IDeg + IAsp OD-0.04

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Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)

Values for change in HbA1c from baseline to 26 weeks of treatment period. (NCT01388361)
Timeframe: week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg0.10
IDeg + Liraglutide-0.74
IDeg + IAsp OD-0.39

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Change From Baseline in Body Weight

Corresponds to the values of change in body weight in kilograms from baseline to week 26. (NCT01388361)
Timeframe: week 0, week 26

Interventionkg (Mean)
IDeg0.1
IDeg + Liraglutide-1.0
IDeg + IAsp OD0.3

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Change in Body Weight

Observed mean change from baseline in body weight after 26 Weeks of treatment. (NCT01392573)
Timeframe: Week 0, week 26

Interventionkg (Mean)
IDegLira-2.7
IDeg0.0

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Observed mean change from baseline in HbA1c after 26 Weeks of treatment. (NCT01392573)
Timeframe: Week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegLira-1.90
IDeg-0.89

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Frequency of Hypoglycemia

Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject. (NCT01408628)
Timeframe: 6-month follow up period following the Internet Intervention

Interventionincidents per person-year (Mean)
Internet Insulin Education6.88

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Change in HbA1c

Change in HbA1c (average measure of the % of glycosolated hemoglobin in the blood over the past 3 months) from baseline to end of follow up period. (NCT01408628)
Timeframe: Change from Baseline through Month 6 of follow-up period

Interventionpercentage of glycosolated hemoglobin (Mean)
Internet Insulin Education-1.33

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Severity of Self-reported Hypoglycemia

Severity was defined by the scale used by the DCCT: grade 1 - subject was able to recognize and treat appropriately without assistance; grade 2 - subject required help from another person either to recognize or recognize/treat; grade 3 - subject required injection of glucagon or treatment in ER (NCT01408628)
Timeframe: 6 Months

Interventionincidents (count) (Number)
Grade 1Grade 2Grade 3
Internet Insulin Education14110

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Difference Between Heart Rate Variability Between Intravenous and Subcutaneous Group

difference in mean low frequency/high frequency heart rate variability (LF/HF HRV)at 6 hour. 2 patients were excluded who did not have usable LF/HF HRV data at 6 hours. These patients remained in the study as they did have other measures. (NCT01409239)
Timeframe: 6 hour

Interventionnone (ratio) (Median)
Subcutaneous Insulin1.0
Intravenous Insulin2.6

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Pre-lunch Blood Glucose Level

Blood glucose levels were documented at 12 pm just prior to being served lunch. (NCT01421225)
Timeframe: Participants will be followed for the duration of the 48 hour protocol

Interventionmg/dL (Mean)
Standard Insulin Pump Therapy273
Closed-Loop Insulin Therapy189

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Nocturnal Glycemic Control

Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group. (NCT01421225)
Timeframe: Participants will be followed for the duration of the 48 hour protocol.

InterventionHours (Mean)
Standard Insulin Pump Therapy3.2
Closed-Loop Insulin Therapy5.3

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Number of Interventions for Hypoglycemia

The number of interventions for hypoglycemia between 10 PM - 8 AM. (NCT01421225)
Timeframe: Participants will be followed for the duration of the 48 hour protocol

InterventionInterventions (Number)
Standard Insulin Pump Therapy4
Closed-Loop Insulin Therapy5

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Post-prandial Glycemic Control

Peak post-prandial blood sugar between 8 AM and noon (NCT01421225)
Timeframe: Participants will be followed for the duration of the 48 hour protocol

Interventionmg/dL (Mean)
Standard Insulin Pump Therapy353
Closed-Loop Insulin Therpay367

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Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.

Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method. (NCT01432275)
Timeframe: 25 days

Interventionparticipants (Number)
Per Protocol Population125

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Preference Questionnaire (Insulin Calculator Not Activated)

"Result for the question: The meter the subject would change to" (NCT01432275)
Timeframe: 25 days (results recorded after the two 7 day periods)

Interventionparticipants (Number)
Subject would change to FreeStyle InsuLinxSubject would change to a comparison meterNot likely to change / not sure / missing answer
Per Protocol Population983234

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Insulin Sensitivity

Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge. (NCT01439672)
Timeframe: 24 hours

Intervention1/min per uU/mL (Mean)
Insulin Sensitivity3.37*10^-4

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Change in Body Weight From Baseline to Week 24

Change in body weight from Baseline to Week 24 (NCT01445951)
Timeframe: Baseline to Week 24

Interventionkg (Least Squares Mean)
Technosphere Insulin-Gen2 + Basal Insulin-0.39
Technosphere Insulin-MedTone + Basal Insulin-0.19
Insulin Aspart + Basal Insulin0.93

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FEV1 Change From Baseline to Week 24

Forced Expiratory Volume in 1 second - change from baseline to week 24 (NCT01445951)
Timeframe: Baseline to Week 24

InterventionLiters (Least Squares Mean)
Technosphere Insulin-Gen2 + Basal Insulin-0.07
Technosphere Insulin-MedTone + Basal Insulin-0.08
Insulin Aspart + Basal Insulin-0.04

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FPG Change From Baseline to Week 24

Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results) (NCT01445951)
Timeframe: Baseline to Week 24

Interventionmg/dL (Least Squares Mean)
Technosphere Insulin-Gen2 + Basal Insulin-25.27
Technosphere Insulin-MedTone + Basal Insulin7.15
Insulin Aspart + Basal Insulin10.15

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Incidence of Severe Hypoglycemia

Severe Hypoglycemia defined as: Requiring 3rd party assistance. (NCT01445951)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
Technosphere Insulin-Gen2 + Basal Insulin18.4
Technosphere Insulin-MedTone + Basal Insulin21.4
Insulin Aspart + Basal Insulin29.2

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Mean 7-point Glucose Week 24 Values

(NCT01445951)
Timeframe: Week 24

,,
Interventionmg/dL (Mean)
Before breakfastAfter breakfastBefore lunchAfter lunchBefore dinnerAfter dinnerBedtime
Insulin Aspart + Basal Insulin155.3163.0149.1158.2156.8157.8175.4
Technosphere Insulin-Gen2 + Basal Insulin148.2169.7168.2173.7177.8180.8185.2
Technosphere Insulin-MedTone + Basal Insulin147.9164.1165.9163.1177.3168.2185.6

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Severe Hypoglycemia Event Rate

Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months) (NCT01445951)
Timeframe: Baseline to Week 24

InterventionEvents/Subject-Month (Number)
Technosphere Insulin-Gen2 + Basal Insulin8.05
Technosphere Insulin-MedTone + Basal Insulin9.99
Insulin Aspart + Basal Insulin14.45

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Mean 7-point Glucose Baseline Values

Mean 7-point glucose at baseline (NCT01445951)
Timeframe: Baseline

,,
Interventionmg/dL (Mean)
Before breakfastAfter breakfastBefore lunchAfter lunchBefore dinnerAfter dinnerBedtime
Insulin Aspart + Basal Insulin147.0162.6142.3157.6154.0158.5164.4
Technosphere Insulin-Gen2 + Basal Insulin154.1173.3158.0169.5169.9176.2178.3
Technosphere Insulin-MedTone + Basal Insulin151.8173.5156.6169.7168.1177.0175.1

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Total Hypoglycemia Event Rate

Number of Hypoglycemic Events/Total Subject Exposure Time (in months) (NCT01445951)
Timeframe: Baseline to Week 24

InterventionEvents/Subject-Month (Number)
Technosphere Insulin-Gen2 + Basal Insulin9.80
Technosphere Insulin-MedTone + Basal Insulin10.30
Insulin Aspart + Basal Insulin13.97

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Proportion of Responders Achieving HbA1c <= 7.0%

Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0% (NCT01445951)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Technosphere Insulin-Gen2 + Basal Insulin18.3
Technosphere Insulin-MedTone + Basal Insulin21.7
Insulin Aspart + Basal Insulin30.7

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Incidence of Total Hypoglycemia

Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates. (NCT01445951)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
Technosphere Insulin-Gen2 + Basal Insulin96.0
Technosphere Insulin-MedTone + Basal Insulin96.0
Insulin Aspart + Basal Insulin99.4

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Change From Baseline to Week 24 in HbA1c

Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24 (NCT01445951)
Timeframe: Baseline to Week 24

InterventionPercent of hemoglobin (Least Squares Mean)
Technosphere Insulin-Gen2 + Basal Insulin-0.21
Technosphere Insulin-MedTone + Basal Insulin-0.29
Insulin Aspart + Basal Insulin-0.40

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Change in Body Weight From Baseline to Week 24

Change in body weight from Baseline to Week 24 (NCT01451398)
Timeframe: Baseline to Week 24

Interventionkg (Least Squares Mean)
TI Inhalation Powder + OADs0.49
Technosphere Powder-1.13

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Change From Baseline to Week 24 in HbA1c

Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24 (NCT01451398)
Timeframe: Baseline to Week 24

Interventionpercentage of hemoglobin (Least Squares Mean)
TI Inhalation Powder + OADs-0.82
Technosphere Powder-0.42

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Time to Rescue

Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment (NCT01451398)
Timeframe: Baseline to Week 24

InterventionDays (Median)
TI Inhalation Powder + OADs95
Technosphere Powder85

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Total Hypoglycemia Event Rate

Number of Hypoglycemic Events/Total Subject Exposure Time (in months) (NCT01451398)
Timeframe: Baseline to Week 24

InterventionEvents/Subject-Month (Number)
TI Inhalation Powder + OADs1.16
Technosphere Powder0.50

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Mean 7-point Glucose Baseline Values

Mean 7-point self-monitored glucose at baseline (NCT01451398)
Timeframe: Baseline

,
Interventionmg/dL (Mean)
Before BreakfastAfter BreakfastBefore LunchAfter LunchBefore DinnerAfter DinnerBedtime
Technosphere Powder182.2219.9183.6209.1187.6211.2203.8
TI Inhalation Powder + OADs178.5212.8176.7197.0176.8205.2203.3

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Proportion of Responders Achieving HbA1c <= 6.5%

Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% at Week 24 (NCT01451398)
Timeframe: Week 24

Interventionpercentage of participants (Number)
TI Inhalation Powder + OADs15.9
Technosphere Powder4.2

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Proportion of Subjects Requiring Rescue Therapy

(NCT01451398)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
TI Inhalation Powder + OADs6.8
Technosphere Powder9.7

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Incidence of Total Hypoglycemia

Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates. (NCT01451398)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
TI Inhalation Powder + OADs67.8
Technosphere Powder30.7

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Incidence of Severe Hypoglycemia

Severe Hypoglycemia defined as: Requiring 3rd party assistance. (NCT01451398)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
TI Inhalation Powder + OADs5.1
Technosphere Powder1.7

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Severe Hypoglycemia Event Rate

Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months) (NCT01451398)
Timeframe: Baseline to Week 24

InterventionEvents/100 Subject-Month (Number)
TI Inhalation Powder + OADs2.37
Technosphere Powder0.60

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FEV1 Change From Baseline to Week 24

Forced Expiratory Volume in 1 second - change from baseline to week 24 (NCT01451398)
Timeframe: Baseline to Week 24

InterventionLiters (Mean)
TI Inhalation Powder + OADs-0.13
Technosphere Powder-0.04

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FPG Change From Baseline to Week 24

Efficacy as measured by mean change in fasting plasma glucose (FPG) (NCT01451398)
Timeframe: Baseline to Week 24

Interventionmg/dL (Least Squares Mean)
TI Inhalation Powder + OADs-11.20
Technosphere Powder-3.78

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Proportion of Responders Achieving HbA1c <= 7.0%

Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0% (NCT01451398)
Timeframe: Week 24

Interventionpercentage of participants (Number)
TI Inhalation Powder + OADs37.7
Technosphere Powder19.0

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Mean 7-point Glucose Week 24 Values

Mean 7-point self-monitored blood glucose at Week 24 (NCT01451398)
Timeframe: Week 24

,
Interventionmg/dL (Mean)
Before BreakfastAfter BreakfastBefore LunchAfter LunchBefore DinnerAfter DinnerBedtime
Technosphere Powder160.9194.7163.4183.8164.7188.5178.7
TI Inhalation Powder + OADs156.6170.3152.4158.0157.4164.3163.0

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Low Blood Sugar Survey (LBSS) at 26 Weeks

LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM including stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline number of insulin injections [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline LBSS score. (NCT01468987)
Timeframe: 26 weeks

Interventionunits on a scale (Least Squares Mean)
LY2605541 + Insulin Lispro21.44
Insulin Glargine + Insulin Lispro21.67

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HbA1c at 26 Weeks

HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for stratification factors (country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment, visit-by-treatment interaction, and baseline HbA1c. (NCT01468987)
Timeframe: 26 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
LY2605541 + Insulin Lispro6.76
Insulin Glargine + Insulin Lispro6.97

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Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks

LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FSG. (NCT01468987)
Timeframe: 26 weeks

Interventionmg/dL (Least Squares Mean)
LY2605541 + Insulin Lispro125.33
Insulin Glargine + Insulin Lispro132.02

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Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks

9-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to Weeks 0, 4, 12, and 26. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline BG values. (NCT01468987)
Timeframe: 26 weeks

,
Interventionmg/dL (Least Squares Mean)
Pre-morning meal2 hours post-morning mealPre-midday meal2 hours post-midday mealPre-evening meal2 hours post-evening mealBedtime0300 hoursPre-morning meal next day
Insulin Glargine + Insulin Lispro133.81156.41133.63156.17149.19166.59163.62140.19132.07
LY2605541 + Insulin Lispro137.31162.77130.02145.55142.65156.56160.15143.90135.09

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Rapid Assessment of Physical Activity (RAPA) at 26 Weeks

The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility. Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility activity, either strength or flexibility activity (not both), both strength and flexibility activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, multiplied by 100. (NCT01468987)
Timeframe: up to 26 weeks

,
Interventionpercentage of participants (Number)
RAPA 1, SedentaryRAPA 1, UnderactiveRAPA 1, Light activityRAPA 1, Regular underactiveRAPA 1, ActiveRAPA 2, Neither strength/flexibilityRAPA 2, Either strength/flexibilityRAPA 2, Both strength/flexibility
Insulin Glargine + Insulin Lispro2.46.218.027.146.353.830.615.6
LY2605541 + Insulin Lispro2.24.621.932.738.658.328.113.6

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Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks

The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. (NCT01468987)
Timeframe: up to 26 weeks

,
Interventionpercentage of participants (Number)
HbA1c ≤6.5%HbA1c <7.0%
Insulin Glargine + Insulin Lispro32.653.3
LY2605541 + Insulin Lispro44.463.3

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Lipid Profile at 26 Weeks

Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable], number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. (NCT01468987)
Timeframe: 26 weeks

,
Interventionmg/dL (Least Squares Mean)
CholesterolHDL-CLDL-CTriglycerides
Insulin Glargine + Insulin Lispro174.7947.7198.89141.78
LY2605541 + Insulin Lispro177.1746.4497.87168.79

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Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks

Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each post-baseline visit and stratification variables (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and baseline number of insulin injections [1, 2, or ≥3]). (NCT01468987)
Timeframe: 26 weeks

,
Interventionunits/kg/day (Least Squares Mean)
Basal InsulinBolus InsulinTotal Insulin
Insulin Glargine + Insulin Lispro0.600.631.21
LY2605541 + Insulin Lispro0.680.611.27

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0300-hour Blood Glucose to FBG Excursion at 26 Weeks

Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline excursion. (NCT01468987)
Timeframe: 26 weeks

Interventionmg/dL (Least Squares Mean)
LY2605541 + Insulin Lispro-11.95
Insulin Glargine + Insulin Lispro-15.16

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Body Weight Change From Baseline to 26 Weeks

LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline body weight as fixed effects, and participant as a random effect. (NCT01468987)
Timeframe: Baseline, 26 weeks

Interventionkilograms (kg) (Least Squares Mean)
LY2605541 + Insulin Lispro1.25
Insulin Glargine + Insulin Lispro2.21

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Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks

HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c. (NCT01468987)
Timeframe: Baseline, 26 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
LY2605541 + Insulin Lispro-1.66
Insulin Glargine + Insulin Lispro-1.45

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EuroQoL-5D (EQ-5D) at 26 Weeks

The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥ 3]), and baseline EQ-5D score. (NCT01468987)
Timeframe: up to 26 weeks

Interventionunits on a scale (Least Squares Mean)
LY2605541 + Insulin Lispro0.86
Insulin Glargine + Insulin Lispro0.85

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Total Hypoglycemia Rates (Adjusted for 30 Days)

Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. (NCT01468987)
Timeframe: Baseline through 26 weeks

Interventionepisodes/participant/30 days (Mean)
LY2605541 + Insulin Lispro5.97
Insulin Glargine + Insulin Lispro5.42

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Percentage of Participants With Total Hypoglycemia Episodes

Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. (NCT01468987)
Timeframe: Baseline through 26 weeks

Interventionpercentage of participants (Number)
LY2605541 + Insulin Lispro95.2
Insulin Glargine + Insulin Lispro96.6

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Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥3]) as fixed effects and baseline value of the ITSQ scores as a covariate. (NCT01468987)
Timeframe: up to 26 weeks

Interventionunits on a scale (Least Squares Mean)
LY2605541 + Insulin Lispro77.01
Insulin Glargine + Insulin Lispro77.29

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Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks

FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FBG variability. (NCT01468987)
Timeframe: 26 weeks

Interventionmg/dL (Least Squares Mean)
LY2605541 + Insulin Lispro28.67
Insulin Glargine + Insulin Lispro33.54

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Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)

Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. (NCT01468987)
Timeframe: Baseline through 26 weeks

Interventionevents/participant/30 days (Mean)
LY2605541 + Insulin Lispro0.51
Insulin Glargine + Insulin Lispro0.92

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Percentage of Participants With Nocturnal Hypoglycemia Episodes

Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. (NCT01468987)
Timeframe: Baseline through 26 weeks

Interventionpercentage of participants (Number)
LY2605541 + Insulin Lispro59.5
Insulin Glargine + Insulin Lispro74.0

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Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks

Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100. (NCT01468987)
Timeframe: up to 26 weeks

Interventionpercentage of participants (Number)
LY2605541 + Insulin Lispro23.7
Insulin Glargine + Insulin Lispro12.2

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Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks

The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline. (NCT01468987)
Timeframe: Baseline through 26 weeks

Interventionparticipants (Number)
LY2605541 + Insulin Lispro152
Insulin Glargine + Insulin Lispro161

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Total Daily Insulin Dose

Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%) and participants. (NCT01474538)
Timeframe: Week 16 of each treatment (Periods 1 and 2)

Interventionunits of insulin (Least Squares Mean)
Insulin Lispro80.41
Insulin Aspart80.69

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Rate of Hypoglycemic Events Per 30 Days

A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%). (NCT01474538)
Timeframe: Baseline through 16 weeks of each treatment (Periods 1 and 2)

Interventionhypoglycemic events per 30 days (Least Squares Mean)
Insulin Lispro2.24
Insulin Aspart2.38

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Glycosylated Hemoglobin A1C (HbA1c) at Endpoint

Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (>8% or ≤8%) and participants. (NCT01474538)
Timeframe: After 16 weeks of each treatment (Periods1 and 2)

Interventionpercentage of glycosylated hemoglobin (Least Squares Mean)
Insulin Lispro7.50
Insulin Aspart7.40

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Percentage of Participants With Hypoglycemic Events

A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100. (NCT01474538)
Timeframe: Baseline through 16 weeks of each treatment (Periods 1 and 2)

Interventionpercentage of participants (Number)
Insulin Lispro71.2
Insulin Aspart74.8

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Change From Baseline in Weight

Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%), baseline weight and participants. (NCT01474538)
Timeframe: Baseline, Week 16 of treatment Periods 1 and 2

Interventionkilograms (kg) (Least Squares Mean)
Insulin Lispro0.31
Insulin Aspart0.89

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Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others. (NCT01476475)
Timeframe: First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)

,
Interventionpercentage of participants (Number)
Documented symptomatic hypoglycemiaSevere Symptomatic Hypoglycemia
Insulin Glargine (Lantus® SoloSTAR®)22.80.0
Insulin Glargine/Lixisenatide Fixed Ratio Combination21.70.0

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Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24

2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.91
Insulin Glargine-0.67

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Average Daily Insulin Glargine Dose at Week 24

Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Week 24

InterventionUnits (U) (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination36.08
Insulin Glargine39.32

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Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24

On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP. (NCT01476475)
Timeframe: Week 24

,
Interventionpercentage of participants (Number)
HbA1c ≤6.5%HbA1c <7.0%
Insulin Glargine64.678.3
Insulin Glargine/Lixisenatide Fixed Ratio Combination71.984.4

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Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24

The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-7.49
Insulin Glargine-4.33

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Change in HbA1c From Baseline to Week 24

Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP). (NCT01476475)
Timeframe: Baseline, Week 24

Interventionpercentage of hemoglobin (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-1.82
Insulin Glargine-1.64

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Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24

Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.23
Insulin Glargine-2.93

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Change in Body Weight From Baseline to Week 24

Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24

Interventionkg (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-0.97
Insulin Glargine0.48

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Change in FPG From Baseline to Week 24

Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.35
Insulin Glargine-3.51

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Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP. (NCT01476475)
Timeframe: Baseline up to Week 24

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination67.5
Insulin Glargine59.0

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Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24

Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data. (NCT01476475)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination56.3
Insulin Glargine37.3

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Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period

Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%. (NCT01476475)
Timeframe: Baseline up to Week 24

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination0
Insulin Glargine0.6

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Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24

30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24

,
Interventionmmol/L (Least Squares Mean)
30-minute plasma glucose excursion (n=151, 152)1-hour plasma glucose excursion (n=150, 152)
Insulin Glargine-0.05-0.44
Insulin Glargine/Lixisenatide Fixed Ratio Combination-1.47-2.34

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Change in 30-minute and 1-hour PPG From Baseline to Week 24

The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24

,
Interventionmmol/L (Least Squares Mean)
30-minute PPG (n=151, 153)1-hour PPG (n=150, 153)
Insulin Glargine-3.76-4.10
Insulin Glargine/Lixisenatide Fixed Ratio Combination-5.01-5.94

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Area Under the Curve for Glucose Above Baseline

The change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production [mg/kg/min] measured over time [min]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered. (NCT01483651)
Timeframe: 60 minutes after each glucagon administration

Interventionmg/kg glucose per mcg glucagon (Mean)
Low Insulin Infusion Rate0.623
Medium Insulin Infusion Rate0.59
High Insulin Infusion Rate0.03

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Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment

The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal. (NCT01486966)
Timeframe: Week 0, week 2

Interventionmmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-4.00
Insulin NPH + Human Soluble Insulin ± Metformin-3.47

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Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment

The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime. (NCT01486966)
Timeframe: Week 0, week 2

Interventionmmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-2.47
Insulin NPH + Human Soluble Insulin ± Metformin-2.87

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Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment

Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile. (NCT01486966)
Timeframe: Week 0, week 2

Interventionmmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-2.84
Insulin NPH + Human Soluble Insulin ± Metformin-2.80

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Change From Baseline in Fructosamine After Two Weeks of Treatment

(NCT01486966)
Timeframe: Week 0, week 2

InterventionUmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-31.0
Insulin NPH + Human Soluble Insulin ± Metformin-23.7

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Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment

The FPG referred to pre-breakfast plasma glucose. (NCT01486966)
Timeframe: Week 0, week 2

Interventionmmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-2.22
Insulin NPH + Human Soluble Insulin ± Metformin-2.29

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Incidence of Hypoglycaemic Episodes

"All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.~Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) < 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value < 3.1 mmol/l (56 mg/dl).~A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal." (NCT01486966)
Timeframe: Weeks 0-2

,
Interventionevents (Number)
All eventsSevereNocturnalDiurnalMinor
Insulin Detemir + Insulin Aspart ± Metformin2204182
Insulin NPH + Human Soluble Insulin ± Metformin540114311

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Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment

(NCT01486966)
Timeframe: Week 2

Interventionpercentage (%) of subjects (Number)
Insulin Detemir + Insulin Aspart ± Metformin41.4
Insulin NPH + Human Soluble Insulin ± Metformin34.5

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Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment

FPG target was < 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included). (NCT01486966)
Timeframe: Week 2

Interventionpercentage (%) of subjects (Number)
Insulin Detemir + Insulin Aspart ± Metformin41.4
Insulin NPH + Human Soluble Insulin ± Metformin34.5

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Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment

(NCT01486966)
Timeframe: Week 2

Interventionpercentage (%) of subjects (Number)
Insulin Detemir + Insulin Aspart ± Metformin48.3
Insulin NPH + Human Soluble Insulin ± Metformin48.3

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Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment

FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L. (NCT01486966)
Timeframe: Week 2

Interventionpercentage (%) of subjects (Number)
Insulin Detemir + Insulin Aspart ± Metformin20.7
Insulin NPH + Human Soluble Insulin ± Metformin20.7

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The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)

An event is identified as: LGS feature in the correct setting; CGM values <= 65 mg/dL continuously with starting time between 10pm - 8am; No evidence of patient intervention during the first 20 minutes when CGM value was <= 65 mg/dL; The rate of change before reaching sensor glucose value of <= 65 mg/dL was <= 5 mg/dl/minutes; If the time between two successive events was less than 30 minutes, they will be combined as one event; An evaluable event is defined as any event with CGM value <= 65 mg/dL of greater than 20 minutes and the LGS feature is on the correct setting; Event AUC analysis was performed based on logarithm of AUC data. (NCT01497938)
Timeframe: 5 months

Interventionmg/dL x min (Mean)
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'980
Group B Without Low Glucose Suspend (LGS) Feature1568

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Change in A1C From Baseline to End of Study Participation

The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation. (NCT01497938)
Timeframe: 5 months

InterventionPercent (Mean)
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'0.00
Group B Without Low Glucose Suspend (LGS) Feature-0.04

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Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint

Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). (NCT01499082)
Timeframe: Week 9 Up to Month 6

Interventionpercentage of participants (Number)
HOE901-U30036.1
Lantus46.0

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Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. (NCT01499082)
Timeframe: Baseline, Month 6

Interventionpercentage of mean (Least Squares Mean)
HOE901-U300-1.10
Lantus-1.08

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Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. (NCT01499082)
Timeframe: Baseline, Month 6

Interventionunits on a scale (Least Squares Mean)
HOE901-U3002.32
Lantus2.24

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Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. (NCT01499082)
Timeframe: Baseline, Month 6

Interventionmmol/L (Least Squares Mean)
HOE901-U300-0.90
Lantus-0.84

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Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint

(NCT01499082)
Timeframe: Baseline, Month 6

InterventionU/kg (Least Squares Mean)
HOE901-U3000.28
Lantus0.19

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Change in HbA1c From Baseline to Month 6 Endpoint

(NCT01499082)
Timeframe: Baseline, Month 6

Interventionpercentage of hemoglobin (Least Squares Mean)
HOE901-U300-0.83
Lantus-0.83

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Change in HbA1c From Month 6 to Month 9

Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months. (NCT01499082)
Timeframe: Month 6 Up to Month 9

Interventionpercentage of hemoglobin (Least Squares Mean)
HOE901-U300: Adaptable Dosing Intervals0.21
HOE901-U300: Fixed Dosing Intervals0.15

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Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint

(NCT01499082)
Timeframe: Baseline, Month 6

Interventionmmol/L (Least Squares Mean)
HOE901-U300-1.29
Lantus-1.38

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Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint

(NCT01499082)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901-U30026.5
Lantus23.2

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Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12

Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L). (NCT01499082)
Timeframe: Up to Month 12

,
Interventionpercentage of participants (Number)
Any Hypoglycemia Event: All HypoglycemiaSevere Hypoglycemia: All HypoglycemiaDocumented Symptomatic: All HypoglycemiaAsymptomatic: All HypoglycemiaProbable Symptomatic: All HypoglycemiaRelative: All HypoglycemiaSevere and/or Confirmed: All HypoglycemiaAny Hypoglycemia Event: Nocturnal HypoglycemiaSevere Hypoglycemia: NocturnalDocumented Symptomatic: Nocturnal HypoglycemiaAsymptomatic: Nocturnal HypoglycemiaProbable Symptomatic: Nocturnal HypoglycemiaRelative: Nocturnal HypoglycemiaSevere and/or Confirmed: Nocturnal Hypoglycemia
HOE901-U30087.46.774.870.55.715.885.955.42.544.629.22.25.054.5
Lantus92.07.582.873.48.521.191.566.23.257.231.12.710.064.7

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Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint

Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. (NCT01499082)
Timeframe: Baseline, Month 6

,
Interventionmmol/L (Least Squares Mean)
03:00 at Night Plasma Glucose (n=333,323)Pre-Breakfast Plasma Glucose (n=343,333)2 Hours After Breakfast Plasma Glucose (n=335,326)Pre-Lunch Plasma Glucose (n=337,331)2 Hours After Lunch Plasma Glucose (n=336,325)Pre-Dinner Plasma Glucose (n=338,333)2 Hours After Dinner Plasma Glucose (n=331,327)Bedtime Plasma Glucose (n=324, 325)
HOE901-U300-0.98-1.19-1.60-1.05-0.64-0.47-0.96-0.88
Lantus-1.16-1.49-1.90-1.23-0.63-0.37-1.17-0.91

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Percentage of Participants With HbA1c <7% at Month 6 Endpoint

(NCT01499082)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901-U30039.6
Lantus40.9

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Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint

Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Baseline, Month 6

,
Interventionmmol/L (Least Squares Mean)
03:00 at Night (n= 338, 328)Pre-breakfast (n= 347, 338)2 hours after breakfast (n= 341, 328)Pre-lunch (n= 344, 332)2 hours after lunch (n= 339, 328)Pre-dinner (n=347, 336)2 hours after dinner (n= 338, 327)Bedtime (n= 325, 303)
HOE901-U300-0.56-1.31-1.41-0.64-1.02-0.94-0.69-0.99
Lantus-0.90-1.81-1.82-1.12-1.04-0.69-1.00-1.00

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Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12

Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L). (NCT01499095)
Timeframe: Up to Month 12

,
Interventionpercentage of participants (Number)
Any Hypoglycemia Event: All HypoglycemiaSevere Hypoglycemia: All HypoglycemiaDocumented Symptomatic: All HypoglycemiaAsymptomatic: All HypoglycemiaProbable Symptomatic: All HypoglycemiaRelative: All HypoglycemiaSevere and/or Confirmed: All HypoglycemiaAny Hypoglycemia Event: Nocturnal HypoglycemiaSevere Hypoglycemia: Nocturnal HypoglycemiaDocumented Symptomatic: Nocturnal HypoglycemiaAsymptomatic: Nocturnal HypoglycemiaProbable Symptomatic: Nocturnal HypoglycemiaRelative: Nocturnal HypoglycemiaSevere and/or Confirmed: Nocturnal Hypoglycemia
HOE901-U30079.91.758.858.62.77.978.439.70.229.514.41.22.237.5
Lantus83.01.563.364.03.412.882.046.10.534.222.21.06.444.6

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Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint

Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Week 9 Up to Month 6

Interventionpercentage of participants (Number)
HOE901-U30021.6
Lantus27.9

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Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint

Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Baseline, Month 6

Interventionmmol/L (Least Squares Mean)
HOE901-U300-0.56
Lantus-0.51

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Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint

Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Baseline, Month 6

InterventionU/kg (Least Squares Mean)
HOE901-U3000.28
Lantus0.17

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Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint

Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Baseline, Month 6

Interventionmmol/L (Least Squares Mean)
HOE901-U300-1.03
Lantus-1.21

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Change in HbA1c From Baseline to Month 6 Endpoint

Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Baseline, Month 6

Interventionpercentage of hemoglobin (Least Squares Mean)
HOE901-U300-0.57
Lantus-0.56

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Change in HbA1c From Month 6 to Month 9

Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months. Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Month 6 up to Month 9

Interventionpercentage of hemoglobin (Least Squares Mean)
HOE901-U300: Adaptable Dosing Intervals-0.12
HOE901-U300: Fixed Dosing Intervals-0.25

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Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Baseline, Month 6

Interventionunits on a scale (Least Squares Mean)
HOE901-U3003.05
Lantus3.61

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Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint

Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Baseline, Month 6

Interventionpercentage of mean (Least Squares Mean)
HOE901-U300-2.34
Lantus-0.53

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Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint

Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901-U30029.4
Lantus33.6

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Percentage of Participants With HbA1c <7% at Month 6 Endpoint

Only measurements performed before initiation of rescue therapy were considered in the analysis. (NCT01499095)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901-U30030.6
Lantus30.4

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Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)

Change from baseline in FPG after 52 weeks of treatment. (NCT01513473)
Timeframe: Week 0, week 52

Interventionmmol/L (Mean)
IDeg + IAsp-1.29
IDet + IAsp1.10

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Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)

Change from baseline in FPG after 26 weeks of treatment. (NCT01513473)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
IDeg + IAsp-0.67
IDet + IAsp0.50

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)

Change from baseline in HbA1c (%) after 26 weeks of treatment. (NCT01513473)
Timeframe: Week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg + IAsp-0.20
IDet + IAsp-0.31

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Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)

Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below) (NCT01513473)
Timeframe: After 52 weeks of treatment

,
Intervention%B/T (Mean)
Insulin aspart specific antibodiesInsulin Detemir specific antibodiesInsulin Degludec specific antibodiesX-reacting AB Hu Insulin
IDeg + IAsp1.1NA017.2
IDet + IAsp1.56.1NA26.0

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Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))

Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment (NCT01513473)
Timeframe: After 26 weeks and 52 weeks of treatment

,
Interventionepisodes (Number)
26 weeks52 weeks
IDeg + IAsp44109
IDet + IAsp86161

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Number of Hypoglycaemic Episodes

Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours) (NCT01513473)
Timeframe: After 26 weeks and 52 weeks of treatment

,
Interventionepisodes (Number)
26 weeks (entire day)26 weeks (nocturnal)52 weeks (entire day)52 weeks (nocturnal)
IDeg + IAsp117121261215602336
IDet + IAsp109911458183732586

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Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)

Change from baseline in HbA1c (%) after 52 weeks of treatments. (NCT01513473)
Timeframe: Week 0, week 52

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg + IAsp-0.27
IDet + IAsp-0.22

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Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))

Episodes of PG >11.1mmol/L (200mg/dL) (NCT01513473)
Timeframe: After 26 weeks and 52 weeks of treatment

,
Interventionepisodes (Number)
26 weeks52 weeks
IDeg + IAsp3126458679
IDet + IAsp3117352831

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Number of Treatment Emergent Adverse Events (TEAEs)

TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT01513473)
Timeframe: After 26 weeks and 52 weeks of treatment

,
Interventionevents (Number)
TEAEs -26 weeksTEAEs -52 weeks
IDeg + IAsp8101462
IDet + IAsp7611266

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Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment

Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial. (NCT01513473)
Timeframe: Between week 1 and week 26

,
Interventionpmol/L (Mean)
week 2week 12week 26
IDeg + IAsp4540.44148.14105.6
IDet + IAsp3972.25430.16377.0

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01513590)
Timeframe: Week 0, week 26

InterventionPercent (%) glycosylated haemoglobin (Mean)
IDegAsp BID-1.85
BIAsp 30 BID-1.73

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment. (NCT01513590)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
IDegAsp BID-4.44
BIAsp 30 BID-3.03

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Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01513590)
Timeframe: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product

Interventionepisodes (Number)
IDegAsp BID553
BIAsp 30 BID1221

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Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes

The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am. (NCT01513590)
Timeframe: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product

Interventionepisodes (Number)
IDegAsp BID60
BIAsp 30 BID260

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Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks

Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01513590)
Timeframe: Week 26

Interventionparticipants (Number)
IDegAsp BID77
BIAsp 30 BID59

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Number of Treatment Emergent AEs (Adverse Events)

A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator. (NCT01513590)
Timeframe: Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product

,
Interventionevents (Number)
EventsSeriousSevereModerateMildFatal
BIAsp 30 BID137128271022
IDegAsp BID1972013451392

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Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of treatment. (NCT01513590)
Timeframe: Week 0, week 26

Interventionkg (Mean)
IDegAsp BID2.8
BIAsp 30 BID2.0

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Adverse Events (AEs)

Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. (NCT01519674)
Timeframe: Week 0 to Week 24

,,
InterventionEvents/100 years of patient exposure (Number)
All treatment emergent adverse eventsSerious adverse eventsSevere adverse eventsModerate adverse eventsMild adverse eventsFatal adverse events
BID + Met262.28.46.071.0185.20
BID + Sita + Met209.95.810.574.6124.80
OD + Sita + Met281.210.57.079.7194.50

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Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)

Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment. (NCT01519674)
Timeframe: After 24 weeks of treatment

Interventionpercentage (%) of subjects (Number)
BID + Met30.6
BID + Sita + Met40.7
OD + Sita + Met25.1

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Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)

Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment (NCT01519674)
Timeframe: After 24 weeks of treatment

Interventionpercentage (%) of subjects (Number)
BID + Met49.7
BID + Sita + Met59.8
OD + Sita + Met46.5

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Prandial Plasma Glucose (PPG) Overall Mean Increment.

Estimated overall mean post prandial increment after 24 weeks of treatment. (NCT01519674)
Timeframe: After 24 weeks of treatment

Interventionmmol/L (Least Squares Mean)
BID + Met1.97
BID + Sita + Met1.66
OD + Sita + Met1.88

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Prandial Plasma Glucose (PPG) Increments at Lunch.

Estimated mean post prandial increments at lunch after 24 weeks of treatment. (NCT01519674)
Timeframe: After 24 weeks of treatment

Interventionmmol/L (Least Squares Mean)
BID + Met3.05
BID + Sita + Met2.19
OD + Sita + Met2.52

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Prandial Plasma Glucose (PPG) Increments at Dinner.

Estimated mean post prandial increments at dinner after 24 weeks of treatment. (NCT01519674)
Timeframe: After 24 weeks of treatment

Interventionmmol/L (Least Squares Mean)
BID + Met0.89
BID + Sita + Met1.01
OD + Sita + Met0.17

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Prandial Plasma Glucose (PPG) Increments at Breakfast

Estimated mean post prandial increments at breakfast after 24 weeks of treatment. (NCT01519674)
Timeframe: After 24 weeks of treatment

Interventionmmol/L (Least Squares Mean)
BID + Met2.01
BID + Sita + Met1.73
OD + Sita + Met2.89

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Estimated mean change from baseline in HbA1c after 24 weeks of treatment. (NCT01519674)
Timeframe: Week 0 to Week 24

Interventionpercentage of glycosylated haemoglobin (Least Squares Mean)
BID + Met-1.27
BID + Sita + Met-1.51
OD + Sita + Met-1.15

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Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.

Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. (NCT01519674)
Timeframe: Week 0 to Week 24

Interventionscores (Least Squares Mean)
BID + Met6.22
BID + Sita + Met5.93
OD + Sita + Met6.20

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Change From Baseline in Fasting Plasma Glucose (FPG)

Estimated mean change from baseline in fasting plasma glucose (FPG) (NCT01519674)
Timeframe: Week 0 to Week 24

Interventionmmol/L (Least Squares Mean)
BID + Met-1.90
BID + Sita + Met-2.03
OD + Sita + Met-1.96

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Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.

Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself. (NCT01519674)
Timeframe: Week 0 to Week 24

,,
Interventionepisodes (Number)
Diurnal (ADA)Nocturnal (ADA)Diurnal (additional minor)Nocturnal (additional minor)
BID + Met5156816321
BID + Sita + Met4405411214
OD + Sita + Met249637123

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Weight Change During Trial

Weight in kg at 26 weeks minus weight at baseline. (NCT01524705)
Timeframe: Baseline vs 26 weeks

Interventionkg (Mean)
Insulin Glargine, Metformin, Exenatide-4.8
Insulin Glargine, Metformin, Prandial Insulin0.7

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Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline

The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM) (NCT01524705)
Timeframe: At baseline, 6 months of intervention

Interventionpercentage (Mean)
Insulin Glargine, Metformin, Exenatide-2.43
Insulin Glargine, Metformin, Prandial Insulin0.44

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HbA1C Levels

% of glycosylated hemoglobin in whole blood at 26 weeks (NCT01524705)
Timeframe: Baseline vs 26 weeks

Intervention% of HbA1C (Mean)
Insulin Glargine, Metformin, Exenatide7.1
Insulin Glargine, Metformin, Prandial Insulin7.2

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Number of Participants With Hypoglycemia

Severe hypoglycemia-documented glucose <50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel. (NCT01524705)
Timeframe: 26 weeks

InterventionParticipants (Count of Participants)
Insulin Glargine, Metformin, Exenatide0
Insulin Glargine, Metformin, Prandial Insulin0

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Time to 50% Total Glucose Infused (50%Gtot)

Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp. (NCT01526733)
Timeframe: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4

,
Interventionminutes (Mean)
Day 1Day 4
Insulin (Aspart or Lispro)-rHuPH2040.3354.67
Insulin (Aspart or Lispro)-Sham32.5739.67

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Maximum Glucose Infusion Rate (GIRmax)

Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp. (NCT01526733)
Timeframe: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4

,
Interventionmilligrams/kilogram/minute (Mean)
Day 1Day 4
Insulin (Aspart or Lispro)-rHuPH2013.4710.75
Insulin (Aspart or Lispro)-Sham11.1411.83

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Early Insulin Exposure (%AUC[0-60])

Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0 360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose during a euglycemic clamp. (NCT01526733)
Timeframe: 10 minutes predose; 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose on Days 1 and 4

,
Interventionpercentage of AUC(0-60) (Mean)
Day 1Day 4
Insulin (Aspart or Lispro)-rHuPH2033.5339.45
Insulin (Aspart or Lispro)-Sham17.8533.52

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Duration of Insulin Action (AUMC[0-360]/AUC[0-360])

Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]). AUCM is the total area under the first moment curve. First moment curve is obtained by plotting concentration-time versus time. It can be used to measure how long a drug stays in the body. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp. (NCT01526733)
Timeframe: 10 minutes predose; 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4

,
Interventionratio (Mean)
Day 1Day 4
Insulin (Aspart or Lispro)-rHuPH20119.02111.25
Insulin (Aspart or Lispro)-Sham154.03120.57

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Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max)

Early and late tGIR50%max are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp. (NCT01526733)
Timeframe: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4

,
Interventionminutes (Mean)
Early tGIR50%, Day 1Late tGIR50%, Day 1Early tGIR50%, Day 4Late tGIR50%, Day 4
Insulin (Aspart or Lispro)-rHuPH2040.33114.5232.57113.24
Insulin (Aspart or Lispro)-Sham54.67152.1439.67126.71

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Area Under the Glucose Concentration Curve (AUC[0-360])

Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp. (NCT01526733)
Timeframe: 30 minutes and 10 minutes predose; 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4

,
Interventionpicomoles*minutes/liter (Mean)
Day 1Day 4
Insulin (Aspart or Lispro)-rHuPH201312.411063.77
Insulin (Aspart or Lispro)-Sham1199.541139.65

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Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax)

Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp. (NCT01526733)
Timeframe: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4

,
Interventionminutes (Mean)
Day 1Day 4
Insulin (Aspart or Lispro)-rHuPH2078.9581.86
Insulin (Aspart or Lispro)-Sham132.6297.38

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Percentage Time in Euglycaemia

Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values. (NCT01534013)
Timeframe: 18 months

Interventionpercentage of time (Number)
Closed-loop Insulin Delivery71
Open-loop Insulin Delivery66.9

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Insulin Algorithm Performance: Time to the Target Range

Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. Ideally, the algorithm will minimize time to glucose target range. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high. (NCT01565941)
Timeframe: Until study discharge, up to 28 days following randomization

InterventionHours (Median)
Tight Glycemic Control 1 (TGC-1)5.5
Tight Glycemic Control 2 (TGC-2)1.5

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Nursing Workload: SWAT (Subjective Workload Assessment Technique) Instrument

"The workload burden placed upon bedside nurses when managing a patient on TGC will be described. Bedside nurses will be randomly selected to complete an anonymous survey describing their perceptions of workload burden associated with managing a patient during one shift.~Using the SWAT (Subjective Workload Assessment Technique) instrument, perceived workload of Pediatric Intensive Care Nurses caring for HALF-PINT patients in TGC group 1 and TGC group 2 were assessed. The SWAT has been used to study the effect of workload in the fields of nursing, pharmacy and medicine. It measures the following burdens: cognitive (mental effort or concentration required for complexity of task), time (amount of spare time, interruptions, overlapping tasks) and psychological stress associated with work that impacts performance. The SWAT uses a ranking system to weight perceived workload which results in an overall score ranging from 0-100, where higher scores indicate higher perceived workload." (NCT01565941)
Timeframe: One nursing shift caring for patient on TGC, at anytime during the patient's hospital stay through the tenth nursing shift for the patient. Shift determined randomly by the last digit of the study ID number, 0-9 (0=shift 10, 1=shift 1, 2=shift 2, etc.).

Interventionscore on a scale (Median)
Perceived Nursing Workload: Caring for TGC Group 1 Patients50.0
Perceived Nursing Workload: Caring for TGC Group 2 Patients36.2

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Insulin Algorithm Performance: Time in the Target Range

Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. Ideally, the algorithm will maximize time spent in the glucose target range. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high. (NCT01565941)
Timeframe: Until study discharge, up to 28 days following randomization

InterventionPercentage of time (Median)
Tight Glycemic Control 1 (TGC-1)57
Tight Glycemic Control 2 (TGC-2)91

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Insulin Algorithm Performance: Time-Weighted Glucose Average

Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high. (NCT01565941)
Timeframe: Until study discharge, up to 28 days following randomization

Interventionmg/dL (Median)
Tight Glycemic Control 1 (TGC-1)109
Tight Glycemic Control 2 (TGC-2)123

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Incidence of Wound Infection Incidence of Wound Infection

We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: wound infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This non-device-related infection will be counted per 1,000 ICU days. (NCT01565941)
Timeframe: Up to 48 hours after ICU discharge

InterventionInfections/1000 ICU days (Number)
Tight Glycemic Control 1 (TGC-1)0
Tight Glycemic Control 2 (TGC-2)0

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Nursing Workload: NASA-TLX (National Aeronautics and Space Administration - Task Load Index) Instrument

"The cognitive burden placed upon bedside nurses when managing a patient on TGC will be described. Bedside nurses will be randomly selected to complete an anonymous survey describing their perceptions of workload burden associated with managing a patient on TGC.~Using the NASA-TLX instrument, perceived workload of Pediatric Intensive Care Nurses caring for HALF-PINT patients in TGC group 1 and TGC group 2 were assessed. The instrument uses a ranking system to weight perceived workload which results in an overall sore ranging from 0-100, where higher scores indicate higher perceived workload. It obtains overall perception of workload related to stressful tasks and includes 6 dimensions (cognitive demand, physical demand, time pressure, performance, effort, and frustration." (NCT01565941)
Timeframe: One nursing shift caring for patient on TGC, at anytime during the patient's hospital stay through the tenth nursing shift for the patient. Shift determined randomly by the last digit of the study ID number, 0-9 (0=shift 10, 1=shift 1, 2=shift 2, etc.).

Interventionscore on a scale (Median)
Perceived Nursing Workload: Caring for TGC Group 1 Patients35.0
Perceived Nursing Workload: Caring for TGC Group 2 Patients20.4

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Ventilator-Free Days

Ventilator-free days during the 28 days following randomization encompasses both reduction in the duration of ventilation and improvement in mortality. The end of the subject's duration of ventilation is defined as the date/time of extubation for subjects who are intubated, or the date/time of the discontinuation of mechanical ventilation for subjects with tracheostomy. (NCT01565941)
Timeframe: 28 days following randomization

InterventionDays (Median)
Tight Glycemic Control 1 (TGC-1)21.8
Tight Glycemic Control 2 (TGC-2)20.9

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Participants With Severe Hypoglycemia (<40 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)

Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked. (NCT01565941)
Timeframe: Participants will be followed for the duration of ICU stay, an expected average of 8 days

InterventionParticipants (Count of Participants)
Tight Glycemic Control 1 (TGC-1)5
Tight Glycemic Control 2 (TGC-2)6

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Participants With Hypokalemia (<2.5 mmol/L)

Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked. (NCT01565941)
Timeframe: Participants will be followed for the duration of ICU stay, an expected average of 8 days

InterventionParticipants (Count of Participants)
Tight Glycemic Control 1 (TGC-1)76
Tight Glycemic Control 2 (TGC-2)64

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Participants With Any Hypoglycemia (<60 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)

Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked. (NCT01565941)
Timeframe: Participants will be followed for the duration of ICU stay, an expected average of 8 days

InterventionParticipants (Count of Participants)
Tight Glycemic Control 1 (TGC-1)26
Tight Glycemic Control 2 (TGC-2)29

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Incidence of Ventilator-Associated Pneumonia

We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: respiratory tract infections including ventilator-associated pneumonias that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days. (NCT01565941)
Timeframe: Up to 48 hours after ICU discharge

InterventionInfections/1000 ventilator days (Number)
Tight Glycemic Control 1 (TGC-1)0.94
Tight Glycemic Control 2 (TGC-2)0

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Incidence of Catheter-Associated Urinary Tract Infection

We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: urinary tract infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days. (NCT01565941)
Timeframe: Up to 48 hours after ICU discharge

InterventionInfections/1000 bladder catheter days (Number)
Tight Glycemic Control 1 (TGC-1)2.19
Tight Glycemic Control 2 (TGC-2)1.79

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28-day Hospital Mortality

We will collect data on 28-day hospital mortality. (NCT01565941)
Timeframe: 28 days after randomization

InterventionParticipants (Count of Participants)
Tight Glycemic Control 1 (TGC-1)47
Tight Glycemic Control 2 (TGC-2)32

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90-day Hospital Mortality

In order to enable direct comparisons between data gathered in HALF-PINT and the prior adult NICE-SUGAR trial, we will collect data on 90-day hospital mortality. (NCT01565941)
Timeframe: 90 days after randomization

InterventionParticipants (Count of Participants)
Tight Glycemic Control 1 (TGC-1)52
Tight Glycemic Control 2 (TGC-2)40

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Accumulation of Multiple Organ Dysfunction Syndrome (MODS)

Accumulation of MODS during the 28 days following randomization will be measured. MODS is defined as the concurrent dysfunction of two or more organ systems (e.g., acute lung injury and renal failure). The clinical relevance of MODS as a surrogate outcome measure is well recognized in the intensive care community, and there is a clear relationship between the number of dysfunctional organ systems and the risk of death in critically ill children. (NCT01565941)
Timeframe: 28 days after randomization

InterventionParticipants (Count of Participants)
Tight Glycemic Control 1 (TGC-1)326
Tight Glycemic Control 2 (TGC-2)324

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Developmental Neurobehavioral Outcomes: VABS-II Composite

Reliable, reproducible measures of adaptive functioning, behavior and quality of life will be used to determine outcomes at baseline (CBCL, PedsQL) and at one year after ICU discharge (Vineland-II, CBCL, PedsQL). The goal of baseline data collection is to assess pre-ICU health and quality of life. The results of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) are reported. Scores range from 20-160, with higher scores being better. (NCT01565941)
Timeframe: One year after ICU course

InterventionScore on a scale (Mean)
Tight Glycemic Control 1 (TGC-1)79.9
Tight Glycemic Control 2 (TGC-2)79.4

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ICU-Free Days

28-day hospital mortality-adjusted ICU length of stay. (NCT01565941)
Timeframe: Study day 28

InterventionDays (Median)
Tight Glycemic Control 1 (TGC-1)20
Tight Glycemic Control 2 (TGC-2)19.4

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Incidence of Catheter-Associated Bloodstream Infection

We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: Central Venous Line (CVL)-associated bloodstream infections (BSI) that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days. (NCT01565941)
Timeframe: Up to 48 hours after ICU discharge

InterventionInfections/1000 CVC days (Number)
Tight Glycemic Control 1 (TGC-1)1.94
Tight Glycemic Control 2 (TGC-2)0

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Glycosylated Haemoglobin (HbA1c)

HbA1c after 6 weeks of treatment in each treatment period. (NCT01569841)
Timeframe: At the end of each 6 week treatment period.

,
Interventionpercentage of glycosylated haemoglobin (Mean)
Treatment period ATreatment period B
IDeg/IGlar6.66.9
IGlar/IDeg7.17.3

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Number of Treatment Emergent Adverse Events (AEs)

Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator. (NCT01569841)
Timeframe: Within each week 6 treatment period

,
Interventionevents (Number)
Adverse EventsSerious Adverse EventsSevere Adverse EventsModerate Adverse EventsMild Adverse EventsFatal Adverse Events
IDeg18035100
IGlar16000160

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01569841)
Timeframe: Hypoglycemic episodes reported within each 6 week treatment period.

Interventionevents (Number)
IDeg283
IGlar239

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Mean Interstitial Glucose (IG) Based on 14 Days of CGM

The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period. (NCT01569841)
Timeframe: CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.

Interventionmmol/L (Mean)
IDeg9.6
IGlar9.8

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Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)

Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period. (NCT01569841)
Timeframe: CGM occured during the last 2 weeks of the 6 weeks treatment period.

Interventionhours (Mean)
IDeg1.39
IGlar1.09

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Fasting Plasma Glucose (FPG)

FPG after 6 weeks of treatment in each treatment period. (NCT01569841)
Timeframe: At the end of each 6 week treatment period.

,
Interventionmmol/L (Mean)
Treatment period ATreatment period B
IDeg/IGlar8.810.4
IGlar/IDeg10.910.9

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Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period

Values for change in HbA1c after each 16 weeks of treatment periods A and B. (NCT01570751)
Timeframe: Week 0, week 16 of each treatment period.

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg-0.1
IGlar-0.1

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Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period

Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively. (NCT01570751)
Timeframe: Week 0, week 16 of each treatment period.

,
Interventionscores on a scale (Mean)
Physical scoreMental scoreTotal D-device
IDeg-0.80.711.0
IGlar-0.60.43.5

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Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period

Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods. (NCT01570751)
Timeframe: Week 0, week 16, week 32

Interventionmmol/L (Mean)
IDeg-0.8
IGlar-0.0

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Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B

SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively. (NCT01570751)
Timeframe: Week 16, week 20

,
Interventionscores on a scale (Mean)
Physical scoreMental scoreTotal D-device
IDeg/IGlar0.020.6110.24
IGlar/IDeg0.600.21-6.25

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Number of Adverse Events (AEs)

Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred. (NCT01570751)
Timeframe: From baseline to the end of each 16 week treatment period.

Interventionevents (Number)
IDeg105
IGlar111

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Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B

Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B. (NCT01570751)
Timeframe: Week 16, week 20

Interventionmmol/L (Mean)
IDeg/IGlar-0.78
IGlar/IDeg0.19

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Number of Participants With Change in Anti-LY2605541 Antibodies

The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline. (NCT01582451)
Timeframe: Baseline through 52 weeks

Interventionparticipants (Number)
LY260554170
Insulin Glargine30

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Number of Insulin Dose Adjustments to Steady-state

The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use). (NCT01582451)
Timeframe: Baseline through 26 weeks

Interventionnumber of dose adjustments (Least Squares Mean)
LY26055414.06
Insulin Glargine2.75

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European Quality of Life - 5 Dimension (EuroQol-5D) Score

The EuroQol-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use), and baseline EuroQol-5D score. (NCT01582451)
Timeframe: 26 weeks

Interventionunits on a scale (Least Squares Mean)
LY26055410.87
Insulin Glargine0.88

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Change From Baseline to 52 Weeks in HbA1c

LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c. (NCT01582451)
Timeframe: Baseline, 52 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
LY2605541-0.67
Insulin Glargine-0.22

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Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)

HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c. (NCT01582451)
Timeframe: Baseline, 26 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
LY2605541-0.82
Insulin Glargine-0.29

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Adult Low Blood Sugar Survey (LBSS) Score

LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate. (NCT01582451)
Timeframe: 26 weeks

Interventionunits on a scale (Least Squares Mean)
LY260554116.57
Insulin Glargine15.63

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Insulin Treatment Satisfaction Questionnaire (ITSQ) Score

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate. (NCT01582451)
Timeframe: 26 weeks

Interventionunits on a scale (Least Squares Mean)
LY260554185.69
Insulin Glargine84.43

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Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)

Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. (NCT01582451)
Timeframe: Baseline through 26 weeks and Baseline through 52 weeks

,
Interventionevents/participant/30 days (Least Squares Mean)
Total hypoglycemia, 0-26 weeksTotal hypoglycemia, 0-52 weeksNocturnal hypoglycemia, 0-26 weeksNocturnal hypoglycemia, 0-52 weeks
Insulin Glargine1.981.621.040.88
LY26055411.551.240.430.35

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Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%

The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. (NCT01582451)
Timeframe: 26 and 52 weeks

,
Interventionpercentage of participants (Number)
HbA1c ≤6.5%, 26 weeksHbA1c ≤6.5%, 52 weeksHbA1c <7.0%, 26 weeksHbA1c <7.0%, 52 weeks
Insulin Glargine28.728.052.245.9
LY260554150.343.472.563.9

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Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia

Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100. (NCT01582451)
Timeframe: 26 and 52 weeks

,
Interventionpercentage of participants (Number)
26 weeks52 weeks
Insulin Glargine18.510.2
LY260554140.134.8

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Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events

Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. (NCT01582451)
Timeframe: Baseline through 26 weeks and Baseline through 52 weeks

,
Interventionpercentage of participants (Number)
Total hypoglycemia, 0-26 weeksTotal hypoglycemia, 0-52 weeksNocturnal hypoglycemia, 0-26 weeksNocturnal hypoglycemia, 0-52 weeks
Insulin Glargine80.583.062.367.3
LY260554176.380.346.150.3

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Intra-participant Variability in Fasting Blood Glucose (FBG)

FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability. (NCT01582451)
Timeframe: 26 and 52 weeks

,
Interventionmg/dL (Least Squares Mean)
26 weeks52 weeks
Insulin Glargine17.9017.38
LY260554113.7014.18

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Insulin Dose Per Kilogram of Body Weight

Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose. (NCT01582451)
Timeframe: 26 and 52 weeks

,
Interventionunits per kilogram per day (U/kg/day) (Least Squares Mean)
26 weeks52 weeks
Insulin Glargine0.490.49
LY26055410.570.58

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HbA1c

LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c. (NCT01582451)
Timeframe: 26 and 52 weeks

,
Interventionpercentage of HbA1c (Least Squares Mean)
26 weeks52 weeks
Insulin Glargine7.137.20
LY26055416.606.75

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Fasting Serum Glucose (FSG) (by Laboratory)

LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG. (NCT01582451)
Timeframe: 26 and 52 weeks

,
Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
26 weeks52 weeks
Insulin Glargine119.50115.74
LY2605541103.80107.61

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Fasting Blood Glucose (FBG) (by Self Monitoring)

LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG. (NCT01582451)
Timeframe: 26 and 52 weeks

,
Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
26 weeks52 weeks
Insulin Glargine104.50107.46
LY2605541106.32110.61

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Change From Baseline in Lipid Profile

Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. (NCT01582451)
Timeframe: Baseline, 26 weeks, 52 weeks

,
Interventionmg/dL (Least Squares Mean)
Cholesterol, 26 weeksCholesterol, 52 weeksHDL-C, 26 weeksHDL-C, 52 weeksLDL-C, 26 weeksLDL-C, 52 weeksTriglycerides, 26 weeksTriglycerides, 52 week
Insulin Glargine3.702.78-0.06-2.014.543.41-2.9012.02
LY26055412.24-1.35-1.74-3.52-0.05-3.3822.5327.39

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Change From Baseline in Body Weight

LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight. (NCT01582451)
Timeframe: Baseline, 26 weeks, 52 weeks

,
Interventionkilograms (kg) (Least Squares Mean)
26 weeks52 weeks
Insulin Glargine0.941.32
LY26055410.500.69

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6-point Self-monitored Blood Glucose (SMBG)

SMBG measurements were taken at 6 time points (pre-morning meal [fasting], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal [fasting] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values. (NCT01582451)
Timeframe: 26 and 52 weeks

,
Interventionmg/dL (Least Squares Mean)
Pre-morning meal, 26 weeksPre-midday meal, 26 weeksPre-evening meal, 26 weeksBedtime, 26 weeks0300 hours, 26 weeksPre-morning meal next day, 26 weeksPre-morning meal, 52 weeksPre-midday meal, 52 weeksPre-evening meal, 52 weeksBedtime, 52 weeks0300 hours, 52 weeksPre-morning meal next day, 52 weeks
Insulin Glargine104.11132.56141.45161.48120.42102.79108.22130.55141.31161.83121.07106.68
LY2605541107.93120.87125.87146.54118.43106.28110.84121.34128.53146.92122.23110.38

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Change in HbA1c From Baseline

Change in HbA1c (%) from baseline to the end of the treatment period. (NCT01589653)
Timeframe: Week 0, week 20

Interventionpercentage change in HbA1c (Least Squares Mean)
Subject-driven Titration-1.27
Investigator-driven Titration-1.04

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Number of Hypoglycaemic Episodes During the Trial From Baseline

The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level 3.1 mmol/L [56 mg/dL]) during the trial. (NCT01589653)
Timeframe: Week 20

Interventionepisodes (Number)
Subject-driven Titration167
Investigator-driven Titration222

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Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline

Change in FPG (laboratory values) from baseline to the end of the treatment period (NCT01589653)
Timeframe: Week 0, week 20

Interventionmg/dL (Mean)
Subject-driven Titration-20.0
Investigator-driven Titration-9.1

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Verbal Memory Composite

The composite will consist of the sum of Z scores for Delayed Story Recall and Buschke Selective Reminding Test. In the Story Recall test subjects listen to a story containing 44 informational bits that is read once. Subjects will be asked to recall the story immediately after the reading and after a 20-min delay. Credit is awarded for each bit recalled verbatim or accurately paraphrased. The Buschke Selective Reminding Test measures verbal memory through multiple trials of a list learning task. A list of 12 words is audibly presented to the subject, and subjects recall as many words as possible. On subsequent trials, subjects are only told those words they omitted on the previous trial. The procedure continues until the subject recalls all words on two successive trials or to the twelfth trial. After a 30-minute delay, subjects recall as many items as possible. Number of items recalled after the delay will be summed. Higher scores indicate better performance. (NCT01595646)
Timeframe: Change from Baseline in Verbal Memory at 16 weeks

InterventionChange in Z score memory composite (Mean)
Saline-.31247583
Insulin Detemir.33390008
Insulin-.05181561

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The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision

This cognitive screening measure contains measures of confrontational naming, following commands, constructional praxis, ideational praxis, orientation, and language production and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment. (NCT01595646)
Timeframe: Baseline, Month 2 and Month 4

,,
Interventionunits on a scale (Mean)
BaselineMonth 2Month 4
Insulin19.821.822.6
Insulin Detemir21.623.419.5
Saline2018.520.4

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Cerebral Spinal Fluid (CSF) Biomarkers of AD

CSF Abeta (Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject. (NCT01595646)
Timeframe: Change from Baseline in CSF Biomarkers at 16 Weeks

,,
Interventionpg/mL (Mean)
Abeta42 PreAbeta 42 PostTau PreTau PostTau-P181 PreTau-P181 Post
Insulin305.5325132.3152.27468.5
Insulin Detemir408.5381.8118.3107.663.964.1
Saline331.5384109.7117.165.172.17

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Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio

CSF Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject. A pre and post ratio of TTau-P181/Abeta42 will be given. (NCT01595646)
Timeframe: Change from Baseline in CSF Biomarkers at 16 Weeks

,,
Interventionratio (Mean)
TTau-P181/Abeta42 ratio PreTau-P181/Abeta42 ratio Post
Insulin.27.23
Insulin Detemir.23.23
Saline.27.30

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Functional Ability

Subjects will have a collateral informant (i.e., spouse or friend) rate the subjects' ability to carry out activities of daily living on the Dementia Severity Rating Scale. The Dementia Severity Rating Scale is made up of sub-scales and the scores from each are summed to produce one score. The scale assess memory, ability to get from place to place, and speech and language each with a range from 0-6; recognition of family members and social and community both having a range from 0-5; orientation of time, orientation to place, ability to make decisions, home activities and responsibilities, and control of urination and bowels each having a range of 0-4; personal care- cleanliness and eating both with a range of 0-3. The total score range is from 0-54 and lower scores denotes better outcomes. (NCT01595646)
Timeframe: baseline, month 2, and month 4

,,
Interventionunits on a scale (Mean)
Baselinemonth 2month 4
Insulin7.79.710.6
Insulin Detemir8.79.79.1
Saline7.376.9

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Hemoglobin A1C

Compare the efficacy and safety of three daily injections of Humalog® Mix50/50TM to six daily injections of Humalog® and Humulin N® insulin, by hemoglobin A1C. (NCT01613807)
Timeframe: During Pregnancy (at approximately 28 weeks gestation)

InterventionA1c percent (Mean)
Mix 50/505.5
Usual Insulin Regimen5.6

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Birthweight of Infant

Birthweight of infant born to mother with gestational diabetes using insulin (NCT01613807)
Timeframe: End of pregnancy

Interventiongrams (Mean)
Mix 50/503178
Usual Insulin Regimen3375

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Change in Mean Daily Insulin Lispro Dose

The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. (NCT01621178)
Timeframe: Baseline, 52 Weeks

InterventionU/day (Least Squares Mean)
Insulin Glargine16.84
Dulaglutide 0.75 mg27.46
Dulaglutide 1.5 mg20.05

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Change From Baseline in Mean Daily Insulin Lispro Dose

The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. (NCT01621178)
Timeframe: Baseline, 26 Weeks

InterventionUnits/day (U/day) (Least Squares Mean)
Insulin Glargine16.64
Dulaglutide 0.75 mg26.16
Dulaglutide 1.5 mg18.12

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Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)

The change from baseline in Urinary Albumin to Creatinine Ratio (UACR). (NCT01621178)
Timeframe: Baseline, 26 Weeks

Interventiongram/kilogram (g/kg) (Median)
Insulin Glargine-1.3
Dulaglutide 0.75 mg-11.1
Dulaglutide 1.5 mg-10.2

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Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)

The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime). (NCT01621178)
Timeframe: Baseline, 26 Weeks

Interventionmilligrams/deciliter (mg/dL) (Least Squares Mean)
Insulin Glargine-37.6
Dulaglutide 0.75 mg-31.7
Dulaglutide 1.5 mg-33.7

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Percentage of Participants With Estimated Average Glucose <154 mg/dL

Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF). (NCT01621178)
Timeframe: 26 Weeks

Interventionpercentage of participants (Number)
Insulin Glargine64.9
Dulaglutide 0.75 mg52.5
Dulaglutide 1.5 mg56.4

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Percentage of Participants Whose HbA1c Was <8.0%

Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF). (NCT01621178)
Timeframe: 26 Weeks

Interventionpercentage of participants (Number)
Insulin Glargine75.3
Dulaglutide 0.75 mg72.6
Dulaglutide 1.5 mg78.3

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Percentage of Participants Whose HbA1c Was <7.0%

Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF). (NCT01621178)
Timeframe: 26 Weeks

Interventionpercentage of participants (Number)
Insulin Glargine34.6
Dulaglutide 0.75 mg31.7
Dulaglutide 1.5 mg37.5

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Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. (NCT01621178)
Timeframe: Baseline through 52 Weeks

,,
Interventionpercentage of participants (Number)
Total HypoDocumented Symptomatic HypoSevere HypoNocturnal Hypo
Dulaglutide 0.75 mg59.848.12.623.8
Dulaglutide 1.5 mg50.040.5020.5
Insulin Glargine74.763.46.747.9

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Change From Baseline in UACR

The change from baseline in UACR (NCT01621178)
Timeframe: Baseline, 52 Weeks

Interventiong/kg (Median)
Insulin Glargine3.5
Dulaglutide 0.75 mg-3.0
Dulaglutide 1.5 mg-11.5

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Participants With Events of Allergic/Hypersensitivity Reactions

Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ (NCT01621178)
Timeframe: Baseline through 52 Weeks

,,
Interventionparticipants with events (Number)
Angioedema SMQAngioedemaEyelid edemaFace edemaUrticariaAnaphylactic Reaction SMQCirculatory collapseSevere Cutaneous Adverse Reactions SMQ
Dulaglutide 0.75 mg20110000
Dulaglutide 1.5 mg21010000
Insulin Glargine10001110

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Percentage of Participants Whose HbA1c is <7.0%

Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF). (NCT01621178)
Timeframe: 52 Weeks

Interventionpercentage of participants (Number)
Insulin Glargine29.1
Dulaglutide 0.75 mg33.5
Dulaglutide 1.5 mg32.9

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Percentage of Participants Whose HbA1c is <8.0%

Percentage of participants whose HbA1c was <8.0% based on last observation carried forward (LOCF). (NCT01621178)
Timeframe: 52 Weeks

Interventionpercentage of participants (Number)
Insulin Glargine70.3
Dulaglutide 0.75 mg69.5
Dulaglutide 1.5 mg69.1

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Change From Baseline in Serum Creatinine (sCr)

Change from baseline in serum creatinine (sCr) levels after treatment. (NCT01621178)
Timeframe: Baseline, 26 Weeks

Interventionmg/dL (Median)
Insulin Glargine0.10
Dulaglutide 0.75 mg0.02
Dulaglutide 1.5 mg0.04

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Change From Baseline in sCr

Change from baseline in sCr levels after treatment. (NCT01621178)
Timeframe: Baseline, 52 Weeks

Interventionmg/dL (Median)
Insulin Glargine0.12
Dulaglutide 0.75 mg0.04
Dulaglutide 1.5 mg0.07

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Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. (NCT01621178)
Timeframe: Baseline, 26 Weeks

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Glargine-1.13
Dulaglutide 0.75 mg-1.12
Dulaglutide 1.5 mg-1.19

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Change From Baseline in eGFR

The change in eGFR by using CKD-EPI equation. (NCT01621178)
Timeframe: Baseline, 52 Weeks

InterventionmL/min/1.73m2 (Median)
Insulin Glargine-3.3
Dulaglutide 0.75 mg-1.5
Dulaglutide 1.5 mg-2.0

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Change From Baseline in HbA1c

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. (NCT01621178)
Timeframe: Baseline, 52 Weeks

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Glargine-1.00
Dulaglutide 0.75 mg-1.10
Dulaglutide 1.5 mg-1.10

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Change From Baseline in FG

LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured (NCT01621178)
Timeframe: Baseline, 52 Weeks

Interventionmg/dL (Least Squares Mean)
Insulin Glargine-6.4
Dulaglutide 0.75 mg20.8
Dulaglutide 1.5 mg28.3

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Change From Baseline in Fasting Glucose (FG)

LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured (NCT01621178)
Timeframe: Baseline, 26 Weeks

Interventionmilligram/deciliter (mg/dL) (Least Squares Mean)
Insulin Glargine-19.1
Dulaglutide 0.75 mg17.7
Dulaglutide 1.5 mg23.1

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Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation. (NCT01621178)
Timeframe: Baseline, 26 Weeks

Interventionmilliliter/minute/1.73m2 (mL/min/1.73m2) (Median)
Insulin Glargine-2.5
Dulaglutide 0.75 mg-1.0
Dulaglutide 1.5 mg-1.0

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Change From Baseline in Estimated Creatinine Clearance (eCrCl)

Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight. (NCT01621178)
Timeframe: Baseline, 26 Weeks

Interventionmilliliter/minute (ml/min) (Median)
Insulin Glargine-2.0
Dulaglutide 0.75 mg-1.0
Dulaglutide 1.5 mg-0.5

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Change From Baseline in eCrCl

eCrCl was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight. (NCT01621178)
Timeframe: Baseline, 52 Weeks

InterventionmL/min (Median)
Insulin Glargine-2.5
Dulaglutide 0.75 mg-1.3
Dulaglutide 1.5 mg-1.5

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Change From Baseline in Body Weight

LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured. (NCT01621178)
Timeframe: Baseline, 52 Weeks

Interventionkg (Least Squares Mean)
Insulin Glargine1.57
Dulaglutide 0.75 mg-1.71
Dulaglutide 1.5 mg-2.66

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Change From Baseline in Body Weight

"LS means were calculated from a REML based MMRM model: Change from Baseline = treatment, week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.~•" (NCT01621178)
Timeframe: Baseline, 26 Weeks

Interventionkilogram (kg) (Least Squares Mean)
Insulin Glargine1.11
Dulaglutide 0.75 mg-2.02
Dulaglutide 1.5 mg-2.81

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Change From Baseline in 8-Point SMPG

The daily mean of 8-point SMPG profile at Week 52 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime). (NCT01621178)
Timeframe: Baseline, 52 Weeks

Interventionmg/dL (Least Squares Mean)
Insulin Glargine-40.5
Dulaglutide 0.75 mg-30.0
Dulaglutide 1.5 mg-27.2

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Rate of Hypoglycemic Events (HE)

HE were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. (NCT01621178)
Timeframe: Baseline through 52 Weeks

,,
InterventionEvents/Participant/Year (Mean)
Total HE RateDocumented Symptomatic HE RateSevere HE RateNocturnal HE Rate
Dulaglutide 0.75 mg7.594.340.030.76
Dulaglutide 1.5 mg5.824.440.000.70
Insulin Glargine14.369.620.092.48

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Rate of Hypoglycemic Events

Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. (NCT01621178)
Timeframe: Baseline through 26 Weeks

,,
InterventionEvents/Participant/Year (Mean)
Total HE RateDocumented Symptomatic HE RateSevere HE RateNocturnal HE Rate
Dulaglutide 0.75 mg7.764.860.030.73
Dulaglutide 1.5 mg5.454.190.000.63
Insulin Glargine17.0711.340.103.06

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Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. (NCT01621178)
Timeframe: Baseline through 26 Weeks

,,
Interventionpercentage of participants (Number)
Total HypoDocumented Symptomatic HypoSevere HypoNocturnal Hypo
Dulaglutide 0.75 mg50.840.71.115.9
Dulaglutide 1.5 mg43.231.6013.2
Insulin Glargine71.660.34.138.1

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Percentage of Participants With Estimated Average Glucose <154 mg/dL

Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF). (NCT01621178)
Timeframe: 52 Weeks

Interventionpercentage of participants (Number)
Insulin Glargine73.7
Dulaglutide 0.75 mg57.4
Dulaglutide 1.5 mg50.9

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Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast

Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. (NCT01621776)
Timeframe: averaged over 5 days

Interventionmg/dl (Mean)
Humalog225.62
Apidra225.46
Novolog208.64

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Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner

Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. (NCT01621776)
Timeframe: averaged over 5 days

Interventionmg/dl (Mean)
Humalog170.57
Apidra160.96
Novolog153.46

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The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.

"Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.~The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona." (NCT01621776)
Timeframe: averaged over 5 days

Interventionmg/dl (Mean)
Humalog146.69
Apidra143.68
Novolog149.02

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Incidence of Poor Graft Function After Kidney Transplant

Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of <10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine >3 mg/dL 5 days after transplant without dialysis) (NCT01643382)
Timeframe: 7 days after transplant

InterventionParticipants (Count of Participants)
Tight Glucose Control13
Standard Glucose Control22

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Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])

Percentage of time with glucose above the upper limit of glycemic range (>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval. (NCT01658579)
Timeframe: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

Interventionpercentage of time (Least Squares Mean)
HOE901-U300 Combined58.24
Lantus Combined57.38

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Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])

Percentage of time with glucose below the lower limit of glycemic range (<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval. (NCT01658579)
Timeframe: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

Interventionpercentage of time (Least Squares Mean)
HOE901-U300 Combined10.01
Lantus Combined11.64

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Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])

Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval. (NCT01658579)
Timeframe: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

Interventionpercentage of time (Least Squares Mean)
HOE901-U300 Combined31.75
Lantus Combined30.99

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Evaluation of Diurnal Glucose Exposure, Variability, and Stability

The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval. (NCT01658579)
Timeframe: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

,
Interventionmmol/L (Least Squares Mean)
Diurnal Glucose ExposureDiurnal Glucose StabilityDiurnal Glucose Variability
HOE901-U300 Combined8.8690.6734.931
Lantus Combined8.9100.7035.279

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Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B

Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval. (NCT01658579)
Timeframe: Weeks 7-8 in Period A and Weeks 15-16 in Period B

,
Interventionpercentage of time (Mean)
Week 7, 8 (n=28, 27)Week 15, 16 (n=29, 26)
HOE901-U300 Combined32.0833.02
Lantus Combined29.0728.70

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Change in HbA1c From Baseline to Week 8 and 16

(NCT01658579)
Timeframe: Baseline, Week 8, 16

,
Interventionpercentage of hemoglobin (Mean)
Week 8 (n= 29, 20)Week 16 (n= 28, 27)
HOE901-U300 Combined-0.22-0.44
Lantus Combined-0.23-0.22

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16

(NCT01658579)
Timeframe: Baseline, Week 8, 16

,
Interventionmmol/L (Mean)
Week 8 (n=24, 23)Week 16 (n= 24, 22)
HOE901-U300 Combined-0.89-0.99
Lantus Combined-0.100.78

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Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16

(NCT01658579)
Timeframe: Baseline, Week 8, 16

,
InterventionU/kg (Mean)
Week 8 (n= 30, 29)Week 16 (n=29, 27)
HOE901-U300 Combined0.060.05
Lantus Combined0.030.03

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Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16

Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime. (NCT01658579)
Timeframe: Baseline, Week 8, 16

,
Interventionmmol/L (Mean)
Week 8Week 16
HOE901-U300 Combined-0.39-0.47
Lantus Combined0.390.58

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Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16

Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L). (NCT01658579)
Timeframe: Up to Week 16

,
Interventionpercentage of participants (Number)
Any Hypoglycemia Event: All HypoglycemiaSevere Hypoglycemia: All HypoglycemiaDocumented Symptomatic: All HypoglycemiaAsymptomatic: All HypoglycemiaProbable Symptomatic: All HypoglycemiaRelative: All HypoglycemiaSevere and/or Confirmed: All HypoglycemiaAny Hypoglycemia Event: Nocturnal HypoglycemiaSevere Hypoglycemia: Nocturnal HypoglycemiaDocumented Symptomatic: Nocturnal HypoglycemiaAsymptomatic: Nocturnal HypoglycemiaProbable Symptomatic: Nocturnal HypoglycemiaRelative: Nocturnal HypoglycemiaSevere and/or Confirmed: Nocturnal Hypoglycemia
HOE901-U300 Combined1003.393.386.716.70.010080.00.066.740.03.30.080.0
Lantus Combined10010.396.696.627.66.910093.16.979.348.310.36.993.1

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Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint

Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. (NCT01676220)
Timeframe: Baseline, Month 6

Interventionpercentage of mean (Least Squares Mean)
HOE901-U3001.53
Lantus1.41

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Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. (NCT01676220)
Timeframe: Baseline, Month 6

Interventionunits on a scale (Least Squares Mean)
HOE901-U3004.89
Lantus5.12

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Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. (NCT01676220)
Timeframe: Baseline, Month 6

Interventionmmol/L (Least Squares Mean)
HOE901-U300-2.16
Lantus-2.33

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Change in HbA1c From Baseline to Month 6 Endpoint

Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. (NCT01676220)
Timeframe: Baseline, Month 6

Interventionpercentage of hemoglobin (Least Squares Mean)
HOE901-U300-1.42
Lantus-1.46

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Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint

Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. (NCT01676220)
Timeframe: Baseline, Month 6

Interventionmmol/L (Least Squares Mean)
HOE901-U300-3.41
Lantus-3.80

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Change in Daily Basal Insulin Dose From Baseline to Month 6

Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. (NCT01676220)
Timeframe: Baseline, Month 6

InterventionU/kg (Mean)
HOE901-U3000.43
Lantus0.34

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Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint

Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. (NCT01676220)
Timeframe: Baseline, Month 6

Interventionmmol/L (Least Squares Mean)
HOE901-U300-2.72
Lantus-2.90

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Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12

Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L). (NCT01676220)
Timeframe: Up to 12 months

,
Interventionpercentage of participants (Number)
Any Hypoglycemia Event: All HypoglycemiaSevere Hypoglycemia: All HypoglycemiaDocumented Symptomatic: All HypoglycemiaAsymptomatic: All HypoglycemiaProbable Symptomatic: All HypoglycemiaRelative: All HypoglycemiaSevere and/or Confirmed: All HypoglycemiaAny Hypoglycemia Event: Nocturnal HypoglycemiaSevere Hypoglycemia: Nocturnal HypoglycemiaDocumented Symptomatic: Nocturnal HypoglycemiaAsymptomatic: Nocturnal HypoglycemiaProbable Symptomatic: Nocturnal HypoglycemiaRelative: Nocturnal HypoglycemiaSevere and/or Confirmed: Nocturnal Hypoglycemia
HOE901-U30058.91.439.141.63.210.656.327.60.018.613.30.74.425.3
Lantus63.22.144.146.83.011.661.230.10.720.816.00.03.229.5

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Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6

Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. (NCT01676220)
Timeframe: Baseline, Month 6

,
Interventionmmol/L (Mean)
03:00 at Night Plasma Glucose (n=281,277)Pre-Breakfast Plasma Glucose (n=292,286)2 Hours After Breakfast Plasma Glucose (n=278,278)Pre-Lunch Plasma Glucose (n=289,281)2 Hours After Lunch Plasma Glucose (n=280,269)Pre-Dinner Plasma Glucose (n=291,285)2 Hours After Dinner Plasma Glucose (n=282,269)Bedtime Plasma Glucose (n=249,249)
HOE901-U300-2.63-3.28-3.69-2.58-2.19-2.57-2.36-2.19
Lantus-3.01-3.72-4.08-3.39-3.13-2.43-2.33-2.26

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Variability of Preinjection SMPG at Month 6 Endpoint

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. (NCT01676220)
Timeframe: Month 6

Interventionpercentage of mean (Least Squares Mean)
HOE901-U30018.70
Lantus18.33

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Percentage of Participants With HbA1c <7% at Month 6

Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. (NCT01676220)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901-U30043.1
Lantus42.1

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Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6

Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. (NCT01676220)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901-U30026.2
Lantus29.5

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Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6

Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively. (NCT01676220)
Timeframe: Week 9 Up to Month 6

Interventionpercentage of participants (Number)
HOE901-U30015.5
Lantus17.4

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01680341)
Timeframe: Week 0, Week 26

InterventionPercent (%) glycosylated haemoglobin (Least Squares Mean)
IDegAsp Simple-1.45
IDegAsp Step Wise-1.33

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period

Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01680341)
Timeframe: From week 16 to end of trial including follow-up (week 27)

Interventionepisodes (Number)
IDegAsp Simple230
IDegAsp Step Wise143

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Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes

Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am. (NCT01680341)
Timeframe: Weeks 0-27

Interventionepisodes (Number)
IDegAsp Simple82
IDegAsp Step Wise49

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Incidence of Treatment Emergent Adverse Events (TEAEs)

A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT01680341)
Timeframe: Weeks 0-28

Interventionnumber of events (Number)
IDegAsp Simple242
IDegAsp Step Wise286

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT01680341)
Timeframe: Weeks 0-27

Interventionepisodes (Number)
IDegAsp Simple552
IDegAsp Step Wise323

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Subjects With HbA1c Below 7.0%

Number of subjects with HbA1c below 7% after 26 weeks of treatment. (NCT01680341)
Timeframe: Week 26

InterventionSubjects (Number)
IDegAsp Simple91
IDegAsp Step Wise85

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Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia

Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment. (NCT01680341)
Timeframe: Week 26

Interventionpercentage of subjects (Number)
IDegAsp Simple25.4
IDegAsp Step Wise32.0

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment (NCT01680341)
Timeframe: Week 0, Week 26

Interventionmmol/L (Least Squares Mean)
IDegAsp Simple-1.68
IDegAsp Step Wise-1.98

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Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12

Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L). (NCT01683266)
Timeframe: Up to Month 12

,
Interventionpercentage of participants (Number)
Any Hypoglycemia Event: All HypoglycemiaSevere Hypoglycemia: All HypoglycemiaDocumented Symptomatic: All HypoglycemiaAsymptomatic: All HypoglycemiaProbable Symptomatic: All HypoglycemiaRelative: All HypoglycemiaSevere and/or Confirmed: All HypoglycemiaAny Hypoglycemia Event: Nocturnal HypoglycemiaSevere Hypoglycemia: Nocturnal HypoglycemiaDocumented Symptomatic: Nocturnal HypoglycemiaAsymptomatic: Nocturnal HypoglycemiaProbable Symptomatic: Nocturnal HypoglycemiaRelative: Nocturnal HypoglycemiaSevere and/or Confirmed: Nocturnal Hypoglycemia
HOE901--U30095.39.187.676.611.314.694.973.43.364.235.05.14.072.6
Lantus94.911.386.581.515.39.594.574.93.363.338.96.55.574.5

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Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint

Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. (NCT01683266)
Timeframe: Baseline, Month 6

,
Interventionmmol/L (Mean)
03:00 at Night (n= 156, 159)Pre--Breakfast (n= 166, 167)2 Hours After Breakfast (n= 152, 156)Pre--Lunch (n= 166, 166)2 Hours After Lunch (n= 163,163)Pre--Dinner (n= 165,166)2 Hours After Dinner (n= 154,152)Bedtime (n= 141,146)
HOE901--U300-0.47-0.86-0.62-0.95-0.13-0.56-0.93-0.80
Lantus-0.67-0.07-1.18-0.93-1.43-1.74-1.19-1.91

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Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint

(NCT01683266)
Timeframe: Baseline, Month 6

Interventionmmol/L (Least Squares Mean)
HOE901--U300-0.95
Lantus-1.14

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Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint

(NCT01683266)
Timeframe: Baseline, Month 6

InterventionU/kg (Mean)
HOE901--U3000.19
Lantus0.10

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Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. (NCT01683266)
Timeframe: Baseline, Month 6

Interventionmillimole per liter (mmol/L) (Least Squares Mean)
HOE901--U300-1.16
Lantus-0.82

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Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint

(NCT01683266)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901--U3008.1
Lantus5.5

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Percentage of Participants With HbA1c <7% at Month 6 Endpoint

(NCT01683266)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901--U30016.8
Lantus15.0

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Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint

(NCT01683266)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901--U30025.3
Lantus25.6

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Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6

(NCT01683266)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901--U3009.9
Lantus12.8

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Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. (NCT01683266)
Timeframe: Baseline, Month 6

Interventionpercentage of mean (Least Squares Mean)
HOE901--U300-3.03
Lantus-1.76

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Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. (NCT01683266)
Timeframe: Baseline, Month 6

Interventionunits on a scale (Least Squares Mean)
HOE901--U3001.00
Lantus1.41

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Change In HbA1c From Baseline to Month 6 Endpoint

(NCT01683266)
Timeframe: Baseline, Month 6

Interventionpercentage of hemoglobin (Least Squares Mean)
HOE901--U300-0.40
Lantus-0.44

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The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation

"NODAT will be defined according to American Diabetes Association definition:~Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or~2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or~Glycosylated hemoglobin A1c equal or greater than 6.5; and/or~On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria." (NCT01683331)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Insulin Treatment for Hyperglycemia3
Standard of Care1

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The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation

"NODAT will be defined according to American Diabetes Association definition:~Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or~2 hours OGTT values equal or greater than 200 mg/dl; and/or~Glycosylated hemoglobin A1c equal or greater than 6.5; and/or~On oral hypoglycemic agents and/or insulin therapy;" (NCT01683331)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Insulin Treatment for Hyperglycemia1
Standard of Care0

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Multiplex PK: Average Number of Hypoglycemia Events Over the Last Month at Baseline Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual

Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average number of hypoglycemic events per month per group is reported. (NCT01684943)
Timeframe: 1 month prior to study entry

Interventionevents in the month prior to study entry (Mean)
Participants Using the Faster Insulin8.6
Participants Using the Slower Insulin15.0
Participants Where the Two Insulins Were the Same13.1

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Multiplex PK: Count of Subjects With Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax That is > 25%

(NCT01684943)
Timeframe: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose

InterventionParticipants (Count of Participants)
All Participants11

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For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin

(NCT01684943)
Timeframe: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose

,
Interventionminutes (Number)
Plasma insulin tmaxCIM insulin tmax
Experiment #34044
Experiment #460106

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For Multiplex PK Profiling: Aggregate Mean Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax for Individuals

The average difference in tmax between lispro and aspart in all participants (NCT01684943)
Timeframe: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose

Interventionminutes (Mean)
All Participants24.28

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Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual

Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average A1c for each of the three categories is reported. (NCT01684943)
Timeframe: Baseline

Interventionpercentage of glycosylated hemoglobin (Mean)
Participants Using the Faster Insulin8.1
Participants Using the Slower Insulin8.6
Participants Where the Two Insulins Were the Same7.5

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Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog With Tmax < 60 Minutes vs. Use of an Insulin Analog With Tmax > 60 Minutes for Each Individual

Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with tmax less than or equal to 60 minutes or using insulin with tmax > 60 minutes. The average A1c per group is reported. (NCT01684943)
Timeframe: Baseline

Interventionpercentage of glycosylated hemoglobin (Mean)
Subjects Using Insulin With a Tmax < 60 Minutes7.8
Subjects Using Insulin With a Tmax of > 60 Minutes7.3

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Change From Baseline in HbA1c (%)

Change from baseline in HbA1c (%) after 26 weeks of treatment (NCT01713530)
Timeframe: Week 0, week 26

Interventionpercentage change in HbA1c (Least Squares Mean)
IDegAsp BID-1.23
IDeg OD+IAsp-1.42

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 26 weeks of treatment (NCT01713530)
Timeframe: Week 0, week 26

Interventionmmol/L (Least Squares Mean)
IDegAsp BID-2.22
IDeg OD+IAsp-1.90

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Number of Treatment Emergent Hypoglycaemic Episodes

According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL)) (NCT01713530)
Timeframe: During Weeks 0-26

Interventionepisodes (Number)
IDegAsp BID706
IDeg OD+IAsp841

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Number of Treatment Emergent Hypoglycaemic Episodes

"According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:~Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia" (NCT01713530)
Timeframe: During Weeks 0-26

,
Interventionepisodes (Number)
ADA (American Diabetes Association)SevereDocumented symptomaticAsymptomaticProbable symptomaticRelative
IDeg OD+IAsp26851518437283366
IDegAsp BID28942918189302691

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Incidence of Treatment Emergent Adverse Events (TEAE)

A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment (NCT01713530)
Timeframe: Weeks 0-26

Interventionnumber of events (Number)
IDegAsp BID330
IDeg OD+IAsp298

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Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes

Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT01713530)
Timeframe: Weeks 0-26

Interventionepisodes (Number)
IDegAsp BID75
IDeg OD+IAsp96

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Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone

Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion) (NCT01755416)
Timeframe: 0-1500 min

Interventionmg/dl (Mean)
Closed Loop/Insulin159.7
Closed Loop/Insulin/Liraglutide144.6

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Change in Hippocampal and Entorhinal Atrophy as Measured by Magnetic Resonance Imaging (MRI)

MRI will be used to assess the effect of treatment on rate of hippocampal and entorhinal atrophy, and conduct exploratory analyses of other brain regions. Volume change was normalized to the participant's own intracranial volume to account for each participant's brain size. (NCT01767909)
Timeframe: Screen and Month 12

,
Intervention% change in volume (Mean)
Normalized hippocampal volume changeNormalized entorhinal volume changeNormalized whole brain volume change
Insulin (Humulin® R U-100)-0.01-0.01-1.35
Placebo-0.02-0.01-1.41

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Change in Memory Composite as Measured by Story Recall (Immediate Paragraph Recall and Delayed Paragraph Recall) and Free and Cued Selective Reminding Test (FCSRT)

Memory Composite is composed from Story Recall (both Immediate Paragraph Recall and Delayed Paragraph Recall) and the Free and Cued Selective Reminding Test (FCSRT). Each of the three component scores were normalized by subtracting the baseline sample mean, and dividing by the baseline sample standard deviation, to form three separately standardized z-scores with mean 0 and standard deviation 1. The three Z-scores were summed to form the memory composite. No other standardization was performed on the sum. If any of Immediate Paragraph Recall, Delayed Paragraph Recall and FCSRT is missing, the memory composite is missing. Higher scores indicate better performance. In this study the scores ranged from about -4.74 to 9.15 at baseline, and about -5.10 to 9.43 across all visits over 12 months. (NCT01767909)
Timeframe: 12 months (blinded phase) followed by 6 months (open label phase)

,
Interventionmodeled change score on a scale (Least Squares Mean)
Blinded Phase (M12 change from Baseline)Open Label Phase (M18 change from Baseline)
Insulin (Humulin® R U-100)-0.496-0.594
Placebo-0.433-0.802

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Change in Cognitive Deficit as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)

"The Clinical Dementia Rating - Sum of Boxes (CDR-SB) is administered as a structured interview with the participant and study partner, where impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or box scores, are added together to give the CDR-Sum of Boxes which ranges from 0-18 with higher scores indicated more impairment." (NCT01767909)
Timeframe: 12 months (blinded phase) followed by 6 months (open label phase)

,
InterventionModeled change in test score (Least Squares Mean)
Blinded Phase (M12 change from Baseline)Open Label Phase (M18 change from Baseline)
Insulin (Humulin® R U-100)1.6822.361
Placebo1.4022.122

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Change in CSF Biomarkers of AD

Quantify Abeta and Tau biomarkers in CSF (NCT01767909)
Timeframe: Baseline and Month 12

,
Interventionpg/ml (Mean)
Abeta 40Abeta 42Total Taup-Tau
Insulin (Humulin® R U-100)-264.851-15.552-4.717-2.764
Placebo-127.539-4.4561.937-0.567

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Change in Daily Functioning as Measured by the ADCS-MCI Activities of Daily Living (ADCS-ADL-MCI)

The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL) is an activities of daily living questionnaire aimed at detecting functional decline in people with Mild Cognitive Impairment (MCI). In a structured interview format, informants are queried as to whether participants attempted each item in the inventory during the prior 4 weeks and their level of performance. The questions focus predominantly on instrumental activities of daily living scales (e.g. shopping, preparing meals, using household appliances, keeping appointments, reading). The total score can range from 0-54. A higher score indicates greater functional ability. (NCT01767909)
Timeframe: 12 months (blinded phase) and 6 months (open label phase)

,
Interventionmodeled change score on a scale (Least Squares Mean)
Blinded Phase (M12 change from Baseline)Open Label Phase (M18 change from baseline)
Insulin (Humulin® R U-100)-3.63-7.35
Placebo-4.26-6.56

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Change in Global Measure of Cognition as Measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12)

The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. The ADAS-Cog12 version was used in this study which includes Delayed Word Recall - a measure of episodic memory. Scores from the original portion of the test range from 0 (best) to 70 (worse) and then number of items not recalled ranging from 0-10 is added for a maximum score of 80. A positive change indicates cognitive worsening. (NCT01767909)
Timeframe: 12 months (blinded phase) followed by 6 months (open label phase)

,
InterventionModeled change score on a scale (Least Squares Mean)
Blinded Phase (M12 change from Baseline)Open Label Phase (M18 change from Baseline)
Insulin (Humulin® R U-100)3.8937.091
Placebo3.8676.164

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Change in Average 7-point SMPG Profiles From Baseline to Week 26

Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
Lixisenatide-0.784
Insulin Glulisine QD-0.782
Insulin Glulisine TID-1.053

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Change in Body Weight From Baseline to Week 26

"Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.~Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug." (NCT01768559)
Timeframe: Baseline, Week 26

Interventionkg (Least Squares Mean)
Lixisenatide-0.63
Insulin Glulisine QD1.03
Insulin Glulisine TID1.37

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Change in FPG From Baseline to Week 26

Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
Lixisenatide-0.23
Insulin Glulisine QD-0.21
Insulin Glulisine TID-0.06

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Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)

Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26

Interventionmmol/L (Mean)
Lixisenatide-3.42
Insulin Glulisine QD-1.59
Insulin Glulisine TID-1.56

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Change in Insulin Glargine Dose From Baseline to Week 26

Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26

InterventionU (Least Squares Mean)
Lixisenatide0.7
Insulin Glulisine QD-0.06
Insulin Glulisine TID-3.13

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Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)

The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26

Interventionmmol/L (Mean)
Lixisenatide-3.93
Insulin Glulisine QD-1.62
Insulin Glulisine TID-1.87

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Insulin Glulisine Dose at Week 26

The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. (NCT01768559)
Timeframe: Week 26

InterventionU (Mean)
Insulin Glulisine QD9.97
Insulin Glulisine TID20.24

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Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26

The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. (NCT01768559)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Lixisenatide31.2
Insulin Glulisine QD16.7
Insulin Glulisine TID17.6

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Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period

The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. (NCT01768559)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Lixisenatide29.4
Insulin Glulisine QD24.2
Insulin Glulisine TID26.1

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Total Insulin Dose at Week 26

"The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.~The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9." (NCT01768559)
Timeframe: Week 26

InterventionU (Mean)
Insulin Glulisine QD73.61
Insulin Glulisine TID81.05

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Percentage of Participants With no Weight Gain at Week 26

The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug. (NCT01768559)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Lixisenatide64.7
Insulin Glulisine QD36.6
Insulin Glulisine TID30.5

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Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period

The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data. (NCT01768559)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Lixisenatide22.2
Insulin Glulisine QD9.2
Insulin Glulisine TID10.8

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Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26

The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF. (NCT01768559)
Timeframe: Week 26

,,
Interventionpercentage of participants (Number)
HbA1c ≤6.5%HbA1c <7.0%
Insulin Glulisine QD17.838.4
Insulin Glulisine TID30.849.2
Lixisenatide20.542.1

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Change in HbA1c From Baseline to Week 26

Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. (NCT01768559)
Timeframe: Baseline, Week 26

Interventionpercentage of hemoglobin (Least Squares Mean)
Lixisenatide-0.63
Insulin Glulisine QD-0.58
Insulin Glulisine TID-0.84

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Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. (NCT01768559)
Timeframe: First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)

,,
Interventionpercentage of participants (Number)
Documented symptomatic hypoglycemiaSevere symptomatic hypoglycemia
Insulin Glulisine QD37.50.7
Insulin Glulisine TID44.60
Lixisenatide31.50

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VLDL-TG Oxidation Rate

VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. (NCT01771250)
Timeframe: Day 22: 240 min to 420 min

Interventionμmol/min (Geometric Mean)
Insulin Peglispro20.13
Insulin Glargine15.34

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VLDL-TG Secretion Rate

VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. (NCT01771250)
Timeframe: Day 22: 240 min to 420 min

Interventionμmol/min (Geometric Mean)
Insulin Peglispro38.79
Insulin Glargine25.61

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Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations

VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine. (NCT01771250)
Timeframe: Day 22: 240 minutes (min) to 420 min

Interventionmicromole per Liter (μmol/L) (Geometric Mean)
Insulin Peglispro0.27
Insulin Glargine0.17

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VLDL-TG Clearance Rate

VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. (NCT01771250)
Timeframe: Day 22: 240 min to 420 min

Interventionmilliliters per minute (mL/min) (Geometric Mean)
Insulin Peglispro142.16
Insulin Glargine155.11

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Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26

LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect. (NCT01773473)
Timeframe: Baseline, Week 26

Interventionmicrograms/milliliter (µg/mL) (Least Squares Mean)
Insulin Lispro Mix254.24
Insulin Lispro Mix505.62

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Change From Baseline in Body Weight at Week 26

LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect. (NCT01773473)
Timeframe: Baseline, Week 26

Interventionkilogram (kg) (Least Squares Mean)
Insulin Lispro Mix252.31
Insulin Lispro Mix502.32

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Change From Baseline in Fasting Blood Glucose (FBG) at Week 26

LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect. (NCT01773473)
Timeframe: Baseline, Week 26

Interventionmillimoles per liter (mmol/L) (Least Squares Mean)
Insulin Lispro Mix25-2.37
Insulin Lispro Mix50-1.99

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Insulin Dose at Week 26

Insulin dose is the total daily dose including basal and prandial doses. (NCT01773473)
Timeframe: Week 26

Interventionunits of insulin per day (IU/day) (Mean)
Insulin Lispro Mix2540.02
Insulin Lispro Mix5039.32

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Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)

A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a BG concentration of ≤ 70milligrams/deciliter [mg/dL (3.9 mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005]. (NCT01773473)
Timeframe: Baseline through Week 26

,
Interventionevents (Number)
All Hypoglycemic EventsSevere Hypoglycemic Events
Insulin Lispro Mix255680
Insulin Lispro Mix505831

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Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26

HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100. (NCT01773473)
Timeframe: Baseline through Week 26

,
Interventionpercentage of participants (Number)
<7.0%≤6.5%
Insulin Lispro Mix2545.926.1
Insulin Lispro Mix5059.742.3

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Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26

HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect. (NCT01773473)
Timeframe: Baseline, Week 26

Interventionpercentage of glycosylated hemoglobin (Least Squares Mean)
Insulin Lispro Mix25-1.52
Insulin Lispro Mix50-1.69

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Percentage of Participants With Hypoglycemic Events

Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The percentage of participants with HE at 24 weeks was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01774968)
Timeframe: Baseline through Week 24

,
Interventionpercentage of participants (Number)
Severe HEDocumented Symptomatic HEDocumented Symptomatic Nocturnal HEAsymptomatic HE
Human Regular U-500 Insulin BID3.7390.0680.7566.46
Human Regular U-500 Insulin TID1.8591.9877.7864.20

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Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24

The percentage of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24 was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100. (NCT01774968)
Timeframe: Week 24

,
Interventionpercentage of participants (Number)
HbA1c ≤6.5% (n=159, 161)HbA1c <7.0% (n=158, 159)HbA1c <7.5% (n=148, 143)HbA1c <8.0% (n=120, 123)
Human Regular U-500 Insulin BID23.6041.5161.5477.24
Human Regular U-500 Insulin TID20.1342.4164.1977.50

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Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg

Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

,
Interventionkg (Least Squares Mean)
Baseline TDD insulin ≤2.0 units/kg (n=50, 46)Baseline TDD insulin >2.0 units/kg (n=112, 115)
Human Regular U-500 Insulin BID6.094.40
Human Regular U-500 Insulin TID6.115.08

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Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg

Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (DS; an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), or nocturnal (Noc; any documented symptomatic HE that occurred between bedtime and waking). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01774968)
Timeframe: Baseline, Week 24

,
Interventionevents per participant per 30 days (Mean)
Severe HE, TDD ≤2 units/kg, Baseline (n=50, 46)Severe HE, TDD ≤2 units/kg, Week 24 (n=50, 46)Severe HE, TDD >2 units/kg, Baseline (n=112, 115)Severe HE, TDD >2 units/kg, Week 24 (n=112, 115)DS HE, TDD ≤2 units/kg, Baseline (n=50, 46)DS HE, TDD ≤2 units/kg, Week 24 (n=50, 46))DS HE, TDD >2 units/kg, Baseline (n=112, 115)DS HE, TDD >2 units/kg, Week 24 (n=112, 115)Noc. HE, TDD ≤2 units/kg, Baseline (n=50, 46)Noc. HE, TDD ≤2 units/kg, Week 24 (n=50, 46)Noc. HE, TDD >2 units/kg, Baseline (n=112, 115)Noc. HE, TDD >2 units/kg, Week 24 (n=112, 115)
Human Regular U-500 Insulin BID0000.0131.4543.1311.7304.1860.7111.2820.5851.753
Human Regular U-500 Insulin TID00.00400.0041.9582.3562.0373.7841.0661.1050.7921.522

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Time to Reach HbA1c Target Values

The cumulative number of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% is summarized at Weeks 6, 12, 18, and 24. The number of participants at risk (n) is also provided for each target value and timepoint. (NCT01774968)
Timeframe: Baseline through 6, 12, 18, and 24 weeks.

,
Interventionparticipants (Number)
HbA1c ≤6.5%, Week 6 (n=154, 155)HbA1c ≤6.5%, Week 12 (n=145, 151)HbA1c ≤6.5%, Week 18 (n=140, 145)HbA1c ≤6.5%, Week 24 (n=76, 65)HbA1c <7.0%, Week 6 (n=154, 153)HbA1c <7.0%, Week 12 (n=148, 149)HbA1c <7.0%, Week 18 (n=144, 145)HbA1c <7.0%, Week 24 (n=53, 52)HbA1c <7.5%, Week 6 (n=144, 137)HbA1c <7.5%, Week 12 (n=140, 134)HbA1c <7.5%, Week 18 (n=136, 132)HbA1c <7.5%, Week 24 (n=34, 31)HbA1c <8.0%, Week 6 (n=117, 117)HbA1c <8.0%, Week 12 (n=114, 115)HbA1c <8.0%, Week 18 (n=111, 113)HbA1c <8.0%, Week 24 (n=20, 19)
Human Regular U-500 Insulin BID6152737103655652059788734728695
Human Regular U-500 Insulin TID1152428143152603059819032668589

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Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin

Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

Interventionunits per kilogram (units/kg) (Least Squares Mean)
Human Regular U-500 Insulin TID0.32
Human Regular U-500 Insulin BID0.32

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Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)

Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

Interventionpercentage of HbA1c (Least Squares Mean)
Human Regular U-500 Insulin TID-1.12
Human Regular U-500 Insulin BID-1.22

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Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels

LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline FPG as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
Human Regular U-500 Insulin TID-6.66
Human Regular U-500 Insulin BID-8.86

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Change From Baseline to Week 24 in Body Weight

LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

Interventionkilograms (kg) (Least Squares Mean)
Human Regular U-500 Insulin TID5.44
Human Regular U-500 Insulin BID4.88

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30-Day Adjusted Rate of Hypoglycemic Events

Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01774968)
Timeframe: Baseline through Week 24

,
Interventionevents per participant per 30 days (Mean)
Severe HEDocumented Symptomatic HEDocumented Symptomatic Nocturnal HEAsymptomatic HE
Human Regular U-500 Insulin BID0.0093.8851.2991.028
Human Regular U-500 Insulin TID0.0043.3431.0131.340

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Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg

Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

,
Interventionpercentage of HbA1c (Least Squares Mean)
Baseline TDD ≤2.0 units/kg (n=50, 46)Baseline TDD >2.0 units/kg (n=112, 115)
Human Regular U-500 Insulin BID-1.32-1.18
Human Regular U-500 Insulin TID-0.99-1.19

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Change From Baseline to Week 24 in Number of Insulin Injections

The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented. (NCT01774968)
Timeframe: Baseline, Week 24

,
Interventioninjections per day (Mean)
BaselineWeek 24
Human Regular U-500 Insulin BID4.7832.000
Human Regular U-500 Insulin TID4.7653.000

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Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg

Participants were stratified by their baseline TDD insulin (≤2.0 units (U)/kg or >2.0 U/kg). The percentage of participants at risk of developing hypoglycemia (including documented symptomatic, asymptomatic, probable symptomatic, unspecified, or severe hypoglycemia) is presented at Baseline and at Week 24 and was calculated using MMRM fit with options of the binomial distribution and log link function including treatment, TDD (>300 units or ≤300 units), pioglitazone use (yes or no), visit, and treatment-by-visit interaction as fixed effects, and baseline HbA1c value as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

,
Interventionpercentage of participants (Number)
Baseline TDD≤2.0 U/kg, Baseline risk (n=50, 46)Baseline TDD ≤2.0 U/kg, Week 24 risk (n=50, 46)Baseline TDD >2.0 U/kg, Baseline risk (n=112, 115)Baseline TDD >2.0 U/kg, Week 24 risk (n=112, 115)
Human Regular U-500 Insulin BID39.1386.9651.3097.39
Human Regular U-500 Insulin TID56.0094.0047.3296.43

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Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)

The 7-point SMBG is a participant self-administered blood glucose test which utilizes measurements at specific time points over a 24-hour period, including pre-morning meal (fasting), 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and 3 AM. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline SMBG as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

,
Interventionmg/dL (Least Squares Mean)
Pre-morning Meal (n=150, 149)2 Hours After Morning Meal (n=146, 133)Pre-midday Meal (n=150, 149)2 Hours After Midday Meal (n=143, 133)Pre-evening Meal (n=150, 149)2 Hours After Evening Meal (n=147, 142)3 AM (n=147, 140)
Human Regular U-500 Insulin BID-29.19-31.32-32.26-22.53-32.96-38.36-47.82
Human Regular U-500 Insulin TID-24.10-21.68-23.54-24.31-34.17-40.56-36.77

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Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin

Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate. (NCT01774968)
Timeframe: Baseline, Week 24

Interventionunits (Least Squares Mean)
Human Regular U-500 Insulin TID55.19
Human Regular U-500 Insulin BID51.39

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Parent Targeted Visual Analog Scale (PTSVAS) - Scale 3

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-17.854.705.654.155.006.204.804.854.604.134.55
rhIGF-1 First, Then Placebo5.705.005.205.355.105.354.955.155.254.555.10

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Parental Global Impression - Improvement (PGI-I)

"As part of each visit after the study intervention was initiated, the parent/caregiver was asked to compare the patient's overall clinical condition to the score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.003.003.003.004.003.003.003.003.003.00
rhIGF-1 First, Then Placebo4.004.004.003.003.003.003.003.003.003.00

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Parental Global Impression - Severity (PGI-S)

"The PGI-S is the parent version of the CGI-S. Parents/caregivers/LAR are asked to rate the severity of their child's symptoms at baseline on a 7-point scale from not at all impaired to the most impaired. The parents/caregivers/LAR will complete the PGI-S at each study visit.~The scores that correspond to each possible grouping are as follows:~1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.004.004.004.004.004.004.004.004.004.004.00
rhIGF-1 First, Then Placebo6.004.004.004.004.004.004.006.006.005.004.00

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Quantitative Measures of Respiration: Apnea Index

"Respiratory data was collected using non-invasive respiratory inductance plethysmography from a BioCapture® recording device. BioCapture® is a child-friendly measurement device that can record from 1 to 12 physiological signal transducers in a time-locked manner. It can be configured with the pediatric chest and abdominal plethysmography bands and the 3 lead ECG signals we plan to use for monitoring cardiac safety throughout the study. Each transducer is placed on the patient independently to provide a customized fit that yields the highest signal quality for each patient irrespective of body shape and proportion. The transducer signals captured by the BioCapture® are transmitted wirelessly to a laptop computer where all signals are displayed in real-time.~The apnea index is given as apneas/hour. Data on apneas greater than or equal to 10 seconds are displayed below. The higher the frequency of apnea, the more severe the breathing abnormality." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

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InterventionApneas/Hour (Median)
Visit 1 - First Intervention: Apnea IndexVisit 3 - First Intervention: Apnea IndexVisit 5 - First Intervention: Apnea IndexVisit 6 - Second Intervention: Apnea IndexVisit 8 - Second Intervention: Apnea IndexVisit 10 - Second Intervention: Apnea Index
Placebo First, Then rhIGF-17.584.806.937.907.288.91
rhIGF-1 First, Then Placebo4.053.483.073.625.555.56

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Rett Syndrome Behavior Questionnaire (RSBQ) - Fear/Anxiety Subscale

"The RSBQ is an informant/parent-completed measure of abnormal behaviors typically observed in individuals with RTT, which is completed by a parent/caregiver/LAR. Each item, grouped into eight domains/factors: General mood, Breathing problems, Body rocking and expressionless face, Hand behaviors, Repetitive face movements, Night-time behaviors, Fear/anxiety and Walking/standing), is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of items in each subscale is reported.~For the fear/anxiety subscale, the sum total could be between 0-8. The higher the sum total score, the greater the frequency of fear/anxiety behaviors." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.005.004.004.003.004.004.003.003.004.003.50
rhIGF-1 First, Then Placebo5.003.003.003.003.004.003.004.003.003.003.50

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Vineland Adaptive Behavior Scales, Second Edition (VABS-II)

"The VABS-II is a survey designed to assess personal and social functioning. Within each domain (Communication, Daily Living Skills, Socialization, and Motor Skills), items can given a score of 2 if the participant successfully performs the activity usually; a 1 if the participant successfully performs the activity sometimes, or needs reminders; a 0 if the participant never performs the activity, and a DK if the parent/caregiver is unsure of the participant's ability for an item.~The raw scores in each sub-domain are reported and the ranges for these are as follows: [Communication Domain], Receptive Language=0-40, Expressive Language=0-108, Written Language=0-50; [Daily Living Skills Domain], Personal=0-82, Domestic=0-48, Community=0-88; [Socialization Domain], Interpersonal Relationships=0-76, Play and Leisure Time=0-62, Coping Skills=0-60; [Motor Skills Domain]: Gross Motor Skills=0-80, Fine Motor Skills=0-72.~A higher score indicates more advanced abilities." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

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Interventionunits on a scale (Median)
Visit 1 - First Intervention: ReceptiveVisit 5 - First Intervention: ReceptiveVisit 6 - Second Intervention: Receptive LanguageVisit 10 - Second Intervention: Receptive LanguageVisit 1 - First Intervention: ExpressiveVisit 5 - First Intervention: ExpressiveVisit 6 - Second Intervention: Expressive Lang.Visit 10 - Second Intervention: Expressive Lang.Visit 1 - First Intervention: WrittenVisit 5 - First Intervention: WrittenVisit 6: - Second Intervention Written LanguageVisit 10 - Second Intervention: Written LanguageVisit 1 - First Intervention: PersonalVisit 5 - First Intervention: PersonalVisit 6 - Second Intervention: PersonalVisit 10 - Second Intervention: PersonalVisit 1 - First Intervention: DomesticVisit 5 - First Intervention: DomesticVisit 6 - Second Intervention: DomesticVisit 10 - Second Intervention: DomesticVisit 1 - First Intervention: CommunityVisit 5 - First Intervention: CommunityVisit 6 - Second Intervention: CommunityVisit 10 - Second Intervention: CommunityVisit 1 - First Intervention: Interpersonal Rel.Visit 5 - First Intervention: Interpersonal Rel.Visit 6 - Second Intervention: Interpersonal Rel.Visit 10 - Second Intervention: Interpersonal Rel.Visit 1 - First Intervention: Play and LeisureVisit 5 - First Intervention: Play and LeisureVisit 6 - Second Intervention: Play and LeisureVisit 10 - Second Intervention: Play and LeisureVisit 1 - First Intervention: Coping SkillsVisit 5 - First Intervention: Coping SkillsVisit 6 - Second Intervention: Coping SkillsVisit 10 - Second Intervention: Coping SkillsVisit 1 - First Intervention: Gross MotorVisit 5 - First Intervention: Gross MotorVisit 6 - Second Intervention: Gross MotorVisit 10 - Second Intervention: Gross MotorVisit 1 - First Intervention: Fine MotorVisit 5 - First Intervention: Fine MotorVisit 6 - Second Intervention: Fine MotorVisit 10 - Second Intervention: Fine Motor
Placebo First, Then rhIGF-113.0015.0018.0020.0016.0017.0018.0020.000.000.004.006.009.0010.009.0010.000.000.000.000.000.001.001.002.0018.0018.0019.0020.008.0011.0012.0011.003.002.003.004.0031.0034.0027.0027.006.006.007.005.00
rhIGF-1 First, Then Placebo18.0021.0022.0024.5018.0022.0025.0024.004.005.007.007.008.009.008.509.500.000.000.000.003.003.005.005.0021.0022.0021.0022.5013.0012.0013.0012.503.004.006.004.5010.0010.0011.5010.502.003.004.004.00

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Clinical Global Impression - Severity (CGI-S)

"This scale is used to judge the severity of the subject's disease prior to entry into the study. The clinician will rate the severity of behavioral symptoms at baseline on a 7-point scale from not impaired to the most impaired.~The scores that correspond to each possible grouping are as follows: 1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

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Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 3 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 8 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-14.004.004.004.004.004.00
rhIGF-1 First, Then Placebo4.004.004.004.004.004.50

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Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)

"The CSBS-DP was designed to measure early communication and symbolic skills in infants and young children (that is, functional communication skills of 6 month to 2 year olds). The CSBS-DP measures skills from three composites: (a) Social (emotion, eye gaze, and communication); (b) Speech (sounds and words); and (c) Symbolic (understanding and object use) and asks about developmental milestones. The data reported are the composite scores for these three categories.~The possible scores for the three composite categories are as follows:~Social Composite = 0-48; Speech Composite = 0-40; Symbolic Composite = 0-51.~A higher score indicates more advanced abilities in that area." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

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Interventionunits on a scale (Median)
Visit 1 - First Intervention: SocialVisit 2: Social Composite ScoreVisit 3: Social Composite ScoreVisit 4: Social Composite ScoreVisit 5: Social Composite ScoreVisit 6 - Second Intervention: SocialVisit 7 - Second Intervention: SocialVisit 8 - Second Intervention: SocialVisit 9 - Second Intervention: SocialVisit 10 - Second Intervention: SocialFollow-up: Social Composite ScoreVisit 1 - First Intervention: SpeechVisit 2 - First Intervention: SpeechVisit 3 - First Intervention: SpeechVisit 4 - First Intervention: SpeechVisit 5 - First Intervention: SpeechVisit 6 - Second Intervention: SpeechVisit 7 - Second Intervention: SpeechVisit 8 - Second Intervention: SpeechVisit 9 - Second Intervention: SpeechVisit 10 - Second Intervention: SpeechFollow-up: Speech Composite ScoreVisit 1 - First Intervention: SymbolicVisit 2 - First Intervention: SymbolicVisit 3 - First Intervention: SymbolicVisit 4 - First Intervention: SymbolicVisit 5 - First Intervention: SymbolicVisit 6 - Second Intervention: SymbolicVisit 7 - Second Intervention: SymbolicVisit 8 - Second Intervention: SymbolicVisit 9 - Second Intervention: SymbolicVisit 10 - Second Intervention: SymbolicFollow-up: Symbolic Composite Score
Placebo First, Then rhIGF-119.0020.0018.0018.0020.0018.0020.0021.0021.0022.5022.504.003.005.005.506.504.004.005.005.005.006.009.5010.5010.5012.0011.5013.0010.2511.5011.5013.7514.25
rhIGF-1 First, Then Placebo22.0024.0024.0024.0023.0028.0025.0027.0029.0027.0028.007.005.008.005.008.008.507.006.505.007.256.0014.0014.5015.0014.0016.5018.5017.0017.0018.0017.0018.00

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Aberrant Behavior Checklist - Community Edition (ABC-C)

"The ABC-C is a global behavior checklist implemented for the measurement of drug and other treatment effects in populations with intellectual disability. Behavior based on 58 items that describe various behavioral problems.~Each item is rated on the parents perceived severity of the behavior. The answer options for each item are:~0 = Not a problem~= Problem but slight in degree~= Moderately serious problem~= Severe in degree~The measure is broken down into the following subscales with individual ranges as follows:~Subscale I (Irritability): 15 items, score range = 0-45 Subscale II (Lethargy): 16 items, score range = 0-48 Subscale III (Stereotypy): 7 items, score range = 0-21 Subscale IV (Hyperactivity): 16 items, score range = 0-48 Subscale V (Inappropriate Speech) was not included in the breakdown because it was not applicable (no participants in the study had verbal language)." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

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Interventionunits on a scale (Median)
Visit 1 - First Intervention: Subscale IVisit 3 - First Intervention: Subscale IVisit 5 - First Intervention: Subscale IVisit 6 - Second Intervention: Subscale IVisit 8 - Second Intervention: Subscale IVisit 10 - Second Intervention: Subscale IFollow-up: Subscale I (Irritability)Visit 1 - First Intervention: Subscale IIVisit 3 - First Intervention: Subscale IIVisit 5 - First Intervention: Subscale IIVisit 6 - Second Intervention: Subscale IIVisit 8 - Second Intervention: Subscale IIVisit 10 - Second Intervention: Subscale IIFollow-up: Subscale II (Lethargy)Visit 1 - First Intervention: Subscale IIIVisit 3 - First Intervention: Subscale IIIVisit 5 - First Intervention: Subscale IIIVisit 6 - Second Intervention: Subscale IIIVisit 8 - Second Intervention: Subscale IIIVisit 10 - Second Intervention: Subscale IIIFollow-up: Subscale III (Stereotypy)Visit 1 - First Intervention: Subscale IVVisit 3 - First Intervention: Subscale IVVisit 5 - First Intervention: Subscale IVVisit 6 - Second Intervention: Subscale IVVisit 8 - Second Intervention: Subscale IVVisit 10 - Second Intervention: Subscale IVFollow-up: Subscale IV (Hyperactivity)
Placebo First, Then rhIGF-19.009.007.007.004.005.003.0013.0011.009.0011.008.006.006.0013.0010.0011.0011.0010.008.008.0013.0012.0011.0011.007.0010.009.00
rhIGF-1 First, Then Placebo6.004.002.004.003.005.002.008.007.006.005.005.004.005.0012.0010.009.0011.009.009.009.008.008.006.007.004.005.005.00

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Anxiety, Depression, and Mood Scale (ADAMS)

"Remaining subscales of the ADAMS that are not primary outcome measures include: Manic/hyperactive, Depressed mood, General anxiety, Obsessive/compulsive behavior.~The range for each subscale is as follows:~Manic/Hyperactive Behavior: 0-15 Depressed Mood: 0-21 General Anxiety: 0-21 Obsessive/Compulsive Behavior: 0-9~The higher the score for each subscale, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

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Interventionunits on a scale (Median)
Visit 1- First Intervention: Manic/HyperactiveVisit 2- First Intervention: Manic/HyperactiveVisit 3- First Intervention: Manic/HyperactiveVisit 4- First Intervention: Manic/HyperactiveVisit 5- First Intervention: Manic/HyperactiveVisit 6- Second Intervention: Manic/HyperactiveVisit 7- Second Intervention: Manic/HyperactiveVisit 8- Second Intervention: Manic/HyperactiveVisit 9- Second Intervention: Manic/HyperactiveVisit 10- First Intervention: Manic/HyperactiveFollow-up: Manic/Hyperactive SubscaleVisit 1- First Intervention: Depressed MoodVisit 2- First Intervention: Depressed MoodVisit 3- First Intervention: Depressed MoodVisit 4- First Intervention: Depressed MoodVisit 5- First Intervention: Depressed MoodVisit 6- Second Intervention: Depressed MoodVisit 7- Second Intervention: Depressed MoodVisit 8- Second Intervention: Depressed MoodVisit 9- Second Intervention: Depressed MoodVisit 10- Second Intervention: Depressed MoodFollow-up: Depressed Mood SubscaleVisit 1- First Intervention: General AnxietyVisit 2- First Intervention: General AnxietyVisit 3- First Intervention: General AnxietyVisit 4- First Intervention: General AnxietyVisit 5- First Intervention: General AnxietyVisit 6- Second Intervention: General AnxietyVisit 7- Second Intervention: General AnxietyVisit 8- Second Intervention: General AnxietyVisit 9- Second Intervention: General AnxietyVisit 10- Second Intervention: General AnxietyFollow-up: General Anxiety SubscaleVisit 1- First Intervention: Obsessive CompulsiveVisit 2- First Intervention: Obsessive CompulsiveVisit 3- First Intervention: Obsessive CompulsiveVisit 4- First Intervention: Obsessive CompulsiveVisit 5- First Intervention: Obsessive CompulsiveVisit 6- Second Intervention: Obsessive CompulsiveVisit 7- Second Intervention: Obsessive CompulsiveVisit 8- Second Intervention: Obsessive CompulsiveVisit 9- Second Intervention: Obsessive CompulsiveVisit 10- First Intervention: Obsessive CompulsiveFollow-up: Obsessive Compulsive Behavior Subscale
Placebo First, Then rhIGF-18.007.007.007.007.008.006.506.006.005.005.002.004.003.002.002.002.003.002.003.002.002.008.006.006.005.005.006.006.006.004.004.005.504.004.004.003.003.003.003.003.003.002.003.50
rhIGF-1 First, Then Placebo7.007.006.005.004.006.005.005.004.004.505.004.005.003.003.004.004.003.003.002.003.003.506.007.006.005.005.007.005.004.003.004.004.003.004.004.003.003.003.003.003.002.002.503.00

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Anxiety, Depression, and Mood Scale (ADAMS) - Social Avoidance Subscale

"The ADAMS is completed by the parent/caregiver/LAR and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The instructions ask the rater to describe the individual's behavior over the last six months on the following scale: 0 if the behavior has not occurred, 1 if the behavior occurs occasionally or is a mild problem, 2 if the behavior occurs quite often or is moderate problem, or 3 if the behavior occurs a lot or is a severe problem.~The Social Avoidance subscale of the ADAMS will be used as a primary outcome measure for this trial. The range for this subscale is 0-21. The higher the subscale score, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

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Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-16.005.005.006.005.004.004.004.003.003.504.00
rhIGF-1 First, Then Placebo4.005.004.004.003.004.004.004.003.003.503.00

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Clinical Global Impression - Improvement (CGI-I)

"Each time the patient was seen after the study intervention was initiated, the clinician compared the patient's overall clinical condition to the CGI-S score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

,
Interventionunits on a scale (Median)
Visit 3 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 8 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-14.004.004.004.004.00
rhIGF-1 First, Then Placebo4.004.004.004.004.00

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Rett Syndrome Behavior Questionnaire (RSBQ)

"The RSBQ is a parent-completed measure of abnormal behaviors typically observed in individuals with RTT. Each item, grouped into eight subscales, is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of each subscale is reported. The higher the score, the more severe the symptoms of that subscale in the participant.~The range for each subscale is as follows:~General Mood: 0-16 Body rocking and expressionless face: 0-14 Hand behaviors: 0-12 Breathing Problems: 0-10 Repetitive Face Movements: 0-8 Night-time behaviors: 0-6 Walking Standing: 0-4~The fear/anxiety subscale was used as a primary outcome measure in this study and results can be found in that section." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

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Interventionunits on a scale (Median)
Visit 1- First Intervention: General MoodVisit 2- First Intervention: General MoodVisit 3- First Intervention: General MoodVisit 4- First Intervention: General MoodVisit 5- First Intervention: General MoodVisit 6- Second Intervention: General MoodVisit 7- Second Intervention: General MoodVisit 8- Second Intervention: General MoodVisit 9- Second Intervention: General MoodVisit 10- Second Intervention: General MoodFollow-up: General MoodVisit 1- First Intervention: Body RockingVisit 2- First Intervention: Body RockingVisit 3- First Intervention: Body RockingVisit 4- First Intervention: Body RockingVisit 5- First Intervention: Body RockingVisit 6- Second Intervention: Body RockingVisit 7- Second Intervention: Body RockingVisit 8- Second Intervention: Body RockingVisit 9- Second Intervention: Body RockingVisit 10- Second Intervention: Body RockingFollowup: Body RockingVisit 1- First Intervention: Hand BehaviorsVisit 2- First Intervention: Hand BehaviorsVisit 3- First Intervention: Hand BehaviorsVisit 4- First Intervention: Hand BehaviorsVisit 5- First Intervention: Hand BehaviorsVisit 6- Second Intervention: Hand BehaviorsVisit 7- Second Intervention: Hand BehaviorsVisit 8- Second Intervention: Hand BehaviorsVisit 9- Second Intervention: Hand BehaviorsVisit 10- Second Intervention: Hand BehaviorsFollow-up: Hand BehaviorsVisit 1- First Intervention: Breathing ProblemsVisit 2- First Intervention: Breathing ProblemsVisit 3- First Intervention: Breathing ProblemsVisit 4- First Intervention: Breathing ProblemsVisit 5- First Intervention: Breathing ProblemsVisit 6- Second Intervention: Breathing ProblemsVisit 7- Second Intervention: Breathing ProblemsVisit 8- Second Intervention: Breathing ProblemsVisit 9- Second Intervention: Breathing ProblemsVisit 10- Second Intervention: Breathing ProblemsFollow-up: Breathing ProblemsVisit 1- First Intervention: Repetitive Face MovemVisit 2- First Intervention: Repetitive Face MovemVisit 3- First Intervention: Repetitive Face MovemVisit 4- First Intervention: Repetitive Face MovemVisit 5- First Intervention: Repetitive Face MovemVisit 6- Second Intervention: Repetitive Face MovVisit 7- Second Intervention: Repetitive Face MovVisit 8- Second Intervention: Repetitive Face MovVisit 9- Second Intervention: Repetitive Face MovVisit 10- Second Intervention: Repetitive Face MovFollow-up: Repetitive Face MovementsVisit 1- First Intervention: Night time BehaviorsVisit 2- First Intervention: Night time BehaviorsVisit 3- First Intervention: Night time BehaviorsVisit 4- First Intervention: Night time BehaviorsVisit 5- First Intervention: Night time BehaviorsVisit 6- Second Intervention: Night time BehaviorVisit 7- Second Intervention: Night time BehaviorVisit 8- Second Intervention: Night time BehaviorVisit 9- Second Intervention: Night time BehaviorVisit 10- Second Intervention: Night time BehaviorFollow-up: Night time BehaviorsVisit 1- First Intervention: Walking/StandingVisit 2- First Intervention: Walking/StandingVisit 3- First Intervention: Walking/StandingVisit 4- First Intervention: Walking/StandingVisit 5- First Intervention: Walking/StandingVisit 6- Second Intervention: Walking/StandingVisit 7- Second Intervention: Walking/StandingVisit 8- Second Intervention: Walking/StandingVisit 9- Second Intervention: Walking/StandingVisit 10- Second Intervention: Walking/StandingFollow-up: Walking/Standing
Placebo First, Then rhIGF-17.005.006.005.005.004.005.505.006.004.005.506.005.005.006.005.004.005.005.004.005.004.508.009.008.008.008.009.008.008.008.007.007.506.004.005.005.005.006.004.506.005.006.005.002.002.003.002.003.003.003.003.003.003.002.000.000.000.000.000.000.000.001.000.000.000.002.002.002.002.002.002.002.002.003.001.502.00
rhIGF-1 First, Then Placebo4.003.002.002.003.004.002.002.001.002.502.004.004.003.004.004.004.003.004.003.004.004.008.008.008.009.009.008.009.009.007.009.008.504.004.004.005.004.004.003.003.003.004.003.002.002.003.002.002.003.002.002.002.001.502.001.001.000.000.001.001.000.000.000.000.000.002.002.002.002.002.002.002.002.002.002.002.00

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Kerr Clinical Severity Scale

"The Kerr clinical severity scale (Kerr scale) is a quantitative measure of global disease severity. The Kerr scale is a summation of individual items related to Rett syndrome phenotypic characteristics. The items are based on the severity or degree of abnormality of each characteristic on a discrete scale (0, 1, 2) with the highest level corresponding to the most severe or most abnormal presentations.~The possible range of scores is 0-48. The higher the score, the more severe the symptoms." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-116.5015.0015.0014.00
rhIGF-1 First, Then Placebo18.0018.0019.0020.00

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Mullen Scales of Early Learning (MSEL)

"The MSEL is a standardized developmental test for children ages 3 to 68 months consisting of five subscales: gross motor, fine motor, visual reception, expressive language, and receptive language.~The raw score is reported for each subscale domain. The potential score ranges are as follows:~Visual Reception: 33 items, score range=0-50, Fine Motor: 30 items, score range= 0-49, Receptive Language: 33 items, score range= 0-48, Expressive Language: 28 items, score range= 0-50. The gross motor subscale was not included in this population.~A higher raw score indicates more advanced abilities in that section." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

,
Interventionunits on a scale (Median)
Visit 1- First Intervention: Visual ReceptionVisit 5- First Intervention: Visual ReceptionVisit 6- Second Intervention: Visual ReceptionVisit 10: Visual Reception Raw ScoreVisit 1- First Intervention: Fine MotorVisit 5- First Intervention: Fine MotorVisit 6- Second Intervention: Fine MotorVisit 10- Second Intervention: Fine MotorVisit 1- First Intervention: Receptive LanguageVisit 5- First Intervention: Receptive LanguageVisit 6- Second Intervention: Receptive LanguageVisit 10- Second Intervention: Receptive LanguageVisit 1- First Intervention: Expressive LanguageVisit 5- First Intervention: Expressive LanguageVisit 6- Second Intervention: Expressive LanguageVisit 10- Second Intervention: Expressive Language
Placebo First, Then rhIGF-117.0026.0023.0028.0010.009.0011.009.0020.0030.0031.0031.008.009.006.008.00
rhIGF-1 First, Then Placebo26.0039.5042.0044.007.007.0010.008.5025.5032.0038.0036.509.008.0010.008.00

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Parent Targeted Visual Analog Scale (PTSVAS) - Scale 1

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-16.504.705.655.054.804.954.555.654.154.805.60
rhIGF-1 First, Then Placebo8.804.805.355.105.155.204.655.005.155.055.08

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Parent Targeted Visual Analog Scale (PTSVAS) - Scale 2

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-17.754.505.855.005.005.355.505.153.804.905.15
rhIGF-1 First, Then Placebo6.355.255.955.405.457.105.855.005.134.955.20

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Salivary Cortisol

(NCT01781234)
Timeframe: 90 minutes

Interventionmcg/dL (Mean)
Intranasal Insulin0.23
Placebo0.13

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Nicotine Craving (Measured by Questionnaire of Smoking Urges)

Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome (NCT01781234)
Timeframe: 90 minutes

Interventionunits on a scale (Mean)
Intranasal Insulin30.48
Placebo43.44

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Episodic Memory

California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome (NCT01781234)
Timeframe: 90 minutes

Interventionnumber of words recalled (Mean)
Intranasal Insulin11.6
Placebo10.0

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Fasting Blood Glucose (FBG) (by Self Monitoring)

LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects. (NCT01790438)
Timeframe: 26 Weeks

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
LY2605541111.37
Human Insulin NPH109.75

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Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)

Glycosylated hemoglobin A1 (HbA1c) is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects. (NCT01790438)
Timeframe: Baseline, 26 Weeks

Interventionpercentage of HbA1c (Least Squares Mean)
LY2605541-1.73
Human Insulin NPH-1.36

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Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores

The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. (NCT01790438)
Timeframe: Baseline, 26 Weeks

Interventionunits on a scale (Mean)
LY26055412.52
Human Insulin NPH1.41

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Change From Baseline to 26 Weeks in Body Weight

LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline weight as the fixed effects. (NCT01790438)
Timeframe: Baseline, 26 Weeks

Interventionkilograms (kg) (Least Squares Mean)
LY26055412.02
Human Insulin NPH2.34

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Time to Steady-State (Stable Maximum Dose)

Steady-state was defined as the first local maximum dose (peak dose value) of LY2605541 or human insulin NPH within the window of -2 to +2 weeks. The median time to steady-state of basal insulin dose estimated from Kaplan-Meier analysis was summarized by treatment. (NCT01790438)
Timeframe: Baseline through 26 Weeks

Interventionweeks (Median)
LY26055417.14
Human Insulin NPH5.86

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Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index

The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and extreme problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United States (US) population-based algorithm. The EQ-5D-3L US based index scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. LS means were calculated from ANCOVA using treatment, stratification factor (country, baseline sulfonylurea sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]) and baseline value of EQ-5D-3Las covariates. (NCT01790438)
Timeframe: Baseline, 26 Weeks

Interventionunits on a scale (Least Squares Mean)
LY26055410.02
Human Insulin NPH0.01

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Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores

Adult LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (always). Items are categorized in 2 domains: Behavior (or avoidance) with 15 items and Worry (or affect) with 18 items. Sum all the items to obtain a total score (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, stratification factor (country, baseline sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c (≤8.5% or >8.5%), and baseline value of LBSS. (NCT01790438)
Timeframe: Baseline, 26 Weeks

Interventionunits on a scale (Least Squares Mean)
LY26055410.53
Human Insulin NPH2.05

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HbA1c

HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects. (NCT01790438)
Timeframe: 26 Weeks

Interventionpercentage of HbA1c (Least Squares Mean)
LY26055416.76
Human Insulin NPH7.12

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Rate of Severe Hypoglycemic Events

Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The hypoglycemia rate per 100 years during a defined period was calculated by the number of hypoglycemia events within the period divided by the number of days participant at risk within the period*36525 days. (NCT01790438)
Timeframe: Baseline through 26 Weeks

Interventionevents per 100 participant years (Mean)
LY26055411.00
Human Insulin NPH0.00

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Fasting Serum Glucose (FSG) (by Laboratory)

LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects. (NCT01790438)
Timeframe: 26 Weeks

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
LY2605541112.61
Human Insulin NPH118.60

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Insulin Dose Per Kilogram (kg) of Body Weight

LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, and treatment-by-visit interaction as the fixed effects. (NCT01790438)
Timeframe: 26 Weeks

Interventionunits per kilogram (Least Squares Mean)
LY26055410.40
Human Insulin NPH0.35

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Insulin Treatment Satisfaction Questionnaire (ITSQ) Score

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, higher scores indicate better treatment satisfaction. LS means were calculated using analysis of variance (ANOVA) adjusting for treatment and stratification factors (country, baseline sulfonylureas/meglitinide use [Yes/No], baseline HbA1c [≤8.5% or >8.5%]). (NCT01790438)
Timeframe: 26 Weeks

Interventionunits on a scale (Least Squares Mean)
LY260554185.04
Human Insulin NPH83.84

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30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events

Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline event rate of the corresponding hypoglycemia as covariates, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. (NCT01790438)
Timeframe: Baseline through 26 Weeks

,
Interventionepisodes per participant per 30 days (Mean)
TotalNocturnal
Human Insulin NPH1.730.61
LY26055411.460.31

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6-Point Self-Monitored Blood Glucose (SMBG)

6-point SMBG profiles were obtained on 3 nonconsecutive days in the week prior to Weeks 0, 4, 8, 12, 16, and 26. The SMBG measurements were performed while fasting (prior to the morning meal [breakfast]), prior to the midday meal (lunch), prior to the evening meal (dinner), at bedtime, at approximately 0300 hours, and the next day fasting (prior to the morning meal). LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), ], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline SMBG at the same time point of the response variable as the fixed effects. (NCT01790438)
Timeframe: 26 Weeks

,
Interventionmg/dL (Least Squares Mean)
Pre-morning mealPre-midday mealPre-evening mealBedtime0300 hoursPre-morning meal the next day
Human Insulin NPH109.56133.77146.99159.17117.66109.03
LY2605541111.22123.78130.90144.14116.35110.42

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Intra-Participant Variability in FBG by Standard Deviation

Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline FBG variability as the fixed effects. (NCT01790438)
Timeframe: 26 Weeks

Interventionmg/dL (Least Squares Mean)
LY260554114.44
Human Insulin NPH19.07

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Intra-Participant Variability in FBG by the Coefficient of Variation

Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG. (NCT01790438)
Timeframe: 26 Weeks

Interventionmg/dL (Geometric Mean)
LY260554112.87
Human Insulin NPH17.05

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Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia

Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants reaching target HbA1c without nocturnal hypoglycemia divided by the total number of participants analyzed, multiplied by 100. (NCT01790438)
Timeframe: 26 Weeks

Interventionpercentage of participants (Number)
LY260554139.1
Human Insulin NPH12.6

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Percentage of Participants With Insulin Antibodies

The percentage of participants with a positive treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR was defined as change from baseline to postbaseline in the anti-LY2605541 antibody level either (1) from undetectable to detectable or (2) from detectable to the value with at least 130% relative increase from baseline. Percentage of participants was calculated by dividing the number of participants with TEAR anytime during the treatment period by the total number of participants analyzed, multiplied by 100. (NCT01790438)
Timeframe: Baseline to 26 Weeks

Interventionpercentage of participants (Number)
LY260554119.7
Human Insulin NPH45.8

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Change From Baseline to 26 Weeks in Lipid Profile

Lipid profile includes total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. LS means for post-baseline measures were calculated using MMRM with the fixed effects of stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. LS means for End Of Study measures were calculated using ANCOVA adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL]except for the LDL-C outcome variable), treatment, and baseline value of corresponding lipid outcome variable. (NCT01790438)
Timeframe: Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks)

,
Interventionmg/dL (Least Squares Mean)
Total cholesterol, 26 WeeksTotal cholesterol, End Of Study (Up to 30 Weeks)HDL, 26 WeeksHDL, End Of Study (Up to 30 Weeks)LDL, 26 WeeksLDL, End Of Study (Up to 30 Weeks)Triglycerides, 26 WeeksTriglycerides, End Of Study (Up to 30 Weeks)
Human Insulin NPH2.862.940.410.405.903.89-15.38-0.45
LY26055412.08-0.12-0.240.533.012.54-1.49-20.34

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Percentage of Participants With Severe Hypoglycemic Events

Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The percentage of participants with at least one severe hypoglycemia is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01790438)
Timeframe: Baseline through 26 Weeks

Interventionpercentage of participants (Number)
LY26055410.5
Human Insulin NPH0.0

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Percentage of Participants With HbA1c ≤6.5% and <7.0%

Percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. (NCT01790438)
Timeframe: 26 Weeks

,
InterventionPercentage of Participants (Number)
HbA1c ≤6.5%HbA1c <7.0%
Human Insulin NPH24.144.7
LY260554143.466.3

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Percentage of Participants With Total and Nocturnal Hypoglycemic Events

Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants with at least one hypoglycemia divided by the total number of participants analyzed, multiplied by 100. (NCT01790438)
Timeframe: Baseline through 26 Weeks

,
Interventionpercentage of participants (Number)
TotalNocturnal
Human Insulin NPH83.567.5
LY260554176.741.6

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Percentage of Participants With Injection Site Reactions

The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01790438)
Timeframe: Baseline through 26 Weeks

Interventionpercentage of participants (Number)
LY26055410.9
Human Insulin NPH1.4

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Self-Monitored Blood Glucose (SMBG) at 12 Weeks

SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. SMBG measures were assessed at Weeks 0, 4, 8, and 12 within each Randomization Period. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Week in Each Randomization Period

,
Interventionmg/dL (Least Squares Mean)
Pre-morning meal2 hours post-morning mealPre-midday meal2 hours post-midday mealPre-evening meal2 hours post-evening mealBedtime0300 hoursSubsequent morning pre-meal
LY2605541 Fixed Time Dosing133.21151.03122.96147.05137.75150.37153.81131.40125.16
LY2605541 Variable Time Dosing141.05160.41137.55141.54134.43153.21150.77143.16130.57

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Fasting Blood Glucose (FBG) Measured by Self-Monitored Blood Glucose

FBG was measured by self-monitored blood glucose (SMBG). LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline FBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Weeks in Each Randomization Period

Interventionmg/dL (Least Squares Mean)
LY2605541 Fixed Time Dosing131.35
LY2605541 Variable Time Dosing139.65

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0300-Hour Blood Glucose to Fasting Blood Glucose Excursion

Excursion results were calculated by subtracting the 0300 hours glucose value from the next day pre-morning glucose value within a single SMBG profile. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline 0300-hour to next day pre-breakfast excursion (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Week in Each Randomization Period

Interventionmg/dL (Least Squares Mean)
LY2605541 Fixed Time Dosing-6.41
LY2605541 Variable Time Dosing-15.24

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Change From Day 1 of Lead-In Period to 36 Weeks in Body Weight

LS means were calculated using MMRM analysis, including visit and baseline weight (last non-missing value at or before the beginning of Lead-in Period) as covariates. (NCT01792284)
Timeframe: Day 1 of Lead-In Period, 36 Weeks

Interventionkg (Least Squares Mean)
All Participants-1.16

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Change From Randomization to 12 Weeks in Body Weight

LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline body weight (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: Randomization, 12 Weeks in Each Randomization Period

Interventionkilograms (kg) (Least Squares Mean)
LY2605541 Fixed Time Dosing-0.06
LY2605541 Variable Time Dosing0.00

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Change From Randomization to 12 Weeks in HbA1c

LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: Randomization, 12 Weeks in Each Randomization Period

Interventionpercentage of HbA1c (Least Squares Mean)
LY2605541 Fixed Time Dosing0.10
LY2605541 Variable Time Dosing0.18

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Change From Day 1 of Lead-in to 36 Weeks in Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C)

LS means were calculated using MMRM analysis including visit and baseline lipid level (last nonmissing value at or before the beginning of Lead-in) as covariates. (NCT01792284)
Timeframe: Day 1 of Lead-In Period, 36 Weeks

Interventionmg/dL (Least Squares Mean)
TriglyceridesTotal CholesterolLDL-CHDL-C
All Participants26.443.754.45-5.70

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Fasting Serum Glucose (FSG) at 12 Weeks

LS means for FSG (obtained from clinical laboratory tests) were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline FSG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Weeks in Each Randomization Period

Interventionmg/dL (Least Squares Mean)
LY2605541 Fixed Time Dosing121.51
LY2605541 Variable Time Dosing120.45

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Hemoglobin A1c (HbA1c) at 12 Weeks

HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Week in Each Randomization Period

Interventionpercentage of HbA1c (Least Squares Mean)
LY2605541 Fixed Time Dosing6.87
LY2605541 Variable Time Dosing6.93

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Intra-participant Variability in SMBG at 12 Weeks

A summary of glucose variability (intra-participant variability) as measured by the average of between-day standard deviations of individual SMBG time points. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline intra-participant variability in SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Week in Each Randomization Period

Interventionmg/dL (Least Squares Mean)
LY2605541 Fixed Time Dosing34.82
LY2605541 Variable Time Dosing36.21

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Intra-Participant Variability of FBG at 12 Weeks

FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline intra-participant variability in FBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Weeks in Each Randomization Period

Interventionmg/dL (Least Squares Mean)
LY2605541 Fixed Time Dosing37.97
LY2605541 Variable Time Dosing39.80

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Basal, Bolus, and Total Insulin Doses at 12 Weeks

LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline insulin dose (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Weeks in Each Randomization Period

,
Interventionunits/kg/day (Least Squares Mean)
BasalBolusTotal Insulin
LY2605541 Fixed Time Dosing0.500.200.71
LY2605541 Variable Time Dosing0.510.200.71

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Participants With Treatment-Emergent Anti-LY2605541 Antibody Response

The number of participants with a treatment emergent anti-LY2605541 antibody response (TEAR) is presented. Positive TEAR was defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from 1) undetectable to detectable or from 2) detectable to the value with at least 130% relative increase from baseline. (NCT01792284)
Timeframe: Day 1 of Lead-in Period through 36 Weeks

Interventionparticipants (Number)
All Participants80

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Proportion of Bolus to Total Insulin Doses at 12 Weeks

Proportion of bolus to total insulin dose is presented, where LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline proportion of bolus to total insulin dose (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: At 12 Weeks in Each Randomization Period

Interventionunits/day (Least Squares Mean)
LY2605541 Fixed Time Dosing0.29
LY2605541 Variable Time Dosing0.28

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30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events

Total hypoglycemic events (HE) include any event based on a blood glucose <=70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), with or without signs/symptoms of hypoglycemia or an event associated with signs/symptoms of hypoglycemia but without a glucose measurement. Nocturnal HE include any total HE that occurred between bedtime and waking. Group Means are presented and were calculated from negative binomial regression models (number of episodes = treatment + period + treatment sequence + baseline HbA1c [<=8.0% or >8.0%], with log [exposure in days/30] as an offset variable). Group Mean (LS mean) is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. (NCT01792284)
Timeframe: Baseline (Day 1) of Randomization Period through 24 Weeks (12 weeks in each Randomization Period)

,
Interventionevents/participant/30 days (Least Squares Mean)
Total HENocturnal HE
LY2605541 Fixed Time Dosing10.541.52
LY2605541 Variable Time Dosing10.371.34

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Change From Randomization to 12 Weeks in 9-Point SMBG

SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. SMBG measures were assessed at Weeks 0, 4, 8, and 12 within each Randomization Period. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction. (NCT01792284)
Timeframe: Randomization, 12 Weeks in Each Randomization Period

,
Interventionmg/dL (Least Squares Mean)
Pre-morning meal2 hours post-morning mealPre-midday meal2 hours post-midday mealPre-evening meal2 hours post-evening mealBedtime0300 hoursSubsequent morning pre-meal
LY2605541 Fixed Time Dosing-7.77-1.240.2710.911.985.498.40-7.05-7.84
LY2605541 Variable Time Dosing0.078.1314.875.40-1.348.335.364.71-2.44

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Percentage of Participants With HbA1c <7.0% and ≤6.5% at 12 Weeks

The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. (NCT01792284)
Timeframe: At 12 Weeks in Each Randomization Period

,
Interventionpercentage of participants (Number)
HbA1c <7.0%HbA1c <=6.5%
LY2605541 Fixed Time Dosing60.534.1
LY2605541 Variable Time Dosing54.534.1

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Percentage of Participants With Total and Nocturnal Hypoglycemic Events

Total HE include any event based on a blood glucose <=70 mg/dL (3.9 mmol/L), with or without signs/symptoms of hypoglycemia or an event associated with signs/symptoms of hypoglycemia but without a glucose measurement. Nocturnal HE include any total HE that occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. (NCT01792284)
Timeframe: Baseline (Day 1) of Randomization Period through 24 weeks (12 weeks in each Randomization Period)

,
Interventionpercentage of participants (Number)
Total HENocturnal HE
LY2605541 Fixed Time Dosing98.278.4
LY2605541 Variable Time Dosing97.880.6

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Glucose Values <70 mg/dL.

# participants with glucose values <70 mg/dL (NCT01810952)
Timeframe: 1-5 days

,
Interventionparticipants (Number)
# with glucose values <70 mg/dL# with glucose values <60 mg/dL# with glucose <50
Glargine/Lispro Insulin Arm541
Glargine/Lispro/NPH Insulin Arm420

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Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.

"Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm." (NCT01810952)
Timeframe: 1-5 days

,
Interventionmg/dL (Mean)
Day 1 (n=20, 17)Day 2 (n=20, 17)Day 3 (n=20, 17)Day 4 (n=14, 12)Day 5 (n=10, 7)
Glargine/Lispro Insulin Arm181.8160.5155.1159.5151.7
Glargine/Lispro/NPH Insulin Arm173.7148.4140.8133.4132.0

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Daily Insulin Dose/Kg Body Weight

Total daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL (NCT01810952)
Timeframe: 1-5 days

,
Interventionunits of insulin/Kg body weight (Mean)
Day 1 (n=20, 17)Day 2 (n=20, 17)Day 3 (n=20, 17)Day 4 (n=14, 12)Day 5 (n=10, 7)
Glargine/Lispro Insulin Arm0.890.910.961.011.12
Glargine/Lispro/NPH Insulin Arm0.800.820.770.750.65

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Percent of Glucose Determinations >180 mg/dL

(NCT01810952)
Timeframe: 1-5 days

InterventionPercent of glucose values (Number)
Glargine/Lispro Insulin Arm31.0
Glargine/Lispro/NPH Insulin Arm24.6

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Percent of Participants With Average Glucose >70 and <180 mg/dL

Percent of Participants with Average Daily Glucose >70 and <180 mg/dL (NCT01810952)
Timeframe: Last Full Day of Protocol for Participant (up to Day 5)

Interventionpercentage of participants (Number)
Glargine/Lispro Insulin Arm90
Glargine/Lispro/NPH Insulin Arm94

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of treatment (NCT01814137)
Timeframe: Week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Least Squares Mean)
IDegAsp BID + IAsp OD0.05
IDeg OD + IAsp TID-0.49

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Incidence of Treatment Emergent Adverse Events (TEAEs)

A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product. (NCT01814137)
Timeframe: During 26 weeks of treatment

Interventionnumber of events (Number)
IDegAsp BID + IAsp OD33
IDeg OD + IAsp TID45

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Number of Treatment Emergent Hypoglycaemic Episodes

"Confirmed hypoglycaemic episodes were defined as episodes that are either:~severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or~biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia." (NCT01814137)
Timeframe: During 26 weeks of treatment

Interventionepisodes (Number)
IDegAsp BID + IAsp OD54
IDeg OD + IAsp TID95

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Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes

Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL). (NCT01814137)
Timeframe: During 26 weeks of treatment

Interventionepisodes (Number)
IDegAsp BID + IAsp OD13
IDeg OD + IAsp TID12

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally. (NCT01814137)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
IDegAsp BID + IAsp OD-0.80
IDeg OD + IAsp TID-2.57

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Change From Baseline in HbA1c

The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement. (NCT01819129)
Timeframe: Week 0, Week 26

,
InterventionPercentage of glycosylated haemoglobin (Mean)
Baseline (week 0)Week 26
Faster Aspart7.966.63
NovoRapid7.896.59

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

A hypoglycaemic episode was defined as treatment-emergent if the onset of the episode was on or after the first day of exposure to randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. (NCT01819129)
Timeframe: From Week 0 to Week 26.

InterventionNumber of episodes (Number)
Faster Aspart2857
NovoRapid2692

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Change From Baseline in 2-hour PPG Increment (Meal Test)

For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement. (NCT01819129)
Timeframe: Week 0, week 26

,
Interventionmmol/L (Mean)
Baseline (week 0)Week 26
Faster Aspart7.574.55
NovoRapid7.344.9

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Change From Baseline in Body Weight

For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement. (NCT01819129)
Timeframe: Week 0, week 26

,
InterventionKg (Mean)
Baseline (week 0)Week 26
Faster Aspart89.091.6
NovoRapid88.390.8

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Change in HbA1c

Change from baseline in HbA1c (%) after 52 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 52

,
InterventionPercentage of glycosylated haemoglobin (Mean)
Week 0 (baseline)Week 52
Faster Aspart (Meal)7.627.51
NovoRapid (Meal)7.587.58

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Change From Baseline in HbA1c (Post Meal Arm)

Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 26

,
InterventionPercentage of glycosylated haemoglobin (Mean)
Week 0 (baseline)Week 26
Faster Aspart (Post)7.637.51
NovoRapid (Meal)7.587.42

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 26

,,
InterventionPercentage of glycosylated haemoglobin (Mean)
Week 0 (Baseline)Week 26
Faster Aspart (Meal)7.627.31
Faster Aspart (Post)7.637.51
NovoRapid (Meal)7.587.42

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Change in PPG (Postprandial Glucose)

Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 52

,
Interventionmmol/L (Mean)
PPG at 120 minutes (Baseline)PPG at 120 minutes (Week 52)PPG increment at 120 mins (Baseline)PPG increment at 120 mins(Week 52)
Faster Aspart (Meal)14.5114.266.065.71
NovoRapid (Meal)14.1414.516.246.14

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Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 26

,,
InterventionKg (Mean)
Week 0: BaselineWeek 26
Faster Aspart (Meal)78.5679.21
Faster Aspart (Post)80.4981.17
NovoRapid (Meal)80.1580.69

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Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)

Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test). (NCT01831765)
Timeframe: Week 0, week 26

,,
Interventionmmol/L (Mean)
Week 0: BaselineWeek 26
Faster Aspart (Meal)6.065.88
Faster Aspart (Post)6.066.73
NovoRapid (Meal)6.246.55

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. (NCT01831765)
Timeframe: From baseline until week 26

Interventionevent rate/100 patient yrs of exposure (Number)
Faster Aspart (Meal)5899
Faster Aspart (Post)5443
NovoRapid (Meal)5865

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Frequency of Adverse Events

All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment. (NCT01831765)
Timeframe: After 52 weeks of randomised treatment

Interventionevent /100 patient yrs of exposure (Number)
Faster Aspart (Meal)445.8
Faster Aspart (Post)441
NovoRapid (Meal)411

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Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill

The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionepisodes (Number)
IDegAsp OD599
IDet OD/BID449

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Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)

The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionepisodes (Number)
IDegAsp OD6
IDet OD/BID12

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)

"Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia).~Confirmed hypoglycaemic episodes were defined as episodes that were either:~Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or~An episode biochemically confirmed by PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia." (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionepisodes (Number)
IDegAsp OD2532
IDet OD/BID2672

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Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes

The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionepisodes (Number)
IDegAsp OD316
IDet OD/BID291

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)

Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment. (NCT01835431)
Timeframe: Week 0 to week 16

Interventionpercentage (%) (Mean)
IDegAsp OD-0.3
IDet OD/BID-0.3

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Change From Baseline in Fasting Plasma Glucose

Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment. (NCT01835431)
Timeframe: week 0, week 16

Interventionmmol/L (Mean)
IDegAsp OD-0.3
IDet OD/BID-0.1

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Incidence of Treatment Emergent Adverse Events (TEAEs)

A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment. (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionnumber of events (Number)
IDegAsp OD501
IDet OD/BID460

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Weight Gain

Total weight gain in pregnancy (NCT01837680)
Timeframe: Number of pounds gained at each visit up to 41 weeks

Interventionlbs (Mean)
Insulin NPH27.7
Levemir28.6

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Time to Achieve Glycemic Control

Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl (NCT01837680)
Timeframe: up to 41 weeks

Interventionweeks (Median)
Insulin NPH5
Levemir5

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Post-prandial Blood Glucose

Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits. (NCT01837680)
Timeframe: up to 41 weeks

Interventionmg/dL (Mean)
Insulin NPH115.2
Levemir112.9

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Number of Patients Obtaining Glycemic Control

Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl. (NCT01837680)
Timeframe: up to 41 weeks

InterventionParticipants (Count of Participants)
Insulin NPH28
Levemir35

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Neonatal Weight

Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight >90th percentile for gestational age (NCT01837680)
Timeframe: At delivery, up to 41 weeks

Interventiong (Median)
Insulin NPH3230
Levemir3235

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Neonatal Hypoglycemia

Number of participants with incidence of blood sugar <40mg/dl in neonate (NCT01837680)
Timeframe: at birth, up to 41 weeks

InterventionParticipants (Count of Participants)
Insulin NPH0
Levemir2

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Maternal Hypoglycemia

Number of participants with incidence of maternal hypoglycemia (<60mg/dl) (NCT01837680)
Timeframe: at delivery, up to 41 weeks

InterventionParticipants (Count of Participants)
Insulin NPH11
Levemir16

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Intensive Care Admissions

Number of participants with incidence of neonatal intensive care unit admissions (NCT01837680)
Timeframe: at birth, up to 41 weeks

InterventionParticipants (Count of Participants)
Insulin NPH3
Levemir6

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Glycemic Control

Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits. (NCT01837680)
Timeframe: up to 41 weeks

Interventionmg/dL (Mean)
Insulin NPH109.5
Levemir107.4

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Gestational Age at Delivery

Gestational age at delivery (NCT01837680)
Timeframe: at delivery, up to 41 weeks

Interventionweeks (Median)
Insulin NPH38.9
Levemir38.8

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Birth Rate

Number of live birth rate (NCT01837680)
Timeframe: at birth, up to 41 weeks

InterventionParticipants (Count of Participants)
Insulin NPH42
Levemir45

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Average Fasting Glucose

Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits (NCT01837680)
Timeframe: up to 41 weeks

Interventionmg/dL (Mean)
Insulin NPH100.7
Levemir97.3

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Time Per Day <56 Milligrams Per Deciliter (mg/dL), ≤70 mg/dL, >70 mg/dL, <140 mg/dL, ≥140 mg/dL, Outside of 71 to 180 mg/dL, and Outside of 71 to 139 mg/dL

For each participant, the following CGM parameters were calculated using CGM values recorded after Randomization up to Month 12: time per day spent in the pre-defined glucose classes. (NCT01848990)
Timeframe: Randomization to Month 12

,
Interventionminutes (Least Squares Mean)
Time per day <56 mg/dLTime per day ≤70 mg/dLTime per day >70 mg/dLTime per day <140 mg/dLTime per day ≥140 mg/dLTime per day outside of 71 to 180 mg/dLTime per day outside of 71 to139 mg/dL
Hylenex Recombinant18.163.01358.8660.3756.4464.4819.4
Standard Rapid-Acting Insulin CSII20.368.51351.9683.7732.5461.7801.0

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Average Carbohydrate Factor (CarbF) Values

CarbF is calculated as 2.6 * weight (pounds) / total daily dose of insulin (grams per unit). (NCT01848990)
Timeframe: Month 1 to Month 12

Interventiongrams per unit (Least Squares Mean)
Hylenex Recombinant11.1
Standard Rapid-Acting Insulin CSII11.0

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Number of Participants With the Indicated Responses to the Question Regarding the Difficulty of Infusion Site Change

Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program. (NCT01848990)
Timeframe: Month 12

,
InterventionParticipants (Count of Participants)
Very easyEasyDifficultVery difficult
Hylenex Recombinant14313030
Standard Rapid-Acting Insulin CSII494611

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Change From Baseline in Average Weighted Impact ADDQoL Values at Month 12

The ADDQoL is a validated, diabetes-specific questionnaire to evaluate the participant's assessment of QoL. Participants rated the impact of diabetes on 19 applicable domains on a scale from -3 (maximum negative impact) to +3 (maximum positive impact) and then rated the importance of those domains for their QoL on a scale from 3 (very important) to 0 (not at all important). Impact ratings were multiplied by the corresponding importance ratings to provide a weighted-impact score for each domain from -9 (maximum negative impact) to +9 (maximum positive impact). Weighted impact scores were summed and divided by the number of applicable domains to give an overall Average Weighted Impact (AWI) score (higher values represent more positive impact). If there were less than 13 non-missing weighted-impact values, AWI was not to be calculated. Baseline is defined as the last measurement prior to randomization. (NCT01848990)
Timeframe: Baseline; Month 12

Interventionscore on a scale (Least Squares Mean)
Hylenex Recombinant0.0
Standard Rapid-Acting Insulin CSII0.0

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Change From Baseline to 12 Months in HbA1c

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT01848990)
Timeframe: Baseline; 12 Months

Interventionpercentage of HbA1c (Mean)
Hylenex Recombinant-0.13
Standard Rapid-Acting Insulin CSII-0.26

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Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c)

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT01848990)
Timeframe: Baseline; 6 Months

Interventionpercentage of HbA1c (Mean)
Hylenex Recombinant-0.14
Standard Rapid-Acting Insulin CSII-0.18

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Mean Times Per Week Participants Said They Were Eating to Avoid Going Low Due to Late Insulin Action

Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program. (NCT01848990)
Timeframe: Month 12

Interventionoccurrences per week (Mean)
Hylenex Recombinant2.1
Standard Rapid-Acting Insulin CSII2.5

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Number of Participants Achieving HbA1c <7.0% and HbA1c ≤6.5% at Month 12

The number of participants achieving HbA1c goals of <7% and ≤6.5% was calculated. (NCT01848990)
Timeframe: Month 12

,
InterventionParticipants (Count of Participants)
HbA1c <7.0%HbA1c ≤6.5%
Hylenex Recombinant6118
Standard Rapid-Acting Insulin CSII216

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Rates of HEs to Month 12

Overall rates of hypoglycemia (defined as blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were based on measurements after 1 month up to 12 months. A severe HE was classified as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. A nocturnal HE was classified as an event with a blood glucose of ≤70 mg/dL with start time between 2300 and 0600, inclusive. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. (NCT01848990)
Timeframe: After Month 1 up to Month 12

,
Interventionevents per participant per month (Number)
<56 mg/dL≤70 mg/dLNocturnal HEsSevere HEs
Hylenex Recombinant2.679211.38031.67540.0091
Standard Rapid-acting Insulin CSII3.302212.35911.92030.0085

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Mean Time to Change Infusion Site

Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program. (NCT01848990)
Timeframe: Month 12

Interventionminutes (Mean)
Hylenex Recombinant5.7
Standard Rapid-Acting Insulin CSII4.7

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Rates of Hyperglycemia Events to Month 12

Overall rates of hyperglycemia (defined as blood glucose >240 mg/dL and >300 mg/dL) were based on measurements after 1 month up to 12 months. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. (NCT01848990)
Timeframe: After Month 1 up to Month 12

,
Interventionevents per participant per month (Number)
>240 mg/dL>300 mg/dL
Hylenex Recombinant18.97847.1138
Standard Rapid-acting Insulin CSII18.27856.8900

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Rates of Hyperglycemia Events to Month 6

Overall rates of hyperglycemia (defined as blood glucose >240 mg/dL and >300 mg/dL) were based on measurements after 1 month up to 6 months. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. (NCT01848990)
Timeframe: After Month 1 up to Month 6

,
Interventionevents per participant per month (Number)
>240 mg/dL>300 mg/dL
Hylenex Recombinant18.04226.4768
Standard Rapid-acting Insulin CSII18.46966.8155

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Rates of Hypoglycemia Events (HE) to Month 6

Overall rates of hypoglycemia (defined as blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were based on measurements after 1 month up to 6 months. A severe HE was classified as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. A nocturnal HE was classified as an event with a blood glucose of ≤70 mg/dL with start time between 2300 and 0600, inclusive. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. (NCT01848990)
Timeframe: After Month 1 up to Month 6

,
Interventionevents per participant per month (Number)
<56 mg/dL≤70 mg/dLNocturnal HEsSevere HEs
Hylenex Recombinant2.910311.62191.62240.0055
Standard Rapid-acting Insulin CSII4.197014.71122.07270.0160

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Mean Additional Time for Hylenex Pre-administration

Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program. (NCT01848990)
Timeframe: Month 12

Interventionminutes (Mean)
Hylenex Recombinant2.9
Standard Rapid-Acting Insulin CSII3.8

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Mean Glucose Excursions at 6 Months

A 4-hour postprandial glucose excursion was measured for 3 meals after 1 month up to 6 months. For each of the 3 meals, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal (for measurements taken within 15 minutes before a meal). The average of all excursions is presented. Least Squares (LS) means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. (NCT01848990)
Timeframe: After Month 1 up to Month 6

,
Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
BreakfastLunchDinnerOverall
Hylenex Recombinant17.322.212.617.1
Standard Rapid-acting Insulin CSII20.717.912.516.9

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Mean Glucose Excursions at 12 Months

A 4-hour postprandial glucose excursion was measured for 3 meals after 1 month up to 12 months. For each of the 3 meals, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal (for measurements taken within 15 minutes before a meal). The average of all excursions is presented. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. (NCT01848990)
Timeframe: After Month 1 up to Month 12

,
Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
BreakfastLunchDinnerOverall
Hylenex Recombinant20.122.412.717.1
Standard Rapid-acting Insulin CSII24.921.013.819.7

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Change From Baseline in Weighted Impact ADDQoL Values at Month 12

The Audit of Diabetes Dependent Quality of Life (ADDQoL) is a validated, diabetes-specific questionnaire to evaluate the participant's assessment of quality of life (QoL). Participants rated the impact of diabetes on 19 applicable domains on a scale from -3 (maximum negative impact) to +3 (maximum positive impact) and then rated the importance of those domains for their QoL on a scale from 3 (very important) to 0 (not at all important). Impact ratings were multiplied by the corresponding importance ratings to provide a weighted-impact score for each domain from -9 (maximum negative impact) to +9 (maximum positive impact). (NCT01848990)
Timeframe: Baseline; Month 12

,
Interventionscore on a scale (Least Squares Mean)
Leisure activitiesWork lifeLocal or long distance travelVacationsDo physicallyFamily lifeFriendships and social lifeClose personal relationshipSex lifePhysical appearanceSelf-confidenceMotivationThe way people in general reactFeelings about the futureFinancial situationLiving situation and conditionsDepend on othersFreedom to eatFreedom to drink
Hylenex Recombinant-0.2-0.1-0.40.0-0.10.20.30.10.00.10.00.00.2-0.10.10.0-0.10.0-0.2
Standard Rapid-Acting Insulin CSII0.00.0-0.20.2-0.20.10.10.1-0.3-0.2-0.10.3-0.10.30.0-0.10.4-0.3-0.3

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Change From Baseline in DTSQs and DTSQc at Month 12

The Diabetes Treatment Satisfaction Questionnaire-status version (DTSQs) and DTSQ-change version (DTSQc) are validated tools to assess treatment satisfaction and change in treatment satisfaction after therapy changes have occurred. The scale total was computed by adding the 6 items (1, 4, 5, 6, 7, and 8) to produce the Treatment Satisfaction scale total, which has a minimum of 0 and a maximum of 36 on the DTSQs and a minimum of -18 and a maximum of 18 on the DTSQc. Higher scores represent greater satisfaction. If any of the 6 item scores were missing and the numbers of missing scores were less than the number of non-missing scores, the Treatment Satisfaction scale score was to be computed by taking the average of the existing scores and multiplying the average by 6. If there were less than 4 non-missing item scores, the Treatment Satisfaction scale score was not to be calculated. Baseline is defined as the last measurement prior to randomization. (NCT01848990)
Timeframe: Baseline; Month 12

,
Interventionscore on a scale (Least Squares Mean)
DTSQsDTSQc
Hylenex Recombinant0.09.4
Standard Rapid-Acting Insulin CSII0.09.4

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Change From Baseline in Body Weight to Month 12

Baseline is defined as the last measurement prior to randomization. (NCT01848990)
Timeframe: Baseline; Week 2; Months 1, 2, 3, 4, 6, 9, and 12

,
Interventionkilograms (Mean)
Week 2Month 1Month 2Month 3Month 4Month 6Month 9Month 12
Hylenex Recombinant-0.10-0.11-0.030.160.040.600.910.61
Standard Rapid-Acting Insulin CSII0.190.200.480.370.370.830.920.48

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Average of Daily Insulin Doses (Bolus, Basal, and Total)

The daily bolus insulin dose is calculated as the daily prandial (occurring before a meal) insulin dose plus the daily corrective insulin dose. Cumulative basal dosage is to generally be within 40% to 60% of the total daily dose. (NCT01848990)
Timeframe: from Randomization up to Month 12

,
InterventionInternational units (Least Squares Mean)
Daily bolus doseDaily basal doseDaily total dose
Hylenex Recombinant21.928.049.9
Standard Rapid-Acting Insulin CSII22.925.748.5

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Average of Bolus Times Relative to Meal Times

The average meal bolus timing relative to meal time is defined as the minutes between the start time of a meal bolus and the start time of a meal. (NCT01848990)
Timeframe: Month 1 to Month 12

,
Interventionminutes (Mean)
BreakfastLunchDinnerOverall
Hylenex Recombinant-2.3-1.8-1.7-1.9
Standard Rapid-Acting Insulin CSII-3.9-1.6-1.7-2.4

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Average Glucose, Median Glucose, and Average Daily Standard Deviation

For each participant, the following continuous glucose monitoring (CGM) parameters were calculated using CGM values recorded after Randomization up to Month 12: average glucose, median glucose, and average daily standard deviation. (NCT01848990)
Timeframe: Randomization to Month 12

,
Interventionmilliliters per deciliter (Least Squares Mean)
Average glucoseMedian glucoseAverage daily standard deviation
Hylenex Recombinant152.9145.248.9
Standard Rapid-Acting Insulin CSII151.9143.449.7

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Area Per Day <56 mg/dL, ≤70 mg/dL, ≥140 mg/dL, Outside of 71 to 180 mg/dL, and Outside of 71 to 139 mg/dL

For each participant, the following continuous glucose monitoring (CGM) parameters were calculated using CGM values recorded after Randomization up to Month 12: area per day spent in the pre-defined glucose classes. The area per day for a specific glucose concentration range (e.g., <56 mg/dL) is the sum of the area under the curve with glucose concentration falling in the specific glucose concentration range (e.g., <56 mg/dL). For example, if the glucose stays constant at 50 mg/dL for the whole day (1,440 minutes), the area per day for glucose < 56 mg/dL equals: 50*1440 = 72,000 mg*minutes/dL. (NCT01848990)
Timeframe: Randomization to Month 12

,
Interventionmg*minutes/deciliter (Least Squares Mean)
Area per day <56 mg/dLArea per day ≤70 mg/dLArea per day ≥140 mg/dLArea per day outside of 71 to 180 mg/dLArea per day outside of 71 to 139 mg/dL
Hylenex Recombinant129.7687.042660.220033.843347.2
Standard Rapid-Acting Insulin CSII163.2771.742317.220411.243089.0

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Average Correction Factor (CorrF) Values

CorrF is calculated as 1960 / total daily dose of insulin (milligrams/[deciliter*unit]). (NCT01848990)
Timeframe: Month 1 to Month 12

Interventionmilligrams/(deciliter*unit) (Least Squares Mean)
Hylenex Recombinant43.2
Standard Rapid-Acting Insulin CSII45.3

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Number of Participants With the Indicated Responses to the Device Handling Questions

Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program. Question 1: Achieve excellent post meal glucose control; Question 2: Insulin responds quickly when basal rate is changed; Question 3: Insulin responds quickly when correction bolus is given. (NCT01848990)
Timeframe: Month 12

InterventionParticipants (Count of Participants)
Question 172221138Question 172221139Question 272221138Question 272221139Question 372221139Question 372221138
Neither agree or disagreeDisagreeCompletely agreeAgreeCompletely disagree
Standard Rapid-Acting Insulin CSII0
Hylenex Recombinant110
Standard Rapid-Acting Insulin CSII28
Hylenex Recombinant97
Standard Rapid-Acting Insulin CSII44
Hylenex Recombinant59
Standard Rapid-Acting Insulin CSII22
Hylenex Recombinant5
Standard Rapid-Acting Insulin CSII3
Hylenex Recombinant31
Standard Rapid-Acting Insulin CSII8
Hylenex Recombinant146
Standard Rapid-Acting Insulin CSII48
Hylenex Recombinant71
Hylenex Recombinant25
Standard Rapid-Acting Insulin CSII12
Hylenex Recombinant3
Standard Rapid-Acting Insulin CSII1
Hylenex Recombinant36
Standard Rapid-Acting Insulin CSII14
Hylenex Recombinant165
Standard Rapid-Acting Insulin CSII39
Hylenex Recombinant34
Hylenex Recombinant38
Standard Rapid-Acting Insulin CSII20
Standard Rapid-Acting Insulin CSII2

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Standard Deviation of Self-Monitoring Blood Glucose Values at 6 Months

Standard deviation of self-monitoring blood glucose values was calculated based on measurements taken within 15 minutes before a meal, 1 month and up to 6 months after study drug administration. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. (NCT01848990)
Timeframe: After Month 1 up to Month 6

Interventionmg/dL (Least Squares Mean)
Hylenex Recombinant70.9
Standard Rapid-acting Insulin CSII72.2

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Standard Deviation of Self-Monitoring Blood Glucose Values at 12 Months

Standard deviation of self-monitoring blood glucose values was calculated based on measurements taken within 15 minutes before a meal, 1 month and up to 12 months after study drug administration. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. (NCT01848990)
Timeframe: After Month 1 up to Month 12

Interventionmg/dL (Least Squares Mean)
Hylenex Recombinant72.9
Standard Rapid-acting Insulin CSII72.4

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Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL). (NCT01849289)
Timeframe: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD85
IGlar OD97

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Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)

Change from baseline in HbA1c (%) after 26 weeks of treatment. (NCT01849289)
Timeframe: Week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-1.3
IGlar OD-1.2

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Number of Treatment Emergent AEs (Adverse Events)

Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration) (NCT01849289)
Timeframe: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)

Interventionnumber of events (Number)
IDeg OD612
IGlar OD387

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Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes

A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment. (NCT01849289)
Timeframe: Week 26

Interventionparticipants (Number)
IDeg OD252
IGlar OD114

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Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)

Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below. (NCT01849289)
Timeframe: Week 26

Interventionpercentage (Mean)
IDeg OD10.65
IGlar OD10.01

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Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)

Change from baseline in FPG after 26 weeks of treatment. (NCT01849289)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
IDeg OD-3.35
IGlar OD-3.14

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Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)

"For this endpoint the end of trial data containing last available measurements are presented. Prandial PG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point profiles (SMPG) as the difference between the PPG value 2 hours after each meal and the PG value before each meal. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements." (NCT01850615)
Timeframe: After 18 weeks of randomised treatment

,
Interventionmmol/L (Mean)
Breakfast increment; SMPGLunch increment; SMPGMain evening meal increment; SMPG
Basal2.91.81.4
Faster Aspart + Basal1.20.90.7

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Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)

"For this endpoint the end of trial data containing last available measurements are presented. PPG measurements were recorded by the subjects at 2 hours after each meal (breakfast, lunch and main evening meal) as part of three 7-point profiles (SMPG) prior to the visits. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements." (NCT01850615)
Timeframe: After 18 weeks of randomised treatment

,
Interventionmmol/L (Mean)
PPG breakfast; SMPGPPG lunch; SMPGPPG main evening meal; SMPG
Basal99.710.1
Faster Aspart + Basal7.27.17.4

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Change From Baseline in HbA1c

"For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the end of trial data containing last available measurements." (NCT01850615)
Timeframe: Week 0, week 18

,
InterventionPercentage of glycosylated haemoglobin (Mean)
BaselineWeek 18
Basal7.927.7
Faster Aspart + Basal7.936.78

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Number of Treatment Emergent Hypoglycaemic Episodes

Plasma glucose (PG) was measured and recorded when a hypoglycaemic episode was suspected. All PG values ≤3.9 mmol/L (70 mg/dL) or >3.9 mmol/L (70 mg/dL) when they occurred in conjunction with hypoglycaemic symptoms were recorded by the subject. Numbers of treatment emergent hypoglycaemic episodes were recorded during 18 weeks of treatment. (NCT01850615)
Timeframe: Weeks 0-18

InterventionNumber of episodes (Number)
Faster Aspart + Basal1908
Basal347

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Number of Adverse Events

All adverse events (AEs) described here refer to treatment emergent adverse events (TEAE). A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment, week 18. (NCT01850615)
Timeframe: Weeks 0-18

InterventionNumber of events (Number)
Faster Aspart + Basal123
Basal121

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Change From Baseline in Body Weight

"For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the end of trial data containing last available measurements." (NCT01850615)
Timeframe: Week 0, week 18

,
InterventionKg (Mean)
BaselineWeek 18
Basal85.185.4
Faster Aspart + Basal82.283.9

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Number of Patients Developed Episodes of Severe Hyperglycemia

Hyperglycemic events are defined as BG > 300 mg/dL. (NCT01855243)
Timeframe: during hospital stay which is expected to be average 3 weeks

Interventionparticipants (Number)
Glargine Plus Supplemental Glulisine10
70/30 Insulin Plus Supplemental Lunch Insulin4
Sliding Scale Insulin (SSI)15

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Mortality Rate

(NCT01855243)
Timeframe: during the hospital stay which is expected to be average 3 weeks

Interventionparticipants (Number)
Glargine Plus Supplemental Glulisine0
70/30 Insulin Plus Supplemental Lunch Insulin0
Sliding Scale Insulin (SSI)0

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Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.

(NCT01855243)
Timeframe: during hospital stay which is expected to be average 3 weeks

Interventionmg/dL (Mean)
Glargine Plus Supplemental Glulisine221
70/30 Insulin Plus Supplemental Lunch Insulin179
Sliding Scale Insulin (SSI)222

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Mean BG After First Day of Hospitalization

(NCT01855243)
Timeframe: after first day of hospitalization

Interventionmg/dL (Mean)
Glargine Plus Supplemental Glulisine225
70/30 Insulin Plus Supplemental Lunch Insulin171
Sliding Scale Insulin (SSI)218

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Number of Patients Developed Hypoglycemic Events

Hypoglycemic episodes are classified as major (BG ≤ 40 mg/dL or associated with impaired mental status or loss of consciousness), or minor (BG between 40 and 59 mg/dL) events. (NCT01855243)
Timeframe: during hospital stay which is expected to be average 3 weeks

,,
Interventionparticipants (Number)
Minor (BG between 40 - 59 mg/dLMajor (BG ≤ 40 mg/dL)
70/30 Insulin Plus Supplemental Lunch Insulin00
Glargine Plus Supplemental Glulisine32
Sliding Scale Insulin (SSI)10

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Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Overnight target range: [70-180] mg/dL (NCT01874392)
Timeframe: 7 hours overnight

Interventionpercentage time in range (70 - 180 mg/dL (Median)
T1DM100

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Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range for the entire study: [80-140] mg/dL (NCT01874392)
Timeframe: 25-28 hours

Interventionpercentage time in range(80-140mg/dL) (Median)
T1DM67.5

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Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System

To evaluate the performance of the AP device combined with the Technosphere® Insulin Powder System after breakfast by measuring the postprandial excursion of blood glucose (NCT01874392)
Timeframe: 120 minutes

Interventionmg/dL (Median)
T1DM61

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Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System

To evaluate the performance of the AP device combined with the Technosphere® Insulin Powder System after dinner by measuring the postprandial excursion of blood glucose. (NCT01874392)
Timeframe: 150 minutes

Interventionmg/dL (Median)
T1DM64

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Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range 5 hours after meal: [70-180] mg/dL. (NCT01874392)
Timeframe: 5 hours

Interventionpercentage time in range (70 - 180 mg/dL (Median)
T1DM81.6

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Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range during exercise: [70-150] mg/dL (NCT01874392)
Timeframe: 30 minutes

Interventionpercentage time in range (70-150 mg/dL) (Median)
T1DM94.4

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Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range 3 hours after exercise: [70-150] mg/dL (NCT01874392)
Timeframe: 3 hours

Interventionpercentage time in range (70-150 mg/dL) (Median)
T1DM94.4

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Costs - Co-pays

At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital. (NCT01879579)
Timeframe: baseline

Interventionparticipants (Number)
All Participants37

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Percentage of Text Message Responses

The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent. (NCT01879579)
Timeframe: 12 weeks

Interventionpercentage of text messages (Number)
Mobile Insulin Titration Intervention84

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Baseline Treatment Satisfaction

The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied. (NCT01879579)
Timeframe: baseline

Interventionscore on satisfaction scale (Mean)
Mobile Insulin Titration Intervention4.99
Current Best Practice5.20

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Incidence of Hypoglycemia

The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms. (NCT01879579)
Timeframe: 12 weeks

Interventioninstances of hypoglycemia (Number)
Mobile Insulin Titration Intervention5
Current Best Practice3

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Time to Reach Optimal Long-acting Insulin Dose

The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms. (NCT01879579)
Timeframe: 12 weeks

Interventionweeks (Median)
Mobile Insulin Titration Intervention3.00
Current Best Practice7.07

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Patient Healthcare Utilization

The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits). (NCT01879579)
Timeframe: 12 weeks

Interventionhospital visits (Number)
Mobile Insulin Titration Intervention6
Current Best Practice11

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Hemoglobin A1c

Change in hemoglobin A1c (NCT01879579)
Timeframe: baseline, 12 weeks (approximately 3 months)

Interventionmg/dL (Mean)
Mobile Insulin Titration Intervention-1.90
Current Best Practice-1.81

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Costs - Provider Time Spent on Insulin Titration Visits

Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic. (NCT01879579)
Timeframe: 12 weeks

Interventionminutes (Median)
Insulin Titration Visits by Phone6
Insulin Titration Visits in the Clinic30

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Costs - Titration Visit Information

The number of insulin titration visits (whether by phone or in the clinic). (NCT01879579)
Timeframe: 12 weeks

Interventioninsulin titration visits (Median)
Mobile Insulin Titration Intervention3.5
Current Best Practice2

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Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose

(NCT01879579)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Mobile Insulin Titration Intervention88
Current Best Practice37

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Costs - Patient Travel Time

The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits. (NCT01879579)
Timeframe: 12 weeks

Interventionminutes (Median)
All Participants45

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Percentage of Successful Phone Calls

The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent. (NCT01879579)
Timeframe: 12 weeks

Interventionpercentage of phone calls (Number)
Mobile Insulin Titration Intervention91

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Change in Treatment Satisfaction

The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now. (NCT01879579)
Timeframe: 12 weeks (approximately 3 months)

Interventionscore on satisfaction scale (Mean)
Mobile Insulin Titration Intervention2.71
Current Best Practice2.42

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Treatment Satisfaction After Initiation of Insulin Titration

The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied. (NCT01879579)
Timeframe: 12 weeks (approximately 3 months)

Interventionscore on satisfaction scale (Mean)
Mobile Insulin Titration Intervention5.74
Current Best Practice5.53

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Incidence of Treatment Emergent Adverse Events (TEAEs)

The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). (NCT01880736)
Timeframe: Weeks 0-26

Interventionevents (Number)
IDeg OD Flexible (Arm C+Arm D)150
IDeg OD Fixed (Arm A+Arm B)154
IDeg OD Simple (Arm A+Arm C)138
IDeg OD Stepwise (Arm B+Arm D)166

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))

The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L [less than 56 mg/dL]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). (NCT01880736)
Timeframe: Weeks 0-26

Interventionepisodes (Number)
IDeg OD Flexible (Arm C+Arm D)476
IDeg OD Fixed (Arm A+Arm B)371
IDeg OD Simple (Arm A+Arm C)469
IDeg OD Stepwise (Arm B+Arm D)378

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Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period

The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT01880736)
Timeframe: From week 16 to end of trial (week 27)

Interventionepisodes (Number)
IDeg OD Flexible (Arm C+Arm D)34
IDeg OD Fixed (Arm A+Arm B)23
IDeg OD Simple (Arm A+Arm C)40
IDeg OD Stepwise (Arm B+Arm D)17

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Change From Baseline in Fasting Plasma Glucose (FPG)

Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). (NCT01880736)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
IDeg OD Flexible (Arm C+Arm D)-28.8
IDeg OD Fixed (Arm A+Arm B)-25.4
IDeg OD Simple (Arm A+Arm C)-27.0
IDeg OD Stepwise (Arm B+Arm D)-27.2

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition

Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). (NCT01880736)
Timeframe: Weeks 0-26

,,,
Interventionepisodes (Number)
ADA Events OverallSevereDocumented symptomaticAsymptomaticProbable symptomaticRelative
IDeg OD Fixed (Arm A+Arm B)2736111411283131180
IDeg OD Flexible (Arm C+Arm D)305301262152387181
IDeg OD Simple (Arm A+Arm C)3089112931505103187
IDeg OD Stepwise (Arm B+Arm D)2700011101301115174

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Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial

The number of subjects who achieved the pre-defined HbA1c target (<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). (NCT01880736)
Timeframe: After 26 weeks of treatment

InterventionSubjects (Number)
IDeg OD Flexible (Arm C+Arm D)90
IDeg OD Fixed (Arm A+Arm B)95
IDeg OD Simple (Arm A+Arm C)91
IDeg OD Stepwise (Arm B+Arm D)94

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Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes

The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. (NCT01880736)
Timeframe: Weeks 0-26

Interventionepisodes (Number)
IDeg OD Flexible (Arm C+Arm D)77
IDeg OD Fixed (Arm A+Arm B)58
IDeg OD Simple (Arm A+Arm C)80
IDeg OD Stepwise (Arm B+Arm D)55

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period

The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. (NCT01880736)
Timeframe: From Week 16 to end of trial (week 27)

Interventionepisodes (Number)
IDeg OD Flexible (Arm C+Arm D)227
IDeg OD Fixed (Arm A+Arm B)192
IDeg OD Simple (Arm A+Arm C)241
IDeg OD Stepwise (Arm B+Arm D)178

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Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)

Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise) (NCT01880736)
Timeframe: Week 0, week 26

InterventionPercent (%) glycosylated haemoglobin (Mean)
IDeg OD Flexible (Arm C+Arm D)-0.54
IDeg OD Fixed (Arm A+Arm B)-0.62
IDeg OD Simple (Arm A+Arm C)-0.57
IDeg OD Stepwise (Arm B+Arm D)-0.59

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The Effect of ORMD-0801 on Morning Fasting Serum Insulin

Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801 (NCT01889667)
Timeframe: Screening, Day 2. Day 9

,,
Interventionmg/dL (Mean)
ScreeningDay 2Day 9
ORMD-0801 Dose # 120.8011.9315.70
ORMD-0801 Dose # 217.3412.9415.51
Placebo34.519.019.85

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The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo

Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801 (NCT01889667)
Timeframe: Screening, Day 2, Day 9

,,
Interventionmg/dL (Mean)
ScreeningDay 2Day 9
ORMD-0801 Dose # 14.2333.1803.875
ORMD-0801 Dose # 23.1253.0643.090
Placebo5.1592.4002.715

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Evaluate the Safety and Tolerability of ORMD-0801.

Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug (NCT01889667)
Timeframe: Eight (8) days

InterventionNumber of Events (Number)
ORMD-0801 Dose # 10
ORMD-0801 Dose # 20
Placebo0

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The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)

Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801 (NCT01889667)
Timeframe: Seven (7) days, and last two days (Day 6 and day 7)

,,
Interventionmg/dL (Mean)
All Seven DaysLast two days (day 6 and day 7)
ORMD-0801 Dose # 1152.55153.23
ORMD-0801 Dose # 2163.05158.58
Placebo175.99176.06

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The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)

Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801 (NCT01889667)
Timeframe: Seven (7) days, and last two days (Day 6 and day 7)

,,
Interventionmg/DL (Mean)
Last two days (day 6 and day 7)All Seven Days
ORMD-0801 Dose # 1135.64139.73
ORMD-0801 Dose # 2150.24149.38
Placebo167.95165.85

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Incidence of AEs (Adverse Event)

Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. (NCT01892020)
Timeframe: During 4 weeks of treatment in each treatment sequence

InterventionEvents/100 years of patient exposure (Number)
BIAsp 50322.7
BHI 50245.1

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The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile

Mean post prandial PG increment over all meals was derived as the mean of all available meal increments. (NCT01892020)
Timeframe: After 4 weeks of treatment in each treatment sequence

Interventionmmol/L (Least Squares Mean)
BIAsp 502.39
BHI 502.25

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2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test

The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value. (NCT01892020)
Timeframe: After 4 weeks of treatment in each treatment sequence

Interventionmmol/L (Mean)
BIAsp 505.30
BHI 506.41

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-IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test

AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model. (NCT01892020)
Timeframe: After 4 weeks of treatment in each treatment sequence

Interventionmin*mmol/L (Mean)
BIAsp 50465.39
BHI 50503.64

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-1-hour PPG Increment Following a Standard Meal Test

The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value. (NCT01892020)
Timeframe: After 4 weeks of treatment in each treatment sequence

Interventionmmol/L (Mean)
BIAsp 504.42
BHI 504.74

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Incidence of Hypoglycemic Episodes

Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia. (NCT01892020)
Timeframe: During 4 weeks of treatment in each treatment sequence

,
Interventionevents per patient per year (Number)
All eventsSevereDocumented SymptomaticAsymptomaticProbable SymptomaticRelativeUnclassifiable
BHI 5014.380.088.332.531.721.720
BIAsp 5012.1005.971.292.582.100.16

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2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile

PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal. (NCT01892020)
Timeframe: After 4 weeks of treatment in each treatment sequence

,
Interventionmmol/L (Least Squares Mean)
Increment at breakfast, N=151, 149Increment at Lunch, N=150, 148Increment at dinner, N=151, 149
BHI 502.862.930.99
BIAsp 502.523.581.08

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Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])

(NCT01894568)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Insulin Peglispro96.9
Insulin Glargine97.2

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Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)

Percentage of participants with hypoglycemic events (total or nocturnal) to Week 26 based on BG Threshold 70mg/dL. (NCT01894568)
Timeframe: Baseline to Week 26

,
Interventionpercentage of participants (Number)
Nocturnal Hypoglycemia BG 70mg/dLTotal Hypoglycemia BG 70mg/dL
Insulin Glargine29.676.5
Insulin Peglispro26.677.1

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Insulin Treatment Satisfaction Questionnaire (ITSQ) Score

The Insulin Treatment Satisfaction Questionnaire is a validated instrument containing 22 items that assessed treatment satisfaction for participants with diabetes on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means was achieved using a MMRM model for post-baseline measures with stratification factors (country, HbA1c, and SU/meglitinide use) treatment, visit, treatment-by-visit as fixed effects. ITSQ was assessed at Week 4 (baseline) and Week 26. (NCT01894568)
Timeframe: Week 4 and 26

,
Interventionunits on a scale (Least Squares Mean)
ITSQ Wk4ITSQ Wk26
Insulin Glargine75.9478.29
Insulin Peglispro74.1378.73

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Fasting Serum Glucose (FSG)

LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and sulfonylurea [SU]/meglitinide use), visit, and treatment-by-visit interaction. (NCT01894568)
Timeframe: Weeks 0 and 26

,
Interventionmg/dL (Least Squares Mean)
Week 0Week 26
Insulin Glargine166.61110.32
Insulin Peglispro164.31103.85

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Fasting Blood Glucose (FBG)

LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. (NCT01894568)
Timeframe: Weeks 0 and 26

,
Interventionmg/dL (Least Squares Mean)
Week 0Week 26
Insulin Glargine161.19108.22
Insulin Peglispro159.53108.39

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Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26

LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit, and treatment-by-visit interaction. (NCT01894568)
Timeframe: Week 26

,
Interventionmg/dL (Least Squares Mean)
Cholesterol Wk26HDL Wk26Triglycerides Wk26LDL Wk26
Insulin Glargine177.9052.99122.83101.07
Insulin Peglispro175.7651.64132.4397.95

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Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26

The EuroQoL-5D-3L questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. Overall health state score was self-reported using a VAS marked on a scale of 0 to 100 (0 indicates worst imaginable health state and 100 indicates best imaginable health state. LS means were calculated using analysis of covariance (ANCOVA) for actual measures and changes from baseline at endpoint using LOCF method: adjusting for treatment, stratification factors (region, HbA1c and SU/meglitin. (NCT01894568)
Timeframe: Baseline, Week 26

,
Interventionunits on a scale (Least Squares Mean)
Change from Baseline to Endpoint EQ-5D-3L ScoreChange from Baseline VAS Health State Score
Insulin Glargine0.003.66
Insulin Peglispro0.012.29

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9-Point Self-Monitored Blood Glucose (SMBG)

LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. The 9-point SMBG are measured at: Pre-morning meal, 2 hours(hr) post morning meal, pre-midday meal, 2 hr post midday meal, pre-evening meal, 2 hr post pre-evening meal, bedtime, 0300 hr, and pre-morning meal next day, and should be performed on 2 non-consecutive days. (NCT01894568)
Timeframe: Week 0 and Week 26

,
Interventionmg/dL (Least Squares Mean)
Morning Pre-meal Wk0Morning Pre-meal Wk26Morning Post-meal Wk0Morning Post-meal Wk26Mid-day Pre-meal Wk0Mid-day Pre-meal Wk26Mid-day Post-meal Wk0Mid-day Post-meal Wk26Evening Pre-meal Wk0Evening Pre-meal Wk26Evening Post-meal Wk0Evening Post-meal Wk26Bed Time Wk0Bed Time Wk260300 Hours (Hrs) Wk00300 Hrs Wk26Pre-morning Meal Next Day Wk0Pre-morning Meal Next Day Wk26
Insulin Glargine162.83108.71233.37176.93166.68122.85226.11183.88172.83135.55219.54182.80197.68161.44162.13114.77159.96105.18
Insulin Peglispro160.19108.24237.19176.97169.24122.01224.22182.32176.49131.65219.45176.23198.64153.41158.82115.18156.28108.42

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30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events

Hypoglycemia Events (HE) occurs when blood glucose level ≤ 70 milligram per deciliter (mg/dL) (<3.9 micromoles per liter [mmol/L]). Nocturnal HE includes any total HE that occurred between bedtime and waking. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline total hypoglycemia event rate, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. (NCT01894568)
Timeframe: Baseline to Week 26

,
InterventionNumber of events per participant per 30d (Mean)
Total HENocturnal HE
Insulin Glargine1.210.27
Insulin Peglispro1.280.19

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Percentage of Participants With HbA1c ≤6.5%

Percentage of participants with HbA1c ≤6.5% at Week 26 were made using a logistic regression model for endpoint used last observation carried forward (LOCF) method including treatment, baseline HbA1c value. (NCT01894568)
Timeframe: Week 26

InterventionPercentage of participants (Number)
Insulin Peglispro29.8
Insulin Glargine22.7

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Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26

For participants with detectable anti-insulin peglispro antibody level, the percentage of participants with positive cross-react with endogenous insulin was summarized. (NCT01894568)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Insulin Peglispro24.6
Insulin Glargine32.5

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Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)

Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months.LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. (NCT01894568)
Timeframe: Baseline, Week 12

Interventionpercent of HbA1c (Least Squares Mean)
Insulin Peglispro-1.43
Insulin Glargine-1.22

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Percent Hemoglobin A1c at Week 26

HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. (NCT01894568)
Timeframe: Week 26

Interventionpercent of HbA1c (Least Squares Mean)
Insulin Peglispro6.92
Insulin Glargine7.17

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Intra-Participant Variability of the Fasting Blood Glucose (FBG)

Intra-participant variability of Fasting Blood Glucose (FBG), which was measured by Self Monitored Blood Glucose (SMBG), was assessed by the standard deviation of the FBG measurement at the Week 26 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. (NCT01894568)
Timeframe: Week 26

Interventionmg/dL (Least Squares Mean)
Insulin Peglispro14.97
Insulin Glargine15.12

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Insulin Dose Per Kilogram (kg) of Body Weight

LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide), visit, and treatment-by-visit interaction. (NCT01894568)
Timeframe: Week 26

Interventionunits per kg (Least Squares Mean)
Insulin Peglispro0.26
Insulin Glargine0.26

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Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)

Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein [LDL-C], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C. (NCT01894568)
Timeframe: Baseline, Week 26

Interventionpercent of HbA1c (Least Squares Mean)
Insulin Peglispro-1.61
Insulin Glargine-1.36

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Change From Baseline to Week 26 in Body Weight

LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. (NCT01894568)
Timeframe: Baseline, Week 26

InterventionKilogram (kg) (Least Squares Mean)
Insulin Peglispro1.06
Insulin Glargine1.57

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Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores

LBSS is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 5 - always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range 0 to 132). Higher total scores reflect greater fear of hypoglycemia. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. LBSS was assessed during screening visit (baseline) and again at Week 26. (NCT01894568)
Timeframe: Baseline, Week 26

Interventionunits on a scale (Least Squares Mean)
Insulin Peglispro1.51
Insulin Glargine1.62

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Day 14 Follow-Up: Average Serum BG

(NCT01945138)
Timeframe: Day 14 Follow-Up

Interventionmg/dL (Mean)
Control135
Closed Loop Insulin106

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Study Period: Serum BG Standard Deviation

Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient. (NCT01945138)
Timeframe: 3 days of investigation period

Interventionmg/dL (Mean)
Control21.0
Closed Loop Insulin14.1

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Study Period: Percent Time BG in Range 70-140 mg/dL

Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM (NCT01945138)
Timeframe: continuous over the 72 hour investigation period

Intervention% of time (Mean)
Control70.6
Closed Loop Insulin89.2

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Study Period: Morning C-peptide

A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient. (NCT01945138)
Timeframe: Average of 3 day study period

Interventionng/mL (Mean)
Control1.6
Closed Loop Insulin1.3

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Study Period: Daily Insulin Needs

Calculated as total daily dose of insulin. (NCT01945138)
Timeframe: Average of 3 day study period

InterventionU/kg/day (Mean)
Control0.56
Closed Loop Insulin0.26

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Study Period: Continuous Glucose Monitor Standard Deviation of BG

measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings. (NCT01945138)
Timeframe: continuous over the 72 hour investigation period

Interventionmg/dL (Mean)
Control21.0
Closed Loop Insulin20.1

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Study Period: Continuous Glucose Monitor (CGM) BG Average

Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period (NCT01945138)
Timeframe: continuously over the 72 hour investigational period

Interventionmg/dL (Mean)
Control125
Closed Loop Insulin114

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Study Period: CGM AUC With Glucose> 140 mg/dL

(NCT01945138)
Timeframe: continuous over the 72 hour investigation period

Interventionmin*mg/dL/day (Mean)
Control7860
Closed Loop Insulin2025

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Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL

Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL. (NCT01945138)
Timeframe: continuous over the 72 hour investigation period

Interventionmin*mg/dL/day (Mean)
Control1615
Closed Loop Insulin146

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Study Period: Average Serum BG

Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups. (NCT01945138)
Timeframe: 3 days of investigation period

Interventionmg/dL (Mean)
Control130
Closed Loop Insulin111

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Study Period: % of Time CGM BG > 140 mg/dL

(NCT01945138)
Timeframe: continuous over the 72 hour investigation period

Intervention% of time (Mean)
Control23.7
Closed Loop Insulin9.7

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Study Period: % of Time CGM BG <70 mg/dL

(NCT01945138)
Timeframe: continuous over the 72 hour investigation period

Intervention% of time (Mean)
Control4.8
Closed Loop Insulin1.1

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Day 28 Follow-Up: C-Peptide

(NCT01945138)
Timeframe: Day 28 Follow-Up

Interventionng/mL (Mean)
Control1.0
Closed Loop Insulin1.7

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Day 28 Follow-Up: Average Serum BG

(NCT01945138)
Timeframe: Day 28 Follow-Up

Interventionmg/dL (Mean)
Control113
Closed Loop Insulin100

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Day 14 Follow-Up: C-Peptide

(NCT01945138)
Timeframe: Day 14 Follow-Up:

Interventionng/mL (Mean)
Control1.0
Closed Loop Insulin1.6

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of treatment (NCT01952145)
Timeframe: Week 0, week 26

InterventionPercentage (%) (Mean)
Insulin Degludec/Liraglutide (IDegLira)-1.81
Insulin Glargine (IGlar)-1.13

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia. (NCT01952145)
Timeframe: During 26 weeks of treatment

InterventionNumber of episodes (Number)
Insulin Degludec/Liraglutide (IDegLira)289
Insulin Glargine (IGlar)683

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Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of treatment (NCT01952145)
Timeframe: Week 0, week 26

InterventionKg (Mean)
Insulin Degludec/Liraglutide (IDegLira)-1.4
Insulin Glargine (IGlar)1.8

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Ischemic Foot Ulcer

The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code (NCT01957930)
Timeframe: Until hospitalization for ischemic foot ulcer or until 31 December 2011

Interventionparticipants (Number)
Intensified Insulin Treatment3
Standard-treatment10

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Change in Glycosylated Haemoglobin (HbA1c)

Mean change in HbA1c from week 0 to month 24. (NCT01959529)
Timeframe: Randomisation to 24 months

Interventionpercentage of HbA1c (Mean)
Insulin Degludec-0.86
Insulin Glargine-0.84

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Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke

Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months. (NCT01959529)
Timeframe: From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)

,
InterventionParticipants (Count of Participants)
First EAC-confirmed MACEMyocardial infarction (non-fatal)Stroke (non-fatal)Cardiovascular death
Insulin Degludec32514368114
Insulin Glargine35616374119

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Number of EAC-confirmed Severe Hypoglycaemic Episodes

Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months. (NCT01959529)
Timeframe: From randomisation to individual end of trial (maximum patient year observation: 2.75 years)

InterventionNumber of severe episodes (Number)
Insulin Degludec280
Insulin Glargine472

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Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no)

Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. (NCT01959529)
Timeframe: From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)

InterventionParticipants (Count of Participants)
Insulin Degludec187
Insulin Glargine252

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Mean Change From Randomization in A1c at Week 26

Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy (NCT01966978)
Timeframe: Baseline and Week 26

InterventionPercentage of glycosylated hemoglobin (Mean)
Control: Metformin, Insulin Detemir, Insulin Aspart3.4
Metformin, Insulin Determir, Liraglutide4.1

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Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means

Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

,
Interventionscore on a scale (Least Squares Mean)
General Health PerceptionCurrent Health PerceptionTreatment SatisfactionDiabetes Related WorrySocial or Vocational WorryHypoglycemia FearGlycemic Control PerceptionSatisfaction with Insulin TreatmentWillingness to Continue Insulin TreatmentLifeStyle FlexibilitySocial Stigma
Control: Metformin, Insulin Detemir, Insulin Aspart-0.3-0.5-0.30.03-0.020.3-1.1-1.3-0.9-0.090.1
Metformin, Insulin Determir, Liraglutide-0.9-1.1-0.6-0.2-0.2-0.2-1.6-1.7-1.1-0.20.01

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Change in Short Form-36 (SF-36) Questionnaire Score

Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. SF-36 is scored on a 1-100 scale; a higher score represents a better self-assessed health - for all domains. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

,
Interventionscore on a scale (Least Squares Mean)
Physical Component SummaryMental Component Summary
Control: Metformin, Insulin Detemir, Insulin Aspart-0.10.04
Metformin, Insulin Determir, Liraglutide0.0070.09

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Percentage of Participants Reaching Target A1c of <7% at Week 26

(NCT01966978)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart20
Metformin, Insulin Determir, Liraglutide44

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"Percentage of Participants Reaching Pre-specified Treatment Failure Outcome"

Treatment Failure defined as A1c>10% at week 13 (visit 5) (NCT01966978)
Timeframe: week 13

Interventionpercentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart16.1
Metformin, Insulin Determir, Liraglutide7.4

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Composite End-point

Percentage of participants with glycosylated Hemoglobin A1c (A1c)<8% AND no documented severe hypoglycemia (<56 mg/dL) during the study AND no significant weight gain (>3% from baseline) (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

Interventionpercentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart16
Metformin, Insulin Determir, Liraglutide34

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Hypoglycemic Episodes

Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of <70 mg/dl (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 2, week 4, week 13, Week 26

Interventionpercentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart66.1
Metformin, Insulin Determir, Liraglutide35.2

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Mean Change From Randomization in Body Weight

Change in body weight from randomization to end of study. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

Interventionkilogram (Mean)
Control: Metformin, Insulin Detemir, Insulin Aspart3.1
Metformin, Insulin Determir, Liraglutide-0.6

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Mean Point of Care (POC) Glucose Level in Both Groups.

The overall mean point of care glucose levels in the NPH group and control group on the first day of the study. (NCT01970241)
Timeframe: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.

Interventionmg/dL (mean values) (Mean)
NPH Insulin (Intervention Group)246.9
Control280.9

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Mean POC Glucose Level Between Groups

Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose. (NCT01970241)
Timeframe: Assessed from enrollment to discharge or enrollment to day five.

Interventionmg/dl (Mean)
NPH With Corticosteroid225
Control266

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Mean Point of Care (POC) Glucose Level in Both Groups.

The overall mean point of care glucose levels in the NPH group and control group on the last day of the study. (NCT01970241)
Timeframe: On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.

Interventionmg/dL (mean values) (Mean)
NPH Insulin (Intervention Group)197.3
Control253.5

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Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl

Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl. (NCT01970241)
Timeframe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

InterventionPercentage of total measurements (Number)
NPH Insulin (Intervention Group)16.9
Control27.0

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Correlation of C-peptide With ALT

(NCT01970241)
Timeframe: Measured once at the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)-0.358
Control0.436

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Correlation of C-peptide With Age

(NCT01970241)
Timeframe: plasma C-peptide was measured once at the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)0.197
Control-0.226

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Correlation of C-peptide With Hemoglobin A1c

(NCT01970241)
Timeframe: Measured once at the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)-0.325
Control-0.251

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Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL

Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl. (NCT01970241)
Timeframe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

InterventionPercentage of total measurements of gluc (Number)
NPH Insulin (Intervention Group)33.1
Control19.2

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Correlation of C-peptide With BMI

(NCT01970241)
Timeframe: Measured once at the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)0.095
Control0.305

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Correlation of C-peptide With Duration of Diabetes

(NCT01970241)
Timeframe: Measured once at the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)-0.320
Control-0.380

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Correlation of C-peptide With eGFR

(NCT01970241)
Timeframe: Measured once at the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)-0.272
Control-0.063

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Correlation of C-peptide With Length of Stay

(NCT01970241)
Timeframe: Measured once at the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)-0.068
Control-0.002

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Correlation of C-peptide With Plasma Glucose

(NCT01970241)
Timeframe: Measured the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)0.171
Control-0.053

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Correlation of C-peptide With Serum Creatinine

(NCT01970241)
Timeframe: Measured once at the time of enrollment

Interventioncorrelation coefficient (Number)
NPH Insulin (Intervention Group)0.328
Control-0.026

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Difference in Length of Stay Between NPH and Control Group

Time difference of hospitalization between the NPH and control groups. (NCT01970241)
Timeframe: Measured from the day of admission till the day of discharge

InterventionDays (Mean)
NPH Insulin (Intervention Group)5.21
Control5.23

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Episodes of Hypoglycemia Between NPH and Control Groups

Hypoglycemia was defined as point of care glucose less than 70 mg/dL. (NCT01970241)
Timeframe: Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.

InterventionHypoglycemic episodes. (Number)
NPH Insulin (Intervention Group)6
Control0

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Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL

Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements > 400 mg/dL. (NCT01970241)
Timeframe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

InterventionPercentage of total measurements (Number)
NPH Insulin (Intervention Group)5.9
Control8.5

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Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL

Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL. (NCT01970241)
Timeframe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

InterventionPercentage of total measurements (Number)
NPH Insulin (Intervention Group)42.1
Control45.3

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Overnight Glucose

"Mean overnight glucose during camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group." (NCT01973413)
Timeframe: 6 nights

Interventionmg/dL (Mean)
Experimental: Closed-Loop Control140
Control: Sensor-Augmented Pump Therapy147

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Percent Time Near Normoglycemia

"Percent of time in a glucose target range of 70-150 mg/dl during camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group." (NCT01973413)
Timeframe: 6 nights

Interventionpercentage of time (Median)
Experimental: Closed-Loop Control73
Control: Sensor-Augmented Pump Therapy52

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Glycemic Events

"Number of nights with >= 1 hypo- and hyperglycemic event occurring overnight during the camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group." (NCT01973413)
Timeframe: 6 nights

,
Interventionnights with >= 1 event (Number)
Hyperglycemic (>250mg/dl)Hypoglycemic (<70mg/dl)
Control: Sensor-Augmented Pump Therapy414
Experimental: Closed-Loop Control47

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Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro

(NCT01995526)
Timeframe: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

Interventionhours (Median)
Insulin Peglispro39.00

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Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro

(NCT01995526)
Timeframe: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

Interventionpicomoles/liter (pmol/L) (Geometric Mean)
Insulin Peglispro3720

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Glucodynamics: Maximum Glucose Infusion Rate (Rmax)

(NCT01995526)
Timeframe: Predose up to 36 hours post clamp procedure

Interventionmilligrams/minute/kilogram (mg/min/kg) (Geometric Mean)
Insulin Peglispro1.75

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Glucodynamics: Total Amount of Glucose Infused (Gtot)

(NCT01995526)
Timeframe: Predose up to 36 hours post clamp procedure.

Interventionmilligrams/kilograms (mg/kg) (Geometric Mean)
Insulin Peglispro2180

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Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro

AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated. (NCT01995526)
Timeframe: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

Interventionpicomoles*hours/liter (pmol*h/L) (Geometric Mean)
Insulin Peglispro280000

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Number of Premature Infusion Set Changes

"A premature infusion set change was defined as not being a routine change. This was defined as an infusion set changed at home due to suspicion of occlusion, leakage, unexplained hyperglycaemic episode, infusion site reaction, technical reason, or other. The change of infusion set at a site visit was considered a routine change unless an occlusion was actually suspected at the site." (NCT01999322)
Timeframe: During 6 weeks of treatment

InterventionEpisodes (Number)
Faster-acting Insulin Aspart21
NovoRapid®4

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Number of Microscopically Confirmed Episodes of Infusion Set Occlusions

The number of microscopically confirmed episodes of infusion set occlusions during 6 weeks of treatment. Episodes of infusion set occlusions were confirmed by microscopic examination of the infusion sets at each routine weekly visit and infusion sets that had been changed prematurely because of leakage, unexplained hyperglycaemia or suspicion of occlusion (observation of a plug). (NCT01999322)
Timeframe: During 6 weeks of treatment

InterventionEpisodes (Number)
Faster-acting Insulin Aspart0
NovoRapid®0

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Number of Episodes of Possible Infusion Set Occlusions

Episodes of possible infusion set occlusions were defined as infusion sets changed due to suspicion of occlusion, leakage or unexplained hyperglycaemic episode. Possible occlusion excluded technical reasons. This endpoint was calculated from the recorded date/times of changes of infusion set combined with the subjects' own assessment. (NCT01999322)
Timeframe: During 6 weeks of treatment

InterventionEpisodes (Number)
Faster-acting Insulin Aspart7
NovoRapid®0

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Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))

Unexplained hyperglycaemia was defined as a confirmed plasma glucose value ≥ 16.7 mmol/L (300 mg/dL) and was unexplained (i.e., no apparent medical, dietary, insulin dosage or pump failure reason) (NCT01999322)
Timeframe: During 6 weeks of treatment

Interventionevents (Number)
Faster-acting Insulin Aspart28
NovoRapid®16

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Mean Change in A1C From Baseline to 1 Year

"Comparison of A1C measurement from baseline to end of study in the CEP266 study population.~The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population." (NCT02003898)
Timeframe: 1 year

Interventionpercentage (Mean)
Medtronic MiniMed 530G Insulin Pump0.034

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Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%

Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%. (NCT02003898)
Timeframe: 1 year

Interventionpercentage (Mean)
Medtronic MiniMed 530G Insulin Pump0.32

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Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%

Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9% (NCT02003898)
Timeframe: 1 year

Interventionpercentage (Mean)
Medtronic MiniMed 530G Insulin Pump-0.04

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Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%

Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c > 9% (NCT02003898)
Timeframe: 1 year

Interventionpercentage (Mean)
Medtronic MiniMed 530G Insulin Pump-0.39

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Intensive Care Unit Length of Stay

Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients. (NCT02006342)
Timeframe: Participants monitored from hospital admission to discharge, an average of 4 days

Interventiondays (Median)
Insulin Glargine Plus Regular Insulin1.8
Control - Regular Insulin1.2

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Hospital Length of Stay

Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital. Results reported are adjusted for age, hospital site, and etiology of diabetic ketoacidosis. (NCT02006342)
Timeframe: Participants monitored from hospital admission to discharge, an average of 4 days

Interventiondays (Mean)
Insulin Glargine Plus Regular Insulin3.9
Control - Regular Insulin4.6

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Number of Participants Who Developed Hypoglycemia

"To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure.~Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production." (NCT02006342)
Timeframe: Participants monitored during the 24 hours after anion gap closure

Interventionparticipants (Number)
Insulin Glargine Plus Regular Insulin2
Control - Regular Insulin3

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Number of Participants Admitted to the ICU

The goal was to determine if the amount of patients admitted to the ICU could be reduced by providing more efficient resolution of the critical condition which is the acidosis. (NCT02006342)
Timeframe: Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours

Interventionparticipants (Number)
Insulin Glargine Plus Regular Insulin6
Control - Regular Insulin4

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Time to Anion Gap Closure

Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities. (NCT02006342)
Timeframe: Participants monitored from hospital admission to discharge, an average of 4 days

Interventionhours (Mean)
Insulin Glargine Plus Regular Insulin10.2
Control - Regular Insulin11.6

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∆g of Lunch With/Without Pomelo

"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after lunch were obtained and analyzed.~g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch without pomelo - mean of 3 days of blood glucose before this lunch.~g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch with pomelo- mean of 3 days of blood glucose before this lunch." (NCT02006836)
Timeframe: 9 days

Interventionmmol/l (Mean)
Diabetic 2 - Without Pomelo1.39
Diabetic 2 - With Pomelo2.87

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∆g of Breakfast With/Without Pomelo

"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after breakfast were obtained and analyzed.~g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast." (NCT02006836)
Timeframe: 9 days

Interventionmmol/l (Mean)
Diabetic 2 - Without Pomelo2.93
Diabetic 2 - With Pomelo3.61

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∆g of Dinner With/Without Pomelo

"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after dinner were obtained and analyzed.~g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner without pomelo - mean of 3 days of blood glucose before this dinner.~g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner with pomelo - mean of 3 days of blood glucose before this dinner." (NCT02006836)
Timeframe: 9 days

Interventionmmol/l (Mean)
Diabetic 2 - Without Pomelo0.34
Diabetic 2 - With Pomelo1.41

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Glycemic Index

"Glycemic index (GI) measurement was carried out after an overnight fast on 2 occasions in every subject, each test being separated from the next by a washout day.The first test day utilized 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of the Majia pomelos. Venous blood samples were collected and monitored during 3 hrs for both the healthy and T2DM individuals at 0, 30, 60, 90, 120, 150, and 180 min. Areas under the curves (AUC) of blood glucose concentrations were obtained. The 50 g of glucose was used as the reference (GI = 100) according to the literature. The AUC under the incremental glycemic-response curves for Majia were expressed as a percentage of the areas under the glucose curves for the same subject. The resulting values for all subjects were averaged to calculate the GI.~GI measurement is only calculated in case-control period." (NCT02006836)
Timeframe: 3 days

Interventionpercentage of AUC from GI100 (Mean)
Diabetic76.79
Healthy86.92

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AUCs With/Without Pomelo

Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. Capillary blood samples were detected before and after meals, 10pm, and 3am. Mean of each time point(before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner,10pm, and 3am ) of blood glucose concentrations on 4th to 6th day（without pomelo） were calculated and so as each time point of blood glucose concentrations on 7th to 9th day (with pomelo). Areas under the curves (AUC) of mean blood glucose concentrations of each time point were obtained with/without pomelo. (NCT02006836)
Timeframe: 9 days

Interventionmmol*hour/L (Mean)
Diabetic 2 - Without Pomelo164.04
Diabetic 2 - With Pomelo163.07

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Nicotine Cravings Measured by Questionnaire of Smoking Urges

Range: 7-70. Higher scores mean worse outcome (NCT02028871)
Timeframe: 210 minutes

Interventionscore on a scale (Mean)
Placebo35.98
Intranasal Insulin Arm32.52

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Amount Eaten in Taste Test

(NCT02028871)
Timeframe: 90 minutes

Interventiongrams (Mean)
Intranasal Insulin Arm124
Placebo116

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c value was considered as baseline for calculating change from baseline in HbA1c at week 64. (NCT02030600)
Timeframe: Week 32, Week 64

,
Interventionpercentage of glycosylated haemoglobin (Mean)
week 32 (n=308, 313)week 64 (n=295, 301)
Insulin Degludec/Insulin Glargine (IDeg/IGlar)-0.490.03
Insulin Glargine/Insulin Degludec (IGlar/IDeg)-0.580.10

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Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period

Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. (NCT02030600)
Timeframe: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

Interventionpercentage of subjects (Number)
Insulin Degludec (IDeg)1.6
Insulin Glargine (IGlar)2.4

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period

Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. (NCT02030600)
Timeframe: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

Interventionevents (Number)
Insulin Degludec (IDeg)105
Insulin Glargine (IGlar)175

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period

Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. (NCT02030600)
Timeframe: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

Interventionevents (Number)
Insulin Degludec (IDeg)353
Insulin Glargine (IGlar)496

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Incidence of Treatment Emergent Adverse Events

Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. (NCT02030600)
Timeframe: During 32 weeks of treatment for each treatment period

Interventionevents (Number)
Insulin Degludec (IDeg)1293
Insulin Glargine (IGlar)1381

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FPG (Fasting Plasma Glucose)

Fasting plasma glucose values at week 32 and week 64. (NCT02030600)
Timeframe: week 32, week 64

,
Interventionmg/dL (Mean)
week 32 (n=307, 311)week 64 (n=293, 302)
Insulin Degludec/Insulin Glargine (IDeg/IGlar)107.33114.07
Insulin Glargine/Insulin Degludec (IGlar/IDeg)106.96107.55

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Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.10
Ertugliflozin 5 mg-0.28
Ertugliflozin 15 mg0.07

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Percent Change From Baseline in Bone Biomarker Carboxy-Terminal Cross-Linking Telopeptides of Type I Collagen (CTX) at Week 26 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Mean)
Placebo/Glimepiride10.8
Ertugliflozin 5 mg51.9
Ertugliflozin 15 mg80.2

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Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach)

Pharmacokinetic samples were collected at approximately 24 hours following the prior day's dose and before administration of the current day's dose. The lower limit of quantitation (LLOQ) was 0.500 mg/mL. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Pre-dose and/or 60 minutes post-dose on Weeks 6, 12, 18, and 30

,,
Interventionng/mL (Mean)
Week 6:Pre-doseWeek 12:Pre-doseWeek 12:60 mins post-doseWeek 18:Pre-doseWeek 18:60 mins post-doseWeek 30:Pre-dose
Ertugliflozin 15 mg38.3829.23228.1324.46214.9630.55
Ertugliflozin 5 mg14.8912.3474.849.9174.3912.66
Placebo/GlimepirideNANANA0.010.010.15

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Time to Glycemic Rescue Therapy at Week 26

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Week 26

InterventionDays (Median)
Placebo/Glimepiride105
Ertugliflozin 5 mg112
Ertugliflozin 15 mg139

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Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Placebo/Glimepiride30.6
Ertugliflozin 5 mg34.8
Ertugliflozin 15 mg36.6

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Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 26

InterventionPercentage of Participants (Number)
Placebo/Glimepiride15.8
Ertugliflozin 5 mg35.3
Ertugliflozin 15 mg40.0

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Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 104

InterventionPercentage of Participants (Number)
Placebo/Glimepiride19.1
Ertugliflozin 5 mg24.6
Ertugliflozin 15 mg33.7

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Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Placebo/Glimepiride11.0
Ertugliflozin 5 mg10.6
Ertugliflozin 15 mg14.6

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Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 26

InterventionPercentage of Participants (Number)
Placebo/Glimepiride2.9
Ertugliflozin 5 mg8.7
Ertugliflozin 15 mg12.2

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Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 104

InterventionPercentage of Participants (Number)
Placebo/Glimepiride7.2
Ertugliflozin 5 mg10.6
Ertugliflozin 15 mg12.2

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Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 52

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 52

InterventionPercentage of Participants (Number)
Placebo/Glimepiride17.2
Ertugliflozin 5 mg4.3
Ertugliflozin 15 mg1.5

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Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 26

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 26

InterventionPercentage of Participants (Number)
Placebo/Glimepiride17.7
Ertugliflozin 5 mg2.9
Ertugliflozin 15 mg1.5

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Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.82
Ertugliflozin 5 mg-1.04
Ertugliflozin 15 mg-1.32

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Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 104

Per protocol participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 104

InterventionPercentage of participants (Number)
Placebo/Glimepiride24.4
Ertugliflozin 5 mg11.1
Ertugliflozin 15 mg10.7

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Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 106

InterventionPercentage of Participants (Number)
Placebo/Glimepiride77.5
Ertugliflozin 5 mg70.5
Ertugliflozin 15 mg75.6

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Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 104

InterventionPercentage of Participants (Number)
Placebo/Glimepiride2.4
Ertugliflozin 5 mg3.4
Ertugliflozin 15 mg3.9

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Percent Change From BMD at Week 104 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.58
Ertugliflozin 5 mg-0.40
Ertugliflozin 15 mg-0.64

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Percent Change From Baseline in Bone Biomarker PTH at Week 52 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent Change (Mean)
Placebo/Glimepiride8.11
Ertugliflozin 5 mg11.09
Ertugliflozin 15 mg2.48

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Percent Change From Baseline in Bone Biomarker PTH at Week 104 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Mean)
Placebo/Glimepiride10.12
Ertugliflozin 5 mg8.16
Ertugliflozin 15 mg5.46

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Percent Change From Baseline in Bone Biomarker Procollagen Type I N-terminal Propeptide (P1NP) at Week 26 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Mean)
Placebo/Glimepiride0.5
Ertugliflozin 5 mg0.8
Ertugliflozin 15 mg0.5

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Percent Change From Baseline in Bone Biomarker Parathyroid Hormone (PTH) at Week 26 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Mean)
Placebo/Glimepiride-0.98
Ertugliflozin 5 mg0.28
Ertugliflozin 15 mg0.14

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Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)

This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionmmHg (Least Squares Mean)
Placebo/Glimepiride0.23
Ertugliflozin 5 mg-1.59
Ertugliflozin 15 mg-2.19

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Percent Change From Baseline in Bone Biomarker P1NP at Week 104 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Mean)
Placebo/Glimepiride19.38
Ertugliflozin 5 mg10.11
Ertugliflozin 15 mg24.21

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Change From Baseline in A1C at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 104 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent A1C (Mean)
Placebo/Glimepiride-0.58
Ertugliflozin 5 mg-0.60
Ertugliflozin 15 mg-0.89

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Change From Baseline in A1C at Week 26 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent A1C (Least Squares Mean)
Placebo/Glimepiride-0.03
Ertugliflozin 5 mg-0.73
Ertugliflozin 15 mg-0.91

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Change From Baseline in A1C at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 52 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent A1C (Mean)
Placebo/Glimepiride-0.68
Ertugliflozin 5 mg-0.72
Ertugliflozin 15 mg-0.96

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Change From Baseline in Body Weight at Week 104 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 104 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionKilograms (Mean)
Placebo/Glimepiride-0.18
Ertugliflozin 5 mg-3.77
Ertugliflozin 15 mg-3.63

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Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionKilograms (Least Squares Mean)
Placebo/Glimepiride-1.33
Ertugliflozin 5 mg-3.01
Ertugliflozin 15 mg-2.93

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Change From Baseline in Body Weight at Week 52 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionKilograms (Mean)
Placebo/Glimepiride0.07
Ertugliflozin 5 mg-3.23
Ertugliflozin 15 mg-3.35

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Percent Change From Baseline in Bone Biomarker P1NP at Week 52 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent Change (Mean)
Placebo/Glimepiride24.50
Ertugliflozin 5 mg8.41
Ertugliflozin 15 mg19.79

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Change From Baseline in Fasting Plasma Glucose at Week 104 (Excluding Rescue Approach)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 104 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 104 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

Interventionmg/dL (Mean)
Placebo/Glimepiride-10.9
Ertugliflozin 5 mg-18.2
Ertugliflozin 15 mg-28.2

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Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo/Glimepiride-0.85
Ertugliflozin 5 mg-27.54
Ertugliflozin 15 mg-39.10

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Change From Baseline in Fasting Plasma Glucose at Week 52 (Excluding Rescue Therapy)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

Interventionmg/dL (Mean)
Placebo/Glimepiride-12.0
Ertugliflozin 5 mg-22.4
Ertugliflozin 15 mg-35.2

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Change From Baseline in Sitting Diastolic Blood Pressure at Week 104 (Excluding Rescue Approach)

This change from baseline reflects the Week 104 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionmmHg (Mean)
Placebo/Glimepiride-0.46
Ertugliflozin 5 mg-2.36
Ertugliflozin 15 mg-1.52

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Percent Change From Baseline in Bone Biomarker CTX at Week 52 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Mean)
Placebo/Glimepiride15.54
Ertugliflozin 5 mg34.36
Ertugliflozin 15 mg41.57

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Percent Change From Baseline in Bone Biomarker CTX at Week 104 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Mean)
Placebo/Glimepiride19.29
Ertugliflozin 5 mg26.94
Ertugliflozin 15 mg32.53

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Change From Baseline in Sitting Diastolic Blood Pressure at Week 52 (Excluding Rescue Approach)

This change from baseline reflects the Week 52 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionmmHg (Mean)
Placebo/Glimepiride0.38
Ertugliflozin 5 mg-1.40
Ertugliflozin 15 mg-1.19

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Change From Baseline in Sitting Systolic Blood Pressure at Week 104 (Excluding Rescue Approach)

This change from baseline reflects the Week 104 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionmmHg (Mean)
Placebo/Glimepiride0.05
Ertugliflozin 5 mg-3.61
Ertugliflozin 15 mg-3.13

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Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)

This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionmmHg (Least Squares Mean)
Placebo/Glimepiride-0.70
Ertugliflozin 5 mg-4.38
Ertugliflozin 15 mg-5.20

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Change From Baseline in Sitting Systolic Blood Pressure at Week 52 (Excluding Rescue Approach)

This change from baseline reflects the Week 52 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionmmHg (Mean)
Placebo/Glimepiride0.65
Ertugliflozin 5 mg-2.63
Ertugliflozin 15 mg-4.28

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Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-1.23
Ertugliflozin 5 mg-1.11
Ertugliflozin 15 mg-0.96

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Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride0.09
Ertugliflozin 5 mg-0.19
Ertugliflozin 15 mg-0.13

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Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-1.18
Ertugliflozin 5 mg-1.72
Ertugliflozin 15 mg-2.02

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Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride0.06
Ertugliflozin 5 mg-0.15
Ertugliflozin 15 mg-0.13

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Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.40
Ertugliflozin 5 mg-0.10
Ertugliflozin 15 mg0.30

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Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercentage change (Least Squares Mean)
Placebo/Glimepiride0.22
Ertugliflozin 5 mg-0.01
Ertugliflozin 15 mg0.12

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Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.63
Ertugliflozin 5 mg-0.55
Ertugliflozin 15 mg-0.36

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Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.44
Ertugliflozin 5 mg-0.59
Ertugliflozin 15 mg-0.39

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Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.69
Ertugliflozin 5 mg-0.49
Ertugliflozin 15 mg-0.44

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c absolute value was considered as baseline for calculating change from baseline in HbA1c at week 64. (NCT02034513)
Timeframe: Week 32, Week 64

,
InterventionPercentage of glycosylated haemoglobin (Mean)
week 32 (n=209, 205)week 64 (n=203, 199)
Insulin Degludec/Insulin Glargine (IDeg/IGlar)-0.730.04
Insulin Glargine/Insulin Degludec (IGlar/IDeg)-0.660.17

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Incidence of Treatment Emergent Adverse Events

Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. (NCT02034513)
Timeframe: During 32 weeks of treatment for each treatment period

InterventionEvent (Number)
Insulin Degludec (IDeg)925
Insulin Glargine (IGlar)937

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FPG (Fasting Plasma Glucose)

Fasting plasma glucose values at week 32 and week 64. (NCT02034513)
Timeframe: Week 32 and Week 64

,
Interventionmmol/L (Mean)
week 32 (n=208, 204)week 64 (n=203, 201)
Insulin Degludec/Insulin Glargine (IDeg/IGlar)7.458.62
Insulin Glargine/Insulin Degludec (IGlar/IDeg)8.127.54

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Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period

Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64). (NCT02034513)
Timeframe: A 16-week treatment period.

InterventionEvent (Number)
Insulin Degludec (IDeg)2772
Insulin Glargine (IGlar)3126

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period

Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. (NCT02034513)
Timeframe: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

InterventionEvent (Number)
Insulin Degludec (IDeg)349
Insulin Glargine (IGlar)544

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Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period

Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. (NCT02034513)
Timeframe: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

InterventionPercentage of subjects (Number)
Insulin Degludec (IDeg)10.3
Insulin Glargine (IGlar)17.1

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Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30

Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach. (NCT02058147)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.35
Insulin Glargine-2.66
Lixisenatide-1.95

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Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period

Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) was performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%. (NCT02058147)
Timeframe: Baseline up to Week 30

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination3.6
Insulin Glargine3.4
Lixisenatide12.4

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Change in Body Weight From Baseline to Week 30

Change in body weight was calculated by subtracting baseline value from Week 30 value. (NCT02058147)
Timeframe: Baseline, Week 30

Interventionkg (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-0.29
Insulin Glargine1.11
Lixisenatide-2.3

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Percentage of Participants With Documented Symptomatic Hypoglycemia

Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L). (NCT02058147)
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination25.6
Insulin Glargine23.6
Lixisenatide6.4

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Percentage of Participants With Severe Symptomatic Hypoglycemia

Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not have been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk of injury to themselves or others. (NCT02058147)
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination0
Insulin Glargine0.2
Lixisenatide0

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Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30

Participants without Week 30 value for HbA1c were counted as non-responders. (NCT02058147)
Timeframe: Week 30

,,
Interventionpercentage of participants (Number)
HbA1c <7.0%HbA1c ≤6.5%
Insulin Glargine59.439.5
Insulin Glargine/Lixisenatide Fixed Ratio Combination73.755.8
Lixisenatide3319.3

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Average Daily Insulin Glargine Dose at Week 30

The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy. (NCT02058147)
Timeframe: Week 30

InterventionUnits (U) (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination39.77
Insulin Glargine40.46

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Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30

The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF. (NCT02058147)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-5.68
Insulin Glargine-3.31
Lixisenatide-4.58

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30

Change in FPG was calculated by subtracting baseline value from Week 30 value. (NCT02058147)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.46
Insulin Glargine-3.27
Lixisenatide-1.5

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Change in HbA1c From Baseline to Week 30

"Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine.~Change in HbA1c was calculated by subtracting baseline value from Week 30 value." (NCT02058147)
Timeframe: Baseline, Week 30

Interventionpercentage of hemoglobin (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-1.63
Insulin Glargine-1.34
Lixisenatide-0.85

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Change in Plasma Glucose Excursion From Baseline to Week 30

Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF). (NCT02058147)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-2.31
Insulin Glargine-0.18
Lixisenatide-3.23

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Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year

Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L). (NCT02058147)
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)

InterventionEvents per subject-year (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination1.44
Insulin Glargine1.22
Lixisenatide0.34

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Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication. (NCT02058147)
Timeframe: Baseline up to Week 30

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination53.6
Insulin Glargine44.4
Lixisenatide30.5

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Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30

(NCT02058147)
Timeframe: Week 30

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination43.2
Insulin Glargine25.1
Lixisenatide27.9

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Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). (NCT02058147)
Timeframe: Baseline up to Week 30

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination31.8
Insulin Glargine18.9
Lixisenatide26.2

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Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period

Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%. (NCT02058160)
Timeframe: Baseline up to Week 30

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination2.7
Insulin Glargine6

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Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). (NCT02058160)
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])

Interventionevents per subject-year (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination3.03
Insulin Glargine4.22

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Change in 2-hour PPG From Baseline to Week 30

Change in PPG was calculated by subtracting baseline value from Week 30 value. (NCT02058160)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-4.72
Insulin Glargine-1.39

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Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30

(NCT02058160)
Timeframe: Week 30

,
Interventionpercentage of participants (Number)
HbA1c <7.0%HbA1c ≤ 6.5%
Insulin Glargine29.614.2
Insulin Glargine/Lixisenatide Fixed Ratio Combination54.933.9

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Percentage of Participants With Severe Symptomatic Hypoglycemia

Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others. (NCT02058160)
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination1.1
Insulin Glargine0.3

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Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). (NCT02058160)
Timeframe: Baseline up to Week 30

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination31.7
Insulin Glargine18.6

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Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30

Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value. (NCT02058160)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.9
Insulin Glargine-0.47

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Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30

(NCT02058160)
Timeframe: Week 30

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination34.2
Insulin Glargine13.4

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Percentage of Participants With Documented Symptomatic Hypoglycemia

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). (NCT02058160)
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination40
Insulin Glargine42.5

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Change in Body Weight From Baseline to Week 30

Change in body weight was calculated by subtracting baseline value from Week 30 value. (NCT02058160)
Timeframe: Baseline, Week 30

Interventionkg (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-0.67
Insulin Glargine0.7

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Change in FPG From Baseline to Week 30

Change in FPG was calculated by subtracting baseline value from Week 30 value. (NCT02058160)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-0.35
Insulin Glargine-0.46

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Change in Daily Insulin Glargine Dose From Baseline to Week 30

(NCT02058160)
Timeframe: Baseline, Week 30

InterventionUnits (U) (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination10.64
Insulin Glargine10.89

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Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30

Change in HbA1c was calculated by subtracting baseline value from Week 30 value. (NCT02058160)
Timeframe: Baseline, Week 30

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-1.13
Insulin Glargine-0.62

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Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). (NCT02058160)
Timeframe: Baseline up to Week 30

Interventionpercentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination19.9
Insulin Glargine9.0

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Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30

Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach. (NCT02058160)
Timeframe: Baseline, Week 30

Interventionmmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination-1.5
Insulin Glargine-0.6

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Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24

Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). (NCT02059161)
Timeframe: Week 24

InterventionInsulin units/kg. (Least Squares Mean)
MK-12930.75
Lantus0.77

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Total Insulin Dose at Week 52

Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). (NCT02059161)
Timeframe: Week 52

InterventionInsulin units (Least Squares Mean)
MK-129359.16
Lantus60.93

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Total Insulin Dose at Week 24

Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). (NCT02059161)
Timeframe: Week 24

InterventionInsulin units (Least Squares Mean)
MK-129358.74
Lantus60.51

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Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C. (NCT02059161)
Timeframe: Baseline and Week 24

InterventionPercent (Least Squares Mean)
MK-1293-0.62
Lantus-0.66

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Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52

Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline. (NCT02059161)
Timeframe: Up to Week 52

InterventionPercentage of participants (Number)
MK-129340.6
Lantus39.8

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Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24

Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline. (NCT02059161)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
MK-129332.7
Lantus35.7

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Percentage of Participants With Confirmed Positive AIA Up Through Week 52

Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline. (NCT02059161)
Timeframe: Up to Week 52 including baseline

InterventionPercentage of participants (Number)
MK-129373.4
Lantus75.6

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Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24

Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline. (NCT02059161)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
MK-129370.1
Lantus74.0

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Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52

Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment. (NCT02059161)
Timeframe: Up to Week 52

InterventionPercentage of participants (Number)
MK-12934.7
Lantus6.9

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Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24

Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment. (NCT02059161)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
MK-12933.9
Lantus5.3

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Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52

Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). (NCT02059161)
Timeframe: Week 52

InterventionInsulin units/kg. (Least Squares Mean)
MK-12930.75
Lantus0.77

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Basal Insulin Dose at Week 52

Basal Insulin Dose at Week 52. (NCT02059161)
Timeframe: Week 52

InterventionUnits (Least Squares Mean)
MK-129336.08
Lantus36.51

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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0. (NCT02059161)
Timeframe: Baseline and Week 24

Interventionmg/dL (Least Squares Mean)
MK-1293-16.8
Lantus-26.4

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Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.

Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment. (NCT02059161)
Timeframe: 52 weeks

,
InterventionPercentage of participants (Number)
A1C < 7.0%A1C < 6.5%
Lantus30.818.6
MK-129331.014.2

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Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.

Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment. (NCT02059161)
Timeframe: 24 weeks

,
InterventionPercentage of participants (Number)
A1C < 7.0%A1C < 6.5%
Lantus37.721.6
MK-129337.020.5

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Bolus Insulin Dose Per kg of Body Weight at Week 52

Bolus Insulin Dose per kg of Body Weight at Week 52. (NCT02059161)
Timeframe: Week 52

InterventionUnits/kg (Least Squares Mean)
MK-12930.28
Lantus0.30

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Change From Baseline in FPG at Week 52

Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0. (NCT02059161)
Timeframe: Baseline and Week 52

Interventionmg/dL (Least Squares Mean)
MK-1293-17.9
Lantus-12.5

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Change From Baseline in AIA Titer After 52 Weeks of Treatment

This immunogenicity analysis assessed the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0. (NCT02059161)
Timeframe: Baseline and Week 52

InterventionAIA Titers (Mean)
MK-1293-1.6
Lantus0.1

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Change From Baseline in AIA Titer After 24 Weeks of Treatment

This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer. (NCT02059161)
Timeframe: Baseline and Week 24

InterventionAIA Titers (Mean)
MK-12930.4
Lantus0.3

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Change From Baseline in A1C at Week 52

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. (NCT02059161)
Timeframe: Baseline and Week 52

InterventionPercent (Least Squares Mean)
MK-1293-0.35
Lantus-0.33

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Change From Baseline in 7-point SMBG at Week 52

The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning. (NCT02059161)
Timeframe: Baseline and Week 52

Interventionmg/dL (Least Squares Mean)
MK-1293-12.0
Lantus-4.0

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Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24

The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning. (NCT02059161)
Timeframe: Baseline and Week 24

Interventionmg/dL (Least Squares Mean)
MK-1293-4.9
Lantus-4.6

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Bolus Insulin Dose Per kg of Body Weight at Week 24

Bolus Insulin Dose per kg of Body Weight at Week 24. (NCT02059161)
Timeframe: Week 24

InterventionUnits/kg (Least Squares Mean)
MK-12930.28
Lantus0.29

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Bolus Insulin Dose at Week 52

Bolus Insulin Dose at Week 52. (NCT02059161)
Timeframe: Week 52

InterventionUnits (Least Squares Mean)
MK-129322.15
Lantus23.65

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Bolus Insulin Dose at Week 24

Bolus Insulin Dose at Week 24. (NCT02059161)
Timeframe: Week 24

InterventionUnits (Least Squares Mean)
MK-129321.65
Lantus22.91

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Basal Insulin Dose Per kg of Body Weight at Week 52

Basal Insulin Dose per kg of Body Weight at Week 52. (NCT02059161)
Timeframe: Week 52

InterventionUnits/kg (Least Squares Mean)
MK-12930.46
Lantus0.47

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Basal Insulin Dose Per kg of Body Weight at Week 24

Basal Insulin Dose per kg of Body Weight at Week 24. (NCT02059161)
Timeframe: Week 24

InterventionUnits/kg (Least Squares Mean)
MK-12930.46
Lantus0.48

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Basal Insulin Dose at Week 24

Basal Insulin Dose at Week 24. (NCT02059161)
Timeframe: Week 24

InterventionUnits (Least Squares Mean)
MK-129336.33
Lantus37.07

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Percentage of Participants Experiencing an AE Over the 24-week Treatment Period

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE. (NCT02059187)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
MK-129378.3
Lantus™71.5

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Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24

Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels NCT02059187)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
MK-129354.0
Lantus™54.0

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Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24

Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg). (NCT02059187)
Timeframe: Week 24

InterventionUnits/kg (Least Squares Mean)
MK-12930.53
Lantus™0.51

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Change From Baseline in Participant Hemoglobin A1C Level at Week 24

A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications. (NCT02059187)
Timeframe: Baseline and Week 24

InterventionPercent A1C (Least Squares Mean)
MK-1293-1.28
Lantus™-1.30

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Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24

Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits. (NCT02059187)
Timeframe: Baseline and Week 24

Interventionmg/dL (Least Squares Mean)
MK-1293-35.0
Lantus™-38.4

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Percentage of Participants With Hemoglobin A1C <6.5% at Week 24

Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24. (NCT02059187)
Timeframe: Week 24

InterventionPercentage of participants (Number)
MK-129321.6
Lantus™22.4

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Change From Baseline in Participant Body Weight at Week 24

Change from baseline in participant body weight at Week 24. (NCT02059187)
Timeframe: Baseline and Week 24

Interventionkilograms (Mean)
MK-12931.3
Lantus™1.4

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Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24

7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM. (NCT02059187)
Timeframe: Baseline and Week 24

Interventionmg/dL (Least Squares Mean)
MK-1293-30.7
Lantus™-27.3

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Daily Basal Insulin Dose (Units) at Week 24

The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date. (NCT02059187)
Timeframe: Week 24

InterventionUnits (Least Squares Mean)
MK-129348.2
Lantus™46.9

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Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24

Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24. (NCT02059187)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
MK-129334.7
Lantus™29.0

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Percentage of Participants With Hemoglobin A1C <7% at Week 24

Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24. (NCT02059187)
Timeframe: Week 24

InterventionPercentage of participants (Number)
MK-129346.5
Lantus™43.7

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Gait Analysis (4-meter Test)

Changes in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment. (NCT02064166)
Timeframe: Baseline and post-treatment

Interventioninch (Mean)
Insulin Baseline22.0
Insulin Post Treatment21.5
Placebo Baseline21.0
Placebo Post Treatment19.6

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Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)

The Montreal Cognitive Assessment (MoCA) is a one-page 30-point test administered in approximately 10 minutes and is used to assess symptoms of cognitive impairment and their changes after treatment as compared to baseline. MoCA scores range between 0 and 30 with higher scores indicative of better cognitive performance. A score of 26 and above is considered to be normal. (NCT02064166)
Timeframe: Baseline and post-treatment

Interventionscore on a scale (Mean)
Insulin Baseline28.7
Insulin Post Treatment28.0
Placebo Baseline26.8
Placebo Post Treatment28.2

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Change in Verbal Fluency FAS (F, A or S Words) Total Score

Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency. (NCT02064166)
Timeframe: Baseline and post-treatment

InterventionWords (Mean)
Insulin Baseline38.8
Insulin Post Treatment41.0
Placebo Baseline32.8
Placebo Post Treatment30.8

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Beck Depression Inventory Score (BDI)

Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression. (NCT02064166)
Timeframe: Baseline and post-treatment

Interventionscore on a scale (Mean)
Insulin Baseline7.8
Insulin Post Treatment8.25
Placebo Baseline13.5
Placebo Post Treatment12.8

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Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)

UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The total score for subscale 3 ranges from 0 to 108 (the sum of scores from 14 items with 27 observations). The higher the value, the more severe the symptoms. The outcomes reflect the UPDRS Part III score at baseline and 4 weeks post treatment with post treatment scores compared to baseline in the insulin and placebo groups. (NCT02064166)
Timeframe: Baseline and post-treatment

Interventionscore on a scale (Mean)
Insulin Baseline31.5
Insulin Post Treatment25.6
Placebo Baseline31.7
Placebo Post Treatment30.5

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Modified Hoehn and Yahr Scale

The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson Disease and treatment response post treatment as compared to baseline. The scale ranges from 1 to 5. The lower score indicates better outcome, e.g. less severe parkinsonism. (NCT02064166)
Timeframe: Baseline and post-treatment

Interventionscore on a scale (Mean)
Insulin Baseline2.0
Insulin Post Treatment2.0
Placebo Baseline2.4
Placebo Post Treatment2.4

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Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose

The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. (NCT02081599)
Timeframe: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16

Interventionmg*hr/dL (Least Squares Mean)
Placebo/Teneli (Teneligliptin) + Insulin9.827
Teneli (Teneligliptin) /Teneli + Insulin-54.035

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Change From Baseline in 2-hour Postprandial Plasma Glucose

The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. (NCT02081599)
Timeframe: at Week 0 and Week 16

Interventionmg/dL (Least Squares Mean)
Placebo/Teneli (Teneligliptin) + Insulin3.0
Teneli (Teneligliptin) /Teneli + Insulin-42.9

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Change From Baseline in Fasting Plasma Glucose

The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. (NCT02081599)
Timeframe: at Week 0 and Week 16

Interventionmg/dL (Least Squares Mean)
Placebo/Teneli (Teneligliptin) + Insulin8.0
Teneli (Teneligliptin) /Teneli + Insulin-5.4

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Change From Baseline in HbA1c

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. (NCT02081599)
Timeframe: at Week 0 and Week 16

Interventionpercentage of HbA1c (Least Squares Mean)
Placebo/Teneli (Teneligliptin) + Insulin-0.07
Teneli (Teneligliptin) /Teneli + Insulin-0.87

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Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements

Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo. (NCT02094534)
Timeframe: Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)

,
Interventionmg/dL (Mean)
Total Exogenous Insulin UsageBasal Exogenous Insulin UsageBolus Exogenous Insulin Usage
ORMD-0801-2.09-1.92-0.18
Placebo2.83-1.103.93

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Mean Nighttime, Daytime, and Fasting Glucose Levels

Mean glucose levels (by continuous glucose monitoring (CGM)) in Type 1 diabetes patients treated with ORMD-0801, compared to the mean glucose levels (by continuous glucose monitoring) for patients treated with placebo. (NCT02094534)
Timeframe: last two days (day 6 and day 7, averaged)

,
Interventionmg/dL (Mean)
Mean nighttime levels by CGMMean daytime glucose levels by CGMMean fasting glucose levels by CGM
ORMD-0801137.65145.15122.15
Placebo133.17165.73138.69

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Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of treatment. (NCT02100475)
Timeframe: Week 0, week 26

InterventionKilograms (Mean)
IDegLira0.9
IDegLira + IAsp1.5

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Number of Treatment-emergent Confirmed Hypoglycaemic Episodes

Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL). (NCT02100475)
Timeframe: Week 0 - 26

InterventionNumber of episodes (Number)
IDegLira34
IDegLira + IAsp4

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of treatment. (NCT02100475)
Timeframe: Week 0, week 26

InterventionPercentage of glycosylated haemoglobin (Mean)
IDegLira-0.43
IDegLira + IAsp-0.14

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Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test

(NCT02104804)
Timeframe: Baseline to 24 weeks

Interventionmg*min/dL (Least Squares Mean)
Saxagliptin Plus Insulin-4702.2
Vs. Placebo Plus Insulin1431.0

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The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)

(NCT02104804)
Timeframe: Baseline to Average of Weeks 20 and 24

Interventionmg/dL (Least Squares Mean)
Saxagliptin Plus Insulin-11.23
Vs. Placebo Plus Insulin4.65

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Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test

(NCT02104804)
Timeframe: Baseline to 24 weeks

Interventionmg/dL (Least Squares Mean)
Saxagliptin Plus Insulin-30.28
Vs. Placebo Plus Insulin8.84

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Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24

(NCT02104804)
Timeframe: Baseline to 24 weeks

InterventionIU (Least Squares Mean)
Saxagliptin Plus Insulin-0.09
Vs. Placebo Plus Insulin0.04

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Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%

(NCT02104804)
Timeframe: At Week 24

Intervention% of participants (Number)
Saxagliptin Plus Insulin11.4
Vs. Placebo Plus Insulin3.5

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Change in HbA1c From Baseline to Week 24

(NCT02104804)
Timeframe: Baseline to 24 weeks

InterventionPercentage change (Least Squares Mean)
Saxagliptin Plus Insulin-0.64
Vs. Placebo Plus Insulin-0.06

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Part B: Pharmacokinetics: ISF-to-Serum Concentrations

Absolute concentration of ISF of insulin peglispro and human insulin. (NCT02109029)
Timeframe: 16, 20, 24, and 28 hours postdose

Interventionpicomol per liter (pmol/L) (Number)
Insulin Peglispro1428.4
Human Insulin137.9

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Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)

(NCT02109029)
Timeframe: 16, 20, 24, and 28 hours postdose

Interventionpicomol per liter (pmol/L) (Geometric Mean)
Insulin Peglispro11200
Human Insulin425

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Overall Mean Change in A1C

The overall mean change in A1C from baseline to 1 year will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects. (NCT02120794)
Timeframe: Baseline and 1 year after screening

Interventionpercentage (Mean)
530G Insulin Pump0.26

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Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups

Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c > 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c > 9% (NCT02120794)
Timeframe: Baseline and 1 year after screening

Interventionpercentage (Mean)
530G Insulin Pump-0.02

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Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups

Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9% (NCT02120794)
Timeframe: Baseline and 1 year after screening

Interventionpercentage (Mean)
530G Insulin Pump0.34

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Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups

Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7% (NCT02120794)
Timeframe: Baseline and 1 year after screening

Interventionpercentage (Mean)
530G Insulin Pump0.37

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Severe Hypoglycemia

Evaluation of incidence of severe hypoglycemia during in-clinic procedures (NCT02130284)
Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

InterventionParticipants (Count of Participants)
Predictive Low Glucose Management (PLGM)0

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Unanticipated Device Effect (UADE)

Evaluation of incidence of UADE during in-clinic procedures (NCT02130284)
Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

InterventionParticipants (Count of Participants)
Predictive Low Glucose Management (PLGM)0

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Sensor Performance: Accuracy

MARD (Mean Absolute Relative Difference) between sensor glucose value and YSI. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). (NCT02130284)
Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Interventionpercentage (Mean)
Predictive Low Glucose Management (PLGM)12.56

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Rescue Events During In-clinic Procedues

(NCT02130284)
Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

InterventionParticipants (Count of Participants)
Predictive Low Glucose Management (PLGM)7

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PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.

Hypoglycemic event rate among 71 subjects who underwent the PLGM experiment. Hypoglycemic events are defined based on: occurrence of 2 or more continuous YSI <= 65 mg/dL during in-clinic procedures. (NCT02130284)
Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Interventionpercentage of total subjects (Number)
Predictive Low Glucose Management (PLGM)39.13

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Diabetic Ketoacidosis

Evaluation of DKA during in-clinic procedures (NCT02130284)
Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

InterventionParticipants (Count of Participants)
Predictive Low Glucose Management (PLGM)0

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Device Metric/Performance - All Device Deficiencies

(NCT02130284)
Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Interventiondevice performance issues (Number)
Predictive Low Glucose Management (PLGM)13

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Serious Adverse Events (SAE)

Evaluation of incidence of SAE during in-clinic procedures (NCT02130284)
Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

InterventionParticipants (Count of Participants)
Predictive Low Glucose Management (PLGM)0

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Change in Body Weight Standard Deviation Score (SDS)

Change in body weight standard deviation score (SDS) from baseline to week 26. In order to reduce the variability in body weight measurements, SDS were calculated. SDS for weight was derived by comparing the actual measurements with standard growth charts for the United States. Standard values provided by the standard growth charts according to the subject's sex and age at the time of the measurement were used to calculate the SDS. (NCT02131272)
Timeframe: week 0, week 26

Interventionstandard deviation score (Mean)
Insulin Detemir + Metformin + Diet/Exercise0.006
Insulin NPH + Metformin + Diet/Exercise0.098

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Change in HbA1c (Glycosylated Haemoglobin)

Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26. (NCT02131272)
Timeframe: week 0, week 26

InterventionPercentage of glycosylated haemoglobin (Least Squares Mean)
Insulin Detemir + Metformin + Diet/Exercise-0.64
Insulin NPH + Metformin + Diet/Exercise-0.81

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Incidence of Adverse Events (AEs)

The total number of treatment emergent adverse events (the onset of the adverse event is on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration) reported during the 26 weeks of treatment. (NCT02131272)
Timeframe: weeks 0 - 26

InterventionNumber of events (Number)
Insulin Detemir + Metformin + Diet/Exercise30
Insulin NPH + Metformin + Diet/Exercise41

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Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment.

Proportion of subjects achieving HbA1c <7.0% is presented as percentage of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment. (NCT02131272)
Timeframe: At week 26

InterventionPercentage of subjects (Number)
Insulin Detemir + Metformin + Diet/Exercise25.0
Insulin NPH + Metformin + Diet/Exercise33.3

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Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Total number of treatment emergent severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial. (NCT02131272)
Timeframe: Weeks 0 - 26

,
InterventionNumber of episodes (Number)
SevereBlood glucose confirmed symptomatic
Insulin Detemir + Metformin + Diet/Exercise04
Insulin NPH + Metformin + Diet/Exercise012

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Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

The total number of blood glucose confirmed symptomatic nocturnal (time of onset between 23:00 and 06.59 both inclusive) severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial. (NCT02131272)
Timeframe: Weeks 0 - 26

,
InterventionNumber of episodes (Number)
SevereBlood glucose confirmed symptomatic
Insulin Detemir + Metformin + Diet/Exercise00
Insulin NPH + Metformin + Diet/Exercise01

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Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment

Proportion of subjects achieving HbA1c below 7.5% is presented as percentage of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment. (NCT02131272)
Timeframe: At week 26

InterventionPercentage of subjects (Number)
Insulin Detemir + Metformin + Diet/Exercise30.0
Insulin NPH + Metformin + Diet/Exercise38.1

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Beta Cell Function

Beta cell function assessed by the change between pre meal tolerance test and 30 minutes post meal tolerance test in C-peptide corrected insulin/Glucose (ΔC-peptide corrected insulin/ΔGlucose). LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. (NCT02132637)
Timeframe: 0-30 minutes during the meal tolerance test on the day following the standard dose

Interventionmmol/L (Least Squares Mean)
Insulin Peglispro88.65
Insulin Glargine103.62

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Duration of Glucose ≤70 mg/dL

The duration in minutes of each hypoglycemia episode with glucose ≤70 mg/dL (3.9 mmol/L) was calculated from start time to end time. The duration for a participant was the sum of the durations over the multiple hypoglycemia episodes. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. (NCT02132637)
Timeframe: Predose to 84 Hours Post Double Dose

InterventionMinutes per participant (Least Squares Mean)
Insulin Peglispro95.28
Insulin Glargine362.26

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Nadir Glucose

Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. (NCT02132637)
Timeframe: Predose to 84 Hours Post Double Dose

Interventionmg/dL (Least Squares Mean)
Insulin Peglispro61.70
Insulin Glargine55.93

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Percentage of Participants With Clinically Significant Hypoglycemia

The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 milligrams per deciliter (mg/dL) (3.0 millimole per liter [mmol/L]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100. (NCT02132637)
Timeframe: Predose to 84 Hours Post Double Dose

Interventionpercentage of participants (Number)
Insulin Peglispro6.6
Insulin Glargine35.5

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Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose

The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 mg/dL (3.0 mmol/L) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100. (NCT02132637)
Timeframe: Predose to 12 Hours Post Double Dose

Interventionpercentage of participants (Number)
Insulin Peglispro1.6
Insulin Glargine22.6

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Time to the Nadir Glucose

Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). The average time was calculated by dividing the sum of time from double dose to the nadir glucose for participants with blood glucose ≤70 mg/dL (3.9 mmol/L) by the number of participants with blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose. (NCT02132637)
Timeframe: Predose to 84 Hours Post Double Dose

Interventionhours (Mean)
Insulin Peglispro35.92
Insulin Glargine28.15

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Fasting Blood Glucose

Fasting blood glucose (FBG) was measured by self-monitored blood glucose. LS means were calculated by MMRM analysis with fixed effects of treatment, dosing day, sequence, period, interaction of treatment and dosing day, baseline basal insulin dose stratification factor, and baseline FBG. (NCT02132637)
Timeframe: Day 1, Day 2, and Day 3 Following Double Dose

,
Interventionmg/dL (Least Squares Mean)
Day 1Day 2Day 3
Insulin Glargine85.6186.1686.27
Insulin Peglispro102.03100.94102.18

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Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC)

Glucose AUC within 3 hours after each meal assessed by the AUC of glucose from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. (NCT02132637)
Timeframe: Preprandial to 3 Hours Postprandial during the day following the standard dose

,
Interventionmg/dL*h (Least Squares Mean)
BreakfastLunchDinner
Insulin Glargine568.64568.20577.46
Insulin Peglispro633.50566.00564.68

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Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion

Glucose AUC excursion within 3 hours after each meal assessed by the AUC of adjusted glucose (= observed glucose - preprandial glucose) from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. (NCT02132637)
Timeframe: Preprandial to 3 Hours Postprandial during the day following the standard dose

,
Interventionmg/dL*h (Least Squares Mean)
BreakfastLunchDinner
Insulin Glargine270.3236.92150.23
Insulin Peglispro266.33-2.38134.40

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Percentage of Participants With Hypoglycemia

The percentage was calculated by dividing the number of participants with hypoglycemia events defined as blood glucose ≤70 mg/dL (3.9 mmol/L) by the total number of participants analyzed, multiplied by 100. (NCT02132637)
Timeframe: Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose

,
Interventionpercentage of participants (Number)
12 Hours Post Double Dose84 Hours Post Double Dose
Insulin Glargine64.582.3
Insulin Peglispro19.742.6

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Cardiovascular Mortality

All cause mortality and composite mortality from myocardial infarction, stroke and renal failure (NCT02138006)
Timeframe: Up to 28 years

Interventionparticipants (Number)
Intensive Insulin Treatment7
Standard Insulin Treatment11

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Morbidity of Cardiovascular Complications

Morbidity of: coronary heart disease, stroke and renal failure (NCT02138006)
Timeframe: Up to 28 years

Interventionparticipants (Number)
Intensive Insulin Treatment6
Standard Insulin Treatment11

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Duration (in Hours) of 20 % Dextrose Infusion Requirement

(NCT02148250)
Timeframe: 24 hours post insulin injection

Interventionhours (Mean)
100 Syringe Units11
200 Syringe Units16.5

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Peak Infusion Rate Achieved After U-500

(NCT02148250)
Timeframe: 4 hours after insulin injection

Interventionmg/kg/min (Mean)
100 Syringe Units5.3
200 Syringe Units4.2

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Time Following Injection the Glucose Infusion Was Started to Maintain EU

(NCT02148250)
Timeframe: 24 hours

Interventionhours (Mean)
100 Syringe Units2.6
200 Syringe Units2.2

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Total Glucose Given After U-500 Dose

(NCT02148250)
Timeframe: 4 hours

Interventionmg/kg (Mean)
100 Syringe Units5.3
200 Syringe Units4.7

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Total Glucose Required to Maintain Euglycaemia

(NCT02148250)
Timeframe: 24 hours

Interventionmg/kg (Mean)
100 Syringe Units18.5
200 Syringe Units20.1

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Pharmacodynamics (PD): Area Under the Concentration Zero Through 5 Hours (AUC 0-5h) for Triglycerides

(NCT02152384)
Timeframe: Day 29, predose and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast

Interventionng*hr/mL (Mean)
Insulin Peglispro (LY2605541), With Insulin Lispro)6.85
Insulin Glargine (With Insulin Lispro)6.01

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Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Last Time (AUC [0 Tlast]) for Paracetamol

(NCT02152384)
Timeframe: Day 29: Pre-breakfast, and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast

Interventionng*hr/mL (Geometric Mean)
Insulin Peglispro (LY2605541, With Insulin Lispro)33400
Insulin Glargine (With Insulin Lispro)33600

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Pharmacokinetics (PK): Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro

Abbreviation for hours times picomol per liter (pmol*h/L) (NCT02152384)
Timeframe: Day 29: Pre-breakfast, and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast

Interventionpmol*h/L (Geometric Mean)
Insulin Peglispro (LY2605541)850
Insulin Glargine852

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Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp

During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin (Low) of which the effect is largely on the liver and a high dose of insulin (high) at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. AUC is taking during infusion for this outcome measure. (NCT02152384)
Timeframe: Day 35, insulin clearance during lispro infusion (dosing=infusion)

,
Interventionpmol* hr/L (Mean)
Clamp Period 1-3 HoursClamp Period 4-6 Hours
Insulin Glargine (With Insulin Lispro)222897
Insulin Peglispro (LY2605541, With Insulin Lispro)243926

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Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro

To quantitate the pharmacodynamic (PD) effect of a range of prandial insulin lispro doses after treatment with insulin peglispro (LY2605541) compared to insulin glargine during a meal tolerance test (MTT), with sequenced doses of insulin lispro ranging from 25% to 150% of each participant's normal dose. Data presented as hours times milligrams per deciliter (mg*h/dL) (NCT02152384)
Timeframe: Day 30, 31, 32, 33, 34, pre-breakfast and10,20,30,40,50,60,90,120,150,180,210,240,270, 300 minutes (5 hours) post-breakfast

,
Interventionmg*h/dL (Mean)
25% Normal Dose50% Normal Dose75% Normal Dose100% Normal Dose150% Normal Dose
Insulin Glargine716.52506.22369.08307.81123.97
Insulin Peglispro (LY2605541)677.84572.96393.28270.46174.38

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Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)

Abbreviation for micro mole per kilogram per minute (µmol/kg/min). Both arms received insulin lispro in addition to their respective study drug. During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure. (NCT02152384)
Timeframe: Day 35, last 60 minutes of euglycemic 2-step hyperinsulinemic clamp

,
Interventionµmol/kg/min (Mean)
High Dose InsulinLow Dose Insulin
Insulin Glargine (With Insulin Lispro)56.32118.765
Insulin Peglispro (LY2605541, With Insulin Lispro)52.75613.908

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Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29

"VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount.~The questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount.~Day 29 and cumulative insulin lispro doses of 25%, 50%, 75%, 100% and 150 % of normal insulin lispro dose included.Scores were averaged will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints and reported in millimeters." (NCT02152384)
Timeframe: Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast

,
Interventionmillimeters (mm) (Mean)
Day 29: Hunger, wakingDay 29: Hunger, 5 hours post breakfastDay 29: Food amount, wakingDay 29: Food amount, 5 hours post-breakfastOverall 25%: Hunger, wakingOverall 25%: Hunger, 5 hours post breakfastOverall 25%: Food amount, wakingOverall 25%: Food amount, 5 hours post-breakfastOverall 50%: Hunger, wakingOverall 50%: Hunger, 5 hours post breakfastOverall 50%: Food amount, wakingOverall 50%: Food amount, 5 hours post-breakfastOverall 75%: Hunger, wakingOverall 75%: Hunger, 5 hours post breakfastOverall 75%: Food amount, wakingOverall 75%: Food amount, 5 hours post-breakfastOverall 100%: Hunger, wakingOverall 100%: Hunger, 5 hours post breakfastOverall 100%: Food amount, wakingOverall 100%: Food amount, 5 hours post-breakfastOverall 150%: Hunger, wakingOverall 150%: Hunger, 5 hours post breakfastOverall 150%: Food amount, wakingOverall 150%: Food amount, 5 hours post-breakfast
Insulin Glargine (With Insulin Lispro)32.158.937.738.135.858.036.459.028.264.031.764.230.962.531.462.229.659.035.758.628.558.634.158.3
Insulin Peglispro (LY2605541, With Insulin Lispro)27.153.832.531.827.556.130.856.536.056.537.155.029.855.532.657.028.955.032.355.331.452.234.352.7

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LH

Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms (NCT02154477)
Timeframe: 4 hours

,
InterventionIU/L (Mean)
baselinepost-intervention salinepost-intervention insulin
Control3.33.83.4
Diabetes7.77.98

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Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro

(NCT02197520)
Timeframe: Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast

,
Interventionmilligram*hour per deciliter (Mean)
10% Insulin Lispro Dose20% Insulin Lispro Dose30% Insulin Lispro Dose
Insulin Glargine398.26343.54239.83
Insulin Peglispro437.78334.23244.68

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Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen

(NCT02197520)
Timeframe: Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast

Interventionnanograms*hour per milliliter (Geometric Mean)
Insulin Peglispro33700
Insulin Glargine35700

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Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29

"VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount.~The questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount. Scores were averaged and will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints." (NCT02197520)
Timeframe: Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast

,
Interventionmillimeters (Mean)
Hunger: WakingFood amount: WakingHunger: Pre-breakfastFood amount: Pre-breakfastHunger: 1 hour Post-breakfastFood amount: 1 hour Post-breakfastHunger: 2 hour Post-breakfastFood amount: 2 hour Post-breakfastHunger:3 hour Post-breakfastFood amount: 3 hour Post-breakfastHunger: 4 hour Post-breakfastFood amount: 4 hour Post-breakfastHunger: 5 hour Post-breakfastFood amount: 5 hour Post-breakfast
Insulin Glargine38.634.451.451.56.26.014.916.329.231.148.048.555.553.4
Insulin Peglispro25.730.241.543.97.88.719.720.734.835.646.648.256.857.5

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Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)

During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure. (NCT02197520)
Timeframe: Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp

,
Interventionmilligram*hour per deciliter (Mean)
High Dose InsulinLow Dose Insulin
Insulin Glargine55.5219.67
Insulin Peglispro59.0917.22

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Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro

(NCT02197520)
Timeframe: Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast

Interventionpicomol*hour per liter (Mean)
Insulin Peglispro839
Insulin Glargine835

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Number of Participants With Hematology Values of Clinical Concern

Hematology parameters included basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, neutrophils, neutrophil bands, platelets, red blood cell (RBC) count, segmented neutrophils and white blood cell (WBC) count. The potential clinical concern values were: Hematocrit >0.05 below lower limit of normal (LLN) and >0.04 above upper limit of normal (ULN), hemoglobin: >20 grams cells per Liter (g/L) below LLN and >10 g/L above ULN, lymphocytes: <0.5 x LLN, neutrophils: <1 giga cells per liter (GI/L), platelets: <80 GI/L and >500 GI/L, segmented neutrophils: <0.5 x LLN, RBC count: >1 GI/L below LLN and >5 GI/L above ULN and none for basophils, eosinophils, monocytes, neutrophil bands and RBC count. Only those parameters for which at least one value of potential clinical concern was reported are summarized. (NCT02229227)
Timeframe: Up to 30 weeks

,
InterventionParticipants (Number)
Hematocrit: >0.05 (fraction) below LLNHematocrit: >0.04 (fraction) above ULNHemoglobin: >20 g/L below LLNHemoglobin: >10 g/L above ULNLeukocytes: >1 GI/L below LLNLeukocytes: >5 GI/L above ULNNeutrophils: <1 GI/LNeutrophils, Segmented: <0.5 x LLNPlatelets: <80 GI/LPlatelets: >500 GI/L
Albiglutide + Insulin Glargine5992142213
Insulin Lispro + Insulin Glargine61293113311

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Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)

The American Diabetes Association has categorized hypoglycemic events as follows: Severe, documented symptomatic, asymptomatic, probably symptomatic and pseudohypoglycemia. Number of participants with hypoglycemic events in total are also presented. (NCT02229227)
Timeframe: Up to Week 26

,
InterventionParticipants (Number)
SevereDocumented SymptomaticAsymptomaticProbably SymptomaticPseudohypoglycemiaMissingTotal
Albiglutide + Insulin Glargine920323029459305
Insulin Lispro + Insulin Glargine22299293528313361

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Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication

AE is any untoward medical occurrence in a participant, temporally associated with use of medicinal product (MP), whether or not considered related to MP. AE can be any unfavorable, unintended sign (also an abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Safety Population: All participants who received at least 1 dose of randomized study medication. A participant randomized to Albiglutide + Insulin glargine by mistake received Insulin Lispro + Insulin Glargine instead. Since this participant received actual treatment as Insulin Lispro + Insulin Glargine, was summarized as such in Safety Population. (NCT02229227)
Timeframe: Up to Week 26

,
InterventionParticipants (Number)
AESAEAE leading to study medication discontinuation
Albiglutide + Insulin Glargine2612312
Insulin Lispro + Insulin Glargine254316

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Number of Participants With Other AE of Special Interest

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a MP, whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. AE of special interest included hypoglycemic events, cardiovascular events, gastrointestinal events, injection site reactions, potential systemic allergic reactions, pancreatitis, pancreatic cancer, malignant neoplasms following treatment with insulin, diabetic retinopathy events, appendicitis, liver events, pneumonia, and atrial fibrillation/flutter. (NCT02229227)
Timeframe: Up to Week 26

,
InterventionParticipants (Number)
Hypoglycemic EventsCardiovascular EventsGastrointestinal EventsInjection Site ReactionsSystemic Allergic ReactionsPancreatitisPancreatic cancerMalignant NeoplasmDiabetic RetinopathyAppendicitisLiver EventsPneumoniaAtrial Fibrillation/Flutter
Albiglutide + Insulin Glargine30571028310241014
Insulin Lispro + Insulin Glargine36195310002170231

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Number of Participants With Vital Signs of Clinical Concern

Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values. Assessment of vitals were performed with the participant in a semi recumbent or seated position having rested in this position for at least 5 minutes before each reading. The potential clinical concern values were: SBP: <100 millimeters of mercury (mmHg) and >170 mmHg, DBP: <50 mmHg and >110 mmHg and pulse rate: <50 beats per minute (bpm) and > 120 bpm. Number of participants with vital signs of clinical concern are presented. (NCT02229227)
Timeframe: Up to 30 weeks

,
InterventionParticipants (Number)
SBP: < 100 mmHgSBP: > 170 mmHgDBP: < 50 mmHgDBP: > 110 mmHgPulse Rate: < 50 bpmPulse Rate: > 120 bpm
Albiglutide + Insulin Glargine21271143
Insulin Lispro + Insulin Glargine20304591

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Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26

Hypoglycemic events with confirmed home plasma glucose monitoring <3.9 millimoles per Liter and/or requiring third party intervention were severe, documented symptomatic (DS) and asymptomatic hypoglycemic events. Participants with more than one hypoglycemic event are counted in all categories reported. Any severe, documented symptomatic, and asymptomatic hypoglycemic events in 3-month intervals (i.e., from Day 0 to Week 12, >Week 12 to Week 26) are presented. (NCT02229227)
Timeframe: Up to Week 26

,
InterventionPercentage of participants (Number)
Any event: Onset date falls under 0 to <= 12 weeksAny event: Onset date falls > 12 to <= 26 WeeksSevere: Onset date falls under 0 to <= 12 weeksSevere: Onset date falls > 12 to <= 26 WeeksDS: Onset date falls under 0 to <= 12 weeksDS: Onset date falls > 12 to <= 26 WeeksAsymptomatic: Onset date under 0 to <= 12 weeksAsymptomatic: Onset date falls > 12 to <= 26 Weeks
Albiglutide + Insulin Glargine55.360.31.80.833.840.838.344.3
Insulin Lispro + Insulin Glargine79.279.43.61.963.062.056.954.7

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Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits

Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily basal insulin (insulin glargine) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. (NCT02229227)
Timeframe: Weeks 4, 10, 18, and 26

,
InterventionInternational Units (Least Squares Mean)
Week 4, n=388,403Week 10, n=375,386Week 18, n=359,361Week 26, n=342,341
Albiglutide + Insulin Glargine49.9756.1459.4259.83
Insulin Lispro + Insulin Glargine50.9455.7959.1859.43

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Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits

Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily bolus insulin (insulin lispro) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. (NCT02229227)
Timeframe: Weeks 4, 10, 18, and 26

,
InterventionInternational Units (Least Squares Mean)
Week 4, n=388,403Week 10, n=375,386Week 18, n=359,361Week 26, n=342,341
Albiglutide + Insulin Glargine0.621.908.8910.64
Insulin Lispro + Insulin Glargine56.6766.6671.8172.47

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Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms

Number of participants with hypoglycemia with blood glucose <56 mg/dL (<3.1 mmol/L), regardless of symptoms are presented. (NCT02229227)
Timeframe: Up to Week 26

InterventionParticipants (Number)
Albiglutide + Insulin Glargine141
Insulin Lispro + Insulin Glargine239

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Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26

Total number of weekly insulin injections (7 days) to achieve glycemic control at Baseline/Randomization and Week 4, 10, 18, and 26 are presented. Only those participants available at the specified time points were analyzed represented by n=X,X in category titles. (NCT02229227)
Timeframe: Baseline (Day -1) and Weeks 4, 10, 18 and 26

,
InterventionInsulin Injections (Mean)
Baseline, n=401,412Week 4, n=388,403Week 10, n=375,386Week 18, n=359,361Week 26, n=342,341
Albiglutide + Insulin Glargine28.798.119.0612.6213.22
Insulin Lispro + Insulin Glargine28.0028.0028.0028.0028.00

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Number of Participants Achieving a HbA1c <6.5% at Week 26

Number of participants achieving a HbA1c <6.5% at Week 26 are presented. (NCT02229227)
Timeframe: Week 26

InterventionParticipants (Number)
Albiglutide + Insulin Glargine147
Insulin Lispro + Insulin Glargine169

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Change From Baseline in Body Weight at Week 26

Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. (NCT02229227)
Timeframe: Baseline (Day -1) and Week 26

InterventionKilograms (Least Squares Mean)
Albiglutide + Insulin Glargine-1.95
Insulin Lispro + Insulin Glargine2.43

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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

FPG was measured at Baseline (Day -1). FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the fasting serum glucose (FSG) values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. (NCT02229227)
Timeframe: Baseline and Week 26

InterventionMillimoles per Liter (Least Squares Mean)
Albiglutide + Insulin Glargine-2.01
Insulin Lispro + Insulin Glargine-1.46

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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. (NCT02229227)
Timeframe: Baseline (Day -1) and Week 26

InterventionPercentage of glycosylated hemoglobin (Least Squares Mean)
Albiglutide + Insulin Glargine-1.04
Insulin Lispro + Insulin Glargine-1.10

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Number of Participants Achieving HbA1c <7.0% at Week 26

HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% at Week 26 are presented. (NCT02229227)
Timeframe: Week 26

InterventionParticipants (Number)
Albiglutide + Insulin Glargine244
Insulin Lispro + Insulin Glargine255

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Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26

Participants who did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 were those participants treated with once-weekly albiglutide that were able to replace prandial insulin without lispro re-introduction through Week 26. Number of participants treated with once-weekly albiglutide that were able to discontinue insulin lispro at Week 4 and did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 have been presented. (NCT02229227)
Timeframe: Up to Week 26

InterventionParticipants (Number)
Albiglutide + Insulin Glargine218

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Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26

Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants who met prespecified criteria for severe, persistent hyperglycemia at Week 26 are presented. (NCT02229227)
Timeframe: Week 26

InterventionParticipants (Number)
Albiglutide + Insulin Glargine3
Insulin Lispro + Insulin Glargine3

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Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26

Percentage of participants achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia are presented. (NCT02229227)
Timeframe: Week 26

InterventionPercentage of participants (Number)
Albiglutide + Insulin Glargine21.1
Insulin Lispro + Insulin Glargine9.5

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Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26

Percentage of participants achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia are presented. (NCT02229227)
Timeframe: Week 26

InterventionPercentage of participants (Number)
Albiglutide + Insulin Glargine15.9
Insulin Lispro + Insulin Glargine3.9

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Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26

Percentage of participants achieving HbA1c <7.0% without weight gain are presented. (NCT02229227)
Timeframe: Week 26

InterventionPercentage of participants (Number)
Albiglutide + Insulin Glargine49.8
Insulin Lispro + Insulin Glargine21.4

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Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26

Severe hypoglycemia was considered as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 milligrams per deciliters (mg/dL) (<=3.9 millimoles per liters [mmol/L]). (NCT02229227)
Timeframe: Up to Week 26

InterventionPercentage of participants (Number)
Albiglutide + Insulin Glargine57.2
Insulin Lispro + Insulin Glargine75.0

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Total Daily Insulin Dose at Week 26

Insulin dose at Week 26 was defined as the prescribed insulin dose at Week 25. Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 26 is presented. Only those participants available at the specified time points were analyzed. (NCT02229227)
Timeframe: Week 26

InterventionInternational Units (Least Squares Mean)
Albiglutide + Insulin Glargine70.36
Insulin Lispro + Insulin Glargine131.19

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Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26

Lipid parameters included TC, LDL-c, HDL-c, TG and FFA. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. LDL-c and FFA were collected as part of the lipid panel and results were reviewed by investigators for individual participants. Change from Baseline at Week 10 and Week 26 was not assessed for these parameters. Analysis of these parameters was not a specific study objective and would not have any impact on study conclusions. Only those parameters with data values have been presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. (NCT02229227)
Timeframe: Baseline, Week 10 and Week 26

,
InterventionMillimoles per Liters (Mean)
TC: Week 10, n=376,393TC: Week 26, n=348,351HDL-c: Week 10, n=376,393HDL-c: Week 26, n=348,351TG: Week 10, n=376,393TG: Week 26, n=348,351
Albiglutide + Insulin Glargine-0.244-0.059-0.041-0.013-0.0390.025
Insulin Lispro + Insulin Glargine0.0410.0730.0160.005-0.065-0.028

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Change From Baseline to Week 26 in Body Weight

Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Change from Baseline to Week 26 in body weight are presented. FA Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. (NCT02229227)
Timeframe: Baseline (Day -1) to Week 26

,
InterventionKilograms (Least Squares Mean)
Week 4, n=368,384Week 5, n=382,393Week 10, n=379,397Week 18, n=365,372Week 26, n=349,352
Albiglutide + Insulin Glargine-0.55-0.95-1.71-1.96-1.95
Insulin Lispro + Insulin Glargine0.660.851.462.062.43

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Change From Baseline to Week 26 in FPG

FPG was measured at Baseline (Day -1) up to Week 26. FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the FSG values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. (NCT02229227)
Timeframe: Baseline to Week 26

,
InterventionMillimoles per Liter (Least Squares Mean)
Week 4, n=356,371Week 5, n=366,388Week 18, n=348,353Week 26, n=345,349
Albiglutide + Insulin Glargine-1.30-1.07-1.76-2.01
Insulin Lispro + Insulin Glargine-0.76-0.88-1.23-1.46

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Change From Baseline to Week 26 in HbA1c

HbA1c is glycosylated hemoglobin and was measured up to Week 26. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. (NCT02229227)
Timeframe: Baseline to Week 26

,
InterventionPercentage of glycosylated hemoglobin (Least Squares Mean)
Week 4, n=358,375Week 5, n=374,392Week 10, n=376,390Week 18, n=360,365Week 26, n=345,350
Albiglutide + Insulin Glargine-0.59-0.67-0.88-1.04-1.04
Insulin Lispro + Insulin Glargine-0.47-0.58-0.96-1.14-1.1

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Mean Albumin at Week 0 and Week 26

Urine samples were collected for analysis of albumin. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean albumin at Week 0 and Week 26 are presented. (NCT02229227)
Timeframe: Week 0 and Week 26

,
InterventionMilligrams per Liter (Mean)
Week 0, n=394,405Week 26, n=348,345
Albiglutide + Insulin Glargine127.7110.5
Insulin Lispro + Insulin Glargine108.2146.3

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Mean Creatinine at Week 0 and Week 26

Urine samples were collected for analysis of creatinine. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean creatinine at Week 0 and Week 26 are presented. (NCT02229227)
Timeframe: Week 0 and Week 26

,
InterventionMicromoles per Liter (Mean)
Week 0, n=395,406Week 26, n=350,345
Albiglutide + Insulin Glargine10646.311364.6
Insulin Lispro + Insulin Glargine10663.811394.2

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Mean Specific Gravity at Week 0 and Week 26

Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. (NCT02229227)
Timeframe: Week 0 and Week 26

,
InterventionRatio (Mean)
Week 0, n=388,402Week 26, n=347,343
Albiglutide + Insulin Glargine1.01821.0180
Insulin Lispro + Insulin Glargine1.01801.0186

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Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26

Urine samples were collected for analysis of albumin/creatinine ratio. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean urine albumin/creatinine ratio at Week 0 and Week 26 are presented. (NCT02229227)
Timeframe: Week 0 and Week 26

,
InterventionGrams per mole (Mean)
Week 0, n=369,376Week 26, n=317,324
Albiglutide + Insulin Glargine14.4010.37
Insulin Lispro + Insulin Glargine11.5711.55

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Number of Participants Achieving a HbA1c <6.5% up to Week 26

Number of participants achieving a HbA1c <6.5% up to Week 26 are presented. (NCT02229227)
Timeframe: Up to Week 26

,
InterventionParticipants (Number)
Week 4Week 5Week 10Week 18Week 26
Albiglutide + Insulin Glargine3963116150147
Insulin Lispro + Insulin Glargine3362140178169

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Number of Participants Achieving HbA1c <7.0% up to Week 26

HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% up to Week 26 are presented. (NCT02229227)
Timeframe: Up to Week 26

,
InterventionParticipants (Number)
Week 4Week 5Week 10Week 18Week 26
Albiglutide + Insulin Glargine142157220251244
Insulin Lispro + Insulin Glargine139182261281255

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Number of Participants With Clinical Chemistry Values of Clinical Concern

Clinical chemistry parameters and their potential clinical concern values were: albumin (>5 g/L above ULN or below LLN), alkaline phosphatase(>3 x ULN), alanine aminotransferase (>3 x ULN), aspartate aminotransferase (>3 x ULN), carbon dioxide content (<16 millimoles per Liter [mmol/L] and > 40 mmol/L), blood urea nitrogen (>2 x ULN), calcium (<1.8 mmol/L and >3.0 mmol/L), chloride (none), creatinine (>159 micromoles/Liter), direct bilirubin (>1.35 x ULN), gamma glutamyl transferase (>3 x ULN), glucose (fasting) (<3 mmol/L and >22 mmol/L), magnesium (<0.411 mmol/L and >1.644 mmol/L), phosphate (>0.323 mmol/L above ULN or below LLN), potassium (>0.5 mmol/L below LLN and >1.0 mmol/L above ULN), sodium (>5 mmol/L above ULN or below LLN), triglycerides (> 9.04 mmol/L), total bilirubin (>1.5 x ULN), total protein (>15 g/L above ULN or below LLN) and uric acid (>654 umol/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. (NCT02229227)
Timeframe: Up to 30 weeks

,
InterventionParticipants (Number)
Fasting Serum Glucose: <3 mmol/L, n= 394,405Fasting Serum Glucose: >22 mmol/L, n= 394,405Fasting Plasma Glucose: <3 mmol/L, n= 388,406Fasting Plasma Glucose: >22 mmol/L, n= 388,406Albumin: >5 g/L below LLN, n=394,407Albumin: >5 g/L above ULN, n=394,407Calcium: <1.8 mmol/L, n=394,407Calcium: >3.0 mmol/L, n=394,407Carbon Dioxide: <16 mmol/L, n=394,407Carbon Dioxide: >40 mmol/L, n=394,407Magnesium: <0.411 mmol/L, n=394,407Magnesium: >1.644 mmol/L, n=394,407Phosphate: >0.323 mmol/L below LLN, n=394,407Phosphate: >0.323 mmol/L above ULN, n=394,407Potassium: >0.5 mmol/L below LLN, n=394,407Potassium: >1.0 mmol/L above ULN, n=394,407Protein: >15 g/L below LLN, n=394,407Protein: >15 g/L above ULN, n=394,407Sodium: >5 mmol/L below LLN, n=394,407Sodium: >5 mmol/L above ULN, n=394,407Triglycerides: >9.04 mmol/L, n=393,405Urate: >654 μmol/L, n=394,407Urea: >2 x ULN, n=394,407Alanine Aminotransferase: >3 x ULN, n=396,410Alkaline Phosphatase: >3 x ULN, n=396,410Aspartate Aminotransferase: >3 x ULN, n=396,410Bilirubin: >1.5 x ULN, n=396,410Creatinine: >159 μmol/L, n=396,410Direct Bilirubin: >1.35 x ULN, n=396,410Gamma Glutamyl Transferase: >3 x ULN, n=396,410
Albiglutide + Insulin Glargine120910010501002100011702010120014
Insulin Lispro + Insulin Glargine1611400010801004010000121502116114

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Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters

A single 12-lead ECG recordings were performed in a participant in semi recumbent position for 10 to 15 minutes before obtaining the ECG. Any clinically significant favorable and unfavorable findings are reported. (NCT02229227)
Timeframe: Up to 30 weeks

,
InterventionParticipants (Number)
Clinically Significant Change: FavorableClinically Significant Change: Unfavorable
Albiglutide + Insulin Glargine184
Insulin Lispro + Insulin Glargine95

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Number of Participants With Daytime and Nocturnal Hypoglycemia

Daytime hypoglycemia was defined as hypoglycemic events with an onset between 06:00 hours and 00:00 hours (inclusive), and nocturnal hypoglycemia (in total and by category), defined as hypoglycemic events with an onset between 00:01 hours and 05:59 hours (inclusive). Number of participants with daytime and nocturnal hypoglycemia (in total and by category) are presented. (NCT02229227)
Timeframe: Up to Week 26

,
InterventionParticipants (Number)
Any (Total) Daytime Hypoglycemic EventAny (Total) Nocturnal Hypoglycemic EventSevere Daytime Hypoglycemic EventSevere Nocturnal Hypoglycemic EventDocumented Symptomatic Daytime Hypoglycemic eventDocumented Symptomatic Nocturnal HypoglycemiaAsymptomatic Daytime Hypoglycemic eventAsymptomatic Nocturnal Hypoglycemic eventProbably Symptomatic Daytime Hypoglycemic eventProbably Symptomatic Nocturnal Hypoglycemic eventPseudohypoglycemia Daytime Hypoglycemic eventPseudohypoglycemia Nocturnal Hypoglycemic eventMissing Daytime Hypoglycemic EventMising Nocturnal Hypoglycemic Event
Albiglutide + Insulin Glargine2881556418710121777227361792
Insulin Lispro + Insulin Glargine35622514629315228110644217034114

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Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26

Urine samples were collected for analysis of erythrocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of erythrocytes in urine at Week 0 and Week 26 are presented. (NCT02229227)
Timeframe: Week 0 and Week 26

,
InterventionParticipants (Number)
None Seen; Week 0, n=171,1870 to 1; Week 0, n=171,1871 to 3; Week 0, n=171,1873 to 5; Week 0, n=171,1875 to 10; Week 0, n=171,18710 to 15; Week 0, n=171,18715 to 25; Week 0, n=171,18750 to 100; Week 0, n=171,187>100; Week 0, n=171,187None Seen; Week 26, n=166,1440 to 1; Week 26, n=166,1441 to 3; Week 26, n=166,1443 to 5; Week 26, n=166,1445 to 10; Week 26, n=166,14425 to 50; Week 26, n=166,14450 to 100; Week 26, n=166,144>100; Week 26, n=166,144
Albiglutide + Insulin Glargine1193493202029848844121
Insulin Lispro + Insulin Glargine1015114124211179361934201

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Total Daily Insulin Dose at Week 4, Week 10 and Week 18

Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 4, Week 10 and Week 18 is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. (NCT02229227)
Timeframe: Weeks 4, 10, and 18

,
InterventionInternational Units (Least Squares Mean)
Week 4, n=388,403Week 10, n=375,386Week 18, n=359,361
Albiglutide + Insulin Glargine50.5357.9968.23
Insulin Lispro + Insulin Glargine106.91121.69130.22

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Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26

Urine samples were collected for analysis of leukocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of leukocytes in urine at Week 0 and Week 26 are presented. (NCT02229227)
Timeframe: Week 0 and Week 26

,
InterventionParticipants (Number)
None Seen; Week 0, n=171,1870 to 1; Week 0, n=171,1871 to 3; Week 0, n=171,1873 to 5; Week 0, n=171,1875 to 10; Week 0, n=171,18710 to 15; Week 0, n=171,18715 to 25; Week 0, n=171,18725 to 50; Week 0, n=171,18750 to 100; Week 0, n=171,187>100; Week 0, n=171,187Innumerable; Week 0, n=171,187None Seen; Week 26, n=166,1440 to 1; Week 26, n=166,1441 to 3; Week 26, n=166,1443 to 5; Week 26, n=166,1445 to 10; Week 26, n=166,14410 to 15; Week 26, n=166,14415 to 25; Week 26, n=166,14420 to 50; Week 26, n=166,14425 to 50; Week 26, n=166,14450 to 100; Week 26, n=166,144>100; Week 26, n=166,144Innumerable; Week 26, n=166,144
Albiglutide + Insulin Glargine692720161775514065252210228305510
Insulin Lispro + Insulin Glargine67311813196111173144292015145316511

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Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26

Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Safety Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. (NCT02229227)
Timeframe: Week 0 and Week 26

,
InterventionParticipants (Number)
pH=5; Week 0, n=388,402pH=5.5; Week 0, n=388,402pH=6; Week 0, n=388,402pH=6.5; Week 0, n=388,402pH=7; Week 0, n=388,402pH=7.5; Week 0, n=388,402pH=8; Week 0, n=388,402pH=8.5; Week 0, n=388,402pH=5; Week 26, n=347,343pH=5.5; Week 26, n=347,343pH=6; Week 26, n=347,343pH=6.5; Week 26, n=347,343pH=7; Week 26, n=347,343pH=7.5; Week 26, n=347,343pH=8; Week 26, n=347,343pH=8.5; Week 26, n=347,343pH>9; Week 26, n=347,343
Albiglutide + Insulin Glargine9213286292913618010769421917751
Insulin Lispro + Insulin Glargine107132774324117110010470232318500

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Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26

Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants meeting prespecified criteria for severe, persistent hyperglycemia up to Week 26 are presented. (NCT02229227)
Timeframe: Up to Week 26

,
InterventionParticipants (Number)
0 to <=4 Weeks>4 to <=5 Weeks>5 to <=10 Weeks>10 to <=18 Weeks>18 to <=26 Weeks
Albiglutide + Insulin Glargine00201
Insulin Lispro + Insulin Glargine00012

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Retrospective Re-Analysis (MARD With 1 Additional Calibration)

Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. (NCT02246582)
Timeframe: 7 Days

Interventionpercentage (Mean)
640G PumpGuardian Mobile
Group9.649.43

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Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)

Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. (NCT02246582)
Timeframe: 7 Days

Interventionpercentage (Mean)
minimum calibration3-4 calibrations
Group9.098.68

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Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)

Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. (NCT02246582)
Timeframe: 7 Days

Interventionpercentage (Mean)
640G PumpGuardian Mobile
Group10.5510.35

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Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions

Percentage of participants with hypersensitivity reactions and injection site reactions were reported. (NCT02273180)
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)

,
Interventionpercentage of participants (Number)
Any hypersensitivity reactionsAny injection site reactions
Humalog6.31.2
SAR34243461.2

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Change in Daily Insulin Dose From Baseline to Week 26 and Week 52

Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively. (NCT02273180)
Timeframe: Baseline, Week 26, Week 52

,
InterventionU/kg (Mean)
Basal insulin dose at Week 26Mealtime insulin dose at Week 26Total insulin dose at Week 26Basal insulin dose at Week 52Mealtime insulin dose at Week 52Total insulin dose at Week 52
Humalog0.014-0.0050.010.0130.0070.019
SAR3424340.030.0050.0190.0460.0180.039

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Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26

Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26. (NCT02273180)
Timeframe: Baseline, Week 26

,
Interventionmmol/L (Least Squares Mean)
At breakfastAt lunchAt dinner
Humalog0.19-0.260.56
SAR342434-0.460.140.48

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Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year

Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed. (NCT02273180)
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)

,
Interventionevents per participant-year (Number)
Any hypoglycemiaSevere hypoglycemiaDocumented Symptomatic Hypoglycemia (<=3.9 mmol/L)Documented Symptomatic Hypoglycemia (<3.0 mmol/L)
Humalog92.70.2831.376.85
SAR34243490.710.7329.366.29

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Change in HbA1c From Baseline to Week 26

Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26. (NCT02273180)
Timeframe: Baseline, Week 26

Interventionpercentage of HbA1c (Least Squares Mean)
SAR342434-0.42
Humalog-0.47

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Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26

Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26. (NCT02273180)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
SAR342434-0.23
Humalog-0.49

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Percentage of Participants With HbA1c <7.0% at Week 26

Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders. (NCT02273180)
Timeframe: Week 26

Interventionpercentage of participants (Number)
SAR34243422.5
Humalog21.7

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Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)

Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA). (NCT02273180)
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)

Interventionpercentage of participants (Number)
SAR34243422.6
Humalog24.2

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26. (NCT02273180)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
SAR342434-0.46
Humalog-0.62

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Percentage of Participants With Treatment-Emergent Anti-insulin Antibodies (AIAs)

Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were participants who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA). (NCT02294474)
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)

Interventionpercentage of participants (Number)
SAR34243418.8
Humalog14.5

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Change in Daily Insulin Dose From Baseline to Week 26

Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 value. (NCT02294474)
Timeframe: Baseline, Week 26

,
InterventionU/kg (Mean)
Basal insulinMealtime insulinTotal insulin
Humalog0.0710.080.151
SAR3424340.0820.0870.172

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Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26

Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the 6-month period and adequate contrasts at Week 26. (NCT02294474)
Timeframe: Baseline, Week 26

,
Interventionmmol/L (Least Squares Mean)
At breakfastAt lunchAt dinner
Humalog-0.230.11-0.1
SAR342434-0.720.060.11

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Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26

Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders. (NCT02294474)
Timeframe: Week 26

,
Interventionpercentage of participants (Number)
HbA1c <7.0%HbA1c<=6.5%
Humalog40.524.2
SAR34243442.327.3

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the 6-month period and adequate contrasts at Week 26. (NCT02294474)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
SAR342434-0.62
Humalog-0.67

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Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions

Percentage of participants with hypersensitivity reactions and injection site reactions were reported. (NCT02294474)
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)

,
Interventionpercentage of participants (Number)
Any hypersensitivity reactionsAny injection site reactions
Humalog3.61.6
SAR34243440.4

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Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26

The mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. 7-point SMPGs were performed at least two times in a week before baseline, before visit Week 12 and before visit Week 26. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during 6-month period and adequate contrasts at Week 26. (NCT02294474)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
SAR342434-1
Humalog-0.91

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Change in HbA1c From Baseline to Week 26

Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 6-month period and adequate contrasts at Week 26. (NCT02294474)
Timeframe: Baseline, Week 26

Interventionpercentage of HbA1c (Least Squares Mean)
SAR342434-0.92
Humalog-0.85

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Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)

Percentage of participants with at least one treatment emergent hypoglycemia reported at any time of the day were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed. (NCT02294474)
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)

,
Interventionpercentage of participants (Number)
Any hypoglycemiaSevere hypoglycemiaDocumented Symptomatic Hypoglycemia (<=3.9mmol/L)Documented Symptomatic Hypoglycemia (<3.0mmol/L)
Humalog74.61.666.327.4
SAR34243468.42.460.128.9

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Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment

Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%. (NCT02320721)
Timeframe: Baseline up to Week 26

Interventionpercentage of participants (Number)
HOE901-U3003.7
Lantus2.6

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period. (NCT02320721)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
HOE901-U300-1.68
Lantus-1.77

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Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period

Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses. (NCT02320721)
Timeframe: Baseline up to Week 26

,
Interventionpercentage of participants (Number)
HbA1c <7.5%HbA1c <7.0%
HOE901-U30060.633.3
Lantus58.935.2

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Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period

Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL). (NCT02320721)
Timeframe: Baseline up to Week 26

Interventionpercentage of participants (Number)
HOE901-U30059.4
Lantus62.7

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Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period

Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL). (NCT02320721)
Timeframe: Baseline up to Week 26

Interventionpercentage of participants (Number)
HOE901-U30020.2
Lantus22.5

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Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment

Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L). (NCT02320721)
Timeframe: Baseline up to Week 26

,
Interventionevents per participant year (Number)
Any hypoglycemiaDocumented symptomatic hypoglycemiaSevere and/or confirmed hypoglycemia
HOE901-U3006.061.855.17
Lantus7.742.566.36

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Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment

Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L). (NCT02320721)
Timeframe: Baseline up to Week 26

,
Interventionevents per participant year (Number)
Any hypoglycemia:<75 years ageAny hypoglycemia:≥75 years ageDocumented symptomatic hypoglycemia:<75 years ageDocumented symptomatic hypoglycemia:≥75 years ageSevere and/or confirmed hypoglycemia:<75 years ageSevere and/or confirmed hypoglycemia:≥75 years age
HOE901-U3006.445.012.111.125.434.46
Lantus7.857.322.522.716.376.28

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Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period

Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL). (NCT02320721)
Timeframe: Baseline up to Week 26

,
Interventionpercentage of participants (Number)
HbA1c <7.5%HbA1c <7.0%
HOE901-U30026.414.0
Lantus21.512.3

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Change in HbA1c From Baseline to Week 26

Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period. (NCT02320721)
Timeframe: Baseline, Week 26

Interventionpercentage of hemoglobin (Least Squares Mean)
HOE901-U300-0.89
Lantus-0.91

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Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment

Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L). (NCT02320721)
Timeframe: Baseline up to Week 26

,
Interventionpercentage of participants (Number)
Any hypoglycemiaDocumented symptomatic hypoglycemiaSevere and/or confirmed hypoglycemiaSevere and/or confirmed hypoglycemia:<75 years ageSevere and/or confirmed hypoglycemia:≥75 years age
HOE901-U30062.632.958.159.254.8
Lantus66.534.760.660.959.4

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Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26

WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life). (NCT02320721)
Timeframe: Baseline, Week 26

Interventionscores on a scale (Least Squares Mean)
HOE901-U300-1.16
Lantus0.22

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Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo

Serum glucagon concentrations were measured in the CL setting in the treatment arm, sitagliptin, compared to the placebo (Insulin monotherapy) (NCT02328040)
Timeframe: 18 months

InterventionPmol/L (Mean)
Placebo/Insulin6.04
Sitagliptin/Insulin5.66

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Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo

Better targeted blood glucose levels in the CL setting in the treatment arm, Sitagliptin, compared to placebo (insulin monotherapy) (NCT02328040)
Timeframe: 18 Months

Interventionmg/dl (Mean)
Placebo/Insulin149.7
Sitagliptin/Insulin155.9

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Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes

"As measured by the number of events of plasma glucose values ≤ 50 mg/dL OR frequency of system alerts preceding a plasma glucose value of ≤ 50 mg/dL in all subjects~As measured by the number of events of system alerts of plasma glucose values >300 mg/dL lasting for more than one hour in all subjects.~As measured by number of events of serum ketones >3 mmol/L in all subjects~As measured by the number of events meeting the criteria for severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose in all subjects" (NCT02366767)
Timeframe: 6 days

,
InterventionEvents (Number)
Plasma glucose <50 mg/dLPlasma glucose >300 mg/dL lasting more than 1 hourSerum Ketones >3 mmol/LSevere Hypoglycemia
Automatic Closed-loop Insulin Delivery9000
Control6001

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Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes

"As measured by the system initiating and operating properly for at least 75% of the time for 75% of subjects.~As measure by the completion of study enrollment procedures and education on system use within 2 hours for 75% of the subjects." (NCT02366767)
Timeframe: 6 days

,
Interventionparticipants (Number)
Operational System >75% timeEducation completed within 2 hours
Automatic Closed-loop Insulin Delivery1010
Control1010

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Efficacy of Hybrid Closed-loop System in Comparison With Control

As measured by overall mean sensor glucose percent time in range 70-180 mg/dL. (NCT02366767)
Timeframe: 6 days

InterventionPercent time (Mean)
Automatic Closed-loop Insulin Delivery69.9
Control73.1

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Percentage of Time in Target Range Over 24 Hour

The primary outcome from the studies will be time spent with a glucose concentration in the target range (3.9-10.0mmol/l). (NCT02397265)
Timeframe: 24 hours

Interventionpercentage of time (Median)
Bihormonal Closed Loop2
Standard Opened Loop Pump4.7
Insulin Only1.3

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Mean Daily BG Levels

Blood glucose (BG) will be measured, and mean daily BG levels will be calculated. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventionmg/dL (Mean)
Insulin Aspart for BG > 140 mg/dL172
Insulin Aspart for BG > 260 mg/dL173

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Average Number of Days of Hospital Stay

The average number of days in the hospital for subjects will be calculated. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventiondays (Median)
Insulin Aspart for BG > 140 mg/dL4
Insulin Aspart for BG > 260 mg/dL4

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Incidence of Hyperglycemia

The number of occurrences of hyperglycemia (blood glucose levels > 260 mg/dL) will be recorded. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventionnumber of events (Number)
Insulin Aspart for BG > 140 mg/dL45
Insulin Aspart for BG > 260 mg/dL42

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Mean Blood Glucose Levels at Bedtime

The blood glucose levels will be assessed at bedtime using a glucose meter. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventionmg/dl (Mean)
Insulin Aspart for BG > 140 mg/dL157
Insulin Aspart for BG > 260 mg/dL171

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Mean Blood Glucose Levels Before Dinner

The blood glucose levels will be assessed before dinner using a glucose meter. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventionmg/dL (Mean)
Insulin Aspart for BG > 140 mg/dL151
Insulin Aspart for BG > 260 mg/dL160

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Mean Blood Glucose Levels Before Lunch

The blood glucose levels will be assessed prior to lunch using a glucose meter. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventionmg/dL (Mean)
Insulin Aspart for BG > 140 mg/dL160
Insulin Aspart for BG > 260 mg/dL172

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Mean Daily Dose of Insulin

Daily dose of insulin will be recorded (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventionunits/day (Mean)
Insulin Aspart for BG > 140 mg/dL47
Insulin Aspart for BG > 260 mg/dL41

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Mortality

The total number of subject deaths during hospital stay will be recorded. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

InterventionParticipants (Count of Participants)
Insulin Aspart for BG > 140 mg/dL1
Insulin Aspart for BG > 260 mg/dL0

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Number of Blood Glucose Readings Within 100-140 mg/dL Range

The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventionnumber of readings (Number)
Insulin Aspart for BG > 140 mg/dL59
Insulin Aspart for BG > 260 mg/dL57

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Number of Hypoglycemia Events

The number of occurrences of hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

Interventionnumber of events (Number)
Insulin Aspart for BG > 140 mg/dL16
Insulin Aspart for BG > 260 mg/dL15

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Number of Subjects That Experienced Hospital Complications

The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury [rise of serum creatinine >0.5 mg/dL (or 50%) of baseline value]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria. (NCT02408120)
Timeframe: 5 days (average time of discharge from the hospital)

InterventionParticipants (Count of Participants)
Insulin Aspart for BG > 140 mg/dL11
Insulin Aspart for BG > 260 mg/dL12

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Weight (kg).

Long-term safety measure of weight difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo. (NCT02415556)
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).

,,,
Interventionkg (Mean)
BaselineOn-treatment averagePost-treatment average
Control - Insulin75.8975.9776.15
Control - Placebo76.4077.1478.18
Type 2 Diabetes Mellitus - Insulin90.3688.4490.41
Type 2 Diabetes Mellitus - Placebo90.9693.7992.59

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Gait Speed Normal Walk (cm/s).

Gait speed normal walk (cm/s) - difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo. (NCT02415556)
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).

,,,
Interventioncm/s (Mean)
BaselineOn-treatment averagePost-treatment average
Control - Insulin121.58123.89124.79
Control - Placebo119.51119.44120.50
Type 2 Diabetes Mellitus - Insulin112.23112.43113.12
Type 2 Diabetes Mellitus - Placebo103.42105.83107.27

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Gait Speed Dual-task (cm/s).

Gait speed dual-task (cm/s) - walking and counting backwards (subtracting 7) difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo. (NCT02415556)
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).

,,,
Interventioncm/s (Mean)
BaselineOn-treatment averagePost-treatment average
Control - Insulin109.44114.66117.29
Control - Placebo110.24112.58113.08
Type 2 Diabetes Mellitus - Insulin104.23105.34108.77
Type 2 Diabetes Mellitus - Placebo93.1898.27102.22

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Fasting Plasma Glucose (mg/dL).

Long-term safety measure of fasting plasma glucose difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo. (NCT02415556)
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).

,,,
Interventionmg/dL (Mean)
BaselineOn-treatment averagePost-treatment average
Control - Insulin92.0790.1190.05
Control - Placebo90.5489.6191.94
Type 2 Diabetes Mellitus - Insulin138.63140.47143.28
Type 2 Diabetes Mellitus - Placebo141.25132.18140.34

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Executive Function Composite z Score

"The executive function composite score was calculated as a sum of Paired Associates Learning (PAL) and Spatial Working Memory (SWM) z-scores (range -2 to +2, 0 indicates the mean; higher score indicates worse outcome). Paired Associates Learning - raw score of Total Errors Adjusted (range 0-120) was converted to z-score. Spatial Working Memory - raw score SWM-Between Errors (range 0-42) and raw score of SWM-Strategy (range 8-56) were converted to z-scores. Executive function composite scores were compared between:~Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo." (NCT02415556)
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).

,,,
Interventionunits on a scale (Mean)
BaselineOn-treatment averagePost-treatment average
Control - Insulin0.46-0.51-1.08
Control - Placebo0.660.14-0.31
Type 2 Diabetes Mellitus - Insulin0.840.13-0.19
Type 2 Diabetes Mellitus - Placebo1.400.47-0.11

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Cerebral Blood Flow on Magnetic Resonance Imaging (MRI).

Difference in regional cerebral blood flow in right medial prefrontal cortex (MPFC) was measured by pseudo-continuous arterial spin labeling (PCASL) MRI at 3 Tesla in 8 Type 2 Diabetes Mellitus - Insulin participants and 3 Type 2 Diabetes Mellitus - Placebo participants only. (NCT02415556)
Timeframe: At baseline and at V8 (week 24) the last intervention.

,
Intervention50ml/100g/min (Mean)
BaselineEnd of treatment
Type 2 Diabetes Mellitus - Insulin86.4092.68
Type 2 Diabetes Mellitus - Placebo95.2392.73

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Verbal Memory Composite z Score

Verbal memory composite score was calculated as the sum of Verbal Recognition Memory (VRM) z scores ( 0 indicates the mean; lower score indicates worse outcome). VRM- Free Recall raw score (range 0-12), immediate and delayed VRM-Recognition raw score (range 0-24) were converted to z-scores. Verbal memory composite scores were compared between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo. (NCT02415556)
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).

,,,
Interventionscore on a scale (Mean)
BaselineOn-treatment averagePost-treatment average
Control - Insulin0.070.341.01
Control - Placebo-0.22-0.010.23
Type 2 Diabetes Mellitus - Insulin-0.74-0.160.05
Type 2 Diabetes Mellitus - Placebo-0.89-0.50-0.24

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Efficacy Index (%EI)

Every three days the pressure ulcers (PUs) of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos were evaluated for measurement of PUs and any kind of irritation. At the end of this stage, the properly gathered study data was interpreted using the analysis software Mobile Wound Analyzer® (MOWA). Healing efficacy indices (% EI) were calculated as percentage reduction in the wound size at days 3, 6, 9, 12 and 15 from treatment beginning (d0). The % EI of the wound size was calculated by the following equation: %EI= ((Vsp.day-Vi)/Vi))x100. Vsp.day refers to the diameter (mm) values measured at day 3, 6, 9,12 and 15, while Vi refers to the baseline value measured before treatment (d0). The most representative result of treatment efficacy was observed on day 15, therefore it was used to calculate the % EI. For each group assessed, it was calculated the mean % EI of the five patients, resulting in a single value. (NCT02418676)
Timeframe: Measured every 3 days for 15 days

Interventionpercentage (%) (Mean)
Gel With HPβCD-I Complex82.76
Gel With Insulin43.66
Control Gel14.58

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Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients

Dosages were provided four times daily (04h, 10h, 16h and 22h) to each patient during the 15-day study period, giving a total of 60 doses. To obtain these dosages, a drop of blood of patients was placed on a colorimetric strip and blood glucose was measured with the use of an Accu Check Active® glucose meter. The mean of 60 dosages was calculated for each patient at the end of 15 days. For each group assessed, it was calculated the mean of the measurements of the five patients, resulting in a single value. (NCT02418676)
Timeframe: Assessed daily at 04 h, 10 h, 16 h and 22 h for 15 days

Interventionmg/dL (Mean)
Gel With HPβCD-I Complex167.20
Gel With Insulin168.88
Control Gel196.07

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Responder for HbA1c Below 7.0%

Number of subjects with HbA1c below 7% after 26 weeks of treatment. (NCT02420262)
Timeframe: After 26 weeks of treatment

,
InterventionParticipants (Count of Participants)
YesNo
IDegLira15781
IGlar + IAsp15677

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Change in HbA1c (Glycosylated Haemoglobin)

Change in HbA1c values after 26 weeks of treatment. (NCT02420262)
Timeframe: Week 0, Week 26

InterventionPercentage of glycosylated haemoglobin (Least Squares Mean)
IDegLira-1.48
IGlar + IAsp-1.46

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Change in Body Weight

Change in body weight after 26 weeks of treatment. (NCT02420262)
Timeframe: Week 0, Week 26

Interventionkg (Least Squares Mean)
IDegLira-0.93
IGlar + IAsp2.64

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Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.

Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. (NCT02420262)
Timeframe: Weeks 0-26

InterventionNumber of episodes (Number)
IDegLira129
IGlar + IAsp975

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Responder for HbA1c Below or Equal to 6.5 %

Number of subjects with HbA1c below 6.5% after 26 weeks of treatment. (NCT02420262)
Timeframe: After 26 weeks of treatment

,
InterventionParticipants (Count of Participants)
YesNo
IDegLira118120
IGlar + IAsp104129

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Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME)

"During the examination, a patient is presented with ten common objects they are asked to identify by touch. The test uses distraction to test recall. For all, a higher score indicates a better outcome.~Learning curve is the number of objects the difference in the number of items they are able to correctly identify from the greater of trials 4 or 5 compared to trial 1. Range: 0-10~Total immediate recall is the number of objects recalled over all of the trials. Range: 0-50~Total delayed recall is the number of objects recalled after 5 minutes. Range: 0-10~Recognition memory is the number of items correct from a multiple choice list of three when unable to correctly identify items from delayed recall. Range: 0-10~Retention estimate is the number of items recalled after 5 minutes or being reminded with multiple choice. Range: 0-10" (NCT02432716)
Timeframe: 20 minutes

,
Interventionscore on a scale (Mean)
Learning CurveTotal Immediate RecallTotal Delayed RecallRecognition MemoryRetention Estimate
Post- Placebo2.333.86.12.38.3
Post-Insulin (Glulisine)2.036.86.41.98.3

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Safety Measured by Adverse Events

Number of adverse and/or serious events (NCT02432716)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Insulin (Glulisine), Then Placebo0
Placebo, Then Insulin (Glulisine)0

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Memory Retention Measured by Rivermead Behavioral Memory Test (RBMT-C).

The RBMT-C provides an objective measure of everyday memory problems reported and observed in subjects with memory difficulties. The test is standardized for use with children ranging in age from 5 to 10 years. Here, we used it for evaluation of Down Syndrome subjects. The story recall subtests involves immediate free recall, cued recall, and delayed recall of short story material which is presented orally to subjects by the examiner. The RBMT-C is appealing for use in this population because the task is engaging, simple, and has been shown in other studies to be an effective measure of memory functions. Memory retention is the percentage of story elements recalled after a delay compared to right after the story is complete. Range: 0-100. A higher score means a better outcome. (NCT02432716)
Timeframe: 20 minutes

Interventionpercentage of story elements recalled (Mean)
Post- Placebo9.7
Post-Insulin (Glulisine)16.9

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Memory Retention Measured by Fuld Object-Memory Evaluation (FOME)

Memory retention is the percentage of items correctly identify during the delayed recall trial compared storage trial 5. Range: 0-100 percent. A higher percentage indicates a better outcome. (NCT02432716)
Timeframe: 20 minutes

Interventionpercentage of items correctly identified (Mean)
Post- Placebo72.3
Post-Insulin (Glulisine)68.7

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Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C)

"The RBMT-C provides an objective measure of everyday memory problems reported and observed in subjects with memory difficulties. The test is standardized for use with children ranging in age from 5 to 10 years. Here, we used it for evaluation of Down Syndrome subjects. The story recall subtests involves immediate free recall, cued recall, and delayed recall of short story material which is presented orally to subjects by the examiner. The RBMT-C is appealing for use in this population because the task is engaging, simple, and has been shown in other studies to be an effective measure of memory functions. For all, a higher score means a better outcome.~Immediate Recall is the number of story elements recalled right after the story is complete. Range: 0-31~Delayed Recall is the number of story elements recalled after a delay. Range: 0-31" (NCT02432716)
Timeframe: 20 minutes

,
Interventionscore on a scale (Mean)
Immediate RecallDelayed Recall
Post- Placebo6.66.6
Post-Insulin (Glulisine)5.47.2

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Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration

The blood glucose levels will be assessed throughout the day using a glucose meter. An average will be calculated. The normal BG range for someone with diabetes is 80-130 mg/dL. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

Interventionmg/dL (Mean)
Sitagliptin137
Placebo138

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Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)

Number of participants with blood glucose (BG) <70 after transition from ICU. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

InterventionParticipants (Count of Participants)
Sitagliptin1
Placebo0

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Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay

Number of participants with blood glucose (BG) <70 during ICU stay. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

InterventionParticipants (Count of Participants)
Sitagliptin2
Placebo1

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Number of Participants With Infections Not Requiring Hospital Re-admission

Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge. (NCT02443402)
Timeframe: Post-Hospital Discharge (Up to 30 Days)

InterventionParticipants (Count of Participants)
Sitagliptin0
Placebo1

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Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)

Number of participants who developed stress hyperglycemia (BG >180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

InterventionParticipants (Count of Participants)
Sitagliptin22
Placebo25

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Duration of Continuous Intravenous Insulin (CII)

Mean number of hours on continuous intravenous insulin (CII) after ICU discharge. (NCT02443402)
Timeframe: Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)

Interventionhours (Mean)
Sitagliptin12
Placebo17

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Mean Units Subcutaneous (SQ) Insulin Required

Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin). (NCT02443402)
Timeframe: Post-Surgery (Up to 10 Days)

Interventionunits (Mean)
Sitagliptin2.4
Placebo2.4

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Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia

Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

InterventionParticipants (Count of Participants)
Sitagliptin7
Placebo7

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Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)

Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

InterventionParticipants (Count of Participants)
Sitagliptin7
Placebo6

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Number of Participants Re-admitted to the Hospital Due to Wound Infections

Number of subjects readmitted to the hospital within 30 days due to wound infection. (NCT02443402)
Timeframe: Post-Hospital Discharge (Up to 30 Days)

InterventionParticipants (Count of Participants)
Sitagliptin1
Placebo1

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Number of Participants Re-admitted to the Hospital Not Due to Wound Infections

Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection. (NCT02443402)
Timeframe: Post-Hospital Discharge (Up to 30 Days)

InterventionParticipants (Count of Participants)
Sitagliptin3
Placebo0

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Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)

Number of participants with blood glucose (BG) >180 after transition from ICU. (NCT02443402)
Timeframe: Post-Surgery (Up to 10 Days)

InterventionParticipants (Count of Participants)
Sitagliptin8
Placebo8

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Number of Subject Requiring Surgical Re-Intervention

The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage. (NCT02443402)
Timeframe: Post-Surgery (Up to 10 Days)

InterventionParticipants (Count of Participants)
Sitagliptin1
Placebo2

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Number of Participants With Blood Glucose Less Than 40 mg/dl

Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization. (NCT02443402)
Timeframe: Duration of Hospitalization (Up to 30 Days)

InterventionParticipants (Count of Participants)
Sitagliptin0
Placebo0

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Number of Participants With Cerebrovascular Events

Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events. (NCT02443402)
Timeframe: Post-Hospital Discharge (Up to 10 Days)

InterventionParticipants (Count of Participants)
Sitagliptin2
Placebo1

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Number of Participants With Emergency Room (ER) Visits

Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge. (NCT02443402)
Timeframe: Post-Hospital Discharge (Up to 30 Days)

InterventionParticipants (Count of Participants)
Sitagliptin2
Placebo1

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Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)

The mean number of insulin infusions given per day (unit/day) while subjects are in the ICU. The more insulin given, the more hyperglycemic events experienced. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

Interventionunits per day (Mean)
Sitagliptin37
Placebo83

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Total Insulin Therapy in the Intensive Care Unit (ICU)

Total amount of insulin glargine insulin (units) administered in the ICU per day. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

Interventionunits per day (Mean)
Sitagliptin0
Placebo0

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Number of Subjects With Persistent Hyperglycemia

Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG > 180 mg/dL, or with average daily BG >180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII) (NCT02443402)
Timeframe: Post-Surgery (Up to 10 Days)

InterventionParticipants (Count of Participants)
Sitagliptin7
Placebo6

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Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours

The number of subjects requiring the use of inotropes for >24 hours post CABG. (NCT02443402)
Timeframe: Post-Surgery (Up to 2 Days)

InterventionParticipants (Count of Participants)
Sitagliptin11
Placebo7

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Number of Subjects Requiring Re-intubation Within 24 Hours

The number of subjects requiring re-intubation with 24 after CABG. (NCT02443402)
Timeframe: Post-Surgery (Up to 24 Hours)

InterventionParticipants (Count of Participants)
Sitagliptin2
Placebo1

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Number of Subjects Requiring Re-intubation

The number of subjects requiring re-intubation after CABG. (NCT02443402)
Timeframe: Post-Surgery (Up to 2 Days)

InterventionParticipants (Count of Participants)
Sitagliptin1
Placebo2

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Hospital Complication Rate

The total number of all complications experienced during hospitalization. Participants may experience more than one complication during hospitalization and these will be included in the hospital complication rate. (NCT02443402)
Timeframe: Duration of Hospitalization (Up to 30 days)

Interventionnumber of complications (Number)
Sitagliptin47
Placebo57

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Hospital Mortality Rate

The total number of subject deaths during hospital stay will be recorded. (NCT02443402)
Timeframe: Post-Surgery (Up to 10 Days)

InterventionParticipants (Count of Participants)
Sitagliptin0
Placebo0

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Intensive Care Unit (ICU) Mortality Rate

The total number of subject deaths during ICU stay will be recorded. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

InterventionParticipants (Count of Participants)
Sitagliptin0
Placebo0

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Length of Hospital Stay After Study Randomization

Number of days in the hospital after a participant is randomized to a study intervention. (NCT02443402)
Timeframe: Post-Randomization (Up to 9 days)

Interventiondays (Mean)
Sitagliptin6.0
Placebo6.5

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Length of Stay: Intensive Care Unit (ICU)

Number of days in the ICU after coronary artery bypass graft surgery (CABG). (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

Interventiondays (Mean)
Sitagliptin2
Placebo2

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Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)

The blood glucose levels will be assessed throughout the day using a glucose meter after transition form the ICU. The normal BG range for someone with diabetes is 80-130 mg/dL. (NCT02443402)
Timeframe: Post-Surgery (Up to 4 Days)

Interventionmg/dl (Mean)
Sitagliptin123
Placebo124

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Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12

DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items, each answered on a Likert scale of 0 to 6. Responses of 6 questions (Items 1, 4, 5, 6, 7 and 8) were summarized to derive total treatment satisfaction score, such that a higher score was indicative of better satisfaction. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (improvement in treatment satisfaction). Item 2 and Item 3 scores were used for hyperglycemia perception and hypoglycemia perception respectively, where lower scores indicated better health outcome. Perceived frequency of hyperglycemia score (Item 2) and perceived frequency of hypoglycemia score (Item 3) range from 0 (none of the time) to 6 (most of time), where lower scores indicated more satisfaction/better health outcome. (NCT02451137)
Timeframe: At Baseline, Month 6, Month 12

,
Interventionscore on a scale (Mean)
Total treatment satisfaction score:BaselineTotal treatment satisfaction score: Month 6Total treatment satisfaction score: Month 12Perceived frequencyof hyperglycemia score:BaselinePerceived frequency of hyperglycemia score:Month 6Perceived frequency of hyperglycemia score:Month12Perceived frequency of hypoglycemia score:BaselinePerceived frequency of hypoglycemia score: Month 6Perceived frequency of hypoglycemia score:Month 12
Standard of Care26.431.130.74.32.82.60.81.01.0
Toujeo26.531.030.94.32.82.60.90.90.9

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Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12

Percentage of participants with hospitalizations, emergency room visits, and specialty visits during the 6-month and 12-month randomized period were reported. The 12-month randomized period was defined as the time from randomization up to Day 365 or discontinuation date, whichever comes earlier. (NCT02451137)
Timeframe: From Baseline to Month 6 and Month 12

,
Interventionpercentage of participants (Number)
Hospitalizations: Month 6Emergency Room Visits: Month 6Specialty Visits: Month 6Hospitalizations: Month 12Emergency Room Visits: Month 12Specialty Visits: Month 12
Standard of Care7.510.374.08.011.175.9
Toujeo8.111.378.39.112.780.1

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"Percentage of Responders (Participants and Provider) Who Reported Excellent or Good Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12"

"Participant and Physician (Provider) reported GES for this diabetes study. The GES assessed impact of treatment on scale ranges as: excellent (complete control of diabetes), good (marked improvement of diabetes), moderate (discernible, but limited improvement in diabetes), poor (no appreciable change in diabetes), or worsening of condition (worsening of diabetes). There was no score expressed by numbers and no change measured over the time of the study. Percentage of participants and providers who reported excellent or good on the GES at Month 6 and Month 12 are reported here." (NCT02451137)
Timeframe: At Month 6, Month 12

,
Interventionpercentage of responders (Number)
Percentage of Participants: Month 6Percentage of Providers: Month 6Percentage of Participants: Month 12Percentage of Providers: Month 12
Standard of Care65.657.764.256.3
Toujeo67.262.164.758.8

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Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period

HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (3.0 mmol/L). (NCT02451137)
Timeframe: Baseline to Month 6

Interventionpercentage of participants (Number)
Toujeo37.3
Standard of Care34.3

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Treatment Persistence Measured by Medication Possession Ratio (MPR)

Treatment persistence was determined based on vendor claims database that would be responsible for managing and administration of the study drugs. Medication use was assessed by MPR and persistence measures based on data collected by the smart card vendor (date of fill or refill and quantity of medication dispensed for 30-day supply). The MPR was assessed based on total number of days of supply divided by the total number of days in 6 or 12 months period. (NCT02451137)
Timeframe: At Month 6 and Month 12

,
InterventionMedication Possession ratio (Mean)
Month 6Month 12
Standard of Care63.1457.82
Toujeo62.0658.21

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Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12

DTSQc version evaluates the change in treatment satisfaction at Month 12 as compared to the start of the study . It consists of 8 items, each answered on a Likert scale from -3 to +3. The sum of treatment satisfaction scores (items 1, 4, 5, 6, 7,and 8) ranged from score -18 (deterioration in treatment satisfaction) to +18 (improvement in treatment satisfaction). Perceived frequency of hypoglycemia and perceived frequency of hyperglycemia score ranges from score -3 (fewer problems) to +3 (more problems). (NCT02451137)
Timeframe: At Month 12

,
Interventionscore on a scale (Least Squares Mean)
Total satisfaction scorePerceived frequency of hyperglycemia scorePerceived frequency of hypoglycemia
Standard of Care13.790.21-0.82
Toujeo13.810.14-0.82

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Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia

HEDIS criteria: Individualized HbA1c target <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 milligrams per deciliter (mg/dL) (<=3.9 millimoles per litre [mmol/L]). Analysis was performed using all post-baseline data available on the 6 month randomized period (defined as time from randomization up to Day 180 or discontinuation date, whichever comes earlier). (NCT02451137)
Timeframe: Baseline to Month 6

Interventionpercentage of participants (Number)
Toujeo31.3
Standard of Care27.9

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Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period

Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (<=3.9 mmol/L) or <54 mg/dL (3.0 mmol/L). (NCT02451137)
Timeframe: Up to Month 6 and Month 12

,
Interventionpercentage of participants (Number)
Any hypoglycemia: Any time: Month 6Any hypoglycemia: Nocturnal: Month 6Any hypoglycemia: Any time: Month 12Any hypoglycemia: Nocturnal: Month 12Severe hypoglycemia: Any time: Month 6Severe hypoglycemia:Nocturnal: Month 6Documented Symptomatic <=70 mg/dL:Any time:Month 6Documented Symptomatic <54 mg/dL:Any time:Month 6Documented Symptomatic <=70mg/dL:Nocturnal:Month 6Documented Symptomatic <54 mg/dL:Nocturnal:Month 6Severe hypoglycemia: Any time: Month 12Severe hypoglycemia:Nocturnal: Month 12Documented Symptomatic<=70 mg/dL:Any time:Month 12Documented Symptomatic <54 mg/dL:Any time:Month 12Documented Symptomatic<=70mg/dL:Nocturnal:Month 12Documented Symptomatic <54mg/dL:Nocturnal:Month 12
Standard of Care30.410.041.814.91.00.614.93.15.60.81.90.720.85.68.31.7
Toujeo28.98.939.113.61.00.513.93.64.50.81.20.519.95.66.51.2

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Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12

Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline FPG (as continuous) and baseline FPG-by-visit interaction. (NCT02451137)
Timeframe: Baseline, Month 6, Month 12

,
Interventionmg/dL (Least Squares Mean)
Month 6Month 12
Standard of Care-50.4-47.3
Toujeo-48.9-48.0

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Change From Baseline in Body Weight at Month 6 and Month 12

Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline weight (as continuous) and baseline weight-by-visit interaction. (NCT02451137)
Timeframe: Baseline, Month 6, Month 12

,
Interventionkilogram (kg) (Least Squares Mean)
Month 6Month 12
Standard of Care1.141.40
Toujeo1.021.51

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Change From Baseline in Basal Insulin Dose at Month 6 and Month 12

Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values. (NCT02451137)
Timeframe: Baseline, Month 6, Month 12

,
InterventionUnit/kg (U/kg) (Mean)
Month 6Month 12
Standard of Care0.1830.224
Toujeo0.1790.222

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Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period

HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) and < 3.0 mmol/L (< 54 mg/dL). (NCT02451137)
Timeframe: Baseline to Month 12

,
Interventionpercentage of participants (Number)
Month 12: <=70 mg/dLMonth 12: <54 mg/dL
Standard of Care23.729.5
Toujeo26.133.0

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Change From Baseline in HbA1c at Month 6 and Month 12

Change in HbA1c was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted Least Squares (LS) means and Standard Errors (SE) were obtained using Mixed Effect Model with Repeated Measures (MMRM ) with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline HbA1c (as continuous) and baseline HbA1c-by-visit interaction. (NCT02451137)
Timeframe: Baseline, Month 6, Month 12

,
Interventionpercentage of HbA1c (Least Squares Mean)
Month 6Month 12
Standard of Care-1.36-1.24
Toujeo-1.40-1.29

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Total Daily Insulin Dose

Daily total insulin dose at baseline compared to dose at week 24. (NCT02451917)
Timeframe: baseline and 24 weeks

,
Interventionunits/Kg/day (Mean)
Baseline24 weeks treatment
Glargine Insulin0.610.64
NPH Insulin0.630.64

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Serum Creatinine

Creatinine is measured in milligrams per deciliter of blood (mg/dL (NCT02451917)
Timeframe: baseline and 24 weeks

,
Interventionmg/dL (Mean)
Baseline24 weeks treatement
Glargine Insulin Period2.42.6
NPH Insulin Period2.52.6

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Body Mass Index (BMI)

The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. (NCT02451917)
Timeframe: baseline and 24 weeks

,
InterventionKg/m² (Mean)
Baseline24 weeks treatement
Glargine Insulin Period29.730.0
NPH Insulin Period30.030.4

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Difference in A1c Levels

A1c using high performance liquid chromatography measured in percentage (NCT02451917)
Timeframe: baseline and 24 weeks

,
Interventionpercentage (Mean)
Baseline24 weeks treatement
Glargine Insulin Period8.867.95
NPH Insulin Period8.218.44

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Estimated Glomerular Filtration Rate (eGFR) Calculated by CKD-EPI

"Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is one of the most widely used IDMS traceable equations for estimating GFR in patients age 18 and over. CKD-EPI equation includes variables for age, gender, and race, which may allow providers to observe that CKD is present despite a serum creatinine concentration that appears to fall within or just above the normal reference interval.~CKD-EPI equation expressed as a single equation: GFR = 141 × min (Scr /κ, 1)α × max(Scr /κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] where: Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males,min indicates the minimum of Scr /κ or 1, and max indicates the maximum of Scr /κ or 1." (NCT02451917)
Timeframe: baseline and 24 weeks

,
Interventionml/min/1.7m² (Mean)
Baseline24 weeks treatement
Glargine Insulin Period28.026.9
NPH Insulin Period27.425.9

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Glycemic Variability

In order to observe variability in interstitial glucose levels related to the therapy in use, participants wore a blinded CGM for 3 days. Changes in glycemic patterns were expressed by the average daily time spent in hypoglycemia (≤70 mg/dL or <3.9 mmol/L), hyperglycemia (>180 mg/dL or >10 mmol/L) and euglycemia (70-180 mg/dL or 3.9-10 mmol/L). (NCT02451917)
Timeframe: 24 week

,
Interventionpercentage of time (Mean)
hyperglycemianormoglycemiahypoglycemia
Glargine Insulin Period30673
NPH Insulin Period38593

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Number of Hypoglycemic Events

"Hypoglycemia was defined by capillary glycemia< 70 mg/dL (3.9 mmol/L), even if it was not accompanied by typical symptoms. Otherwise, hypoglycemia was classified as severe with SMBG below 50 mg/dL (2.8 mmol/L) or when it resulted in stupor, seizure, or unconsciousness that precluded self-treatment, thus requiring the assistance of another individual. Nocturnal events were defined as SMBG < 70mg/dL occurring after midnight and before wake-up in the morning (before 7:00am)12." (NCT02451917)
Timeframe: between 1rst and 24 weeks of each treatment arm

,
Interventionevents per patients during 24 weeks (Mean)
total hypoglycemic eventsnocturnal hypoglycemias
Glargine Insulin Period4.870.52
NPH Insulin Period6.341.52

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HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes

Percentage of subjects with HbA1c below 7.0% after 32 weeks of randomised treatment without treatment emergent severe hypoglycaemic episodes during the last 12 weeks of treatment. Subjects withdrawn before 32 weeks were handled as non-responders. Severe hypoglycaemic episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. (NCT02453685)
Timeframe: After 32 weeks of treatment (yes/no)

,
InterventionPercentage of subjects (Number)
YesNo
Basal-bolus56.343.7
BIAsp 3042.357.7

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Change in HbA1c (Glycosylated Haemoglobin)

Change in HbA1c from baseline (week 0) to week 32. (NCT02453685)
Timeframe: Week 0, week 32

InterventionPercentage of HbA1c (Mean)
BIAsp 30-1.16
Basal-bolus-1.30

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Total Daily Insulin Dose

Total daily insulin dose in the basal bolus treatment group and in BIAsp 30 treatment group at each week of each treatment. (NCT02453685)
Timeframe: Weeks 0-32

,
InterventionU/kg (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24Week 25Week 26Week 27Week 28Week 29Week 30Week 31Week 32
Basal-bolus0.1270.1670.1970.2240.2440.2640.2810.2960.3390.3650.3910.4130.4250.4390.4550.4680.4960.5160.5320.5440.5630.5800.5900.6050.6180.6430.6530.6640.6740.6820.6930.708
BIAsp 300.1570.1870.2140.2380.2590.2800.2960.3080.3690.3970.4210.4430.4560.4720.4870.5010.5280.5460.5570.5690.5880.6020.6070.6150.6280.6430.6610.6710.6880.6920.7030.700

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Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions

Hypoglycaemic episodes were classified as severe, Asymptomatic, Documented symptomatic, Pseudo, and Probable symptomatic as per ADA classification. As symptoms of hypoglycaemia occur below a PG level of 3.1 mmol/L, (56 mg/dL) Novo Nordisk classification included hypoglycaemia with plasma glucose (PG) levels below 3.1 mmol/L (56 mg/dL) in the definition of blood glucose confirmed hypoglycaemia. Hence, Novo Nordisk classification included following types of hypoglycaemia in addition to ADA classification: Severe hypoglycaemia, Symptomatic blood glucose confirmed hypoglycaemia, Asymptomatic blood glucose confirmed hypoglycaemia, Severe or blood glucose confirmed symptomatic hypoglycaemia, Blood glucose confirmed hypoglycaemia, and Severe or blood glucose confirmed hypoglycaemia. Reported data represents total of all hypoglycaemic episodes. (NCT02453685)
Timeframe: Weeks 0-32

,
InterventionHypoglycaemic episodes (Number)
ADA classificationNovo Nordisk classification
Basal-bolus18411841
BIAsp 3016501650

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Change in A1C

There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C. (NCT02463097)
Timeframe: Baseline and 3 months

InterventionPercent (Mean)
Study Arm-0.5

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Number of Diabetic Ketoacidosis (DKA) Events

There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event. (NCT02463097)
Timeframe: 3 months

Interventionevents (Number)
Study Arm0

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Number of Severe Hypoglycemia Events

There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events. (NCT02463097)
Timeframe: 3 months

Interventionevents (Number)
Study Arm0

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The Effect of ORMD-0801 on Mean 24-hour Glucose

The effect of ORMD-0801 (Dose 1 and Dose 2 individually) on mean 24-hour glucose based on 2 nights of CGM data by comparison of the mean percent change between baseline and Wk 4 of ORMD-0801 treatment and the placebo groups. (NCT02496000)
Timeframe: Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)

Interventionpercent change (Mean)
Placebo Comparator5.34
ORMD-0801 Dose 13.33
ORMD-0801 Dose 2 = 1.5 * Dose 11.93

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The Effect of ORMD-0801 on the Percent Change in HbA1c

The effect of ORMD-0801 (Dose 1 and Dose 2 individually) on the percent change from baseline to Wk 4 in HbA1c (NCT02496000)
Timeframe: Study day 1 (± 1 day) through Study day 29 (± 1 day)

Interventionpercent change (Mean)
Placebo Comparator0.2
ORMD-0801 Dose 10.00
ORMD-0801 Dose 2 = 1.5 * Dose 1-.03

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Measure the Change From Baseline to End of the Study of Morning Fasting C-Peptide (Nmol/L)

The measurement of the change in Morning Fasting C-peptide between baseline to end of the study, measured in Nmol/L (NCT02496000)
Timeframe: Study day 1 (±1 day) through Study day43 (± 1 day)

InterventionNmol/L (Mean)
Placebo Comparator0.08
ORMD-0801 Dose 10.03
ORMD-0801 Dose 2 = 1.5 * Dose 10.7

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Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.

The Effect of ORMD-0801 (Doses 1 & 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject. (NCT02496000)
Timeframe: Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)

Interventionmg/dL (Mean)
Placebo Comparator13.70
ORMD-0801 Dose 1-3.67
ORMD-0801 Dose 2 = 1.5 * Dose 16.64
ORMD-0801 Doses 1 and 2 Combined1.66

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Measure Percent Change in Continuous Glucose Monitoring Mean Fasting Glucose Between Treatment and Run-In

The percent change in the Continuous Glucose Monitoring Mean Fasting Glucose between treatment and mean of the last two days of the baseline(run-in period). (NCT02496000)
Timeframe: Baseline (Run-in days 13-14) and Study day 1 (± 1 day) through Study day 29 (± 1 day)

Interventionpercent change (Mean)
Placebo Comparator12.76
ORMD-0801 Dose 14.54
ORMD-0801 Dose 2 = 1.5 * Dose 13.28

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Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)

"ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.~NN Classification:~Severe: same as per ADA classification~Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia~BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive." (NCT02500706)
Timeframe: Week 0 to week 26 (+1 day)

,,
Interventionhypoglycaemic episodes (Number)
Daytime hypoglycaemic episodesNocturnal hypoglycaemic episodes
Faster Aspart (Meal)145701190
Faster Aspart (Post)153791200
NovoRapid (Meal)152571263

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Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal

"ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.~NN Classification:~Severe: same as per ADA classification~Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia~BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes related to meals." (NCT02500706)
Timeframe: Week 0 to week 26 (+1 day)

,,
Interventionhypoglycaemic episodes (Number)
Within 1 hour after mealWithin 2 hours after mealWithin 4 hours after mealBetween 1 (exclusive) to 2 hours (inclusive)Between 2 (exclusive) to 3 hours (inclusive)Between 2 (exclusive) to 4 hours (inclusive)Between 3 (exclusive) to 4 hours (inclusive) hours
Faster Aspart (Meal)62413143920690123626061370
Faster Aspart (Post)61414704794856163433241690
NovoRapid (Meal)45912244129765130229051603

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Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation

The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders. (NCT02500706)
Timeframe: 26 weeks after randomisation

,,
Interventionpercentage of subjects (Number)
YesNo
Faster Aspart (Meal)16.483.6
Faster Aspart (Post)17.982.1
NovoRapid (Meal)19.380.7

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Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation

The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders. (NCT02500706)
Timeframe: 26 weeks after randomisation

,,
Interventionpercentage of subjects (Number)
YesNo
Faster Aspart (Meal)25.774.3
Faster Aspart (Post)26.473.6
NovoRapid (Meal)30.469.6

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Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation

The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders. (NCT02500706)
Timeframe: 26 weeks after randomisation

,,
Interventionpercentage of subjects (Number)
YesNo
Faster Aspart (Meal)28.771.3
Faster Aspart (Post)28.271.8
NovoRapid (Meal)32.767.3

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Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L

Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders. (NCT02500706)
Timeframe: 26 weeks after randomisation

,,
Interventionpercentage of subjects (Number)
YesNo
Faster Aspart (Meal)27.872.2
Faster Aspart (Post)19.980.1
NovoRapid (Meal)21.678.4

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Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia

The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L [140 mg/dL], had HbA1c < 7.0% and had minimal weight gain (increase in body weight from baseline <3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders. (NCT02500706)
Timeframe: 26 weeks after randomisation

,,
Interventionpercentage of subjects (Number)
YesNo
Faster Aspart (Meal)7.692.4
Faster Aspart (Post)4.795.3
NovoRapid (Meal)8.291.8

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Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation

Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionmmol/L (Mean)
Change in PPG at 30 minChange in PPG at 1 hourChange in PPG at 2 hoursChange in PPG at 3 hoursChange in PPG at 4 hours
Faster Aspart (Meal)-0.47-1.05-0.41-0.120.005
Faster Aspart (Post)1.311.390.800.930.83
NovoRapid (Meal)0.210.200.330.510.53

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Change From Baseline in Body Mass Index 26 Weeks After Randomisation

The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionkg/m^2 (Mean)
Faster Aspart (Meal)0.49
Faster Aspart (Post)0.39
NovoRapid (Meal)0.43

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Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation

Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionmmol/L (Mean)
Change in PPG increment at 30 minChange in PPG increment at 1 hourChange in PPG increment at 2 hoursChange in PPG increment at 3 hoursChange in PPG increment at 4 hours
Faster Aspart (Meal)-0.55-1.13-0.47-0.20-0.10
Faster Aspart (Post)0.941.040.420.550.45
NovoRapid (Meal)-0.14-0.15-0.010.110.16

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Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements

The subject was instructed to perform 7-9-7 SMPG point profile on 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast,60 minutes after the start of breakfast,before lunch,60 minutes after the start of lunch, before main evening meal,60 minutes after the start of main evening meal,and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period). (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionmmol/L (Mean)
Change in nocturnal increment-bedtime to 04:00Change in nocturnal increment-bedtime to breakfastChange in nocturnal increment-04:00 to breakfast
Faster Aspart (Meal)0.140.860.78
Faster Aspart (Post)0.190.931.01
NovoRapid (Meal)0.450.33-0.02

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Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionmmol/L (Mean)
Change in PPG breakfastChange in PPG lunchChange in PPG main evening mealChange in PPG all meals
Faster Aspart (Meal)-0.83-0.59-0.53-0.65
Faster Aspart (Post)-0.030.06-0.01-0.004
NovoRapid (Meal)-0.31-0.33-0.14-0.25

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Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia

Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders. (NCT02500706)
Timeframe: 26 weeks after randomisation

,,
Interventionpercentage of subjects (Number)
YesNo
Faster Aspart (Meal)24.675.4
Faster Aspart (Post)18.881.2
NovoRapid (Meal)20.579.5

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Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionmmol/L (Mean)
Change in PPG increment breakfastChange in PPG increment lunchChange in PPG increment main evening mealChange in PPG increment all meals
Faster Aspart (Meal)-1.14-0.67-0.29-0.72
Faster Aspart (Post)0.06-0.080.340.08
NovoRapid (Meal)-0.30-0.0040.26-0.02

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Change From Baseline in Blood Pressure 26 Weeks After Randomisation

Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

,,
InterventionmmHg (Mean)
Diastolic blood pressureSystolic blood pressure
Faster Aspart (Meal)0.50.6
Faster Aspart (Post)0.21.4
NovoRapid (Meal)0.80.8

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Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation

Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionpercentage of subjects (Number)
Week 0: NegativeWeek 0: PositiveWeek 0: TraceWeek 0: 1+Week 0: 2+Week 0: 3+Last on-treatment value: NegativeLast on-treatment value:PositiveLast on-treatment value: TraceLast on-treatment value:1+Last on-treatment value: 2+Last on-treatment value: 3+
Faster Aspart (Meal)96.20.02.01.80.00.092.30.05.02.10.60.0
Faster Aspart (Post)97.10.01.81.20.00.089.70.06.53.20.60.0
NovoRapid (Meal)92.70.05.31.80.30.090.00.06.52.90.60.0

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Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation

The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionpercentage of subjects (Number)
Week 0: NormalWeek 0: Abn, NCSWeek 0: Abn, CSLast on-treatment value: NormalLast on-treatment value: Abn, NCSLast on-treatment value: Abn, CS
Faster Aspart (Meal)80.719.30.080.819.20.0
Faster Aspart (Post)81.817.60.684.015.10.9
NovoRapid (Meal)84.215.80.082.317.10.6

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Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation

The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionpercentage of subjects (Number)
Left eye-Week 0: NormalLeft eye-Week 0: Abn, NCSLeft eye-Week 0: Abn, CSLeft eye-Last on-treatment value: NormalLeft eye-Last on-treatment value: Abn, NCSLeft eye-Last on-treatment value: Abn, CSRight eye-Week 0: NormalRight eye-Week 0: Abn, NCSRight eye-Week 0: Abn, CSRight eye-Last on-treatment value: NormalRight eye-Last on-treatment value: Abn, NCSRight eye-Last on-treatment value: Abn, CS
Faster Aspart (Meal)65.826.97.362.529.77.865.227.87.064.029.16.9
Faster Aspart (Post)68.023.58.569.421.09.668.922.38.867.922.59.6
NovoRapid (Meal)69.323.47.369.321.19.667.025.47.668.722.68.7

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Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)

Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period). (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionratio (Geometric Mean)
HDL cholesterolLDL cholesterolTotal cholesterol
Faster Aspart (Meal)0.9811.0251.002
Faster Aspart (Post)0.9981.0531.030
NovoRapid (Meal)0.9991.0621.020

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Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation

Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionpercentage of subjects (Number)
Week 0: NegativeWeek 0: PositiveWeek 0: TraceWeek 0: 1+Week 0: 2+Week 0: 3+Last on-treatment value: NegativeLast on-treatment value:PositiveLast on-treatment value: TraceLast on-treatment value:1+Last on-treatment value: 2+Last on-treatment value: 3+
Faster Aspart (Meal)95.30.01.80.91.20.993.50.02.71.50.61.8
Faster Aspart (Post)93.30.02.31.50.92.191.70.03.80.92.11.5
NovoRapid (Meal)93.30.03.22.00.60.991.80.02.62.11.81.8

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Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation

Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionpercentage of subjects (Number)
Week 0: NegativeWeek 0: PositiveWeek 0: TraceWeek 0: 1+Week 0: 2+Week 0: 3+Last on-treatment value: NegativeLast on-treatment value:PositiveLast on-treatment value: TraceLast on-treatment value:1+Last on-treatment value: 2+Last on-treatment value: 3+
Faster Aspart (Meal)82.20.012.04.41.20.383.50.08.65.91.50.6
Faster Aspart (Post)79.50.014.44.11.20.982.60.010.94.71.20.6
NovoRapid (Meal)80.40.013.53.52.00.678.80.012.46.52.10.3

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Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)

The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

,,
InterventionUnits (Mean)
Daily bolus insulin dose: week 0Daily bolus insulin dose: Last on-treatment valueDaily basal insulin dose: week 0Daily basal insulin dose: Last on-treatment valueTotal daily insulin dose: week 0Total daily insulin dose: Last on-treatment valueDaily breakfast bolus insulin dose: Last valueDaily lunch bolus insulin dose: Last valueDaily main evening meal bolus insulin: Last valueDaily other bolus insulin dose: Last value
Faster Aspart (Meal)25.531.125.326.750.857.78.810.511.94.7
Faster Aspart (Post)25.430.526.727.352.257.88.610.311.64.3
NovoRapid (Meal)26.633.526.227.253.160.49.511.212.74.2

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Change From Baseline in Potassium 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Faster Aspart (Meal)0.01
Faster Aspart (Post)0.04
NovoRapid (Meal)0.04

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Change From Baseline in Pulse 26 Weeks After Randomisation

Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionbeats/minute (Mean)
Faster Aspart (Meal)0.0
Faster Aspart (Post)-0.7
NovoRapid (Meal)0.7

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Change From Baseline in Thrombocytes 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

InterventionNumber of thrombocytes 10^9/L (Mean)
Faster Aspart (Meal)-0.7
Faster Aspart (Post)-2.0
NovoRapid (Meal)-1.8

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Change From Baseline in Total Bilirubin 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionumol/L (Mean)
Faster Aspart (Meal)-0.1
Faster Aspart (Post)-0.2
NovoRapid (Meal)-0.2

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Change From Baseline in Total Protein 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventiong/dL (Mean)
Faster Aspart (Meal)0.03
Faster Aspart (Post)0.02
NovoRapid (Meal)-0.02

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Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionmg/mmol (Mean)
Faster Aspart (Meal)0.636
Faster Aspart (Post)-0.379
NovoRapid (Meal)0.656

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Change From Baseline in Creatinine 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionumol/L (Mean)
Faster Aspart (Meal)2.0
Faster Aspart (Post)1.8
NovoRapid (Meal)1.8

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Change From Baseline in Body Weight 26 Weeks After Randomisation

The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionkg (Mean)
Faster Aspart (Meal)1.43
Faster Aspart (Post)1.14
NovoRapid (Meal)1.24

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Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

InterventionU/L (Mean)
Faster Aspart (Meal)-0.0
Faster Aspart (Post)-0.1
NovoRapid (Meal)-0.3

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Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall

"ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia.~NN Classification:~Severe:same as per ADA classification~Symptomatic blood glucose (BG) confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed:PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~BG confirmed:PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period." (NCT02500706)
Timeframe: Week 0 to week 26 (+1 day)

Interventionhypoglycaemic episodes (Number)
Faster Aspart (Meal)15760
Faster Aspart (Post)16579
NovoRapid (Meal)16520

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Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation

Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). (NCT02500706)
Timeframe: Week 0, week 26

,,
Intervention% B/T (Mean)
Anti-insulin aspart specific antibodiesCross-reacting to human insulin
Faster Aspart (Meal)0.033-0.972
Faster Aspart (Post)-0.027-1.799
NovoRapid (Meal)-0.013-1.427

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Change From Baseline in Leukocytes 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

InterventionNumber of leukocytes 10^9/L (Mean)
Faster Aspart (Meal)-0.17
Faster Aspart (Post)-0.03
NovoRapid (Meal)-0.01

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Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation

A treatment emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment. (NCT02500706)
Timeframe: Week 0 to week 26 (+7 days)

Interventionevents (Number)
Faster Aspart (Meal)649
Faster Aspart (Post)656
NovoRapid (Meal)627

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Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Faster Aspart (Meal)-0.304
Faster Aspart (Post)-0.231
NovoRapid (Meal)-0.309

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Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionratio (Geometric Mean)
Faster Aspart (Meal)0.876
Faster Aspart (Post)0.875
NovoRapid (Meal)0.890

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Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

InterventionU/L (Mean)
Faster Aspart (Meal)1.3
Faster Aspart (Post)0.9
NovoRapid (Meal)0.6

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Change From Baseline in Albumin 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventiong/dL (Mean)
Faster Aspart (Meal)-0.02
Faster Aspart (Post)-0.05
NovoRapid (Meal)-0.03

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Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

InterventionU/L (Mean)
Faster Aspart (Meal)2.1
Faster Aspart (Post)1.4
NovoRapid (Meal)-0.2

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Change From Baseline in HbA1c 26 Weeks After Randomisation

Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact. (NCT02500706)
Timeframe: Week 0, week 26

Interventionpercentage of HbA1c (Mean)
Faster Aspart (Meal)-0.12
Faster Aspart (Post)0.005
NovoRapid (Meal)-0.09

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Change From Baseline in Haemoglobin 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Faster Aspart (Meal)-0.04
Faster Aspart (Post)-0.04
NovoRapid (Meal)-0.05

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Change From Baseline in Haematocrit 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionpercentage of red blood cells in blood (Mean)
Faster Aspart (Meal)-0.48
Faster Aspart (Post)-0.52
NovoRapid (Meal)-0.57

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Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation

The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Faster Aspart (Meal)0.17
Faster Aspart (Post)0.44
NovoRapid (Meal)0.64

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Change From Baseline in Erythrocytes 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionnumber of erythrocytes 10^12/L (Mean)
Faster Aspart (Meal)-0.01
Faster Aspart (Post)-0.03
NovoRapid (Meal)-0.02

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Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation

The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionug/mL (Mean)
Faster Aspart (Meal)0.22
Faster Aspart (Post)-0.15
NovoRapid (Meal)0.22

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Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)

The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02500706)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Faster Aspart (Meal)-1.13
Faster Aspart (Post)1.04
NovoRapid (Meal)-0.15

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Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation

A treatment emergent event was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment. (NCT02500706)
Timeframe: Week 0 to week 26 (+7 days)

InterventionInjection site reactions (Number)
Faster Aspart (Meal)9
Faster Aspart (Post)12
NovoRapid (Meal)10

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Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)

The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period. (NCT02500706)
Timeframe: Week 0, week 26

,,
Interventionpercentage of subjects (Number)
Cardiovascular system - Week 0: NormalCardiovascular system - Week 0: Abn, NCSCardiovascular system - Week 0: Abn, CSCardiovascular system - Last value: NormalCardiovascular system - Last value: Abn, NCSCardiovascular system - Last value: Abn, CSNervous system - Week 0: NormalNervous system - Week 0: Abn, NCSNervous system - Week 0: Abn, CSNervous system - Last value: NormalNervous system - Last value: Abn, NCSNervous system - Last value: Abn, CSGastrointestinal system-week 0: NormalGastrointestinal system-week 0: Abn, NCSGastrointestinal system-week 0: Abn, CSGastrointestinal system-Last value: NormalGastrointestinal system-Last value: Abn, NCSGastrointestinal system-Last value: Abn, CSHead,ears,eyes,nose,throat,neck:week 0-NormalHead,ear,eye,nose,throat,neck-week 0:Abn,NCSHead,ears,eyes,nose,throat,neck-week 0:Abn,CSHead,ears,eyes,nose,throat,neck-Last value:NormalHead,ear,eye,nose,throat,neck-Last value:Abn,NCSHead,ear,eye,nose,throat,neck-Last value:Abn,CSMusculoskeletal system-week 0: NormalMusculoskeletal system-week 0: Abn, NCSMusculoskeletal system-week 0: Abn, CSMusculoskeletal system-Last value: NormalMusculoskeletal system-Last value: Abn, NCSMusculoskeletal system-Last value: Abn, CSRespiratory system-week 0: NormalRespiratory system-week 0: Abn, NCSRespiratory system-week 0: Abn, CSRespiratory system-Last value: NormalRespiratory system-Last value: Abn, NCSRespiratory system-Last value: Abn, CSSkin-week 0: NormalSkin-week 0: Abn, NCSSkin-week 0: Abn, CSSkin-Last value: NormalSkin-Last value: Abn, NCSSkin-Last value: Abn, CS
Faster Aspart (Meal)97.42.60.097.42.60.083.915.50.683.815.60.699.70.30.099.10.90.095.04.10.995.33.80.995.94.10.096.83.20.099.40.60.099.70.30.091.57.31.291.57.60.9
Faster Aspart (Post)98.80.90.398.80.90.386.812.90.387.112.90.098.80.90.397.91.20.995.63.80.692.96.20.997.12.90.097.42.60.099.40.30.399.40.30.389.78.81.591.56.22.4
NovoRapid (Meal)97.72.00.397.91.80.386.313.20.686.812.40.998.20.90.998.50.60.993.35.80.994.14.41.596.23.50.395.33.80.999.10.60.399.40.30.391.57.90.692.46.51.2

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Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration

Mean time to maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). (NCT02500979)
Timeframe: 24 hours

Interventionh (Mean)
Placebo & Regular Insulin10.556
Pramlintide & Regular Insulin11.653

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Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC)

Mean areas under the plasma insulin concentration curves for the 24-hour periods of pramlintide and placebo administration (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). (NCT02500979)
Timeframe: 24 hours

InterventionmU/L*h (Mean)
Placebo & Regular Insulin380.525
Pramlintide & Regular Insulin377.324

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Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration.

Mean values of the average plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). (NCT02500979)
Timeframe: 24 hours

InterventionmIU/L (Mean)
Placebo & Regular Insulin15.855
Pramlintide & Regular Insulin15.722

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Fasting Plasma Glucose Concentration

Fasting plasma glucose concentration at 0600 hours (6:00 AM) (NCT02500979)
Timeframe: 12 hours after dinner meal

Interventionmmol/L (Least Squares Mean)
Placebo & Regular Insulin7.794
Pramlintide & Regular Insulin8.459

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Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM)

Percent time spent in the normoglycemic range of tissue glucose concentrations between >70 mg/dL and <180 mg/dL, measured by CGM. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). (NCT02500979)
Timeframe: 24 h

InterventionPercentage of time (Least Squares Mean)
Placebo & Regular Insulin43.8
Pramlintide & Regular Insulin57.2

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Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM)

Incremental (i.e., baseline-corrected) area under the 24-hour tissue glucose concentration curve (AUC0-24h) measured by continuous glucose monitoring (CGM) with a pre-test, non-fasting tissue glucose value as baseline. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). (NCT02500979)
Timeframe: 24 h

Interventionmg/dL*min (Least Squares Mean)
Placebo & Regular Insulin26243
Pramlintide & Regular Insulin-2489

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Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)

Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). (NCT02500979)
Timeframe: 24 hours

Interventionmmol/L*h (Mean)
Placebo & Regular Insulin11.181
Pramlintide & Regular Insulin-12.753

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Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)

Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucagon concentration curve with a pre-test, non-fasting plasma glucagon value as baseline. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). (NCT02500979)
Timeframe: 24 h

Interventionpmol/L*h (Mean)
Placebo & Regular Insulin-14.954
Pramlintide & Regular Insulin-16.055

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Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch

Absolute postprandial plasma glucose AUC was measured for the first 3 hours (AUC0-3h) following lunch based on sample availability. (Sample times: 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). (NCT02500979)
Timeframe: 3 hours

Interventionmmol/L*h (Least Squares Mean)
Placebo & Regular Insulin36.233
Pramlintide & Regular Insulin28.336

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Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner

Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following dinner based on sample availability. (Sample times: 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours). (NCT02500979)
Timeframe: 2 hours

Interventionmmol/L*h (Least Squares Mean)
Placebo & Regular Insulin23.247
Pramlintide & Regular Insulin17.970

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Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast

Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following breakfast based on sample availability. (Sample times: 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours). (NCT02500979)
Timeframe: 2 hours

Interventionmmol/L*h (Least Squares Mean)
Placebo & Regular Insulin23.535
Pramlintide & Regular Insulin19.101

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Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)

Absolute mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). (NCT02500979)
Timeframe: 24 h

Interventionmmol/L*h (Least Squares Mean)
Placebo & Regular Insulin243.835
Pramlintide & Regular Insulin215.417

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Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)

Absolute mean area under the 24-hour plasma glucagon concentration curve, measured as total area under the curve (total AUC0-24). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours). (NCT02500979)
Timeframe: 24 h

Interventionh*pmol/L (Least Squares Mean)
Placebo & Regular Insulin506.265
Pramlintide & Regular Insulin481.633

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Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM)

24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period. (NCT02500979)
Timeframe: 24 h

Interventionmg/dL (Least Squares Mean)
Placebo & Regular Insulin173.8
Pramlintide & Regular Insulin152.2

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Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration

Mean maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours). (NCT02500979)
Timeframe: 24 hours

InterventionmIU/L (Mean)
Placebo & Regular Insulin33.144
Pramlintide & Regular Insulin32.838

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Change in Fasting C-peptide

Change in fasting C-peptide (measured in nanomoles per liter [nmol/L]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionRatio of C-peptide (Geometric Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.630.58
Insulin Glargine0.570.54

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Change in Fasting Free Fatty Acids

Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionRatio of free fatty acids (Geometric Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.680.70
Insulin Glargine0.750.78

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Change in Fasting HDL-cholesterol

Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionRatio of HDL-cholesterol (Geometric Mean)
Week 26Week 104
Insulin Degludec/Liraglutide1.031.02
Insulin Glargine1.021.03

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Number of TEAEs During 26 Weeks of Treatment

An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-26

InterventionAdverse events (Number)
Insulin Degludec/Liraglutide718
Insulin Glargine624

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Number of TEAEs During 104 Weeks of Treatment

An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Week 0 to week 104

InterventionAdverse events (Number)
Insulin Degludec/Liraglutide1788
Insulin Glargine1368

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Change in Urine Albumin/Creatinine Ratio

Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 104

InterventionMilligrams per millimole (mg/mmol) (Mean)
Insulin Degludec/Liraglutide-1.09
Insulin Glargine-0.74

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Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment

Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment emergent hypoglycaemic episodes according to ADA during 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-104

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide8934
Insulin Glargine10658

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Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification

"Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c < 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function." (NCT02501161)
Timeframe: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

,
InterventionWeeks (Median)
Baseline HbA1c <8.5% + Non-SU usersBaseline HbA1c <8.5% + SU usersBaseline HbA1c >=8.5% + Non-SU usersBaseline HbA1c >=8.5% + SU users
Insulin Degludec/LiraglutideNA106.7NA104.0
Insulin Glargine104.390.364.626.6

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Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits

"Time to HbA1c > 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c > 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was > 6.5% at week 12). Time from randomisation to HbA1c >6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c < 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function." (NCT02501161)
Timeframe: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

,
InterventionWeeks (Median)
Baseline HbA1c <8.5% + Non-SU usersBaseline HbA1c <8.5% + SU usersBaseline HbA1c >=8.5% + Non-SU usersBaseline HbA1c >=8.5% + SU users
Insulin Degludec/LiraglutideNA90.164.152.1
Insulin Glargine64.126.626.626.1

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SMPG-9-point Profile (Individual Points in the Profile)

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
Interventionmmol/L (Mean)
Week 26: Before breakfastWeek 26: 90 minutes after breakfastWeek 26: Before lunchWeek 26: 90 minutes after lunchWeek 26: Before dinnerWeek 26: 90 minutes after dinnerWeek 26: BedtimeWeek 26: At 4:00 a.m.Week 26: Before breakfast the following dayWeek 104: Before breakfastWeek 104: 90 minutes after breakfastWeek 104: Before lunchWeek 104: 90 minutes after lunchWeek 104: Before dinnerWeek 104: 90 minutes after dinnerWeek 104: BedtimeWeek 104: At 4:00 a.m.Week 104: Before breakfast the following day
Insulin Degludec/Liraglutide5.598.346.038.026.678.317.485.725.535.587.996.067.806.588.207.475.675.44
Insulin Glargine5.588.766.438.796.919.108.135.915.565.578.646.378.877.029.107.905.965.47

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Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain

Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionPercentage of participants (Number)
Week 26: YesWeek 26: NoWeek 104: YesWeek 104: No
Insulin Degludec/Liraglutide33.266.817.682.4
Insulin Glargine9.990.15.794.3

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Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionPercentage of participants (Number)
Week 26: YesWeek 26: NoWeek 104: YesWeek 104: No
Insulin Degludec/Liraglutide30.269.816.683.4
Insulin Glargine8.791.35.594.5

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Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionPercentage of participants (Number)
Week 26: YesWeek 26: NoWeek 104: YesWeek 104: No
Insulin Degludec/Liraglutide57.942.140.159.9
Insulin Glargine27.972.119.280.8

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Participants Who Achieved (Yes/no): HbA1c ≤6.5%

Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionPercentage of participants (Number)
Week 26: YesWeek 26: NoWeek 104: YesWeek 104: No
Insulin Degludec/Liraglutide63.636.443.356.7
Insulin Glargine35.464.621.778.3

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Change in Fasting Human Insulin

Change in fasting human insulin (measured in picomoles per liter [pmol/L]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionRatio of insulin (Geometric Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.670.60
Insulin Glargine0.680.62

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Change in Fasting LDL-cholesterol

Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionRatio of LDL-cholesterol (Geometric Mean)
Week 26Week 104
Insulin Degludec/Liraglutide1.050.96
Insulin Glargine1.020.98

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Change in Fasting Total Cholesterol

Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionRatio of total cholesterol (Geometric Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.990.97
Insulin Glargine0.990.97

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Change in Fasting Triglycerides

Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionRatio of triglycerides (Geometric Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.840.89
Insulin Glargine0.850.89

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Change in Fasting VLDL-cholesterol

Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionRatio of VLDL-cholesterol (Geometric Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.850.90
Insulin Glargine0.850.88

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Change in FPG

Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
Interventionmmol/L (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide-3.97-3.93
Insulin Glargine-3.79-3.73

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Change in Haematological Parameter- Basophils

Change in basophils from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionPercentage of basophils (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.000.20
Insulin Glargine-0.000.16

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Change in Haematological Parameter- Eosinophils

Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionPercentage of eosinophils (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.100.32
Insulin Glargine0.060.43

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Change in Haematological Parameter- Erythrocytes

Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
Intervention10^12 cells/L (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide-0.02-0.12
Insulin Glargine-0.03-0.11

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Change in Haematological Parameter- Haematocrit

Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionPercentage of red blood cells (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide-0.33-0.71
Insulin Glargine-0.36-0.95

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Change in Haematological Parameter- Haemoglobin

Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
Interventiong/dL (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.08-0.00
Insulin Glargine0.08-0.03

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Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionPercentage of participants (Number)
Week 26: YesWeek 26: NoWeek 104: YesWeek 104: No
Insulin Degludec/Liraglutide35.264.820.080.0
Insulin Glargine13.686.46.193.9

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Change in Haematological Parameter- Lymphocytes

Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionPercentage of lymphocytes (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide-1.87-2.25
Insulin Glargine-0.84-2.38

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Change in Haematological Parameter- Monocytes

Change in monocytes from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionPercentage of monocytes (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide-0.100.49
Insulin Glargine0.010.59

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Change in HbA1c

Change in HbA1c from baseline (week 0) to week 26 is presented. (NCT02501161)
Timeframe: Week 0, week 26

InterventionPercentage of HbA1c (Mean)
Insulin Degludec/Liraglutide-1.99
Insulin Glargine-1.69

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Change in Haematological Parameter- Neutrophils

Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionPercentage of neutrophils (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide1.861.25
Insulin Glargine0.781.21

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Change in Haematological Parameter- Thrombocytes and Leukocytes

Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
Intervention10^9 cells/L (Mean)
Week 26: ThrombocytesWeek 104: ThrombocytesWeek 26: LeukocytesWeek 104: Leukocytes
Insulin Degludec/Liraglutide8.7716.870.490.07
Insulin Glargine7.0518.730.390.32

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Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment

Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA during 26 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-26

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide3190
Insulin Glargine3806

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Change in Pulse Rate

Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionBeats per minute (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide2.01.7
Insulin Glargine-0.4-0.5

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Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionScore on a scale (Mean)
Week 26: Physical functioningWeek 104: Physical functioningWeek 26: Role-physicalWeek 104: Role-physicalWeek 26: Bodily painWeek 104: Bodily painWeek 26: General healthWeek 104: General healthWeek 26: VitalityWeek 104: VitalityWeek 26: Social functioningWeek 104: Social functioningWeek 26: Role-emotionalWeek 104: Role-emotionalWeek 26: Mental healthWeek 104: Mental healthWeek 26: PCSWeek 104: PCSWeek 26: MCSWeek 104: MCS
Insulin Degludec/Liraglutide1.20.71.41.41.51.62.52.31.41.51.80.90.61.61.72.51.61.01.32.0
Insulin Glargine1.10.60.50.70.40.12.12.11.41.50.91.10.71.21.30.30.90.81.21.0

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Change in SMPG-mean 9-point Profile

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
Interventionmmol/L (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide-3.34-3.27
Insulin Glargine-3.32-2.76

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Change in SMPG-mean Postprandial Increment Over All Meals

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
Interventionmmol/L (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide-0.28-0.47
Insulin Glargine0.200.12

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Change in TRIM-D

Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionScore on a scale (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide9.611.4
Insulin Glargine7.39.5

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-104

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide61
Insulin Glargine164

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ECG Evaluation

The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented. (NCT02501161)
Timeframe: Baseline (within 2 weeks prior to week 0), week 104

,
InterventionParticipants (Count of Participants)
Normal (Baseline)Abnormal NCS (Baseline)Abnormal CS (Baseline)Normal (week 104)Abnormal NCS (week 104)Abnormal CS (week 104)
Insulin Degludec/Liraglutide3351629227977
Insulin Glargine3351654122652

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Eye Examination Category

Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented. (NCT02501161)
Timeframe: Baseline (within 12 weeks prior to week 0), week 104

,
InterventionParticipants (Count of Participants)
Left eye: Normal (baseline)Left eye: Abnormal NCS (baseline)Left eye: Abnormal CS (baseline)Left eye: Normal (week 104)Left eye: Abnormal NCS (week 104)Left eye: Abnormal CS (week 104)Right eye: Normal (baseline)Right eye: Abnormal NCS (baseline)Right eye: Abnormal CS (baseline)Right eye: Normal (week 104)Right eye: Abnormal NCS (week 104)Right eye: Abnormal CS (week 104)
Insulin Degludec/Liraglutide345151102049717344151112009919
Insulin Glargine34115581295063551436132485

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Insulin Dose

Insulin dose after 26 and 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionUnits (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide34.636.1
Insulin Glargine48.650.6

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Change in Biochemistry Parameter- Creatinine, Total Bilirubin

Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionMicromoles per liter (umol/L) (Mean)
Week 26: creatinineWeek 104: creatinineWeek 26: total bilirubinWeek 104: total bilirubin
Insulin Degludec/Liraglutide-0.500.75-0.30-0.33
Insulin Glargine0.252.20-0.32-0.59

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Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain

Percentage of participants who achieved (yes/no) HbA1c <7.0% without weight gain at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionPercentage of participants (Number)
Week 26: YesWeek 26: NoWeek 104: YesWeek 104: No
Insulin Degludec/Liraglutide38.561.520.979.1
Insulin Glargine15.484.66.393.7

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Participants Who Achieved (Yes/no): HbA1c <7.0%

Percentage of participants who achieved (yes/no) HbA1c <7.0% at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionPercentage of participants (Number)
Week 26: YesWeek 26: NoWeek 104: YesWeek 104: No
Insulin Degludec/Liraglutide78.721.355.544.5
Insulin Glargine55.744.328.571.5

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Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

,
InterventionPercentage of participants (Number)
Week 26: YesWeek 26: NoWeek 104: YesWeek 104: No
Insulin Degludec/Liraglutide71.328.751.848.2
Insulin Glargine44.955.125.574.5

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-26

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide27
Insulin Glargine60

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Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-104

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide319
Insulin Glargine642

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Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-26

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide143
Insulin Glargine261

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Change in Biochemistry Parameter- Albumin

Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionGrams per deciliter (g/dL) (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide-0.030.01
Insulin Glargine-0.030.03

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Change in Biochemistry Parameter- Sodium, Potassium and Calcium

Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
Interventionmmol/L (Mean)
Week 26: sodiumWeek 104: sodiumWeek 26: potassiumWeek 104: potassiumWeek 26: calciumWeek 104: calcium
Insulin Degludec/Liraglutide0.891.22-0.05-0.06-0.01-0.07
Insulin Glargine1.031.47-0.08-0.07-0.00-0.06

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Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase

Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionUnits per liter (U/L) (Mean)
Week 26: ALPWeek 104: ALPWeek 26: ALTWeek 104: ALTWeek 26: ASTWeek 104: ASTWeek 26: lipaseWeek 104: lipaseWeek 26: amylaseWeek 104: amylase
Insulin Degludec/Liraglutide-4.16-1.35-5.45-5.39-1.62-1.849.265.419.727.23
Insulin Glargine-4.33-1.34-3.33-3.45-0.39-0.67-7.97-13.332.79-0.13

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Change in Blood Pressure (Systolic and Diastolic)

Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionMillimeters of mercury (mmHg) (Mean)
Week 26: Systolic blood pressureWeek 26: Diastolic blood pressureWeek 104: Systolic blood pressureWeek 104: Diastolic blood pressure
Insulin Degludec/Liraglutide-1.20.10.5-0.1
Insulin Glargine0.5-0.30.9-0.2

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Change in Body Weight

Change in body weight from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionKilogram (kg) (Mean)
Week 26Week 104
Insulin Degludec/Liraglutide0.51.2
Insulin Glargine2.23.0

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Change in Calcitonin

The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

,
InterventionParticipants (Count of Participants)
Week 0: LowWeek 0: NormalWeek 0: HighWeek 26: LowWeek 26: NormalWeek 26: HighWeek 104: LowWeek 104: NormalWeek 104: High
Insulin Degludec/Liraglutide048125043740030131
Insulin Glargine047232043130016917

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Insulin Maximum Observed Concentration (Cmax)

Insulin Cmax after a dose of Afrezza (NCT02527265)
Timeframe: 250 minutes post-dose

InterventionμU/mL (Mean)
4 unit cartridge8 unit cartridge12 unit cartridge16 unit cartridge
Afrezza Cohort 1 (Ages 13-17)28.5101201105

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Insulin Time to Reach Cmax (Tmax)

Insulin Tmax after a dose of Afrezza (NCT02527265)
Timeframe: 250 minutes post-dose

Interventionminutes (Mean)
4 unit cartridge8 unit cartridge12 unit cartridge
Afrezza Cohort 2 (Ages 8-12)9.514.110.0

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Insulin Maximum Observed Concentration (Cmax)

Insulin Cmax after a dose of Afrezza (NCT02527265)
Timeframe: 250 minutes post-dose

InterventionμU/mL (Mean)
4 unit cartridge8 unit cartridge12 unit cartridge
Afrezza Cohort 2 (Ages 8-12)102133251

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Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2)

FDKP (inert carrier excipient) calculated half life t1/2 (NCT02527265)
Timeframe: Using PK data collected over 250 minutes post-dose of Afrezza

Interventionminutes (Mean)
4 unit cartridge8 unit cartridge12 unit cartridge
Afrezza Cohort 2 (Ages 8-12)86.886.595.5

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Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2)

FDKP (inert carrier excipient) calculated half life t1/2 (NCT02527265)
Timeframe: Using PK data collected over 250 minutes post-dose of Afrezza

Interventionminutes (Mean)
4 unit cartridge8 unit cartridge12 unit cartridge16 unit cartridge
Afrezza Cohort 1 (Ages 13-17)103123109144

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Insulin Area Under Concentration Time Curve (AUC)

Insulin AUC after a dose of Afrezza (NCT02527265)
Timeframe: 250 minutes post-dose

Interventionmin*μU/mL (Mean)
4 unit cartridge8 unit cartridge12 unit cartridge
Afrezza Cohort 2 (Ages 8-12)293149755971

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Insulin Area Under Concentration Time Curve (AUC)

Insulin AUC after a dose of Afrezza (NCT02527265)
Timeframe: 250 minutes post-dose

Interventionmin*μU/mL (Mean)
4 unit cartridge8 unit cartridge12 unit cartridge16 unit cartridge
Afrezza Cohort 1 (Ages 13-17)1468448864005778

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Insulin Time to Reach Cmax (Tmax)

Insulin Tmax after a dose of Afrezza (NCT02527265)
Timeframe: 250 minutes post-dose

Interventionminutes (Mean)
4 unit cartridge8 unit cartridge12 unit cartridge16 unit cartridge
Afrezza Cohort 1 (Ages 13-17)12.513.515.320.0

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Plasma Insulin Concentrations

Baseline and every 15 minutes during procedures (microIU/mL). (NCT02535715)
Timeframe: Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month

,,
InterventionmicroUnits/mL (Mean)
Baseline15 minutes30 minutes45 minutes60 minutes75 minutes90 minutes105 minutes120 minutes135 minutes150 minutes165 minutes180 minutes195 minutes210 minutes230 minutes240 minutes
One 16mg ORAMED Capsule77877777777666677
Three 8mg ORAMED Capsules88878888888888887
Two 8mg ORAMED Capsules Containing Insulin99888899988999899

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Plasma Glucose Concentrations

Measured at baseline and every 5 minutes during the procedures(mg/dL), Averaged over 30 minute intervals during the procedure (NCT02535715)
Timeframe: Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month

,,
Interventionmg/dl (Mean)
-180 to 01-30 minutes31-60 minutes61-90 minutes91-120 minutes121 to 150 minutes151 to 180 minutes181 to 210 minutes210 to 240 minutes
One 16mg ORAMED Capsule123115116116115118120122128
Three 8mg ORAMED Capsules120110113118117115113112117
Two 8mg ORAMED Capsules Containing Insulin1099898100103105107110111

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Plasma Glucagon Concentrations

Measured at baseline and every 30 minutes during the procedures (pg/mL) (NCT02535715)
Timeframe: Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month

,,
Interventionpg/mL (Mean)
-180 to 0 minutes1-30 minutes31-60 minutes61-90 minutes91-120 minutes121-150 minutes151-180 minutes181 to 210 minutes211-240 minutes
1X 16mg Oral Insulin Capsules373634343334333132
2X 8mg Oral Insulin Capsules292927292826262324
3X 8mg Oral Insulin Capsules373837363435353536

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Plasma Free Fatty Acid Concentrations

Measured at baseline and every 30 minutes during the procedures (micro mol/L) (NCT02535715)
Timeframe: Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month

,,
Interventionmmol/L (Mean)
Baseline1-30 minutes31-60 minutes61-90 minutes91-120 minutes121-150 minutes151-180 minutes181-210 minutes211-240 minutes
1X 16mg Oral Insulin Capsules410467448489506509545533538
2X 8mg Oral Insulin Capsules380408463472495528547523490
3X 8mg Oral Insulin Capsules402465533545473501486485486

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Hepatic Glucose Production (Co-primary Outcome)

Tritiated glucose infusion during procedures (Baseline and every 30 minutes during procedures) Calculated from plasma(mg/kg-minute). Averaged every 30 minutes. (NCT02535715)
Timeframe: Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month

,,
Interventionmg/kg-minute (Mean)
-180 to 01-30 minutes31-60 minutes61-90 minutes91-120 minutes121-150 minutes151-180 minutes181-210 minutes211-240
1X 16mg Oral Insulin Capsules2.12.12.11.91.71.61.71.41.5
2X 8mg Oral Insulin Capsules2.01.81.61.51.61.51.61.51.4
3X 8mg Oral Insulin Capsules2.01.91.71.61.71.61.61.51.5

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Change in A1C From Baseline to Week 44

Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy (NCT02542631)
Timeframe: 44 weeks

InterventionA1C % (Least Squares Mean)
Bolus Insulin Patch-1.63
Insulin Pen-1.63

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Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy

Change in A1C, with bolus insulin dosing with patch versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy (NCT02542631)
Timeframe: 24 weeks

InterventionA1C % (Least Squares Mean)
Bolus Insulin Patch-1.69
Insulin Pen-1.60

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Change in Quality of Life From Baseline to Week 24

Change in Diabetes-Specific Quality of Life (QOL), baseline to week 24. was assessed by self-report on the validated Diabetes Specific Quality of Life Survey. Scale is 0-100. Higher score is better. (NCT02542631)
Timeframe: 24 weeks

Interventionunits on a scale (Least Squares Mean)
Bolus Insulin Patch2.37
Insulin Pen-1.95

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Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24

Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients) (NCT02542631)
Timeframe: 24 weeks

Intervention% of glucose values (Least Squares Mean)
Bolus Insulin Patch26.87
Insulin Pen29.84

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Change in Treatment Satisfaction From Baseline to Week 24

Change in treatment satisfaction with insulin delivery system from baseline to week 24 was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better. (NCT02542631)
Timeframe: 24 weeks

Interventionunits on a scale (Least Squares Mean)
Bolus Insulin Patch13.63
Insulin Pen4.47

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Number of Participants With Severe Hypoglycemic Event

An event requiring the assistance of another person to actively administer carbohydrate (including IV dextrose), glucagon, or other resuscitative actions. Neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. (NCT02542631)
Timeframe: 44 weeks

InterventionParticipants (Count of Participants)
Bolus Insulin Patch3
Insulin Pen3

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Number of Patients With A1C ≤7.0% at Week 24

Number of patients with A1C ≤7.0% at week 24 (NCT02542631)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Bolus Insulin Patch85
Insulin Pen77

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Number of Patients With A1C ≤7.0% at Week 44

Number of patients with A1C ≤7.0% after 44 weeks of basal and bolus insulin therapy (NCT02542631)
Timeframe: 44 weeks

InterventionParticipants (Count of Participants)
Bolus Insulin Patch70
Insulin Pen68

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Change in A1C From Week 24 to Week 44

Change in A1C from week 24 to week 44 after basal and bolus insulin therapy (NCT02542631)
Timeframe: 44 weeks

InterventionA1C % (Least Squares Mean)
Bolus Insulin Patch0.12
Insulin Pen0.07

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Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU)

Number of Patients With severe hypoglycemia (blood glucose less than 40 mg/dL) in patients in intensive care unit (ICU). (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

InterventionParticipants (Count of Participants)
Sitagliptin0
Placebo0

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Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU)

Number of Patients With hypoglycemic events (blood glucose less than 40 mg/dL) in patients in non-intensive care unit (ICU). (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

InterventionParticipants (Count of Participants)
Sitagliptin0
Placebo0

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Number of Subjects Readmitted to the Hospital

Number of subjects readmitted to the hospital within 30 days (all-cause). (NCT02556918)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Sitagliptin10
Placebo12

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Number of Subjects Returning to the ER Within 30 Days

Number of subjects returning to the ER within 30 days (all-cause). (NCT02556918)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Sitagliptin61
Placebo57

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Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU

Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in non-ICU recovery period. (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

InterventionParticipants (Count of Participants)
Sitagliptin20
Placebo12

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Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU)

Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in ICU recovery period. (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

InterventionParticipants (Count of Participants)
Sitagliptin5
Placebo3

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Total IV Insulin in ICU

Total IV insulin in ICU during recovery period. (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

Interventionunits (Mean)
Sitagliptin100.43
Placebo95.68

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Total Length of Hospital Stay

Total number of days spent in hospital (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

Interventiondays (Median)
Sitagliptin9
Placebo7

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Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours

Amount of subcutaneous (SC) insulin in intensive care unit (ICU) 48 hours during recovery period. (NCT02556918)
Timeframe: 48 hours during recovery period

Interventionunits (Mean)
Sitagliptin0.48
Placebo1.5

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Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)

Total amount of SC insulin taken by ICU patients during recovery period. (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

Interventionunits (Mean)
Sitagliptin1.0
Placebo2.2

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Composite of Perioperative Complications

Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction. (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

Interventionevents (Number)
Sitagliptin63
Placebo42

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Duration of Continuous Intravenous Insulin Infusion (CII)

Total hours of continuous intravenous insulin infusion (CII) (NCT02556918)
Timeframe: Up to 48 hours (average time of discharge from ICU)

Interventionhours (Mean)
Sitagliptin27.7
Placebo27.7

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Duration of Intubation

Duration that patients required to be intubated (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

Interventiondays (Mean)
Sitagliptin0.5
Placebo0.7

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Length of Intensive Care Unit (ICU) Stay

Total number of days spent in intensive care unit (ICU) (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

Interventiondays (Median)
Sitagliptin2.0
Placebo2.2

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Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)

Mean blood glucose (BG) concentration of ICU patients during recovery period. (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

Interventionmmol/L (Mean)
Sitagliptin148.7
Placebo149.8

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Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery

Mean insulin infusion dose per day of ICU patients during recovery period. (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

Interventionunit/day (Mean)
Sitagliptin45.9
Placebo46.4

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Mean Post-operative Blood Glucose (BG) Concentration

Mean post-operative blood glucose (BG) concentration during recovery period. (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

Interventionmmol/L (Mean)
Sitagliptin154.2
Placebo156.5

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Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)

Median number of days patients requiring SC insulin after discontinuation of CII (NCT02556918)
Timeframe: Up to 14 days (time of discharge from the hospital)

Interventiondays (Median)
Sitagliptin4
Placebo4

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Number of Cerebrovascular Events

Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

Interventionevents (Number)
Sitagliptin5
Placebo7

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Number of Intensive Care Unit (ICU) Readmission

Number of re-admissions to intensive care unit during the same hospital course. (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

Interventionreadmissions (Number)
Sitagliptin14
Placebo7

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Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)

Number of patients requiring CII to achieve a blood glucose level (BG) target between 150-200 mg/dl (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

InterventionParticipants (Count of Participants)
Sitagliptin86
Placebo85

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Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)

Number of patients requiring subcutaneous (SQ) insulin after discontinuation of continuous intravenous insulin infusion (CII) (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

InterventionParticipants (Count of Participants)
Sitagliptin74
Placebo78

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Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)

Number of patients with blood glucose (BG) levels greater than 180 mg/dl (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

InterventionParticipants (Count of Participants)
Sitagliptin76
Placebo68

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Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU)

Number of patients with events (blood glucose less than 70 mg/dL) in patients in intensive care unit (ICU). (NCT02556918)
Timeframe: 2 days (average time of discharge from ICU)

InterventionParticipants (Count of Participants)
Sitagliptin8
Placebo6

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Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU)

Number of Patients With hypoglycemic events (blood glucose less than 70 mg/dL) in patients in non-intensive care unit (ICU). (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

InterventionParticipants (Count of Participants)
Sitagliptin8
Placebo8

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Number of Patients With Persistent Hyperglycemia

Number of patients with two consecutive fasting and/or pre-meal blood glucose (BG) greater than 180 mg/dl, or with average daily BG greater than 80 mg/dl who require rescue therapy with subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII). (NCT02556918)
Timeframe: 10 days (average time of discharge from the hospital)

InterventionParticipants (Count of Participants)
Sitagliptin58
Placebo59

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Co-primary Efficacy Variables: Percent Positive and Percent Negative Agreement of Macimorelin-GHST (MAC) With ITT

"In the primary efficacy analysis, the estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The probability for a Negative Agreement equals the sum of the probability of both tests being correct (negative test results for both tests for subjects with true non-AGHD) and the probability of both tests being wrong (negative test results for both tests for subjects with true AGHD).~The performance of the GHST with Macimorelin was considered to be acceptable if the lower bound of the two-sided 95% confidence interval (or lower bound of the one-sided 97.5% confidence interval) for the primary efficacy variables was 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'.~The following cut-off values for stimulated GH levels were used: - MAC: GH: 2.8 ng/mL, - ITT: GH: 5.1 ng/mL." (NCT02558829)
Timeframe: 90 minutes

InterventionParticipants (Count of Participants)
Positive MAC, Positive ITT55
Positive MAC, Negative ITT4
Negative MAC, Positive ITT19
Negative MAC, Negative ITT62

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ECG: Change in Heart Rate From Baseline at 60 Minutes Post-dose

During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit. (NCT02558829)
Timeframe: 60 minutes

Interventionbeats per minute (Mean)
MAC, Heart Rate at Pre-dose63.4
MAC, HR at Post-dose60.5
ITT, HR at Pre-dose63.7
ITT, HR at Post-dose65.6

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Agreement (Positive/Negative) for MAC Core Study Part and MAC Repeatability Extension (Amendment 1)

Amendment no 1 (repeatability extension) had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study. Pre-defined MAC cut-off point GH: 2.8 ng/mL. Agreements were calculated with two-sided 95% confidence intervals. (NCT02558829)
Timeframe: 90 minutes

InterventionParticipants (Count of Participants)
Positive MAC Core, Positive MAC Repeatability16
Positive MAC Core, Negative MAC Repeatability2
Negative MAC Core, Negative MAC Repeatability16
Negative MAC Core, Positive MAC Repeatability0

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Sensitivity and Specificity of the MAC, GH: 2.8 ng/mL

Exploratory evaluation of sensitivity and specificity of the MAC as performance characteristic, based on test outcome in Group A and Group D subjects. (NCT02558829)
Timeframe: 90 minutes

InterventionParticipants (Count of Participants)
Positive MAC, Group A33
Positive MAC, Group D1
Negative MAC, Group A5
Negative MAC, Group D24

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Overall Agreements (Positive/ Negative) for MAC and ITT

As part of the secondary efficacy analysis, the percent of overall agreement was analyzed, using the same methodology described for the analyses for the primary efficacy variables. (NCT02558829)
Timeframe: 90 minutes

InterventionParticipants (Count of Participants)
Positive MAC, Positive ITT55
Positive MAC, Negative ITT4
Negative MAC, Positive ITT19
Negative MAC, Negative ITT62

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Number of Participants With Any Test Emergent Adverse Event (TEAE), With Any TEAE Likely or Possibly Related, and With Any Test Emergent Severe AE

GHST ('Test') emergent AEs (TEAEs): AEs occurring or observed from the day of first GHST (administration of an IMP) throughout End-of-Study (EOS) visit or Early Termination, whichever occurred first. TEAEs were analyzed and compared for both GHSTs. Detailed listings are presented in the Adverse Events section. The frequencies presented in this section refer to number of subjects with any TEAE, each subject was counted only once within each category. (NCT02558829)
Timeframe: up to 70 days

,
InterventionParticipants (Count of Participants)
Any TEAE (any relation)Any TEAE (likely or possible related)Any test emergent severe AE
Insulin Tolerance Test (ITT), All Groups, SAF Population15114911
Macimorelin GHST (MAC), All Groups, SAF Population39221

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Percentage of Participants With HbA1c <7.0%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Longitudinal logistic regression was used to model the likelihood of having hbA1c<7.0% at Week 26 with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction. (NCT02561078)
Timeframe: 26 Weeks

InterventionPercentage of participants (Number)
Human Regular U-500 Insulin Administered by CSII28.65
Human Regular U-500 Insulin Administered by MDI18.44

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Change From Baseline in Body Weight

Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, treatment by time interaction. (NCT02561078)
Timeframe: Baseline, 26 Weeks

InterventionKilograms (kg) (Least Squares Mean)
Human Regular U-500 Insulin Administered by CSII4.2
Human Regular U-500 Insulin Administered by MDI3.4

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Change From Baseline in Fasting Plasma Glucose (FPG)

Fasting plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction. (NCT02561078)
Timeframe: Baseline, 26 Weeks

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
Human Regular U-500 Insulin Administered by CSII-33.9
Human Regular U-500 Insulin Administered by MDI1.7

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Change From Baseline in Hemoglobin A1c (HbA1c)

"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction." (NCT02561078)
Timeframe: Baseline, 26 Weeks

InterventionPercentage of HbA1c (Least Squares Mean)
Human Regular U-500 Insulin Administered by CSII-1.27
Human Regular U-500 Insulin Administered by MDI-0.85

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Change From Baseline in Total Daily Dose (TDD)

Baseline TDD was defined as the last prestudy insulin TDD prior to randomization to receiving the first dose of U-500 insulin post randomization. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction. (NCT02561078)
Timeframe: Baseline, 26 Weeks

Interventionunits/day (Least Squares Mean)
Human Regular U-500 Insulin Administered by CSII2.8
Human Regular U-500 Insulin Administered by MDI51.3

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Percentage of Participants With HbA1c <7.5%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Longitudinal logistic regression was used to model the likelihood of having hbA1c<7.5% at Week 26 with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction. (NCT02561078)
Timeframe: 26 Weeks

InterventionPercentage of Participants (Number)
Human Regular U-500 Insulin Administered by CSII52.63
Human Regular U-500 Insulin Administered by MDI38.55

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Percentage of Participants With Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)

The percentage of participants with hypoglycemic episodes (documented hypoglycemia) was calculated by dividing the number of participants with at least 1 hypoglycemic episode (documented hypoglycemia) over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. Logistic regression was used to estimate the odds ratio between the two treatments of at least 1 hypoglycemic episode (documented hypoglycemia) over 26 week treatment period adjusted for baseline documented hypoglycemia rate, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction. (NCT02561078)
Timeframe: 26 Weeks

InterventionPercentage of Participants (Number)
Human Regular U-500 Insulin Administered by CSII95.69
Human Regular U-500 Insulin Administered by MDI95.71

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Rate of Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)

Documented Hypoglycemic episodes with blood glucose<=70mg/dL was used in this outcome measure. Hypoglycemia rate (documented hypoglycemia) per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia (documented hypoglycemia) was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline documented hypoglycemia rate, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, with log of exposure in days divided by 30 as the offset, treatment, visit, and visit by treatment interaction. (NCT02561078)
Timeframe: Baseline to 26 Weeks

InterventionEpisodes/participant/30 days (Least Squares Mean)
Human Regular U-500 Insulin Administered by CSII5.16
Human Regular U-500 Insulin Administered by MDI4.27

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Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values

Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, Bed Time and 03:00 AM hours. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction. (NCT02561078)
Timeframe: Baseline, 26 Weeks

,
Interventionmg/dL (Least Squares Mean)
Pre Morning Meal2 Hours Post Morning MealPre Mid-Day Meal2 Hours Post Mid-Day MealPre Evening Meal2 HOURS POST EVENING MEALOVERNIGHT (3:00 AM)
Human Regular U-500 Insulin Administered by CSII-34.3-25.0-19.8-8.3-15.1-14.6-25.4
Human Regular U-500 Insulin Administered by MDI-11.8-7.8-10.9-16.6-24.3-31.3-26.0

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Myocardial Fatty Acid Uptake Rate

PET measure of fatty acid uptake rate (NCT02563834)
Timeframe: 4 Hours

Interventionumol/min/100g (Mean)
Lean Control - Saline18.492
Lean Control - Insulin Clamp2.123
Type 2 DM - Saline36.005
Type 2 DM - Insulin Clamp7.8

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Myocardial Oxidation Rate

PET measure of total oxidation rate (NCT02563834)
Timeframe: 4 Hours

Interventionml/min/100g (Mean)
Lean Control - Saline15.006
Lean Control - Insulin Clamp19.847
Type 2 DM - Saline17.381
Type 2 DM - Insulin Clamp22.940

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Myocardial Perfusion Rate

PET measure of total myocardial perfusion (blood flow) (NCT02563834)
Timeframe: 4 Hours

Interventionml/min/100g (Mean)
Lean Control - Saline39.3
Lean Control - Insulin Clamp46.5
Type 2 DM - Saline44.2
Type 2 DM - Insulin Clamp49.4

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Change in mIAA Autoantibody Titer From Baseline

Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response (NCT02580877)
Timeframe: 13 and 26 weeks after first dose versus baseline

,
InterventionDK Units/mL (Mean)
13 weeks26 weeks
500mg Oral Insulin Crystals Every Other Week0.0200.017
67.5 mg Oral Insulin Crystals Daily0.0210.020

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Change in GAD65 Autoantibody Titer (DK Units/mL)

Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response (NCT02580877)
Timeframe: 13 and 26 weeks after first dose versus baseline

,
InterventionDK Units/mL (Mean)
13 weeks26 weeks
500 mg Oral Insulin Crystals Every Other Week234196
67.5 mg Oral Insulin Crystals Daily247193

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Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R

Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC[0-24]) of U-500R. (NCT02588950)
Timeframe: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

InterventionPicomoles hour per liter (pmol*h/L) (Geometric Mean)
U-500R BID7790
U-500R TID11700

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Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R

Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R. (NCT02588950)
Timeframe: Period 1 and 2: 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose

InterventionHour (h) (Geometric Least Squares Mean)
100-U Bolus U-500R SC8.50
100-U Bolus U-500R CSII8.53

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Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R

Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R. (NCT02588950)
Timeframe: Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24 hours (h) post dose

InterventionHours (h) (Median)
100-U Bolus U-500R SC6
100-U Bolus U-500R CSII5

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Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R

Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R. (NCT02588950)
Timeframe: Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose

InterventionPicomole hours per liter (pmol^h/L) (Geometric Mean)
100-U Bolus U-500R SC5230
100-U Bolus U-500R CSII6070

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Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R

Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R. (NCT02588950)
Timeframe: Period 3 day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18h post dose

InterventionMilligram per Minute (mg/min) (Geometric Mean)
U-500R BID524
U-500R TID588

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Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R

Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R. (NCT02588950)
Timeframe: Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

InterventionHours (Geometric Mean)
U-500R BID12.4
U-500R TID13.8

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Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R

Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R. (NCT02588950)
Timeframe: Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

InterventionGrams (g) (Geometric Mean)
U-500R BID441
U-500R TID510

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Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R

Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R. (NCT02588950)
Timeframe: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

InterventionPico mole per liter (Pmol/L) (Geometric Mean)
U-500R BID699
U-500R TID1050

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Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R

Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R. (NCT02588950)
Timeframe: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

InterventionHours (Median)
U-500R BID15
U-500R TID15

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Change in Clinical Evaluation: Electrocardiogram (ECG)

The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 52. (NCT02607306)
Timeframe: at screening (week -2 to week 0), at week 52

,,
InterventionParticipants (Count of Participants)
At screening visit - normalAt screening visit - Abn, NCSAt screening visit - Abn, CSWeek 52 - normalWeek 52 - Abn, NCSWeek 52 - Abn, CS
Insulin Degludec230383232354
Insulin Degludec/Liraglutide228407238307
Liraglutide2224110233346

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Change in Clinical Evaluation: Fundoscopy or Fundus Photography

The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 52. (NCT02607306)
Timeframe: at screening (week -2 to week 0), at week 52

,,
InterventionParticipants (Count of Participants)
Left eye - at screening visit - normalLeft eye - at screening visit - Abn, NCSLeft eye - at screening visit - Abn, CSLeft eye - week 52 - normalLeft eye - week 52 - Abn, NCSLeft eye - week 52 - Abn, CSRight eye - at screening visit - normalRight eye - at screening visit - Abn, NCSRight eye - at screening visit - Abn, CSRight eye - week 52 - normalRight eye - week 52 - Abn, NCSRight eye - week 52 - Abn, CS
Insulin Degludec2131642214164121214452171440
Insulin Degludec/Liraglutide2251039217174022410412201441
Liraglutide2111447212154520712542091549

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Plasma Concentrations of Liraglutide

Samples from the IDegLira and liraglutide arms were assayed for plasma concentrations of liraglutide using validated ELISA assays. (NCT02607306)
Timeframe: Weeks 2, 8, 16, 26, 44, 52

,
Interventionpmol/L (Geometric Mean)
At week 2At week 8At week 16At week 26At week 44At week 52
Insulin Degludec/Liraglutide5681.39107.810038.19995.38791.77426.2
Liraglutide6081.614539.514046.513904.212855.612127.4

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Responder (Yes/no): HbA1c Less Than 6.5%

Number of subjects with HbA1c less than 6.5% after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

,,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec134137
Insulin Degludec/Liraglutide21362
Liraglutide171102

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Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero

Number of subjects with HbA1c less than 6.5% and without weight gain after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

,,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec17254
Insulin Degludec/Liraglutide41234
Liraglutide126147

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Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.

"Number of subjects with HbA1c less than 7.0% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02607306)
Timeframe: After 52 weeks of treatment

,,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec16996
Insulin Degludec/Liraglutide22743
Liraglutide20665

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Total Cholesterol as a Ratio to Baseline at 52 Weeks

Total cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.92
Insulin Degludec0.97
Liraglutide0.94

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Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.

"Number of subjects with HbA1c less than 6.5% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02607306)
Timeframe: After 52 weeks of treatment

,,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec123142
Insulin Degludec/Liraglutide19872
Liraglutide170101

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Responder (Yes/no): HbA1c Less Than 7.0%

Number of subjects with HbA1c less than 7.0% after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

,,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec18982
Insulin Degludec/Liraglutide24530
Liraglutide20865

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Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero

Number of subjects with HbA1c less than 7.0% and without weight gain after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

,,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec22249
Insulin Degludec/Liraglutide44231
Liraglutide142131

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Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than 7.0% and without weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02607306)
Timeframe: After 52 weeks of treatment

,,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec22243
Insulin Degludec/Liraglutide37233
Liraglutide141130

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Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. (NCT02607306)
Timeframe: After 52 weeks of the treatment

,,
Interventionmmol/L (Mean)
Before breakfast90 minutes after start of breakfastBefore lunch90 minutes after start of lunchBefore dinner90 minutes after start of dinnerBedtimeAt 4:00 a.m.Before breakfast the following day
Insulin Degludec5.9310.436.7211.126.9010.899.496.415.71
Insulin Degludec/Liraglutide5.909.576.019.856.479.678.276.125.77
Liraglutide7.3510.596.8710.597.0310.148.737.277.13

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Serum Concentrations of Insulin Degludec

Samples from the IDegLira and IDeg arms were analysed for serum concentrations of insulin degludec using validated ELISA assays. (NCT02607306)
Timeframe: Weeks 2, 8, 16, 26, 44, 52

,
Interventionpmol/L (Geometric Mean)
At week 2At week 8At week 16At week 26At week 44At week 52
Insulin Degludec1477.12524.62856.42946.93238.83124.4
Insulin Degludec/Liraglutide1468.72246.02511.02597.32766.62393.8

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Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than 6.5% with no weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02607306)
Timeframe: After 52 weeks of treatment

,,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec17248
Insulin Degludec/Liraglutide35235
Liraglutide125146

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Anti-drug Antibodies: Anti-insulin Degludec Antibodies

Insulin degludec (IDeg)-specific antibodies were measured at week 52, as %B/T (percentage of bound & precipitated radioactive drug/total added drug to the sample). A sample is measured in 2 different series. In series 1, the radioactive IDeg (tracer) and surplus unlabeled IDeg are added to the sample. In series 2, the tracer and surplus unlabeled human insulin are added to the sample. Series 1 represents unspecific background binding. Series 2 represents IDeg specific antibodies including unspecific background binding. The reported %B/T is calculated by subtracting the background %B/T in series 1 from the %B/T result in series 2. If the background result has higher values than the %B/T in series 2, the resulting value is negative %B/T. Here, a negative %B/T value means that the test samples do not have IDeg-specific antibodies. The reason for getting a negative value for %B/T is due to variation in the analytical background. Thus, the results presented are not a change from baseline. (NCT02607306)
Timeframe: at week 52

InterventionPercentage B/T (Mean)
Insulin Degludec/Liraglutide0.12
Insulin Degludec-0.11

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Change From Baseline in Body Weight (kg)

Change from baseline (week 0) in body weight after 52 weeks of treatment. (NCT02607306)
Timeframe: Week 0, Week 52

InterventionKg (Mean)
Insulin Degludec/Liraglutide2.9
Insulin Degludec4.1
Liraglutide-1.0

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG after 52 weeks (NCT02607306)
Timeframe: Week 0, Week 52

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-4.08
Insulin Degludec-3.97
Liraglutide-2.62

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira

Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira). (NCT02607306)
Timeframe: Week 0, Week 52

InterventionPercentage of HbA1c (Mean)
Insulin Degludec/Liraglutide-2.42
Insulin Degludec-1.80
Liraglutide-1.80

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg

Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analysis was performed to test the hypothesis: superiority of IDegLira vs. IDeg. (NCT02607306)
Timeframe: Week 0, Week 52

InterventionPercentage of HbA1c (Mean)
Insulin Degludec/Liraglutide-2.42
Insulin Degludec-1.80
Liraglutide-1.80

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Change in Clinical Evaluation: Pulse

Change in pulse after 52 weeks of treatment. (NCT02607306)
Timeframe: Week 0, week 52

Interventionbeats per minute (Mean)
Insulin Degludec/Liraglutide3.9
Insulin Degludec0.8
Liraglutide4.2

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Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments. (NCT02607306)
Timeframe: Week 0, week 52

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-0.74
Insulin Degludec-0.27
Liraglutide-1.01

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Change in SMBG 9-point Profile - Mean of the 9-point Profile

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time. (NCT02607306)
Timeframe: Week 0, week 52

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-4.60
Insulin Degludec-3.84
Liraglutide-3.46

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference after 52 weeks of treatment. (NCT02607306)
Timeframe: Week 0, Week 52

InterventionCm (Mean)
Insulin Degludec/Liraglutide2.5
Insulin Degludec3.4
Liraglutide-1.1

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Fasting C-peptide as a Ratio to Baseline at 52 Weeks

Fasting C-peptide after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.61
Insulin Degludec0.42
Liraglutide1.12

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Fasting Glucagon as a Ratio to Baseline at 52 Weeks

Fasting glucagon after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.95
Insulin Degludec0.94
Liraglutide0.96

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Fasting Human Insulin as a Ratio to Baseline at 52 Weeks

Fasting human insulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.90
Insulin Degludec0.61
Liraglutide1.52

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Free Fatty Acids as a Ratio to Baseline at 52 Weeks

Free fatty acids after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.74
Insulin Degludec0.70
Liraglutide0.93

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High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks

High density lipoprotein (HDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.94
Insulin Degludec0.94
Liraglutide0.99

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Insulin Dose

Actual daily total insulin dose after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionInsulin Units/Day (Mean)
Insulin Degludec/Liraglutide27.7
Insulin Degludec34.8

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Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Low density lipoprotein (LDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.91
Insulin Degludec0.99
Liraglutide0.93

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Number of Treatment Emergent Adverse Events (TEAEs)

Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE. (NCT02607306)
Timeframe: 0-52 weeks

InterventionEvents (Number)
Insulin Degludec/Liraglutide873
Insulin Degludec829
Liraglutide885

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Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition

"Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:~Severe hypoglycaemia~Documented symptomatic hypoglycaemia~Asymptomatic hypoglycaemia~Probable symptomatic hypoglycaemia~Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product." (NCT02607306)
Timeframe: 0-52 weeks

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide4830
Insulin Degludec6340
Liraglutide162

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02607306)
Timeframe: 0-52 weeks

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide16
Insulin Degludec42
Liraglutide0

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Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02607306)
Timeframe: Weeks 0-52

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide467
Insulin Degludec869
Liraglutide13

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Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02607306)
Timeframe: 0-52 weeks

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide135
Insulin Degludec362
Liraglutide136

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Proinsulin as a Ratio to Baseline at 52 Weeks

Proinsulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.18
Insulin Degludec0.17
Liraglutide0.59

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Triglycerides as a Ratio to Baseline at 52 Weeks

Triglycerides after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.91
Insulin Degludec0.96
Liraglutide0.91

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Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Very low density lipoprotein (VLDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

InterventionRatio (Geometric Mean)
Insulin Degludec/Liraglutide0.92
Insulin Degludec0.97
Liraglutide0.91

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Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies

Anti-liraglutide antibodies were measured at week 52. Number of participants positive or negative for anti-liraglutide antibodies at week 52 were reported. (NCT02607306)
Timeframe: at week 52

,
InterventionParticipants (Count of Participants)
NegativePositive
Insulin Degludec/Liraglutide24728
Liraglutide22449

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Change in Blood Pressure (Systolic and Diastolic)

Change from baseline in blood pressure (systolic and diastolic) after 52 weeks of treatment. (NCT02607306)
Timeframe: Week 0, Week 52

,,
InterventionmmHg (Mean)
Systolic blood pressureDiastolic blood pressure
Insulin Degludec3.40.6
Insulin Degludec/Liraglutide1.70.5
Liraglutide-1.8-0.4

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Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic

"Treatment-emergent hypoglycaemic episodes: If the onset of the episode occurred on or after the first day of investigational medicinal product (IMP; IDegAsp/BIAsp 30) administration, and no later than 1 day after the last day on IMP, before switching to or being treated with another insulin product.~The above mentioned definitions (in endpoint title) should read as the following:~Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~American Diabetes Association (ADA) definition; documented symptomatic hypoglycaemia: An episode, during which typical symptoms of hypoglycaemia were accompanied by a measured PG concentration ≤3.9 mmol/L (70 mg/dL).~Due to character limitation, severe hypoglycaemia as per ADA classification is not defined here; see next outcome measure." (NCT02648217)
Timeframe: From week 0 to 4 weeks post Ramadan

,
InterventionNumber of episodes. (Number)
Severe or BG confirmed symptomatic hypoglycaemiaDocumented symptomatic hypoglycaemia
Biphasic Insulin Aspart 30389775
Insulin Degludec/Insulin Aspart93521

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Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )

Number of subjects who achieved HbA1c below 7% (53 mmol/mol; ADA target) at the end of Ramadan (day 29 of Ramadan). (NCT02648217)
Timeframe: End of Ramadan (day 29 of Ramadan)

,
InterventionNumber of subjects (Number)
Subjects with HbA1c <7.0% (Yes)Subjects with HbA1c <7.0% (No)
Biphasic Insulin Aspart 304281
Insulin Degludec/Insulin Aspart3883

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Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)

Number of subjects who achieved FPG <=7.2 mmol/L at the end of Ramadan (day 29 of Ramadan). The above written (in the endpoint title) 'ADA target' is not applicable for FPG. (NCT02648217)
Timeframe: End of Ramadan (day 29 of Ramadan)

,
InterventionNumber of subjects. (Number)
Subjects with FPG <=7.2 mmol/L (Yes)Subjects with FPG <=7.2 mmol/L (No)
Biphasic Insulin Aspart 308340
Insulin Degludec/Insulin Aspart6556

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Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

"Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes, which occurred between 00:01 and 05:59 both inclusive.~Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02648217)
Timeframe: From week 0 to 4 weeks post Ramadan

InterventionNumber of episodes. (Number)
Insulin Degludec/Insulin Aspart18
Biphasic Insulin Aspart 30106

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Change in HbA1c (%) (Glycosylated Haemoglobin)

Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan). (NCT02648217)
Timeframe: From week 0 to end of Ramadan (day 29 of Ramadan)

InterventionPercentage (%) of HbA1c (Least Squares Mean)
Insulin Degludec/Insulin Aspart-1.11
Biphasic Insulin Aspart 30-1.13

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Change in Fructosamine

Mean change in fructosamine was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan). (NCT02648217)
Timeframe: From week 0 to end of Ramadan (day 29 of Ramadan)

Interventionmmol/L (Mean)
Insulin Degludec/Insulin Aspart-0.035
Biphasic Insulin Aspart 30-0.035

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Change in Fasting Plasma Glucose (FPG)

Mean change in FPG was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan). (NCT02648217)
Timeframe: From week 0 to end of Ramadan (day 29 of Ramadan)

Interventionmmol/L (Mean)
Insulin Degludec/Insulin Aspart-2.0
Biphasic Insulin Aspart 30-4.4

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Change in MRI-Proton Density Fat Fraction (MRI-PDFF)

Absolute Change in MRI-Proton Density Fat Fraction (expressed as percent fat in the liver) from baseline to week 12 (NCT02653300)
Timeframe: Two timepoints: Baseline (week 0) and Week 12

Interventionpercentage fat in the liver (Mean)
MRPDFF (%) at baselineMR PDFF (%) at Week 12Absolute Mean Change in MR PDFF (%) from Baseline
Oral Insulin21.314.4-6.9

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Mean Fibrosis Score CAP™ (FibroMax)

Mean fibrosis score (severity scale of liver fibrosis) measured at baseline and week 12. Fibrosis Score CAP measures the amount of steatosis (fatty change) in the liver. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m with higher values indicating more fatty change (NCT02653300)
Timeframe: Two timepoints: Baseline (week 0) and Week 12

InterventiondB/M (Mean)
Mean Fibrosis Score at BaselineMean Fibrosis Score at week 12
Oral Insulin338.5315.5

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Mean Transient Elastography Measurement (Fibroscan)

Mean Transient elasticity, measured in kPA (kilo Pascal), (NCT02653300)
Timeframe: Two timepoints: Baseline (week 0) and Week 12

InterventionkPa (Mean)
BaselineWeek 12
Oral Insulin8.67.4

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Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL)

mean change in % of time in hypoglycemia (< 70 mg/dL) from baseline to 3 months study period (NCT02660827)
Timeframe: baseline and 3 months

Interventionpercent of time (Mean)
Age 2-13 Years Old Wearing the MMT-670G Insulin Pump-1.19

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Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL

Event rate without Hypoglycemia at YSI-FST <=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST <= 65mg/dL during in-clinic procedures. (NCT02660827)
Timeframe: Up to 12 hours after the start of PLGM period

Interventionpercentage of total experiments (Number)
Age 7-13 Years Old Wearing the MMT-670G Insulin Pump84.8

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Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event

Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period. (NCT02660827)
Timeframe: 3 months

Interventionevents (Number)
Age 2-13 Years Old Wearing the MMT-670G Insulin Pump0

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Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL)

mean change in % of time in hyperglycemia (> 180 mg/dL) from baseline to 3 months study period (NCT02660827)
Timeframe: baseline and 3 months

InterventionPercent of time (Mean)
Age 2-13 Years Old Wearing the MMT-670G Insulin Pump-7.39

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Age 2-13 Years Old Subjects Change in A1C

Descriptive analysis of change in A1C from baseline to end of 3-month study period (NCT02660827)
Timeframe: Baseline and end of 3-month study period

Interventionpercentage of hemoglobin (Mean)
Age 2-13 Years Old Wearing MMT-670G Insulin Pump-0.37

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Age 2-13 Years Old - Number of Severe Hypoglycemic Event

Number of severe hypoglycemic events occurred during 3-month study period. (NCT02660827)
Timeframe: 3 months

Interventionevents (Number)
Age 2-13 Years Old Wearing the MMT-670G Insulin Pump0

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Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL)

mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months study period (NCT02660827)
Timeframe: baseline and 3 months

InterventionPercentage of time (Mean)
Age 2-13 Years Old Wearing the MMT-670G Insulin Pump8.58

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Change in FPG

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)7.580.41
Faster Aspart (Post)8.03-0.08
NovoRapid (Meal)7.79-0.13

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Change in Haematology: Erythrocytes

Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Intervention10^12 cells/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)4.810.02
Faster Aspart (Post)4.870.04
NovoRapid (Meal)4.880.02

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Change in Haematology: Haematocrit

Change from baseline (week 0) in haematocrit was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Intervention% of red blood cells (Mean)
BaselineChange from baseline
Faster Aspart (Meal)40.870.45
Faster Aspart (Post)41.510.40
NovoRapid (Meal)41.340.32

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Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total

Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) Symptomatic blood glucose (BG) confirmed: episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3) Asymptomatic BG confirmed: episode that is BG confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG confirmed symptomatic: an episode that is severe according to the ISPAD classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG confirmed: an episode that is BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG confirmed: an episode that is severe according to the ISPAD Classification or BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. The results are based on the on-treatment period. (NCT02670915)
Timeframe: Week 0-26

,,
InterventionEpisodes (Number)
SevereBG confirmedSevere or BG confirmed symptomaticSevere or BG confirmedUnclassifiable
Faster Aspart (Meal)33580224235836118
Faster Aspart (Post)83586242735945956
NovoRapid (Meal)43272219432765626

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Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)

Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period. (NCT02670915)
Timeframe: Week 0-26

,,
InterventionEpisodes (Number)
SevereBG confirmedSevere or BG confirmed symptomaticSevere or BG confirmedUnclassifiable
Faster Aspart (Meal)0396180396776
Faster Aspart (Post)3474260477785
NovoRapid (Meal)1312159313641

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Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime

Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period. (NCT02670915)
Timeframe: Week 0-26

,,
InterventionEpisodes (Number)
SevereBG confirmedSevere or BG confirmed symptomaticSevere or BG confirmedUnclassifiable
Faster Aspart (Meal)33184206231875342
Faster Aspart (Post)53112216731175171
NovoRapid (Meal)32960203529634985

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Change in Body Mass Index

Change from baseline (week 0) in body mass index (BMI) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionkg/m^2 (Mean)
BaselineChange from baseline
Faster Aspart (Meal)19.680.37
Faster Aspart (Post)19.670.28
NovoRapid (Meal)19.640.34

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Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total

Treatment emergent: if the onset of the episode occurred on or after the first day of treatment with investigational medicinal product (IMP) after randomisation, and no later than 1 day after the last day on IMP. Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic: episode during which typical symptoms of hypoglycaemia are accompanied by a PG level ≤3.9 mmol/L. 3) Asymptomatic: episode not accompanied by typical symptoms of hypoglycaemia, but with a PG level ≤3.9 mmol/L. 4) Probable symptomatic: an episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. 5) Pseudo-hypoglycaemia: episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a PG level >3.9mmol/L, but approaching that level. The results are based on the on-treatment period. (NCT02670915)
Timeframe: Week 0-26

,,
InterventionEpisodes (Number)
SevereDocumented symptomaticAsymptomaticProbable symptomaticPseudo-hypoglycaemiaUnclassifiable
Faster Aspart (Meal)35391425512355
Faster Aspart (Post)85712378110372
NovoRapid (Meal)45170365624471

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Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)

Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period. (NCT02670915)
Timeframe: Week 0-26

,,
InterventionEpisodes (Number)
SevereDocumented symptomaticAsymptomaticProbable symptomaticPseudo-hypoglycaemiaUnclassifiable
Faster Aspart (Meal)0496671230
Faster Aspart (Post)3635618060
NovoRapid (Meal)1391555250

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Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime

Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period. (NCT02670915)
Timeframe: Week 0-26

,,
InterventionEpisodes (Number)
SevereDocumented symptomaticAsymptomaticProbable symptomaticPseudo-hypoglycaemiaUnclassifiable
Faster Aspart (Meal)34895358410325
Faster Aspart (Post)55077316310312
NovoRapid (Meal)34779310122421

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Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose

Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 26

,,
InterventionUnits (U)/kg (Mean)
BreakfastLunchMain evening meal
Faster Aspart (Meal)0.1510.1700.164
Faster Aspart (Post)0.1500.1740.165
NovoRapid (Meal)0.1440.1660.158

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Insulin Dose (Units/Day): Individual Meal Insulin Dose

Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 26

,,
InterventionUnits (U) (Mean)
BreakfastLunchMain evening meal
Faster Aspart (Meal)7.38.18.1
Faster Aspart (Post)7.18.48.0
NovoRapid (Meal)6.87.97.7

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Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)

Incidence of episodes (number of episodes per 24 hours) with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was calculated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 26

,,
InterventionEpisodes per 24 hours (Number)
Episodes with IG <=2.5 mmol/LEpisodes with IG <=3.0 mmol/LEpisodes with IG <=3.9 mmol/LEpisodes with IG >10 mmol/LEpisodes with IG >12 mmol/L
Faster Aspart (Meal)0.551.012.2911.527.64
Faster Aspart (Post)0.681.102.3011.617.77
NovoRapid (Meal)0.571.032.2411.658.05

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Change in Lipid Profile: High Density Lipoproteins (HDL)

Change from baseline (week 0) in HDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 0, Week 26

InterventionRatio (Geometric Mean)
Faster Aspart (Meal)1.004
Faster Aspart (Post)1.030
NovoRapid (Meal)1.023

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Change in Lipid Profile: Low Density Lipoproteins (LDL)

Change from baseline (week 0) in LDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 0, Week 26

InterventionRatio (Geometric Mean)
Faster Aspart (Meal)1.014
Faster Aspart (Post)1.040
NovoRapid (Meal)1.041

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Change in Lipid Profile: Total Cholesterol

Change from baseline (week 0) in total cholesterol after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 0, Week 26

InterventionRatio (Geometric Mean)
Faster Aspart (Meal)0.989
Faster Aspart (Post)1.023
NovoRapid (Meal)1.016

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Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])

Change from baseline (week 0) in the time spent in low IG (<=3.9 mmol/L [70 mg/dL]) based on continuous glucose monitoring (CGM) was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionMinutes/day (Mean)
BaselineChange from baseline
Faster Aspart (Meal)107.94-24.11
Faster Aspart (Post)100.70-13.06
NovoRapid (Meal)81.526.92

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Change in Vital Sign: Pulse

Change from baseline (week 0) in pulse was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionBeats/minute (Mean)
BaselineChange from baseline
Faster Aspart (Meal)80.6-0.6
Faster Aspart (Post)80.50.3
NovoRapid (Meal)79.40.7

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Change in Vital Sign: Blood Pressure

Change from baseline (week 0) in blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionmmHg (Mean)
SBP: BaselineSBP: Change from baselineDBP: BaselineDBP: Change from baseline
Faster Aspart (Meal)106.40.865.41.2
Faster Aspart (Post)107.01.565.71.4
NovoRapid (Meal)106.81.165.41.4

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Change in Time to the IG Peak After Start of Meal

Change in time to the IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionMinute (Mean)
BaselineChange from baseline
Faster Aspart (Meal)102.855.29
Faster Aspart (Post)94.26-0.04
NovoRapid (Meal)93.80-8.76

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Change in the Percentage of HbA1c

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related participant-site contact and included data collected after a subject discontinued trial product. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionPercentage of HbA1c (Mean)
BaselineChange from baseline
Faster Aspart (Meal)7.570.06
Faster Aspart (Post)7.580.33
NovoRapid (Meal)7.530.23

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Change in Body Weight

Change from baseline (week 0) in body weight was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionkg (Mean)
BaselineChange from baseline
Faster Aspart (Meal)46.692.21
Faster Aspart (Post)46.481.90
NovoRapid (Meal)46.282.15

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Change in SD Score of Body Weight

Change from baseline (week 0) in standard deviation (SD) score of body weight was evaluated after 26 weeks of randomisation. SD-scores are defined to be able to normalise the body weight in the various age groups. To estimate the growth of children, standardised weight is calculated for each year of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. The SD scores are derived from the age and sex of the subjects and the body weight together with growth curves defined for a reference population. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionStandard deviation score (Mean)
BaselineChange from baseline
Faster Aspart (Meal)0.3490.034
Faster Aspart (Post)0.3510.008
NovoRapid (Meal)0.3610.030

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Change in SD Score of Body Mass Index

Change from baseline (week 0) in SD score of BMI was evaluated after 26 weeks of randomisation. SD scores for BMI were determined in a similar way as SD scores for weight by use of a suitable reference population based on age and sex. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionStandard deviation score (Mean)
BaselineChange from baseline
Faster Aspart (Meal)0.2960.016
Faster Aspart (Post)0.2980.004
NovoRapid (Meal)0.3170.007

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Change in Physical Examination

The following physical examinations were done: 1) Cardiovascular system. 2) Central and peripheral nervous system. 3) Gastrointestinal system including the mouth. 4) General appearance. 5) Head, ears, eyes, nose, throat and neck. 6) Musculoskeletal system. 7) Respiratory system. 8) Skin. Presented results are number of participants with the following outcomes: normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Presented results are baseline (week 0) and last on-treatment values. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionParticipants (Number)
1) Baseline: Normal1) Baseline: Abnormal, NCS1) Baseline: Abnormal, CS1) Last on-treatment: Normal1) Last on-treatment: Abnormal, NCS1) Last on-treatment: Abnormal, CS2) Baseline: Normal2) Baseline: Abnormal, NCS2) Baseline: Abnormal, CS2) Last on-treatment: Normal2) Last on-treatment: Abnormal, NCS2) Last on-treatment: Abnormal, CS3) Baseline: Normal3) Baseline: Abnormal, NCS3) Baseline: Abnormal, CS3) Last on-treatment: Normal3) Last on-treatment: Abnormal, NCS3) Last on-treatment: Abnormal, CS4) Baseline: Normal4) Baseline: Abnormal, NCS4) Baseline: Abnormal, CS4) Last on-treatment: Normal4) Last on-treatment: Abnormal, NCS4) Last on-treatment: Abnormal, CS5) Baseline: Normal5) Baseline: Abnormal, NCS5) Baseline: Abnormal, CS5) Last on-treatment: Normal5) Last on-treatment: Abnormal, NCS5) Last on-treatment: Abnormal, CS6) Baseline: Normal6) Baseline: Abnormal, NCS6) Baseline: Abnormal, CS6) Last on-treatment: Normal6) Last on-treatment: Abnormal, NCS6) Last on-treatment: Abnormal, CS7) Baseline: Normal7) Baseline: Abnormal, NCS7) Baseline: Abnormal, CS7) Last on-treatment: Normal7) Last on-treatment: Abnormal, NCS7) Last on-treatment: Abnormal, CS8) Baseline: Normal8) Baseline: Abnormal, NCS8) Baseline: Abnormal, CS8) Last on-treatment: Normal8) Last on-treatment: Abnormal, NCS8) Last on-treatment: Abnormal, CS
Faster Aspart (Meal)2601025700257312552025830253402582125700251912477325920254122591125700239184229199
Faster Aspart (Post)254402535025341253412571025710253322534123813724411325242253322562025800237210233223
NovoRapid (Meal)258002570025800257002543125601254402543024511224214125431253312561125700238164235175

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Change in Mean Time to the IG Peak After Meal

Change from baseline (week 0) in mean time to the IG peak after meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of subjects wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionMinutes (Mean)
BaselineChange from baseline
Faster Aspart (Meal)103.164.70
Faster Aspart (Post)106.21-8.56
NovoRapid (Meal)102.202.29

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Change in Mean IG Peak After Start of Meal

Change from baseline (week 0) in mean IG peak after start of meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)12.90-0.28
Faster Aspart (Post)12.920.80
NovoRapid (Meal)12.900.38

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Change in IG Peak After Start of Meal

Change in IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)14.87-0.55
Faster Aspart (Post)15.151.11
NovoRapid (Meal)15.11-1.36

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Change in Height

Change from baseline (week 0) in height was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionMeter (Mean)
BaselineChange from baseline
Faster Aspart (Meal)1.500.02
Faster Aspart (Post)1.500.02
NovoRapid (Meal)1.500.02

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Change in Haematology: Thrombocytes

Change from baseline (week 0) in thrombocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Intervention10^9 cells/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)268.11.2
Faster Aspart (Post)270.01.6
NovoRapid (Meal)262.56.0

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Change in Haematology: Leukocytes

Change from baseline (week 0) in leukocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Intervention10^9 cells/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)6.100.08
Faster Aspart (Post)6.100.14
NovoRapid (Meal)6.110.10

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Change in Haematology: Haemoglobin

Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)8.330.08
Faster Aspart (Post)8.470.09
NovoRapid (Meal)8.410.09

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Change in Biochemistry: Total Bilirubin

Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionumol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)7.90.2
Faster Aspart (Post)7.90.2
NovoRapid (Meal)8.00.3

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Change in Biochemistry: Sodium

Change from baseline (week 0) in sodium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)139.50.5
Faster Aspart (Post)139.60.3
NovoRapid (Meal)139.70.04

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Change in Biochemistry: Potassium

Change from baseline (week 0) in potassium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)4.480.02
Faster Aspart (Post)4.52-0.06
NovoRapid (Meal)4.520.01

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Change in Biochemistry: Creatinine

Change from baseline (week 0) in creatinine was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionumol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)51.81.1
Faster Aspart (Post)52.61.5
NovoRapid (Meal)52.11.7

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Change in Biochemistry: Aspartate Aminotransferase (AST)

Change from baseline (week 0) in AST was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionU/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)19.90.1
Faster Aspart (Post)20.01.1
NovoRapid (Meal)20.5-0.4

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Change in Biochemistry: Alkaline Phosphatase (AP)

Change from baseline (week 0) in AP was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionU/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)212.7-3.0
Faster Aspart (Post)209.8-1.7
NovoRapid (Meal)226.2-2.8

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Change in Biochemistry: Albumin

Change from baseline (week 0) in albumin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventiong/dL (Mean)
BaselineChange from baseline
Faster Aspart (Meal)4.470.01
Faster Aspart (Post)4.510.01
NovoRapid (Meal)4.500.005

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Change in Biochemistry: Alanine Aminotransferase (ALT)

Change from baseline (week 0) in ALT was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionU/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)14.40.1
Faster Aspart (Post)14.71.3
NovoRapid (Meal)14.80.5

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Change in AUCIG,0-4h

Change in area under the IG curve 0-4 hours post meal (AUCIG,0-4h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)11.21-0.38
Faster Aspart (Post)11.190.62
NovoRapid (Meal)11.46-1.30

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Change in AUCIG,0-30min

Change in area under the IG curve 0-30 minutes post meal (AUCIG,0-30min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)8.28-1.15
Faster Aspart (Post)7.800.22
NovoRapid (Meal)8.13-0.47

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Change in AUCIG,0-15min

Change in area under the IG curve 0-15 minutes post meal (AUCIG,0-15min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. Interstitial glucose (IG) was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)8.01-1.27
Faster Aspart (Post)7.490.08
NovoRapid (Meal)7.66-0.53

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Change in Anti-insulin Aspart Antibody Development: Total

Change from baseline (week 0) in 'total anti-insulin aspart antibodies (specific for insulin aspart and those cross-reacting with human insulin)' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionPercentage of B/T (Mean)
BaselineChange from baseline
Faster Aspart (Meal)20.230-3.271
Faster Aspart (Post)23.044-5.061
NovoRapid (Meal)21.344-4.004

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Change in Anti-insulin Aspart Antibody Development: Specific

Change from baseline (week 0) in 'antibodies specific for insulin aspart' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionPercentage of B/T (Mean)
BaselineChange from baseline
Faster Aspart (Meal)1.436-0.099
Faster Aspart (Post)1.459-0.213
NovoRapid (Meal)1.183-0.201

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Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin

Change from baseline (week 0) in 'antibodies for insulin aspart, those cross-reacting with human insulin' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
InterventionPercentage of B/T (Mean)
BaselineChange from baseline
Faster Aspart (Meal)18.794-3.202
Faster Aspart (Post)21.576-4.845
NovoRapid (Meal)20.156-3.802

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Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)

Change from baseline (week 0) in mean IG increment (0-1 hours and 0-2 hours after start of the meal) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
0-1 hour: Baseline0-1 hour: Change from baseline0-2 hour: Baseline0-2 hour: Change from baseline
Faster Aspart (Meal)0.56-0.190.76-0.35
Faster Aspart (Post)0.730.261.100.55
NovoRapid (Meal)0.610.070.860.09

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Change in 8-point SMPG Profile: PPG Increment Over All Three Meals

Change from baseline (week 0) in mean PPG increment over all three meals was evaluated after 26 weeks of randomisation. Postprandial glucose (PPG) increment for each meal (breakfast, lunch and main evening meal) was derived from the 8-point profile as the difference between PPG (1 hour after the meal) values and the plasma glucose (PG) value before meal. The mean of the derived increments was then calculated separately for each meal. Mean PPG increment over all three meals was derived as the mean of all corresponding mean meal increments. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)1.20-0.92
Faster Aspart (Post)1.010.56
NovoRapid (Meal)0.970.14

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Change in 8-point SMPG Profile: Mean PPG Over All Three Meals

Change from baseline (week 0) in mean post prandial glucose (PPG) over all three meals was evaluated after 26 weeks of randomisation. PPG for each meal (breakfast, lunch and main evening meal) was recorded by the participant as part of the 8-point self-measured plasma glucose (SMPG) profile. Mean PPG over all three meals was derived as the mean of all corresponding mean meal. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)10.19-0.94
Faster Aspart (Post)10.120.36
NovoRapid (Meal)10.03-0.21

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Change in 8-point SMPG Profile: Mean of the 8-point Profile

Change from baseline (week 0) in mean of the 8-point SMPG profile was evaluated after 26 weeks of randomisation. SMPG values were recorded at 8 time-points on two consecutive days: before and after (60 minute after the start of the meal) breakfast, lunch and main evening meal, before bedtime, and before breakfast on the next day. Mean of the 8-point profile was derived as the mean of all corresponding mean SMPG recorded at 8 different time points. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)9.41-0.27
Faster Aspart (Post)9.470.17
NovoRapid (Meal)9.39-0.05

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Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment

Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG increment was evaluated after 26 weeks of randomisation. PPG increment for each meal was derived from the 8-point profile as the difference between PPG values (1 hour after the meal) and the PG value before meal. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
Breakfast: BaselineBreakfast: Change from baselineLunch: BaselineLunch: Change from baselineMain evening meal: BaselineMain evening meal: Change from baseline
Faster Aspart (Meal)1.90-0.821.02-0.580.53-0.92
Faster Aspart (Post)2.100.461.120.12-0.261.03
NovoRapid (Meal)2.120.100.74-0.11-0.060.45

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Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG

Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG was evaluated after 26 weeks of randomisation. PPG for each meal was recorded by the participant as part of the 8-point SMPG profile. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
Breakfast: BaselineBreakfast: Change from baselineLunch: BaselineLunch: Change from baselineMain evening meal: BaselineMain evening meal: Change from baseline
Faster Aspart (Meal)10.51-1.119.69-0.8010.24-0.74
Faster Aspart (Post)10.510.169.990.189.900.61
NovoRapid (Meal)10.490.049.62-0.249.87-0.05

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Change in 30-minute PPG Increment

Change from baseline (week 0) in 30-minute PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 30-minute (after the meal) at the visit. PPG increment was derived as 30-minute PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)3.440.36
Faster Aspart (Post)3.481.92
NovoRapid (Meal)4.02-0.34

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Change in 30-minute PPG

Change from baseline (week 0) in 30-minute PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 30-minute after the meal intake at the visit. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)11.28-0.21
Faster Aspart (Post)10.961.84
NovoRapid (Meal)11.71-0.45

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Change in 2-hour PPG Increment

Change from baseline (week 0) in 2-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 2-hour (after the meal) at the visit. PPG increment was derived as 2-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)4.661.26
Faster Aspart (Post)5.061.62
NovoRapid (Meal)4.67-0.64

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Change in 2-hour PPG

Change from baseline (week 0) in 2-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 2-hour after the meal intake at the visit. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)12.500.69
Faster Aspart (Post)12.541.80
NovoRapid (Meal)12.37-0.75

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Change in 1,5-anhydroglucitol

Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionug/mL (Mean)
BaselineChange from baseline
Faster Aspart (Meal)4.95-0.06
Faster Aspart (Post)5.07-0.85
NovoRapid (Meal)5.13-0.63

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Change in 1-hour PPG Increment

Change from baseline (week 0) in 1-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 1-hour (after the meal) at the visit. PPG increment was derived as 1-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)4.930.42
Faster Aspart (Post)5.082.63
NovoRapid (Meal)5.36-0.52

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Change in 1-hour PPG

Change from baseline (week 0) in 1-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 1-hour after the meal intake at the visit. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)12.77-0.15
Faster Aspart (Post)12.562.54
NovoRapid (Meal)13.06-0.63

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Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included

Percentage of time spent within IG target 4.0-10.0 mmol/L (71-180 mg/dL), both included based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 26

InterventionPercentage of time (Mean)
Faster Aspart (Meal)53.00
Faster Aspart (Post)52.56
NovoRapid (Meal)51.03

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Number of Treatment Emergent Injection Site Reactions

Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP and excluding the events occurring in the run-in period. The results are based on the on-treatment period. (NCT02670915)
Timeframe: Week 0-26

InterventionEvents (Number)
Faster Aspart (Meal)11
Faster Aspart (Post)31
NovoRapid (Meal)17

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Number of Treatment Emergent Adverse Events (AEs)

Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP (faster aspart or NovoRapid®/NovoLog®) and excluding the events occurring in the run-in period. The results are based on the on-treatment period. (NCT02670915)
Timeframe: Week 0-26

InterventionEvents (Number)
Faster Aspart (Meal)576
Faster Aspart (Post)678
NovoRapid (Meal)593

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Insulin Dose (Units/kg/Day): Total Bolus

Total bolus insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 26

InterventionUnits (U)/kg (Mean)
Faster Aspart (Meal)0.483
Faster Aspart (Post)0.491
NovoRapid (Meal)0.468

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Insulin Dose (Units/kg/Day): Total Basal

Total basal insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 26

InterventionUnits (U)/kg (Mean)
Faster Aspart (Meal)0.433
Faster Aspart (Post)0.425
NovoRapid (Meal)0.409

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Insulin Dose (Units/Day): Total Bolus

Total bolus insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. (NCT02670915)
Timeframe: Week 26

InterventionUnits (U) (Mean)
Faster Aspart (Meal)23.3
Faster Aspart (Post)23.5
NovoRapid (Meal)22.5

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Insulin Dose (Units/Day): Total Basal

Total basal insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised NovoRapid®/NovoLog® / faster aspart and no later than 7 days after the day of last dose of NovoRapid®/NovoLog® / faster aspart. The on-treatment observation period includes data collected up to and including 7 days after treatment discontinuation. Number of participants analysed = number of participants contributed to the analysis. Analysis population description: Safety analysis set (SAS) included all participants receiving at least one dose of the investigational product (faster aspart) or its comparator (NovoRapid®/NovoLog®). (NCT02670915)
Timeframe: Week 26

InterventionUnits (U) (Mean)
Faster Aspart (Meal)21.6
Faster Aspart (Post)21.5
NovoRapid (Meal)20.7

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Fluctuation in the 8-point SMPG Profile

Fluctuation in the 8-point SMPG profile was evaluated after 26 weeks of randomisation. Fluctuation in 8-point SMPG profile was the average absolute difference from the mean of the SMPG profile. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 26

Interventionmmol/L (Geometric Mean)
Faster Aspart (Meal)1.88
Faster Aspart (Post)1.94
NovoRapid (Meal)1.83

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Change in AUCIG,0-1h

Change in area under the IG curve 0-1 hour post meal (AUCIG,0-1h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)9.63-0.87
Faster Aspart (Post)9.430.54
NovoRapid (Meal)10.02-0.65

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Change in AUCIG,0-2h

Change in area under the IG curve 0-2 hours post meal (AUCIG,0-2h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 0, Week 26

,,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart (Meal)11.40-0.84
Faster Aspart (Post)11.480.75
NovoRapid (Meal)11.76-0.86

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Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)

Percentage of time spent with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 26

,,
InterventionPercentage of time (Mean)
Time spent with IG <=2.5 mmol/LTime spent with IG <=3.0 mmol/LTime spent with IG <=3.9 mmol/LTime spent with IG >10 mmol/LTime spent with IG >12 mmol/L
Faster Aspart (Meal)1.092.195.9740.4026.09
Faster Aspart (Post)1.802.906.2540.6025.67
NovoRapid (Meal)1.342.485.9742.4728.62

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Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia

Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to ISPAD guidelines, without severe hypoglycaemia was evaluated after 26 weeks of randomisation. Severe hypoglycaemia according to ISPAD guidelines: hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose). The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 26

,,
InterventionPercentage of participants (Number)
YesNo
Faster Aspart (Meal)41.958.1
Faster Aspart (Post)30.969.1
NovoRapid (Meal)38.461.6

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Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines

Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value. (NCT02670915)
Timeframe: Week 26

,,
InterventionPercentage of participants (Number)
YesNo
Faster Aspart (Meal)42.357.7
Faster Aspart (Post)31.768.3
NovoRapid (Meal)39.560.5

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Number of Participants With Hypoglycaemia Events Following the Insulin Dosing

All episodes of hypoglycaemia (BG less than 4 mmol/l) either on continuous glucose monitor or self-monitoring of BG (NCT02680054)
Timeframe: assessed up to 12 hours following the test meal

InterventionParticipants (Count of Participants)
Arm 1 (Usual Treatment)14
Arm 214
Arm 316

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Peak Glucose Excursion From Baseline Following Test Meal

Glucose measured on the continuous subcutaneous glucose monitor (NCT02680054)
Timeframe: assessed up to 12 hours following the test meal

Interventionmmol/l (Mean)
Arm 1 (Usual Treatment)1.864
Arm 21.167
Arm 32.459

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Peak Glucose Level Following Test Meal

Glucose measured on the continuous subcutaneous glucose monitor (NCT02680054)
Timeframe: assessed up to 12 hours following the test meal

Interventionmmol/l (Mean)
Arm 1 (Usual Treatment)10.931
Arm 211.491
Arm 311.491

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Time of Peak Glucose Level Following Test Meal

Glucose measured on the continuous subcutaneous glucose monitor (NCT02680054)
Timeframe: assessed up to 12 hours following the test meal

InterventionMins (Mean)
Arm 1 (Usual Treatment)82.34
Arm 2113.617
Arm 395.106

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Glycemic Variability: Area Under the Curve of Glucose

Area under the curve of glucose of the second day of continuous ambulatory glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge) (NCT02680457)
Timeframe: Every 5 min for 24 hours on day 5 post-dose

Interventionmg*h/dL (Mean)
Insulin Degludec46776
Insulin Glargine46499

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Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE)

Mean amplitude of interstitial glucose excursions (MAGE) during the last 48 h of the ambulatory continuous glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge); starting in the day 3 of the administration of insulin degludec or glargine (NCT02680457)
Timeframe: 2 days

Interventionmg/dl (Mean)
Insulin Degludec75.2
Insulin Glargine68.5

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Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM

The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16). (NCT02688933)
Timeframe: During Week 15 and/or 16

Interventionpercentage of time (Least Squares Mean)
HOE901-U30055.40
Lantus55.18

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Change From Baseline in Daily Insulin Dose at Week 16

Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported. (NCT02688933)
Timeframe: Baseline, Week 16

,
InterventionInternational Units (Mean)
Daily basal Insulin DoseDaily bolus Insulin Dose
HOE901-U3008.8-1.8
Lantus7.0-3.0

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Change From Baseline in Time (Min) of Mean Glucose Concentration Within the Target Range of 70 to 180 mg/dL, by End of Study hbA1c Levels During Week 15 and/or Week 16

Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessments. Data was reported for participants with an end of study HbA1c <7.5 or HbA1c >=7.5% over a 24 hour period. (NCT02688933)
Timeframe: Baseline, during Week 15 and/or Week 16

,
Interventionminutes (Least Squares Mean)
End of study HbA1c <7.5%End of study HbA1c >=7.5%
HOE901-U300105.8411.64
Lantus56.0731.95

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Coefficient of Variation (CV%) in Mean CGM Glucose

CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values. (NCT02688933)
Timeframe: During Week 15 and/or Week 16

,
Interventionpercent of mean glucose level (Least Squares Mean)
Total CV%Within-day CV%Between-days CV%
HOE901-U30041.2736.9917.44
Lantus40.7236.2317.53

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Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year

Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF. (NCT02688933)
Timeframe: Baseline up to Week 16

,
Interventionevents per participant-year (Number)
Documented <=70 mg/dLDocumented <54 mg/dL
HOE901-U30011.384.99
Lantus11.395.61

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Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia

Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF). (NCT02688933)
Timeframe: Baseline up to Week 16

,
Interventionpercentage of participants (Number)
Documented <=70mg/dLDocumented <54 mg/dL
HOE901-U30070.850.9
Lantus68.354.1

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Percentage of Participants With HbA1c Values of <7.5% at Month 6

Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years). (NCT02735044)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901-U30026.18
Lantus23.48

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Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period

Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years). (NCT02735044)
Timeframe: upto Month 6

Interventionpercentage of participants (Number)
HOE901-U3009.44
Lantus7.39

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Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6

8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%), randomization strata of age at screening (<12 years, >=12 years) and the baseline 24-hour average 8-point profile SMPG. (NCT02735044)
Timeframe: Baseline to Month 6

Interventionmmol/L (Least Squares Mean)
HOE901-U3000.139
Lantus-0.266

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Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6

Change in FPG was calculated by subtracting baseline value from Month 6 value. Adjusted LS means and SE were obtained using ANCOVA after multiple imputation to address missing data in the main 6 month randomized period. (NCT02735044)
Timeframe: Baseline to Month 6

Interventionmillimole per liter (mmol/L) (Least Squares Mean)
HOE901-U300-0.563
Lantus-0.549

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Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6

Participants without any available FPG assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years). (NCT02735044)
Timeframe: Month 6

Interventionpercentage of participants (Number)
HOE901-U30027.47
Lantus26.52

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Change From Baseline in HbA1c to Month 6

Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period. (NCT02735044)
Timeframe: Baseline to Month 6

InterventionPercentage of HbA1c (Least Squares Mean)
HOE901-U300-0.399
Lantus-0.402

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Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6

8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Variability was assessed by the coefficient of variation (standard deviation divided by mean) calculated over the 8-point SMPG. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years). (NCT02735044)
Timeframe: Baseline, Month 6

Interventionpercentage of mean variability (Least Squares Mean)
HOE901-U3001.469
Lantus0.789

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Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12

Hyperglycemia with ketosis was defined as SMPG >=252 mg/dL (14 mmol/L) with accompanying self-measured blood ketones >=1.5 mmol/L. (NCT02735044)
Timeframe: Month 12

Interventionpercentage of participants (Number)
HOE901-U3009.9
Lantus13.6

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Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12

Severe hypoglycemia: an event in which the child/adolescent having altered mental status and cannot assist in their care, is semiconscious or unconscious, or in coma ± convulsions and may require parenteral therapy (glucagon or glucose). Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=70 mg/dL. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration <=70 mg/dL. Pseudo-hypoglycemia:an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >70 mg/dL. (NCT02735044)
Timeframe: Month 12

,
Interventionpercentage of participants (Number)
Any hypoglycemiaSevere HypoglycemiaDocumented Symptomatic HypoglycemiaProbable Symptomatic HypoglycemiaAsymptomatic HypoglycemiaPseudo-hypoglycemiaSevere and/or documented hypoglycemia
HOE901-U30099.18.694.810.388.415.999.1
Lantus98.711.093.913.689.514.598.2

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Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period

Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years). (NCT02735044)
Timeframe: upto Month 6

Interventionpercentage of participants (Number)
HOE901-U3004.29
Lantus4.78

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Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point

8-point SMPG profiles were measured for following 8 time points at Baseline and Month 6: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. (NCT02735044)
Timeframe: Baseline to Month 6

,
Interventionmmol/L (Mean)
Between 01:00 and 04:00 at nightPre-breakfast2 hours after breakfastPre-lunch2 hours after lunchPre-dinner2 hours after dinnerBedtime
HOE901-U3000.84-0.41-0.260.430.490.290.510.86
Lantus-0.60-1.71-0.621.11-0.55-0.020.60-0.60

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Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). (NCT02738151)
Timeframe: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

,
InterventionEvents per participant year (Number)
Any hypo Day1-Week12Any hypo Week13-14Any hypo 24 Week periodSevere and/or confirmed hypo (=<70mg/dL) D1-W12Severe and/or confirmed hypo (=<70mg/dL) W13-14Severe and/or confirmed hypo (≤70mg/dL) 24W periodSevere and/or confirmed hypo (< 54mg/dL) D1-W12Severe and/or confirmed hypo( <54 mg/dL) W13-14Severe and/or confirmed hypo (<54mg/dL) 24W period
Toujeo8.9311.2810.098.0810.649.340.490.730.61
Tresiba11.3111.6011.4510.4711.2110.830.860.910.88

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Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24

The DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionscore on a scale (Least Squares Mean)
Week 12Week 24
Toujeo5.085.77
Tresiba5.325.44

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Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point

4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionmmol/L (Mean)
Week 12: Pre-breakfastWeek 12: Pre-lunchWeek 12: Pre-dinnerWeek 12: BedtimeWeek 24: Pre-breakfastWeek 24: Pre-lunchWeek 24: Pre-dinnerWeek 24: Bedtime
Toujeo-3.41-2.63-2.03-2.41-3.38-2.81-1.88-2.51
Tresiba-2.97-2.44-1.92-2.11-2.99-2.26-1.86-2.10

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Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point

8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionmmol/L (Mean)
Week 12: 03:00 at nightWeek 12: Pre-breakfastWeek 12: 2 hours after breakfastWeek 12: Pre-lunchWeek 12: 2 hours after lunchWeek 12: Pre-dinnerWeek 12: 2 hours after dinnerWeek 12: BedtimeWeek 24: 03:00 at nightWeek 24: Pre-breakfastWeek 24: 2 hours after breakfastWeek 24: Pre-lunchWeek 24: 2 hours after lunchWeek 24: Pre-dinnerWeek 24: 2 hours after dinnerWeek 24: Bedtime
Toujeo-2.77-3.42-3.20-2.64-2.51-2.04-2.32-2.44-2.65-3.37-3.30-2.81-2.74-1.87-2.28-2.52
Tresiba-2.28-3.00-3.23-2.50-1.99-1.93-1.76-2.08-2.43-3.03-3.50-2.29-1.93-1.86-2.07-2.09

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Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24

Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
InterventionUnits per kilogram (U/kg) (Mean)
Week 12Week 24
Toujeo0.2890.357
Tresiba0.2550.309

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Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24

Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionmmol/L (Least Squares Mean)
Week 12Week 24
Toujeo-3.64-3.52
Tresiba-3.89-3.95

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Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24

Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionmmol/L (Least Squares Mean)
Week 12Week 24
Toujeo-3.26-3.23
Tresiba-3.25-3.29

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Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). (NCT02738151)
Timeframe: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

,
InterventionEvents per participant year (Number)
Any hypo D1-W12Any hypo W13-14Any hypo 24Week periodSevere and/or confirmed hypo(=<70mg/dL)D1-W12Severe and/or confirmed hypo(=<70mg/dL)W13-14Severe and/or confirmed hypo(=<70mg/dL)24W PeriodSevere and/or confirmed hypo(< 54mg/dL)D1-W12Severe and/or confirmed hypo(< 54mg/dL)W13-14Severe and/or confirmed hypo(< 54mg/dL)24W Period
Toujeo1.652.321.981.422.241.830.160.330.24
Tresiba2.362.392.382.202.332.260.190.260.22

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Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24

Adjusted LS means were obtained from MMRM. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionpercentage of mean variability (Least Squares Mean)
Week 12Week 24
Toujeo4.083.70
Tresiba4.733.95

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Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period

Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis. (NCT02738151)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
Toujeo4.98
Tresiba4.76

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Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =<3.9 mmol/L (=<70 mg/dL). (NCT02738151)
Timeframe: Week 12, and Week 24

,
Interventionpercentage of participants (Number)
Week12: Participants who reached the target <7%Week12: Participants who reached target <=6.5%Week24: Participants who reached the target <7%Week24: Participants who reached target <=6.5%
Toujeo16.454.1113.425.84
Tresiba13.644.5512.995.19

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Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24

Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis. (NCT02738151)
Timeframe: Week 12, and Week 24

,
Interventionpercentage of participants (Number)
Participants who reached the target <7% at Week 12Participants who reached target <=6.5% at Week 12Participants who reached the target <7% at Week 24Participants who reached target <=6.5% at Week 24
Toujeo34.6311.4748.7021.21
Tresiba36.1514.2944.5919.70

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Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported. (NCT02738151)
Timeframe: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

,
Interventionpercentage of participants (Number)
Any hypo Day1-Week 12Any hypo Week13-14Any hypo 24 week periodSevere and/or confirmed hypo (=<70mg/dL) D1-W12Severe and/or confirmed hypo (=<70mg/dL) W13-14Severe and/or confirmed hypo(=<70mg/dL) 24W periodSevere and/or confirmed hypo (< 54mg/dL) D1-W12Severe and/or confirmed hypo( <54 mg/dL) W13-14Severe and/or confirmed hypo (<54mg/dL) 24W period
Toujeo53.057.270.147.454.166.57.89.814.7
Tresiba58.457.471.254.355.869.011.711.218.4

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Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks). (NCT02738151)
Timeframe: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

,
Interventionpercentage of participants (Number)
Any hypo D1-W12Any hypo W13-14Any hypo 24Week periodSevere and/or confirmed hypo (=<70mg/dL)D1-W12Severe and/or confirmed hypo (=<70mg/dL)W13-14Severe and/or confirmed hypo(=<70mg/dL)24W PeriodSevere and/or confirmed hypo(< 54mg/dL)D1-W12Severe and/or confirmed hypo(< 54mg/dL)W13-14Severe and/or confirmed hypo(< 54mg/dL)24W Period
Toujeo18.422.731.215.221.428.62.84.56.1
Tresiba21.021.230.318.821.028.83.53.86.1

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Change From Baseline in HbA1c to Week 12

Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM. (NCT02738151)
Timeframe: Baseline, Week 12

Interventionpercentage of HbA1c (Least Squares Mean)
Toujeo-1.37
Tresiba-1.39

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Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24

Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionpercentage of mean variability (Least Squares Mean)
Week 12Week 24
Toujeo2.381.49
Tresiba2.621.97

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Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24

The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM. (NCT02738151)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionmmol/L (Least Squares Mean)
Week 12Week 24
Toujeo-2.57-2.62
Tresiba-2.50-2.53

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Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period

Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%. (NCT02738151)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
Toujeo1.30
Tresiba1.30

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Change From Baseline in HbA1c to Week 24

Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period. (NCT02738151)
Timeframe: Baseline, Week 24

Interventionpercentage of HbA1c (Least Squares Mean)
Toujeo-1.64
Tresiba-1.59

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Number of Participants With Emergency Room Visits After Discharge

Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known. (NCT02741687)
Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

InterventionParticipants (Count of Participants)
Placebo0
Sitagliptin0

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Number of Participants With Hospital Readmissions After Discharge

Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known. (NCT02741687)
Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

InterventionParticipants (Count of Participants)
Placebo0
Sitagliptin1

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Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization

The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery. (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

InterventionParticipants (Count of Participants)
Placebo1
Sitagliptin2

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Number of Patients Requiring Supplemental, Subcutaneous Insulin

Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

InterventionParticipants (Count of Participants)
Placebo0
Sitagliptin1

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Length of Hospital Stay

Total length of hospital stay (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

Interventiondays (Median)
Placebo9
Sitagliptin11

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Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin

Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

Interventioninternational units of insulin (Number)
Sitagliptin5

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Number of Days in the ICU

The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required. (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

Interventiondays (Median)
Placebo2.0
Sitagliptin1.5

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Number of Participants With Hypoglycemic Events

Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL) (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

,
InterventionParticipants (Count of Participants)
Mild hypoglycemiaClinically significant hypoglycemia
Placebo20
Sitagliptin50

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Number of Participants Experiencing Stress Hyperglycemia

The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL. (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

InterventionParticipants (Count of Participants)
Placebo7
Sitagliptin5

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Number of Participants Experiencing Complications

The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented. (NCT02741687)
Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

,
InterventionParticipants (Count of Participants)
Wound infectionRespiratory failurePneumoniaAcute kidney injuryCardiac eventBacterial septic infection
Placebo000100
Sitagliptin000100

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Incidence of Treatment Emergent Adverse Events (TEAEs)

A treatment emergent adverse event was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Incidence of AEs was reported in terms of rate, defined as number of adverse events divided by patient years of exposure (PYE) multiplied by 100 (1 PYE=365.25 days). (NCT02762578)
Timeframe: Weeks 0-26

Interventionevents per 100 PYE (Number)
IDegAsp BID321.74
BIAsp 30 BID348.82

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Device Specific Questionnaires II (Would You Recommend the Pen?)

"Participants were asked the question would you recommend the pen? Number of participants reporting yes and no are presented. Missing data was imputed using last observed value." (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
YesNo
BIAsp 30 BID16117
IDegAsp BID33819

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Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment

SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. Fluctuation in 9-point SMPG profile is the average absolute difference to the mean of the profile of the 9-point SMPG measurements accumulated over the profile. (NCT02762578)
Timeframe: At week 26

Interventionmmol/L (Median)
IDegAsp BID1.40
BIAsp 30 BID1.43

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Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment

Number of subjects with HbA1c <7% after 26 weeks of treatment. Missing HbA1c data was imputed using last observed value. (NCT02762578)
Timeframe: Week 26

,
InterventionParticipants (Count of Participants)
YesNo
BIAsp 30 BID8894
IDegAsp BID201160

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Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment

Number of subjects with HbA1c <=6.5% after 26 weeks of treatment. Missing HbA1c data was imputed using last observed value. (NCT02762578)
Timeframe: Week 26

,
InterventionParticipants (Count of Participants)
YesNo
BIAsp 30 BID54128
IDegAsp BID106255

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Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?)

Device Specific Questionnaires II (How easy/difficult is it to reach the dose button when inject your insulin dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID908260
IDegAsp BID193153111

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Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?)

Device Specific Questionnaires II (How easy or difficult was it to learn how to use this pen?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficult
BIAsp 30 BID92797
IDegAsp BID2061457

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Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?)

Device Specific Questionnaires II (How easy or difficult is it to inject yourself in different places of the body using this pen?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult, Very difficult and Not applicable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficultVery difficult
BIAsp 30 BID77851600
IDegAsp BID1671692011

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Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?)

Device Specific Questionnaires II (How easy or difficult is it to inject your usual insulin dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID938131
IDegAsp BID193154110

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Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?)

Device Specific Questionnaires II (How easy or difficult is it to distinguish between dialling up and down?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID918160
IDegAsp BID203144101

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Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?)

Device Specific Questionnaires II (How confident are you that the full dose has been delivered?) was measured on following categories: Very confident, Fairly confident, Fairly easy, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Not at all confidentVery confidentFairly confidentFairly easyRather confidentNot very confident
BIAsp 30 BID079421560
IDegAsp BID11845401172

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Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?)

Device Specific Questionnaires I (Overall, how confident are you in your management of your daily insulin injections using this pen?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very confidentFairly confidentRather confident
BIAsp 30 BID823957
IDegAsp BID19759102

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Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?)

Device Specific Questionnaires I (Overall, how confident are you in controlling your blood sugar level using this pen?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very confidentFairly confidentRather confidentNot very confident
BIAsp 30 BID7160423
IDegAsp BID18085921

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Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?)

Device Specific Questionnaires I (How suitable is the pen to use in public?) was measured on following scale: Very suitable, Fairly suitable, Rather suitable, Not very suitable and Not at all suitable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very suitableFairly suitableRather confidentRather suitableNot very suitable
BIAsp 30 BID606413518
IDegAsp BID12911709418

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Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?)

Device Specific Questionnaires I (How easy/difficult is it to turn the dose selector when choosing the right dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID997260
IDegAsp BID22212871

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Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?)

Device Specific Questionnaires I (How easy/difficult is it to know if the push button has been pushed completely down?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult or Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficult
BIAsp 30 BID92779
IDegAsp BID21313411

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Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale)

Device Specific Questionnaires I (How easy or difficult is it to read the dose scale) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID1046950
IDegAsp BID220128100

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Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?)

Device Specific Questionnaires I (How easy or difficult is it to see the dose scale when injecting?) was measured on following categories: Very confident, Very easy, Fairly easy, Neither easy nor difficult, Rather difficult, and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very confidentVery easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID0947842
IDegAsp BID1215126142

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2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets

2-point profiles (SMPG): pre-breakfast and pre-dinner (main evening meal) SMPGs were to be taken for titration/dose adjustments. The pre-specified titration targets were to achieve SMPG level <5 mmol/L (90 mg/dL) both before breakfast and before main evening meal. For each target, the time from randomisation to the date a subject achieves the titration target for the first time was derived (Kaplan-Meier method). Reported results are time to all titration target (pre-breakfast and pre-dinner) was met for the first time. (NCT02762578)
Timeframe: From randomization till achievement of titration target (up to week 26)

Interventionweek (Median)
IDegAsp BIDNA
BIAsp 30 BIDNA

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Change From Baseline in Body Weight

Change from baseline in body week at week 26. The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value. (NCT02762578)
Timeframe: Week 0, Week 26

Interventionkg (Least Squares Mean)
IDegAsp BID2.82
BIAsp 30 BID2.21

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Change From Baseline in FPG (Fasting Plasma Glucose)

Change from baseline in FPG at week 26. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value. (NCT02762578)
Timeframe: At 26 weeks

Interventionmmol/L (Least Squares Mean)
IDegAsp BID-2.99
BIAsp 30 BID-1.57

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Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of treatment. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value. (NCT02762578)
Timeframe: At 26 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
IDegAsp BID-1.48
BIAsp 30 BID-1.40

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period

"Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Maintenance period was defined as the period from week 16 to end of treatment, including 1 week follow-up.~Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days)." (NCT02762578)
Timeframe: From week 16 to end of treatment (week 26) + 1 week follow-up

Interventionhypoglycaemic episodes per 100 PYE (Number)
IDegAsp BID159.08
BIAsp 30 BID361.18

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Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0%

A responder for HbA1c without confirmed hypoglycaemia was defined as a subject who meets the HbA1c target (<7.0%) at end of trial without treatment emergent confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing data is imputed using last observed value. (NCT02762578)
Timeframe: At 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
BIAsp 30 BID48125
IDegAsp BID153195

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment

"ADA classification of hypoglycaemia:~Severe: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Asymptomatic: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG level ≤3.9 mmol/L.~Documented symptomatic: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG level ≤3.9 mmol/L.~Relative: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia, and interprets those as indicative of hypoglycaemia, but with a measured PG level >3.9 mmol/L.~Probable symptomatic: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L.~Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days)." (NCT02762578)
Timeframe: Week 0-26

Interventionhypoglycaemic episodes per 100 PYE (Number)
IDegAsp BID1699.53
BIAsp 30 BID1585.31

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Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period

"Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The nocturnal period was defined as the period between 00:01 and 05:59 a.m. (both inclusive). Maintenance period was defined as the period from week 16 to end of treatment, including 1 week follow-up.~Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days)." (NCT02762578)
Timeframe: From week 16 to end of treatment (week 26) + 1 week follow-up

Interventionhypoglycaemic episodes per 100 PYE (Number)
IDegAsp BID19.20
BIAsp 30 BID38.60

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Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes

The number of events was analysed using a negative binomial model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate. Confirmed hypoglycaemia is defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. The nocturnal period was defined as the period between 00:01 and 05:59 a.m. (both inclusive). A treatment emergent hypoglycaemic episode was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT02762578)
Timeframe: Weeks 0-26

Interventionevents per 100 patient years of exposure (Number)
IDegAsp BID31.18
BIAsp 30 BID58.55

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Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device])

TRIM-D device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change. The scores were transformed to a 0-100 scale with higher scores indicating less treatment related impact. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: At week 26

Interventionunits on a scale (Mean)
IDegAsp BID72.31
BIAsp 30 BID69.43

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2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment

The logarithm transformed SMPG values available before breakfast and main evening meal were analysed separately as repeated measures in a linear mixed model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age as covariate and subject as random factor. The model assumed independent within- and between-subject errors with variances depending on treatment. Within-subject variability as measured by CoV% for a treatment could be calculated from the corresponding residual variance. (NCT02762578)
Timeframe: At week 26

,
InterventionCoefficient of variation (Number)
Before breakfastBefore main evening meal
BIAsp 30 BID17.1922.96
IDegAsp BID17.2622.45

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9-point Profile (SMPG) After 26 Weeks of Treatment

SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. (NCT02762578)
Timeframe: At week 26

,
Interventionmmol/L (Mean)
Before breakfast90 minutes after start of breakfastBefore lunch90 minutes after start of lunchBefore main evening meal90 minutes after the start of main evening mealBefore bedtimeAt 4:00 a.m.Before breakfast the following day
BIAsp 30 BID6.819.566.6510.527.978.968.126.786.87
IDegAsp BID5.818.686.4710.227.099.358.656.005.69

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Change in Health Related Quality of Life Questionnaire (SF -36)

Change from baseline in SF-36 at week 26. The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Missing data was imputed using last observed value. (NCT02762578)
Timeframe: Week 0, week 26

,
Interventionunits on a scale (Mean)
Physical ScorePhysical FunctioningRole-PhysicalBodily PainGeneral HealthMental ScoreVitalitySocial FunctioningRole-EmotionalMental Health
BIAsp 30 BID-0.13-0.50-0.18-0.712.190.720.69-0.121.01-0.17
IDegAsp BID0.19-1.010.410.933.002.081.561.351.541.39

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Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?)

"Participants were asked to report whether they had any problems using the pen. Number of participants reporting yes and no are presented. Missing data was imputed using last observed value." (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
YesNo
BIAsp 30 BID8169
IDegAsp BID12346

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Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?)

Device Specific Questionnaires I (How comfortable do you find the handling of the pen?) was measured on following categories: Very comfortable, Fairly comfortable, Rather comfortable, Not very comfortable and Not at all comfortable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very comfortableFairly comfortableRather comfortableNot very comfortable
BIAsp 30 BID6668440
IDegAsp BID1461071041

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Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?)

Device Specific Questionnaires I (How confident are you that the air shot has been done correctly?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very confidentFairly confidentRather confidentNot very confident
BIAsp 30 BID7355473
IDegAsp BID157851097

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Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?)

Device Specific Questionnaires I (How confident are you that you inject the correct amount of insulin every time?) was measured on following categories: Very confident, Rather confident, Fairly confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very confidentFairly confidentRather confident
BIAsp 30 BID832867
IDegAsp BID20252104

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Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?)

Device Specific Questionnaires I (How confident are you that you set the insulin dose correctly every time?) was measured on following categories: Very confident, Rather confident, Fairly confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very confidentFairly confidentRather confidentNot very confident
BIAsp 30 BID8526652
IDegAsp BID209431060

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9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment

SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. Prandial PG increment for each meal was derived from the 9-point profile (SMPG) as the difference between PG values after meal (90 min) and before meal. The reported results are mean prandial PG increment overall meals (the mean of all available meal increments). (NCT02762578)
Timeframe: At week 26

Interventionmmol/L (Mean)
IDegAsp BID2.95
BIAsp 30 BID2.60

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Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?)

Device Specific Questionnaires I (How convenient do you find the size of the pen?) was measured on following categories: Very convenient, Fairly convenient, Rather convenient, Not very convenient and Not at all convenient. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very convenientFairly convenientRather convenientNot very convenient
BIAsp 30 BID6369424
IDegAsp BID1431091015

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Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?)

Device Specific Questionnaires I (How easy or difficult is it to feel the clicks for each unit increment?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID1036591
IDegAsp BID217128121

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Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?)

Device Specific Questionnaires I (How easy or difficult is it to hear the clicks for each unit increment?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID1086361
IDegAsp BID23011990

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Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes

A responder for HbA1c without severe hypoglycaemia was defined as a subject who meets the HbA1c target (<7%) at end of trial without severe treatment emergent hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing HbA1c data was imputed using last observed value. (NCT02762578)
Timeframe: At week 26

,
InterventionParticipants (Count of Participants)
YesNo
BIAsp 30 BID8489
IDegAsp BID197151

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Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes

A responder for HbA1c without confirmed hypoglycaemia was defined as a subject who meets the HbA1c target (≤6.5%) at end of trial without treatment emergent confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing data is imputed using last observed value. (NCT02762578)
Timeframe: At 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
BIAsp 30 BID26147
IDegAsp BID82266

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Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?)

Device Specific Questionnaires I (How easy or difficult do you find it to hold the pen stable when injecting?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultVery difficult
BIAsp 30 BID997270
IDegAsp BID22812181

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Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes

A responder for HbA1c without severe hypoglycaemia was defined as a subject who meets the HbA1c target (≤6.5%) at end of trial without severe treatment emergent hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing HbA1c data was imputed using last observed value. (NCT02762578)
Timeframe: At week 26

,
InterventionParticipants (Count of Participants)
YesNo
BIAsp 30 BID50123
IDegAsp BID105243

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

The number of events was analysed using a negative binomial model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. A treatment emergent hypoglycaemic episode was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT02762578)
Timeframe: Weeks 0-26

Interventionevents per 100 patient years of exposure (Number)
IDegAsp BID223.56
BIAsp 30 BID394.17

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Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment

SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. The mean of 9-point profile (SMPG) was defined as the area under the profile divided by the measurement time and was calculated using the trapezoidal method. (NCT02762578)
Timeframe: At week 26

Interventionmmol/L (Mean)
IDegAsp BID7.70
BIAsp 30 BID8.11

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Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?)

Device Specific Questionnaires I (How easy or difficult is it to push down the injection button?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. (NCT02762578)
Timeframe: week 26

,
InterventionParticipants (Count of Participants)
Very easyFairly easyNeither easy nor difficultRather difficult
BIAsp 30 BID8975140
IDegAsp BID22412590

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Nucleus Accumbens Blood Flow

Cerebral blood flow in the right and left nucleus accumbent was measured by arterial spin labeling (MRI). Blood flow was normalized for whole brain perfusion and corrected for baseline perfusion in the respective brain area and meal order, as per our a priori statistical analysis plan. (NCT02772783)
Timeframe: 4 hrs postprandial

,,
Interventionml/g/min per ml/g/min (Least Squares Mean)
rightleft
High GI With Matched to Low GI Glucose (HGI HI)1.131.21
High GI With Matched to Low GI Insulin (HGI LI)1.151.18
Low GI (LGI)1.161.18

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Functional Connectivity of Nucleus Accumbens, Hypothalamus and Other Brain Areas Involved in Intake Regulation

Cerebral blood oxygen concentration level was measured by resting state functional MRI (rs-fMRI). Seed based analysis was performed with the seed on the right Nucleus Accumbens. Functional connectivity between Nucleus Accumbens and Hypothalamus was assessed through extraction of temporal correlation measures. (NCT02772783)
Timeframe: 4 hrs postprandial

Interventionunite-less correlation (Least Squares Mean)
High GI With Matched to Low GI Glucose (HGI HI)0.26
Low GI (LGI)0.24
High GI With Matched to Low GI Insulin (HGI LI)0.25

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Blood Flow in Other Brain Areas Involved in Intake Regulation - Ventrolateral Striatum

Cerebral blood flow was measured by arterial spin labeling (MRI). Grouped MRI data was visually inspected for postprandial differences between conditions. Blood flow from a cluster contracting the conditions in the right ventrolateral striatum, just lateral to the nucleus accumbent, was extracted, normalized for whole brain perfusion and corrected for baseline perfusion in the respective brain area and meal order, as per our a priori statistical analysis plan. (NCT02772783)
Timeframe: 1 hr postprandial

Interventionml/g/min per ml/g/min (Least Squares Mean)
High GI With Matched to Low GI Glucose (HGI HI)0.60
Low GI (LGI)0.61
High GI With Matched to Low GI Insulin (HGI LI)0.60

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Functional Connectivity of Nucleus Accumbens, Hypothalamus and Other Brain Areas Involved in Intake Regulation

Cerebral blood oxygen concentration level was measured by resting state functional MRI (rs-fMRI). Seed based analysis was performed with the seed on the right Nucleus Accumbens. Functional connectivity between Nucleus Accumbens and Hypothalamus was assessed through extraction of temporal correlation measures. Functional connectivity between Nucleus Accumbens and other brain areas was visually assessed. (NCT02772783)
Timeframe: 1 hr postprandial

Interventionunite-less correlation (Least Squares Mean)
High GI With Matched to Low GI Glucose (HGI HI)0.36
Low GI (LGI)0.15
High GI With Matched to Low GI Insulin (HGI LI)0.15

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Blood Flow in Other Brain Areas Involved in Intake Regulation - Dorsal Caudate

Cerebral blood flow was measured by arterial spin labeling (MRI). Grouped MRI data was visually inspected for postprandial differences between conditions. Blood flow from a cluster contracting the conditions in the right dorsal caudate, just lateral to the nucleus accumbent, was extracted, normalized for whole brain perfusion and corrected for baseline perfusion in the respective brain area and meal order, as per our a priori statistical analysis plan. (NCT02772783)
Timeframe: 4 hrs postprandial

Interventionml/g/min per ml/g/min (Least Squares Mean)
High GI With Matched to Low GI Glucose (HGI HI)0.60
Low GI (LGI)0.59
High GI With Matched to Low GI Insulin (HGI LI)0.64

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Nucleus Accumbens Blood Flow

Cerebral blood flow in the right and left nucleus accumbent was measured by arterial spin labeling (MRI). Blood flow was normalized for whole brain perfusion and corrected for baseline perfusion in the respective brain area and meal order, as per our a priori statistical analysis plan. (NCT02772783)
Timeframe: 1 hr postprandial

,,
Interventionml/g/min per ml/g/min (Least Squares Mean)
rightleft
High GI With Matched to Low GI Glucose (HGI HI)1.121.20
High GI With Matched to Low GI Insulin (HGI LI)1.111.14
Low GI (LGI)1.161.19

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Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography

Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionNumber of subjects (Number)
Screening, Left eye (Normal)Screening, Left eye (Abnormal -NCS)Screening, Left eye (Abnormal-CS)Screening, Left eye (Missing)Week 26, Left eye (Normal)Week 26, Left eye (Abnormal -NCS)Week 26, Left eye (Abnormal-CS)Week 26, Left eye (Missing)Screening, Right eye (Normal)Screening, Right eye (Abnormal-NCS)Screening, Right eye (Abnormal- CS)Screening, Right eye (Missing)Week 26, Right eye (Normal)Week 26, Right eye (Abnormal-NCS)Week 26, Right eye (Abnormal- CS)Week 26, Right eye (Missing)
IDegLira1346870123662013369701206920
IGlar1317440125684013372401276640

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Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)

Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionNumber of subjects (Number)
Screening, NormalScreening, Abnormal NCSScreening, Abnormal CSScreening, MissingWeek 26, NormalWeek 26, Abnormal NCSWeek 26, Abnormal CSWeek 26, Missing
IDegLira14266101345820
IGlar14169001366400

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Change From Baseline After 26 Weeks in Waist Circumference

Mean change from baseline in waist circumference after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
Interventioncm (Mean)
Waist circum. (cm) at baselineWaist circum. (cm) change from baseline to week 26
IDegLira105.9-0.6
IGlar104.70.7

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Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values <3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia. (NCT02773368)
Timeframe: Week 0-26

InterventionNumber of episodes (Number)
IDegLira38
IGlar95

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks

Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment. (NCT02773368)
Timeframe: Week 0-26

InterventionNumber of episodes (Number)
IDegLira6
IGlar13

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Number of Treatment-emergent Adverse Events

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT02773368)
Timeframe: Week 0-26

InterventionNumber of events (Number)
IDegLira450
IGlar386

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Insulin Dose, Total Daily Dose (U)

Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

InterventionUnits (U) (Mean)
IDegLira36.2
IGlar53.5

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: Week 0, Week 26

,
Interventionmmol/ L (Mean)
FPG (mmol/L) at baselineFPG (mmol/L) change from baseline to week 26
IDegLira9.51-3.72
IGlar9.57-3.50

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Change in Body Weight

The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: Week 0, Week 26

,
Interventionkg (Mean)
Body weight (kg) at baselineBody weight (kg) change from baseline to week 26
IDegLira89.3-0.0
IGlar87.22.0

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Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile

Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Mean)
Before breakfast - BaselineNinety (90) minutes after breakfast - BaselineBefore lunch - BaselineNinety (90) minutes after lunch - BaselineBefore dinner - BaselineNinety (90) minutes after dinner - BaselineAt bedtime - BaselineAt 4.00 AM - BaselineBefore breakfast the following day - BaselineBefore breakfast - Week 26Ninety (90) minutes after breakfast - Week 26Before lunch - Week 26Ninety (90) minutes after lunch - Week 26Before dinner - Week 26:Ninety (90) minutes after dinner - Week 26At bedtime - Week 26At 4.00 AM - Week 26Before breakfast the following day - Week 26
IDegLira9.0111.798.9311.249.3311.4010.388.808.605.407.205.837.256.437.857.055.585.23
IGlar9.0011.779.2011.229.3611.4010.719.008.815.398.356.358.496.778.707.795.725.36

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Change From Baseline in Systolic Blood Pressure

Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionmmHg (Mean)
Systolic BP (mmHg) at baselineSystolic BP (mmHg) change from baseline to week 26
IDegLira130.5-3.0
IGlar128.90.6

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Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments

Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Mean)
BaselineChange from baseline to week 26
IDegLira2.38-0.86
IGlar2.28-0.09

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Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile

Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Mean)
Mean 9-point SMPG (mmol/L) at baselineMean 9-point SMPG change from baseline to week 26
IDegLira9.98-3.47
IGlar10.06-2.98

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Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)

The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionScores on a scale (Median)
Overall physical - BaselineOverall physical - Week 26Overall mental - BaselineOverall mental - Week 26
IDegLira51.353.253.354.4
IGlar51.554.653.354.4

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Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)

The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Median)
VLDL cholesterol (mmol/L) at baselineVLDL cholesterol (mmol/L) at week 26
IDegLira0.750.70
IGlar0.800.67

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Change From Baseline in Fasting Lipid Profile: Triglycerides

The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Median)
Triglycerides (mmol/L) at baselineTriglycerides (mmol/L) at week 26
IDegLira1.671.55
IGlar1.731.47

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Change in HbA1c (Glycosylated Haemoglobin)

The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: Week 0, Week 26

,
InterventionPercentage of glycosylated haemoglobin (Mean)
HbA1c (%) at baselineHbA1c (%) change from baseline to week 26
IDegLira8.20-1.94
IGlar8.36-1.68

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Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain

The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionParticipants (Number)
YesNo
IDegLira84113
IGlar26176

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Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionPartcipants (Number)
YesNo
IDegLira77120
IGlar24178

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Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionParticpants (Number)
YesNo
IDegLira13760
IGlar79123

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Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%

The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionParticipants (Number)
YesNo
IDegLira14750
IGlar100102

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Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain

The proportion of subjects achieving pre-defined HbA1c targets <7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionParticipants (Number)
YesNo
IDegLira91106
IGlar38164

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Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionParticipants (Number)
YesNo
IDegLira83114
IGlar34168

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Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionParticipants (Number)
YesNo
IDegLira15641
IGlar11488

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Responder (Yes/No) for HbA1c Below 7.0%

The proportion of subjects achieving pre-defined HbA1c targets <7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionParticipants (Number)
YesNo
IDegLira16730
IGlar14458

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Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks

American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. (NCT02773368)
Timeframe: Week 0-26

,
InterventionNumber of episodes (Number)
Severe - ADADocumented symptomatic - ADAAsymptomatic - ADAProbably symptomatic - ADAPseudo - ADAUnclassifiable hypoglycaemia - ADA
IDegLira123985023102
IGlar04199025140

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Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)

The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Median)
LDL cholesterol (mmol/L) at baselineLDL cholesterol (mmol/L) at week 26
IDegLira2.282.20
IGlar2.282.31

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Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)

The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Median)
HDL cholesterol (mmol/L) at baselineHDL cholesterol (mmol/L) at week 26
IDegLira1.141.17
IGlar1.141.17

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Change From Baseline in Fasting Lipid Profile: Free Fatty Acids

The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Median)
Free fatty acids (mmol/L) at baselineFree fatty acids (mmol/L) at week 26
IDegLira0.580.38
IGlar0.610.42

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Change From Baseline in Fasting Lipid Profile: Cholesterol

The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
Interventionmmol/L (Median)
Total cholesterol (mmol/L) at baselineTotal cholesterol (mmol/L) at week 26
IDegLira4.424.27
IGlar4.454.27

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Change From Baseline in Diastolic Blood Pressure

Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionmmHg (Mean)
Diastolic (mmHg) at baselineDiastolic (mmHg) change from baseline to week 26
IDegLira79.4-1.2
IGlar78.9-1.1

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Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate

Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

,
InterventionBeats/minute (Mean)
Pulse (beats/min) at baselinePulse (beats/min) change from baseline to week 26
IDegLira76.12.0
IGlar75.0-0.4

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Story Memory Recall

"A narrative of 44 informational bits is read and the recalled information is recorded immediately and after 20 minutes. Information retained over the delay are calculated as delayed recall/ immediate recall. The participant is asked to recite it immediately, and then following a 20-minute delay.~Delayed score (the outcome analyzed here) ranges from 0 to 44 with a higher score denoting a better ability to recall information." (NCT02810392)
Timeframe: baseline, week 3, week 6

,
Interventionscore on a scale (Mean)
baselineweek 3week 6
Intranasal Insulin22.526.123.9
Intranasal Saline31.426.725.8

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Patient Health Questionnaire-9 Question (PHQ-9)

The PHQ-9 is a measure of depression and is comprised of 9 questions with likert scale responses related to how frequent depressive symptoms are occurring. The likert score for each question is totaled for the final score, which ranges from 0-27 with a score of 27 denoting a higher severity of depression. (NCT02810392)
Timeframe: Baseline, week 3, week 6

,
Interventionscore on a scale (Mean)
baselineweek 3week 6
Intranasal Insulin5.48.24.4
Intranasal Saline4.64.03.7

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Montreal Cognitive Assessment (MoCA)

The MoCA is a cognitive screening instrument which provides information about overall mental status. It is useful for identifying overall cognitive impairment, and also provides information about core cognitive domains, such as visuospatial abilities, attention, executive function, language, orientation, and memory. Score ranges from 0-30 with scores of 26-30 denoting no cognitive impairment, 21-25 mild cognitive impairment and 20 or lower, dementia or severe cognitive impairment. (NCT02810392)
Timeframe: Baseline, week 3, week 6

,
Interventionscore on a scale (Mean)
baselineweek 3week 6
Intranasal Insulin22.422.022.1
Intranasal Saline22.822.923.4

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Modified Rankin Score (MRS)

The mRS Score is a score for disability after stroke. A score of 0 indicates no symptoms remaining and normal pre-stroke activity, 1 indicates no disability despite symptoms, 2 indicates mild disability but still independent, 3 indicates moderate disability but able to walk, 4 indicates moderate to severe disability and requiring significant help from others, 5 indicates 24 hour nursing care and complete dependence on others, and 6 is death. (NCT02810392)
Timeframe: Baseline, week 3, week 6

,
Interventionscore on a scale (Mean)
baselineweek 3week 6
Intranasal Insulin1.71.21.5
Intranasal Saline1.31.01.4

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Modified Caregiver Strain Index

13 questions related to caregiver strain, administered to caregivers separately from the stroke survivor. Score ranges from 0-13 with a score of 7 or more indicating significant caregiver strain. (NCT02810392)
Timeframe: baseline, week 3, week 6

,
Interventionscore on a scale (Mean)
baselineweek 3week 6
Intranasal Insulin4.75.25.5
Intranasal Saline4.74.03.5

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Instrumental Activities of Daily Living Scale:

Lawton Instrumental ADL scale includes 8 domains related to higher level function, including using a telephone, handling money, ability to take medications correctly, independence with transportation, food preparation, shopping, laundry, and housekeeping. Score ranges from 0-8 with 0 denoting no independence with IADLs, and 8 the highest level of independence with IADLs. (NCT02810392)
Timeframe: baseline, week 3, week 6

,
Interventionscore on a scale (Mean)
baselineweek 3week 6
Intranasal Insulin5.86.06.8
Intranasal Saline6.97.26.8

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Verbal Fluency

These tasks of verbal fluency provide the subject one minute to say as many words as possible. For Animal Naming, any living creature is counted. For FAS, words beginning with a given letter (F, A, and then S) are counted excluding proper nouns, numbers, and variations of the same word. Raw scores are converted to t scores, normalized by age, and range from 0 (worse) to 100 (better) outcome. (NCT02810392)
Timeframe: week 6

Interventionscore on a scale (Mean)
Intranasal Insulin36.9
Intranasal Saline39.4

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Verbal Fluency

These tasks of verbal fluency provide the subject one minute to say as many words as possible. For Animal Naming, any living creature is counted. For FAS, words beginning with a given letter (F, A, and then S) are counted excluding proper nouns, numbers, and variations of the same word. Raw scores are converted to t scores, normalized by age, and range from 0 (worse) to 100 (better) outcome. (NCT02810392)
Timeframe: week 3

Interventionscore on a scale (Mean)
Intranasal Insulin34.0
Intranasal Saline39.5

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Verbal Fluency

These tasks of verbal fluency provide the subject one minute to say as many words as possible. For Animal Naming, any living creature is counted. For FAS, words beginning with a given letter (F, A, and then S) are counted excluding proper nouns, numbers, and variations of the same word. Raw scores are converted to t scores, normalized by age, and range from 0 (worse) to 100 (better) outcome. (NCT02810392)
Timeframe: baseline

Interventionscore on a scale (Mean)
Intranasal Insulin33.8
Intranasal Saline36.0

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Composite of Memory t Scores

"Hopkins Verbal Learning Test-Revised (HVLT-R) verbal learning and memory and available to facilitate repeat administration in future testing (10 minutes with delay and recognition). The delayed recall is used as the outcome in this study.~Brief Visual Memory Test-Revised (BVMT-R) is a measure of nonverbal learning and memory captured with immediate and delayed free recall trials, and a recognition memory task (10 minutes with delay and recognition). The retained score normalized by age, is used as the outcome for this study.~The t scores for both HVLT-R delayed recall and BVMT-R retained are normalized from the raw scores based on age. The t score ranges from 0-100 with 0 denoting a worse outcome. The Composite is the average of the mean t scores for each component." (NCT02810392)
Timeframe: baseline

Interventionscore on a scale (Mean)
Intranasal Insulin39.5
Intranasal Saline39.7

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Composite of Memory t Scores

"Hopkins Verbal Learning Test-Revised (HVLT-R) verbal learning and memory and available to facilitate repeat administration in future testing (10 minutes with delay and recognition). The delayed recall is used as the outcome in this study.~Brief Visual Memory Test-Revised (BVMT-R) is a measure of nonverbal learning and memory captured with immediate and delayed free recall trials, and a recognition memory task (10 minutes with delay and recognition). The retained score is used as the outcome for this study.~The t scores for both HVLT-R delayed recall and BVMT-R retained are normalized from the raw scores based on age. The t score ranges from 0-100 with 0 denoting a worse outcome. The Composite is the average of the mean t scores for each component." (NCT02810392)
Timeframe: week 6

Interventionscore on a scale (Mean)
Intranasal Insulin42.4
Intranasal Saline33.9

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Composite of Memory t Scores

"Hopkins Verbal Learning Test-Revised (HVLT-R) verbal learning and memory and available to facilitate repeat administration in future testing (10 minutes with delay and recognition). The delayed recall is used as the outcome in this study.~Brief Visual Memory Test-Revised (BVMT-R) is a measure of nonverbal learning and memory captured with immediate and delayed free recall trials, and a recognition memory task (10 minutes with delay and recognition). The retained score is used as the outcome for this study.~The t scores for both HVLT-R delayed recall and BVMT-R retained are normalized from the raw scores based on age. The t score ranges from 0-100 with 0 denoting a worse outcome. The Composite is the average of the mean t scores for each component." (NCT02810392)
Timeframe: week 3

Interventionscore on a scale (Mean)
Intranasal Insulin38.3
Intranasal Saline34.5

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Composite of Executive Function z Scores

"The Trail Making test-B is a test of sequencing between numbers and letters, and the score is the amount of time needed to complete the test. The t score is the raw score for time to completion and errors, normalized by age and education, and ranges from 0 (poor performance) to 100 (good performance).~WAIS Digit Span subtest Reverse is a measure of working memory, and requires repetition of increasingly longer strings of digits in the reverse order. The t scores are raw scores normalized by age and range from 0 to 100.~WAIS-III Digit-Symbol Coding is a measure of visuomotor processing speed, and requires involves rapidly coding geometric symbols given a number, by using a legend of number-symbol pairs at the top of the page. T scores are raw scores normalized by age, and range from 0 to 100.~The composite outcome included average of the mean t scores for Trailmaking B, Digit span reverse, and digit-symbol coding." (NCT02810392)
Timeframe: week 6

Interventionscore on a scale (Mean)
Intranasal Insulin30.7
Intranasal Saline34.2

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Composite of Executive Function z Scores

"The Trail Making test-B is a test of sequencing between numbers and letters, and the score is the amount of time needed to complete the test. The t score is the raw score for time to completion and errors, normalized by age and education, and ranges from 0 (poor performance) to 100 (good performance).~WAIS Digit Span subtest Reverse is a measure of working memory, and requires repetition of increasingly longer strings of digits in the reverse order. The t scores are raw scores normalized by age and range from 0 to 100.~WAIS-III Digit-Symbol Coding is a measure of visuomotor processing speed, and requires involves rapidly coding geometric symbols given a number, by using a legend of number-symbol pairs at the top of the page. T scores are raw scores normalized by age, and range from 0 to 100.~The composite outcome included average of the mean t scores for Trailmaking B, Digit span reverse, and digit-symbol coding." (NCT02810392)
Timeframe: week 3

Interventionscore on a scale (Mean)
Intranasal Insulin29.4
Intranasal Saline34.4

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Composite of Executive Function t Scores

"The Trail Making test-B is a test of sequencing between numbers and letters, and the score is the amount of time needed to complete the test. The t score is the raw score for time to completion and errors, normalized by age and education, and ranges from 0 (poor performance) to 100 (good performance).~WAIS Digit Span subtest Reverse is a measure of working memory, and requires repetition of increasingly longer strings of digits in the reverse order. The t scores are raw scores normalized by age and range from 0 to 100.~WAIS-III Digit-Symbol Coding is a measure of visuomotor processing speed, and requires involves rapidly coding geometric symbols given a number, by using a legend of number-symbol pairs at the top of the page. T scores are raw scores normalized by age, and range from 0 to 100.~The composite outcome included average of the mean t scores for Trailmaking B, Digit span reverse, and digit-symbol coding." (NCT02810392)
Timeframe: baseline

Interventionscore on a scale (Mean)
Intranasal Insulin28.9
Intranasal Saline32.6

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Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck

Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Normal, baselineAbnormal (NCS), baselineAbnormal (CS), baselineNormal, last on-treatment valueAbnormal (NCS), last on-treatment valueAbnormal (CS), last on-treatment value
Faster Aspart219152217154
NovoRapid221141218162

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Change From Baseline in Physical Examination: Musculoskeletal System

Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Normal, baselineAbnormal (NCS), baselineAbnormal (CS), baselineNormal, last on-treatment valueAbnormal (NCS), last on-treatment valueAbnormal (CS), last on-treatment value
Faster Aspart222131223121
NovoRapid2279022880

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Change From Baseline in Physical Examination: Respiratory System

Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Normal, baselineAbnormal (NCS), baselineAbnormal (CS), baselineNormal, last on-treatment valueAbnormal (NCS), last on-treatment valueAbnormal (CS), last on-treatment value
Faster Aspart2341123501
NovoRapid2351023420

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Change From Baseline in Physical Examination: Skin

Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Normal, baselineAbnormal (NCS), baselineAbnormal (CS), baselineNormal, last on-treatment valueAbnormal (NCS), last on-treatment valueAbnormal (CS), last on-treatment value
Faster Aspart2121862042111
NovoRapid211223203294

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Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM

Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L [70 mg/dL]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmin/day (Mean)
BaselineChange from baseline
Faster Aspart85.42-6.96
NovoRapid79.882.85

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Change From Baseline in Time to the IG Peak After Start of Meal

Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionMinute (Mean)
BaselineChange from baseline
Faster Aspart111.21.2
NovoRapid117.0-1.4

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Change From Baseline in Urinalysis: Albumin/Creatine Ratio

Change from baseline (week 0) in albumin/creatine ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmg/mmol (Mean)
BaselineChange from baseline
Faster Aspart2.670.01
NovoRapid2.00-0.04

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Change From Baseline in Urinalysis: Erythrocytes

Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Negative (baseline)Trace (baseline)1+ (baseline)2+ (baseline)3+ (baseline)Negative (last on-treatment value)Trace (last on-treatment value)1+ (last on-treatment value)2+ (last on-treatment value)3+ (last on-treatment value)
Faster Aspart21785512176328
NovoRapid2151051521510344

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Change From Baseline in Urinalysis: Ketones

Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Negative (baseline)Trace (baseline)1+ (baseline)2+ (baseline)3+ (baseline)4+ (baseline)Negative (last on-treatment value)Trace (last on-treatment value)1+ (last on-treatment value)2+ (last on-treatment value)3+ (last on-treatment value)4+ (last on-treatment value)
Faster Aspart19231112001942515200
NovoRapid205238000203275100

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Change From Baseline in Urinalysis: Protein

Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Negative (baseline)Trace (baseline)1+ (baseline)2+ (baseline)3+ (baseline)4+ (baseline)Negative (last on-treatment value)Trace (last on-treatment value)1+ (last on-treatment value)2+ (last on-treatment value)3+ (last on-treatment value)4+ (last on-treatment value)
Faster Aspart1933184001962710210
NovoRapid1952710400196279400

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Change From Baseline in Vital Sign: Blood Pressure

Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionmmHg (Mean)
Systolic blood pressure (baseline)Diastolic blood pressure (baseline)Systolic blood pressure (change from baseline)Diastolic blood pressure (change from baseline)
Faster Aspart123.674.8-0.8-0.7
NovoRapid122.074.6-0.7-0.4

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Change From Baseline in Vital Sign: Pulse

Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionBeats/minute (Mean)
BaselineChange from baseline
Faster Aspart73.7-0.5
NovoRapid74.5-0.8

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Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile

Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Median)
BaselineLast in-trial value
Faster Aspart2.142.06
NovoRapid2.052.06

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Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements

Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
04:00 to breakfast (Baseline)Bedtime to 04:00 (Baseline)Bedtime to breakfast (Baseline)04:00 to breakfast (Change from baseline)Bedtime to 04:00 (Change from baseline)Bedtime to breakfast (Change from baseline)
Faster Aspart-1.29-0.97-1.73-0.500.810.13
NovoRapid-1.06-0.56-1.56-0.080.18-0.20

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Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
Breakfast (baseline)Lunch (baseline)Main evening meal (baseline)Mean over all meals (baseline)Breakfast (Change from baseline)Lunch (Change from baseline)Main evening meal (Change from baseline)Mean over all meals (Change from baseline)
Faster Aspart10.829.659.7910.07-0.330.27-0.350.06
NovoRapid10.289.629.349.740.230.050.580.13

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Change From Baseline in Haematology: Leucocytes

Change from baseline (week 0) in leucocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Intervention10^9/L (Mean)
BaselineChange from baseline
Faster Aspart6.41-0.09
NovoRapid6.32-0.03

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Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
Breakfast (baseline)Lunch (baseline)Main evening meal (baseline)Mean over all meals (baseline)Breakfast (Change from baseline)Lunch (Change from baseline)Main evening meal (Change from baseline)Mean over all meals (Change from baseline)
Faster Aspart2.621.801.041.93-0.75-0.43-0.47-0.53
NovoRapid1.931.770.521.480.03-0.270.350.12

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Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)

Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
Pre-breakfast (baseline)Pre-lunch (baseline)Pre-main evening meal (baseline)Pre-mean over all meals (baseline)Pre-breakfast (Change from baseline)Pre-lunch (Change from baseline)Pre-main evening meal (Change from baseline)Pre-mean over all meals (Change from baseline)
Faster Aspart8.408.288.688.390.360.390.150.39
NovoRapid8.318.218.878.450.260.210.130.21

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Change From Screening in Electrocardiogram (ECG)

Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Normal, screeningAbnormal (NCS), screeningAbnormal (CS), screeningNormal, last on-treatment valueAbnormal (NCS), last on-treatment valueAbnormal (CS), last on-treatment value
Faster Aspart178580188440
NovoRapid181541180482

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Change From Screening in Fundus Photography/Fundoscopy

Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Left eye (Normal), screeningLeft eye (Abnormal [NCS]), screeningLeft eye (Abnormal [CS]), screeningRight eye (Normal), screeningRight eye (Abnormal [NCS]), screeningRight eye (Abnormal [CS]), screeningLeft eye (Normal), last on-treatment valueLeft eye (Abnormal [NCS]), last on-treatment valueLeft eye (Abnormal [CS] last on-treatment valueRight eye (Normal), last on-treatment valueRight eye (Abnormal-NCS), last on-treatment valueRight eye (Abnormal [CS]), last on-treatment value
Faster Aspart13594713298613077101278010
NovoRapid136946132986119827114877

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionPercentage (%) of HbA1c (Mean)
BaselineChange from baseline
Faster Aspart7.49-0.06
NovoRapid7.49-0.14

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Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])

Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 16

,
InterventionNumber of Events (Number)
IG ≤2.5 mmol/L (45 mg/dL)IG ≤3.0 mmol/L (54 mg/dL)IG ≤3.5 mmol/L (63 mg/dL)IG ≤3.9 mmol/L (70 mg/dL)IG >10.0 mmol/L (180 mg/dL)IG >12.0 mmol/L (216 mg/dL)IG >13.9 mmol/L (250 mg/dL)
Faster Aspart1570284845846371351942307014352
NovoRapid1532292047426576331762127612866

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Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets

"Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.~Reasons for change-of-infusion-sets are categorised as follows:~Category-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing" (NCT02825251)
Timeframe: Week 0-16

,
InterventionNumber of subjects (Number)
Category-1Category-2Category-3Category-4Category-5Category-6Category-7
Faster Aspart5010823366163
NovoRapid50751786081

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall

"ADA classification of hypo:~Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.~Documented symptomatic: PG ≤3.9 mmol/L with symptoms.~Asymptomatic: PG ≤3.9 mmol/L without symptoms.~Probable symptomatic: No measurement with symptoms.~Pseudo: PG >3.9 mmol/L with symptoms.~Unclassifiable.~NN classification of hypo:~BG confirmed: PG <3.1 mmol/L with/without symptoms.~Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.~Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.~Unclassifiable.~Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo." (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart21837225308856132582751327977890
NovoRapid78904227332159032402779324781280

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart012581769704824414829680
NovoRapid0107717563404133724138790

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart537677504329014031246140831860
NovoRapid239076771798013991259140133000

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart010341458703903603908040
NovoRapid088714232903623243626990

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart525095743422092180592622180
NovoRapid228305021164098688798824210

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)

Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart12750823217052027992335281171520
NovoRapid57889207126144027692359277473610

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart0224311009281921640
NovoRapid0190333505148511800

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart213272771913049142949311450
NovoRapid11518241738055550855612490

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart31182297159043037643310730
NovoRapid11312261426043137943211720

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)

Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart986420918414594164686370
NovoRapid2101520261504714204737670

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Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])

Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 16

,
Intervention% of time (Mean)
IG ≤2.5 mmol/L (45 mg/dL)IG ≤3.0 mmol/L (54 mg/dL)IG ≤3.5 mmol/L (63 mg/dL)IG ≤3.9 mmol/L (70.2 mg/dL)IG >10.0 mmol/L (180 mg/dL)IG >12.0 mmol/L (216 mg/dL)IG >13.9 mmol/L (250 mg/dL)
Faster Aspart1.112.153.755.4641.5726.3415.87
NovoRapid1.032.193.935.7639.2424.2314.23

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Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)

Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 16

,
Intervention% of time (Mean)
IG 4.0-7.8 mmol/L (71-140 mg/dL)IG 4.0-10.0 mmol/L (71-180 mg/dL)
Faster Aspart31.4952.40
NovoRapid33.1154.40

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Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]

Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 16

Interventionmmol/L (Mean)
Faster Aspart3.19
NovoRapid3.21

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Insulin Delivery Pump Parameter: Active Insulin Time

Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 16

InterventionHour (h) (Mean)
Faster Aspart3.6
NovoRapid3.6

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Insulin Delivery Pump Parameter: Glucose Sensitivity Factor

Glucose sensitivity factor was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 16

Interventionmmol/L/U (Mean)
Faster Aspart2.65
NovoRapid2.60

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Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio

Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 16

InterventionGram (g)/U (Mean)
Faster Aspart9.13
NovoRapid9.74

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Insulin Dose in Units/Day: Total Basal

Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products. (NCT02825251)
Timeframe: Week 16

InterventionUnit (U) (Mean)
Faster Aspart23.82
NovoRapid23.87

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Insulin Dose in Units/Day: Total Bolus

Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 16

InterventionU (Mean)
Faster Aspart25.91
NovoRapid25.27

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Insulin Dose in Units/Day: Total Daily Insulin Dose

Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 16

InterventionU (Mean)
Faster Aspart49.72
NovoRapid49.12

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Insulin Dose in Units/kg/Day: Total Basal

Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 16

InterventionU/Kg (Mean)
Faster Aspart0.30
NovoRapid0.30

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Insulin Dose in Units/kg/Day: Total Bolus

Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 16

InterventionU/Kg (Mean)
Faster Aspart0.33
NovoRapid0.31

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Insulin Dose in Units/kg/Day: Total Daily Insulin Dose

Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 16

InterventionU/Kg (Mean)
Faster Aspart0.63
NovoRapid0.61

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Number of Change-of-infusion-sets Per Week

Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0-16

InterventionNumber of infusion-sets (Mean)
Faster Aspart2.55
NovoRapid2.49

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Number of Treatment Emergent Adverse Events (AEs)

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

InterventionNumber of adverse events (Number)
Faster Aspart440
NovoRapid412

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Number of Treatment Emergent Infusion Site Reactions

Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

InterventionNumber of infusion site reaction events (Number)
Faster Aspart44
NovoRapid32

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Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)

Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period. (NCT02825251)
Timeframe: Weeks 0-16

InterventionNumber of hypoglycaemic episodes (Number)
Faster Aspart1185
NovoRapid1058

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Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)

Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period. (NCT02825251)
Timeframe: Week 16

Intervention% of subjects (Number)
Faster Aspart20.3
NovoRapid23.3

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Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes

Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period. (NCT02825251)
Timeframe: Week 16

Intervention% of subjects (Number)
Faster Aspart18.6
NovoRapid22.5

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Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]

Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period. (NCT02825251)
Timeframe: Week 16

Intervention% of subjects (Number)
Faster Aspart8.1
NovoRapid7.6

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Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia

Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period. (NCT02825251)
Timeframe: Week 16

Intervention% of subjects (Number)
Faster Aspart7.6
NovoRapid6.8

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Variation in the IG Profile

Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 16

Interventionmmol/L (Median)
Faster Aspart3.09
NovoRapid3.04

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Change From Baseline in 1-hour PPG Increment

Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, Week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart4.67-0.89
NovoRapid4.620.05

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Change From Baseline in 1,5-anhydroglucitol

Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, Week 16

,
Interventionug/mL (Mean)
BaselineChange from baseline
Faster Aspart4.200.14
NovoRapid4.130.25

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Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)

Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
30-min (Baseline)1-hour (Baseline)2-hour (Baseline)3-hour (Baseline)4-hour (Baseline)30-min (Change from baseline)1-hour (Change from baseline)2-hour (Change from baseline)3-hour (Change from baseline)4-hour (Change from baseline)
Faster Aspart10.5412.1813.1711.389.07-0.50-0.85-0.80-0.330.00
NovoRapid10.3011.9613.0411.489.180.420.360.420.200.21

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Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)

Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
30-min (Baseline)2-hour (Baseline)3-hour (Baseline)4-hour (Baseline)30-min (Change from baseline)2-hour (Change from baseline)3-hour (Change from baseline)4-hour (Change from baseline)
Faster Aspart3.025.653.851.57-0.53-0.82-0.350.01
NovoRapid2.955.704.131.830.110.09-0.14-0.11

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Change From Baseline in AUCIG,0-15min

Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart7.550.16
NovoRapid7.370.21

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Change From Baseline in AUCIG,0-1h

Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart9.47-0.07
NovoRapid9.350.32

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Change From Baseline in AUCIG,0-2h

Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart11.27-0.38
NovoRapid11.180.37

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Change From Baseline in AUCIG,0-30min

Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart7.980.12
NovoRapid7.860.22

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Change From Baseline in AUCIG,0-4h

Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart11.31-0.32
NovoRapid11.400.29

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Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)

Change from baseline (week 0) in ALT was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionU/L (Mean)
BaselineChange from baseline
Faster Aspart20.00.1
NovoRapid19.10

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Change From Baseline in Biochemistry: Albumin

Change from baseline (week 0) in albumin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventiong/dL (Mean)
BaselineChange from baseline
Faster Aspart4.32-0.01
NovoRapid4.31-0.05

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Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)

Change from baseline (week 0) in ALP was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionU/L (Mean)
BaselineChange from baseline
Faster Aspart68.81.2
NovoRapid69.70.8

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Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)

Change from baseline (week 0) in AST was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionU/L (Mean)
BaselineChange from baseline
Faster Aspart22.2-0.1
NovoRapid20.6-0.4

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Change From Baseline in Biochemistry: Creatinine

Change from baseline (week 0) in creatinine was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionumol/L (Mean)
BaselineChange from baseline
Faster Aspart73.80.9
NovoRapid74.5-0.1

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Change From Baseline in Biochemistry: Potassium

Change from baseline (week 0) in potassium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart4.34-0.02
NovoRapid4.30-0.01

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Change From Baseline in Biochemistry: Sodium

Change from baseline (week 0) in sodium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart140.3-0.2
NovoRapid140.3-0.2

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Change From Baseline in Biochemistry: Total Bilirubin

Change from baseline (week 0) in bilirubin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionumol/L (Mean)
BaselineChange from baseline
Faster Aspart8.2-0.3
NovoRapid8.8-1.0

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Change From Baseline in Biochemistry: Total Protein

Change from baseline (week 0) in total protein was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventiong/dL (Mean)
BaselineChange from baseline
Faster Aspart6.730.03
NovoRapid6.74-0.05

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Change From Baseline in Body Mass Index (BMI)

Change from baseline (week 0) in BMI was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionkg/m^2 (Mean)
BaselineChange from baseline
Faster Aspart26.160.12
NovoRapid26.510.28

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Change From Baseline in Body Weight

Change from baseline (week 0) in body weight was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionKg (Mean)
BaselineChange from baseline
Faster Aspart76.860.34
NovoRapid78.210.80

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart7.60-0.03
NovoRapid7.400.25

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Change From Baseline in Haematology: Erythrocytes

Change from baseline (week 0) in erythrocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Intervention10^12/L (Mean)
BaselineChange from baseline
Faster Aspart4.660.01
NovoRapid4.72-0.03

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Change From Baseline in Haematology: Haematocrit

Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Intervention% of haematocrit (Mean)
BaselineChange from baseline
Faster Aspart42.230.09
NovoRapid42.37-0.30

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Change From Baseline in Haematology: Haemoglobin

Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart8.62-0.01
NovoRapid8.62-0.06

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Change From Baseline in Haematology: Thrombocytes

Change from baseline (week 0) in thrombocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
Intervention10^9/L (Mean)
BaselineChange from baseline
Faster Aspart246.42.2
NovoRapid243.60.2

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Change From Baseline in IG Peak After Start of Meal

Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart14.71-0.57
NovoRapid14.690.36

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Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)

Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Median)
Total cholesterol (Baseline)High density lipoproteins (Baseline)Low density lipoproteins (Baseline)Total cholesterol (Last in-trial value)High density lipoproteins (Last in-trial value)Low density lipoproteins (Last in-trial value)
Faster Aspart4.481.702.464.611.742.56
NovoRapid4.681.712.634.571.742.59

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Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
Breakfast 0-30 min (Baseline)Lunch 0-30 min (Baseline)Main evening meal 0-30 min (Baseline)Mean across all meals 0-30 min (Baseline)Breakfast 0-1 h (Baseline)Lunch 0-1 h (Baseline)Main evening meal 0-1 h (Baseline)Mean across all meals 0-1 h (Baseline)Breakfast 0-2 h (Baseline)Lunch 0-2 h (Baseline)Main evening meal 0-2 h (Baseline)Mean across all meals 0-2 h (Baseline)Breakfast 0-30 min (Change from baseline)Lunch 0-30 min (Change from baseline)Main evening meal 0-30 min (Change from baseline)Mean across all meals 0-30min:Change from baselineBreakfast 0-1 h (Change from baseline)Lunch 0-1 h (Change from baseline)Main evening meal 0-1 h (Change from baseline)Mean across all meals 0-1 h (Change from baseline)Breakfast 0-2 h (Change from baseline)Lunch 0-2 h (Change from baseline)Main evening meal 0-2 h (Change from baseline)Mean across all meals 0-2 h (Change from baseline)
Faster Aspart0.230.020.150.130.780.420.390.521.320.990.540.93-0.030.05-0.07-0.01-0.13-0.02-0.16-0.10-0.28-0.24-0.29-0.25
NovoRapid0.210.030.090.110.730.440.320.501.270.920.500.890.080.10-0.010.060.140.150.040.110.160.22-0.030.12

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Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
Breakfast (Baseline)Lunch (Baseline)Main evening meal (Baseline)Mean across all meals (Baseline)Breakfast (Change from baseline)Lunch (Change from baseline)Main evening meal (Change from baseline)Mean across all meals (Change from baseline)
Faster Aspart12.4312.4212.6512.490.100.100.220.16
NovoRapid12.2512.5612.7012.510.110.19-0.130.03

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Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile

Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart9.240.19
NovoRapid9.100.10

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Change From Baseline in Mean of the IG Profile

Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BaselineChange from baseline
Faster Aspart9.380.28
NovoRapid9.390.04

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Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionMinutes (Mean)
Breakfast (Baseline)Lunch (Baseline)Main evening meal (Baseline)Mean across all meals (Baseline)Breakfast (Change from baseline)Lunch (Change from baseline)Main evening meal (Change from baseline)Mean across all meals (Change from baseline)
Faster Aspart88.95109.47110.11103.240.25-2.00-2.04-1.30
NovoRapid97.29106.94106.91103.99-4.031.64-1.43-1.00

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Change From Baseline in Physical Examination: Cardiovascular System

Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Normal, baselineAbnormal (NCS), baselineAbnormal (CS), baselineNormal, last on-treatment valueAbnormal (NCS), last on-treatment valueAbnormal (CS), last on-treatment value
Faster Aspart2331223141
NovoRapid2297022871

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Change From Baseline in Physical Examination: Central and Peripheral Nervous System

Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Normal, baselineAbnormal (NCS), baselineAbnormal (CS), baselineNormal, last on-treatment valueAbnormal (NCS), last on-treatment valueAbnormal (CS), last on-treatment value
Faster Aspart210224209234
NovoRapid215183216173

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Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth

Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. (NCT02825251)
Timeframe: Week 0, week 16

,
InterventionNumber of subjects (Number)
Normal, baselineAbnormal (NCS), baselineAbnormal (CS), baselineNormal, last on-treatment valueAbnormal (NCS), last on-treatment valueAbnormal (CS), last on-treatment value
Faster Aspart2313223141
NovoRapid2315023132

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Constrained Longitudinal Data Analysis of Change From Baseline in 1,5-anhydroglucitol (1,5-AG) at Week 16 Excluding Data After Glycemic Rescue (Phase A)

1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Data (1,5-AG at Week 16 minus 1,5-AG at baseline) was analyzed by Constrained Longitudinal Data Analysis. Positive data values indicate an increase in 1,5-AG levels and correlate with an improvement in glycemia. (NCT02906709)
Timeframe: Baseline (Day 1) and Week 16

Interventionmg/L (Least Squares Mean)
Omarigliptin 25 mg2.9
Placebo-0.2

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Constrained Longitudinal Data Analysis of Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 Excluding Data After Glycemic Rescue (Phase A)

Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 16 weeks of treatment to determine Constrained Longitudinal Data Analysis change in plasma glucose levels (i.e., FPG at Week 16 minus FPG at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Negative data values indicated a reduction in FPG levels. (NCT02906709)
Timeframe: Baseline (Day 1) and Week 16

Interventionmg/dL (Least Squares Mean)
Omarigliptin 25 mg-11.6
Placebo3.4

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Percentage of Participants Achieving HbA1c Goals (<6.5%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Each of the 10 imputed data sets was summarized to obtain the percentage of responders within each group and were combined using standard multiple imputation techniques to yield an overall estimate of response rate and associated variance for each group. A constrained longitudinal data analysis was used to analyze the data and Wilson score method by treatment groups used for the analysis of percentages of individuals at the HbA1c goals of <6.5% at Week 16 and the 95% confidence intervals (CIs). Miettinen & Nurminen (M&N) method after imputations were used to calculate the treatment differences of the percentages of individuals and the 95% CIs. (NCT02906709)
Timeframe: Week 16

InterventionPercentage of Participants (Number)
Omarigliptin 25 mg1.7
Placebo0.0

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Percentage of Participants Achieving Hemoglobin A1c Goals (<6.5%) at Week 52 (Phase A+B)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. For the HbA1c goals of <6.5% at Week 52, the percentage of participants and the 95% confidence intervals were calculated using Wilson score method by treatment groups of the double-blind period. (NCT02906709)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Omarigliptin 25 mg1.6
Placebo→Omarigliptin 25 mg0.0

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Constrained Longitudinal Data Analysis of Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16 Excluding Data After Glycemic Rescue (Phase A)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 16 to determine the Constrained Longitudinal Data Analysis least squares mean HbA1c change from baseline (i.e., HbA1c at Week 16 minus HbA1c at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Negative data values indicated a reduction in HbA1c levels. (NCT02906709)
Timeframe: Baseline (Day 1) and Week 16

InterventionPercent HbA1c (Least Squares Mean)
Omarigliptin 25 mg-0.61
Placebo0.29

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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Phase A+B)

Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Negative data values indicated a reduction in FPG levels. (NCT02906709)
Timeframe: Baseline (Day 1) and Week 52

Interventionmg/dL (Mean)
Omarigliptin 25 mg-11.5
Placebo→Omarigliptin 25 mg-5.3

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Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Each of the 10 imputed data sets was summarized to obtain the percentage of responders within each group and were combined using standard multiple imputation techniques to yield an overall estimate of response rate and associated variance for each group. A constrained longitudinal data analysis was used to analyze the data and Wilson score method by treatment groups used for the analysis of percentages of individuals at the HbA1c goals of <7.0% at Week 16 and the 95% confidence intervals (CIs). Miettinen & Nurminen (M&N) method after imputations were used to calculate the treatment differences of the percentages of individuals and the 95% CIs. (NCT02906709)
Timeframe: Week 16

InterventionPercentage of Participants (Number)
Omarigliptin 25 mg5.8
Placebo0.0

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Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 (Phase A+B)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 52 to determine the mean HbA1c change from baseline (i.e., HbA1c at Week 52 minus HbA1c at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Negative data values indicated a reduction in HbA1c levels. (NCT02906709)
Timeframe: Baseline (Day 1) and Week 52

InterventionPercent A1C (Mean)
Omarigliptin 25 mg-0.57
Placebo→Omarigliptin 25 mg-0.57

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Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 52 (Phase A+B)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. For the HbA1c goals of <7.0% at Week 52, the percentage of participants and the 95% confidence intervals were calculated using Wilson score method by treatment groups of the double-blind period. (NCT02906709)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Omarigliptin 25 mg7.3
Placebo→Omarigliptin 25 mg8.6

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Percentage of Participants Who Discontinued Study Drug Due to an AE Excluding Data After Glycemic Rescue (Phase A)

An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. (NCT02906709)
Timeframe: Up to Week 16

InterventionPercentage of Participants (Number)
Omarigliptin 25 mg0.8
Placebo4.9

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Percentage of Participants Who Discontinued Study Drug Due to an AE Including Data After Glycemic Rescue (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only])

An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. The results for the Placebo→Omarigliptin group summarized data from the open label period only (36 weeks), which corresponds to the study interval in which those participants were exposed to omarigliptin. (NCT02906709)
Timeframe: Up to Week 52

InterventionPercentage of Participants (Number)
Omarigliptin 25 mg (Phase A and B)3.3
Placebo→Omarigliptin 25 mg (Phase B Only)0

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Percentage of Participants Who Experienced One or More Adverse Events (AE) Excluding Data After Glycemic Rescue (Phase A)

An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. (NCT02906709)
Timeframe: Up to Week 16

InterventionPercentage of participants (Number)
Omarigliptin 25 mg51.2
Placebo44.3

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Percentage of Participants Who Experienced One or More AE (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only])

An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. The results for the Placebo→Omarigliptin group summarized data from the open label period only (36 weeks), which corresponds to the study interval in which those participants were exposed to omarigliptin. (NCT02906709)
Timeframe: Up to Week 52

InterventionPercentage of Participants (Number)
Omarigliptin 25 mg (Phase A and B)84.6
Placebo→Omarigliptin 25 mg (Phase B Only)67.2

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Total Insulin Dose

Total insulin dose was evaluated 26 and 38 weeks after randomisation, respectively. (NCT02906917)
Timeframe: Week 26 and week 38

,
InterventionUnits (Mean)
Week 26Week 38
Insulin Degludec/Insulin Aspart70.983.4
Insulin Glargine + Insulin Aspart79.489.3

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Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia

Participants achieving (yes/no) HbA1c <7% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia, was evaluated 26 and 38 weeks after randomisation, respectively. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. (NCT02906917)
Timeframe: Week 26 and week 38

,
InterventionNumber of participants (Number)
Week 26: YesWeek 26: NoWeek 38: YesWeek 38: No
Insulin Degludec/Insulin Aspart7316860174
Insulin Glargine + Insulin Aspart6118156177

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Responder (Yes/No) for HbA1c < 7%

Participants achieving (yes/no) HbA1c <7% was evaluated 26 and 38 weeks after randomisation, respectively. (NCT02906917)
Timeframe: Week 26 and week 38

,
InterventionNumber of participants (Number)
Week 26: YesWeek 26: NoWeek 38: YesWeek 38: No
Insulin Degludec/Insulin Aspart12012113995
Insulin Glargine + Insulin Aspart12012214093

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. (NCT02906917)
Timeframe: Weeks 0-26, weeks 16-26, weeks 0-38

,
InterventionEpisodes (Number)
Weeks 0-26Weeks 16-26Weeks 0-38
Insulin Degludec/Insulin Aspart329154537
Insulin Glargine + Insulin Aspart376194640

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Incidence of TEAEs

Number of treatment emergent adverse events (TEAEs) were analysed during the following periods: weeks 0-26, weeks 26-38 and weeks 0-38. Treatment emergent: An adverse event that had an onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. If an event had an onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period, or if it had an onset date within 7 days after the last drug date, then this event was also to be considered as a TEAE. (NCT02906917)
Timeframe: Weeks 0-26, weeks 26-38, weeks 0-38

,
InterventionEvents (Number)
Weeks 0-26Weeks 26-38Weeks 0-38
Insulin Degludec/Insulin Aspart441173614
Insulin Glargine + Insulin Aspart408117525

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Change in Body Weight

Change from baseline (week 0) in body weight was evaluated 26 and 38 weeks after randomisation, respectively. (NCT02906917)
Timeframe: Week 0, week 26, week 38

,
InterventionKg (Mean)
Baseline: Week 0Change from basline: Week 26Change from basline: Week 38
Insulin Degludec/Insulin Aspart88.51.72.5
Insulin Glargine + Insulin Aspart88.41.42.4

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Change in FPG

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated 26 and 38 weeks after randomisation, respectively. (NCT02906917)
Timeframe: Week 0, week 26, week 38

,
Interventionmg/dL (Mean)
Baseline: Week 0Change from baseline: Week 26Change from baseline: Week 38
Insulin Degludec/Insulin Aspart162.4-42.1-48.6
Insulin Glargine + Insulin Aspart157.8-40.6-41.5

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Change in HbA1c (%) - Week 26

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation. (NCT02906917)
Timeframe: Week 0, week 26

,
Intervention% of HbA1c (Mean)
Baseline (week 0)Change from baseline (week 26)
Insulin Degludec/Insulin Aspart8.2-1.1
Insulin Glargine + Insulin Aspart8.1-1.1

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Change in HbA1c (%) - Week 38

Change from baseline (week 0) in HbA1c was evaluated 38 weeks after randomisation. (NCT02906917)
Timeframe: Week 0, week 38

,
Intervention% of HbA1c (Mean)
Baseline (week 0)Change from baseline (week 38)
Insulin Degludec/Insulin Aspart8.2-1.2
Insulin Glargine + Insulin Aspart8.1-1.2

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Change in Postprandial SMPG Increment (From 9-point Profile)

Change from baseline (week 0) in postprandial SMPG increment (from 9-point profile) was evaluated 26 and 38 weeks after randomisation, respectively. 9-point SMPG profiles were measured starting in the morning 2 days prior to the scheduled visit at the time points described below: 1) Before breakfast (2 days prior to visit) 2) 90 minutes after start of the breakfast 3) Before lunch 4) 90 minutes after start of the lunch 5) Before dinner/main evening meal 6) 90 minutes after start of the dinner/main evening meal 7) At bedtime (2 days or 1 day prior to visit depending on actual clock time) 8) At 4 a.m. (1 day prior to visit) 9) Before breakfast at the following day (1 day prior to the visit). (NCT02906917)
Timeframe: Week 0, week 26, week 38

,
Interventionmg/dL (Mean)
Baseline: Week 0Change from baseline: Week 26Change from baseline: Week 38
Insulin Degludec/Insulin Aspart54.5-10.8-17.7
Insulin Glargine + Insulin Aspart48.4-8.7-19.7

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Change in Pre-breakfast SMPG (Used for Titration)

Reported results are observed pre-breakfast self-measured plasma glucose (SMPG; used for titration) values at week 1 (baseline) and 26 and 38 weeks after randomisation. (NCT02906917)
Timeframe: Week 1, week 26, week 38

,
Interventionmg/dL (Mean)
Week 1 (Baseline)Week 26Week 38
Insulin Degludec/Insulin Aspart158.3107.5102.9
Insulin Glargine + Insulin Aspart149.4103.4103.8

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Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Number of nocturnal, treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Nocturnal hypoglycaemic episodes: episodes occurring between 00:01 and 05:59 both inclusive. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. (NCT02906917)
Timeframe: Weeks 0-26, weeks 16-26, weeks 0-38

,
InterventionEpisodes (Number)
Weeks 0-26Weeks 16-26Weeks 0-38
Insulin Degludec/Insulin Aspart6124113
Insulin Glargine + Insulin Aspart11858189

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02911948)
Timeframe: During 26 weeks of treatment

InterventionNumber of episodes (Number)
Insulin Degludec/Liraglutide4
Insulin Degludec8

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Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition

"Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:~Severe hypoglycaemia~Documented symptomatic hypoglycaemia~Asymptomatic hypoglycaemia~Probable symptomatic hypoglycaemia~Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product." (NCT02911948)
Timeframe: During 26 weeks of treatment

InterventionNumber of episodes (Number)
Insulin Degludec/Liraglutide780
Insulin Degludec717

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Number of Treatment Emergent Adverse Events (TEAE)

Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE. (NCT02911948)
Timeframe: During 26 weeks of treatment

InterventionNumber of events (Number)
Insulin Degludec/Liraglutide280
Insulin Degludec210

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Daily Insulin Dose

Actual daily total insulin dose after 26 weeks. (NCT02911948)
Timeframe: After 26 weeks

InterventionUnits (Mean)
Insulin Degludec/Liraglutide37.6
Insulin Degludec41.2

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

Interventioncm (Mean)
Insulin Degludec/Liraglutide-0.6
Insulin Degludec0.1

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Change in SMBG 9-point Profile: Mean of the 9-point Profile

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time. (NCT02911948)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-2.90
Insulin Degludec-1.11

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Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments. (NCT02911948)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-0.76
Insulin Degludec0.70

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Change in Pulse

Change in pulse after 26 weeks of treatment. (NCT02911948)
Timeframe: Week 0, week 26

Interventionbeats per minute (Mean)
Insulin Degludec/Liraglutide6.1
Insulin Degludec-0.2

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Change in Body Weight

Change from baseline (week 0) in body weight after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

InterventionKg (Mean)
Insulin Degludec/Liraglutide-0.7
Insulin Degludec0.7

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Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain

Number of subjects with HbA1c less than 7.0% and without weight gain after 26 weeks. (NCT02911948)
Timeframe: After 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec996
Insulin Degludec/Liraglutide5055

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Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile)

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. (NCT02911948)
Timeframe: After 26 weeks

,
Interventionmmol/L (Mean)
Before breakfast90 minutes after start of breakfastBefore lunch90 minutes after start of lunchBefore dinner90 minutes after start of dinnerAt BedtimeAt 4:00 a.m.Before breakfast the following day
Insulin Degludec6.5312.028.4912.848.6013.2711.987.726.40
Insulin Degludec/Liraglutide6.5911.007.2210.597.3911.099.576.756.14

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Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02911948)
Timeframe: After 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec893
Insulin Degludec/Liraglutide5352

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Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than or equal to 6.5% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02911948)
Timeframe: After 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec398
Insulin Degludec/Liraglutide3768

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Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain

Number of subjects with HbA1c less than or equal to 6.5% and without weight gain (NCT02911948)
Timeframe: After 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec4101
Insulin Degludec/Liraglutide3867

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-2.81
Insulin Degludec-2.29

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Responder (Yes/no): HbA1c Less Than or Equal to 6.5%

Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks. (NCT02911948)
Timeframe: After 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec996
Insulin Degludec/Liraglutide5748

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Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than 7.0% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02911948)
Timeframe: After 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec2081
Insulin Degludec/Liraglutide7035

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Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than 7.0% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02911948)
Timeframe: After 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec794
Insulin Degludec/Liraglutide4956

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Responder (Yes/no): HbA1c Less Than 7.0%

Number of subjects with HbA1c less than 7.0% after 26 weeks. (NCT02911948)
Timeframe: After 26 weeks

,
InterventionParticipants (Count of Participants)
YesNo
Insulin Degludec2382
Insulin Degludec/Liraglutide7530

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Fasting Lipid Profile

Lipid profile includes total cholesterol, low density lipoprotein cholesterol (LDL cholesterol), high density lipoprotein cholesterol (HDL cholesterol), very low density lipoprotein cholesterol (VLDL cholesterol), triglycerides and free fatty acids. Lipid profile parameters are represented as ratio to baseline values. (NCT02911948)
Timeframe: Week 0, week 26

,
InterventionRatio (Geometric Mean)
Total cholesterolHDL cholesterolLDL cholesterolVLDL cholesterolTriglyceridesFree fatty acids
Insulin Degludec0.960.950.950.970.970.77
Insulin Degludec/Liraglutide0.900.900.861.021.020.86

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Change in Clinical Evaluation: Fundoscopy or Fundus Photography

The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 26. (NCT02911948)
Timeframe: Screening (week -2 to week 0), week 26

,
InterventionParticipants (Count of Participants)
Left eye - at screening visit - normalLeft eye - at screening visit - Abn, NCSLeft eye - at screening visit - Abn, CSLeft eye - week 26 - normalLeft eye - week 26 - Abn, NCSLeft eye - week 26 - Abn, CSRight eye - at screening visit - normalRight eye - at screening visit - Abn, NCSRight eye - at screening visit - Abn, CSRight eye - week 26 - normalRight eye - week 26 - Abn, NCSRight eye - week 26 - Abn, CS
Insulin Degludec70530647347262769630
Insulin Degludec/Liraglutide53646547445574352845

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Change in Clinical Evaluation: Electrocardiogram (ECG)

The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 26. (NCT02911948)
Timeframe: Screening (week -2 to week 0), week 26

,
InterventionParticipants (Count of Participants)
At screening visit - normalAt screening visit - Abn, NCSAt screening visit - Abn, CSWeek 26 -normalWeek 26 - Abn, NCSWeek 26 - Abn, CS
Insulin Degludec8218582203
Insulin Degludec/Liraglutide8020582176

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Change in Blood Pressure (Systolic and Diastolic)

Change from baseline in blood pressure (systolic and diastolic) after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

,
InterventionmmHg (Mean)
Systolic blood pressureDiastolic blood pressure
Insulin Degludec0.91.2
Insulin Degludec/Liraglutide-0.60.9

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Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire

"Overall health state was rated by patients using the EQ-5D-5L visual analogue scale (VAS) and the EQ-5D-5L index score. The EQ-5D-5L VAS is a vertical scale where patients can rank their health from 0 (worst health imaginable) to 100 (best health imaginable).~The EQ-5D-5L index score was calculated based on the 5 dimensions, i.e., mobility, self-care, usual activities (e.g., work, study), pain/discomfort and anxiety/depression with five response levels for each dimension, i.e., no problems, slight problems, moderate problems, severe problems and extreme problems. The scores from 5 dimensions are then converted to the EQ-5D-5L index score scale: 0 - 1 (full health/best-case response = 1; death/worst-case response = 0)." (NCT02911948)
Timeframe: week 0, week 26

,
InterventionScore on a scale (Mean)
Change in VAS scoreIndex score
Insulin Degludec-1.0-0.01
Insulin Degludec/Liraglutide6.30.02

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Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02911948)
Timeframe: During 26 weeks of treatment

InterventionNumber of episodes (Number)
Insulin Degludec/Liraglutide124
Insulin Degludec109

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02911948)
Timeframe: During 26 weeks of treatment

InterventionNumber of episodes (Number)
Insulin Degludec/Liraglutide52
Insulin Degludec43

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline (week 0) in HbA1c after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

InterventionPercentage of HbA1c (Mean)
Insulin Degludec/Liraglutide-1.95
Insulin Degludec-0.65

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The Number Hypoglycemic Events for Single and Multiple Doses of ORMD-0801 vs Placebo

The number of safety parameter hypoglycemic events for single and multiple doses of ORMD-0801 vs placebo. (NCT02954601)
Timeframe: Day 3 through Day 8 of treatment

Interventionnumber of hypoglycemic events (Number)
Placebo3
Dose 12
Dose 24
Dose 35

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Change in Glucose Levels Between Pre-treatment and End of Treatment as Measured by 24-hour Continuous Glucose Monitoring (CGM)

Measure the change in Glucose (mg/dL) by 24 hour CGM between Day3 and Day8 (Change in mg/dL between run-in and Day 5 of Active treatment) (NCT02954601)
Timeframe: Day 3 (run-in) and Day 8 (Day 5 of Active treatment)

Interventionmg/dL (Mean)
Placebo-4.94
Dose 1-10.00
Dose 2-1.21
Dose 3-11.42

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Calculate the Difference Between Values of Pre-treatment and End-of-treatment Mean Daytime CGM Glucose

Calculate the difference between pre-treatment (Day 3) and end of treatment (Day 8) mean daytime CGM glucose for single and multiple doses of ORMD-0801 vs placebo. (NCT02954601)
Timeframe: Day 3 and Day 8 (two timepoints)

Interventionmg/dL (Mean)
Placebo-4.11
Dose 1-13.96
Dose 21.13
Dose 3-16.78

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Calculate the C-peptide Ratio for Single and Multiple Doses of ORMD-0801 vs Placebo.

For each dose, calculate the ratio of the C-Peptide measurement area-under-the-curve (ng-hr/mL) Day 8 to the C-peptide measurement area-under-the-curve (ng-hr/mL) Day 3. This ratio is called the C-peptide Ratio. (NCT02954601)
Timeframe: Day 3 and Day 8

Interventionratio (Mean)
Placebo0.97
Dose 11.01
Dose 21.03
Dose 30.93

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Fingerstick Blood Glucose (Subset)

Fingerstick blood glucose levels were monitored twice within the 90 minutes following the first dose administration of study drug for the first 15 participants. (NCT02988401)
Timeframe: At the baseline visit, monitored twice within the 90 minutes following the first dose administration of study drug

,,
Interventionmg/dL (Mean)
First timepointSecond timepoint
Intranasal Insulin 10 International Units95.892.2
Intranasal Insulin 20 International Units97.888.4
Placebo90.087.8

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Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT)

This test measures phonemic fluency. The test scores the number of words a participant can provide that begin with a specified letter within one minute, such that scores range from zero (worst) to an infinite number (better). Total score is sum of three 60-second trials. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the COWAT scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units0.090
Intranasal Insulin 10 International Units0.070
Placebo0.021

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Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test

This test measures executive functioning, concept formation, and cognitive flexibility. Scores range from zero to 16; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include DKEFS correct sort scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units-0.001
Intranasal Insulin 10 International Units0.027
Placebo0.002

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Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT)

"The Rao-version of the PASAT evaluates processing speed, working memory, and basic addition skills. Scores range from zero to 60; higher is better. Herein we present 3-second PASAT results (PASAT-3). In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include PASAT-3 scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the SDMT." (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units0.372
Intranasal Insulin 10 International Units0.363
Placebo0.212

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Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT)

This task will be performed at five study visits. The SDMT is one of the most commonly used tests to assess processing speed in the MS population and is included in the Minimal Assessment of Cognitive Function in MS (MACFIMS). Higher scores reflect a better outcome (range 0 to 110). In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the SDMTs acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the SDMT. (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units0.145
Intranasal Insulin 10 International Units0.207
Placebo0.163

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Number of Participants With Adverse Events Leading to Study Discontinuation

An adverse event will be defined as any occurrence or worsening of an undesirable or unintended sign, symptom (or abnormal laboratory test), or disease temporally associated with the use of a medicinal product or intervention, whether or not it is considered related to the product/intervention. We report overall adverse events in the relevant section. Here, we report adverse events that led to study discontinuation. (NCT02988401)
Timeframe: Up to week 24 visit

InterventionParticipants (Count of Participants)
Intranasal Insulin 20 International Units3
Intranasal Insulin 10 International Units2
Placebo1

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Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index)

The sleep questionnaire asks subjects to report various aspects related to their sleep routine. Scores range from zero to 21; higher score indicates worse sleep quality. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the PSQIs acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units-0.026
Intranasal Insulin 10 International Units0.035
Placebo-0.045

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Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II)

This is a verbal learning and memory test. Scores range from zero to 16; a higher number is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the CVLT-II scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units0.082
Intranasal Insulin 10 International Units0.021
Placebo0.020

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Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO)

Judgment of Line Orientation Test measures a person's ability to match the angle and orientation of lines in space. Scores range from zero to 30; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include JLO data acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units-0.031
Intranasal Insulin 10 International Units0.047
Placebo-0.005

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Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II)

The BDI-II is a 21-question multiple-choice self-report inventory test for measuring the severity of depression. Scores range from zero to 63; higher scores indicate greater depression. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the BDI-II scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the scores. (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units-0.022
Intranasal Insulin 10 International Units-0.019
Placebo-0.045

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Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall

This is a visual, nonverbal test of learning and memory. Scores range from zero to 12; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the BVMT-R delayed recall scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Interventionscore on a scale (Mean)
Intranasal Insulin 20 International Units0.027
Intranasal Insulin 10 International Units0.059
Placebo0.030

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Percentage of Participants Who Achieve HbA1c <7% at Week 24

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. (NCT03018938)
Timeframe: 24 Weeks

InterventionPercentage of participants (Number)
Insulin Analog Mid Mixture33.9
Basal Insulin Analog28.3

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Percentage of Participants Who Achieve HbA1c <7% at Week 48

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. (NCT03018938)
Timeframe: 48 Weeks

InterventionPercentage of participants (Number)
Insulin Analog Mid Mixture23.3
Basal Insulin Analog23.4

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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate. (NCT03018938)
Timeframe: 24 Weeks

InterventionPercentage of participants (Number)
Insulin Analog Mid Mixture33.1
Basal Insulin Analog29.0

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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate. (NCT03018938)
Timeframe: 48 Weeks

InterventionPercentage of participants (Number)
Insulin Analog Mid Mixture23.9
Basal Insulin Analog23.7

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Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose

Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate. (NCT03018938)
Timeframe: Baseline, 24 Weeks

,
Interventionmmol/L (Least Squares Mean)
FBGPPG
Basal Insulin Analog-2.374-4.101
Insulin Analog Mid Mixture-2.105-4.184

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Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose

Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate. (NCT03018938)
Timeframe: Baseline, 48 Weeks

,
Interventionmmol/L (Least Squares Mean)
FBGPPG
Basal Insulin Analog-2.724-4.359
Insulin Analog Mid Mixture-2.233-4.372

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Rate of Hypoglycemia at Week 24 and 48

Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable. (NCT03018938)
Timeframe: 24 Weeks, 48 Weeks

,
InterventionEvents/Participant/Year (Mean)
Nocturnal Hypoglycemia (24 Weeks)Nocturnal Hypoglycemia (48 Weeks)Total Hypoglycemia (24 Weeks)Total Hypoglycemia (48 Weeks)
Basal Insulin Analog0.240.200.630.45
Insulin Analog Mid Mixture0.540.331.601.18

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Total Daily Insulin Dose at Week 24 and 48

Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48. (NCT03018938)
Timeframe: 24 Weeks, 48 Weeks

,
InterventionInternational Units (IU) per day (Mean)
24 Weeks48 Weeks
Basal Insulin Analog14.5815.35
Insulin Analog Mid Mixture24.8924.22

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Change From Baseline to Week 24 in Body Weight

LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate. (NCT03018938)
Timeframe: Baseline, 24 Weeks

Interventionkilograms (kg) (Least Squares Mean)
Insulin Analog Mid Mixture1.226
Basal Insulin Analog0.559

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Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)

"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate." (NCT03018938)
Timeframe: Baseline, 24 Weeks

InterventionPercentage of HbA1c (Least Squares Mean)
Insulin Analog Mid Mixture-2.158
Basal Insulin Analog-2.000

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Change From Baseline to Week 24 in Venous Fasting Plasma Glucose

Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate. (NCT03018938)
Timeframe: Baseline, 24 Weeks

Interventionmillimole/liter (mmol/L) (Least Squares Mean)
Insulin Analog Mid Mixture-2.332
Basal Insulin Analog-2.755

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Change From Baseline to Week 48 in Body Weight

LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate. (NCT03018938)
Timeframe: Baseline, 48 Weeks

Interventionkilograms (kg) (Least Squares Mean)
Insulin Analog Mid Mixture1.393
Basal Insulin Analog0.639

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Change From Baseline to Week 48 in HbA1c

"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate." (NCT03018938)
Timeframe: Baseline, 48 Weeks

InterventionPercentage of HbA1c (Least Squares Mean)
Insulin Analog Mid Mixture-2.029
Basal Insulin Analog-1.829

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Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score

The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect. (NCT03018938)
Timeframe: Baseline, 48 Weeks

InterventionUnits on a scale (Least Squares Mean)
Insulin Analog Mid Mixture-0.9
Basal Insulin Analog-0.8

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Change From Baseline to Week 48 in Venous Fasting Plasma Glucose

Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate. (NCT03018938)
Timeframe: Baseline, 48 Weeks

Interventionmillimole/liter (mmol/L) (Least Squares Mean)
Insulin Analog Mid Mixture-2.527
Basal Insulin Analog-3.174

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Change From Baseline Hemoglobin A1c

(NCT03042936)
Timeframe: 16 weeks

InterventionA1c percentage points (Median)
Insulin Superheroes Club Curriculum-0.5

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Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)

Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. (NCT03078478)
Timeframe: 36 Weeks

InterventionEpisodes/(PYE*100) (Number)
Insulin Degludec 200216.8
Insulin Glargine U300243.9

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Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)

Severe or BG confirmed symptomatic hypoglycaemia was evaluated during treatment (up to 88 weeks). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. (NCT03078478)
Timeframe: 88 weeks

InterventionEpisodes/(PYE*100) (Number)
Insulin Degludec 200137.8
Insulin Glargine U300163.7

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Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks)

Participants measured their pre-breakfast self-measured plasma glucose (SMPG) value until end of treatment (week 88). Mean pre-breakfast self-measured plasma glucose used for titration at baseline and end of treatment (up to 88 weeks) are presented. (NCT03078478)
Timeframe: Week 0, week 88

,
Interventionmmol/L (Mean)
Baseline (week 0)End of treatment (week 88)
Insulin Degludec 2008.395.46
Insulin Glargine U3008.415.56

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Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)

Participants achieving a fasting plasma glucose value of less than or equal to 5.0 mmol/L (90 mg/dL) at end of treatment (up to 88 weeks). (NCT03078478)
Timeframe: At 88 weeks

,
InterventionPercentage of participants (Number)
YesNo
Insulin Degludec 20031.568.5
Insulin Glargine U30021.778.3

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Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)

Participants achieving a fasting plasma glucose value of less than or equal to 7.2 mmol/L (130 mg/dL) at end of treatment (up to 88 weeks). (NCT03078478)
Timeframe: At 88 weeks

,
InterventionPercentage of participants (Number)
YesNo
Insulin Degludec 20084.016.0
Insulin Glargine U30072.028.0

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Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)

Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without nocturnal severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks). (NCT03078478)
Timeframe: At 88 weeks

,
InterventionPercentage of participants (Number)
YesNo
Insulin Degludec 20047.452.6
Insulin Glargine U30039.360.7

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Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)

Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks). (NCT03078478)
Timeframe: End of Treatment (up to 88 Weeks)

,
InterventionPercentage of participants (Number)
YesNo
Insulin Degludec 20035.364.7
Insulin Glargine U30030.070.0

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Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)

Change in fasting plasma glucose (FPG) was evaluated from baseline to end of treatment period (week 88). (NCT03078478)
Timeframe: Week 0, week 88

Interventionmg/dL (Mean)
Insulin Degludec 200-35.50
Insulin Glargine U300-25.68

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Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)

The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks). (NCT03078478)
Timeframe: 88 weeks

InterventionUnits (Mean)
Insulin Degludec 20066.6
Insulin Glargine U30073.0

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Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks)

Change in body weight, measured in kilograms, from baseline (week 0) to end of treatment (week 88). (NCT03078478)
Timeframe: Week 0, week 88

Interventionkg (Mean)
Insulin Degludec 2002.9
Insulin Glargine U3001.7

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Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)

Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline to end of treatment period (week 88). (NCT03078478)
Timeframe: Week 0, week 88

InterventionPercentage of HbA1c (Mean)
Insulin Degludec 200-0.54
Insulin Glargine U300-0.46

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Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks)

The adverse events presented are treatment emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment. Number of adverse events expressed in rates, from randomisation to end of maintenance period 2 (up to 88 weeks) is presented. Rate = number of events divided by patient years of exposure multiplied by 100. (NCT03078478)
Timeframe: 88 weeks

InterventionEpisodes/(PYE*100) (Number)
Insulin Degludec 200367.32
Insulin Glargine U300365.42

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Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)

Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. (NCT03078478)
Timeframe: 36 weeks

InterventionEpisodes/(PYE*100) (Number)
Insulin Degludec 20062.30
Insulin Glargine U30093.75

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Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)

Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated at the end of trial (88 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. (NCT03078478)
Timeframe: 88 weeks

InterventionEpisodes/(PYE*100) (Number)
Insulin Degludec 20036.93
Insulin Glargine U30060.03

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Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)

Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for maintenance 2 period. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. (NCT03078478)
Timeframe: 36 weeks (maintenance 2)

InterventionEpisodes/(PYE*100) (Number)
Insulin Degludec 2000.98
Insulin Glargine U3004.88

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Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks)

Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for the total trial period (88 weeks). The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. (NCT03078478)
Timeframe: 88 weeks

InterventionEpisodes/(PYE*100) (Number)
Insulin Degludec 2002.06
Insulin Glargine U3005.21

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Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value

Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units). (NCT03081117)
Timeframe: Changes between baseline and week 24 visits

,
Interventionmmol/L, approx. (institutional units) (Mean)
Available MRS Secondary OutcomesCompleted Trial (Per Protocol)
Insulin, Intranasal0.16700.2028
Placebo, Intranasal-0.1557-0.2128

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Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value

Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units). (NCT03081117)
Timeframe: Changes between baseline and week 24 visits

,
Interventionmmol/L, approx. (institutional units) (Mean)
Available MRS Secondary OutcomesCompleted Trial (Per Protocol)
Insulin, Intranasal-0.1495-0.1905
Placebo, Intranasal0.19070.1162

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Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value

Diffusion tensor imaging (DTI), change in whole brain fractional anisotropy (FA) between baseline and 24 weeks. FA is a unitless index that is used for measuring diffusion asymmetry. FA values range from 0 to 1 (0 equals no anisotropy; greater anisotropy is indicated by higher FA values approaching the maximum of 1). FA was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean FA = (Sum of (each ROI's FA * volume)) / (Sum of all ROI volumes). (NCT03081117)
Timeframe: Changes between baseline and week 24 visits

,
Interventionindex (Mean)
All AvailablePer Protocol
Insulin, Intranasal-0.0011885-0.0022483
Placebo, Intranasal-0.0043236-0.0048070

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Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value

Diffusion weighted imaging, change in whole brain mean diffusivity (MD) between baseline and 24 weeks. MD was measured as the mean of three eigenvalues and has the unit m^2/s. Higher values indicate greater diffusivity. MD was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean MD = (Sum of (each ROI's MD * volume)) / (Sum of all ROI volumes). (NCT03081117)
Timeframe: Changes between baseline and week 24 visits

,
Interventionm^2/s (Mean)
All AvailablePer Protocol
Insulin, Intranasal4.7274*10^-65.8845*10^-6
Placebo, Intranasal4.1177*10^-61.1278*10^-5

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Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score

NPZ-8 score at 24 weeks minus baseline NPZ-8 score: The NPZ-8 is an average of 8 individual Z-scores, where higher values indicate greater neurocognitive performance (better outcome). The NPZ-8 represents the number of standard deviations an individual's performance is away from the mean (Z-score = 0) of age and education matched reference populations where performance worse than the mean had negative Z-scores (i.e. Z-scores were inverted for tests scored on speed). The NPZ-8 average is comprised of 8 data points from 6 tests: timed gait, WAIS symbol-digit, grooved pegboard dominant & non-dominant, CalCAP Choice & Sequential reaction times, and the Trail-making Test parts A & B. Raw scores were transformed to Z-scores for each test and then averaged to calculate the NPZ-8 score at each visit (Z-scores +/-3.5 standard deviations from mean limited to +/-3.5). Positive change in NPZ-8 from baseline to Week 24 indicated improved performance and negative change indicated worse performance. (NCT03081117)
Timeframe: Difference between baseline and week 24 visits

,
Interventionz-score (Mean)
Completed Trial (ITT)Completed Trial (Per Protocol)
Insulin, Intranasal-0.09-0.07
Placebo, Intranasal-0.01-0.02

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Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score

Change in GDS, measured at two time points, baseline and Week 24 visits. GDS is a composite score based on neurocognitive test performance. The 14 data points that comprise the GDS include Hopkins Verbal Learning Test (trials 1-3 total score and delayed recall), Rey Complex Figure Test (copy and delayed recall), WAIS symbol-digit test, grooved pegboard (dominant and non-dominant), CalCAP (Choice reaction time and Sequential reaction time), Trail-making Test (Parts A and B), Stroop Color Interference Test (trial 3), timed gait (3 trials average), and verbal fluency (FAS). Raw scores were transformed to t-scores using age/education stratified normative data, then assigned a discrete value from 0 to 5 using the following t-score categorization: > or = 40 is '0', 35.00 to 39.99 is '1', 30.00 to 34.99 is '2', 25.00 to 29.99 is '3', 20.00 to 24.99 is '4', and <20 is '5'. The 14 individual scores were then averaged. A higher GDS is a worse outcome (0 = no deficits and 5 = maximum deficits). (NCT03081117)
Timeframe: Difference between baseline and week 24 visits

,
Interventionunits on a scale (Mean)
Completed Trial (ITT)Completed Trial (Per Protocol)
Insulin, Intranasal-0.1614-0.2383
Placebo, Intranasal0.23000.2763

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Serious Adverse Event Frequency, Participant Count

Number participants with at least one documented serious adverse event, count (NCT03081117)
Timeframe: Total during 24-week trial

,
InterventionParticipants (Count of Participants)
EnrolledCompleted Trial (ITT)Completed Trial (Per Protocol)
Insulin, Intranasal210
Placebo, Intranasal222

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Serious Adverse Event Frequency

Number of documented serious adverse events per participant, mean (NCT03081117)
Timeframe: Total during 24-week trial

,
InterventionNumber of SAEs/participant (Mean)
EnrolledCompleted Trial (ITT)Completed Trial (Per Protocol)
Insulin, Intranasal0.300.140.00
Placebo, Intranasal0.180.220.25

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Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value

Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units). (NCT03081117)
Timeframe: Changes between baseline and week 24 visits

,
Interventionmmol/L, approx. (institutional units) (Mean)
Available MRS Secondary OutcomesCompleted Trial (Per Protocol)
Insulin, Intranasal0.10500.2597
Placebo, Intranasal0.14320.1134

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Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value

Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units). (NCT03081117)
Timeframe: Changes between baseline and week 24 visits

,
Interventionmmol/L, approx. (institutional units) (Mean)
Available MRS Secondary OutcomesCompleted Trial (Per Protocol)
Insulin, Intranasal-0.5572-0.7895
Placebo, Intranasal-0.1870-0.2915

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Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value

Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units). (NCT03081117)
Timeframe: Changes between baseline and week 24 visits

,
Interventionmmol/L, approx. (institutional units) (Mean)
Available MRS Secondary OutcomesCompleted Trial (Per Protocol)
Insulin, Intranasal0.26170.6063
Placebo, Intranasal0.21550.0382

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Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value

Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in the basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units). (NCT03081117)
Timeframe: Changes between baseline and week 24 visits

,
Interventionmmol/L, approx. (institutional units) (Mean)
Available MRS Secondary OutcomesCompleted Trial (Per Protocol)
Insulin, Intranasal0.78550.5373
Placebo, Intranasal0.47590.3022

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Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip

(NCT03104738)
Timeframe: Hospital arrival - 24 hours postoperatively.

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose0
25% Reduction of Basal Insulin Dose0

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Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.

Capillary blood glucose before surgery, considering a fasting period up to 8 hours prior fasting blood glucose (NCT03104738)
Timeframe: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.

Interventionmg/dl (Mean)
50% Reduction of Basal Insulin Dose144.0
25% Reduction of Basal Insulin Dose152.5

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Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively

Capillary or arterial/venous blood glucose level <80 mg/dl (NCT03104738)
Timeframe: Anesthesia stop time - 24 hours postoperatively.

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose1
25% Reduction of Basal Insulin Dose5

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Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively

Capillary or arterial/venous blood glucose level >179 mg/dl (NCT03104738)
Timeframe: Anesthesia stop time - 24 hours postoperatively.

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose9
25% Reduction of Basal Insulin Dose15

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Mean 24-hour Glucose Postoperatively

(NCT03104738)
Timeframe: Anesthesia stop time - 24 hours postoperatively

Interventionmg/dl (Mean)
50% Reduction of Basal Insulin Dose158.5
25% Reduction of Basal Insulin Dose165.2

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Incidence of Intraoperative Hyperglycemia

Capillary or arterial/venous blood glucose level >179 mg/dl (NCT03104738)
Timeframe: Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose7
25% Reduction of Basal Insulin Dose6

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Incidence of Surgical Delay or Cancellation Due to Hyperglycemia

(NCT03104738)
Timeframe: Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose0
25% Reduction of Basal Insulin Dose0

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Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital

Capillary blood glucose level <70 mg/dl (NCT03104738)
Timeframe: Basal insulin dose administration the evening before surgery - Hospital arrival the morning of the surgery. The time period did not exceed 12 hours, considering a fasting period up to 8 hours and a preoperative period up to 4 hours.

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose0
25% Reduction of Basal Insulin Dose0

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Incidence of Preoperative Hypoglycemia

Capillary blood glucose level <80 mg/dl (NCT03104738)
Timeframe: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose1
25% Reduction of Basal Insulin Dose1

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Incidence of Preoperative Hyperglycemia

Capillary blood glucose level >179 mg/dl (NCT03104738)
Timeframe: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose5
25% Reduction of Basal Insulin Dose5

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Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively

Capillary or arterial/venous blood glucose level <70 mg/dl (NCT03104738)
Timeframe: Anesthesia stop time - 24 hours postoperatively.

InterventionParticipants (Count of Participants)
50% Reduction of Basal Insulin Dose1
25% Reduction of Basal Insulin Dose0

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Number of Participants With a Macrosomic Baby

Fetal macrosomia has been defined birth weight greater than 4500 gm (NCT03106870)
Timeframe: 24 hours after delivery

InterventionParticipants (Count of Participants)
Oral Metformin and Insulin5
Insulin Therapy Only12

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Number of Participants With Neonates Who Were Hypoglycemic

Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery (NCT03106870)
Timeframe: 24 hours after delivery

InterventionParticipants (Count of Participants)
Oral Metformin and Insulin5
Insulin Therapy Only6

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Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation

"Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:~60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus" (NCT03106870)
Timeframe: from 20 weeks to 36 weeks gestation

InterventionParticipants (Count of Participants)
Oral Metformin and Insulin24
Insulin Therapy Only27

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Change in Above the Target Time (%) (>180 mg/dl) on CGM

Difference of time above range between treatment and control group (NCT03143816)
Timeframe: 4 weeks

Interventionpercent time above target (Mean)
Technosphere Insulin (TI, Afrezza) -Treatment Arm38.1
Insulin Aspart ( Novolog) -Control Arm41.2

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Change in Glucose Variability (GV) (mg/dl) (Standard Deviation and/or Coefficient Variation)

Difference of glucose variability metrics between treatment and control groups (NCT03143816)
Timeframe: 4 weeks

Interventionmg/dl (Mean)
Technosphere Insulin (TI, Afrezza) -Treatment Arm57.8
Insulin Aspart ( Novolog) -Control Arm66.3

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Change in HbA1c (%) in One-month Treatment

Difference in HbA1c between treatment and control group (NCT03143816)
Timeframe: 4 weeks

Interventionpercentage (%) (Mean)
Technosphere Insulin (TI, Afrezza) -Treatment Arm0.25
Insulin Aspart ( Novolog) -Control Arm0.02

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The Area Under the Curve Calculation (AUC) (Min*mg/dl) in the PPBG and PPGE,

Difference of area under curve between treatment and control groups. ( 0 to 4 hours duration) (NCT03143816)
Timeframe: 0, 1, 2, 3, 4 hours post-dose at 4 weeks

Interventionmin*mg/dl (Mean)
Technosphere Insulin (TI, Afrezza) -Treatment Arm15020
Insulin Aspart ( Novolog) -Control Arm20020

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Hypoglycemia Frequency (%) (Below the Target <70mg/dl) on CGM

Difference of hypoglycemia frequency between treatment and control groups. (NCT03143816)
Timeframe: 4 weeks

Interventionpercent time below range (Mean)
Technosphere Insulin (TI, Afrezza) -Treatment Arm2.2
Insulin Aspart ( Novolog) -Control Arm4.0

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Change in Time in Range (%) (70-180 mg/dl) With TI on CGM

Difference between Time in range for TI group (treatment) and for Aspart group (control) (NCT03143816)
Timeframe: 4 weeks

Interventionpercent time in range (Mean)
Insulin Aspart ( Novolog) -Control Arm53.5
Technosphere Insulin (TI, Afrezza) -Treatment Arm58.4

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Change in Post-prandial Glucose Excursion (mg/dl) (1-4 Hours After Meals) With TI

Difference in postprandial blood glucose between treatment and control group (NCT03143816)
Timeframe: 4 weeks

Interventionmg/dl (Mean)
Technosphere Insulin (TI, Afrezza) -Treatment Arm45
Insulin Aspart ( Novolog) -Control Arm60

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-3.64
Insulin Degludec-3.45
Liraglutide-1.86

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Change in Fasting Total Cholesterol - Ratio to Baseline

Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting total cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide0.94
Insulin Degludec0.99
Liraglutide0.97

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Change in Fasting Triglycerides - Ratio to Baseline.

Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting triglycerides (Geometric Mean)
Insulin Degludec/Liraglutide0.88
Insulin Degludec0.82
Liraglutide0.90

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Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline

Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting VLDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide0.90
Insulin Degludec0.84
Liraglutide0.92

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Change in Haematologcal Parameter: Leukocytes

Change in leukocytes from baseline (week 0) after 26 weeks of treatment (NCT03172494)
Timeframe: Week 0, week 26

Intervention10^9 cells per liter (10^9/L) (Mean)
Insulin Degludec/Liraglutide0.25
Insulin Degludec0.23
Liraglutide-0.01

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Change in Haematological Parameter - Lymphocytes

Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented (NCT03172494)
Timeframe: Week 0, week 26

Intervention% of lymphocytes (Mean)
Insulin Degludec/Liraglutide-0.46
Insulin Degludec-0.38
Liraglutide0.40

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Change in Haematological Parameter - Neutrophils

Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention% of neutrophils (Mean)
Insulin Degludec/Liraglutide0.57
Insulin Degludec0.18
Liraglutide-0.53

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Change in Haematological Parameter: Basophils

Change in basophils from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention% of basophils (Mean)
Insulin Degludec/Liraglutide-0.02
Insulin Degludec-0.01
Liraglutide-0.03

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Change in Haematological Parameter: Erythrocytes Blood

Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention10^12 cells per liter (10^12/L) (Mean)
Insulin Degludec/Liraglutide-0.05
Insulin Degludec-0.00
Liraglutide-0.05

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Change in Haematological Parameter: Haematocrits

Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

InterventionPercentage points (%) of red blood cells (Mean)
Insulin Degludec/Liraglutide-0.56
Insulin Degludec-0.49
Liraglutide-0.42

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Change in Haematological Parameter: Thrombocytes

Change in thrombocytes from baseline (week 0) after 26 weeks of treatment (NCT03172494)
Timeframe: Week 0, week 26

Intervention10^9 cells per liter (10^9/L) (Mean)
Insulin Degludec/Liraglutide8.19
Insulin Degludec8.32
Liraglutide4.32

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Change in Haematology: Haemoglobin Blood

Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-0.10
Insulin Degludec-0.06
Liraglutide-0.05

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Change in Haemotological Parameter- Eosinophils

Change in eosinophils from baseline after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention% of eosinophils (Mean)
Insulin Degludec/Liraglutide-0.06
Insulin Degludec0.19
Liraglutide0.11

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Change in Haemotological Parameter- Monocytes

Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented (NCT03172494)
Timeframe: Week 0, week 26

Intervention% of monocytes (Mean)
Insulin Degludec/Liraglutide-0.03
Insulin Degludec0.01
Liraglutide0.05

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Change in HbA1c

Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

InterventionPercentage points of HbA1c (Mean)
Insulin Degludec/Liraglutide-1.71
Insulin Degludec-1.20
Liraglutide-1.16

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Change in HOMA-B (Beta Cell Function)- Ratio to Baseline

Change in HOMA-B (measured in %) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of HOMA-B (beta cell function) (Geometric Mean)
Insulin Degludec/Liraglutide1.38
Insulin Degludec0.94
Liraglutide1.53

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Change in Mean Post-prandial Plasma Glucose (PG) Increments

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-0.20
Insulin Degludec0.09
Liraglutide-0.54

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Change in Pulse

Change in pulse from baseline (week 0) after 26 weeks of treatment is presented (NCT03172494)
Timeframe: Week 0, week 26

InterventionBeats per minuts (beats/min) (Mean)
Insulin Degludec/Liraglutide4.6
Insulin Degludec-0.1
Liraglutide4.9

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Change in Electrocardiogram (ECG)

Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented. (NCT03172494)
Timeframe: Week -2, week 26

InterventionParticipants (Count of Participants)
Week -272192333Week -272192331Week -272192332Week 2672192332Week 2672192333Week 2672192331
Abnormal, NCSAbnormal CSNormal
Insulin Degludec/Liraglutide223
Insulin Degludec109
Liraglutide108
Insulin Degludec/Liraglutide94
Insulin Degludec46
Liraglutide52
Insulin Degludec/Liraglutide41
Insulin Degludec20
Liraglutide20
Insulin Degludec/Liraglutide227
Insulin Degludec108
Liraglutide87
Insulin Degludec/Liraglutide76
Insulin Degludec47
Liraglutide40
Insulin Degludec/Liraglutide38
Insulin Degludec12
Liraglutide24

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Change in Mean of 9-point SMPG Profile

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented. (NCT03172494)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-3.17
Insulin Degludec-2.47
Liraglutide-2.13

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Change in Calcitonin

Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter [pg/mL]). Number of participants in each category at baseline (week 0) and week 26 are presented. (NCT03172494)
Timeframe: Week 0, week 26

InterventionParticipants (Count of Participants)
Week 072192332Week 072192333Week 072192331Week 2672192331Week 2672192332Week 2672192333
NormalHighLow
Insulin Degludec0
Liraglutide0
Insulin Degludec/Liraglutide351
Insulin Degludec172
Liraglutide178
Insulin Degludec/Liraglutide7
Insulin Degludec3
Liraglutide2
Insulin Degludec/Liraglutide0
Insulin Degludec/Liraglutide334
Insulin Degludec165
Liraglutide147
Insulin Degludec/Liraglutide6
Insulin Degludec2
Liraglutide3

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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented (NCT03172494)
Timeframe: Week 0, week 26

,,
InterventionMillimeters of mercury (mmHg) (Mean)
Systolic blood pressureDistolic blood pressure
Insulin Degludec-1.2-0.7
Insulin Degludec/Liraglutide-3.5-0.4
Liraglutide-3.30.0

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Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum

Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

,,
Interventionmicromoles per liter (umol/L) (Mean)
Total bilirubincreatinine serum
Insulin Degludec-0.551.36
Insulin Degludec/Liraglutide-0.781.02
Liraglutide-1.16-0.60

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Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum

Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

,,
Interventionmmol/L (Mean)
Calcium serum (total)Calcium corrected serumSodium serumUrea serumPotassium serum
Insulin Degludec-0.02-0.000.980.03-0.09
Insulin Degludec/Liraglutide-0.01-0.001.210.05-0.04
Liraglutide-0.00-0.010.320.16-0.04

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Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum

Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

,,
InterventionUnits per liter (U/L) (Mean)
Alkaline phosphataseALTASTCreatine kinaseAmylaseLipase
Insulin Degludec-2.29-6.17-2.6515.375.09-1.87
Insulin Degludec/Liraglutide-2.0-4.63-1.3110.679.8416.13
Liraglutide-0.48-2.81-0.990.525.6814.11

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Change in Biochemistry Parameters (Albumin Serum, Total Protein)

Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

,,
Interventiongrams per decileter (g/dL) (Mean)
Albumin serumTotal protein
Insulin Degludec-0.09-0.08
Insulin Degludec/Liraglutide-0.05-0.08
Liraglutide0.04-0.01

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9-point SMPG Profile

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Week 26

,,
Interventionmmol/L (Mean)
Before breakfast90 minutes after the start of breakfastBefore lunch90 minutes after the start of the lunchBefore dinner90 minutes after start of the dinnerAt bedtimeAt 4:00 amBefore breakfast the following day
Insulin Degludec5.669.857.1010.187.3910.278.866.125.47
Insulin Degludec/Liraglutide5.418.976.318.876.529.337.995.605.35
Liraglutide6.8910.047.489.547.509.458.496.866.81

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Serum Concentrations of Insulin Degludec

This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms. (NCT03172494)
Timeframe: Week 0, week 26

Interventionpmol/L (Geometric Mean)
Insulin Degludec/Liraglutide3583
Insulin Degludec4133

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Plasma Concentration of Liraglutide

This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms. (NCT03172494)
Timeframe: Week 0, week 26

Interventionpmol/L (Geometric Mean)
Insulin Degludec/Liraglutide9963
Liraglutide21602

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Occurence of Total Insulin Antibodies

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). (NCT03172494)
Timeframe: Week 27

Intervention%B/T (Mean)
Insulin Degludec/Liraglutide6.83
Insulin Degludec3.11

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Occurence of Neutralising Liraglutide Antibodies

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented. (NCT03172494)
Timeframe: Week 27

InterventionParticipants (Count of Participants)
Insulin Degludec/Liraglutide9
Liraglutide8

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Change in Waist Circumferance

Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

InterventionCentimeters (cm) (Mean)
Insulin Degludec/Liraglutide-0.3
Insulin Degludec1.2
Liraglutide-2.6

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Insulin Dose

The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms. (NCT03172494)
Timeframe: Week 26

InterventionUnits of insulin (U) (Mean)
Insulin Degludec/Liraglutide24.8
Insulin Degludec30.1

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Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide668.55
Insulin Degludec746.20
Liraglutide37.19

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide4.45
Insulin Degludec4.54

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide2.78
Insulin Degludec3.40

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Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose (BG) confirmed by a plasma glucose (PG) value < 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide23.94
Insulin Degludec17.01
Liraglutide3.60

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide15.03
Insulin Degludec9.07
Liraglutide1.20

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Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline

Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting LDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide0.92
Insulin Degludec1.01
Liraglutide0.96

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Change in Body Weight

Change in body weight from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

InterventionKilogram (Kg) (Mean)
Insulin Degludec/Liraglutide0.2
Insulin Degludec1.3
Liraglutide-2.5

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Change in Fasting C-peptide - Ratio to Baseline

Change in fasting C-peptide (measured in nanomoles per liter [nmol/L]) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting C-peptide (Geometric Mean)
Insulin Degludec/Liraglutide0.54
Insulin Degludec0.38
Liraglutide0.98

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Change in Fasting Free Fatty Acid - Ratio to Baseline

Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting free fatty acid (Geometric Mean)
Insulin Degludec/Liraglutide0.55
Insulin Degludec0.48
Liraglutide0.80

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Change in Fasting Glucagon - Ratio to Baseline

Change in fasting glucagon (measured in picograms per milliliter [pg/mL]) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting glucagon (Geometric Mean)
Insulin Degludec/Liraglutide0.90
Insulin Degludec0.95
Liraglutide0.98

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Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline

Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting HDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide1.01
Insulin Degludec1.02
Liraglutide1.03

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Change in Fasting Human Insulin - Ratio to Baseline

Change in fasting human insulin (measured in picomoles per liter [pmol/L]) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

InterventionRatio of fasting human insulin (Geometric Mean)
Insulin Degludec/Liraglutide0.53
Insulin Degludec0.38
Liraglutide1.04

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Number of Treatment-emergent Adverse Events (TEAE)

A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention(Number of AEs/PYE)*100 (Number)
Insulin Degludec/Liraglutide410.82
Insulin Degludec306.19
Liraglutide541.00

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Occurence of Antibodies Cross-reacting to Human Insulin

This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). (NCT03172494)
Timeframe: Week 27

Intervention%B/T (Mean)
Insulin Degludec/Liraglutide6.61
Insulin Degludec2.99

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Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)

This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented. (NCT03172494)
Timeframe: Week 27

InterventionParticipants (Count of Participants)
Insulin Degludec/Liraglutide6
Liraglutide3

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Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented. (NCT03172494)
Timeframe: Week 27

InterventionParticipants (Count of Participants)
Insulin Degludec/Liraglutide0
Liraglutide0

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Urinalysis (Protein, Glucose, Erythrocytes and Ketones)

The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented. (NCT03172494)
Timeframe: Week 0, week 26

InterventionParticipants (Count of Participants)
Week 0: Erythrocytes72192331Week 0: Erythrocytes72192332Week 0: Erythrocytes72192333Week 26: Erythrocytes72192331Week 26: Erythrocytes72192332Week 26: Erythrocytes72192333Week 0: Glucose72192331Week 0: Glucose72192332Week 0: Glucose72192333Week 26: Glucose72192331Week 26: Glucose72192332Week 26: Glucose72192333Week 0: Ketones72192331Week 0: Ketones72192332Week 0: Ketones72192333Week 26: Ketones72192331Week 26: Ketones72192332Week 26: Ketones72192333Week 0: Protein72192331Week 0: Protein72192332Week 0: Protein72192333Week 26: Protein72192331Week 26: Protein72192332Week 26: Protein72192333
NegativeTracePositive
Insulin Degludec/Liraglutide299
Insulin Degludec153
Liraglutide156
Insulin Degludec/Liraglutide36
Insulin Degludec16
Liraglutide16
Insulin Degludec/Liraglutide22
Insulin Degludec6
Liraglutide8
Insulin Degludec/Liraglutide297
Insulin Degludec146
Liraglutide136
Insulin Degludec/Liraglutide28
Insulin Degludec/Liraglutide14
Insulin Degludec5
Liraglutide4
Insulin Degludec/Liraglutide253
Insulin Degludec119
Liraglutide123
Insulin Degludec/Liraglutide35
Insulin Degludec19
Insulin Degludec/Liraglutide69
Insulin Degludec37
Liraglutide39
Insulin Degludec/Liraglutide322
Insulin Degludec157
Liraglutide131
Insulin Degludec/Liraglutide11
Liraglutide5
Insulin Degludec/Liraglutide6
Insulin Degludec7
Liraglutide15
Insulin Degludec/Liraglutide325
Insulin Degludec152
Liraglutide167
Insulin Degludec/Liraglutide25
Insulin Degludec20
Liraglutide11
Insulin Degludec/Liraglutide7
Insulin Degludec3
Liraglutide2
Insulin Degludec/Liraglutide334
Insulin Degludec163
Liraglutide141
Insulin Degludec/Liraglutide4
Liraglutide10
Insulin Degludec/Liraglutide1
Insulin Degludec1
Liraglutide0
Insulin Degludec/Liraglutide216
Insulin Degludec104
Liraglutide116
Insulin Degludec/Liraglutide86
Insulin Degludec40
Liraglutide37
Insulin Degludec/Liraglutide55
Insulin Degludec31
Liraglutide27
Insulin Degludec/Liraglutide254
Insulin Degludec120
Liraglutide105
Insulin Degludec/Liraglutide58
Insulin Degludec26
Liraglutide28
Insulin Degludec/Liraglutide27
Insulin Degludec21
Liraglutide18

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Eye Examination

Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented. (NCT03172494)
Timeframe: Week -2, Week 26

InterventionParticipants (Count of Participants)
Week -2: Left eye72192333Week -2: Left eye72192332Week -2: Left eye72192331Week 26: Left eye72192332Week 26: Left eye72192333Week 26: Left eye72192331Week -2: Right eye72192332Week -2: Right eye72192333Week -2: Right eye72192331Week 26: Right eye72192331Week 26: Right eye72192333Week 26: Right eye72192332
Abnormal, NCSAbnormal, CSNormal
Insulin Degludec/Liraglutide222
Insulin Degludec109
Liraglutide110
Insulin Degludec/Liraglutide45
Insulin Degludec14
Liraglutide20
Insulin Degludec/Liraglutide91
Insulin Degludec52
Liraglutide50
Insulin Degludec99
Liraglutide100
Insulin Degludec/Liraglutide39
Insulin Degludec20
Liraglutide13
Insulin Degludec/Liraglutide85
Insulin Degludec48
Liraglutide38
Insulin Degludec/Liraglutide230
Insulin Degludec112
Liraglutide111
Insulin Degludec/Liraglutide42
Insulin Degludec16
Liraglutide22
Insulin Degludec/Liraglutide86
Insulin Degludec47
Liraglutide47
Insulin Degludec/Liraglutide217
Insulin Degludec103
Liraglutide96
Insulin Degludec/Liraglutide40
Insulin Degludec23
Liraglutide15
Insulin Degludec/Liraglutide84
Insulin Degludec41
Liraglutide40

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Change in Physical Examination

Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at screening (week -2) and week 26 per each category is presented. (NCT03172494)
Timeframe: Week -2, week 26

InterventionParticipants (Count of Participants)
Week -2: Cardiovascular system72192331Week -2: Cardiovascular system72192333Week -2: Cardiovascular system72192332Week 26: Cardiovascular system72192332Week 26: Cardiovascular system72192333Week 26: Cardiovascular system72192331Week -2: Central and peripheral nervous system72192331Week -2: Central and peripheral nervous system72192332Week -2: Central and peripheral nervous system72192333Week 26: Central and peripheral nervous system72192331Week 26: Central and peripheral nervous system72192332Week 26: Central and peripheral nervous system72192333Week -2: Gastrointestinal system including mouth72192333Week -2: Gastrointestinal system including mouth72192331Week -2: Gastrointestinal system including mouth72192332Week 26: Gastrointestinal system including mouth72192331Week 26: Gastrointestinal system including mouth72192332Week 26: Gastrointestinal system including mouth72192333Week -2: General appearance72192331Week -2: General appearance72192332Week -2: General appearance72192333Week 26: General appearance72192331Week 26: General appearance72192332Week 26: General appearance72192333Week -2: Head, ears, eyes, nose, throat, neck72192333Week -2: Head, ears, eyes, nose, throat, neck72192331Week -2: Head, ears, eyes, nose, throat, neck72192332Week 26: Head, ears, eyes, nose, throat, neck72192332Week 26: Head, ears, eyes, nose, throat, neck72192333Week 26: Head, ears, eyes, nose, throat, neck72192331Week -2: Lymph node palpation72192333Week -2: Lymph node palpation72192331Week -2: Lymph node palpation72192332Week 26: Lymph node palpation72192331Week 26: Lymph node palpation72192332Week 26: Lymph node palpation72192333Week -2: Musculoskeletal system72192332Week -2: Musculoskeletal system72192333Week -2: Musculoskeletal system72192331Week 26: Musculoskeletal system72192332Week 26: Musculoskeletal system72192333Week 26: Musculoskeletal system72192331Week-2: Respiratory system72192332Week-2: Respiratory system72192331Week-2: Respiratory system72192333Week 26: Respiratory system72192332Week 26: Respiratory system72192333Week 26: Respiratory system72192331week -2: Skin72192331week -2: Skin72192332week -2: Skin72192333Week 26: Skin72192332Week 26: Skin72192333Week 26: Skin72192331Week -2: Thyroid gland72192331Week -2: Thyroid gland72192332Week -2: Thyroid gland72192333Week 26: Thyroid gland72192332Week 26: Thyroid gland72192331Week 26: Thyroid gland72192333
Abnormal, NCSAbnormal CSNormal
Insulin Degludec173
Insulin Degludec/Liraglutide336
Insulin Degludec166
Insulin Degludec/Liraglutide355
Insulin Degludec/Liraglutide338
Insulin Degludec164
Liraglutide150
Liraglutide179
Liraglutide1
Insulin Degludec0
Insulin Degludec/Liraglutide339
Insulin Degludec/Liraglutide351
Insulin Degludec169
Insulin Degludec2
Insulin Degludec/Liraglutide4
Insulin Degludec4
Insulin Degludec161
Insulin Degludec170
Liraglutide175
Insulin Degludec1
Insulin Degludec/Liraglutide332
Insulin Degludec/Liraglutide6
Insulin Degludec/Liraglutide357
Insulin Degludec174
Insulin Degludec/Liraglutide0
Insulin Degludec/Liraglutide1
Insulin Degludec/Liraglutide340
Insulin Degludec/Liraglutide353
Insulin Degludec172
Liraglutide177
Insulin Degludec/Liraglutide2
Insulin Degludec/Liraglutide3
Liraglutide3
Insulin Degludec165
Liraglutide149
Insulin Degludec/Liraglutide7
Liraglutide2
Insulin Degludec/Liraglutide358
Insulin Degludec175
Liraglutide180
Liraglutide0
Insulin Degludec/Liraglutide341
Insulin Degludec167
Insulin Degludec/Liraglutide312
Insulin Degludec152
Liraglutide156
Insulin Degludec/Liraglutide37
Insulin Degludec20
Liraglutide20
Insulin Degludec/Liraglutide9
Insulin Degludec3
Liraglutide4
Insulin Degludec/Liraglutide297
Insulin Degludec146
Liraglutide134
Insulin Degludec/Liraglutide36
Insulin Degludec19
Liraglutide15
Insulin Degludec/Liraglutide8
Insulin Degludec/Liraglutide348
Insulin Degludec171
Insulin Degludec/Liraglutide5
Insulin Degludec/Liraglutide334
Insulin Degludec163
Liraglutide151

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Occurence of Anti-insulin Degludec Specific Antibodies

This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). (NCT03172494)
Timeframe: Week 27

Intervention%B/T (Mean)
Insulin Degludec/Liraglutide0.22
Insulin Degludec0.12

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Eye Examination

Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented. (NCT03175120)
Timeframe: Week -2, week 26

InterventionParticipants (Count of Participants)
Week -2: Left eye72482247Week -2: Left eye72482246Week 26: Left eye72482246Week 26: Left eye72482247Week -2: Right eye72482246Week -2: Right eye72482247Week 26: Right eye72482246Week 26: Right eye72482247
NormalAbnormal CSAbnormal NCS
Insulin Degludec/Liraglutide167
Insulin Degludec87
Insulin Degludec/Liraglutide34
Insulin Degludec15
Insulin Degludec/Liraglutide100
Insulin Degludec49
Insulin Degludec/Liraglutide147
Insulin Degludec80
Insulin Degludec/Liraglutide35
Insulin Degludec14
Insulin Degludec/Liraglutide105
Insulin Degludec45
Insulin Degludec/Liraglutide162
Insulin Degludec85
Insulin Degludec/Liraglutide41
Insulin Degludec18
Insulin Degludec/Liraglutide98
Insulin Degludec47
Insulin Degludec/Liraglutide139
Insulin Degludec84
Insulin Degludec/Liraglutide37
Insulin Degludec12
Insulin Degludec/Liraglutide111
Insulin Degludec42

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Change in Physical Examination

Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at week -2 and week 26 is presented. (NCT03175120)
Timeframe: Week -2, week 26

InterventionParticipants (Count of Participants)
Week-2: Cardiovascular system72482246Week-2: Cardiovascular system72482247Week 26: Cardiovascular system72482246Week 26: Cardiovascular system72482247Week-2: Central and peripheral nervous system72482246Week-2: Central and peripheral nervous system72482247Week 26: Central and peripheral nervous system72482246Week 26: Central and peripheral nervous system72482247Week -2: Gastrointestinal system72482246Week -2: Gastrointestinal system72482247Week 26: Gastrointestinal system72482247Week 26: Gastrointestinal system72482246Week -2: General appearance72482246Week -2: General appearance72482247Week 26: General appearance72482246Week 26: General appearance72482247Week -2: Head, eyes, ENTand Neck72482246Week -2: Head, eyes, ENTand Neck72482247Week 26: Head, eyes, ENTand Neck72482246Week 26: Head, eyes, ENTand Neck72482247Week -2: Lymph node palpation72482247Week -2: Lymph node palpation72482246Week 26: Lymph node palpation72482246Week 26: Lymph node palpation72482247Week -2: Musculoskeletal system72482246Week -2: Musculoskeletal system72482247Week 26: Musculoskeletal system72482246Week 26: Musculoskeletal system72482247Week -2: Respiratory system72482247Week -2: Respiratory system72482246Week 26: Respiratory system72482246Week 26: Respiratory system72482247Week -2: Skin72482246Week -2: Skin72482247Week 26: Skin72482246Week 26: Skin72482247Week -2: Thyroid gland72482247Week -2: Thyroid gland72482246Week 26: Thyroid gland72482246Week 26: Thyroid gland72482247
NormalAbnormal NCSAbnormal CS
Insulin Degludec149
Insulin Degludec/Liraglutide286
Insulin Degludec137
Insulin Degludec/Liraglutide287
Insulin Degludec/Liraglutide0
Insulin Degludec/Liraglutide299
Insulin Degludec150
Insulin Degludec/Liraglutide285
Insulin Degludec139
Insulin Degludec/Liraglutide2
Insulin Degludec0
Insulin Degludec/Liraglutide1
Insulin Degludec/Liraglutide283
Insulin Degludec141
Insulin Degludec/Liraglutide11
Insulin Degludec/Liraglutide7
Insulin Degludec8
Insulin Degludec/Liraglutide273
Insulin Degludec130
Insulin Degludec2
Insulin Degludec/Liraglutide6
Insulin Degludec7
Insulin Degludec1
Insulin Degludec/Liraglutide296
Insulin Degludec145
Insulin Degludec/Liraglutide3
Insulin Degludec3
Insulin Degludec/Liraglutide280
Insulin Degludec/Liraglutide5
Insulin Degludec/Liraglutide301
Insulin Degludec151
Insulin Degludec/Liraglutide288
Insulin Degludec/Liraglutide270
Insulin Degludec132
Insulin Degludec/Liraglutide22
Insulin Degludec13
Insulin Degludec/Liraglutide9
Insulin Degludec6
Insulin Degludec/Liraglutide259
Insulin Degludec126
Insulin Degludec9
Insulin Degludec4
Insulin Degludec/Liraglutide295
Insulin Degludec147
Insulin Degludec/Liraglutide4
Insulin Degludec/Liraglutide284
Insulin Degludec134

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Change in Electrocardiogram (ECG)

The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented. (NCT03175120)
Timeframe: Week -2, week 26

InterventionParticipants (Count of Participants)
Week -272482246Week -272482247Week 2672482246Week 2672482247
NormalAbnormal NCSAbnormal CS
Insulin Degludec/Liraglutide175
Insulin Degludec90
Insulin Degludec/Liraglutide76
Insulin Degludec41
Insulin Degludec/Liraglutide50
Insulin Degludec20
Insulin Degludec91
Insulin Degludec/Liraglutide73
Insulin Degludec32
Insulin Degludec/Liraglutide39
Insulin Degludec16

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Change in Calcitonin

Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionParticipants (Count of Participants)
Week 072482246Week 072482247Week 2672482246Week 2672482247
NormalLowHigh
Insulin Degludec/Liraglutide293
Insulin Degludec149
Insulin Degludec/Liraglutide8
Insulin Degludec2
Insulin Degludec/Liraglutide0
Insulin Degludec0
Insulin Degludec/Liraglutide279
Insulin Degludec136
Insulin Degludec/Liraglutide10
Insulin Degludec3

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SMPG-9-point Profile (Individual Points in the Profile)

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented. (NCT03175120)
Timeframe: Week 26

,
Interventionmmol/L (Mean)
Before breakfast90 minutes after start of breakfastBefore lunch90 minutes after start of lunchBefore main evening meal90 minutes after main evening mealAt bedtimeAt 4:00 a.m.Before breakfast the following day
Insulin Degludec5.8810.508.1711.217.8710.869.526.615.83
Insulin Degludec/Liraglutide5.489.516.939.687.249.878.575.975.48

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Change in Haematological Parameter- Leukocytes and Thrombocytes

Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

,
Intervention10^9 cells per liter (10^9/L) (Mean)
LeukocytesThrombocytes
Insulin Degludec0.3112.19
Insulin Degludec/Liraglutide0.3214.13

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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

,
InterventionMillimeters of mercury (mmHg) (Mean)
Systolic blood pressureDiastolic blood pressure
Insulin Degludec-0.5-0.4
Insulin Degludec/Liraglutide-3.50.1

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Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea

Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

,
Interventionmmol/L (Mean)
Calcium (total)Albumin corrected calciumPotassiumSodiumUrea
Insulin Degludec-0.01-0.01-0.111.400.17
Insulin Degludec/Liraglutide0.01-0.00-0.031.03-0.09

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Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)

Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

,
InterventionUnits per liter (U/L) (Mean)
AmylaseLipaseCreatinine kinaseALTASTALP
Insulin Degludec2.69-0.356.99-4.06-2.06-1.70
Insulin Degludec/Liraglutide10.4516.973.32-3.02-1.42-1.62

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Total Insulin Antibodies

Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). (NCT03175120)
Timeframe: Week 27

Intervention%B/T (Mean)
Insulin Degludec/Liraglutide9.31
Insulin Degludec8.77

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Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented. (NCT03175120)
Timeframe: Up to 26 weeks

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide38
Insulin Degludec36

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Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented. (NCT03175120)
Timeframe: Weeks 0-27

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide23
Insulin Degludec21

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented. (NCT03175120)
Timeframe: Weeks 0-27

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide7
Insulin Degludec7

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented. (NCT03175120)
Timeframe: Weeks 0-27

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide9
Insulin Degludec8

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Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition

Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA definition is presented. (NCT03175120)
Timeframe: Weeks 0-27

InterventionEpisodes (Number)
Insulin Degludec/Liraglutide1099
Insulin Degludec680

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Number of Treatment-emergent Adverse Events (TEAEs)

A TEAE was defined as an adverse event with onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE. (NCT03175120)
Timeframe: Weeks 0-27

InterventionAdverse events (Number)
Insulin Degludec/Liraglutide641
Insulin Degludec230

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Insulin Dose

The mean of actual daily total insulin dose after 26 weeks of treatment is presented. (NCT03175120)
Timeframe: Week 26

InterventionUnits of insulin (U) (Mean)
Insulin Degludec/Liraglutide34.6
Insulin Degludec37.9

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Change in Waist Circumference

Change in waist circumference from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionCentimeter (cm) (Mean)
Insulin Degludec/Liraglutide-0.4
Insulin Degludec0.7

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Change in Total Protein

Change in total protein from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Interventiong/dL (Mean)
Insulin Degludec/Liraglutide0.08
Insulin Degludec0.03

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Change in Total Bilirubin

Change in total bilirubin from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionMicromoles per liter (umol/L) (Mean)
Insulin Degludec/Liraglutide-0.30
Insulin Degludec-0.54

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Change in SMPG-mean Post Prandial Increments

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide0.08
Insulin Degludec0.28

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Change in Pulse

Change in pulse from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionBeats per minute (beats/min) (Mean)
Insulin Degludec/Liraglutide5.7
Insulin Degludec1.3

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Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-3.35
Insulin Degludec-2.31

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Change in HOMA-B (Beta-cell Function)- Ratio to Baseline

Change in HOMA-B from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of beta-cell function (Geometric Mean)
Insulin Degludec/Liraglutide1.47
Insulin Degludec0.99

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Change in HbA1c

Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionPercentage point of HbA1c (Mean)
Insulin Degludec/Liraglutide-1.93
Insulin Degludec-1.06

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Change in Haematological Parameter- Monocytes

Change in monocytes from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionPercentage of monocytes (Mean)
Insulin Degludec/Liraglutide-0.19
Insulin Degludec-0.06

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Change in Haematological Parameter- Lymphocytes

Change in lymphocytes from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionPercentage of lymphocytes (Mean)
Insulin Degludec/Liraglutide-1.00
Insulin Degludec-0.82

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Change in Haematological Parameter- Haemoglobin

Change in haemoglobin from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-0.08
Insulin Degludec-0.09

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Change in Haematological Parameter- Haematocrit

Change in haematocrit from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionPercentage of red blood cells (Mean)
Insulin Degludec/Liraglutide-0.07
Insulin Degludec-0.12

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Change in Haematological Parameter- Erythrocytes

Change in erythrocytes from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention10^12 cells per liter (10^12/L) (Mean)
Insulin Degludec/Liraglutide-0.06
Insulin Degludec-0.05

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Change in Haematological Parameter- Eosinophils

Change in eosinophils from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionPercentage of eosinophils (Mean)
Insulin Degludec/Liraglutide-0.15
Insulin Degludec-0.25

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Change in Haematological Parameter- Basophils

Change in basophils from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionPercentage of basophils (Mean)
Insulin Degludec/Liraglutide0.00
Insulin Degludec0.01

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Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline

Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of VLDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide0.92
Insulin Degludec0.93

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Change in Fasting Triglycerides- Ratio to Baseline

Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of triglycerides (Geometric Mean)
Insulin Degludec/Liraglutide0.91
Insulin Degludec0.92

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Change in Fasting Total Cholesterol- Ratio to Baseline

Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of total cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide0.92
Insulin Degludec0.97

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Change in Fasting Plasma Glucose (FPG)

Change in FPG from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Degludec/Liraglutide-3.57
Insulin Degludec-2.82

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Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline

Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of LDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide0.89
Insulin Degludec0.95

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Antibodies Cross-reacting to Human Insulin

Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). (NCT03175120)
Timeframe: Week 27

Intervention%B/T (Mean)
Insulin Degludec/Liraglutide9.07
Insulin Degludec8.64

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Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline

Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of HDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide1.00
Insulin Degludec1.03

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Change in Fasting Glucagon- Ratio to Baseline

Change in fasting glucagon (measured in picograms per milliliter (pg/mL)) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of glucagon (Geometric Mean)
Insulin Degludec/Liraglutide1.01
Insulin Degludec1.09

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Change in Fasting Free Fatty Acids- Ratio to Baseline

Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of free fatty acids (Geometric Mean)
Insulin Degludec/Liraglutide0.65
Insulin Degludec0.64

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Change in Fasting C-peptide- Ratio to Baseline

Change in fasting C-peptide (measured in nanomoles per liter (nmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of C-peptide (Geometric Mean)
Insulin Degludec/Liraglutide0.64
Insulin Degludec0.52

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Change in Creatinine

Change in creatinine from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Interventionumol/L (Mean)
Insulin Degludec/Liraglutide0.44
Insulin Degludec-0.32

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Change in Body Weight

Change in body weight from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionKilogram (kg) (Mean)
Insulin Degludec/Liraglutide-0.7
Insulin Degludec0.5

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Change in Haematological Parameter- Neutrophils

Change in neutrophils from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionPercentage of neutrophils (Mean)
Insulin Degludec/Liraglutide1.34
Insulin Degludec0.99

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Change in Albumin

Change in albumin from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionGrams per deciliter (g/dL) (Mean)
Insulin Degludec/Liraglutide0.05
Insulin Degludec0.02

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Change in Fasting Insulin- Ratio to Baseline

Change in fasting insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

InterventionRatio of insulin (Geometric Mean)
Insulin Degludec/Liraglutide0.63
Insulin Degludec0.50

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Urinalysis (Erythrocytes, Protein, Glucose and Ketones)

The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at week 0 and week 26 are presented. (NCT03175120)
Timeframe: Week 0, week 26

InterventionParticipants (Count of Participants)
Week 0: Erythrocytes72482247Week 0: Erythrocytes72482246Week 26: Erythrocytes72482246Week 26: Erythrocytes72482247Week 0: Glucose72482246Week 0: Glucose72482247Week 26: Glucose72482246Week 26: Glucose72482247Week 0: Ketones72482246Week 0: Ketones72482247Week 26: Ketones72482246Week 26: Ketones72482247Week 0: Protein72482246Week 0: Protein72482247Week 26: Protein72482246Week 26: Protein72482247
Trace1+2+3+Negative
Insulin Degludec/Liraglutide258
Insulin Degludec121
Insulin Degludec22
Insulin Degludec4
Insulin Degludec3
Insulin Degludec1
Insulin Degludec/Liraglutide255
Insulin Degludec120
Insulin Degludec/Liraglutide22
Insulin Degludec11
Insulin Degludec/Liraglutide6
Insulin Degludec/Liraglutide171
Insulin Degludec92
Insulin Degludec/Liraglutide33
Insulin Degludec13
Insulin Degludec/Liraglutide30
Insulin Degludec17
Insulin Degludec/Liraglutide25
Insulin Degludec/Liraglutide41
Insulin Degludec/Liraglutide256
Insulin Degludec110
Insulin Degludec/Liraglutide14
Insulin Degludec16
Insulin Degludec/Liraglutide10
Insulin Degludec/Liraglutide4
Insulin Degludec/Liraglutide3
Insulin Degludec/Liraglutide274
Insulin Degludec137
Insulin Degludec/Liraglutide21
Insulin Degludec/Liraglutide5
Insulin Degludec0
Insulin Degludec/Liraglutide272
Insulin Degludec132
Insulin Degludec7
Insulin Degludec/Liraglutide1
Insulin Degludec/Liraglutide0
Insulin Degludec/Liraglutide172
Insulin Degludec89
Insulin Degludec/Liraglutide72
Insulin Degludec32
Insulin Degludec/Liraglutide36
Insulin Degludec18
Insulin Degludec/Liraglutide16
Insulin Degludec10
Insulin Degludec2
Insulin Degludec/Liraglutide198
Insulin Degludec/Liraglutide47
Insulin Degludec/Liraglutide29
Insulin Degludec/Liraglutide11
Insulin Degludec9
Insulin Degludec/Liraglutide2

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Anti-insulin Degludec Specific Antibodies

Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). (NCT03175120)
Timeframe: Week 27

Intervention%B/T (Mean)
Insulin Degludec/Liraglutide0.25
Insulin Degludec0.13

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52

All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in FPG at Week 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). (NCT03211858)
Timeframe: Baseline, Week 26, and Week 52

,
Interventionmillimoles per liter (mmol/L) (Least Squares Mean)
At Week 26At Week 52
NovoLog/NovoRapid-0.17-0.34
SAR341402-0.49-0.10

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Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52

Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in mean 24-hour plasma glucose concentration at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). (NCT03211858)
Timeframe: Baseline, Week 26, and Week 52

,
Interventionmmol/L (Least Squares Mean)
At Week 26At Week 52
NovoLog/NovoRapid-0.53-0.18
SAR341402-0.340.12

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Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52

Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as the average across profiles performed in the week before the visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in PPG excursions at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). (NCT03211858)
Timeframe: Baseline, Week 26, and Week 52

,
Interventionmmol/L (Least Squares Mean)
Week 26: At BreakfastWeek 26: At LunchWeek 26: At DinnerWeek 52: At BreakfastWeek 52: At LunchWeek 52: At Dinner
NovoLog/NovoRapid0.650.120.660.910.340.51
SAR3414020.500.180.360.730.430.26

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Change in Glycated Hemoglobin A1c From Baseline to Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c at Week 26 and Week 52 was calculated by subtracting baseline value from Week 26 and Week 52 value, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae). (NCT03211858)
Timeframe: Baseline, Week 26 and Week 52

,,,
Interventionpercentage of HbA1c (Least Squares Mean)
At Week 26At Week 52
Prior Humalog/Liprolog Use: NovoLog/NovoRapid-0.24-0.26
Prior Humalog/Liprolog Use: SAR341402-0.39-0.19
Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid-0.33-0.26
Prior NovoLog/NovoRapid Use: SAR341402-0.37-0.28

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Number of Hypoglycemia Events Per Participant-Year

Number of hypoglycemia events (any, severe and documented [both thresholds]) per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). (NCT03211858)
Timeframe: From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

,
Interventionevents per participant-year (Number)
Week 26: Any hypoWeek 26: Severe hypoWeek 26:Documented symptomatic hypo (<=3.9 mmol/L)Week 26: Documented symptomatic hypo (<3.0 mmol/L)Week 52: Any hypoWeek 52: Severe hypoWeek 52:Documented symptomatic hypo (<=3.9 mmol/L)Week 52: Documented symptomatic hypo (<3.0 mmol/L)
NovoLog/NovoRapid69.710.1036.379.8164.460.0833.738.91
SAR34140273.330.1440.3611.1866.000.1235.689.37

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Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52

Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit. (NCT03211858)
Timeframe: Baseline, Day 1, Week 26 and Week 52

,
InterventionUnits/kilogram (U/kg) (Mean)
Basal insulin dose at Day 1Mealtime insulin dose at Day 1Total insulin dose at Day 1Basal insulin dose at Week 26Mealtime insulin dose at Week 26Total insulin dose at Week 26Basal insulin dose at Week 52Mealtime insulin dose at Week 52Total insulin dose at Week 52
NovoLog/NovoRapid-0.0000.0030.0020.0030.0110.0150.0050.0090.013
SAR341402-0.0040.003-0.0010.005-0.011-0.0070.006-0.0010.005

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Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day 1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit. (NCT03211858)
Timeframe: Baseline, Day 1, Week 26, Week 52

,,,
InterventionU/kg (Mean)
Basal insulin dose at Day 1Mealtime insulin dose at Day 1Total insulin dose at Day 1Basal insulin dose at Week 26Mealtime insulin dose at Week 26Total insulin dose at Week 26Basal insulin dose at Week 52Mealtime insulin dose at Week 52Total insulin dose at Week 52
Prior Humalog/Liprolog Use: NovoLog/NovoRapid-0.0020.0130.011-0.006-0.003-0.006-0.009-0.001-0.009
Prior Humalog/Liprolog Use: SAR341402-0.0020.0080.0060.008-0.015-0.0080.010-0.0010.009
Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid0.0000-0.003-0.0030.0090.0190.0270.0130.0150.025
Prior NovoLog/NovoRapid Use: SAR341402-0.005-0.000-0.0060.003-0.009-0.0070.004-0.0000.003

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Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point

7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 26, and Week 52): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit. (NCT03211858)
Timeframe: Baseline, Week 26, and Week 52

,
Interventionmmol/L (Mean)
Week 26: Before BreakfastWeek 26: 2 Hours After BreakfastWeek 26: Before LunchWeek 26: 2 Hours After LunchWeek 26: Before DinnerWeek 26: 2 Hours After DinnerWeek 26: BedtimeWeek 52: Before BreakfastWeek 52: 2 Hours After BreakfastWeek 52: Before LunchWeek 52: 2 Hours After LunchWeek 52: Before DinnerWeek 52: 2 Hours After DinnerWeek 52: Bedtime
NovoLog/NovoRapid-0.50-0.30-0.60-0.62-0.78-0.25-0.54-0.310.05-0.13-0.37-0.06-0.170.10
SAR341402-0.62-0.39-0.60-0.61-0.04-0.36-0.71-0.54-0.210.240.050.750.16-0.11

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Change in HbA1c From Baseline to Week 52

All values up to Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 52 value. Missing changes at Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae). (NCT03211858)
Timeframe: Baseline, Week 52

Interventionpercentage of HbA1c (Least Squares Mean)
SAR341402-0.25
NovoLog/NovoRapid-0.26

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Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26

All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae). (NCT03211858)
Timeframe: Baseline, Week 26

Interventionpercentage of HbA1c (Least Squares Mean)
SAR341402-0.38
NovoLog/NovoRapid-0.30

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Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample

Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence). (NCT03211858)
Timeframe: From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

,
Interventionpercentage of participants (Number)
At Week 26At Week 52
NovoLog/NovoRapid52.458.2
SAR34140248.054.7

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Percentage of Participants With HbA1c <7% at Week 26 and Week 52

Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders. (NCT03211858)
Timeframe: Week 26 and Week 52

,
Interventionpercentage of participants (Number)
At Week 26At Week 52
NovoLog/NovoRapid14.518.2
SAR34140216.619.6

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Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions

Participants with at least one treatment-emergent adverse event linked to hypersensitivity reaction and injection site reaction regardless of relationship to IMP during the main 6-month and the 12-month on-treatment periods was assessed and reported. (NCT03211858)
Timeframe: From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

,
Interventionpercentage of participants (Number)
Week 26: Hypersensitivity ReactionsWeek 26: Injection site reactionsWeek 52: Hypersensitivity ReactionsWeek 52: Injection site reactions
NovoLog/NovoRapid3.71.47.11.4
SAR3414023.70.75.60.7

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Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)

AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). 2) Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. (NCT03211858)
Timeframe: From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

,
Interventionpercentage of participants (Number)
Week 26: Treatment-Induced AIAWeek 26: Treatment-Boosted AIAWeek 26: Treatment-Emergent AIAWeek 52: Treatment-Induced AIAWeek 52: Treatment-Boosted AIAWeek 52: Treatment-Emergent AIA
NovoLog/NovoRapid28.45.120.537.113.329.1
SAR34140223.04.216.933.29.425.5

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Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs): Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample. 2) Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. Data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog). (NCT03211858)
Timeframe: From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

,,,
Interventionpercentage of participants (Number)
Week 26: Treatment-Induced AIAWeek 26: Treatment-Boosted AIAWeek 26: Treatment-Emergent AIAWeek 52: Treatment-Induced AIAWeek 52: Treatment-Boosted AIAWeek 52: Treatment-Emergent AIA
Prior Humalog/Liprolog Use: NovoLog/NovoRapid28.46.121.541.99.131.8
Prior Humalog/Liprolog Use: SAR34140229.910.724.838.017.932.7
Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid28.34.620.034.215.427.6
Prior NovoLog/NovoRapid Use: SAR34140218.71.512.630.15.921.5

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Number of Participants With at Least One Hypoglycemic Event: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). (NCT03211858)
Timeframe: From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

,,,
InterventionParticipants (Count of Participants)
Week 26: Any hypoglycemiaWeek 26: Severe hypoglycemiaWeek 26: Documented symptomatic <=3.9 mmol/LWeek 26: Documented symptomatic < 3.0 mmol/LWeek 52: Any hypoglycemiaWeek 52: Severe hypoglycemiaWeek 52: Documented symptomatic <=3.9 mmol/LWeek 52: Documented symptomatic < 3.0 mmol/L
Prior Humalog/Liprolog Use: NovoLog/NovoRapid1063897010659682
Prior Humalog/Liprolog Use: SAR3414021046946710589974
Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid17971621231849171138
Prior NovoLog/NovoRapid Use: SAR341402187617013919010175149

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Number of Participants With at Least One Hypoglycemic Event

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). (NCT03211858)
Timeframe: From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

,
InterventionParticipants (Count of Participants)
Week 26: Any hypoglycemiaWeek 26: Severe hypoglycemiaWeek 26: Documented symptomatic <=3.9 mmol/LWeek 26: Documented symptomatic < 3.0 mmol/LWeek 52: Any hypoglycemiaWeek 52: Severe hypoglycemiaWeek 52: Documented symptomatic <=3.9 mmol/LWeek 52: Documented symptomatic hypo < 3.0 mmol/L
NovoLog/NovoRapid2851025119329014267220
SAR3414022911226420729518274223

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Number of Participants With Adverse Events: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog

Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during the main 6-month or 12-month on-treatment periods. (NCT03211858)
Timeframe: From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52

,,,
InterventionParticipants (Count of Participants)
Week 26: Any TEAEWeek 52: Any TEAE
Prior Humalog/Liprolog Use: NovoLog/NovoRapid5259
Prior Humalog/Liprolog Use: SAR3414026469
Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid94109
Prior NovoLog/NovoRapid Use: SAR34140292115

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Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26

"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug." (NCT03214367)
Timeframe: Baseline, Week 26

InterventionPercentage of HbA1c (Least Squares Mean)
LY900014-0.13
LY900014 Postmeal0.08
Insulin Lispro (Humalog)-0.05

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Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug. (NCT03214367)
Timeframe: Baseline, Week 26

InterventionUnits on a scale (Least Squares Mean)
LY9000141.4
LY900014 Postmeal1.5
Insulin Lispro (Humalog)0.7

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Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug. (NCT03214367)
Timeframe: Baseline, Week 26

InterventionUnits on a scale (Least Squares Mean)
LY9000142.1
LY900014 Postmeal3.7
Insulin Lispro (Humalog)1.3

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Percentage of Participants With HbA1c <7%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. (NCT03214367)
Timeframe: Week 26

InterventionPercentage of participants (Number)
LY90001436.00
LY900014 Postmeal24.84
Insulin Lispro (Humalog)33.94

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Rate of Documented Symptomatic Hypoglycemia at Week 26

Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable. (NCT03214367)
Timeframe: Baseline through Week 26

InterventionEvents per participant per year (Least Squares Mean)
LY9000146.71
LY900014 Postmeal7.75
Insulin Lispro (Humalog)7.35

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Change From Baseline in Insulin Dose at Week 26

LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug. (NCT03214367)
Timeframe: Baseline, Week 26

,,
InterventionUnits (U)/day (Least Squares Mean)
Total Daily Insulin DoseDaily Basal Insulin DoseDaily Prandial Insulin Dose
Insulin Lispro (Humalog)2.00.90.9
LY9000142.91.01.5
LY900014 Postmeal2.21.21.0

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Rate of Severe Hypoglycemia at Week 26

Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525. (NCT03214367)
Timeframe: Baseline through Week 26

InterventionEvents per 100 participant years (Number)
LY90001416.50
LY900014 Postmeal13.70
Insulin Lispro (Humalog)18.34

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Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26

SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug. (NCT03214367)
Timeframe: Baseline, Week 26

,,
Interventionmg/dL (Least Squares Mean)
Morning PremealMorning 1-hour PostmealMorning 2-hour PostmealMidday PremealMidday 1-hour PostmealMidday 2-hour PostmealEvening PremealEvening 1-hour PostmealEvening 2-hour PostmealBedtime
Insulin Lispro (Humalog)-3.3-1.01.41.91.4-2.7-1.4-0.9-0.6-2.9
LY900014-1.1-14.8-10.16.6-2.2-5.25.2-7.0-8.2-6.8
LY900014 Postmeal2.95.4-0.24.011.40.00.415.3-1.6-11.0

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Change From Baseline in HbA1c at Week 52

"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by MMRM model with variables of baseline, pooled country, type of basal insulin during lead-in, prandial Insulin Dosing Plan, treatment (Type III sum of squares) as fixed factors. The analysis included data prior to permanent discontinuation of study drug." (NCT03214367)
Timeframe: Baseline, Week 52

InterventionPercentage of HbA1c (Least Squares Mean)
LY9000140.13
Insulin Lispro (Humalog)0.20

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Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. 2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. (NCT03214367)
Timeframe: Baseline, Week 26

Interventionmg/dL (Least Squares Mean)
LY900014-34.7
LY900014 Postmeal-10.2
Insulin Lispro (Humalog)-3.5

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Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26

1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug. (NCT03214367)
Timeframe: Baseline, Week 26

Interventionmilligram per liter (mg/L) (Least Squares Mean)
LY9000140.19
LY900014 Postmeal-0.38
Insulin Lispro (Humalog)-0.22

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Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. 1-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. (NCT03214367)
Timeframe: Baseline, Week 26

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
LY900014-28.6
LY900014 Postmeal12.5
Insulin Lispro (Humalog)-0.7

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Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26

Change from baseline in 10-point SMBG values was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug. (NCT03214380)
Timeframe: Baseline, Week 26

,
Interventionmg/dL (Least Squares Mean)
Morning PremealMorning 1-hour PostmealMorning 2-hour PostmealMidday PremealMidday 1-hour PostmealMidday 2-hour PostmealEvening PremealEvening 1-hour PostmealEvening 2-hour PostmealBedtime
Insulin Lispro (Humalog)-0.8-2.00.62.43.0-2.27.0-2.10.2-3.4
LY9000141.5-14.1-14.94.1-2.0-6.510.1-3.0-2.1-2.2

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Change From Baseline in Insulin Dose at Week 26

Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug. (NCT03214380)
Timeframe: Baseline, Week 26

,
InterventionUnits (U) (Least Squares Mean)
Basal Insulin DosePrandial Insulin DoseTotal Daily Insulin Dose
Insulin Lispro (Humalog)4.28.312.1
LY9000144.612.017.3

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Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26

Change from baseline in HbA1c was performed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. (NCT03214380)
Timeframe: Baseline, Week 26

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Lispro (Humalog)-0.43
LY900014-0.38

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1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand

1-hour PPG excursion during MMTT uses the analysis of covariance (ANCOVA) model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. (NCT03214380)
Timeframe: Week 26

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
Insulin Lispro (Humalog)74.9
LY90001463.1

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2-hour PPG Excursion During MMTT Efficacy Estimand

2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. (NCT03214380)
Timeframe: Week 26

Interventionmg/dL (Least Squares Mean)
Insulin Lispro (Humalog)97.8
LY90001480.4

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Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26

Change from baseline in 1,5-AG was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug. (NCT03214380)
Timeframe: Baseline, Week 26

Interventionmilligram per liter (mg/L) (Least Squares Mean)
Insulin Lispro (Humalog)2.15
LY9000141.99

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Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26

"ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction.~Change from baseline in ITSQ regimen inconvenience domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug." (NCT03214380)
Timeframe: Baseline, Week 26

Interventionunits on a scale (Least Squares Mean)
Insulin Lispro (Humalog)-0.9
LY900014-2.4

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Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26

"ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction.~Change from baseline in ITSQ lifestyle flexibility domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug." (NCT03214380)
Timeframe: Baseline, Week 26

Interventionunits on a scale (Least Squares Mean)
Insulin Lispro (Humalog)1.4
LY9000140.2

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Number of Participants With HbA1c <7%

Number of participants with HbA1c <7% at Week 26. (NCT03214380)
Timeframe: Week 26

InterventionParticipants (Count of Participants)
Insulin Lispro (Humalog)168
LY900014184

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Rate of Documented Symptomatic Hypoglycemia

Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable. (NCT03214380)
Timeframe: Baseline through Week 26

InterventionEvents per participant per 30 days/year (Least Squares Mean)
Insulin Lispro (Humalog)1.34
LY9000142.21

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Rate of Severe Hypoglycemia

Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525. Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience com with or without seizures, and may require parenteral therapy. (NCT03214380)
Timeframe: Baseline through Week 26

InterventionEvents per 100 participant years (Number)
Insulin Lispro (Humalog)4.19
LY9000142.44

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Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24

Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value. (NCT03260868)
Timeframe: Baseline, Week 16, Week 24

,
Interventionmillimole per liter (mmol/L) (Mean)
Week 16Week 24
Traditional-0.2002.900
Virtual-0.660-3.625

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Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >3.9 mmol/L (70 mg/dL). (NCT03260868)
Timeframe: During 24 weeks treatment period

,
InterventionParticipants (Count of Participants)
Any hypoglycemiaSevere hypoglycemiaDocumented symptomatic hypoglycemia: <=3.9 mmol/LDocumented symptomatic hypoglycemia: <3.0 mmol/LProbable symptomatic hypoglycemiaAsymptomatic hypoglycemia <=3.9 mmol/LAsymptomatic hypoglycemia <3.0 mmol/LPseudo-hypoglycemia >3.9 mmol/L
Traditional30330310
Virtual70640411

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Change From Baseline in Glycated Hemoglobin A1c to Week 16

Change in HbA1c was calculated by subtracting baseline value from Week 16 value. (NCT03260868)
Timeframe: Baseline, Week 16

Interventionpercentage of HbA1c (Mean)
Virtual0.23
Traditional0.45

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Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24

Change in HbA1c was calculated by subtracting baseline value from Week 24 value. (NCT03260868)
Timeframe: Baseline, Week 24

Interventionpercentage of HbA1c (Mean)
Virtual0.10
Traditional0.33

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Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day

The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia (NCT03262116)
Timeframe: 7 days

Interventiongrams of carbohydrates (Mean)
Insulin-only Bionic Pancreas With BC222 Lispro12.42
Insulin-only Bionic Pancreas With Insulin Lispro9.27
Insulin-only Bionic Pancreas With Insulin Aspart14.00

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Mean Post Prandial Excursion

Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges. (NCT03262116)
Timeframe: 7 days

Interventionmg/dl (Mean)
Insulin-only Bionic Pancreas With BC222 Lispro95.06
Insulin-only Bionic Pancreas With Insulin Lispro103.13
Insulin-only Bionic Pancreas With Insulin Aspart104.07

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Number of Symptomatic Hypoglycemic Events Per Day

The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm (NCT03262116)
Timeframe: 7 days

Interventionnumber of events (Mean)
Insulin-only Bionic Pancreas With BC222 Lispro0.73
Insulin-only Bionic Pancreas With Insulin Lispro0.60
Insulin-only Bionic Pancreas With Insulin Aspart1.02

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Percentage of Time Spent With CGM Glucose < 54 mg/dl

The amount of time the subject spent in the hypoglycemic range < 54 mg/dl as measured by the continuous glucose monitor during each arm (NCT03262116)
Timeframe: 7 days

Interventionpercentage of CGM glucose values (Mean)
Insulin-only Bionic Pancreas With BC222 Lispro0.30
Insulin-only Bionic Pancreas With Insulin Lispro0.55
Insulin-only Bionic Pancreas With Insulin Aspart1.01

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Percentage of Time Spent Within Each of the Following Ranges:

The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm (NCT03262116)
Timeframe: 7 days

,,
Interventionpercentage of CGM glucose values (Mean)
% time CGM glcuose < 50 mg/dl% time CGM glcuose < 60 mg/dl% time CGM glcuose < 70 mg/dl% time CGM glcuose 70-120 mg/dl% time CGM glcuose 70-180 mg/dl% time CGM glcuose >180 mg/dl% time CGM glcuose > 250 mg/dl
Insulin-only Bionic Pancreas With BC222 Lispro0.200.802.6527.4967.7729.587.67
Insulin-only Bionic Pancreas With Insulin Aspart0.631.854.3130.4470.0625.637.11
Insulin-only Bionic Pancreas With Insulin Lispro0.241.313.5927.2072.1624.265.21

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Within Day Coefficient of Variation

A measure of dispersion of glucose values around the mean (NCT03262116)
Timeframe: 7 days

Interventionpercentage of CGM glucose values (Mean)
Insulin-only Bionic Pancreas With BC222 Lispro37.4
Insulin-only Bionic Pancreas With Insulin Lispro35.5
Insulin-only Bionic Pancreas With Insulin Aspart38.6

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Total Daily Dose of Insulin

The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm. (NCT03262116)
Timeframe: 7 days

Interventionunits per kilogram per day (Mean)
Insulin-only Bionic Pancreas With BC222 Lispro0.71
Insulin-only Bionic Pancreas With Insulin Lispro0.60
Insulin-only Bionic Pancreas With Insulin Aspart0.61

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Average Continuous Glucose Monitor (CGM) Glucose

The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm (NCT03262116)
Timeframe: 7 days

Interventionmg/dl (Mean)
Insulin-only Bionic Pancreas With BC222 Lispro157.0
Insulin-only Bionic Pancreas With Insulin Lispro151.4
Insulin-only Bionic Pancreas With Insulin Aspart151.2

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Change From Baseline in Fundoscopy/Fundus Photography

Changes in fundoscopy/fundus photography from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

InterventionParticipants (Count of Participants)
Left eye (week 0)72531735Left eye (week 0)72531736Left eye (week 16)72531735Left eye (week 16)72531736Right eye (week 0)72531735Right eye (week 0)72531736Right eye (week 16)72531735Right eye (week 16)72531736
NormalAbnormal CSAbnormal NCS
Faster Aspart225
NovoRapid219
Faster Aspart287
NovoRapid297
Faster Aspart32
NovoRapid27
Faster Aspart205
NovoRapid198
Faster Aspart278
NovoRapid288
Faster Aspart31
NovoRapid30
Faster Aspart224
NovoRapid217
Faster Aspart288
NovoRapid300
Faster Aspart208
NovoRapid194
Faster Aspart276
Faster Aspart30
NovoRapid26

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Change From Baseline in Haematology - Haemoglobin

Changes in haematology - haemoglobin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventionmmol/L (Mean)
Faster Aspart-0.02
NovoRapid-0.04

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Change From Baseline in Haematology - Haematocrit

Changes in haematology - haematocrit from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

InterventionPercentage (Mean)
Faster Aspart0.48
NovoRapid0.35

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Change From Baseline in 1-hour PPG Increment

Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

Interventionmmol/L (Mean)
Faster Aspart-0.43
NovoRapid0.08

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Individual Meal Insulin Dose: in Units/kg

Individual meal time bolus insulin dose (Units/kg) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: 16 weeks from randomisation

,
InterventionUnits/kg (Mean)
BreakfastLunchDaily main evening meal
Faster Aspart0.170.190.21
NovoRapid0.160.190.20

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Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall

"ADA classification of hypos:~Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.~Documented symptomatic: PG ≤3.9 mmol/L with symptoms.~Asymptomatic: PG ≤3.9 mmol/L without symptoms.~Probable symptomatic: No measurement with symptoms.~Pseudo: PG >3.9 mmol/L with symptoms.~Unclassifiable.~NN classification of hypos:~BG confirmed: PG <3.1 mmol/L with/without symptoms.~Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.~Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.~Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia." (NCT03268005)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart185038376168145322091490222768060
NovoRapid14616536816875327352055274972570

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Change From Baseline in Physical Examination

Participants with physical examination findings, normal, abnormal NCS (non- clinically significant) and abnormal CS (clinically significant) at baseline (week 0) and week 16 presented. Results are based on the data from the on-treatment observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system 2) Central & Peripheral nervous system 3) Gastrointestinal system incl. mouth 4) Head, ears, eyes, nose, throat and neck 5) Musculoskeletal system 6) Respiratory system 7) Skin (NCT03268005)
Timeframe: Week 0, week 16

InterventionParticipants (Count of Participants)
Cardiovascular system (week 0)72531735Cardiovascular system (week 0)72531736Cardiovascular system (week 16)72531735Cardiovascular system (week 16)72531736Central and Peripheral nervous sys. (week 0)72531735Central and Peripheral nervous sys. (week 0)72531736Central and Peripheral nervous sys. (week 16)72531735Central and Peripheral nervous sys. (week 16)72531736Gastrointestinal sys. including mouth (Week 0)72531735Gastrointestinal sys. including mouth (Week 0)72531736Gastrointestinal sys. including mouth (week 16)72531735Gastrointestinal sys. including mouth (week 16)72531736Head, ears, eyes, nose, throat, neck (week 0)72531736Head, ears, eyes, nose, throat, neck (week 0)72531735Head, ears, eyes, nose, throat, neck (week 16)72531735Head, ears, eyes, nose, throat, neck (week 16)72531736Musculoskeletal system (week 0)72531735Musculoskeletal system (week 0)72531736Musculoskeletal system (week 16)72531735Musculoskeletal system (week 16)72531736Respiratory system (week 0)72531735Respiratory system (week 0)72531736Respiratory system (week 16)72531735Respiratory system (week 16)72531736Skin (week 0)72531735Skin (week 0)72531736Skin (week 16)72531735Skin (week 16)72531736
NormalAbnormal NCSAbnormal CS
Faster Aspart459
NovoRapid460
Faster Aspart79
NovoRapid79
Faster Aspart6
NovoRapid5
Faster Aspart448
NovoRapid457
Faster Aspart71
NovoRapid72
Faster Aspart398
NovoRapid404
Faster Aspart133
NovoRapid127
Faster Aspart13
NovoRapid13
Faster Aspart383
NovoRapid400
Faster Aspart128
NovoRapid122
Faster Aspart14
NovoRapid11
Faster Aspart491
NovoRapid485
Faster Aspart53
NovoRapid59
NovoRapid0
Faster Aspart480
NovoRapid476
Faster Aspart45
NovoRapid57
Faster Aspart498
NovoRapid492
Faster Aspart43
NovoRapid48
Faster Aspart3
NovoRapid4
Faster Aspart485
NovoRapid483
Faster Aspart40
NovoRapid49
Faster Aspart504
NovoRapid496
Faster Aspart36
NovoRapid42
Faster Aspart4
Faster Aspart489
NovoRapid494
Faster Aspart32
NovoRapid33
NovoRapid6
Faster Aspart535
NovoRapid534
Faster Aspart9
NovoRapid9
Faster Aspart0
NovoRapid1
Faster Aspart520
NovoRapid517
Faster Aspart5
NovoRapid14
NovoRapid2
Faster Aspart438
NovoRapid429
Faster Aspart96
NovoRapid108
Faster Aspart10
NovoRapid7
Faster Aspart418
NovoRapid430
Faster Aspart98
NovoRapid98

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Change From Baseline in Haematology - Erythrocytes

Changes in haematology - erythrocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Intervention10^12 erythrocytes/L (Mean)
Faster Aspart-0.02
NovoRapid-0.04

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

Interventionmmol/L (Mean)
Faster Aspart0.56
NovoRapid0.68

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Change From Baseline in Body Weight

Changes in body weight from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventionkg (Mean)
Faster Aspart1.19
NovoRapid1.12

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Change From Baseline in Body Mass Index (BMI)

Change in the body mass index (BMI) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventionkg/m^2 (Mean)
Faster Aspart0.43
NovoRapid0.40

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Change From Baseline in Biochemistry - Total Protein

Changes in biochemistry - total protein from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventiong/dL (Mean)
Faster Aspart-0.01
NovoRapid-0.02

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Change From Baseline in Biochemistry - Total Bilirubin

Changes in biochemistry - total bilirubin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventionumol/L (Mean)
Faster Aspart0.1
NovoRapid0.1

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Change From Baseline in Biochemistry - Sodium

Changes in biochemistry - sodium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventionmmol/L (Mean)
Faster Aspart-0.6
NovoRapid-0.7

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Change From Baseline in Biochemistry - Potassium

Changes in biochemistry - potassium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventionmmol/L (Mean)
Faster Aspart-0.001
NovoRapid0.02

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Change From Baseline in Biochemistry - Creatinine

Changes in biochemistry - creatinine from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventionumol/L (Mean)
Faster Aspart0.1
NovoRapid1.5

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Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)

Changes in biochemistry - aspratate aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

InterventionU/L (Mean)
Faster Aspart-0.2
NovoRapid2.2

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Change From Baseline in Biochemistry - Alkaline Phosphatase

Changes in biochemistry - alkaline phosphatase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

InterventionU/L (Mean)
Faster Aspart2.9
NovoRapid2.2

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Change From Baseline in Biochemistry - Albumin

Changes in biochemistry - albumin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Interventiong/dL (Mean)
Faster Aspart0.02
NovoRapid0.01

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Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)

Changes in biochemistry - alanine aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

InterventionU/L (Mean)
Faster Aspart-0.1
NovoRapid3.1

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Change From Baseline in 1,5-anhydroglucitol

Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

Interventionmmol/L (Mean)
Faster Aspart1.38
NovoRapid0.89

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Individual Meal Insulin Dose: in Units

Individual meal time bolus insulin dose (Units) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: 16 weeks from randomisation

,
InterventionUnits (Mean)
BreakfastLunchDaily main evening meal
Faster Aspart16.2718.5119.88
NovoRapid15.5217.9619.85

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Change From Baseline in Electrocardiogram (ECG)

Changes in electrocardiogram (ECG) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

InterventionParticipants (Count of Participants)
Week 072531735Week 072531736Week 1672531736Week 1672531735
NormalAbnormal NCSAbnormal CS
Faster Aspart287
NovoRapid270
Faster Aspart252
NovoRapid264
Faster Aspart5
NovoRapid10
Faster Aspart274
NovoRapid272
Faster Aspart245
NovoRapid253
Faster Aspart6
NovoRapid8

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)

Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart23351446401931571952960
NovoRapid24651974902932412953820

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart616278523755076255776818090
NovoRapid918827442726096582097417140

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart2465201161002331812354590
NovoRapid144615911702462122473770

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart21498711207248741770
NovoRapid0148808406550651750

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)

Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart164703361762141320161333203265100
NovoRapid12570034846466324421814245468750

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Weeks 0-16

,
InterventionNumber of hypoglycaemic episodes (Number)
ADA: SevereADA: Documented symptomaticADA: AsymptomaticADA: Probable symptomaticADA: PseudoADA: UnclassifiableNN: BG confirmedNN: Severe or BG confirmed symptomaticNN: Severe or BG confirmedNN: UnclassifiableNot able to selftreat - unclassifiable
Faster Aspart411626512145052937653313500
NovoRapid814365851619071960872713370

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Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. PPG increment based on the 7-9-7-point profiles were derived separately for PG measurements made at 1 hour after main meals (breakfast, lunch and main evening meal). PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value. In trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BreakfastLunchMain evening mealAll meals
Faster Aspart-0.56-0.38-0.44-0.48
NovoRapid-0.42-0.23-0.10-0.23

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Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
BreakfastLunchMain evening mealAll meals
Faster Aspart-0.38-0.78-1.04-0.75
NovoRapid-0.28-0.58-0.71-0.52

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Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements

Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
Bedtime to 04:00Bedtime to breakfast04:00 to breakfast
Faster Aspart0.701.300.66
NovoRapid0.290.900.75

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Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure

Change in vital signs - systolic and diastolic blood pressure from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

,
InterventionmmHg (Mean)
Systolic blood pressureDiastolic blood pressure
Faster Aspart0.4-0.4
NovoRapid-1.2-0.7

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Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline

Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values are given as ratio to baseline (week 0) after 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

,
InterventionRatio (Geometric Mean)
Total cholesterolHigh density lipoproteinsLow density lipoproteins
Faster Aspart1.010.970.99
NovoRapid1.000.980.99

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Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)

Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value. (NCT03268005)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
30-min1-hour2-hour3-hour4-hour
Faster Aspart-0.13-0.43-0.37-0.150.04
NovoRapid-0.050.080.0010.280.15

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Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])

Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. (NCT03268005)
Timeframe: Week 0, week 16

,
Interventionmmol/L (Mean)
30-min1-hour2-hour3-hour4-hour
Faster Aspart0.310.030.080.300.51
NovoRapid0.550.680.610.890.75

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Total Bolus Insulin Dose: in Units/kg/Day

Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: 16 weeks from randomisation

InterventionUnits/kg/day (Mean)
Faster Aspart0.57
NovoRapid0.55

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Total Bolus Insulin Dose: in Units/Day

Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: 16 weeks from randomisation

InterventionUnits/day (Mean)
Faster Aspart54.72
NovoRapid53.38

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Total Basal Insulin Dose: in Units/kg/Day

Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: 16 weeks from randomisation

InterventionUnits/kg/day (Mean)
Faster Aspart0.66
NovoRapid0.64

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Total Basal Insulin Dose: in Units/Day

Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: 16 weeks from randomisation

InterventionUnits/day (Mean)
Faster Aspart63.76
NovoRapid62.25

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Number of Treatment Emergent Injection Site Reactions

Number of treatment emergent injection site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Weeks 0-16

InterventionNumber of injection site reactions (Number)
Faster Aspart3
NovoRapid1

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Number of Treatment Emergent Adverse Events

Number of treatment emergent adverse events were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Weeks 0-16

InterventionEvents (Number)
Faster Aspart667
NovoRapid643

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

InterventionPercentage of HbA1c (Mean)
Faster Aspart-0.15
NovoRapid-0.09

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Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile

Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-9-7 point SMPG profile from baseline (week 0) after 16 weeks of randomisation (i.e., week 16). The results are presented as ratio to baseline. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. (NCT03268005)
Timeframe: Week 0, week 16

InterventionRatio (Geometric Mean)
Faster Aspart0.82
NovoRapid0.85

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Change From Baseline in Vital Signs: Pulse

Change in vital signs - pulse from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

InterventionBeats per min (Mean)
Faster Aspart0.5
NovoRapid0.03

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Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile

Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-9-7 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast. (NCT03268005)
Timeframe: Week 0, week 16

Interventionmmol/L (Mean)
Faster Aspart-0.56
NovoRapid-0.50

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Change From Baseline in Haematology - Thrombocytes

Changes in haematology - thrombocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Intervention10^9 thrombocytes/L (Mean)
Faster Aspart-0.9
NovoRapid-1.3

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Change From Baseline in Haematology - Leukocytes

Changes in haematology - leukocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment. (NCT03268005)
Timeframe: Week 0, week 16

Intervention10^9 leukocytes/L (Mean)
Faster Aspart0.01
NovoRapid-0.01

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Change in Quality of Life

"A 15-item Diabetes-Specific Quality-of-Life Scale was used to assess the subjective appraisal of participants in their perceived degree to which their current health-related aspects in life were affected by emotional suffering, social functioning, adherence to treatment regimen, and diabetic-specific symptoms. Each item was rated from very much (0 point) to not at all (4 points). The total score ranged from 0 to 60. A higher score indicated better quality of life." (NCT03324451)
Timeframe: At baseline and 12 months after the intervention

Interventionscore on a scale (Mean)
Intervention Arm2.6
Control Arm5.45

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Change in Glycosylated Hemoglobin (HbA1c) Levels

Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels (NCT03324451)
Timeframe: At baseline and 12 months after the intervention

Interventionpercent of glycosylated Hb (Mean)
Intervention Arm-1.47
Control Arm-2.00

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Change in Diabetes Empowerment Process

A 13-item Chinese version of the Diabetes Empowerment Process Scale was used to assess the perceived level of empowerment by healthcare providers in participants. Each item was rated on a 5-point scale with scores ranging from 0 (strongly disagree) to 4 (strongly agree). The total score range from 13 to 65. A higher score indicated higher perceived patient empowerment. (NCT03324451)
Timeframe: At baseline and 12 months after the intervention

Interventionscore on a scale (Mean)
Intervention Arm0.52
Control Arm-2.13

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Change in Diabetes Distress

An 8-item Chinese version of the short-form Problem Areas in Diabetes Scale was used to assess the levels of diabetes distress in participants. The response of each item was rated from 0 (not a problem) to 4 (serious problem). The total score ranged from 8 to 32. A higher score represented severer diabetes distress. (NCT03324451)
Timeframe: At baseline and 12 months after the intervention

Interventionscore on a scale (Mean)
Intervention Arm-2.91
Control Arm-3.63

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Change in Body Mass Index

Physiological parameter which will be collected from body weight scale and height scale, and will be converted to body mass index (weight (kg)/ height(m) 2 (NCT03324451)
Timeframe: At baseline and 12 months after the intervention

InterventionKg/m^2 (Mean)
Intervention Arm1.06
Control Arm0.85

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Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo

The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 1h and 2h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means. (NCT03337477)
Timeframe: Baseline to 2h potassium measurements.

,
Interventionmmol/L (Least Squares Mean)
1h2h
Placebo-0.67-0.36
Sodium Zirconium Cyclosilicate (SZC) 10g-0.67-0.72

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The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo

Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing (NCT03337477)
Timeframe: Baseline to 4h potassium meansurements.

,
InterventionProportion of participants (Number)
1h2h4h
Placebo0.1390.0560.056
Sodium Zirconium Cyclosilicate (SZC) 10g0.1560.1250.063

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Fraction of Patients Responding to Therapy Defined as: S-K <6.0mmol/L Between 1 and 4h and S-K <5.0mmol/L at 4h; and no Additional Potassium Lowering Therapy From 0 to 4h With Exception of the Initial Insulin Treatment

Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K. Patients with any missing potassium value from 1h to 4h inclusive will be treated as non-responders. (NCT03337477)
Timeframe: Baseline to 4h potassium meansurements.

InterventionProportion of participants (Number)
Sodium Zirconium Cyclosilicate (SZC) 10g0.063
Placebo0.056

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Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo

The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means. (NCT03337477)
Timeframe: Baseline to 4h potassium measurements.

Interventionmmol/L (Least Squares Mean)
Sodium Zirconium Cyclosilicate (SZC) 10g-0.41
Placebo-0.27

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The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.

Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K. (NCT03337477)
Timeframe: Baseline to 4h potassium meansurements.

InterventionProportion of participants (Number)
Sodium Zirconium Cyclosilicate (SZC) 10g0.156
Placebo0.306

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The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo

(NCT03337477)
Timeframe: Baseline to 4h potassium meansurements.

,
InterventionProportion of paticipants (Number)
1h2h4h
Placebo0.6110.4720.361
Sodium Zirconium Cyclosilicate (SZC) 10g0.6560.6250.469

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The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo

(NCT03337477)
Timeframe: Baseline to 4h potassium meansurements.

,
InterventionProportion of paticipants (Number)
1h2h4h
Placebo0.3060.1670.139
Sodium Zirconium Cyclosilicate (SZC) 10g0.3130.3750.156

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the Number of Participants With Mild and Severe Hypoglycemic Events

To measure the number of participants with mild and severe hypoglycemic events (NCT03350984)
Timeframe: Duration of hospital stay, up to 4 weeks.

InterventionParticipants (Count of Participants)
NPH Insulin Group15
Glargine and Lispro Insulin Group15

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Number of Participants With Sustained Glycemic Control During Hospital Stay

Sustained glycemic control were the number of participants who not had: discharged before sustained control, critical status suspension, death before control, bad attachment to the protocol, interruption due to more than 2 hypoglycemic events during their hospital stay. (NCT03350984)
Timeframe: blood glucose was taken every day, up to 4 weeks.

InterventionParticipants (Count of Participants)
NPH Insulin Group30
Glargine and Lispro Insulin Group20

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Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.

To determine the differences in the mean daily blood glucose measured in mg/dl, between a basal-bolus scheme and NPH schemes of insulin measured by the mean daily blood glucose. (NCT03350984)
Timeframe: Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 week

,
Interventionmg/dl (Mean)
Fasting blood glucosePostprandial glucoseGlucose in the early morning
Glargine and Lispro Insulin Group135156.2136.2
NPH Insulin Group129.6155.4127.4

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Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]

Number of live born infants with birth weight >90th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants. In the reported data,'Yes' infers number of live born infants with birth weight >90th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not >90th percentile for gestational age and sex.Unaddressed category refers to cases where either parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if THE participants did not fill the pregnancy outcome form.The endpoint was evaluated based on the data from in-trial observation period:started at randomization and ended at the date of trial completion,up to 24 months. Date of trial completion:final scheduled follow-up visit (delivery + 58 days). (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg55301
IDet43411

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Birth Weight for Live Birth Infants

Mean birth weight for live birth infants is presented. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

Interventiongrams (g) (Mean)
IDeg3691.0
IDet3490.2

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Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)

Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. For pregnant women, eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between treatment baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy. (NCT03377699)
Timeframe: From treatment baseline (week 0) to end of treatment (28 days after delivery)

InterventionParticipants (Count of Participants)
Left eye72577227Left eye72577228Right eye72577227Right eye72577228
MissingYesNo
IDet13
IDeg2
IDet2
IDeg79
IDet79
IDeg10

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Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)

Number of participants who had infant loss after delivery is presented. Neonatal mortality: death of infant between ≥7 completed days after delivery and < 28 completed days after delivery. In the reported data, 'Yes' infers infant deaths whereas 'No' infers no infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: Between at least 7 completed days after delivery and before 28 completed days after delivery

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg0911
IDet0924

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Birth Weight Standard Deviation (SD) Score for Live Birth Infants

Mean of birth weight SD score for live infants is presented. Birth weight SD score indicates how far an infant's score deviates from the mean of the reference population of same age and same sex born at the same gestational week as per local normal curves. The SD score of 0 indicates that the infants born weigh approximately the same, negative score indicates that the infants born weigh lesser and positive score indicates that the infants born weigh more when compared with the reference population. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

InterventionStandard Deviation score (Mean)
IDeg1.7
IDet1.2

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Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)

Number of participants who achieved pre-defined HbA1c targets ≤ 6.0% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.0% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.0% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: From GW 16 to GW 36

,
InterventionParticipants (Count of Participants)
YesNo
IDeg3648
IDet3153

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Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)

Number of participants who had early foetal death (delivery before 20 completed GWs) is presented. In the reported data, 'Yes' infers early foetal deaths whereas 'No' infers no foetal deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg4871
IDet5874

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Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)

Mean of post-prandial glucose (PPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. Average PPG is defined as the average of the available blood glucouse (BG) measurements 90 minutes after breakfast, lunch and main evening meal respectively. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: From GW 16 to GW 36

Interventionmmol/L (Mean)
IDeg7.37
IDet6.96

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Last Planned Fasting Plasma Glucose Prior to Delivery

Mean of fasting plasma glucose (FPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from in-trial observation period. The in-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: From GW 16 to GW 36

Interventionmmol/L (Mean)
IDeg6.17
IDet6.79

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Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery

Number of participants who had delivered by which mode of delivery (vaginal, operative vaginal, planned caesarean section or unplanned caesarean section delivery) is presented. Planned caesarean section: decision taken > 8 hours prior to delivery. Unplanned caesarean section: decision taken ≤ 8 hours prior to delivery. In case of 'early foetal death' or if the participant did not fill the pregnancy outcome form then mode of delivery was reported as 'missing'. (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
Spontaneous vaginal birthPlanned caesarean sectionOperative vaginal birthNon planned caesarean sectionMissing
IDeg11428237
IDet18459157

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Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)

Number of participants who had foetal/infant loss at delivery is presented. Perinatal mortality: death of foetus/infant between ≥ 20 completed GWs before delivery and <1 completed week after delivery). In the reported data, 'Yes' infers early foetal/infant deaths whereas 'No' infers no foetal/infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion, up to 24 months. Date of trial completion: final scheduled follow-up visit (delivery + 58 days). (NCT03377699)
Timeframe: Between at least 20 completed GWs before delivery and before 7 completed days after delivery

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg0911
IDet0924

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Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)

Number of participants who achieved pre-defined HbA1c targets ≤ 6.5% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.5% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.5% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: From GW 16 to GW 36

,
InterventionParticipants (Count of Participants)
YesNo
IDeg5826
IDet5331

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Number of Participants With Live Born Infants (Yes/no)

Number of participants with live born infants is presented. In the reported data, 'Yes' infers number of live infants whereas 'No' infers early foetal death or termination of pregnancy (induced/elective abortion). The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg8651
IDet8574

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Number of Adverse Events During Pregnancy Period

Number of adverse events (AEs) during pregnancy period is reported. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs presented are treatment-emergent AEs (TEAEs). The TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT03377699)
Timeframe: From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)

InterventionEvents (Number)
IDeg429
IDet328

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Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)

Number of live born infants with birth weight <10th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants.In the reported data,'Yes' infers number of live born infants with birth weight <10th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not <10th percentile for gestational age and sex.Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.Endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion,up to 24 months.Date of trial completion:final scheduled follow-up visit (delivery + 58 days). (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg1841
IDet3811

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Number of Adverse Events in the Infant

AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs in foetus/infant with particular focus on the AEs from delivery to follow-up are presented. (NCT03377699)
Timeframe: From delivery to final follow-up 30 days after delivery

InterventionEvents (Number)
IDeg164
IDet150

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Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no)

Number of participants with one or more events of pre-eclampsia during pregnancy period is reported. Pre-eclampsia was defined as new-onset hypertension (greater than or equal to) ≥ 140 millimeters of mercury (mmHg) systolic or ≥ 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart) occurring from GW 20 to delivery and simultaneous proteinuria (defined as ≥ 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of ≥ 300 mg/g in a urine sample or a urine dipstick protein of 1+) or presence of eclampsia, haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, or other severe organ involvement. In the reported data, 'Yes' infers number of participants who had pre-eclampsia events whereas 'No' infers number of participants who have not had pre-eclampsia events. (NCT03377699)
Timeframe: From GW 20 to delivery

,
InterventionParticipants (Count of Participants)
YesNo
IDeg1279
IDet787

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Number of Participants With Pre-term Delivery

Number of pregnant women who had pre-term delivery is presented. Pre-term delivery refers to delivery in < 37 completed GWs. In the reported data, 'Yes' infers number of participants who had pre-term delivery whereas 'No' infers number of participants who has not had pre-term delivery. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion,up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery+58 days). For participants who had not attended the follow-up visit,the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg34571
IDet26664

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Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants

Number of participants who delivered foetuses/infants with abnormalities (classified according to EUROCAT) is presented. Presence of major abnormalities were based on adjudicated data, as after adjudication congenital anomalies were classified into major or minor anomalies or in other categories. In reported data, 'Yes' infers presence of major abnormalities whereas 'No' infers absence of major abnormalities in foetus/infant. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion up to 24 months. Date of trial completion : final scheduled follow-up visit (delivery + 58 days). (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNo
IDeg884
IDet888

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Number of Hypoglycaemic Episodes During the Pregnancy Period

Number of treatment emergent hypoglycaemic episodes during the pregnancy period is presented. Hypoglycaemic episode (plasma glucose <= 3.9 mmol/L (70 milligrams per decilitre (mg/dL)) Or > 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs on or after the first day of trial product administration, and no later than 7 days from the last day on trial product. The endpoint was evaluated based on the data from pregnancy period. Pregnancy period started from first day of pregnancy (date of conception corresponding to the first day in GW 2) or randomisation (whichever comes last) to the date of delivery. (NCT03377699)
Timeframe: From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)

InterventionEpisodes (Number)
IDeg5431
IDet5982

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Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)

Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. Eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between pregnancy baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy. (NCT03377699)
Timeframe: From pregnancy baseline (corresponding to GW 8-13) to end of treatment (28 days after delivery)

InterventionParticipants (Count of Participants)
Left eye72577228Left eye72577227Right eye72577227Right eye72577228
YesNoMissing
IDet2
IDeg79
IDeg2
IDet79
IDeg10
IDet13

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Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)

Number of infants with neonatal hypoglycaemic episodes is presented. Neonatal hypoglycaemic episodes defined as plasma glucose ≤ 1.7 mmol/L (31 mg/dL) during the first 24 hours after birth or below or equal to 2.5 mmol/L (45 mg/dl) between 24 hours and 48 hours after birth. In the reported data, 'Yes' infers number of infants with neonatal hypoglycaemic episodes whereas 'No' infers number of infants with no neonatal hypoglycaemic episodes. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. (NCT03377699)
Timeframe: During between 24 and 48 hours after birth

InterventionParticipants (Count of Participants)
During the first 24 hours after birth72577228During the first 24 hours after birth72577227Between 24 hours and 48 hours after birth72577227Between 24 hours and 48 hours after birth72577228
YesNoUnaddressed category
IDeg20
IDet19
IDeg64
IDet65
IDeg2
IDet1
IDeg4
IDet5
IDeg77
IDet78
IDeg5
IDet2

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Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery

Change in body weight from pregnancy baseline to last planned visit prior to delivery is presented. (NCT03377699)
Timeframe: From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth)

InterventionKilogram (Kg) (Mean)
IDeg11.97
IDet10.81

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Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery

Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months. (NCT03377699)
Timeframe: From GW 16 to GW 36

,
InterventionPercentage glycosylated hemoglobin (Mean)
in-trialon-treatment
IDeg6.306.32
IDet6.266.26

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Participants Achieving HbA1c < 7% (Part 1)

Number of participants achieving HbA1c < 7% at Week 12 and Week 24. (NCT03430856)
Timeframe: Week 12, Week 24

,,
InterventionParticipants (Count of Participants)
Week 12Week 24
Insulin Aspart1310
Insulin Tregopil (IN-105) - 30mg32
Insulin Tregopil (IN-105) - 45mg42

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Post-prandial Glucose (PPG) Excursion (Part 1)

Change from Baseline in the mean 60, 90, 120 minutes PPG excursions assessed from standardized test meal at Week 24. (NCT03430856)
Timeframe: Week 0, Week 24

,,
Interventionmg/dL (Mean)
Week 0, 60 minWeek 0, 90 minWeek 0, 120 minWeek 24, 60 minWeek 24, 90 minWeek 24, 120 min
Insulin Aspart74.490.893.755.166.365.5
Insulin Tregopil (IN-105) - 30mg98.3106.4113.532.747.250.2
Insulin Tregopil (IN-105) - 45mg79.592.4100.935.853.864.1

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Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24

Number of participants achieving HbA1c < 7% at Week 12 and Week 24 without reported clinically significant or severe hypoglycemic events between end of Week 8 and Week 24. (NCT03430856)
Timeframe: Week 12, Week 24

,,
InterventionParticipants (Count of Participants)
Week 12Week 24
Insulin Aspart117
Insulin Tregopil (IN-105) - 30mg33
Insulin Tregopil (IN-105) - 45mg41

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Change From Baseline in HbA1c at 24 Weeks (Part 1)

The primary endpoint is change from baseline in HbA1c after 24 weeks of randomized treatment. (NCT03430856)
Timeframe: Week 0, Week 24

,,
InterventionPercentage of glycosylated hemoglobin (Mean)
Baseline (Week 0)Week 24
Insulin Aspart8.077.29
Insulin Tregopil (IN-105) - 30mg8.108.21
Insulin Tregopil (IN-105) - 45mg8.238.38

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Weight (Kgs) (Part 1)

Change from Baseline in weight (kgs) to 24 weeks (NCT03430856)
Timeframe: Week 0 and Week 24

,,
InterventionKg (Mean)
Baseline (Week 0)Week24Change from Baseline
Insulin Aspart67.7668.470.66
Insulin Tregopil (IN-105) - 30mg68.8870.150.30
Insulin Tregopil (IN-105) - 45mg68.5468.980.93

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Number of Participants With Treatment-Emergent Adverse Events (Part 1)

Includes participants who have experienced at least one treatment emergent adverse events over 24 weeks (NCT03430856)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Insulin Tregopil (IN-105) - 45mg5
Insulin Tregopil (IN-105) - 30mg6
Insulin Aspart4

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Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1)

A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)] (NCT03430856)
Timeframe: Week 0 through Week 24

InterventionParticipants (Count of Participants)
Insulin Tregopil (IN-105) - 45mg26
Insulin Tregopil (IN-105) - 30mg26
Insulin Aspart25

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Change From Baseline in HbA1c at Week 12 (Part 1)

This secondary outcome is the change from baseline in HbA1c after 12 weeks of randomized treatment. For this endpoint baseline (Week 0) and Week 12 have been presented. (NCT03430856)
Timeframe: Week 0, Week 12

,,
InterventionPercentage of glycosylated haemoglobin (Mean)
Baseline (Week 0)Week 12Change from Baseline
Insulin Aspart8.077.18-0.88
Insulin Tregopil (IN-105) - 30mg8.108.01-0.07
Insulin Tregopil (IN-105) - 45mg8.238.04-0.17

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Change From Baseline in Daily Insulin Glargine Dose at Week 26

Change in daily dose was calculated by subtracting baseline value from Week 26 value. (NCT03434119)
Timeframe: Baseline, Week 26

InterventionInternational Units (IU) (Mean)
Soliqua 100/3318.7
Lantus14.1

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Percentage of Participants Achieving HbA1c Target of <7% at Week 26

Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders. (NCT03434119)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Soliqua 100/3352.6
Lantus30.8

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Change From Baseline in Body Weight at Week 26

Change in body weight was calculated by subtracting baseline value from Week 26 value. (NCT03434119)
Timeframe: Baseline, Week 26

Interventionkilograms (kg) (Mean)
Soliqua 100/331.69
Lantus1.52

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Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of <=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose <=70 mg/dL (3.9 mmol/L) and excluding plasma glucose <54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of <54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose <54 mg/dL (3.0 mmol/L) regardless of symptoms. (NCT03434119)
Timeframe: Baseline to Week 26

,
Interventionpercentage of participants (Number)
Any hypoglycemiaSevere hypoglycemiaDocumented hypoglycaemia <=70 mg/dL (3.9 mmol/L)Documented hypoglycaemia <54 mg/dL (3.0 mmol/L)
Lantus52.82.448.818.4
Soliqua 100/3348.71.743.512.2

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Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

Change in HbA1c was calculated by subtracting baseline value from Week 26 value. (NCT03434119)
Timeframe: Baseline, Week 26

Interventionpercentage of HbA1c (Mean)
Soliqua 100/33-1.86
Lantus-1.07

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Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)

PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (NCT03449433)
Timeframe: Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose

Interventionmilligrams times hour per deciliter (Mean)
LY90001481.5
Insulin Lispro (Humalog®)141
Insulin Aspart (NovoRapid®)157
Insulin Aspart (Fiasp®)101
Healthy Participants44.1

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Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm

PK: Insulin Lispro or Insulin Aspart AUC(0-7h) (NCT03449433)
Timeframe: 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose

Interventionpicomols times hour per Liter (Geometric Mean)
LY900014786
Insulin Lispro (Humalog®)756
Insulin Aspart (NovoRapid®)938
Insulin Aspart (Fiasp®)928

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Change From Baseline of HbA1C (Glycated Hemoglobin)

Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C. (NCT03467932)
Timeframe: baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up)

Interventionpercent HbA1C (Least Squares Mean)
Combined Cohort A +Cohort B: Matched-Placebo Oral Capsule-0.13
Cohort A: ORMD-0801 Once Daily - QHS-0.60
Cohort A: ORMD-0801 Twice Daily - BID-0.59
Cohort A: ORMD-0801 Three Times Daily - TID-0.51
Cohort B:ORMD-0801, 8 mg Once Daily - QHS:-0.95
Cohort B: ORMD-0801 8 mg Twice Daily - BID-0.95
Cohort B: ORMD-0801 16 mg Once Daily - QHS:0.12
Cohort B: ORMD-0801 16 mg Twice Daily - BID-0.50

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Mean Change From Baseline Over Time for HbA1C

Mean change from baseline (Run-In, Week 0 Visit 1) to Part 1, Visit 3 for HbA1C (measured in mmols/mol) (NCT03467932)
Timeframe: Baseline (Run-In:Week 0, Visit 1) to Part 1, Visit 3, elapsed time: 3 weeks.

Interventionmmol/mol (Least Squares Mean)
Combined Cohort A+Cohort B: Matched-Placebo Oral Capsule-2.12
Cohort A: ORMD-0801 Once Daily - QHS-2.56
Cohort A: ORMD-0801 Twice Daily - BID-1.95
Cohort A: ORMD-0801 Three Times Daily - TID-2.91
Cohort B:ORMD-0801, 8 mg Once Daily - QHS:-3.26
Cohort B: ORMD-0801 8 mg Twice Daily - BID-5.51
Cohort B: ORMD-0801 16 mg Once Daily - QHS:-2.06
Cohort B: ORMD-0801 16 mg Twice Daily - BID-1.87

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Change Over Time in Hb1Ac

Change of Hb1Ac from Baseline to Week 10, measured in mmol/mol (NCT03467932)
Timeframe: Baseline (week 0, visit 1) to Week 10, part 2

Interventionmmol/mol (Least Squares Mean)
Cohort A+Cohort B: Combined Matched Placebo Oral Capsule-1.27
Cohort A: ORMD-0801 Once Daily - QD-5.95
Cohort A: ORMD-0801 Twice Daily - BID-4.95
Cohort A: ORMD-0801 Three Times Daily - TID-6.16
Cohort B:ORMD-0801, 8 mg Once Daily - QD-10.34
Cohort B: ORMD-0801 8 mg Twice Daily - BID-10.71
Cohort B: ORMD-0801 16 mg Once Daily - QD-0.25
Cohort B: ORMD-0801 16 mg Twice Daily - BID-4.66

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Plasma Insulin

MRS scan to measure plasma insulin (NCT03469492)
Timeframe: 12 weeks

InterventionμU/ml (Mean)
Type 2 Diabetes Mellitus38

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Plasma Glucose

MRS scan to measure plasma glucose (NCT03469492)
Timeframe: 0 weeks

Interventionmmol/l (Mean)
Type 2 Diabetes Mellitus1.07

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Change in HbA1c Levels

HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels. (NCT03469492)
Timeframe: Baseline and 12 weeks

Interventionmmol/mol (Mean)
Type 2 Diabetes Mellitus24.3

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Optional Hyperglycemic Clamp

Hyperglycemic clamp administered to measure glucose levels. Data represented is the number of participants the clamp was used on successfully. (NCT03469492)
Timeframe: upon enrollment

Interventionparticipants (Number)
Type 2 Diabetes Mellitus8

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Plasma Glucose

MRS scan to measure plasma glucose (NCT03469492)
Timeframe: 12 weeks

Interventionmmol/l (Mean)
Type 2 Diabetes Mellitus0.88

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Plasma Insulin

MRS scan to measure plasma insulin (NCT03469492)
Timeframe: 0 weeks

InterventionμU/ml (Mean)
Type 2 Diabetes Mellitus31

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Device Satisfaction and Treatment Preference

Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device. (NCT03478969)
Timeframe: Baseline up to Week 39

,
InterventionScores on a Scale (Mean)
Screening (Blood Glucose Meter)Week 13 (Blood Glucose Meter)Week 26 (Blood Glucose Meter)Week 39 (Blood Glucose Meter)Week 13 (Insulin Pump)Week 26 (Insulin Pump)Week 39 (Insulin Pump)
Group A: Accu-Chek® Solo35.334.934.334.732.733.433.4
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo35.734.934.934.835.335.331.0

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Number of Participants With Skin Reactions (Including Type and Intensity)

"Number of Participants who experienced Skin Reactions at the Insulin Pump Insertion Sites (along with their Type and Intensity) are presented below, from Baseline up to Week 39. Participants were asked to assess five different properties describing potential problems at the pump insertion site, namely itching, redness, swelling, heat and pain. Each of these questions could be answered with one of four alternatives, None, Minor, Moderate and Severe." (NCT03478969)
Timeframe: Baseline up to Week 39

,,
InterventionNumber of Participants (Number)
Baseline (Itching) (Minor Intensity)Baseline (Itching) (Moderate Intensity)Baseline (Itching) (Severe Intensity)Week 13 (Itching) (Minor Intensity)Week 13 (Itching) (Moderate Intensity)Week 13 (Itching) (Severe Intensity)Week 26 (Itching) (Minor Intensity)Week 26 (Itching) (Moderate Intensity)Week 26 (Itching) (Severe Intensity)Week 39 (Itching) (Minor Intensity)Week 39 (Itching) (Moderate Intensity)Week 39 (Itching) (Severe Intensity)Baseline (Redness) (Minor Intensity)Baseline (Redness) (Moderate Intensity)Baseline (Redness) (Severe Intensity)Week 13 (Redness) (Minor Intensity)Week 13 (Redness) (Moderate Intensity)Week 13 (Redness) (Severe Intensity)Week 26 (Redness) (Minor Intensity)Week 26 (Redness) (Moderate Intensity)Week 26 (Redness) (Severe Intensity)Week 39 (Redness) (Minor Intensity)Week 39 (Redness) (Moderate Intensity)Week 39 (Redness) (Severe Intensity)Baseline (Swelling) (Minor Intensity)Baseline (Swelling) (Moderate Intensity)Baseline (Swelling) (Severe Intensity)Week 13 (Swelling) (Minor Intensity)Week 13 (Swelling) (Moderate Intensity)Week 13 (Swelling) (Severe Intensity)Week 26 (Swelling) (Minor Intensity)Week 26 (Swelling) (Moderate Intensity)Week 26 (Swelling) (Severe Intensity)Week 39 (Swelling) (Minor Intensity)Week 39 (Swelling) (Moderate Intensity)Week 39 (Swelling) (Severe Intensity)Baseline (Heat) (Minor Intensity)Baseline (Heat) (Moderate Intensity)Baseline (Heat) (Severe Intensity)Week 13 (Heat) (Minor Intensity)Week 13 (Heat) (Moderate Intensity)Week 13 (Heat) (Severe Intensity)Week 26 (Heat) (Minor Intensity)Week 26 (Heat) (Moderate Intensity)Week 26 (Heat) (Severe Intensity)Week 39 (Heat) (Minor Intensity)Week 39 (Heat) (Moderate Intensity)Week 39 (Heat) (Severe Intensity)Baseline (Pain) (Minor Intensity)Baseline (Pain) (Moderate Intensity)Baseline (Pain) (Severe Intensity)Week 13 (Pain) (Minor Intensity)Week 13 (Pain) (Moderate Intensity)Week 13 (Pain) (Severe Intensity)Week 26 (Pain) (Minor Intensity)Week 26 (Pain) (Moderate Intensity)Week 26 (Pain) (Severe Intensity)Week 39 (Pain) (Minor Intensity)Week 39 (Pain) (Moderate Intensity)Week 39 (Pain) (Severe Intensity)
Group A: Accu-Chek® Solo20042060050110082015001610110320500200000110000100400311310310
Group B: MDI, Then Accu-Chek® Solo1000002008303004003001161000100000140000010000111300110300412
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo10041125033230011509401061000730310620000300110100320320320430

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Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)

Continuous Subcutaneous Insulin Infusion (CSII) therapy is also referred to as Insulin Pump Therapy. Presented below, are the Number of Participants for whom certain indications e.g. HbA1c goals not met, resulted in commencement of CSII therapy. (NCT03478969)
Timeframe: Baseline up to Week 39

,,
InterventionParticipants (Number)
HbA1c goals not metParticipant wishFrequent hypoglycemiaDawn phenomenonGlycemic variabilityShift working
Group A: Accu-Chek® Solo62479311
Group B: MDI, Then Accu-Chek® Solo61459230
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo563213221

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Therapy Success Indicated by Change in Weight

Change in Weight from Baseline to Week 39 (NCT03478969)
Timeframe: Baseline up to Week 39

,,
Interventionkg (Mean)
BaselineWeek 13Week 26Week 39
Group A: Accu-Chek® Solo77.277.678.478.8
Group B: MDI, Then Accu-Chek® Solo81.782.382.282.4
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo83.483.884.381.8

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Therapy Success Indicated by Change in Body Mass Index (BMI)

This outcome measure represents one reported value calculated by combining weight and height to report BMI in kg/m^2. Change in BMI from Baseline to Week 39. (NCT03478969)
Timeframe: Baseline up to Week 39

,,
Interventionkg/m^2 (Mean)
BaselineWeek 13Week 26Week 39
Group A: Accu-Chek® Solo25.425.325.425.7
Group B: MDI, Then Accu-Chek® Solo27.127.127.327.4
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo27.027.027.327.3

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Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels

Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39 (NCT03478969)
Timeframe: Baseline up to Week 39

,,
InterventionPercentage (Mean)
HbA1c at BaselineHbA1c after 13 weeksHbA1c after 26 weeksHbA1c after 39 weeks
Group A: Accu-Chek® Solo8.07.87.97.8
Group B: MDI, Then Accu-Chek® Solo8.08.08.28.2
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo8.07.97.98.1

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Change in Therapy Parameters Based on Type of Insulin Used

(NCT03478969)
Timeframe: Baseline up to Week 39

,
InterventionU/kg (Number)
Short Acting Insulin: Insulin aspart (Screening)Short Acting Insulin: Insulin glulisine (Screening)Short Acting Insulin: Insulin lispro (Screening)Short Acting Insulin: Regular human insulin (Screening)Long Acting Insulin: Insulatard (Screening)Long Acting Insulin: Insulin degludec (Screening)Long Acting Insulin: Insulin detemir (Screening)Long Acting Insulin: Insulin glargine (Screening)Long Acting Insulin: Protaphane (Screening)Short Acting Insulin: Insulin aspart (Week 13)Short Acting Insulin: Insulin glulisine (Week 13)Short Acting Insulin: Insulin lispro (Week 13)Long Acting Insulin: Insulin degludec (Week 13)Long Acting Insulin: Insulin detemir (Week 13)Long Acting Insulin: Insulin glargine (Week 13)Short Acting Insulin: Insulin aspart (Week 26)Short Acting Insulin: Insulin glulisine (Week 26)Short Acting Insulin: Insulin lispro (Week 26)Short Acting Insulin: NovoRapid (Week 26)Long Acting Insulin: Insulin degludec (Week 26)Long Acting Insulin: Insulin detemir (Week 26)Long Acting Insulin: Insulin glargine (Week 26)Short Acting Insulin: Insulin aspart (Week 39)Short Acting Insulin: Insulin glulisine (Week 39)Short Acting Insulin: Insulin lispro (Week 39)Long Acting Insulin: Insulin degludec (Week 39)Long Acting Insulin: Insulin detemir (Week 39)Long Acting Insulin: Insulin glargine (Week 39)
Group A: Accu-Chek® Solo37221219104203422000134219000136222310
Group B: MDI, Then Accu-Chek® Solo3092201912381115938142071611092527822133

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Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)

Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39 (NCT03478969)
Timeframe: Baseline up to Week 39

,,
InterventionU/kg (Mean)
ScreeningWeek 13Week 26Week 39
Group A: Accu-Chek® Solo0.30.30.30.3
Group B: MDI, Then Accu-Chek® Solo0.30.30.30.3
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo0.30.20.30.3

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Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges

Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges. (NCT03478969)
Timeframe: Baseline up to Week 39

,,
InterventionPercentage of Time Spent (Mean)
>180 to <250 mg/dL (Baseline to Week 13)>180 to <250 mg/dL (Week 13 to Week 26)>180 to <250 mg/dL (Week 26 to Week 39)>250 mg/dL (Baseline to Week 13)>250 mg/dL (Week 13 to Week 26)>250 mg/dL (Week 26 to Week 39)
Group A: Accu-Chek® Solo19.319.320.317.415.620.3
Group B: MDI, Then Accu-Chek® Solo25.925.521.619.518.926.8
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo26.425.426.616.421.029.2

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Change in Glycemic Index

Change in Glycemic Index from Baseline to Week 39 (NCT03478969)
Timeframe: Baseline up to Week 39

,,
Interventionmg/dL (Mean)
Baseline to Week 13Week 13 to Week 26Week 26 to Week 39
Group A: Accu-Chek® Solo77.075.075.0
Group B: MDI, Then Accu-Chek® Solo71.770.273.9
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo68.168.977.1

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Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score

The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes. (NCT03478969)
Timeframe: 26 weeks

InterventionScores on a Scale (Least Squares Mean)
Group A: Accu-Chek® Solo105.1
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo108.7

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Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score

The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes. (NCT03478969)
Timeframe: 26 weeks

InterventionScores on a Scale (Least Squares Mean)
Group A: Accu-Chek® Solo105.9
Group B: MDI, Then Accu-Chek® Solo94.8

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Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day

Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39 (NCT03478969)
Timeframe: Baseline up to Week 39

InterventionSMBGs per day (Mean)
Group A: Accu-Chek® Solo3.2
Group B: MDI, Then Accu-Chek® Solo3.4
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo2.5

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Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)

Total Daily Insulin Dose at Baseline compared to dose at Week 39 (NCT03478969)
Timeframe: Baseline up to Week 39

,,
InterventionU/kg (Mean)
ScreeningWeek 13Week 26Week 39
Group A: Accu-Chek® Solo0.70.60.60.6
Group B: MDI, Then Accu-Chek® Solo0.60.60.60.6
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo0.70.60.60.6

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Device Satisfaction and Treatment Preference

Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device. (NCT03478969)
Timeframe: Baseline up to Week 39

InterventionScores on a Scale (Mean)
Screening (Blood Glucose Meter)Week 13 (Blood Glucose Meter)Week 26 (Blood Glucose Meter)Week 39 (Blood Glucose Meter)Week 39 (Insulin Pump)
Group B: MDI, Then Accu-Chek® Solo33.834.033.834.533.8

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Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges

Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges. (NCT03478969)
Timeframe: Baseline up to Week 39

,,
InterventionPercentage of Time Spent (Mean)
<54 mg/dL (Baseline to Week 13)<54 mg/dL (Week 13 to Week 26)<54 mg/dL (Week 26 to Week 39)>=54 and <70 mg/dL (Baseline to Week 13)>=54 and <70 mg/dL (Week 13 to Week 26)>=54 and <70 mg/dL (Week 26 to Week 39)<70 mg/dL (Baseline to Week 13)<70 mg/dL (Week 13 to Week 26)<70 mg/dL (Week 26 to Week 39)
Group A: Accu-Chek® Solo3.01.81.75.84.95.68.86.77.3
Group B: MDI, Then Accu-Chek® Solo1.61.60.84.54.23.06.15.83.8
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo1.10.91.13.13.21.44.24.12.5

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Change in Therapy Parameters Based on Type of Insulin Used

(NCT03478969)
Timeframe: Baseline up to Week 39

InterventionU/kg (Number)
Short Acting Insulin: Insulin aspart (Screening)Short Acting Insulin: Insulin glulisine (Screening)Short Acting Insulin: Insulin lispro (Screening)Short Acting Insulin: Regular human insulin (Screening)Long Acting Insulin: Insulatard (Screening)Long Acting Insulin: Insulin degludec (Screening)Long Acting Insulin: Insulin detemir (Screening)Long Acting Insulin: Insulin glargine (Screening)Long Acting Insulin: Protaphane (Screening)Short Acting Insulin: Insulin aspart (Week 13)Short Acting Insulin: Insulin glulisine (Week 13)Short Acting Insulin: Insulin lispro (Week 13)Short Acting Insulin: Insulin aspart (Week 26)Short Acting Insulin: Insulin glulisine (Week 26)Short Acting Insulin: Insulin lispro (Week 26)Short Acting Insulin: NovoRapid (Week 26)Short Acting Insulin: Insulin aspart (Week 39)Short Acting Insulin: Insulin glulisine (Week 39)Short Acting Insulin: Insulin lispro (Week 39)Long Acting Insulin: Insulin degludec (Week 39)Long Acting Insulin: Insulin detemir (Week 39)Long Acting Insulin: Insulin glargine (Week 39)
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo392170013133203202032020032021022

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Percentage of Glucose Values Within Therapeutic Range

Percentage of the glucose values (premeal and bedtime for 3 days) within the therapeutic target of 80 - 180 mg/dL (NCT03511521)
Timeframe: 3 days

Interventionpercentage of glucose values in range (Mean)
NPH Insulin4.2
Basal/Bolus Insulin50

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Percentage of Glucose Values Within the Hypoglycemic Range

Percentage of the glucose values (premeal and bedtime for 3 days) less than 70 mg/dL and 54 mg/dL (NCT03511521)
Timeframe: 3 days

InterventionPercentage of glucose values < 70 mg/dL (Mean)
NPH Insulin0
Basal/Bolus Insulin0

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Glycemic Control

mean of 4 glucose levels per day (premeal and bedtime) for each group for first 3 days after intervention (NCT03511521)
Timeframe: 3 days

Interventionmg/dL (Mean)
NPH Insulin284.3
Basal/Bolus Insulin184.3

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Mean Sensor Glucose in mg/dl

Mean sensor data over the second week of using a randomized, blinded insulin. (NCT03554486)
Timeframe: 7 days (during 2nd half of 2-week intervention period)

Interventionmg/dL (Mean)
Fiasp Insulin146
Novolog Insulin147

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Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl

Measured as percentage of time in range (days). (NCT03554486)
Timeframe: 7 days (during 2nd half of 2-week intervention period)

Interventionpercentage of time (Mean)
Fiasp Insulin78.4
Novolog Insulin75.3

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Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl

Percentage of time in range (days) as a measure of hypoglycemia. (NCT03554486)
Timeframe: 7 days (during 2nd half of 2-week intervention period)

Interventionpercentage of time (Mean)
Fiasp Insulin2.3
Novolog Insulin3.1

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PD: Maximum Glucose Infusion Rate (Rmax)

Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. (NCT03555305)
Timeframe: 30 minutes predose through 24 hours postdose

Interventionmilligrams/kilograms/minute (mg/kg/min) (Geometric Mean)
0.5 U/kg Insulin Glargine2.72
0.5 U/kg Lantus2.99

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Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)

Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. (NCT03555305)
Timeframe: 30 minutes predose through 24 hours postdose

Interventionmilligrams/kilogram (mg/kg) (Geometric Mean)
0.5 U/kg Insulin Glargine2390
0.5 U/kg Lantus2680

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PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus

PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin glargine and Lantus. (NCT03555305)
Timeframe: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose

Interventionpicomole*hour per liter (pmol*hr/L) (Geometric Mean)
0.5 U/kg Insulin Glargine2170
0.5 U/kg Lantus2310

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Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus. (NCT03555305)
Timeframe: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose

Interventionpicomole per liter (pmol/L) (Geometric Mean)
0.5 U/kg Insulin Glargine124
0.5 U/kg Lantus129

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Percentage of Time Where Glucose is Less Than 54 mg/dL

(NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionpercentage of time (Median)
Usual Care Arm0.58
iLet With Insulin Analogue (Novolog/Humalog) Arm0.53
iLet Using Fiasp Arm0.56

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Percentage of Time Where Glucose is Greater Than 250 mg/dL

(NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionpercentage of time (Mean)
Usual Care Arm3.64
iLet Using Humalog/Novolog Arm10.42
iLet Using Fiasp Arm7.73

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Percentage of Time Where Glucose is Greater Than 180 mg/dL

(NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionpercentage of time (Mean)
Usual Care Arm21.8
iLet Using Humalog/Novolog Arm34.4
iLet Using Fiasp Arm27.96

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Episodes of Diabetic Ketoacidosis (DKA)

pre-specified to report the total number of episodes summed across all participants (NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionnumber of episodes (Number)
Usual Care Arm0
iLet With Insulin Analogue (Novolog/Humalog) Arm0
iLet Using Fiasp Arm0

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Episodes of Severe Hypoglycemia

Pre-specified to report the total number of episodes summed across all participants (NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionnumber of episodes (Number)
Usual Care Arm0
iLet With Insulin Analogue (Novolog/Humalog) Arm0
iLet Using Fiasp Arm1

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Mean CGM Glucose

(NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionmg/dl (Mean)
Usual Care Arm144.3
iLet With Insulin Analogue (Novolog/Humalog) Arm162
iLet Using Fiasp Arm155

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Percentage of Time in the Glucose Target Range of 70-180 mg/dl

(NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionpercentage of time (Mean)
Usual Care Arm73.3
iLet Using Humalog/Novolog Arm62.2
iLet Using Fiasp Arm69.2

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Percentage Time in the Glucose Target Range of 70-120mg/dL

(NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionpercentage of time (Mean)
Usual Care Arm30.65
iLet Using Humalog/Novolog Arm25.65
iLet Using Fiasp Arm28.24

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Percentage of Time Where Glucose is Less Than 70 mg/dL

(NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionpercentage of time (Median)
Usual Care Arm5.09
iLet Using Humalog/Novolog Arm3.2
iLet Using Fiasp Arm2.7

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Percentage of Time Where Glucose is Less Than 60 mg/dL

(NCT03565666)
Timeframe: Days 3-7 for the RCT Period

Interventionpercentage of time (Mean)
Usual Care Arm1.67
iLet Using Humalog/Novolog Arm1.3
iLet Using Fiasp Arm1.19

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Hemoglobin A1c (HbA1c)

The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group (NCT03660553)
Timeframe: 6 months

Interventionpercentage of HbA1c (Mean)
Multiple Subcutaneous Injection (MSI)8.5
Basal Insulin (BI)7.8

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Incidence of Any Hypoglycemia

Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups (NCT03660553)
Timeframe: 6 months

Interventionparticipants (Number)
Multiple Subcutaneous Injection (MSI)0
Basal Insulin (BI)0

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Incidence of Severe Hypoglycemia

Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups. (NCT03660553)
Timeframe: 6 months

Interventionparticipants (Number)
Multiple Subcutaneous Injection (MSI)0
Basal Insulin (BI)0

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Continuous Glucose Monitoring - Time in Range (70-180 mg/dl)

Time in range (70-180 mg/dl) [percentage of glucose readings or hours per day] by continuous glucose monitoring (CGM) during the first 24 hours after arriving in HNL and EWR (starting within 2 hours after arrival). (NCT03668808)
Timeframe: During the initial 24 hours local time and starting within 2 hours after arrival

,
Interventionpercentage of Time in Range 70-180mg/dL (Mean)
Eastward travelWestward travel
Insulin Degludec55.054.5
Insulin Glargine U10062.361.2

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Continuous Glucose Monitoring - Time in Range (70-140 mg/dl)

Time in range (70-140 mg/dl) [percentage of glucose readings or hours per day] by continuous glucose monitoring (CGM) during the initial 24 hours local time (starting within 2 hours after arriving) in Newark, NJ after flying 9-10 hours West to East (from Honolulu, HI) and after the return journey from Newark to Honolulu (flying East to West). (NCT03668808)
Timeframe: During the initial 24 hours local time and starting within 2 hours after arrival

,
Interventionpercentage of Time in Range 70-140mg/dL (Mean)
Eastward travelWestward travel
Insulin Degludec36.337.2
Insulin Glargine U10045.643.9

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CGM % Time 70-180 mg/dl

% time 70-180 mg/dl by CGM (NCT03668808)
Timeframe: In flight period of time and for 72 hours at each destination

,
Interventionpercentage of Time in Range 70-180mg/dL (Mean)
Eastward travel in-flightWestward travel in-flightEastward travel 72 hours at destinationWestward travel 72 hours at destination
Insulin Degludec50.565.158.356.7
Insulin Glargine U10058.964.062.059.2

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CGM % Time >180 mg/dl

% time >180 mg/dl by CGM (NCT03668808)
Timeframe: In flight period of time and for 72 hours at each destination

,
Interventionpercentage of Time above Range >180mg/dL (Mean)
In flight Eastward travel %Time above Range >180mg/dLIn flight Westward travel %Time above Range >180mg/dLEastward 72 hours at destination % Time above Range >180mg/dLWestward 72 hours at destination % Time above Range >180mg/dL
Insulin Degludec39.530.831.734.9
Insulin Glargine U10032.326.027.632.7

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CGM % Time <70 mg/dl

% time <70 mg/dl by CGM (NCT03668808)
Timeframe: In flight period of time and for 72 hours at each destination

,
Interventionpercentage of Time below range <70 mg/dL (Mean)
Eastward travel in flightWestward travel in flightEastward flight 72 hours at destinationWestward flight 72 hours at destination
Insulin Degludec9.94.110.08.4
Insulin Glargine U1008.99.910.58.2

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CGM - Coefficient of Variation (CV)

Coefficient of variation of CGM values - glycemic variability (CV, %) (NCT03668808)
Timeframe: In flight period of time and for 72 hours at each destination

,
Interventionpercentage of Glycemic Variability % (Mean)
Eastward In-flight Glycemic variability CV %Westward In-flight Glycemic variability CV %Eastward 72-hours at destination Glycemic variability CV %Westward 72-hours at destination Glycemic variability CV %
Insulin Degludec30.628.239.938.6
Insulin Glargine U10031.033.741.039.5

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Sleep Quantity Measured by ActiGraph

Measurement of sleep duration (TST - Total sleep time in minutes) (NCT03668808)
Timeframe: During 24 hours at each destination

InterventionMinutes (Median)
Total sleep time, minutes in NYTotal sleep time, minutes in HI
Sleep at Each Destination489398

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Sleep Efficiency Measured by ActiGraph

Measurement of sleep efficiency (SE% - total sleep time in minutes divided by time in bed in minutes) (NCT03668808)
Timeframe: During 24 hours at each destination

Interventionpercentage of total sleep/time in bed (Median)
SE% in NYSE% in HI
Sleep at Each Destination9289

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Mean ± SD CGM Glucose (mg/dl)

Mean ± standard deviation of CGM glucose (mg/dl) by CGM during the flight and during the 72 hours at the destination (NCT03668808)
Timeframe: In flight period of time and for 72 hours at each destination

,
Interventionmg/dL (Mean)
In-flight eastwardIn-flight westward72 hours at destination after eastward travel72 hours at destination after westward travel
Insulin Degludec166.3157.0154.3160.4
Insulin Glargine U100158.8146.1147.6156.3

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Liverpool Jet-Lag Questionnaire

This is a Questionnaire about jet-lag and fatigue administered at the destinations after arrival. Jet Lag is rated on a 0-10 scale (0 - insignificant jet lag to 10 - very bad jet lag). Fatigue is rated on a scale of -5 to +5 (more fatigue to less fatigue). (NCT03668808)
Timeframe: After 24 and 48 hours at the destination after arrival

,
Interventionscore on a scale (Mean)
Eastward jet lag after 24 hoursEastward jet lag after 48 hoursEastward fatigue after 24 hoursEastward fatigue after 48 hoursWestward jetlag after 24 hoursWestward jetlag after 48 hoursWestward fatigue after 24 hoursWestward fatigue after 48 hours
Insulin Degludec2.51.60.2-0.73.23.5-1.63.5
Insulin Glargine U1004.13.80.2-1.53.52.9-1.5-0.7

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CGM Fasting Blood Glucose (FBG)

Fasting Blood Glucose (FBG) was determined using CGM at each destination on the morning after arrival. (NCT03668808)
Timeframe: At 0600 local time on the morning after arrival at each destination

,
Interventionmg/dL (Mean)
After eastward travelAfter westward travel
Insulin Degludec143137
Insulin Glargine U100137140

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Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring

The percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, during the 2-week maintenance periods using FGM (visit 9-21 (week 16-17) and visit 37-39 (week 34-35)). (NCT03687827)
Timeframe: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

InterventionPercentage of Time (Least Squares Mean)
Insulin Degludec 100U/mL52.97
Insulin Glargine 100U/mL51.45

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Time Spent in Nocturnal Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, in the Nocturnal Period (00:01 am - 05:59 am Both Inclusive) Using Flash Glucose Monitoring

Percentage of time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am - 05:59 am both inclusive) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)). (NCT03687827)
Timeframe: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

InterventionPercentage of Time (Least Squares Mean)
Insulin Degludec 100U/mL15.15
Insulin Glargine 100U/mL14.91

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Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM)

The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 milligrams per deciliter [mg/dL] (3.9-10.0 millimoles per litre [mmol/L]), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis. (NCT03687827)
Timeframe: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)

InterventionPercentage of Time (Least Squares Mean)
Insulin Degludec 100U/mL72.11
Insulin Glargine 100U/mL70.68

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Mean Glucose Levels Using Flash Glucose Monitoring (FGM)

Mean glucose levels (mmol/L) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)). (NCT03687827)
Timeframe: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

Interventionmmol/L (Least Squares Mean)
Insulin Degludec 100U/mL7.57
Insulin Glargine 100U/mL7.61

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Level of Glycated Haemoglobin (HbA1c) - Percentage

Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)). (NCT03687827)
Timeframe: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

InterventionPercentage of glycated haemoglobin (Least Squares Mean)
Insulin Degludec 100U/mL7.10
Insulin Glargine 100U/mL7.16

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Level of Glycated Haemoglobin (HbA1c) - mmol/Mol

Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)). (NCT03687827)
Timeframe: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

Interventionmillimoles per mole (mmol/mol) (Least Squares Mean)
Insulin Degludec 100U/mL54.10
Insulin Glargine 100U/mL54.78

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Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)

Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

InterventionRatio of total cholesterol (Geometric Mean)
Semaglutide1.0
Insulin Aspart1.0

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Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)

Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

InterventionRatio of triglycerides (Geometric Mean)
Semaglutide0.9
Insulin Aspart1.0

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Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)

Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

Interventionmillimoles per liter (mmol/L) (Mean)
Semaglutide-1.3
Insulin Aspart-0.8

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Change From Baseline to Week 52 in Pulse Rate

Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

InterventionBeats per minute (beats/min) (Mean)
Semaglutide2.2
Insulin Aspart1.1

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Daily Basal Insulin Dose at Week 52

Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: At week 52

InterventionUnits of insulin (Mean)
Semaglutide35.8
Insulin Aspart40.7

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Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52

Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52

InterventionEpisodes (Number)
Semaglutide254
Insulin Aspart1744

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Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52

Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration <= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52

InterventionEpisodes (Number)
Semaglutide1420
Insulin Aspart5616

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Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52

Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose < 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose < 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52

InterventionEpisodes (Number)
Semaglutide339
Insulin Aspart2270

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Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52

Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52

InterventionEpisodes (Number)
Semaglutide4
Insulin Aspart7

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Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52

Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52

InterventionEpisodes (Number)
Semaglutide2
Insulin Aspart4

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Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)

Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

Interventionmmol/L (Mean)
Semaglutide-2.1
Insulin Aspart-2.1

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Change From Baseline in Glycated Haemoglobin (HbA1c)

Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

InterventionPercentage of HbA1c (Mean)
Semaglutide-1.5
Insulin Aspart-1.2

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Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52

First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) up to week 52

InterventionFirst event per 100 years of exposure (Number)
Semaglutide0.4
Insulin Aspart0.7

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Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52

First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) up to week 52

InterventionFirst event per 100 years of exposure (Number)
Semaglutide0.2
Insulin Aspart0.4

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Total Daily Insulin Dose at Week 52

Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: At week 52

InterventionUnits of insulin (Mean)
Semaglutide35.8
Insulin Aspart77.7

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Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains

SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

,
InterventionScores on a scale (Mean)
Physical Component SummaryMental Component SummaryPhysical FunctioningRole Physical HealthBodily PainGeneral HealthVitalitySocial FunctioningRole Emotional ProblemMental Health
Insulin Aspart0.4-0.30.2-0.20.80.30.1-0.6-0.20.1
Semaglutide1.40.11.40.11.51.61.10.20.00.6

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Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains

The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

,
InterventionScores on a scale (Mean)
Physical functionEnergy or fatigueHealth distressMental healthSatisfactionTreatment satisfactionTreatment flexibilityFrequency of symptoms
Insulin Aspart-0.40.40.30.5-0.20.8-1.21.8
Semaglutide2.42.3-0.27.24.19.94.24.1

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Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure

Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

,
Interventionmillimeter of mercury (mmHg) (Mean)
Diastolic Blood PressureSystolic Blood Pressure
Insulin Aspart-0.41.0
Semaglutide-1.4-2.8

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Change From Baseline to Week 52 in Waist Circumference

Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

Interventioncentimeters (cm) (Mean)
Semaglutide-3.3
Insulin Aspart2.1

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Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)

Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

Interventionmmol/L (Mean)
Semaglutide-0.7
Insulin Aspart-0.9

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Change From Baseline to Week 52 in Body Mass Index (BMI)

Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

Interventionkilograms per meter square (kg/m^2) (Mean)
Semaglutide-1.5
Insulin Aspart1.0

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Change From Baseline to Week 52 in Body Weight (Kilogram (kg))

Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

Interventionkilograms (Mean)
Semaglutide-4.2
Insulin Aspart2.9

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Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline

Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

InterventionRatio of body weight (Mean)
Semaglutide1.0
Insulin Aspart1.0

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Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

InterventionRatio of HDL cholesterol (Geometric Mean)
Semaglutide1.0
Insulin Aspart1.0

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Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52

InterventionRatio of LDL cholesterol (Geometric Mean)
Semaglutide1.0
Insulin Aspart1.0

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Change From Baseline in Insulin Dose (LY3209590)

The baseline for both LY3209590 arms was the first regular weekly dose at Week 1. (NCT03736785)
Timeframe: Week 1, Week 32

InterventionMilligrams (mg) (Mean)
LY3209590 Algorithm 10.12
LY3209590 Algorithm 20.60

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Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590

PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value. (NCT03736785)
Timeframe: Week 32

InterventionNanomole * hour per Liter (nmol * hr/L) (Geometric Mean)
LY3209590 Algorithm 15360
LY3209590 Algorithm 25430

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Change From Baseline in Insulin Dose (Insulin Degludec)

Change from Baseline in Insulin Dose for Insulin Degludec arm was reported. (NCT03736785)
Timeframe: Baseline, Week 32

InterventionInternational Units (IU) (Mean)
Insulin Degludec16.40

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Change From Baseline in HbA1c Compared to Insulin Degludec

"HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate." (NCT03736785)
Timeframe: Baseline, Week 32

InterventionHbA1C % (Least Squares Mean)
LY3209590 Algorithm 1-0.58
LY3209590 Algorithm 2-0.57
Insulin Degludec-0.66

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Change From Baseline in HbA1c

"HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate." (NCT03736785)
Timeframe: Baseline, Week 32

InterventionHbA1C % (Least Squares Mean)
LY3209590 Algorithm 1-0.58
LY3209590 Algorithm 2-0.57
Insulin Degludec-0.66

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Change From Baseline in Body Weight

Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate. (NCT03736785)
Timeframe: Baseline, Week 32

InterventionKilogram (kg) (Least Squares Mean)
LY3209590 Algorithm 11.0
LY3209590 Algorithm 21.0
Insulin Degludec2.0

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Change From Baseline in Fasting Glucose

Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry, HbA1c strata [<8.5% or ≥8.5%]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate. (NCT03736785)
Timeframe: Baseline, Week 32

InterventionMilligram per deicliter (mg/dL) (Least Squares Mean)
LY3209590 Algorithm 1-13.1
LY3209590 Algorithm 2-18.6
Insulin Degludec-31.5

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Rate of Total Documented Symptomatic Hypoglycemia

The hypoglycemia events were defined by participant reported events with glucose ≤54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants. (NCT03736785)
Timeframe: Baseline through week 32

InterventionEvents per participant per year (Mean)
LY3209590 Algorithm 10.73
LY3209590 Algorithm 21.22
Insulin Degludec1.56

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Average Daily Blood Glucose

Mean daily blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. Blood glucose levels vary depending on when and what food has been consumed. A blood glucose level taken regardless of timing of meals of greater than 200 mg/dL often indicates diabetes. Blood glucose decreases with improved diabetes management. (NCT03737240)
Timeframe: Week1, Week 12, Week 26

,
Interventionmg/dL (Mean)
Week 1 (Baseline)Week 12Week 26
Basal-Bolus Insulin225.18135.08144.25
IDegLira220.81143.80134.59

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Percentage of Time With Interstitial Glucose <54 mg/dL

Percentage of time with a interstitial glucose level below <54 mg/dL as obtained by CGM will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention% of time (Mean)
IDegLira0.31
Basal-Bolus Insulin0.72

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Number of Participants With Documented Symptomatic Hypoglycemic Events

Documented symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs at any time of the day. Number of participants with documented hypoglycemic events will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

,
Interventionparticipants (Number)
Hypoglycemia < 70 mg/dLHypoglycemia < 54 mg/dL by CGM
Basal-Bolus Insulin3526
IDegLira2021

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Change in Hemoglobin A1c (HbA1c)

HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Interventionpercentage of HbA1c (Mean)
IDegLira-3.18
Basal-Bolus Insulin-3.00

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Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score

Satisfaction with the study treatment will be assessed with items 1, 4, 5, 6, 7, and 8 the DTSQc. Items are rated on a scale of -3 (much less satisfied compared to prior treatment) to 3 (much more satisfied compared to prior treatment). Total scores for these three items range from -18 to +18 with higher scores indicating greater satisfaction with the study treatment compared to their prior treatment. (NCT03737240)
Timeframe: Week 26

Interventionscore on a scale (Mean)
IDegLira15.55
Basal-Bolus Insulin15.77

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Nocturnal Asymptomatic Hypoglycemic Events

Nocturnal asymptomatic hypoglycemia is defined as SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL between midnight and 5:59 am. Incidence of nocturnal asymptomatic hypoglycemic events will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

InterventionNumber of events (Mean)
IDegLira4.81
Basal-Bolus Insulin3.45

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Nocturnal Symptomatic Hypoglycemic Events

Nocturnal symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs between midnight and 5:59 am. Incidence of nocturnal symptomatic hypoglycemic events will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

InterventionNumber of events (Mean)
IDegLira0.15
Basal-Bolus Insulin0.16

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Number of Emergency Room (ER) Visits

The number of emergency room visits occurring during the treatment period will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

InterventionNumber of ER visits (Number)
IDegLira14
Basal-Bolus Insulin12

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Number of Hospital Readmissions

The number of hospital readmissions occurring during the treatment period will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

InterventionNumber of Hospital readmissions (Number)
IDegLira0
Basal-Bolus Insulin4

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Number of Participants With Severe Hypoglycemic Events

Severe hypoglycemia is defined as severe cognitive impairment requiring assistance from another person. Number of participants with severe hypoglycemic events will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Interventionparticipants (Number)
IDegLira7
Basal-Bolus Insulin14

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Participants With HbA1c <7.0% and no Hypoglycemia

Percent of study participants experiencing HbA1c <7.0% and no hypoglycemia will be compared between groups. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. (NCT03737240)
Timeframe: Week 26

InterventionParticipants (Count of Participants)
IDegLira19
Basal-Bolus Insulin6

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Participants With HbA1c <7.0% and no Hypoglycemia

Percent of study participants reaching A1c < 7% without hypoglycemia will be compared between groups. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. (NCT03737240)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
IDegLira21
Basal-Bolus Insulin8

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Participants With HbA1c <7.0% and no Weight Gain

Percent of study participants reaching A1c < 7% without weight gain will be compared between groups. (NCT03737240)
Timeframe: Week 26

InterventionParticipants (Count of Participants)
IDegLira13
Basal-Bolus Insulin3

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Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia

Percent of study participants reaching A1c < 7% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. (NCT03737240)
Timeframe: Week 26

InterventionParticipants (Count of Participants)
IDegLira8
Basal-Bolus Insulin1

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Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia

Percent of study participants reaching A1c < 7.5% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. (NCT03737240)
Timeframe: Week 26

Interventionpercentage of participants (Number)
IDegLira19.6
Basal-Bolus Insulin5.2

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Participants With HbA1c >10% Achieving HbA1c <7.5%

Percent of study participants with baseline HbA1c >10% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Interventionpercentage of participants (Number)
IDegLira56.8
Basal-Bolus Insulin37.5

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Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL

Percentage of time with interstitial glucose in the range of 70-180 mg/dL as measured by CGM will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention% of time (Mean)
IDegLira38.39
Basal-Bolus Insulin31.17

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Percentage of Time With Interstitial Glucose <70 mg/dL

Percentage of time with a interstitial glucose level below 70 mg/dL as obtained by CGM will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention% of time (Mean)
IDegLira2.67
Basal-Bolus Insulin1.23

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Total Daily Insulin Dose

The total insulin dose measured in units per day will be compared between study groups. (NCT03737240)
Timeframe: Baseline, Week 26

,
Interventionunits per day (Mean)
Baseline26 weeks
Basal-Bolus Insulin46.0575.65
IDegLira24.5635.74

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Participants With HbA1c >11% Achieving HbA1c <8.0%

Percent of study participants with baseline HbA1c >11% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Interventionpercentage of participants (Number)
IDegLira60.0
Basal-Bolus Insulin29.6

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Participants With HbA1c >11% Achieving HbA1c <7.5%

Percent of study participants with baseline HbA1c >11% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Interventionpercentage of participants (Number)
IDegLira52.0
Basal-Bolus Insulin25.9

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Average Fasting Blood Glucose

Mean fasting blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. The measurement taken before breakfast is used to assess fasting blood glucose. For people without diabetes, fasting blood glucose is typically between 70-100 mg/dL while fasting blood glucose for those with diabetes is in the range of 70-130 mg/dL. (NCT03737240)
Timeframe: Week1, Week 12, Week 26

,
Interventionmg/dL (Mean)
Baseline (Week 1)Week 12Week 26
Basal-Bolus Insulin206.53125.18143.14
IDegLira202.37131.94143.31

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Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score

Treatment satisfaction will be assessed with the DTSQs. The DTSQs contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained by summing responses to yield a total score between 0 to 48. Higher scores indicate higher satisfaction with diabetes treatment. (NCT03737240)
Timeframe: Baseline, Week 12

,
Interventionscore on a scale (Mean)
BaselineFollow up at 24 weeks
Basal-Bolus Insulin29.0733.94
IDegLira26.0033.15

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Participants With HbA1c >10% Achieving HbA1c <8.0%

Percent of study participants with baseline HbA1c >10% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Interventionpercentage of participants (Number)
IDegLira61.4
Basal-Bolus Insulin45.8

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Glycemic Variability

Glycemic variability will be assessed with continuous glucose monitoring (CGM). It will be calculated using CGM and Standard Deviation. (NCT03737240)
Timeframe: Week1, Week 12, Week 26

,
Interventionmg/dl (Mean)
CGM Week 1CGM Week 12CGM Week 26
Basal-Bolus Insulin51.647.148.4
IDegLira50.541.843.6

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Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26

"Change from baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors.~The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26." (NCT03740919)
Timeframe: Baseline, Week 26

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Lispro (Humalog)0.09
LY9000140.06

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Change From Baseline in HbA1c (Postprandial) at Week 26

"Change from baseline in HbA1c postprandial was analyzed using (MMRM and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors.~The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26." (NCT03740919)
Timeframe: Baseline, Week 26

Interventionpercentage of HbA1c (Least Squares Mean)
Insulin Lispro (Humalog)0.09
LY900014 Postmeal0.07

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Percentage of Participants With Documented Hypoglycemic Events

Documented hypoglycemia is defined as <54 mg/dL and ≤70 mg/dL, respectively. (NCT03740919)
Timeframe: Baseline through Week 26

,,
Interventionpercentage of participants (Least Squares Mean)
<54 mg/dL≤70 mg/dL
Insulin Lispro (Humalog)80.8193.98
LY90001481.3792.55
LY900014 Postmeal74.4587.62

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Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose

Documented post-dose hypoglycemia event is an event of blood glucose of < 54 mg/dL and ≤70 mg/dL that occurred within 1 and 2 hours after the prandial dose. The rate of documented hypoglycemia was estimated by a negative binomial regression including treatment and age group as independent variable and number of episodes as dependent variables with log (exposure/365.25 days) as the offset in the model. (NCT03740919)
Timeframe: Baseline through Week 26

,,
InterventionEvents per participant per year (Least Squares Mean)
< 54mg/dL 1 Hour Post Dose< 54 mg/dL 2 Hour Post Dose≤70 mg/dL 1 Hour Post Dose≤70 mg/dL 2 Hour Post Dose
Insulin Lispro (Humalog)1.594.486.5419.0
LY9000142.045.958.4623.7
LY900014 Postmeal1.386.175.2921.1

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Rate of Documented Hypoglycemia Events

Documented hypoglycemia is defined as a hypoglycemic event of blood glucose of ≤70 mg/dL or <54 mg/dL. The rate of documented hypoglycemia was estimated by negative binomial regression including treatment and age group as independent variables and number of episodes as dependent variable with log (exposure/365.25 days) as the offset in the model. (NCT03740919)
Timeframe: Week 0 through Week 26

,,
Interventionevents per participant per year (Least Squares Mean)
< 54 mg/dL≤70 mg/dL
Insulin Lispro (Humalog)16.678.0
LY90001416.175.1
LY900014 Postmeal17.776.1

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Percentage of Participants With HbA1c < 7.0% and <7.5%

Percentage of participants with HbA1c < 7.0% and <7.5% was analyzed using a longitudinal logistic regression with repeated measurements conducted by a generalized linear mixed model including independent variables of treatment, baseline HbA1c value, visit, baseline HbA1c-by-visit interaction, and treatment-by-visit interaction. An unstructured covariance structure was used. (NCT03740919)
Timeframe: Week 26

,,
Interventionpercentage of participants (Number)
HbA1c <7%HbA1c < 7.5%
Insulin Lispro (Humalog)20.0040.00
LY90001421.9237.31
LY900014 Postmeal19.0832.82

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Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose

Documented post-dose hypoglycemia <54 milligrams per deciliter (mg/dL) and ≤ 70 mg/dL that occurred 1 and 2 hours after prandial dose. (NCT03740919)
Timeframe: Baseline through Week 26

,,
Interventionpercentage of participants (Least Squares Mean)
<54 mg/dL 1 Hour Post Dose<54 mg/dL 2 Hour Post Dose≤70 mg/dL 1 Hour Post Dose≤70 mg/dL 2 Hour Post Dose
Insulin Lispro (Humalog)26.5054.0449.6777.03
LY90001436.7963.6163.9282.67
LY900014 Postmeal29.7057.8848.5170.29

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Change From Baseline in Insulin Dose at Week 26

Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, age group, and HbA1c stratum (≤8.0%, >8.0%)), baseline value, visit and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors. (NCT03740919)
Timeframe: Baseline, Week 26

,,
InterventionUnit per day (Least Squares Mean)
Total Daily Basal Insulin DoseTotal Daily Insulin Dose
Insulin Lispro (Humalog)2.35.3
LY9000142.95.8
LY900014 Postmeal2.75.0

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Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26

Change from baseline in 7-point SMBG values were analyzed using MMRM and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group, and HbA1c stratum (≤8.0%, >8.0%)) baseline value, visit, and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors. (NCT03740919)
Timeframe: Baseline, Week 26

,,
Interventionmg/dL (Least Squares Mean)
Morning Premeal - FastingMorning 1 hour PostmealMidday PremealMidday 1 hour PostmealEvening PremealEvening 1 hour PostmealBedtime
Insulin Lispro (Humalog)1.0-3.2-3.10.91.06.9-1.9
LY900014-3.4-17.92.5-5.24.6-6.2-2.3
LY900014 Postmeal-5.9-9.8-6.0-1.50.3-3.9-2.7

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Rate of Severe Hypoglycemia

"Severe hypoglycemia: during these episodes, participants have an altered mental status and cannot assist in their own care, may be semiconscious or unconscious, or experience coma with or without seizures, and require assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~The rate of severe hypoglycemia per 100 years was calculated as: 100 times the total number of severe hypoglycemia episodes within the period divided by total exposure (in year) for all participants within the treatment group." (NCT03740919)
Timeframe: Week 0 through Week 26

InterventionEvents per participant per 100 years (Number)
Insulin Lispro (Humalog)2.05
LY9000142.20
LY900014 Postmeal0.00

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Change in Anti-insulin 287 Antibody Titres

Samples from the insulin 287 arm of the study were analysed for anti-insulin 287 antibodies. Confirmed anti-insulin 287 antibody positive samples had an antibody titre value determined. The endpoint was evaluated based on the data from in-trial period, starting at randomisation, and ending at the last direct participant-site contact, or when participant withdrew their informed consent, or the last participant-investigator contact for participants lost to follow-up, or death. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 31 (Visit 30)

InterventionAntibody titers (Mean)
Insulin 287979.9

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Change in Body Weight

Change in body weight from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)

InterventionKilogram (Least Squares Mean)
Insulin 2871.49
Insulin Glargine1.56

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Number of Hypoglycaemic Alert Episodes (Level 1) (≥3.0 and <3.9 mmol/L (≥54 and <70 mg/dL), Confirmed by BG Meter)

Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and less than (<) 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Number of hypoglycaemic alert episodes (level 1) that occurred from week 0 to week 26 are presented. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)

InterventionEpisodes (Number)
Insulin 287358
Insulin Glargine145

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Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occurred from week 0 to week 26 are presented. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)

InterventionEpisodes (Number)
Insulin 28738
Insulin Glargine31

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Fluctuations of the 9-point Profile (Defined as the Integrated Absolute Distance From the Mean Profile Value Divided by Measurement Time).

Participants measured their plasma glucose (PG) levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Presented fluctuation in 9-point SMPG profile is the integrated absolute distance from the mean profile value divided by measurement time and is calculated using the trapezoidal method. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: Week 26 (Visit 28)

Interventionmmol/l (Least Squares Mean)
Insulin 2870.92
Insulin Glargine0.94

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Fasting C-peptide

Fasting C-peptide at week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: At week 26 (Visit 28)

InterventionNanomoles per liter (nmol/l) (Least Squares Mean)
Insulin 2870.44
Insulin Glargine0.47

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Change in Mean of the 9-point Profile, Defined as the Area Under the Profile Divided by Measurement Time

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)

Interventionmmol/l (Least Squares Mean)
Insulin 287-2.70
Insulin Glargine-2.26

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Change in HbA1c [Millimoles/Mole (mmol/Mol)]

Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)

Interventionmmol/mol (Least Squares Mean)
Insulin 287-14.51
Insulin Glargine-12.54

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Change in Glycated Haemoglobin (HbA1c) [Percentage Point (%-Point)]

Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)

InterventionPercentage point of HbA1c (Least Squares Mean)
Insulin 287-1.33
Insulin Glargine-1.15

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Change in Fasting Plasma Glucose

Change in fasting plasma glucose from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)

Interventionmmol/l (Least Squares Mean)
Insulin 287-3.20
Insulin Glargine-2.99

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Change in Cross-reactive Anti-human Insulin Antibody Status (Positive/Negative)

Anti-insulin 287 or glargine antibodies were classified as negative if % B/T was below a certain cut point. Samples positive for anti-insulin 287 or glargine antibodies were further tested for cross-reactivity to endogenous insulin. Samples not further tested are categorised as not applicable (NA). Unknown refers to samples with insufficient volume to perform analysis. The endpoint was evaluated based on the data from in-trial period, starting at randomisation, and ending at the last direct participant-site contact, or when participant withdrew their informed consent, or the last participant-investigator contact for participants lost to follow-up, or death. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 31 (Visit 30)

InterventionParticipants (Count of Participants)
Week 072515459Week 072515460Week 3172515460Week 3172515459
PositiveUnknownNot ApplicableNegative
Insulin Glargine1
Insulin 2871
Insulin Glargine9
Insulin 287124
Insulin Glargine112
Insulin 2879
Insulin Glargine0
Insulin 28786
Insulin Glargine26
Insulin 2870
Insulin 28725
Insulin Glargine89

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9-point Profile (Individual SMPG Values)

Participants measured their plasma glucose (PG) levels using blood glucose meters (as plasma equivalent values of capillary whole blood glucose) at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values after 26 weeks are presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: Week 26 (Visit 28)

,
Interventionmmol/l (Least Squares Mean)
Before breakfast90 minutes after start of breakfastBefore lunch90 minutes after start of lunchBefore main evening meal90 minutes after the start of main evening mealBefore bedtimeAt 4:00 a.m.Before breakfast the following day
Insulin 2875.707.906.097.836.558.017.355.725.74
Insulin Glargine6.198.516.198.506.968.477.875.986.05

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Weekly Dose of Insulin 287 and Weekly Dose of Insulin Glargine

Weekly dose of insulin 287 and weekly dose of glargine at week 25 and week 26 are presented.The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: week 25 (Visit 27) and 26 (Visit 28)

InterventionUnits of Insulin (Least Squares Mean)
Insulin 287229.06
Insulin Glargine284.05

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Number of Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical trial subject administered or using a medicinal product, whether or not considered related to the medicinal product or usage. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The endpoint was evaluated based on the data from on-treatment period, starting at the date of first dose of trial product, and ending at follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 31 (Visit 30)

InterventionEvents (Number)
Insulin 287229
Insulin Glargine158

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Number of Severe Hypoglycaemic Episodes (Level 3)

Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred from week 0 to week 26 are presented. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)

InterventionEpisodes (Number)
Insulin 2871
Insulin Glargine0

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Go/No-Go Accuracy

"Go/No-Go is used to measure a participants capacity for sustained attention and response control. The test requires a participant to perform an action given certain stimuli (e.g., press a button - Go) and inhibit that action under a different set of stimuli (e.g., not press that same button - No-Go).~Average of the 2 runs (run 1 - insulin; run 2 - placebo) were calculated for mean reaction time (+SEM) of smokers and non-smokers on no-go stimuli. The minimum reaction time was 23.08 ms and the maximum reaction time was 97.44 ms. The higher mean value represents slower the reaction time, and the lower mean value represents quicker the reaction time. The higher value means that participants have difficulties with inhibiting a prepotent response. The values do not represent a better or worse outcome." (NCT03811951)
Timeframe: From time of drug administration to 70 minutes following drug administration, up to 90 minutes

InterventionMilliseconds (Mean)
Run 1 (Insulin)Run 2 (Placebo)
Non-Smokers70.77167.693

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Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16

"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug." (NCT03830281)
Timeframe: Baseline, Week 16

InterventionPercentage of HbA1c (Least Squares Mean)
Insulin Lispro (Humalog)-0.09
Ultra-Rapid Lispro-0.06

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Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change

Percentage of participants with at least 1 event of unexplained hyperglycemia >300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated. (NCT03830281)
Timeframe: Baseline through Week 16

InterventionPercentage of participants (Number)
Insulin Lispro (Humalog)18.4
Ultra-Rapid Lispro16.3

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Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change

Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated. (NCT03830281)
Timeframe: Baseline through Week 16

InterventionPercentage of participants (Number)
Insulin Lispro (Humalog)12.7
Ultra-Rapid Lispro14.8

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Rate of Documented Symptomatic Hypoglycemia at Week 16

Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable. (NCT03830281)
Timeframe: Baseline through Week 16

InterventionEvents per participant per year (Least Squares Mean)
Insulin Lispro (Humalog)30.7
Ultra-Rapid Lispro24.6

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Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16

Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03830281)
Timeframe: Week 16

,
Interventionpercentage of time (Least Squares Mean)
Daytime24-Hour
Insulin Lispro (Humalog)58.657.5
Ultra-Rapid Lispro59.357.9

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Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. (NCT03830281)
Timeframe: Baseline, Week 16

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
Insulin Lispro (Humalog)-2.2
Ultra-Rapid Lispro-26.3

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Percentage of Participants With HbA1c <7%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. (NCT03830281)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Insulin Lispro (Humalog)20.77
Ultra-Rapid Lispro18.85

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Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. (NCT03830281)
Timeframe: Baseline, Week 16

Interventionmg/dL (Least Squares Mean)
Insulin Lispro (Humalog)-4.2
Ultra-Rapid Lispro-32.0

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Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16

The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug. (NCT03830281)
Timeframe: Baseline, Week 16

InterventionPercentage of bolus/total insulin dose (Least Squares Mean)
Insulin Lispro (Humalog)0.6
Ultra-Rapid Lispro-1.3

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Rate of Severe Hypoglycemia at Week 16

Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525. (NCT03830281)
Timeframe: Baseline through Week 16

InterventionEvents per 100 participant years (Number)
Insulin Lispro (Humalog)2.95
Ultra-Rapid Lispro6.36

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Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16

SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, HbA1c stratum : less than or equal to (≤)7.5%, greater than (>)7.5% and participant's personal CGM or FGM use during the study), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug. (NCT03830281)
Timeframe: Baseline, Week 16

,
Interventionmg/dL (Least Squares Mean)
Morning PremealMorning 1-hour PostmealMorning 2-hour PostmealMidday PremealMidday 1-hour PostmealMidday 2-hour PostmealEvening PremealEvening 1-hour PostmealEvening 2-hour PostmealBedtime
Insulin Lispro (Humalog)0.2-3.1-2.7-0.6-4.2-0.23.82.66.38.6
Ultra-Rapid Lispro0.5-12.9-2.94.9-6.34.417.58.612.219.0

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Change From Baseline in Insulin Dose at Week 16

LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug. (NCT03830281)
Timeframe: Baseline, Week 16

,
Interventionunits per day (U/day) (Least Squares Mean)
Daily Basal Insulin DoseDaily Bolus Insulin DoseTotal Daily Insulin Dose
Insulin Lispro (Humalog)-0.20.80.6
Ultra-Rapid Lispro-0.1-1.0-1.1

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Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16

1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug. (NCT03830281)
Timeframe: Baseline, Week 16

Interventionmilligram per liter (mg/L) (Least Squares Mean)
Insulin Lispro (Humalog)0.16
Ultra-Rapid Lispro0.11

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Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline

"Change from Baseline in Score on Hypoglycemia Confidence Scale (HCS)~The 9-item scale assessed a subject's confidence about safety regarding hypoglycemia. The questionnaire had 4 responses possible for each question, ranging from 1=not confident at all (min.) to 4=very confident (max.). Higher scores are considered better outcomes, while lower scores are considered worse outcomes. The lower the score (1 to 4), the less likely the subject was to engage in exercise.~The mean of the scores of the 9 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 4." (NCT03841526)
Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Follow-up (Visit 11)
Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction3.340.17
Outpatient Phase: Glucagon RTU With Insulin Pump Reduction3.230.07

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Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline

"Change from Baseline in Score on Hypoglycemia Confidence Scale (HCS)~The 9-item scale assessed a subject's confidence about safety regarding hypoglycemia. The questionnaire had 4 responses possible for each question, ranging from 1=not confident at all (min.) to 4=very confident (max.). Higher scores are considered better outcomes, while lower scores are considered worse outcomes. The lower the score (1 to 4), the less likely the subject was to engage in exercise.~The mean of the scores of the 9 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 4." (NCT03841526)
Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Follow-up (Visit 11)Change from Baseline at Early Termination
Glucagon RTU Without Insulin Pump Reduction3.200.200.15

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Outpatient Phase: Insulin Use Change From Baseline

Insulin use as reported by subject as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12 (NCT03841526)
Timeframe: Insulin use measured continuously from Study Baseline to End of Study and assessed during Outpatient Phase as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12

Interventionunits of insulin (Mean)
Fiasp (Insluin Aspart) - Change from Baseline at Week 4Humalog (Insulin Lispro) - Change from Baseline at Week 4Humalog (Insulin Lispro) - Change from Baseline at Week 8Humalog (Insulin Lispro) - Change from Baseline at Week 12NovoRapid (Insulin Aspart) - Change from Baseline at Week 4
Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction0.106.203.20-0.85-2.85

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Outpatient Phase: Insulin Use Change From Baseline

Insulin use as reported by subject as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12 (NCT03841526)
Timeframe: Insulin use measured continuously from Study Baseline to End of Study and assessed during Outpatient Phase as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12

Interventionunits of insulin (Mean)
Fiasp (Insluin Aspart) - Change from Baseline at Week 4Fiasp (Insluin Aspart) - Change from Baseline at Week 12Humalog (Insulin Lispro) - Change from Baseline at Week 8Humalog (Insulin Lispro) - Change from Baseline at Week 12NovoRapid (Insulin Aspart) - Change from Baseline at Week 4NovoRapid (Insulin Aspart) - Change from Baseline at Week 8NovoRapid (Insulin Aspart) - Change from Baseline at Week 12
Outpatient Phase: Glucagon RTU With Insulin Pump Reduction-2.80-7.600.900.60-2.43-0.15-0.05

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Outpatient Phase: Insulin Use Change From Baseline

Insulin use as reported by subject as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12 (NCT03841526)
Timeframe: Insulin use measured continuously from Study Baseline to End of Study and assessed during Outpatient Phase as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12

Interventionunits of insulin (Mean)
Fiasp (Insluin Aspart) - Change from Baseline at Week 4Fiasp (Insluin Aspart) - Change from Baseline at Week 8Fiasp (Insluin Aspart) - Change from Baseline at Week 12Humalog (Insulin Lispro) - Change from Baseline at Week 4Humalog (Insulin Lispro) - Change from Baseline at Week 8Humalog (Insulin Lispro) - Change from Baseline at Week 12NovoRapid (Insulin Aspart) - Change from Baseline at Week 4NovoRapid (Insulin Aspart) - Change from Baseline at Week 8NovoRapid (Insulin Aspart) - Change from Baseline at Week 12
Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction2.60-2.10-1.703.057.201.05-1.57-2.85-4.20

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Outpatient Phase: Interstitial Glucose Levels Below Target Range

"Analysis of interstitial glucose (IG) was performed by treatment, during the randomized Outpatient Phase. The number of participants are categorized by the following IG levels:~Below range, as defined by IG <= 70 mg/dl (<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG <54 mg/dL (<3 mmol/L)" (NCT03841526)
Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of each qualified exercise session corresponding to each of the treatments during the Outpatient Phase.

,,,
InterventionParticipants (Count of Participants)
Below range <=70 mg/dLBetween Range 54-70 mg/dLBelow range <54 mg/dL
Outpatient Phase: Glucagon RTU With Insulin Pump Reduction141411
Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction12129
Outpatient Phase: Overall404034
Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction141414

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CRC Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise Exercise.

"Mean incidence rate of hypoglycemia during or after moderate to high intensity aerobic exercise at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level.~Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level.~Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.~Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session." (NCT03841526)
Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.

Interventionevents/session (Number)
CRC Phase: Glucagon RTU With Insulin Pump Reduction0.02
CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction0.19
CRC Phase: Overall0.11

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CRC Phase: Mean Number of Hypoglycemic Events Exercise.

"CRC Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) assessed at group level.~A qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.~A hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session." (NCT03841526)
Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.

Interventionnumber of events/participant (Number)
CRC Phase: Glucagon RTU With Insulin Pump Reduction0.02
CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction0.19
CRC Phase: Overall0.21

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CRC Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions

"Mean number of high intensity aerobic exercise sessions at each CRC Phase visit. With crossover, each subject was to have 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level.~A qualified exercise session was defined as one where (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session." (NCT03841526)
Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the number of qualified exercise sessions that occurred.

Interventionmean number of sessions/participant (Number)
CRC Phase: Glucagon RTU With Insulin Pump Reduction1
CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction1
CRC Phase: Overall1.94

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Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise.

"Mean incidence rate of hypoglycemia during and after sessions of moderate to high intensity aerobic exercise in 12-week Outpatient Phase. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level.~Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) self-administered study drug no more than 10 min prior to exercise (5 min target), (3) conducted a protocol allowed exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.~Exercise sessions were to occur at least 2-3 times per week. Only 1 qualified exercise session/subject/day was included in the analysis (the first if >1).~Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session." (NCT03841526)
Timeframe: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously during and within the 30 (+2) minute period following a qualified exercise session.

Interventionevents/session (Number)
Outpatient Phase: Glucagon RTU With Insulin Pump Reduction0.12
Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction0.39
Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction0.16
Outpatient Phase: Overall0.24

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Outpatient Phase: Mean Number of Hypoglycemic Events

"Outpatient Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions, assessed at group level.~A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session.~A hypoglycemic event was defined as any hypoglycemic event occurring during or within 30 (+2) minutes after completion of a qualified exercise session.~Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if >1)." (NCT03841526)
Timeframe: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.

Interventionmean number of events/participant (Number)
Outpatient Phase: Glucagon RTU With Insulin Pump Reduction1.94
Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction8.43
Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction2.86
Outpatient Phase: Overall4.3

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Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions

"Outpatient Phase: Mean number of qualified exercise sessions, assessed at group level.~A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session.~Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if >1)." (NCT03841526)
Timeframe: Daily; During the 12-week Outpatient Phase the occurrence of qualified exercise sessions were assessed daily.

Interventionmean number of sessions/participant (Number)
Outpatient Phase: Glucagon RTU With Insulin Pump Reduction15.69
Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction21.64
Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction17.36
Outpatient Phase: Overall18.11

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CRC Phase: Interstitial Glucose Below Target Range

"Analysis of interstitial glucose (IG) was performed by treatment, independent of the order of treatment during the randomized cross-over CRC Phase. The number of participants are categorized by the following IG levels:~Below range, as defined by IG <= 70 mg/dl (<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG <54 mg/dL (<3 mmol/L)" (NCT03841526)
Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of the exercise session corresponding to each of the treatments during the corresponding in-clinic visit during the CRC Phase.

,,
InterventionParticipants (Count of Participants)
Below range (<=70 mg/dL)Between range (54-70 mg/dL)Below range (<54 mg/dL)
CRC Phase: Glucagon RTU With Insulin Pump Reduction441
CRC Phase: Overall992
CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction551

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Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline

"Change from Baseline to End of the Outpatient Phase in Score on Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Questionnaire A total of 12 factors were scored from 1=unlikely (min.) to 7=extremely likely (max.) for their propensity to keep the subject from practicing regular physical exercise during the next 6 months. Lower scores are considered better, while higher scores are considered worse outcomes. The higher the score (1 to 7), the less likely the subject was to engage in exercise.~The mean of the scores of the 12 factors were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 7." (NCT03841526)
Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

,
Interventionscore on a scale (Mean)
Baseline BAPAD-1 (Study Visit 3)Change from Baseline at Follow-up in BAPAD-1 (Study Visit 11)
Outpatient Phase: Glucagon RTU With Insulin Pump Reduction2.250.01
Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction2.17-0.38

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Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline

"Change from Baseline to End of the Outpatient Phase in Score on Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Questionnaire A total of 12 factors were scored from 1=unlikely (min.) to 7=extremely likely (max.) for their propensity to keep the subject from practicing regular physical exercise during the next 6 months. Lower scores are considered better, while higher scores are considered worse outcomes. The higher the score (1 to 7), the less likely the subject was to engage in exercise.~The mean of the scores of the 12 factors were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 7." (NCT03841526)
Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

Interventionscore on a scale (Mean)
Baseline BAPAD-1 (Study Visit 3)Change from Baseline at Follow-up in BAPAD-1 (Study Visit 11)Change from Baseline at Early Termination in BAPAD-1
Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction2.59-0.34-1.00

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Outpatient Phase: HFS-II Overall Score Change From Baseline

"Change from Baseline in Score on Hypoglycemia Fear Survey-II (HFS-II)~A total of 33 items were scored from 0=never (min.) to 4=almost always (max.) for how often in the past 6 months they had done the following:~Behavior (15 items): things that people with diabetes often do to avoid low blood sugar.~Worry (18 items): things that people with diabetes often worry about because of low blood sugar.~Lower scores are considered better outcomes, higher scores are considered worse outcomes.~The higher the score (0 to 4), the greater the subject's fear of hypoglycemia. The mean of the scores of the 33 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 0 to 4." (NCT03841526)
Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Follow-up (Visit 11)
Outpatient Phase: Glucagon RTU With Insulin Pump Reduction1.28-0.19
Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction1.16-0.01

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Outpatient Phase: HFS-II Overall Score Change From Baseline

"Change from Baseline in Score on Hypoglycemia Fear Survey-II (HFS-II)~A total of 33 items were scored from 0=never (min.) to 4=almost always (max.) for how often in the past 6 months they had done the following:~Behavior (15 items): things that people with diabetes often do to avoid low blood sugar.~Worry (18 items): things that people with diabetes often worry about because of low blood sugar.~Lower scores are considered better outcomes, higher scores are considered worse outcomes.~The higher the score (0 to 4), the greater the subject's fear of hypoglycemia. The mean of the scores of the 33 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 0 to 4." (NCT03841526)
Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Follow-up (Visit 11)Change from Baseline at Early Termination
Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction1.50-0.03-0.60

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Correlation Between Penn Spasm Frequency Scale and Insulin Resistance

Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. HOMA index is a simple, and inexpensive method used for evaluating insulin sensitivity. In most of the studies, values >2.7 were accepted as insulin resistance. HOMA-IR was calculated by using fasting plasma glucose (mg/dL) X fasting insulin (uIU/mL) /405 formula. Pearson correlation was used to calculate the correlation coefficient (r). (NCT03859960)
Timeframe: One day

Interventioncorrelation coefficient (Number)
Motor Complete Group0.354
Motor Incomplete Group-0.002

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Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass%

The body composition of the individuals was measured by dual-energy absorptiometry (DXA) device. Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. Pearson correlation was used to calculate correlation coefficient. (NCT03859960)
Timeframe: One day

Interventioncorrelation coefficient (Number)
Motor Complete0.201
Motor Incomplete0.287

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Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity

We used the Matsuda index to assess insulin sensitivity. Matsuda index was calculated 10.000/square root (Fasting plasma glucose x fasting plasma insulin) x (mean OGTT glucose concentration X mean OGTT insulin concentration) formula. Higher scores mean better. Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). (NCT03859960)
Timeframe: One day

Interventioncorrelation coefficient (Number)
Motor Complete0.797
Motor Incomplete-0.084

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Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance

Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. HOMA index was used to evaluate insulin resistance. HOMA index is a simple, and inexpensive method used for evaluating insulin sensitivity. In most of the studies, values >2.7 were accepted as insulin resistance. HOMA-IR was calculated by using fasting plasma glucose (mg/dL) X fasting insulin (uIU/mL) /405 formula. Pearson correlation was used to calculate the correlation coefficient (r). (NCT03859960)
Timeframe: One day

Interventioncorrelation coefficient (Number)
Motor Complete-0.692
Motor Incomplete0.23

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Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass%

The body composition of the individuals was measured by dual-energy absorptiometry (DXA) device. Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). (NCT03859960)
Timeframe: One day

Interventioncorrelation coefficient (Number)
Motor Complete-0.138
Motor Incomplete0.526

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Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity

We used the Matsuda index to assess insulin sensitivity. Matsuda index was calculated 10.000/square root (Fasting plasma glucose x fasting plasma insulin) x (mean OGTT glucose concentration X mean OGTT insulin concentration) formula. Higher scores mean better. Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). (NCT03859960)
Timeframe: One day

Interventioncorrelation coefficient (Number)
Motor Complete0.289
Motor Incomplete-0.103

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Number of Participants With at Least One Hypoglycemic Event

Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant was not capable of helping self. Documented symptomatic hypoglycemia: event in which typical symptoms of hypoglycemia (SOH) were accompanied by measured plasma glucose concentration (PGC) less than or equal to (<=) 3.9 millimoles per liter (mmol/L)(<70 milligrams per deciliter [mg/dL]) or <3.0 mmol/L(<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and with measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L (<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC <=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC greater than (>) 3.9 mmol/L (70 mg/dL). (NCT03874715)
Timeframe: From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)

,
InterventionParticipants (Count of Participants)
Any hypoglycemiaSevere hypoglycemiaDocumented symptomatic hypoglycemia <=3.9 mmol/LDocumented symptomatic hypoglycemia < 3.0 mmol/LAsymptomatic hypoglycemia <= 3.9 mmol/LAsymptomatic hypoglycemia < 3.0 mmol/LProbable symptomatic hypoglycemiaRelative hypoglycemia
Non-switching: NovoLog10549890684492
Switching: NovoLog/SAR3414029568978694883

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Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)

Tmax was defined as the time taken to reach the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog. (NCT03874715)
Timeframe: 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112

Interventionhours (Median)
Switching: NovoLog/SAR3414021.33
Non-switching: NovoLog1.00

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Number of Hypoglycemic Events Per Participant-year

Number of hypoglycemia events (any, severe, documented [both threshold], asymptomatic [both threshold], probable symptomatic and relative) per participant-year of exposure were reported. Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant wasn't capable of helping self. Documented symptomatic hypoglycemia: event in which typical SOH were accompanied by measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L(<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L(<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC <=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC >3.9 mmol/L (70 mg/dL). (NCT03874715)
Timeframe: From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)

,
Interventionevents per participant-year (Number)
Any hypoglycemiaSevere hypoglycemiaDocumented symptomatic hypoglycemia <= 3.9 mmol/LDocumented symptomatic hypoglycemia < 3.0 mmol/LAsymptomatic hypoglycemia <= 3.9 mmol/LAsymptomatic hypoglycemia < 3.0 mmol/LProbable symptomatic hypoglycemiaRelative hypoglycemia
Non-switching: NovoLog97.090.3863.5425.7032.257.030.810.12
Switching: NovoLog/SAR341402103.180.7664.2927.7237.339.110.700.09

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Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)

Cmax was defined as the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog. (NCT03874715)
Timeframe: 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112

Interventionpicograms per milliliter (pg/mL) (Mean)
Switching: NovoLog/SAR34140211800
Non-switching: NovoLog3330

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the on-treatment period (from first injection of IMP up to 1 day after the last injection of IMP). (NCT03874715)
Timeframe: From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)

,
InterventionParticipants (Count of Participants)
Any TEAEsAny TESAEs
Non-switching: NovoLog475
Switching: NovoLog/SAR341402255

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Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)

AUC was defined as area under the concentration versus time curve. Insulin aspart is the active ingredient of SAR341402 and NovoLog. (NCT03874715)
Timeframe: 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2 hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112

Interventionpg*h/mL (Mean)
Switching: NovoLog/SAR3414026720
Non-switching: NovoLog7260

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Number of Participants With Treatment-emergent Anti-Insulin Aspart Antibodies (AIAs)

AIA was categorized as: treatment-induced AIA, treatment-boosted AIA, and treatment-emergent AIA. Treatment-induced AIAs: participants who developed AIA following investigational medicinal product (IMP) administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing Baseline sample). Treatment-boosted AIAs: participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to Baseline value at any time during on-treatment period, in those participants with pre-existing AIA). Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. On-treatment period was defined as the time from the first injection of IMP up to the last injection of IMP + 1 day. (NCT03874715)
Timeframe: From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)

,
InterventionParticipants (Count of Participants)
Treatment-emergent AIATreatment-boosted AIATreatment-induced AIA
Non-switching: NovoLog11110
Switching: NovoLog/SAR341402808

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Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)

AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog. (NCT03874715)
Timeframe: 0 hour (hr)(Pre-dose), 10, 20, 30, 40 & 50 minutes (min), 1hr, 1hr-10, 20, 30, 40 & 50min, 2hr, 2hr-15, 30 & 45min, 3hr, 3hr-15, 30 & 45min, 4hr, 4hr-20 & 40min, 5hr, 5hr-20 & 40min, 6hr, 6hr-30min, 7hr, 7hr-30min & 8hr post-dose on Day 112

Interventionpicograms*hour per milliliter (pg*h/mL) (Mean)
Switching: NovoLog/SAR3414028960
Non-switching: NovoLog7190

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Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring)

The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03922750)
Timeframe: During the last 2 weeks of treatment (week 15 and 16)

InterventionPercentage of time (Least Squares Mean)
Insulin 287 (Without Loading Dose)65.99
Insulin 287 (With 100% Loading Dose)72.86
Insulin Glargine U10064.98

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Number of Treatment-emergent Adverse Events (TEAEs)

An adverse event(AE) is any untoward medical occurrence in a clinical trial subject administered or using a medicinal product, whether or not considered related to the medicinal product or usage.. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period was the time period from first dose of trial product until the follow-up visit or the last date on trial product + 5 weeks for once daily insulin and +6 weeks for once weekly insulin. Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. (NCT03922750)
Timeframe: From baseline week 0 (V2) to week 21 (V20)

InterventionCount of events (Number)
Insulin 287 (Without Loading Dose)77
Insulin 287 (With 100% Loading Dose)85
Insulin Glargine U10076

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Number of Severe Hypoglycaemic Episodes (Level 3)

Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred during weeks 0-16 are presented. (NCT03922750)
Timeframe: From baseline week 0 (V2) to week 16 (V18)

InterventionCount of events (Number)
Insulin 287 (Without Loading Dose)0
Insulin 287 (With 100% Loading Dose)0
Insulin Glargine U1000

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Change in Body Weight

Estimated mean change from baseline (week 0) in body weight at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03922750)
Timeframe: From baseline week 0 (V2) to week 16 (V18)

InterventionKilogram (Kg) (Least Squares Mean)
Insulin 287 (Without Loading Dose)1.32
Insulin 287 (With 100% Loading Dose)0.61
Insulin Glargine U1000.10

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Number of Hypoglycaemic Alert Episodes(Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by BG Meter)

Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter) that occured during weeks 0-16 are presented. (NCT03922750)
Timeframe: From baseline week 0 (V2) to week 16 (V18)

InterventionCount of events (Number)
Insulin 287 (Without Loading Dose)79
Insulin 287 (With 100% Loading Dose)78
Insulin Glargine U10071

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Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of <3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG)meter or severe hypoglycaemic episodes (level 3) that occured during weeks 0-16 are presented. (NCT03922750)
Timeframe: From baseline week 0 (V2) to week 16 (V18)

InterventionCount of events (Number)
Insulin 287 (Without Loading Dose)3
Insulin 287 (With 100% Loading Dose)17
Insulin Glargine U10016

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Change in Glycosylated Haemoglobin (HbA1c)

Estimated mean change from baseline (week 0) in HbA1c at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03922750)
Timeframe: From baseline week 0 (V2) to week 16 (V18)

InterventionPercentage point of HbA1c (Least Squares Mean)
Insulin 287 (Without Loading Dose)-0.47
Insulin 287 (With 100% Loading Dose)-0.77
Insulin Glargine U100-0.54

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Change in Fasting Plasma Glucose (FPG)

Estimated mean change from baseline (week 0) in FPG at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03922750)
Timeframe: From baseline week 0 (V2) to week 16 (V18)

InterventionMillimoles per liter (mmol/L) (Least Squares Mean)
Insulin 287 (Without Loading Dose)-0.83
Insulin 287 (With 100% Loading Dose)-0.69
Insulin Glargine U100-0.57

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Weekly Insulin Dose

Estimated mean average weekly insulin dose during the last 2 weeks of treatment is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03922750)
Timeframe: During the last 2 weeks of treatment (week 15 and 16)

InterventionUnits of insulin (U) (Least Squares Mean)
Insulin 287 (Without Loading Dose)242.31
Insulin 287 (With 100% Loading Dose)191.03
Insulin Glargine U100195.91

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Change in HbA1c (Glycated Haemoglobin)

Estimated mean change in HbA1c from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03951805)
Timeframe: From baseline week 0 (visit 2) to week 16 (visit 18)

InterventionPercentage point of HbA1c (Least Squares Mean)
Insulin 287 (Titration Algorithm A)-1.00
Insulin 287 (Titration Algorithm B)-1.22
Insulin 287 (Titration Algorithm C)-1.38
Insulin Glargine (Titration Algorithm D)-1.02

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Number of Hypoglycaemic Alert Episodes (Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by Blood Glucose (BG) Meter)

Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and < 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Number of hypoglycaemic alert episodes (level 1) that occured from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented. (NCT03951805)
Timeframe: From baseline week 0 (visit 2) to week 16 (visit 18)

InterventionCount of events (Number)
Insulin 287 (Titration Algorithm A)14
Insulin 287 (Titration Algorithm B)20
Insulin 287 (Titration Algorithm C)110
Insulin Glargine (Titration Algorithm D)10

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Weekly Insulin Dose

Estimated mean average weekly insulin dose during the last 2 weeks of treatment is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03951805)
Timeframe: During the last 2 weeks of treatment (week 15 and 16)

InterventionUnits of insulin (U) (Least Squares Mean)
Insulin 287 (Titration Algorithm A)142.47
Insulin 287 (Titration Algorithm B)176.38
Insulin 287 (Titration Algorithm C)208.90
Insulin Glargine (Titration Algorithm D)145.56

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Number of Treatment Emergent Adverse Events (TEAEs)

A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period was the time period from first dose of trial product (week 0, visit 2) until the follow-up visit (week 21, visit 20) or the last date on trial product + 5 weeks for once daily insulin and +6 weeks for once weekly insulin. (NCT03951805)
Timeframe: From baseline week 0 (visit 2) to week 21 (visit 20)

InterventionCount of events (Number)
Insulin 287 (Titration Algorithm A)44
Insulin 287 (Titration Algorithm B)67
Insulin 287 (Titration Algorithm C)58
Insulin Glargine (Titration Algorithm D)45

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Number of Severe Hypoglycaemic Episodes (Level 3)

Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented. (NCT03951805)
Timeframe: From baseline week 0 (visit 2) to week 16 (visit 18)

InterventionCount of events (Number)
Insulin 287 (Titration Algorithm A)0
Insulin 287 (Titration Algorithm B)0
Insulin 287 (Titration Algorithm C)0
Insulin Glargine (Titration Algorithm D)0

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Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter) or Severe Hypoglycaemic Episodes (Level 3)

Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occured from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented. (NCT03951805)
Timeframe: From baseline week 0 (visit 2) to week 16 (visit 18)

InterventionCount of events (Number)
Insulin 287 (Titration Algorithm A)1
Insulin 287 (Titration Algorithm B)2
Insulin 287 (Titration Algorithm C)8
Insulin Glargine (Titration Algorithm D)0

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Percentage of Time in Target Range (TIR) 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter (mg/dL) Measured Using CGM (Continuous Glucose Monitoring)

The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). The endpoint is based on data recorded by CGM system. It was required that at least 70% of the planned CGM measurements during weeks 15-16 were available for endpoint data to be included in the analysis. (NCT03951805)
Timeframe: During the last 2 weeks of treatment (week 15 and 16)

InterventionPercentage of time (Least Squares Mean)
Insulin 287 (Titration Algorithm A)76.65
Insulin 287 (Titration Algorithm B)82.97
Insulin 287 (Titration Algorithm C)80.89
Insulin Glargine (Titration Algorithm D)75.89

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Change in Fasting Plasma Glucose (FPG)

Estimated mean change in FPG from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03951805)
Timeframe: From baseline week 0 (visit 2) to week 16 (visit 18)

InterventionMillimoles per liter (mmol/L) (Least Squares Mean)
Insulin 287 (Titration Algorithm A)-2.23
Insulin 287 (Titration Algorithm B)-2.42
Insulin 287 (Titration Algorithm C)-3.01
Insulin Glargine (Titration Algorithm D)-2.34

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Change in Body Weight

Estimated mean change in body weight from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). (NCT03951805)
Timeframe: From baseline week 0 (visit 2) to week 16 (visit 18)

InterventionKilogram (Kg) (Least Squares Mean)
Insulin 287 (Titration Algorithm A)0.87
Insulin 287 (Titration Algorithm B)1.11
Insulin 287 (Titration Algorithm C)1.25
Insulin Glargine (Titration Algorithm D)0.63

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1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables. (NCT03952130)
Timeframe: Week 26

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
Insulin Lispro (Humalog)102.8
LY90001485.0

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2-hour PPG Excursion During MMTT

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables. (NCT03952130)
Timeframe: Week 26

Interventionmg/dL (Least Squares Mean)
Insulin Lispro (Humalog)142.2
LY900014116.7

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Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)

1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. (NCT03952130)
Timeframe: Baseline, Week 26

Interventionmilligrams per liter (mg/L) (Least Squares Mean)
Insulin Lispro (Humalog)0.39
LY9000140.10

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Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values

SMBG 10-point profiles were measured at morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. (NCT03952130)
Timeframe: Baseline, Week 26

,
Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
Morning premeal-fastingMorning 1-hour post mealMorning 2-hour postmealMidday premealMidday 1-hour post mealMidday 2-hour post mealEvening premealEvening 1-hour post mealEvening 2-hour post mealBedtime
Insulin Lispro (Humalog)5.5-6.4-9.5-6.7-4.7-10.8-12.2-2.4-7.0-7.9
LY900014-10.2-20.4-24.4-9.0-13.8-14.1-1.6-8.0-14.8-12.4

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Change From Baseline in Daily Insulin Dose

LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. (NCT03952130)
Timeframe: Baseline, Week 26

,
InterventionUnits per day (Least Squares Mean)
Basal Insulin DoseBolus Insulin DoseTotal Insulin Dose
Insulin Lispro (Humalog)0.06.06.0
LY9000140.06.66.6

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Percentage of Participants With HbA1c <7% and ≤6.5%

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. (NCT03952130)
Timeframe: Week 26

,
InterventionPercentage of participants (Number)
HbA1c < 7%HbA1c ≤ 6.5%
Insulin Lispro (Humalog)28.4815.15
LY90001426.719.94

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Rate of Documented Symptomatic Post Meal Hypoglycemia

Documented symptomatic post meal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group *365.25. (NCT03952130)
Timeframe: Baseline through Week 26

,
InterventionEvents per participant per year (Number)
<=30 minutes post meal<=1 hour post meal<=2 hours post meal<=4 hours post meal>1 to <=2 hours post meal>2 to <=4 hours post meal>4 hours post meal
Insulin Lispro (Humalog)0.110.753.8010.23.056.4014.2
LY9000140.091.204.5212.43.327.8710.5

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Rate of Severe Hypoglycemia

Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525 days. (NCT03952130)
Timeframe: Baseline through Week 26

InterventionEvents per 100 participant years (Number)
Insulin Lispro (Humalog)6.88
LY9000145.87

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Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. (NCT03952130)
Timeframe: Baseline, Week 26

InterventionPercentage of HbA1c (Least Squares Mean)
Insulin Lispro (Humalog)-0.28
LY900014-0.21

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Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)

1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) (NCT03952143)
Timeframe: Baseline, Week 26

Interventionmilligram per liter (mg/L) (Least Squares Mean)
Insulin Lispro (Humalog)2.49
LY9000142.21

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2-hour PPG Excursion During MMTT

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares). (NCT03952143)
Timeframe: Week 26

Interventionmg/dL (Least Squares Mean)
Insulin Lispro (Humalog)133.2
LY900014111.4

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Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values

SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03952143)
Timeframe: Baseline, Week 26

,
Interventionmg/dL (Least Squares Mean)
Morning PremealMorning 1-hour PostmealMorning 2-hour PostmealMidday PremealMidday 1-hour PostmealMidday 2-hour PostmealEvening PremealEvening 1-hour PostmealEvening 2-hour PostmealBedtime
Insulin Lispro (Humalog)2.2-12.9-15.9-9.8-15.2-24.4-25.0-17.6-22.1-22.3
LY9000144.4-18.1-21.3-5.7-13.9-22.5-10.9-15.6-22.3-20.7

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1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares). (NCT03952143)
Timeframe: Week 26

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
Insulin Lispro (Humalog)100.8
LY90001486.2

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Rate of Documented Symptomatic Postmeal Hypoglycemia

Documented symptomatic postmeal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable (NCT03952143)
Timeframe: Baseline through Week 26

,
InterventionEvents per participant per year (Least Squares Mean)
≤30 minutes post meal≤1 hour post meal>1 to ≤2 hours post meal≤2 hours post meal>2 to ≤4 hours post meal≤4 hours post meal
Insulin Lispro (Humalog)0.130.250.670.921.962.89
LY9000140.110.341.071.411.923.32

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Percentage of Participants With HbA1c <7% and ≤6.5%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. (NCT03952143)
Timeframe: Week 26

,
InterventionPercentage of participants (Number)
HbA1c < 7%HbA1c ≤ 6.5%
Insulin Lispro (Humalog)44.5027.23
LY90001446.6527.93

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Change From Baseline in Insulin Dose

LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) (NCT03952143)
Timeframe: Baseline, Week 26

,
InterventionUnits (U) (Least Squares Mean)
Total Daily Insulin DoseDaily Basal Insulin DoseDaily Prandial Insulin Dose
Insulin Lispro (Humalog)15.10.714.7
LY90001417.81.416.7

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Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03952143)
Timeframe: Baseline, Week 26

InterventionPercentage of HbA1c (Least Squares Mean)
Insulin Lispro (Humalog)-0.63
LY900014-0.56

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Rate of Severe Hypoglycemia

Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525. (NCT03952143)
Timeframe: Baseline through Week 26

InterventionEvents per 100 participant years (Number)
Insulin Lispro (Humalog)2.00
LY9000140.52

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Change in Percentage of Euglycemia

The overall mean change in % of time in euglycemia (70-180 mg/dL) from baseline to end of 3-month Study Period will be estimated. (NCT03959423)
Timeframe: Baseline to End of 3-Month Study Period

,
Interventionpercentage (Mean)
Baseline3 Months Study PeriodChange from Baseline to 3 Months Study Period
Subjects 18-75 Years of Age70.575.04.6
Subjects 7-17 Years of Age59.470.311.0

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Number of Severe Hypoglycemic Event

Number of severe hypoglycemic events occurred during 3-month Study Period (NCT03959423)
Timeframe: 3-month Study Period

InterventionEvents (Number)
Subjects 7-17 Years of Age0
Subjects 18-75 Years of Age0

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Number of Diabetic Ketoacidosis (DKA) Event

Number of Diabetic Ketoacidosis (DKA) event occurred during 3-month Study Period (NCT03959423)
Timeframe: 3-month Study Period

InterventionEvents (Number)
Subjects 7-17 Years of Age0
Subjects 18-75 Years of Age0

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Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)

The overall mean change in % of time in hypoglycemic range (<70 mg/dL) from baseline to end of 3-month Study Period will be estimated. (NCT03959423)
Timeframe: Baseline to End of 3-Month Study Period

,
Interventionpercentage (Mean)
Baseline3 Months Study PeriodChange from Baseline to 3 Months Study Period
Subjects 18-75 Years of Age3.42.3-1.0
Subjects 7-17 Years of Age2.72.7-0.0

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Change in HbA1c

The overall mean difference of the change in HbA1c from baseline to end of 3-month Study Period. (NCT03959423)
Timeframe: Baseline to End of 3-Month Study Period

,
Interventionpercentage (Mean)
BaselineEnd of StudyChange from Baseline to End of Study
Subjects 18-75 Years of Age7.46.9-0.5
Subjects 7-17 Years of Age7.97.4-0.5

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Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups

PRO between two groups. The Insulin delivery satisfaction survey (IDSS) measures diabetes patients' satisfaction with their insulin delivery system. Possible scores range from 1-5, with higher scores indicating higher satisfaction and a better outcome. (NCT03987191)
Timeframe: 7 days from the randomization

Interventionscore on a scale (Median)
Standard of Care Transition3.9
Investigational Transition3.9

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Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization

no of correction boluses between two groups (NCT03987191)
Timeframe: 72 hours from the randomization

InterventionBoluses per day (Median)
Standard of Care Transition6.5
Investigational Transition4.0

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"Time Spent in CGM-measured Time-in-range(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups"

CGM TIR between two groups (NCT03987191)
Timeframe: 7 days from the randomization

Interventionpercentage of time spent in range (Median)
Standard of Care Transition47.8
Investigational Transition56.5

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Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups

PRO between two groups (NCT03987191)
Timeframe: 7 days from the randomization

,
InterventionPercent (Median)
Percent work time missed due to problemPercent impairment while workingPercent overall work impairmentPercent activity impairment due to problem
Investigational Transition0.00.21.00.2
Standard of Care Transition0.00.21.00.1

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Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups

The primary outcome will be time spent in CGM glucose >180 mg/dL (hyperglycemia) during 7days of randomization period between two groups. (NCT03987191)
Timeframe: 7 days from the randomization

Interventionpercentage of time spent >180 mg/dL (Median)
Standard of Care Transition46.3
Investigational Transition38.5

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Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups

CGM time below 70 between two groups (NCT03987191)
Timeframe: 7 days from the randomization

Interventionpercentage of time below range (Median)
Standard of Care Transition3.9
Investigational Transition2.1

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Number of Participants With Severe Hypoglycemia as Defined by the ADA (Severe Cognitive Impairment Requiring External Assistance for Recovery) and Severe Hyperglycemia (BG≥250 Needing Hospitalization) Between Two Groups

Frequency of SH and DKA between two groups (NCT03987191)
Timeframe: 7 days from the randomization

,
InterventionParticipants (Count of Participants)
Participants with Severe HypoglycemiaParticipants with Diabetic Ketoacidosis
Investigational Transition00
Standard of Care Transition00

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Mean Glucose From the Study Participants

Mean Glucose from the Study Participants from real-time continuous glucose monitoring (CGM) (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionmg/dL (Mean)
Placebo188.4
Humulin-R190.5

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Percent of Time With Blood Glucose 70-180 mg/dL

Defined using percent of Blood Glucose 70-180 mg/dL from real-time continuous glucose monitoring (CGM) (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionpercentage of time (Mean)
Placebo51.6
Humulin-R49.5

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Percentage of Time Blood Glucose >180 mg/dL

Percentage of time Blood Glucose >180 mg/dL from real-time continuous glucose monitoring (CGM) (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionpercentage of time (Mean)
Placebo25.2
Humulin-R26.3

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Percentage of Time Participant Had Active Sensor Wear

Percentage of time Participant had Active Sensor Wear from real-time continuous glucose monitoring (CGM) (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionpercentage of time (Mean)
Placebo92.3
Humulin-R93.5

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Percentage of Time With Dangerous Hypoglycemia

Defined using percent time below range (<54 mg/dL), from real-time continuous glucose monitoring (CGM) (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionpercentage of time (Mean)
Placebo0.57
Humulin-R0.77

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Percentage of Time With Blood Glucose >250 mg/dL

Percentage of time with Blood Glucose >250 mg/dL from real-time continuous glucose monitoring (CGM) (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionpercentage of time (Mean)
Placebo20.6
Humulin-R21.9

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Coefficient of Variation (%CV) of Blood Glucose Values From CGM Data

The Coefficient of variation was calculated by dividing the standard deviation of blood glucose values by the mean of the blood glucose values based on data from the corresponding CGM readings. (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionpercentage of CV (Mean)
Placebo40.0
Humulin-R37.8

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Percentage of Time With Blood Glucose <70 mg/dL

Defined using percent of Blood Glucose <70 mg/dL from real-time continuous glucose monitoring (CGM) (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionpercentage of time (Mean)
Placebo2.0
Humulin-R1.6

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Glucose Management Indicator (GMI)

An approximate HbA1c based upon real-time continuous glucose monitoring (CGM) values (NCT04028960)
Timeframe: Two 14-20 day treatment periods

Interventionpercentage of HbA1c (Mean)
Placebo7.8
Humulin-R7.9

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Number of Hypoglycemic Events Per Participant Year During the On-treatment Period

Number of hypoglycemia events (any, severe and documented) per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <3.9 mmol/L (<70 milligrams per deciliter). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP. Total participant years = The sum of the duration of exposure for all participants, expressed in participant years. (NCT04075513)
Timeframe: From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)

,
Interventionevents per participant-year (Number)
Any hypoglycemiaSevere hypoglycemiaDocumented symptomatic hypoglycemia
Toujeo109.40.267.1
Tresiba114.90.366.9

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Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)

"The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. All time represent the time between 00.00 hour to 23.59 hours and night represent the time between 00.00 hour to 05.59 hours. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (<8.0% versus >=8.0%), and the continuous fixed covariate of Baseline value." (NCT04075513)
Timeframe: During Week 10 up to Week 12

,
Interventionpercentage of time (Least Squares Mean)
All timeNight
Toujeo5.556.32
Tresiba6.496.26

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Percentage of Time With Glucose Level >180 Milligrams Per Deciliter

The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (<8.0% versus >=8.0%), and the continuous fixed covariate of Baseline value. (NCT04075513)
Timeframe: During Week 10 up to Week 12

Interventionpercentage of time (Least Squares Mean)
Toujeo41.52
Tresiba38.31

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Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <3.9 millimoles per liter (mmol/L) (<70 milligrams per deciliter). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP. (NCT04075513)
Timeframe: From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)

,
InterventionParticipants (Count of Participants)
Any hypoglycemiaSevere hypoglycemiaDocumented symptomatic hypoglycemia
Toujeo1658136
Tresiba16610134

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Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)

"All time represent the time between 00.00 hour to 23.59 hours and night represent the time between 00.00 hour to 05.59 hours. Mean hours per day with glucose level <70 milligrams per deciliter during all time and only during night for the duration of Week 10 to Week 12 is reported in this outcome measure." (NCT04075513)
Timeframe: During Week 10 up to Week 12

,
Interventionhours per day (Least Squares Mean)
All timeNight
Toujeo1.330.38
Tresiba1.560.38

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Glucose Within-day CV% and Between-day CV%

CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated within day and between days as ratio of standard deviation of glucose values to mean of glucose values. LS mean and SE were obtained from ANCOVA model including fixed categorical effects of treatment groups (TOUJEO, TRESIBA), randomization stratum of screening HbA1c (<8.0% versus >=8.0%), and as well as, the continuous fixed covariate of Baseline value. (NCT04075513)
Timeframe: During Week 10 up to Week 12

,
Interventionpercentage of CV (Least Squares Mean)
Within-day CV%Between-day CV%
Toujeo33.4817.23
Tresiba34.3718.08

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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

Change in FPG was analyzed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba) and the randomization stratum of HbA1c at screening (<8.0%, >=8.0%) and the continuous fixed covariate of Baseline FPG value. (NCT04075513)
Timeframe: Baseline, Week 12

Interventionmilligrams per deciliter (Least Squares Mean)
Toujeo-16.05
Tresiba-34.55

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Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis

The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained using analysis of covariance (ANCOVA) model on data obtained from the multiple imputations during Week 10 to Week 12. (NCT04075513)
Timeframe: During Week 10 up to Week 12

Interventionpercentage of time (Least Squares Mean)
Toujeo52.74
Tresiba55.09

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Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis

The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations during Week 10 to Week 12. (NCT04075513)
Timeframe: During Week 10 up to Week 12

Interventionpercentage of time (Least Squares Mean)
Toujeo52.74
Tresiba55.09

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Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter

Mean hours per day with glucose level >180 milligrams per deciliter for the duration of Week 10 to Week 12 is reported in this outcome measure. (NCT04075513)
Timeframe: During Week 10 up to Week 12

Interventionhours per day (Least Squares Mean)
Toujeo9.96
Tresiba9.19

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Glucose Total Coefficient of Variation (CV%)

CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated as ratio of standard deviation of glucose values to mean of glucose values. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (<8.0% versus >=8.0%), and the continuous fixed covariate of Baseline value. (NCT04075513)
Timeframe: During Week 10 up to Week 12

Interventionpercentage of total CV (Least Squares Mean)
Toujeo39.91
Tresiba41.22

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Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12

Change in HbA1c at Week 12 was analyzed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba), and the continuous fixed covariate of Baseline HbA1c value. (NCT04075513)
Timeframe: Baseline, Week 12

Interventionpercentage of HbA1c (Least Squares Mean)
Toujeo-0.75
Tresiba-0.92

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AUC Postprandial Glucose

"Glucose done fasting, 30, 60, 120, and 180 minutes~Glucagon levels done fasting, 30, 60, 120, and 180 minutes~Usual insulin dose will be administered 20 minutes before or after the mixed meal challenge with Ensure Plus*" (NCT04079881)
Timeframe: 4 hours

,
Interventionmg/dL (Number)
30 minutes60 minutes120 minutes180 minutes
Post-prandial Insulin Administration:278316274249
Pre-prandial Insulin Administration245279310301

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Above 250mg/dl.

Percent of time spent above 250mg/dl. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy9.74.2

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Above 180 mg/dl.

Percent of time spent above 180mg/dl. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy34.125.7

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Percent of Time Spent in Closed Loop

Percentage of the amount of time spent with the Control-IQ system running in closed loop mode. (NCT04084171)
Timeframe: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.

Interventionpercentage of time (Mean)
Artificial Pancreas Therapy96.6

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Average of Carbohydrate Treatments (g).

Average amount of carbohydrates (grams) used as a treatment. Participants were treated with ~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after ~20min. Hypoglycemic treatments could occur at any time per study physician request (NCT04084171)
Timeframe: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.

Interventiongrams (Mean)
Artificial Pancreas Therapy17.5

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Average Number of Treatments.

Average number of carbohydrate treatments per day. Participants were treated with ~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after ~20min. Hypoglycemic treatments could occur at any time per study physician request (NCT04084171)
Timeframe: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.

Interventiontreatments/day (Mean)
Artificial Pancreas Therapy0.8

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Below 54 mg/dl.

Percent of time spent below 54mg/dL. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy0.60.3

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Below 50mg/dl.

Percent of time spent below 50mg/dL. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy0.20.2

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Above 300 mg/dl.

Percent of time spent above 300 mg/dl. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy3.40.6

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Below 60 mg/dl.

Percent of time spent below 60mg/dl. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy1.60.7

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Below 70 mg/dl.

Percent of time spent below 70 mg/dl. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy3.73.2

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Primary Outcome

Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of subjects (Number)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy3383

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Number of Hypoglycemia Below 70 mg/dL

Number of hypoglycemia events (below 70 mg/dL). (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionhypoglycemia event (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy2.131.79

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CGM Consensus Goal

Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of participants (Number)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy858

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Between 70-180mg/dl

Percent of time spent between 70 mg/dl and 180mg/dl. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy61.771.3

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Between 70-140mg/dl.

Percent of time spent between 70 mg/dl and 140mg/dl. (NCT04084171)
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Interventionpercentage of time (Mean)
Baseline5 days of AP Therapy
Artificial Pancreas Therapy41.851.5

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Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Eating Habits Subscore

A survey about changes in eating behaviors. The sum of frequency times severity of eating habit related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-72. Higher scores indicate a greater change in eating habits that produces conflict or embarrassment. (NCT04115384)
Timeframe: 4 weeks

Interventionchange in score on a scale (Mean)
Insulin (Novolin-R)7

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Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Food Preference Subscore

A survey about changes in eating behaviors. The sum of frequency times severity of food preference related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-84. Higher scores indicate a greater change in food preferences that produces conflict or embarrassment. (NCT04115384)
Timeframe: 4 weeks

Interventionchange in score on a scale (Mean)
Insulin (Novolin-R)2.67

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Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Other Oral Behaviors Subscore

A survey about changes in eating behaviors. The sum of frequency times severity of other oral behavior related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-60. Higher scores indicate a greater changes that produces conflict or embarrassment. (NCT04115384)
Timeframe: 4 weeks

Interventionchange in score on a scale (Mean)
Insulin (Novolin-R)0.33

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Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Swallowing Subscore

A survey about changes in eating behaviors. The sum of frequency times severity of swallowing related questions is the score for this portion. Caregivers of participant are asked to fill this survey out. Range: 0-96. Higher scores indicate higher difficulty swallowing that produces conflict or embarrassment. (NCT04115384)
Timeframe: 4 weeks

Interventionchange in score on a scale (Mean)
Insulin (Novolin-R)0.67

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Pre to Post Inhibition by EXAMINER - Flanker

Participants are asked to choose the direction of one the center arrow in a group 5 arrows. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance. (NCT04115384)
Timeframe: 4 weeks

Interventionscore on a scale (Mean)
Insulin (Novolin-R)-0.145

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Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency

Participants are asked to name as many animals as he/she can in 60 seconds. Scores are totaled as the number of animals verbalized. A higher score indicates better performance. (NCT04115384)
Timeframe: 4 weeks

Interventionnamed animals (Mean)
Insulin (Novolin-R)-0.33

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Pre to Post Inhibition by EXAMINER - Set Shifting

Participants are asked to match stimulus on different parts of a tablet screen. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance. (NCT04115384)
Timeframe: 4 weeks

Interventionchange is score on a scale (Mean)
Insulin (Novolin-R)-0.36

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Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs)

Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment. (NCT04115384)
Timeframe: 2 months

InterventionTotal number of AEs/SAEs reported (Number)
Insulin (Novolin-R)1

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Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs)

Total number of unique participants experiencing AEs/SAEs during the course of treatment. More unique participants experiencing AEs/SAEs indicates a less safe treatment. (NCT04115384)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Insulin (Novolin-R)1

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Pre to Post Working Memory Measured by EXAMINER - Dot Counting

Dot counting measures verbal working memory. Participants are asked to count colored shapes on a tables and remember the final total over 6 trials. Scores are totaled as the number of correct answers or the number of answers recalled. Range: 0-27. A higher score indicates better performance. (NCT04115384)
Timeframe: 4 weeks

Interventionscore on a scale (Mean)
Insulin (Novolin-R)6.33

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Feasibility Measured by Completion of Study

Number of patients completing the entire study. Range: 0-12. More participants completing the study indicates higher feasibility. (NCT04115384)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Insulin (Novolin-R)3

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Feasibility Measured by Recruitment

Number of patients enrolled in this study. Range: 0-12. More participants enrolling indicates higher feasibility. (NCT04115384)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Insulin (Novolin-R)3

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Feasibility Measured by Screen Fails

Number of patients screen failing during the study. More participants screen failing the study indicates lower feasibility. (NCT04115384)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Insulin (Novolin-R)0

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Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Appetite Subscore

A survey about changes in eating behaviors. The sum of frequency times severity of appetite related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-96. Higher scores indicate a greater change in appetite that produces conflict or embarrassment. (NCT04115384)
Timeframe: 4 weeks

Interventionchange in score on a scale (Mean)
Insulin (Novolin-R)-0.67

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Feasibility Measured by EXAMINER Battery

Number of patients completing the entire EXAMINER battery. Range: 0-3. More participants completing EXAMINER indicates higher feasibility. (NCT04115384)
Timeframe: Baseline and Post Treatment

InterventionParticipants (Count of Participants)
Insulin (Novolin-R)3

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Average Exogenous Bolus Insulin Compared to Baseline (Placebo)

The amount of exogenous bolus insulin utilized over the final ten (10) days of each treatment period measured in mg/dL (NCT04150107)
Timeframe: Combined Final ten days of treatment per treatment period (Days -8 to 1, Days 19 to 28, and Days 47 to 56)

,,
Interventionmg/dL (Least Squares Mean)
Least Squares Means Baseline, Treatment A, Treatment BLeast Squares Means Difference Treatment A minus Baseline, Treatmen B minus Baseline
Baseline20.63NA
Treatment A20.770.14
Treatment B20.54-0.09

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Daytime Low Blood Glucose Index (LBGI) Compared to Baseline

"Least Squares Mean Daytime Low Blood Glucose Index (LBGI) measured over the last ten (10) days of the treatment period, compared to Baseline LBGI is a clinical scale that indicates the probability for hypoglycemia. Blood Glucose Variability is an important measure because it provides additional clarification for HbA1c value.~The risk of hypglycemic events and the LBGI scale is defined as follows:~Minimal Risk ( LBGI < 1.1) Low Risk ( 1.1 < LBGI < 2.5) Moderate Risk (2.5 < LBGI < 5), HIgh Risk ( LBGI > 5)" (NCT04150107)
Timeframe: Combined Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3)

,,
Interventionunits on a scale (Least Squares Mean)
Least Squares Mean Daytime Low Blood Glucose Index (LBGI) for Baseline,Least Squares Mean Difference between Treatment A and Placebo, Treatment B and Placebo.
Baseline1.65NA
Treatment A1.53-0.12
Treatment B1.650.00

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Daytime Glucose Coefficient of Variation Compared to Baseline

Least Squares Mean Continuous Glucose Monitor (CGM) Glucose Coefficient of Variation measured over daytime hours, compared to Baseline (NCT04150107)
Timeframe: Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3)

,,
Interventionpercent (%) (Least Squares Mean)
Least Squares MeanLeast Squares Mean Differece between each treatment and placebo.
Baseline45.287NA
Treatment A46.5501.64
Treatment B44.996-0.291

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Average Exogenous Total Insulin Compared to Baseline

The Least Squares Mean Difeerence ( (mg/dL) of total exogenous insulin (the sum of basal + bolus exogenous insulin) over the final ten (10) days of treatment. (NCT04150107)
Timeframe: Combined Final ten days of treatment , day -8 to 1 (Period 1) Days 19 to 28 (Period 2), Days 47 to 56 (Period 3)

,,
Interventionmg/dL (Least Squares Mean)
Least Squares MeanLeast Squares Mean Difference Treatment A minus Baseline and Treatment B minus Baseline
Baseline47.92NA
Treatment A46.64-0.127
Treatment B47.88-0.04

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Daytime Average Mean Glucose Compared to Baseline

Least Squares Mean Difference from Baseline of Daytime Average Mean Glucose over the final ten (10) days of each treatment and each treatment period as measured by CGM. (NCT04150107)
Timeframe: Combined Study days -8 to 1 (Period 1) Days 19 to 28 (Period 2), and days 47 to 56 (Period 3)

,,
Interventionmg/dL (Least Squares Mean)
Least Sqaures Mean Baseline, Treatment A, Treatment BLeast Squares Mean Difference between each treatment and placebo
Baseline168.72NA
Treatment A174.846.12
Treatment B169.751.02

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Average Exogenous Basal Insulin Compared to Baseline (Placebo)

The least squares means difference of basal exogenous insulin between treatment A and placebo and treatment B and placebo, utilized over the final ten (10) days of each treatment period (NCT04150107)
Timeframe: Combined Final ten days of each treatment period. Period1 (days -8 to 1)Period 2 (days 19 to 28) ,and Period 3 (days 47 to 56)

,,
Interventionmg/dL (Least Squares Mean)
Least Squares Mean Baseline, Treatment A, Treatment BLeast Squares Mean Difference Treatment A minus Baseline or Treatment B minus Baseline
Baseline27.28NA
Treatment A25.84-1.43
Treatment B27.320.04

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Number of All Consented Participants

The capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF). (NCT04157738)
Timeframe: 4 months post-intervention

InterventionParticipants (Count of Participants)
Fixed Group12
Insulin to Carbohydrate Ratio (ICR) Group12

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Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention

The GV was calculated in all subjects using the average blood glucose levels collected from the daily blood glucose paper log. A subjective qualification system was used to label each subject's GV based on their blood glucose levels and an established glucose monitoring (GM) data system. Subjects are considered to have appropriate GV if their blood glucose levels are in the range of 80 mg/dL - 180 mg/dL. Percentage of participants within each specific average BG range is shown. (NCT04157738)
Timeframe: 1 month post-intervention, 4 months post-intervention

,
Interventionpercentage of participants (Number)
BG < 50 mg/dL at 1 month post-interventionBG 50-79 mg/dL at 1 month post-interventionBG 80-180 mg/dL at 1 month post-interventionBG 181-350 mg/dL at 1 month post-interventionBG >350 mg/dL at 1 month post-interventionBG < 50 mg/dL at 4 month post-interventionBG 50-79 mg/dL at 4 month post-interventionBG 80-180 mg/dL at 4 month post-interventionBG 181-350 mg/dL at 4 month post-interventionBG >350 mg/dL at 4 month post-intervention
Fixed Group0.58.967.525.80.80.08.663.328.70.1
Insulin to Carbohydrate Ratio (ICR) Group0.58.363.226.80.30.47.369.021.80.4

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Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention

Caregiver treatment adherence was assessed using a blood glucose log. Subjects and caregivers recorded blood glucose levels and the amount/type of insulin given. This data was used to calculate adherence as a percentage ranging from 0% (no adherence) to 100% (full adherence). (NCT04157738)
Timeframe: 1 month post-intervention and 4 months post-intervention

,
Interventionpercentage of participants (Number)
< 4 times/day at 1-month visit≥ 4 times/day at 1-month visit< 4 times/day at 4-month visit≥ 4 times/day at 4-month visit
Fixed Group3.296.82.697.0
Insulin to Carbohydrate Ratio (ICR) Group10.289.816.183.9

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Caregiver Anxiety

"Caregiver anxiety was measured with the parental stress scale. Caregivers completed the parental stress scale at initial enrollment and at each clinic follow up visit. The Parental Stress Scale includes 18 questions that are rated from 1 (strongly disagree) to 5 (strongly agree). Scoring ranges from 18 - 90. The higher the score, the higher the stress and anxiety level." (NCT04157738)
Timeframe: Baseline, 1 month post-intervention, 4 months post-intervention

,
Interventionscore on a scale (Least Squares Mean)
Baseline1 month post-intervention4 months post-intervention
Fixed Group29.127.027.6
Insulin to Carbohydrate Ratio (ICR) Group30.235.934.4

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Number of Participants That Completed All Visits

Number of participants that were able to complete all study visits, including the visits in-person at 1 month and 4 months post-randomization. (NCT04157738)
Timeframe: 4 months post-intervention

InterventionParticipants (Count of Participants)
Fixed Group11
Insulin to Carbohydrate Ratio (ICR) Group10

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Change in Basal Insulin Rate

Absolute change in insulin basal rate over 24 hours after 3 rounds of basal rate testing (calculated by the sum of absolute changes for each 1 hour block compared with baseline) (NCT04267770)
Timeframe: over 24 hours after 3 rounds of basal rate testing

InterventionUnits of insulin (Median)
Circadian Insulin Infusion Rates1.8
Flat Rates1.49

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Number of Participants With Manifestation of Any Symptom Following the Protocol

The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose. (NCT04292535)
Timeframe: Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)

InterventionParticipants (Count of Participants)
Passive Control - Placebo1
Passive Control - 20 IU2
Passive Control - 40 IU0
Passive Control - 60 IU2
Passive Control - 80 IU1
Passive Control - 100 IU4
Passive Control - 120 IU3
Acute Exercise - Placebo0
Acute Exercise - 20 IU1
Acute Exercise - 40 IU2
Acute Exercise - 60 IU1
Acute Exercise - 80 IU0
Acute Exercise - 100 IU3
Acute Exercise - 120 IU2

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Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol

The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms. (NCT04292535)
Timeframe: During the 20 minute exercise/control period and the cognitive assessments.

InterventionParticipants (Count of Participants)
Passive Control - Placebo4
Passive Control - 20 IU6
Passive Control - 40 IU6
Passive Control - 60 IU4
Passive Control - 80 IU5
Passive Control - 100 IU9
Passive Control - 120 IU5
Acute Exercise - Placebo2
Acute Exercise - 20 IU4
Acute Exercise - 40 IU3
Acute Exercise - 60 IU4
Acute Exercise - 80 IU4
Acute Exercise - 100 IU7
Acute Exercise - 120 IU9

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Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task

"The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.~Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups." (NCT04292535)
Timeframe: Prior to intranasal insulin administration relative to 30 minutes following

Interventioncohens d (Mean)
Passive Control - Placebo0.08
Passive Control - 20 IU-0.06
Passive Control - 40 IU-0.08
Passive Control - 60 IU-0.09
Passive Control - 80 IU0.26
Passive Control - 100 IU0.25
Passive Control - 120 IU-0.10
Acute Exercise - Placebo-0.03
Acute Exercise - 20 IU0.34
Acute Exercise - 40 IU0.00
Acute Exercise - 60 IU0.04
Acute Exercise - 80 IU0.05
Acute Exercise - 100 IU0.10
Acute Exercise - 120 IU0.05

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Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task

"The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.~Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups." (NCT04292535)
Timeframe: Prior to intranasal insulin administration relative to 30 minutes following

Interventioncohens d (Mean)
Passive Control - Placebo-0.22
Passive Control - 20 IU-0.06
Passive Control - 40 IU0.16
Passive Control - 60 IU0.15
Passive Control - 80 IU-0.42
Passive Control - 100 IU0.06
Passive Control - 120 IU-0.05
Acute Exercise - Placebo-0.21
Acute Exercise - 20 IU-0.03
Acute Exercise - 40 IU-0.25
Acute Exercise - 60 IU-0.41
Acute Exercise - 80 IU0.12
Acute Exercise - 100 IU0.19
Acute Exercise - 120 IU0.20

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Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task

The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. (NCT04292535)
Timeframe: Prior to intranasal insulin administration relative to 30 minutes following

Interventioncohens d (Mean)
Passive Control - Placebo-0.02
Passive Control - 20 IU-0.09
Passive Control - 40 IU0.04
Passive Control - 60 IU0.23
Passive Control - 80 IU0.02
Passive Control - 100 IU0.16
Passive Control - 120 IU0.08
Acute Exercise - Placebo0.03
Acute Exercise - 20 IU0.02
Acute Exercise - 40 IU0.02
Acute Exercise - 60 IU0.18
Acute Exercise - 80 IU0.04
Acute Exercise - 100 IU-0.03
Acute Exercise - 120 IU-0.06

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Effect Size of Change in Behavioral Index of Sustained Attention - RT

"The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.~Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups." (NCT04292535)
Timeframe: Prior to intranasal insulin administration relative to 30 minutes following

Interventioncohens d (Mean)
Passive Control - Placebo-0.18
Passive Control - 20 IU-0.16
Passive Control - 40 IU-0.15
Passive Control - 60 IU-0.24
Passive Control - 80 IU-0.20
Passive Control - 100 IU-0.22
Passive Control - 120 IU-0.11
Acute Exercise - Placebo-0.16
Acute Exercise - 20 IU-0.05
Acute Exercise - 40 IU-0.16
Acute Exercise - 60 IU-0.18
Acute Exercise - 80 IU-0.09
Acute Exercise - 100 IU-0.19
Acute Exercise - 120 IU-0.16

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Effect Size for Change in Behavioral Index of Inhibitory Control - RT

"The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.~Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups." (NCT04292535)
Timeframe: Prior to intranasal insulin administration relative to 30 minutes following

Interventioncohens d (Mean)
Passive Control - Placebo-0.04
Passive Control - 20 IU-0.29
Passive Control - 40 IU-0.54
Passive Control - 60 IU-0.10
Passive Control - 80 IU-0.42
Passive Control - 100 IU-0.25
Passive Control - 120 IU-0.10
Acute Exercise - Placebo-0.08
Acute Exercise - 20 IU-0.20
Acute Exercise - 40 IU-0.25
Acute Exercise - 60 IU-0.33
Acute Exercise - 80 IU-0.19
Acute Exercise - 100 IU-0.27
Acute Exercise - 120 IU-0.36

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Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy

"The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.~Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups." (NCT04292535)
Timeframe: Prior to intranasal insulin administration relative to 30 minutes following

Interventioncohens d (Mean)
Passive Control - Placebo-0.03
Passive Control - 20 IU0.16
Passive Control - 40 IU-0.04
Passive Control - 60 IU-0.19
Passive Control - 80 IU-0.06
Passive Control - 100 IU-0.14
Passive Control - 120 IU-0.05
Acute Exercise - Placebo0.05
Acute Exercise - 20 IU-0.26
Acute Exercise - 40 IU-0.12
Acute Exercise - 60 IU0.06
Acute Exercise - 80 IU-0.01
Acute Exercise - 100 IU0.01
Acute Exercise - 120 IU-0.13

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Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task

"The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.~Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups." (NCT04292535)
Timeframe: Prior to intranasal insulin administration relative to 30 minutes following

Interventioncohens d (Mean)
Passive Control - Placebo0.07
Passive Control - 20 IU-0.08
Passive Control - 40 IU-0.01
Passive Control - 60 IU0.00
Passive Control - 80 IU0.00
Passive Control - 100 IU-0.06
Passive Control - 120 IU0.00
Acute Exercise - Placebo0.00
Acute Exercise - 20 IU0.00
Acute Exercise - 40 IU-0.04
Acute Exercise - 60 IU0.01
Acute Exercise - 80 IU-0.03
Acute Exercise - 100 IU0.00
Acute Exercise - 120 IU0.15

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Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy

"The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.~Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups." (NCT04292535)
Timeframe: Prior to intranasal insulin administration relative to 30 minutes following

Interventioncohens d (Mean)
Passive Control - Placebo0.69
Passive Control - 20 IU0.81
Passive Control - 40 IU0.05
Passive Control - 60 IU0.87
Passive Control - 80 IU0.62
Passive Control - 100 IU0.71
Passive Control - 120 IU0.69
Acute Exercise - Placebo0.54
Acute Exercise - 20 IU0.36
Acute Exercise - 40 IU-0.21
Acute Exercise - 60 IU0.78
Acute Exercise - 80 IU0.43
Acute Exercise - 100 IU0.90
Acute Exercise - 120 IU0.60

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Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) [<30, >=30]), visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate. (NCT04450394)
Timeframe: Baseline, Week 26

InterventionPercentage of HbA1c (Least Squares Mean)
LY3209590 Algorithm 1 (Paper)-1.20
Insulin Degludec-1.26

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Change From Baseline in Fasting Serum Glucose

LS mean change from baseline was analysed by MMRM model with treatment, country, DPPIV (yes/no), SGLT2 (yes/no), baseline BMI [<30, >=30]), visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate. (NCT04450394)
Timeframe: Baseline, Week 26

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
LY3209590 Algorithm 1 (Paper)-50.7
Insulin Degludec-58.7

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Rate of Documented Hypoglycemia

Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose <54 mg/dL (3.0 millimole per liter (mmol/L)). Rate of documented hypoglycemia per year during defined period is calculated by the number of documented hypoglycemia events within the period divided by the number of days participant at risk within the period*365.25 days. (NCT04450394)
Timeframe: Baseline through Week 26

InterventionEvents per participant per year (Number)
LY3209590 Algorithm 1 (Paper)0.21
Insulin Degludec0.15

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Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590

AUC of LY3209590 was calculated for individual participants using the participants' Week 26 LY3209590 dose amount and estimated clearance value. (NCT04450394)
Timeframe: Week 26

InterventionNanomole*hour per Liter (nmol*hr/L) (Geometric Mean)
LY3209590 Algorithm 1 (Paper)5890

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Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate. (NCT04450407)
Timeframe: Baseline, Week 26

InterventionPercentage of HbA1c (Least Squares Mean)
LY3209590 Algorithm 1 (Paper)0.04
Insulin Degludec-0.13

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Rate of Documented Hypoglycemia

Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose <54 mg/dL (3.0 millimole per liter (mmol/L)). Negative binomial model using baseline hypoglycaemia incidence, baseline HbA1c and treatment as independent variables was performed to estimate the event rate. Data presented is group mean. Group Mean is estimated by first taking the inverse link function on individual participant covariates, then averaging over all participants. (NCT04450407)
Timeframe: Baseline through Week 26

InterventionEvents per participant per year (Mean)
LY3209590 Algorithm 1 (Paper)20.7
Insulin Degludec18.4

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Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590

AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and the estimated clearance value. (NCT04450407)
Timeframe: Week 26

InterventionNanomole*hour per Liter (nmol*hr/L) (Geometric Mean)
LY3209590 Algorithm 1 (Paper)3520

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Change From Baseline in Bolus Insulin Dose

Bolus insulin dose was the sum of doses for morning, midday, evening meals, snack and correction. LS mean change from baseline was analysed by MMRM model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline bolus insulin dose as a covariate. (NCT04450407)
Timeframe: Baseline, Week 26

InterventionUnits per kilogram per day (U/kg/day) (Least Squares Mean)
LY3209590 Algorithm 1 (Paper)0.04
Insulin Degludec0.05

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Change From Baseline in Fasting Serum Glucose

LS mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate. (NCT04450407)
Timeframe: Baseline, Week 26

Interventionmilligrams per deciliter (mg/dL) (Least Squares Mean)
LY3209590 Algorithm 1 (Paper)-5.9
Insulin Degludec-16.7

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Endogenous Glucose Production (EGP)

is calculated by tracer-based measurement and expressed per kg lean body mass (NCT04461015)
Timeframe: It will be quantified at 90, 180 and 270 minutes for the study with 0.4mU insulin infusion and compared to values obtained for the study with 0.8mU insulin infusion at the same timepoints

,
Interventionumol/kg/min (Mean)
At 90 minutesAt 180 minutesAt 270 minutes
0.4mU Insulin4.996.828.48
0.8mU Insulin5.025.525.38

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Insulin to Carbohydrate Ratio (ICR)

ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin. (NCT04585776)
Timeframe: Day 46

Interventiongrams per insulin unit (g/U) (Mean)
BreakfastLunchDinnerAcross meals
LY900014 + Insulin Degludec9.039.079.119.05

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Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin

Prandial:TDD ratio (NCT04585776)
Timeframe: Day 46

Interventionpercentage of insulin dose (Mean)
LY900014 + Insulin Degludec52.06

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Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)

ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day). (NCT04585776)
Timeframe: Day 46

Interventiong/day (Mean)
BreakfastLunchDinnerAcross meals
LY900014 + Insulin Degludec411.1421.3427.6420.0

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Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)

Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM. (NCT04585776)
Timeframe: Day 46

Interventionpercentage of time (Mean)
Day-timeNight-time24-Hour Period
LY900014 + Insulin Degludec71.5765.7670.18

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INSPIRE Questionnaire

Questionnaire addressing system/technology use. The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items. (NCT04784637)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Group 1 Baseline Measure77
Group 1 Post Randomization74
Group 2 Baseline75
Group 2 Post Randomization75

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Time in Hypoglycemia

Percent of CGM readings <70 mg/dL (NCT04784637)
Timeframe: 6 weeks

Interventionpercentage of time (Mean)
Group 1 Baseline Measure2.35
Group 1 Post Randomization1.41
Group 2 Baseline1.58
Group 2 Post Randomization1.48

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Time in Range

Percent of CGM readings in the target ranges of 70-180mg/dL from 2 weeks of baseline compared to last 2 weeks of treatment period. (NCT04784637)
Timeframe: 6 weeks

Interventionpercentage of time (Mean)
Group 1 Baseline Measure77.0
Group 1 Post Randomization73.8
Group 2 Baseline74.6
Group 2 Post Randomization74.6

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Mortality

In-hospital mortality of the study participants (NCT04834362)
Timeframe: During the hospital stay assessed up to 10 days

InterventionParticipants (Count of Participants)
Analog Insulin Arm15
Human Insulin Arm16

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Length of Hospital Stay

Length of hospital stay of the study participants (NCT04834362)
Timeframe: During the hospital stay assessed up to 10 days

InterventionDays (Mean)
Analog Insulin Arm4.7
Human Insulin Arm4.8

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Glycemic Control

Differences in glycemic control between groups, as measured by mean blood glucose concentration (NCT04834362)
Timeframe: During the hospital stay assessed up to 10 days

Interventionmmol/L (Mean)
Analog Insulin Arm10.7
Human Insulin Arm10.9

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Total Daily Dose of Insulin

Total daily dose of insulin is calculated according to total basal insulin dose plus total bolus insulin dose divided by days of treatment (NCT04834362)
Timeframe: During the hospital stay assessed up to 10 days

InterventionUnits/day (Mean)
Analog Insulin Arm22.3
Human Insulin Arm26.7

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Percent of Level 2 Hypoglycemia

Percent of total SMBG measurements <54 mg/dL (Level 2 hypoglycemia) within the 120 minutes after Afrezza dosing (NCT04849845)
Timeframe: 120 minutes

InterventionSMBG Measurements (Number)
Afrezza Dose 10
Afrezza Dose 21

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Percent of Level 1 Hypoglycemia

Percent of total SMBG measurements <70 mg/dL (Level 1 hypoglycemia) within the 120 minutes after Afrezza dosing. (NCT04849845)
Timeframe: 120 minutes

InterventionSMBG Measurements (Number)
Afrezza Dose 10
Afrezza Dose 22

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Number of Subjects With At Least 1 Event of Severe Hypoglycemia

Number of subjects with at least 1 event (also referred to as incidence) of severe hypoglycemia, defined as events requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions within the 120 minutes after Afrezza dosing. (NCT04849845)
Timeframe: 120 minutes

InterventionParticipants (Count of Participants)
Afrezza Dose 10
Afrezza Dose 20

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Number of Subjects With at Least 1 Event of Level 2 Hypoglycemia

Number of subjects with at least 1 event (also referred to as incidence) of Level 2 hypoglycemia (<54mg/dL) within the 120 minutes after Afrezza dosing as confirmed by SMBG. (NCT04849845)
Timeframe: 120 minutes

InterventionParticipants (Count of Participants)
Afrezza Dose 10
Afrezza Dose 21

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Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Between Two Points, Baseline and 120 Minutes Post-Afrezza Dose

Change in percent predicted forced expiratory volume in 1 second (FEV1) between two points (value at 120 minutes post-Afrezza dose minus value at baseline). Standard deviation was not reported. (NCT04849845)
Timeframe: 120 minutes post-dose

Interventionchange in percent predicted FEV1 (Mean)
Afrezza Dose 10.63
Afrezza Dose 2-2.55

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Number of Subjects With at Least 1 Event of Level 1 Hypoglycemia

Number of subjects with at least 1 event (also referred to as incidence) of Level 1 hypoglycemia (<70mg/dL) within the 120 minutes after Afrezza dosing as confirmed by SMBG. (NCT04849845)
Timeframe: 120 minutes

InterventionParticipants (Count of Participants)
Afrezza Dose 10
Afrezza Dose 21

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Post-prandial Glucose Excursion

Mean glucose change from baseline (or postprandial glucose excursion [PPGE]) based on self-monitored blood glucose (SMBG) at 15, 30, 45, 60, 90 and 120 minutes after the dose of Afrezza with baseline defined as SMBG at the time of the dose of Afrezza (t=0) (NCT04849845)
Timeframe: 120 minutes post-dose

,
Interventionmg/dL (Mean)
15 minutes PPGE30 minutes PPGE45 minutes PPGE60 minutes PPGE90 minutes PPGE120 minutes PPGE
Afrezza Dose 16.825.948.964.282.888.6
Afrezza Dose 25.621.927.034.336.036.9

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Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin

Daily average serum glucose measured by the Continuous Glucose Monitor in measured in mg/dL as a response to a single dose of Human Insulin and reported by the Freestyle 14-day software. Data was collected 4 times an hour throughout the test period and across doses. The prandial segments were included in this average. Data is reported in mg/dL by subject. (NCT04857320)
Timeframe: 72 hours

Interventionmg/dL Serum Glucose (Mean)
Subject 195
Subject 299
Subject 485
Subject 589
Subject 6103

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OECD Acute Dermal Irritation/Corrosion Score According to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404

"The skin at the application site will be assessed at each Clinic Visit by the investigator and/or Study Nurse. Any dermal irritation will be scored according to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404, adopted 17th July, 1992: Acute Dermal Irritation/Corrosion and any score of 0 or greater will be reported.~The Guideline is a scale of from Zero (No erythema or edema), 1: Very slight, 2: Well-defined erythema/Slight edema (edges of area well-defined by definite raising), 3: Moderate to severe erythema/Moderate edema (raised approximately 1 mm) to 4: Severe erythema (beet redness) to eschar formation preventing grading / Severe edema (raised more than 1 mm, extending beyond area of exposure). The higher the score the worse the erythema or edema, so a score of 0 is very good and a score of 4 is very bad." (NCT04857320)
Timeframe: 20 Days

Interventionunits on a scale (Median)
Main Experimental0

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Postprandial Serum Glucose in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin Averaged Per Subject

"An Average Postprandial serum glucose measured by the Continuous Glucose Monitor as a response to a single dose of Human Insulin averaged (Mean) for each Subject. Data is reported in mg/dL. The Average reported was a comparison from Baseline (Day 1) and up to 3.5 hours following each dose (assessed at Day 1 - Baseline, Day 2 - Dose 1, Day 3 - Dose 2, and Day 4 - Dose 3)" (NCT04857320)
Timeframe: Pre-dose Baseline & a Mean of readings over 3.5 hours

Interventionmg/dL (Mean)
Dose 13.8
Dose 2-1.8
Dose 37

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Percentage of Time in Range (Phase 1, Software Release Tag 1.0)

Overall mean percentage of Post-prandial Time in range (% of SG within 70-180 mg/dL) at home and In-Clinic Period during Phase 1 (NCT04964128)
Timeframe: Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic). The time in range metrics are considered in a 4 hours window after each of the test meals.

,
Interventionpercentage of time (Mean)
Meal 1 (Large Meal with Low Carbohydrate Count)Meal 2 (Small Meal with High Carbohydrate Count)Meal 3 (Typical Meal Size with Medium Carbohydrate Count)Meal 4 (Typical Meal Size with High Carbohydrate Count)Meal 5 (Typical Meal Size with Low Carbohydrate Count)
At-Home76.165.57063.982.7
In-Clinic84.34870.927.373.5

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Percentage of Time in Range (Phase 2, Software Release Tag 2.0)

Overall mean percentage of Post-prandial Time in range (% of SG within 70-180 mg/dL) at home and In-Clinic Period during Phase 2 (NCT04964128)
Timeframe: Overall subject participation lasted approximately 3 weeks to 6 months, which included a 5 day at-home and a 5-day in-clinic period. The time in range metrics are considered in a 4 hours window after each of the test meals.

,
Interventionpercentage of time (Mean)
Meal 1 (Long Meal with Low Carbohydrate Count)Meal 2 (Large Meal with Low Carbohydrate Count)Meal 3 (Small Meal with High Carbohydrate Count)Meal 4 (Large Drink with No Carbohydrates)Meal 5 (Typical Meal Size with Medium Carbohydrate Count)Meal 6 (Long Meal with High Carbohydrates)Meal 7 (Large Drink with High Carbohydrate)Meal 8 (Typical Meal Size with Low Carbohydrate Count)
At-Home76.88162.791.991.874.274.886.4
In-Clinic88.273.759.984.376.462.867.890.8

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
aminolevulinic acid
Aminolevulinic Acid: A compound produced from succinyl-CoA and GLYCINE as an intermediate in heme synthesis. It is used as a PHOTOCHEMOTHERAPY for actinic KERATOSIS.. 5-aminolevulinic acid : The simplest delta-amino acid in which the hydrogens at the gamma position are replaced by an oxo group. It is metabolised to protoporphyrin IX, a photoactive compound which accumulates in the skin. Used (in the form of the hydrochloride salt)in combination with blue light illumination for the treatment of minimally to moderately thick actinic keratosis of the face or scalp.		3.31104-oxo monocarboxylic acid;
amino acid zwitterion;
delta-amino acid		antineoplastic agent;
dermatologic drug;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
photosensitizing agent;
plant metabolite;
prodrug;
Saccharomyces cerevisiae metabolite
protoporphyrin ix
protoporphyrin IX: RN given refers to parent cpd; structure in Merck Index, 9th ed, #7685. protoporphyrin : A cyclic tetrapyrrole that consists of porphyrin bearing four methyl substituents at positions 3, 8, 13 and 17, two vinyl substituents at positions 7 and 12 and two 2-carboxyethyl substituents at positions 2 and 18. The parent of the class of protoporphyrins.		2.3110
temoporfin
temoporfin: used as PHOTOCHEMOTHERAPY		3.7620
deuteroporphyrin-ix
[no description available]		3.3110
tetracarboxyphenylporphine
[no description available]		2.3110
tetraphenylporphine
tetraphenylporphyrin: structure in first source		2.1510
5,10,15,20-tetrakis(4-methoxyphenyl)porphyrin
[no description available]		2.1510
5-(4-aminophenyl)-10,15,20-triphenylporphyrin
5-(4-aminophenyl)-10,15,20-triphenylporphyrin: structure in first source		2.1510
alpha,beta,gamma,delta-tetrakis(4-n-trimethylaminophenyl)porphine
alpha,beta,gamma,delta-tetrakis(4-N-trimethylaminophenyl)porphine: for colorimetric determination of serum copper; structure given in first source		2.3110
5,10,15,20-tetra(4-hydroxyphenyl)porphyrin
5,10,15,20-tetra(4-hydroxyphenyl)porphyrin: structure in first source; tumor localizer; do not confuse with THPP		2.3110
ConditionIndicatedRelationship StrengthStudiesTrials
Palmoplantaris Pustulosis
[description not available]		02.1510
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.		02.1510
Experimental Neoplasms
[description not available]		02.3110
Colorectal Cancer
[description not available]		02.3110
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.		02.3110