Trial | Phase | Enrollment | Study Type | Start Date | Status |
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 4 | 403 participants (Actual) | Interventional | 2010-03-31 | Completed |
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) | Interventional | 2009-01-31 | Completed |
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) | Interventional | 2011-01-31 | Active, not recruiting |
Evaluation of Insulin Detemir in Combination With OADs in Type 2 Diabetes Mellitus [NCT00592527] | Phase 3 | 132 participants (Actual) | Interventional | 2004-04-30 | Completed |
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus [NCT00655200] | | 2,286 participants (Actual) | Observational | 2008-02-29 | Completed |
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 3 | 596 participants (Actual) | Interventional | 2006-05-01 | Terminated(stopped due to See termination reason in detailed description) |
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 3 | 225 participants (Actual) | Interventional | 2017-11-22 | Completed |
A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus [NCT01377155] | | 20 participants (Actual) | Interventional | 2011-06-30 | Completed |
Retrospective Cohort Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine [NCT03960814] | | 12,847 participants (Actual) | Observational | 2019-05-21 | Completed |
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus [NCT00706017] | | 2,282 participants (Actual) | Observational | 2007-09-30 | Completed |
"Making an ObeseBrain(and Body)Lean: Insulin Detemir,Monoamines,and Reward" [NCT01239550] | | 240 participants (Anticipated) | Interventional | 2011-04-30 | Active, not recruiting |
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 1 Diabetes [NCT01135927] | Phase 1 | 22 participants (Actual) | Interventional | 2010-06-30 | Completed |
Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients [NCT01281605] | | 181 participants (Actual) | Interventional | 2011-01-31 | Completed |
Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary [NCT00865397] | | 1,032 participants (Actual) | Observational | 2009-02-28 | Completed |
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 3 | 456 participants (Actual) | Interventional | 2010-02-28 | Completed |
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study [NCT05124457] | Phase 2 | 336 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) to Improve Insulin Secretion and Action in Subjects With Type 2 Diabetes [NCT00998335] | Phase 4 | 30 participants (Actual) | Interventional | 2007-06-30 | Completed |
Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea [NCT01003184] | Phase 3 | 222 participants (Actual) | Interventional | 2009-10-31 | Completed |
Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes [NCT00715351] | | 342 participants (Actual) | Observational | 2007-05-31 | Completed |
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 3 | 401 participants (Actual) | Interventional | 2003-04-30 | Completed |
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 4 | 120 participants (Anticipated) | Interventional | 2004-07-31 | Active, not recruiting |
Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation. [NCT00793273] | | 1,074 participants (Actual) | Observational | 2008-11-30 | Completed |
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 1 | 30 participants (Actual) | Interventional | 2008-11-30 | Completed |
A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes [NCT00825643] | | 18,481 participants (Actual) | Observational | 2008-04-30 | Completed |
Insulin Detemir Co-administered With Liraglutide: An Open Label Trial to Assess Insulin Detemir and Liraglutide Pharmacokinetics and Pharmacodynamics Following Liraglutide Therapy in Subjects With Type 2 Diabetes [NCT00873223] | Phase 1 | 33 participants (Actual) | Interventional | 2009-03-31 | Completed |
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) | Interventional | 2014-01-31 | Completed |
Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes: Study of Insulin Sensitivity in the 2 Types of Treatment [NCT02048189] | Phase 4 | 60 participants (Anticipated) | Interventional | 2012-03-31 | Recruiting |
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 3 | 752 participants (Actual) | Interventional | 2001-02-01 | Completed |
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 1 | 13 participants (Actual) | Interventional | 1999-10-31 | Completed |
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 3 | 387 participants (Actual) | Interventional | 2007-06-30 | Completed |
Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus [NCT00709475] | | 747 participants (Actual) | Observational | 2008-05-31 | Completed |
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 4 | 23 participants (Actual) | Interventional | 2007-07-31 | Terminated(stopped due to See detailed description) |
Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents [NCT00740519] | | 882 participants (Actual) | Observational | 2008-09-30 | Completed |
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 3 | 330 participants (Actual) | Interventional | 2007-03-31 | Completed |
Prospective, Multicentre, Open Label, Non-controlled, 24-week Observation in Type 2 Diabetics Using Once Daily Levemir® (Insulin Detemir) as Part of Their ITT Regimen [NCT00806897] | | 74 participants (Actual) | Observational | 2009-01-31 | Completed |
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 3 | 470 participants (Actual) | Interventional | 2007-05-31 | Completed |
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 4 | 112 participants (Actual) | Interventional | 2007-05-31 | Completed |
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 3 | 362 participants (Actual) | Interventional | 2003-12-31 | Completed |
RAndomized SubCutaneous Insulin in INpatients (RASCIN) Trial: Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin [NCT00906529] | Phase 4 | 0 participants (Actual) | Interventional | 2009-05-31 | Withdrawn |
Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia [NCT00490893] | Phase 4 | 12 participants (Actual) | Interventional | 2006-03-31 | Terminated |
Safety and Efficacy of Insulin Detemir (Levemir® FlexPen®) in Patients With Diabetes Mellitus [NCT00670683] | | 797 participants (Actual) | Observational | 2007-07-31 | Completed |
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus [NCT00655044] | | 3,637 participants (Actual) | Observational | 2007-05-31 | Completed |
Evaluation on Glycaemic Control and Weight Change of Once Daily Levemir® (Insulin Detemir) in Type 2 Diabetes Mellitus Treated by an Intensive Insulin Treatment (ICT) [NCT00657930] | | 2,289 participants (Actual) | Observational | 2008-03-31 | Completed |
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) | Observational | 2007-10-31 | Completed |
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) | Observational | 2008-01-31 | Completed |
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) | Observational | 2008-06-30 | Completed |
Cystic Fibrosis - Insulin Deficiency, Early Action [NCT01100892] | Phase 3 | 100 participants (Anticipated) | Interventional | 2010-12-31 | Completed |
Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes [NCT00564395] | Phase 4 | 18 participants (Actual) | Interventional | 2007-08-31 | Completed |
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) | Interventional | 2010-01-31 | Completed |
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 3 | 146 participants (Actual) | Interventional | 2008-02-29 | Completed |
Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus. [NCT00687284] | | 2,188 participants (Actual) | Observational | 2008-02-29 | Completed |
Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus [NCT00700830] | | 1,976 participants (Actual) | Observational | 2008-01-31 | Completed |
Effects of Optimized Glycemic Control Achieved With add-on Basal Insulin Therapy on Indexes of Endothelial Damage and Regeneration in Type 2 Diabetic Patients With Macroangiopathy. A Randomized Cross-over Trial Comparing Detemir vs Glargine [NCT00699686] | Phase 4 | 50 participants (Anticipated) | Interventional | 2008-05-31 | Completed |
Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth) [NCT00704574] | | 159 participants (Actual) | Observational | 2008-01-31 | Completed |
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) | Observational | 2007-05-31 | Completed |
Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus [NCT00789191] | Phase 3 | 222 participants (Actual) | Interventional | 2008-11-30 | Completed |
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes [NCT00435019] | Phase 3 | 348 participants (Actual) | Interventional | 2007-02-28 | Completed |
Safety of Levemir® (Insulin Detemir) Treatment in Patients With Type 2 Diabetes [NCT00735501] | | 314 participants (Actual) | Observational | 2008-03-31 | Completed |
Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus [NCT00738153] | | 798 participants (Actual) | Observational | 2008-06-30 | Completed |
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 4 | 60 participants (Actual) | Interventional | 2009-04-30 | Completed |
Use of Levemir® Improves Metabolic and Clinical Status in CFRD [NCT00639626] | Phase 2/Phase 3 | 6 participants (Actual) | Interventional | 2008-08-31 | Terminated(stopped due to PI left the institution) |
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) | Observational | 2008-11-30 | Completed |
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) | Observational | 2008-11-30 | Completed |
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) | Observational | 2008-02-29 | Completed |
Doubleblind, Randomised, Single Centre Investigator Sponsored Study of Applications Site Reactions After Deep and Superficial Subcutaneous and Intradermal Injection of Insulin Detemir and Saline in Subjects With Diabetes Mellitus [NCT00607737] | Phase 4 | 40 participants (Actual) | Interventional | 2008-01-31 | Completed |
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 3 | 66 participants (Actual) | Interventional | 2007-11-30 | Terminated |
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 4 | 401 participants (Actual) | Interventional | 2010-10-31 | Completed |
Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism [NCT00862875] | Phase 4 | 42 participants (Actual) | Interventional | 2009-03-31 | Completed |
Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients [NCT00742976] | Phase 4 | 24 participants (Actual) | Interventional | 2008-06-30 | Completed |
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) | Observational | 2009-04-30 | Completed |
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 4 | 30 participants (Actual) | Interventional | 2008-04-30 | Completed |
Observational Study Evaluating the Body Weight Progress During the Treatment With Insulin Detemir (Levemir®) in Type 2 Patients, Previously Treated With Other Basal Insulins [NCT00697450] | | 206 participants (Actual) | Observational | 2008-07-31 | Completed |
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 4 | 457 participants (Actual) | Interventional | 2009-05-31 | Completed |
Trial Investigating the Hypoglycaemic Response to Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes [NCT00760448] | Phase 1 | 25 participants (Actual) | Interventional | 2004-04-30 | Completed |
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) | Observational | 2008-10-31 | Completed |
A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins [NCT00849342] | | 580 participants (Actual) | Observational | 2008-12-31 | Completed |
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes. [NCT00184665] | Phase 3 | 501 participants (Actual) | Interventional | 2004-06-30 | Completed |
A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy [NCT00455858] | Phase 4 | 87 participants (Actual) | Interventional | 2007-11-30 | Completed |
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 1 | 63 participants (Actual) | Interventional | 2010-01-31 | Completed |
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 3 | 708 participants (Actual) | Interventional | 2004-11-30 | Completed |
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 3 | 264 participants (Anticipated) | Interventional | 2021-09-29 | 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 4 | 75 participants (Anticipated) | Interventional | 2008-04-30 | Completed |
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus [NCT01892319] | | 2,446 participants (Actual) | Observational | 2013-09-30 | Completed |
Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir. [NCT00717288] | Phase 4 | 82 participants (Actual) | Interventional | 2008-07-31 | Completed |
Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus [NCT00605137] | Phase 3 | 83 participants (Actual) | Interventional | 2004-05-21 | Completed |
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 4 | 10 participants (Actual) | Interventional | 2005-01-31 | Completed |
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 3 | 114 participants (Actual) | Interventional | 2003-12-02 | Completed |
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 4 | 296 participants (Actual) | Interventional | 2007-10-31 | Completed |
A Prospective, Multicentre, Multinational, Open Label, Non-controlled, Observational, 24-week Study in Patients Using Oral Anti-Diabetic (OAD) Drugs + Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Near East Region Countries [NCT00842192] | | 2,155 participants (Actual) | Observational | 2009-04-30 | Completed |
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extensio [NCT00856986] | Phase 3 | 987 participants (Actual) | Interventional | 2009-03-31 | Completed |
Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus [NCT00604396] | Phase 3 | 477 participants (Actual) | Interventional | 2003-03-31 | Completed |
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 3 | 719 participants (Actual) | Interventional | 2003-12-02 | Completed |
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 3 | 548 participants (Actual) | Interventional | 2009-08-31 | Completed |
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 4 | 415 participants (Actual) | Interventional | 2008-04-30 | Completed |
Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus [NCT00658099] | | 699 participants (Actual) | Observational | 2007-11-30 | Completed |
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) | Observational | 2008-02-29 | Completed |
Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy [NCT04222348] | Phase 3 | 200 participants (Actual) | Interventional | 2016-10-26 | Active, not recruiting |
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus [NCT00700765] | | 1,531 participants (Actual) | Observational | 2008-01-31 | Completed |
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 1 | 36 participants (Actual) | Interventional | 2007-04-30 | Completed |
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 3 | 503 participants (Actual) | Interventional | 2005-02-28 | Completed |
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) | Observational | 2007-12-31 | Completed |
Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections in Children and Adolescence With Type 1 Diabetes Mellitus. [NCT00542399] | Phase 4 | 50 participants (Anticipated) | Interventional | 2007-11-30 | Completed |
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 3 | 618 participants (Actual) | Interventional | 2006-08-31 | Terminated(stopped due to See termination reason in detailed description) |
The Effects of Insulin Detemir and Gliclazide-MR Treatments in Addition to Life-style Modification and Metformin Therapy on Endothelial Functions in Patients With Type 2 Diabetes : An Open-labelled Randomized Prospective Study [NCT01420692] | | 64 participants (Actual) | Interventional | 2010-06-30 | Completed |
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes [NCT00097084] | Phase 3 | 324 participants (Actual) | Interventional | 2004-09-30 | Completed |
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) | Observational | 2009-05-31 | Completed |
Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH [NCT00564018] | | 33 participants (Actual) | Interventional | 2006-09-30 | Terminated(stopped due to Presumed loss of clinical equipoise between the agents being investigated) |
Observational Study on Efficacy on Glycaemic Control of Slow-acting Insulin Analogue in Type 2 Diabetes [NCT00700960] | | 2,745 participants (Actual) | Observational | 2007-06-30 | Completed |
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) | Observational | 2003-07-31 | Completed |
A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects [NCT01490099] | Phase 1 | 37 participants (Actual) | Interventional | 2006-08-31 | Completed |
The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies [NCT00467246] | | 0 participants | Interventional | | Withdrawn(stopped due to Ethics approval denied) |
Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics [NCT02922179] | | 103,951 participants (Actual) | Observational | 2011-01-01 | Completed |
A 26-week Randomised, Controlled, Open Label, Multicentre, Multinational, Treat to Target Trial Investigating the Impact of Dietary Intervention on Weight Change and the Relationship Between Weight Change and Baseline Body Mass Index (BMI) in Subjects Wit [NCT01232491] | Phase 4 | 611 participants (Actual) | Interventional | 2010-10-29 | Completed |
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 3 | 598 participants (Actual) | Interventional | 2002-03-31 | Completed |
"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 4 | 705 participants (Actual) | Interventional | 2015-11-05 | Completed |
Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (PREDICTIVE™ 303) [NCT00264901] | Phase 4 | 5,652 participants (Actual) | Interventional | 2005-10-31 | Completed |
The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients [NCT00346996] | Phase 4 | 179 participants (Actual) | Interventional | 2007-05-31 | Completed |
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 4 | 520 participants (Actual) | Interventional | 2005-06-30 | Completed |
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake [NCT01232946] | | 30 participants (Actual) | Interventional | 2012-01-31 | Completed |
Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus [NCT00701155] | | 3,593 participants (Actual) | Observational | 2007-07-31 | Completed |
An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus. [NCT00687063] | | 10,008 participants (Actual) | Observational | 2008-04-30 | Completed |
Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment [NCT00521690] | Phase 4 | 25 participants (Actual) | Interventional | 2006-12-31 | Completed |
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 3 | 277 participants (Actual) | Interventional | 2005-04-30 | Completed |
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 4 | 51 participants (Actual) | Interventional | 2006-04-30 | Completed |
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) | Observational | 2006-03-31 | Completed |
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 1 | 23 participants (Actual) | Interventional | 2002-08-31 | Completed |
Levemir®: the Physiological Basal Insulin. Documentation of Safety Aspects, Glycaemic Control and Weight [NCT01542463] | | 4,464 participants (Actual) | Observational | 2004-09-30 | Completed |
An Observational Study in Dutch Type 1 and Type 2 Diabetes Patients: The Impact of Initiation of/Switching to Levemir® on Emotional Well-being, Insulin Perceptions and Treatment Satisfaction - CONFIDENCE (Clinical ObservatioNs oF Levemir® In Dutch Experie [NCT01542476] | | 299 participants (Actual) | Observational | 2006-08-31 | Completed |
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) | Observational | 2006-10-31 | Completed |
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Patients Using Insulin Detemir for the Treatment of Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study - Predictable Results and Experience in Diabetes Thr [NCT01545791] | | 1,037 participants (Actual) | Observational | 2006-05-31 | Completed |
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days [NCT01547169] | Phase 2 | 60 participants (Actual) | Interventional | 2011-03-31 | Completed |
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) | Observational | 2006-01-31 | Completed |
Efficacy and Safety Comparison of Insulin Detemir and Insulin Glargine Plus Insulin Aspart in Patients With Type 2 Diabetes [NCT00106366] | Phase 3 | 389 participants (Actual) | Interventional | 2005-03-31 | Completed |
Action to Control Cardiovascular Risk in Diabetes (ACCORD) [NCT00000620] | Phase 3 | 10,251 participants (Actual) | Interventional | 1999-09-30 | Completed |
"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 4 | 609 participants (Actual) | Interventional | 2015-12-21 | Completed |
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 4 | 973 participants (Actual) | Interventional | 2006-11-30 | Completed |
A Randomised Study Comparing Continuous Intravenous Insulin Infusion With Subcutaneous Insulin Analogues in Hospitalised Patients With Type II Diabetes and Hyperglycaemia [NCT00135070] | Phase 4 | 41 participants (Actual) | Interventional | 2005-07-31 | Terminated(stopped due to No documentation with MHRA to support clinical trial of a medicinal product.) |
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen. [NCT00184639] | Phase 3 | 71 participants (Actual) | Interventional | 2004-08-16 | Completed |
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes [NCT00095082] | Phase 3 | 447 participants (Actual) | Interventional | 2004-09-30 | Completed |
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) | Interventional | 2008-04-30 | Completed |
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 2 | 65 participants (Actual) | Interventional | 2009-01-31 | Completed |
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 3 | 88 participants (Actual) | Interventional | 2005-10-31 | Completed |
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 4 | 373 participants (Actual) | Interventional | 2005-09-30 | Completed |
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 3 | 583 participants (Actual) | Interventional | 2003-03-31 | Completed |
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes [NCT00312156] | Phase 3 | 347 participants (Actual) | Interventional | 2002-08-31 | Completed |
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes. [NCT00312104] | Phase 3 | 325 participants (Actual) | Interventional | 2002-04-30 | Completed |
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 1 | 40 participants (Actual) | Interventional | 2004-05-27 | Completed |
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 1 | 15 participants (Actual) | Interventional | 2003-03-31 | Completed |
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 1 | 32 participants (Actual) | Interventional | 2005-05-31 | Completed |
A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese Subjects [NCT01497587] | Phase 1 | 20 participants (Actual) | Interventional | 2005-08-31 | Completed |
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 1 | 50 participants (Actual) | Interventional | 2004-02-29 | Completed |
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 1 | 34 participants (Actual) | Interventional | 2005-11-30 | Completed |
A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the 24-hour Pharmacokinetics After Single Dose of Insulin Detemir in Healthy Chinese Male Subjects [NCT01498939] | Phase 1 | 20 participants (Actual) | Interventional | 2007-08-31 | Completed |
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 3 | 131 participants (Actual) | Interventional | 2001-09-30 | Completed |
A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus [NCT01709929] | Phase 3 | 2,287 participants (Actual) | Interventional | 2005-10-31 | Completed |
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 3 | 362 participants (Actual) | Interventional | 2013-10-17 | Completed |
Impact of Insulin Detemir Versus Insulin Glargine on Glycaemic Control and Metabolism During Exercise in Type 1 Diabetes [NCT01440439] | Phase 4 | 30 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting |
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 3 | 19 participants (Actual) | Interventional | 2012-02-29 | Completed |
New Onset Type 1 Diabetes: Role of Exenatide [NCT01269034] | Phase 4 | 13 participants (Actual) | Interventional | 2010-12-31 | Completed |
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120) [NCT01595646] | Phase 2 | 37 participants (Actual) | Interventional | 2011-11-30 | Completed |
A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes [NCT05134987] | Phase 1 | 30 participants (Actual) | Interventional | 2021-12-01 | Completed |
The Relative Effectiveness of Pumps Over Multiple Dose Injections and Structured Education Trial [NCT01616784] | Phase 3 | 267 participants (Actual) | Interventional | 2011-11-30 | Completed |
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 4 | 244 participants (Actual) | Interventional | 2008-02-29 | Completed |
The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients [NCT02496780] | Phase 2/Phase 3 | 66 participants (Actual) | Interventional | 2015-08-31 | Completed |
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 3 | 42 participants (Actual) | Interventional | 2014-06-11 | Terminated |
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 4 | 3,304 participants (Actual) | Interventional | 2015-06-16 | Completed |
Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes [NCT00383877] | Phase 3 | 263 participants (Actual) | Interventional | 2006-09-30 | Completed |
Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study [NCT02741687] | Phase 4 | 80 participants (Actual) | Interventional | 2016-06-30 | Completed |
The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes. [NCT00506662] | Phase 4 | 86 participants (Actual) | Interventional | 2007-07-31 | Terminated(stopped due to See termination reason in detailed description) |
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 4 | 176 participants (Actual) | Interventional | 2008-05-31 | Completed |
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study: Predictable Results and Experienc [NCT00659295] | | 51,170 participants (Actual) | Observational | 2004-06-30 | Completed |
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 3 | 350 participants (Actual) | Interventional | 2012-01-16 | Completed |
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 4 | 25 participants (Actual) | Interventional | 2007-09-30 | Completed |
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes [NCT01831765] | Phase 3 | 1,290 participants (Actual) | Interventional | 2013-08-26 | Completed |
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 4 | 157 participants (Actual) | Interventional | 2014-11-30 | Completed |
Effectiveness of a Subcutaneously Administered Long-Acting Insulin Detemir Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment [NCT01186003] | | 30 participants (Actual) | Interventional | 2010-08-31 | Completed |
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 4 | 58 participants (Actual) | Interventional | 2011-11-30 | Terminated(stopped due to Trial terminated prematurely due to slow recruitment.) |
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 3 | 621 participants (Actual) | Interventional | 2013-12-13 | Completed |
A 20-week, Randomised, Multi-centre, Open-labelled Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Titration Algorithms (3-0-3 Algorithm and 2-4-6-8 Algorithm) After 20 Weeks in Subjects With Type 2 Diabetes Mell [NCT01868542] | Phase 4 | 46 participants (Actual) | Interventional | 2013-06-30 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00000620 (6) [back to overview] | Stroke in the Blood Pressure 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 Lipid Trial. |
NCT00000620 (6) [back to overview] | First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. |
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] | Death From Any Cause in the Glycemia Trial. |
NCT00184600 (15) [back to overview] | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months |
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] | 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] | HbA1c (Glycosylated Haemoglobin) at Month 12 |
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] | HbA1c (Glycosylated Haemoglobin) at Month 36 |
NCT00184600 (15) [back to overview] | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 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 |
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] | Percentage of Participants Who Required A Second Insulin Therapy by Month 36 |
NCT00184600 (15) [back to overview] | Percentage of Participants Who Required A Second Insulin Therapy by 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 Participants Having an 'Other' Adverse Event |
NCT00184600 (15) [back to overview] | Change From Baseline in Body Weight at Month 36 |
NCT00184600 (15) [back to overview] | Change From Baseline in Body Weight at Month 12 |
NCT00435019 (3) [back to overview] | Observed Insulin Antibody Values |
NCT00435019 (3) [back to overview] | Number of Subjects Reporting Adverse Events |
NCT00435019 (3) [back to overview] | Glycosylated Haemoglobin A1c (HbA1c) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Haematology - Leucocytes) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Haematology - Lymphocytes) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Haematology - Monocytes) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Haematology - Thrombocytes) |
NCT00447382 (24) [back to overview] | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) |
NCT00447382 (24) [back to overview] | Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]) |
NCT00447382 (24) [back to overview] | Glycaemic Control Parameters (Change in HbA1c) |
NCT00447382 (24) [back to overview] | Hypoglycaemic Episodes |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Haematology - Neutrophils) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Biochemistry - Sodium) |
NCT00447382 (24) [back to overview] | Adverse Events |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Biochemistry - Albumin) |
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 - Creatinine) |
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 - Potassium) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Biochemistry - Total Protein) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Haematology - Basophilis) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Haematology - Eosinophils) |
NCT00447382 (24) [back to overview] | Clinical Laboratory Values (Change in Haematology - Haemoglobin) |
NCT00447382 (24) [back to overview] | Change From Baseline in Total Antibodies |
NCT00447382 (24) [back to overview] | Change From Baseline in Detemir Specific Antibodies |
NCT00447382 (24) [back to overview] | Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies |
NCT00455858 (5) [back to overview] | Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% |
NCT00455858 (5) [back to overview] | Occurence of Hypoglycaemic Episodes |
NCT00455858 (5) [back to overview] | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 |
NCT00455858 (5) [back to overview] | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 |
NCT00455858 (5) [back to overview] | Change in Fasting Plasma Glucose (FPG) |
NCT00467649 (12) [back to overview] | Change in Body Weight From Baseline at Week 24 |
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] | Hypoglycemia Adverse Events |
NCT00467649 (12) [back to overview] | Fasting Serum Lipids Change From Baseline to 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] | Percentage of Patients With a Severe Hypoglycemia Adverse Event |
NCT00467649 (12) [back to overview] | Percentage of Patients Achieving HbA1c <=7% at Week 24 |
NCT00467649 (12) [back to overview] | Change in Waist Circumference 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 Fasting Plasma Glucose From Baseline at Week 24 |
NCT00467649 (12) [back to overview] | Percentage of Patients With no Weight Gain at Week 24 |
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 Albumin Level (Urinalysis) |
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] | Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36 |
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] | 8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36 |
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 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) |
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] | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint |
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] | 1-Year 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] | Change From Baseline in Absolute Body Weight at 32 Week Endpoint |
NCT00487240 (11) [back to overview] | Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint |
NCT00487240 (11) [back to overview] | Glycemic Variability at Endpoint |
NCT00487240 (11) [back to overview] | Insulin Dose (Total and By Component [Basal and Bolus]) |
NCT00487240 (11) [back to overview] | Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) |
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] | 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] | Total Energy Expenditure, Double-labelled Water Method |
NCT00509925 (18) [back to overview] | Lean Body Mass |
NCT00509925 (18) [back to overview] | Hypoglycaemic Episodes, Diurnal/Nocturnal |
NCT00509925 (18) [back to overview] | Hormonal Assessment: Resistin |
NCT00509925 (18) [back to overview] | Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT) |
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] | Fat Mass |
NCT00509925 (18) [back to overview] | Fasting Plasma Glucose |
NCT00509925 (18) [back to overview] | Body Weight |
NCT00509925 (18) [back to overview] | Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT) |
NCT00509925 (18) [back to overview] | Waist:Hip Ratio |
NCT00537303 (6) [back to overview] | Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide |
NCT00537303 (6) [back to overview] | Biochemistry: Serum Alanine Aminotransferase |
NCT00537303 (6) [back to overview] | Hypoglycaemic Episodes |
NCT00537303 (6) [back to overview] | Glycosylated Haemoglobin A1c (HbA1c) |
NCT00537303 (6) [back to overview] | Glycosylated Haemoglobin A1c (HbA1c) |
NCT00537303 (6) [back to overview] | Haematology: Haemoglobin Measured in Blood |
NCT00542620 (30) [back to overview] | Incidence of Hypoglycaemic Episodes - All Episodes |
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: 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] | Pharmacokinetics: Cmax of Free Insulin |
NCT00542620 (30) [back to overview] | Pharmacokinetics: Cmax of Insulin Aspart |
NCT00542620 (30) [back to overview] | Pharmacokinetics: Cmax of Insulin Detemir |
NCT00542620 (30) [back to overview] | Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin |
NCT00542620 (30) [back to overview] | Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart |
NCT00542620 (30) [back to overview] | Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir |
NCT00542620 (30) [back to overview] | Pharmacokinetics: Tmax of Free Insulin |
NCT00542620 (30) [back to overview] | Pharmacokinetics: Tmax of Insulin Aspart |
NCT00542620 (30) [back to overview] | Pharmacokinetics: Tmax of Insulin Detemir |
NCT00542620 (30) [back to overview] | Weight Z Score |
NCT00542620 (30) [back to overview] | Self-measured Plasma Glucose Profile (After Breakfast) |
NCT00542620 (30) [back to overview] | Self-measured Plasma Glucose Profile (After Dinner) |
NCT00542620 (30) [back to overview] | Self-measured Plasma Glucose Profile (Before Breakfast) |
NCT00542620 (30) [back to overview] | Self-measured Plasma Glucose Profile (Before Dinner) |
NCT00542620 (30) [back to overview] | Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L |
NCT00542620 (30) [back to overview] | "Percentage of Children Assessing Insulin Therapy Injection Pain as 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 Very Happy Face" |
NCT00542620 (30) [back to overview] | Body Mass Index (BMI) Z Score |
NCT00542620 (30) [back to overview] | Fructosamine |
NCT00542620 (30) [back to overview] | Glycosylated Haemoglobin A1c (HbA1c) |
NCT00542620 (30) [back to overview] | Glycosylated Haemoglobin A1c (HbA1c) |
NCT00542620 (30) [back to overview] | Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L |
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] | Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart |
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 the Time of the Last Measured Level of Free Insulin |
NCT00564018 (2) [back to overview] | C-peptide Area Under the Curve |
NCT00564018 (2) [back to overview] | Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis |
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 |
NCT00591227 (1) [back to overview] | Hospital Length of Stay |
NCT00623194 (17) [back to overview] | Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L) |
NCT00623194 (17) [back to overview] | Diabetic Ketoacidosis |
NCT00623194 (17) [back to overview] | Laboratory Values: Leukocytes and Thrombocytes |
NCT00623194 (17) [back to overview] | Fundoscopy/Fundus Photography |
NCT00623194 (17) [back to overview] | Insulin Dose |
NCT00623194 (17) [back to overview] | BMI (Body Mass Index) |
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] | Hypoglycaemic Episodes |
NCT00623194 (17) [back to overview] | Insulin Detemir-insulin Aspart Cross-reacting Antibodies |
NCT00623194 (17) [back to overview] | Laboratory Values: Creatine Serum Umol/L |
NCT00623194 (17) [back to overview] | SD-score (Z-score) for Body Weight |
NCT00623194 (17) [back to overview] | Vital Signs: Pulse |
NCT00623194 (17) [back to overview] | Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies |
NCT00623194 (17) [back to overview] | Vital Signs: Blood Pressure |
NCT00623194 (17) [back to overview] | Glycosylated Haemoglobin A1c (HbA1c) |
NCT00623194 (17) [back to overview] | Fasting Plasma Glucose Values |
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) |
NCT00659165 (1) [back to overview] | Calories Consumed After Fast. |
NCT00659295 (1) [back to overview] | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events |
NCT00717288 (3) [back to overview] | Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) |
NCT00717288 (3) [back to overview] | Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 |
NCT00717288 (3) [back to overview] | Reversion to Intravenous Insulin for Failure of Glycemic Control |
NCT00789191 (12) [back to overview] | Change in BMI (Body Mass Index) |
NCT00789191 (12) [back to overview] | Change in Body Weight |
NCT00789191 (12) [back to overview] | HbA1c (Glycosylated Haemoglobin A1c) |
NCT00789191 (12) [back to overview] | Hypoglycemic Episodes |
NCT00789191 (12) [back to overview] | Hypoglycemic Episodes: Day Time |
NCT00789191 (12) [back to overview] | Hypoglycemic Episodes: Night Time |
NCT00789191 (12) [back to overview] | Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% |
NCT00789191 (12) [back to overview] | Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia |
NCT00789191 (12) [back to overview] | Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% |
NCT00789191 (12) [back to overview] | Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia |
NCT00789191 (12) [back to overview] | Self-measured 9-point Plasma Glucose Profile |
NCT00789191 (12) [back to overview] | FPG (Fasting Plasma Glucose) |
NCT00795600 (56) [back to overview] | Absolute Change in Fasting Plasma Glucose (FPG) |
NCT00795600 (56) [back to overview] | Absolute Change in Adiponectin |
NCT00795600 (56) [back to overview] | Absolute Change in Alanine Aminotransferase (ALAT) |
NCT00795600 (56) [back to overview] | Absolute Change in Albumin |
NCT00795600 (56) [back to overview] | Absolute Change in Alkaline Phosphatase |
NCT00795600 (56) [back to overview] | Absolute Change in Aspartate Aminotransferase (ASAT) |
NCT00795600 (56) [back to overview] | Absolute Change in Basophils |
NCT00795600 (56) [back to overview] | Absolute Change in Urea |
NCT00795600 (56) [back to overview] | Absolute Change in Blood Volume (Haematocrit) |
NCT00795600 (56) [back to overview] | Percentage Change in Visceral Adipose Tissue Area |
NCT00795600 (56) [back to overview] | Percentage Change in Trunk Lean Mass |
NCT00795600 (56) [back to overview] | Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) |
NCT00795600 (56) [back to overview] | Percentage Change in Subcutaneous Adipose Tissue Area |
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 Calculated Whole Body Fat Percentage |
NCT00795600 (56) [back to overview] | Absolute Change in Creatine Phosphokinase |
NCT00795600 (56) [back to overview] | Percentage Change in Liver/Spleen Attenuation Ratio |
NCT00795600 (56) [back to overview] | Absolute Change in Visceral Adipose Tissue Area |
NCT00795600 (56) [back to overview] | Absolute Change in Bilirubin Total |
NCT00795600 (56) [back to overview] | Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio |
NCT00795600 (56) [back to overview] | Number of Non-serious Adverse Events |
NCT00795600 (56) [back to overview] | Number of Hypoglycaemic Episodes |
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 Whole Body Lean Mass |
NCT00795600 (56) [back to overview] | Absolute Change in Whole Body Fat Mass |
NCT00795600 (56) [back to overview] | Absolute Change in Waist Circumference |
NCT00795600 (56) [back to overview] | Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol |
NCT00795600 (56) [back to overview] | Absolute Change in Trunk Lean Mass |
NCT00795600 (56) [back to overview] | Absolute Change in Trunk Fat Mass |
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 Body Weight |
NCT00795600 (56) [back to overview] | Absolute Change in Thrombocytes |
NCT00795600 (56) [back to overview] | Absolute Change in Subcutaneous Adipose Tissue Area |
NCT00795600 (56) [back to overview] | Absolute Change in Sodium |
NCT00795600 (56) [back to overview] | Absolute Change in Potassium |
NCT00795600 (56) [back to overview] | Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1) |
NCT00795600 (56) [back to overview] | Absolute Change in Neutrophils |
NCT00795600 (56) [back to overview] | Absolute Change in Monocytes |
NCT00795600 (56) [back to overview] | Absolute Change in Lymphocytes |
NCT00795600 (56) [back to overview] | Percentual Change in Calculated Whole Body Fat Percentage |
NCT00795600 (56) [back to overview] | Absolute Change in Low Density Lipoprotein (LDL) Cholesterol |
NCT00795600 (56) [back to overview] | Absolute Change in Liver/Spleen Attenuation Ratio |
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] | Absolute Change in Hip Circumference |
NCT00795600 (56) [back to overview] | Percentage Change in Whole Body Fat Mass |
NCT00795600 (56) [back to overview] | Percentage Change in Whole Body Lean Mass |
NCT00795600 (56) [back to overview] | Percentual Change in Calculated Trunk Fat Percentage |
NCT00795600 (56) [back to overview] | Absolute Change in High Density Lipoprotein (HDL) Cholesterol |
NCT00795600 (56) [back to overview] | Absolute Change in HbA1c (Glycosylated Haemoglobin) |
NCT00795600 (56) [back to overview] | Absolute Change in Haemoglobin |
NCT00795600 (56) [back to overview] | Absolute Change in Free Fatty Acids |
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] | Change in Body Weight |
NCT00841087 (7) [back to overview] | Electrocardiogram (ECG) |
NCT00856986 (30) [back to overview] | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Waist Circumference at Week 26. |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Hip Circumference at Week 52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Hip Circumference at Week 26 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Lipids: Triglycerides at Week 26 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF) |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Waist to Hip Ratio at Week 26 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group) |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Fasting Pro-insulin at Week 52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Fasting Pro-insulin at Week 26. |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Body Weight at Week 52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Fasting Plasma Glucose at Week 52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Fasting Plasma Glucose at Week 26 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Fasting C-peptide at Week 52. |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. |
NCT00856986 (30) [back to overview] | Hypoglycaemic Episodes Weeks 0-52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Fasting C-peptide at Week 26. |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Body Weight at Week 26 |
NCT00856986 (30) [back to overview] | Adverse Events From Run-in (Week -12) to Week 52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Lipids: Triglycerides at Week 52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Waist Circumference at Week 52. |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Waist to Hip Ratio at Week 52 |
NCT00856986 (30) [back to overview] | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26. |
NCT00856986 (30) [back to overview] | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. |
NCT00856986 (30) [back to overview] | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. |
NCT00909480 (14) [back to overview] | Hypoglycemic Episodes, Unclassifiable |
NCT00909480 (14) [back to overview] | Incidence of Hypoglycaemic Episodes During the Trial |
NCT00909480 (14) [back to overview] | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) |
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 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] | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% |
NCT00909480 (14) [back to overview] | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia |
NCT00909480 (14) [back to overview] | "Number of Subjects Having the Adverse Event Incorrect Dose Administered" |
NCT00909480 (14) [back to overview] | Change in Body Weight From Baseline |
NCT00909480 (14) [back to overview] | Change in HbA1c From Baseline |
NCT00909480 (14) [back to overview] | Fasting Plasma Glucose (FPG) |
NCT00909480 (14) [back to overview] | Hypoglycaemic Episodes, Diurnal |
NCT00909480 (14) [back to overview] | Hypoglycaemic Episodes, Nocturnal |
NCT00978627 (9) [back to overview] | Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
NCT00978627 (9) [back to overview] | Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) |
NCT00978627 (9) [back to overview] | Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
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 (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] | Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
NCT00978627 (9) [back to overview] | Extension Trial (Primary 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 |
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] | Percent Change From Baseline in Vascular Inflammatory Markers |
NCT00998335 (12) [back to overview] | Plasma Lipid Concentration. |
NCT00998335 (12) [back to overview] | Advanced Lipid Testing |
NCT00998335 (12) [back to overview] | Number of Hypoglycemic Events |
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] | Hepatic Steatosis |
NCT00998335 (12) [back to overview] | Change in Anthropometric Measure (Body Mass Index [BMI]). |
NCT00998335 (12) [back to overview] | Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS). |
NCT00998335 (12) [back to overview] | Metabolic Control as Measured by the A1c |
NCT00998335 (12) [back to overview] | Metabolic Control as Measured by the Fasting Plasma Glucose Concentration |
NCT01003184 (14) [back to overview] | Change in Total Cholesterol From Baseline to Endpoint (Week 26). |
NCT01003184 (14) [back to overview] | Change in Triglycerides From Baseline to Endpoint (Week 26). |
NCT01003184 (14) [back to overview] | Changes in Systolic Blood Pressure From Baseline to Week 26 |
NCT01003184 (14) [back to overview] | Percentage of Patients Achieving ≤6.5% at Endpoint |
NCT01003184 (14) [back to overview] | Percentage of Patients Achieving ≤7.0% at Endpoint |
NCT01003184 (14) [back to overview] | Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26) |
NCT01003184 (14) [back to overview] | Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint |
NCT01003184 (14) [back to overview] | Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26) |
NCT01003184 (14) [back to overview] | Hypoglycemia Rate Per Year |
NCT01003184 (14) [back to overview] | Change in Body Weight From Baseline to Week 26 |
NCT01003184 (14) [back to overview] | Change in Diastolic Blood Pressure From Baseline to Week 26. |
NCT01003184 (14) [back to overview] | Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26). |
NCT01003184 (14) [back to overview] | Change in HbA1c From Baseline to Week 26 |
NCT01003184 (14) [back to overview] | Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26). |
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 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] | Mean of 8-point Plasma Glucose (PG) Profile After 14 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] | Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 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 26 Weeks of Treatment |
NCT01068652 (17) [back to overview] | Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment |
NCT01068652 (17) [back to overview] | Change in Glycosylated Haemoglobin (HbA1c) at Week 50 |
NCT01068652 (17) [back to overview] | Glycosylated Haemoglobin (HbA1c) |
NCT01068652 (17) [back to overview] | Change in Glycosylated Haemoglobin (HbA1c) After 38 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 8-point Plasma Glucose (PG) Profile 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 |
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 50 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 (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) |
NCT01074268 (11) [back to overview] | Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
NCT01074268 (11) [back to overview] | Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
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): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment |
NCT01074268 (11) [back to overview] | Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment |
NCT01074268 (11) [back to overview] | Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
NCT01074268 (11) [back to overview] | Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic 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] | Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment |
NCT01165684 (15) [back to overview] | Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) 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] | 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] | 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] | Fasting Plasma Glucose (FPG) at Week 21 |
NCT01165684 (15) [back to overview] | Fasting Plasma Glucose (FPG) at Week 32 |
NCT01165684 (15) [back to overview] | Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes) |
NCT01165684 (15) [back to overview] | Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at 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 |
NCT01186003 (1) [back to overview] | Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl) |
NCT01232491 (7) [back to overview] | Rate of Treatment Emergent Adverse Events (TEAEs) |
NCT01232491 (7) [back to overview] | Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes |
NCT01232491 (7) [back to overview] | Rate of All Treatment Emergent Hypoglycaemic Episodes |
NCT01232491 (7) [back to overview] | Change From Baseline in Glycosylated Haemoglobin (HbA1c) |
NCT01232491 (7) [back to overview] | Change From Baseline in Fasting Plasma Glucose (FPG) |
NCT01232491 (7) [back to overview] | Change From Baseline in Body Weight |
NCT01232491 (7) [back to overview] | Change From Baseline in Body Mass Index (BMI) |
NCT01232946 (3) [back to overview] | Myocardial Glucose Uptake |
NCT01232946 (3) [back to overview] | Myocardial Fatty Acid Oxidation Rate |
NCT01232946 (3) [back to overview] | Myocardial Fatty Acid Esterification Rate |
NCT01486966 (10) [back to overview] | Change From Baseline in Fructosamine 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 |
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 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 Fasting Plasma Glucose (FPG) After Two Weeks of Treatment |
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 |
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 (%) at 52 Weeks (Analysed by Central Laboratory) |
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 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 |
NCT01595646 (5) [back to overview] | Verbal Memory Composite |
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 |
NCT01595646 (5) [back to overview] | The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision |
NCT01831765 (8) [back to overview] | Change From Baseline in HbA1c (Post Meal Arm) |
NCT01831765 (8) [back to overview] | Change in HbA1c |
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] | Frequency of Adverse Events |
NCT01831765 (8) [back to overview] | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes |
NCT01831765 (8) [back to overview] | Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) |
NCT01831765 (8) [back to overview] | Change From Baseline in HbA1c (Glycosylated Haemoglobin) |
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 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 Nocturnal Confirmed Hypoglycaemic Episodes |
NCT01835431 (7) [back to overview] | Change From Baseline in Fasting Plasma Glucose |
NCT01835431 (7) [back to overview] | Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) |
NCT01835431 (7) [back to overview] | Incidence of Treatment Emergent Adverse Events (TEAEs) |
NCT01835431 (7) [back to overview] | Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill |
NCT01868542 (7) [back to overview] | Proportion of Subjects Achieving HbA1c Below 7.0% |
NCT01868542 (7) [back to overview] | Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours. |
NCT01868542 (7) [back to overview] | Change in Fasting Plasma Glucose From Baseline |
NCT01868542 (7) [back to overview] | Change in Fasting Plasma Glucose From Baseline |
NCT01868542 (7) [back to overview] | Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline. |
NCT01868542 (7) [back to overview] | Change in HbA1c |
NCT01868542 (7) [back to overview] | Incidence of Adverse Events |
NCT01966978 (8) [back to overview] | Composite End-point |
NCT01966978 (8) [back to overview] | "Percentage of Participants Reaching Pre-specified Treatment Failure Outcome" |
NCT01966978 (8) [back to overview] | Change in Short Form-36 (SF-36) Questionnaire Score |
NCT01966978 (8) [back to overview] | Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means |
NCT01966978 (8) [back to overview] | Mean Change From Randomization in A1c at Week 26 |
NCT01966978 (8) [back to overview] | Hypoglycemic Episodes |
NCT01966978 (8) [back to overview] | Mean Change From Randomization in Body Weight |
NCT01966978 (8) [back to overview] | Percentage of Participants Reaching Target A1c of <7% at Week 26 |
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) |
NCT02033889 (49) [back to overview] | Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 52 |
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 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 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 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 Distal Forearm 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 104 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone 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] | 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 104 (Excluding 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 Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach) |
NCT02033889 (49) [back to overview] | Change From Baseline in Sitting Diastolic Blood Pressure 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 104 (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] | Change From Baseline in Body Weight at Week 52 (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 104 (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 A1C 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 A1C at Week 104 (Excluding 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] | Percent Change From Baseline in Bone Biomarker P1NP at Week 52 (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 PTH at Week 104 (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 P1NP at Week 104 (Excluding Bone 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] | Percentage of Participants Experiencing An Adverse Event (AE) (Including 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 Receiving Glycemic Rescue Therapy up to Week 26 |
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 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 52 (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] | 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] | Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 52 (Excluding Rescue Approach) |
NCT02033889 (49) [back to overview] | Time to Glycemic Rescue Therapy at Week 26 |
NCT02033889 (49) [back to overview] | Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (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] | 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] | 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] | 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] | Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach) |
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] | Incidence of Adverse Events (AEs) |
NCT02131272 (7) [back to overview] | Change in HbA1c (Glycosylated Haemoglobin) |
NCT02131272 (7) [back to overview] | Change in Body Weight Standard Deviation Score (SDS) |
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 |
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] | Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
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 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 Status Version (DTSQs) at Baseline, Month 6, Month 12 |
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 Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12 |
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] | 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 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 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] | Change From Baseline in HbA1c at Month 6 and Month 12 |
NCT02741687 (10) [back to overview] | Length of Hospital Stay |
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 Participants With Hypoglycemic Events |
NCT02741687 (10) [back to overview] | Number of Days in the ICU |
NCT02741687 (10) [back to overview] | Number of Participants Experiencing Stress Hyperglycemia |
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 Requiring Supplemental, Subcutaneous Insulin |
NCT02741687 (10) [back to overview] | Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin |
NCT02741687 (10) [back to overview] | Number of Participants Experiencing Complications |
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] | Number of Adverse Events in the Infant |
NCT03377699 (24) [back to overview] | Number of Adverse Events During Pregnancy Period |
NCT03377699 (24) [back to overview] | Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals) |
NCT03377699 (24) [back to overview] | Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery |
NCT03377699 (24) [back to overview] | Birth Weight Standard Deviation (SD) Score for Live Birth Infants |
NCT03377699 (24) [back to overview] | Birth Weight for Live Birth Infants |
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 With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no) |
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] | Last Planned Fasting Plasma Glucose Prior to Delivery |
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 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] | 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] | 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 Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no) |
NCT03377699 (24) [back to overview] | Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery |
NCT03377699 (24) [back to overview] | Number of Hypoglycaemic Episodes During the Pregnancy Period |
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] | Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no) |
NCT03377699 (24) [back to overview] | Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no) |
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
Intervention | participants (Number) |
---|
BP Trial: Intensive Control | 36 |
BP Trial: Standard Control | 62 |
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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
Intervention | participants (Number) |
---|
Lipid Trial: Fenofibrate | 641 |
Lipid Trial: Placebo | 667 |
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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
Intervention | participants (Number) |
---|
Lipid Trial: Fenofibrate | 291 |
Lipid Trial: Placebo | 310 |
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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
Intervention | participants (Number) |
---|
BP Trial: Intensive Control | 208 |
BP Trial: Standard Control | 237 |
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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
Intervention | participants (Number) |
---|
Glycemia Trial: Intensive Control | 503 |
Glycemia Trial: Standard Control | 543 |
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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
Intervention | participants (Number) |
---|
Glycemia Trial: Intensive Control | 391 |
Glycemia Trial: Standard Control | 327 |
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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
Intervention | mg/dL (Mean) |
---|
| All timepoints excluding 3am | Fasting | Postprandial | 3am |
---|
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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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
Intervention | percentage of participants (Number) |
---|
| Total participants who achieved target | Subset who achieved target, n=18, 50, 39 |
---|
Biphasic Insulin Aspart 30 (Biphasic Insulin) | 17.0 | 52.5 |
,Insulin Aspart (Prandial Insulin) | 23.9 | 43.9 |
,Insulin Detemir (Basal Insulin) | 8.1 | 78.9 |
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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
Intervention | hypoglycaemic events/participant/year (Median) |
---|
| All participants, Grade 1 | All participants, Grade 2 | All participants, Grade 3 | All participants, Grade 2 or 3 | Achieved HbA1c target, Grade 1, n=73, 70, 55 | Achieved HbA1c target, Grade 2, n=73, 70, 55 | Achieved HbA1c target, Grade 3, n=73, 70, 55 | Achieved HbA1c target, Grade 2 or 3, n=73, 70, 55 |
---|
Biphasic Insulin Aspart 30 (Biphasic Insulin) | 3.8 | 3.0 | 0 | 3.0 | 3.0 | 2.7 | 0 | 3.0 |
,Insulin Aspart (Prandial Insulin) | 5.7 | 5.5 | 0 | 5.7 | 5.7 | 5.3 | 0 | 5.5 |
,Insulin Detemir (Basal Insulin) | 2.7 | 1.7 | 0 | 1.7 | 3.0 | 2.0 | 0 | 2.0 |
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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
Intervention | percentage (%) of total haemoglobin (Mean) |
---|
| Baseline | Month 12 |
---|
Biphasic Insulin Aspart 30 (Biphasic Insulin) | 8.63 | 7.33 |
,Insulin Aspart (Prandial Insulin) | 8.55 | 7.20 |
,Insulin Detemir (Basal Insulin) | 8.45 | 7.64 |
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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
Intervention | hypoglycaemic events/participant/year (Median) |
---|
| All participants, Grade 1 | All participants, Grade 2 | All participants, Grade 3 | All participants, Grade 2 or 3 | Achieved HbA1c target, Grade 1, n=18, 50, 39 | Achieved HbA1c target, Grade 2, n=18, 50, 39 | Achieved HbA1c target, Grade 3, n=18, 50, 39 | Achieved HbA1c target, Grade 2 or 3, n=18, 50, 39 |
---|
Biphasic Insulin Aspart 30 (Biphasic Insulin) | 5.0 | 3.9 | 0 | 3.9 | 5.4 | 4.0 | 0 | 4.0 |
,Insulin Aspart (Prandial Insulin) | 8.0 | 8.0 | 0 | 8.0 | 7.8 | 8.0 | 0 | 8.7 |
,Insulin Detemir (Basal Insulin) | 2.0 | 0 | 0 | 0 | 3.9 | 3.0 | 0 | 3.0 |
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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
Intervention | percentage (%) of total haemoglobin (Mean) |
---|
| Baseline | Month 36 |
---|
Biphasic Insulin Aspart 30 (Biphasic Insulin) | 8.63 | 7.22 |
,Insulin Aspart (Prandial Insulin) | 8.55 | 7.04 |
,Insulin Detemir (Basal Insulin) | 8.45 | 7.11 |
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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
Intervention | mg/dL (Mean) |
---|
| All timepoints excluding 3am | Fasting | Postprandial | 3am |
---|
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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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
Intervention | units 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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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
Intervention | units 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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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
Intervention | percentage 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 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
Intervention | percentage 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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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
Intervention | percentage 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 Participants Having an 'Other' Adverse Event
(NCT00184600)
Timeframe: Up to month 37 (36 months of treatment plus 1 month follow-up)
Intervention | participants (Number) |
---|
Insulin Detemir (Basal Insulin) | 227 |
Insulin Aspart (Prandial Insulin) | 235 |
Biphasic Insulin Aspart 30 (Biphasic Insulin) | 228 |
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Change From Baseline in Body Weight at Month 36
(NCT00184600)
Timeframe: Week 0 (baseline), month 36
Intervention | kilograms (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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Change From Baseline in Body Weight at Month 12
(NCT00184600)
Timeframe: Week 0 (baseline), month 12
Intervention | kilogram (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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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
Intervention | Percent 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 Detemir | 3.23 | 5.15 | 27.06 | 43.70 | 2.26 | 4.20 |
,NPH Insulin | 2.95 | 3.01 | 27.26 | 30.19 | 2.24 | 2.68 |
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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
Intervention | participants (Number) |
---|
Insulin Detemir | 132 |
NPH Insulin | 135 |
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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
Intervention | Percent (%) glycosylated haemoglobin (Mean) |
---|
Insulin Detemir | 8.75 |
NPH Insulin | 8.64 |
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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
Intervention | Percent (%) of white blood cells (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 6.22 | 6.24 | 0.03 |
,NN729 | 6.3 | 5.96 | -0.32 |
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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
Intervention | Percent (%) of white blood cells (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 33.80 | 28.12 | -3.25 |
,NN729 | 37.45 | 36.67 | 5.33 |
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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
Intervention | Percent (%) of white blood cells (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 3.40 | 3.59 | -2.50 |
,NN729 | 4.00 | 3.42 | 0.67 |
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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
Intervention | 10^9/L (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 254.0 | 242.2 | -12.8 |
,NN729 | 267.1 | 247.2 | -18.6 |
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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
Intervention | mmol/L (Mean) |
---|
| Baseline 1. point | Baseline 2. point | Baseline 3. point | Baseline 4. point | Baseline 5. point | Baseline 6. point | Baseline 7. point | Baseline 8. point | Baseline 9. point | Week 26 change. 1. point | Week 26 change. 2. point | Week 26 change. 3. point | Week 26 change. 4. point | Week 26 change. 5. point | Week 26 change. 6. point | Week 26 change. 7. point | Week 26 change. 8. point | Week 26 change. 9. point | Week 52 change. 1. point | Week 52 change. 2. point | Week 52 change. 3. point | Week 52 change. 4. point | Week 52 change. 5. point | Week 52 change. 6. point | Week 52 change. 7. point | Week 52 change. 8. point | Week 52 change. 9. point |
---|
NN304 | 8.17 | 8.95 | 7.66 | 8.60 | 8.29 | 8.43 | 8.69 | 7.97 | 8.05 | -0.64 | -0.61 | -0.49 | -0.34 | -0.36 | -0.35 | -0.35 | 0.18 | -0.64 | -0.60 | -0.54 | -0.36 | -0.78 | -0.41 | -0.31 | -0.34 | -0.24 | -0.44 |
,NN729 | 8.17 | 9.03 | 7.34 | 8.18 | 8.16 | 8.60 | 8.60 | 7.72 | 7.56 | -0.44 | -0.61 | 0.08 | -0.22 | -0.00 | 0.07 | 0.20 | 0.08 | 0.24 | -0.67 | -0.99 | -0.28 | -0.29 | -0.59 | -0.51 | -0.47 | -0.31 | -0.09 |
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Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
(NCT00447382)
Timeframe: week 0, week 52
Intervention | mmol/L (Mean) |
---|
| Week 52 | Change from Baseline to week 52 |
---|
NN304 | 9.73 | 0.07 |
,NN729 | 9.64 | -0.02 |
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Glycaemic Control Parameters (Change in HbA1c)
HbA1c (Glycosylated haemoglobin). (NCT00447382)
Timeframe: week 0, week 52
Intervention | Percent (%) glycosylated haemoglobin (Mean) |
---|
| Week 52 | Change from Baseline to week 52 |
---|
NN304 | 7.88 | -0.08 |
,NN729 | 7.85 | -0.11 |
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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
Intervention | episodes (Number) |
---|
| All events - Major | All events - Minor | All events - Symptoms Only | Daytime - Major | Daytime - Minor | Daytime - Symptoms Only | Nocturnal - Major | Nocturnal - Minor | Nocturnal - Symptoms Only | Unclassified - Minor |
---|
NN304 | 21 | 3215 | 445 | 9 | 2741 | 381 | 12 | 472 | 64 | 2 |
,NN729 | 21 | 2996 | 318 | 15 | 2590 | 258 | 6 | 404 | 60 | 2 |
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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
Intervention | Percent (%) of white blood cells (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 60.00 | 65.59 | 6.25 |
,NN729 | 56.36 | 57.50 | -6.00 |
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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
Intervention | mmol/L (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 138.9 | 140.3 | 1.4 |
,NN729 | 139.2 | 140.0 | 0.8 |
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Adverse Events
(NCT00447382)
Timeframe: Weeks 0-52
Intervention | events (Number) |
---|
| Serious Adverse Events | Non-Serious Adverse Events |
---|
NN304 | 25 | 259 |
,NN729 | 10 | 346 |
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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
Intervention | U/L (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 29.21 | 30.72 | 1.34 |
,NN729 | 25.98 | 27.81 | 1.76 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 4.30 | 4.28 | -0.02 |
,NN729 | 4.27 | 4.30 | 0.02 |
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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
Intervention | U/L (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 75.40 | 82.35 | 6.77 |
,NN729 | 75.55 | 80.42 | 4.53 |
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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
Intervention | Umol/L (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 73.1 | 72.5 | -0.5 |
,NN729 | 72.3 | 73.1 | 0.8 |
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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
Intervention | U/L (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 161.1 | 164.9 | 3.2 |
,NN729 | 159.4 | 162.7 | 2.6 |
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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
Intervention | mmol/L (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 4.46 | 4.49 | 0.02 |
,NN729 | 4.37 | 4.43 | 0.06 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 7.23 | 7.13 | -0.11 |
,NN729 | 7.24 | 7.19 | -0.06 |
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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
Intervention | Percent (%) of white blood cells (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 0.30 | 0.24 | -0.25 |
,NN729 | 0.36 | 0.33 | 0.00 |
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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
Intervention | Percent (%) of white blood cells (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 2.50 | 2.47 | -0.25 |
,NN729 | 1.82 | 2.08 | 0.00 |
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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
Intervention | mmol/L (Mean) |
---|
| Baseline | Week 52 | Change from Baseline to week 52 |
---|
NN304 | 8.85 | 8.54 | -0.30 |
,NN729 | 8.80 | 8.47 | -0.31 |
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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
Intervention | ratio (Mean) |
---|
NN304 | 1.55 |
NN729 | 1.55 |
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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
Intervention | ratio (Mean) |
---|
NN304 | 1.14 |
NN729 | 1.06 |
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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
Intervention | ratio (Mean) |
---|
NN304 | 1.81 |
NN729 | 1.89 |
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Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%
Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0% (NCT00455858)
Timeframe: week 12, week 20
Intervention | percentage of participants (Number) |
---|
| Achieving HbA1c < 7% after 12 weeks, N=82 | Not achieving HbA1c < 7% after 12 weeks, N=82 | Achieving HbA1c < 7% after 20 weeks, N=81 | Not achieving HbA1c < 7% after 20 weeks, N=81 |
---|
Insulin Detemir | 14.6 | 85.4 | 12.3 | 87.7 |
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Occurence of Hypoglycaemic Episodes
Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment. (NCT00455858)
Timeframe: weeks 0-20
Intervention | episodes (Number) |
---|
| Occurence of hypoglycaemic episodes: Diurnal | Occurence of hypoglycaemic episodes: Nocturnal | Occurence of hypoglycaemic episodes: Total |
---|
Insulin Detemir | 92 | 78 | 170 |
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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20 (NCT00455858)
Timeframe: week 0, week 20
Intervention | percentage change in HbA1c (Mean) |
---|
| HbA1c at baseline | HbA1c at week 20 | Change in HbA1c from baseline to week 20 |
---|
Insulin Detemir | 9.3 | 8.2 | -1.2 |
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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12
Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline (NCT00455858)
Timeframe: week 0, week 12
Intervention | percentage change in HbA1c (Mean) |
---|
| HbA1c at baseline | HbA1c at week 12 | Change in HbA1c from baseline to week 12 |
---|
Insulin Detemir | 9.3 | 8.2 | -1.2 |
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Change in Fasting Plasma Glucose (FPG)
Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20 (NCT00455858)
Timeframe: week 0, week 12, week 20
Intervention | mg/dL (Mean) |
---|
| FPG at baseline, N=81 | FPG at week 12, N=77 | FPG at week 20, N=78 | Change in FPG from baseline to week 12, N=75 | Change in FPG from baseline to week 20, N=73 |
---|
Insulin Detemir | 178 | 118 | 116 | -60 | -62 |
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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
Intervention | kg (Least Squares Mean) |
---|
Group A (Phase 1 SYMLIN) | 0.02 |
Group B (Phase 1 RA Insulin) | 4.65 |
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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
Intervention | Percent (Mean) |
---|
| Phase 1 Baseline | Change From Phase 1 Baseline to Week 36 | Phase 2 Baseline at Week 24 | Change From Phase 2 Baseline to Week 36 |
---|
Group C (Phase 2 SYMLIN) | 8.35 | -1.96 | 6.26 | 0.14 |
,Group D (Phase 2 SYMLIN+RA) | 8.03 | -0.68 | 7.57 | -0.23 |
,Group E (Phase 2 RA Insulin) | 7.85 | -1.49 | 6.14 | 0.22 |
,Group F (Phase 2 RA Insulin + SYMLIN) | 8.38 | -0.99 | 7.32 | 0.07 |
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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
Intervention | kg (Mean) |
---|
| Phase 1 Baseline | Change From Phase 1 Baseline to Week 36 | Phase 2 Baseline at Week 24 | Change From Phase 2 Baseline to Week 36 |
---|
Group C (Phase 2 SYMLIN) | 109.98 | -0.80 | 108.50 | 0.69 |
,Group D (Phase 2 SYMLIN+RA) | 104.83 | 1.34 | 105.67 | 0.50 |
,Group E (Phase 2 RA Insulin) | 104.42 | 3.90 | 107.87 | 0.44 |
,Group F (Phase 2 RA Insulin + SYMLIN) | 105.30 | 4.51 | 110.68 | -0.86 |
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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
Intervention | participants (Number) |
---|
| Mild | Moderate | Severe |
---|
Group A (Phase 1 SYMLIN) | 31 | 12 | 0 |
,Group B (Phase 1 RA Insulin) | 46 | 13 | 0 |
,Group C (Phase 2 SYMLIN) | 7 | 0 | 0 |
,Group D (Phase 2 SYMLIN+RA) | 18 | 1 | 0 |
,Group E (Phase 2 RA Insulin) | 9 | 2 | 0 |
,Group F (Phase 2 RA Insulin + SYMLIN) | 19 | 3 | 0 |
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Fasting Serum Lipids Change From Baseline to Week 24
(NCT00467649)
Timeframe: Baseline, week 24
Intervention | mg/dL (Mean) |
---|
| Total Cholesterol | HDL | LDL | Triglycerides |
---|
Group A (Phase 1 SYMLIN) | -1.81 | 1.11 | 2.36 | -28.96 |
,Group B (Phase 1 RA Insulin) | 5.27 | 1.65 | 9.12 | -31.98 |
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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
Intervention | Percent (Number) |
---|
Group A (Phase 1 SYMLIN) | 30.4 |
Group B (Phase 1 RA Insulin) | 10.7 |
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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
Intervention | Percent (Number) |
---|
Group A (Phase 1 SYMLIN) | 0.0 |
Group B (Phase 1 RA Insulin) | 0.0 |
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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
Intervention | Percent (Number) |
---|
Group A (Phase 1 SYMLIN) | 44.6 |
Group B (Phase 1 RA Insulin) | 55.4 |
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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
Intervention | cm (Least Squares Mean) |
---|
Group A (Phase 1 SYMLIN) | -0.63 |
Group B (Phase 1 RA Insulin) | 2.17 |
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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
Intervention | Percent (Least Squares Mean) |
---|
Group A (Phase 1 SYMLIN) | -1.11 |
Group B (Phase 1 RA Insulin) | -1.27 |
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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
Intervention | mg/dL (Mean) |
---|
Group A (Phase 1 SYMLIN) | -29.0 |
Group B (Phase 1 RA Insulin) | -37.8 |
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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
Intervention | Percent (Number) |
---|
Group A (Phase 1 SYMLIN) | 46.4 |
Group B (Phase 1 RA Insulin) | 14.3 |
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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)
Intervention | mmol/L (Mean) |
---|
| Visit P1 IDet (N)=138, NPH (N)=146 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=136, 145) |
---|
Insulin Detemir | 7.64 | 7.81 | 0.16 |
,Neutral Protamine Hagedorn (NPH) Insulin | 7.64 | 7.69 | 0.05 |
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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)=154 | Visit P4 IDet (N)=109, NPH (N)=110 | Change from Baseline-Visit P4(N=104,109) |
---|
Insulin Detemir | 0.44 | 0.43 | -0.12 |
,Neutral Protamine Hagedorn (NPH) Insulin | 0.46 | 0.36 | -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)=155 | Visit P4 IDet (N)=110, NPH (N)=110 | Change from Baseline-Visit P4(N=105,109) |
---|
Insulin Detemir | 1.13 | 1.36 | 0.04 |
,Neutral Protamine Hagedorn (NPH) Insulin | 1.09 | 1.25 | 0.09 |
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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)=155 | Visit P4 IDet (N)=110, NPH (N)=110 | Change from Baseline-Visit P4(N=106,109) |
---|
Insulin Detemir | 5.21 | 5.40 | -0.43 |
,Neutral Protamine Hagedorn (NPH) Insulin | 5.36 | 4.28 | -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)
Intervention | U/L (Mean) |
---|
| Visit P1 IDet (N)=138, NPH (N)=145 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=136, 145) |
---|
Insulin Detemir | 145.1 | 167.5 | 21.82 |
,Neutral Protamine Hagedorn (NPH) Insulin | 144.1 | 169.5 | 25.46 |
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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)
Intervention | 10^9 cells/L (Mean) |
---|
| Visit P1 IDet (N)=138, NPH (N)=146 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=136, 145) |
---|
Insulin Detemir | 8.01 | 6.68 | -1.36 |
,Neutral Protamine Hagedorn (NPH) Insulin | 8.2 | 6.55 | -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)
Intervention | mmol/L (Mean) |
---|
| Visit P1 IDet (N)=137, NPH (N)=144 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=135, 144) |
---|
Insulin Detemir | 4.13 | 4.30 | 0.15 |
,Neutral Protamine Hagedorn (NPH) Insulin | 4.12 | 4.31 | 0.20 |
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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)
Intervention | mmol/L (Mean) |
---|
| Visit P1 IDet (N)=137, NPH (N)=145 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=135, 145) |
---|
Insulin Detemir | 138.0 | 141.6 | 3.59 |
,Neutral Protamine Hagedorn (NPH) Insulin | 137.8 | 141.2 | 3.36 |
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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)
Intervention | 10^9 cells/L (Mean) |
---|
| Visit P1 IDet (N)=138, NPH (N)=146 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=136, 145) |
---|
Insulin Detemir | 245.3 | 270.6 | 24.25 |
,Neutral Protamine Hagedorn (NPH) Insulin | 247.2 | 263.1 | 16.16 |
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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)
Intervention | g/dL (Mean) |
---|
| Visit P1 IDet (N)=138, NPH (N)=145 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=136, 145) |
---|
Insulin Detemir | 6.84 | 7.08 | 0.24 |
,Neutral Protamine Hagedorn (NPH) Insulin | 6.89 | 7.11 | 0.22 |
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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)
Intervention | g/dL (Mean) |
---|
| Visit P1 IDet (N)=135, NPH (N)=143 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=133, 142) |
---|
Insulin Detemir | 0.01 | 0.02 | 0.01 |
,Neutral Protamine Hagedorn (NPH) Insulin | 0.01 | 0.03 | 0.02 |
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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)
Intervention | mg/dL (Mean) |
---|
| Visit P1 IDet (N)=135, NPH (N)=144 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=133, 143) |
---|
Insulin Detemir | 114.8 | 106.2 | -6.62 |
,Neutral Protamine Hagedorn (NPH) Insulin | 103.1 | 98.61 | -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
Intervention | episodes (Number) |
---|
| All Episodes | Diurnal |
---|
Insulin Detemir | 9496 | 8045 |
,Neutral Protamine Hagedorn (NPH) Insulin | 9453 | 7810 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
| Spontaneous onset of labour (N)=130,136 | Induction of labour (N)=130,136 | Normal Vaginal Delivery(N)=54,50 | Instrumental Vaginal Delivery(N)=54,50 | Non-Planned Caesarean Section(N)=76,86 | Planned Caesarean Section(N)=76,86 |
---|
Insulin Detemir | 19 | 39 | 76 | 24 | 36 | 65 |
,Neutral Protamine Hagedorn (NPH) Insulin | 28 | 36 | 80 | 20 | 43 | 57 |
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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
Intervention | participants (Number) |
---|
| Subjects with (w.) adverse events | Subjects with serious adverse events | Subjects with severe adverse events | Subjects w. AEs related to basal insulin | Subjects w. AEs related to bolus insulin | Subjects with AEs leading to withdrawal |
---|
Insulin Detemir | 138 | 61 | 38 | 18 | 12 | 13 |
,Neutral Protamine Hagedorn (NPH) Insulin | 141 | 49 | 32 | 16 | 14 | 6 |
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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
Intervention | participants (Number) |
---|
| Live Birth | Early Foetal Death (Spont. Abortion) | Early Foetal Death (Ectopic Pregnancy) | Induced Abortion | Stillbirth |
---|
Insulin Detemir | 128 | 10 | 1 | 1 | 2 |
,Neutral Protamine Hagedorn (NPH) Insulin | 136 | 8 | 1 | 0 | 0 |
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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)
Intervention | participants (Number) |
---|
| Live Children | Early Foetal Death (Spont. Abortion) | Early Foetal Death (Ectopic Pregnancy) | Induced Abortion | Perinatal Death | Neonatal Death | Death During Follow-Up |
---|
Insulin Detemir | 128 | 10 | 1 | 1 | 2 | 0 | 0 |
,Neutral Protamine Hagedorn (NPH) Insulin | 135 | 8 | 1 | 0 | 1 | 0 | 0 |
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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
Intervention | participants (Number) |
---|
| Wt. below the 10th percentile(N)=128,136 | Wt. above the 90th percentile(N)=128,136 | Pre-term delivery (N)=142,145 | Major malformations (N)=142,145 | Early foetal death (N)=142,145 | Perinatal mortality (N)=130,136 | Neonatal mortality (N)=126,135 | Compiled(at least 1 of above)(N)=142,145 |
---|
Insulin Detemir | 3 | 59 | 39 | 5 | 11 | 2 | 0 | 89 |
,Neutral Protamine Hagedorn (NPH) Insulin | 1 | 73 | 45 | 1 | 9 | 1 | 0 | 96 |
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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)
Intervention | U/kg (Mean) |
---|
| GW 14 IDet (N)=129, NPH (N)=141 | GW 24 IDet (N)=128, NPH (N)=137 | GW 36 IDet (N)=119, NPH (N)=121 | Follow-Up IDet (N)=124, NPH (N)=133 |
---|
Insulin Detemir | 0.73 | 0.85 | 1.17 | 0.53 |
,Neutral Protamine Hagedorn (NPH) Insulin | 0.74 | 0.84 | 1.05 | 0.57 |
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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)
Intervention | Foetus/Newborns (1 per pregnant woman) (Number) |
---|
| Subjects with adverse events | Subjects with serious adverse events | Subjects with severe adverse events | Subjects w. AEs related to Basal insulin | Subjects w. AEs related to Bolus insulin | Subjects with AEs leading to withdrawal |
---|
Insulin Detemir | 56 | 36 | 15 | 1 | 1 | 0 |
,Neutral Protamine Hagedorn (NPH) Insulin | 55 | 32 | 12 | 0 | 0 | 1 |
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Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36
(NCT00474045)
Timeframe: At gestational week (GW) 36
Intervention | Percent (%) glycosylated haemoglobin (Least Squares Mean) |
---|
Insulin Detemir | 6.27 |
Neutral Protamine Hagedorn (NPH) Insulin | 6.33 |
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Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36
(NCT00474045)
Timeframe: At gestational week (GW) 36
Intervention | Percent (%) glycosylated haemoglobin (Least Squares Mean) |
---|
Insulin Detemir | 6.22 |
Neutral Protamine Hagedorn (NPH) Insulin | 6.37 |
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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)
Intervention | participants (Number) |
---|
Insulin Detemir | 2 |
Neutral Protamine Hagedorn (NPH) Insulin | 1 |
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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)
Intervention | participants (Number) |
---|
Insulin Detemir | 0 |
Neutral Protamine Hagedorn (NPH) Insulin | 0 |
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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
Intervention | episodes (Number) |
---|
Insulin Detemir | 1451 |
Neutral Protamine Hagedorn (NPH) Insulin | 1643 |
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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 Detemir | 0.38 |
Neutral Protamine Hagedorn (NPH) Insulin | 0.32 |
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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 Detemir | 5.99 |
Neutral Protamine Hagedorn (NPH) Insulin | 4.12 |
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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)
Intervention | mmol/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 Detemir | 6 | 7.4 | 5.9 | 6.9 | 6.5 | 7.4 | 7 | 6 |
,Neutral Protamine Hagedorn (NPH) Insulin | 6.3 | 7.5 | 6.1 | 7.1 | 6.5 | 7.4 | 7.2 | 6.4 |
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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 Detemir | 1.31 |
Neutral Protamine Hagedorn (NPH) Insulin | 0.90 |
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Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood
(NCT00474045)
Timeframe: At Delivery
Intervention | pmol/L (Median) |
---|
Insulin Detemir | 25.00 |
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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)
Intervention | ratio (Median) |
---|
Insulin Detemir | 0.84 |
Neutral Protamine Hagedorn (NPH) Insulin | 0.64 |
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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)
Intervention | ratio (Median) |
---|
Insulin Detemir | 1.29 |
Neutral Protamine Hagedorn (NPH) Insulin | 0.90 |
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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)
Intervention | ratio (Median) |
---|
Insulin Detemir | 1.10 |
Neutral Protamine Hagedorn (NPH) Insulin | 0.77 |
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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)
Intervention | participants (Number) |
---|
Insulin Detemir | 57 |
Neutral Protamine Hagedorn (NPH) Insulin | 46 |
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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)
Intervention | mmol/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 Detemir | 6.4 | 7.7 | 6.1 | 7.2 | 6.8 | 7.2 | 7.6 | 6.7 |
,Neutral Protamine Hagedorn (NPH) Insulin | 7.3 | 8.0 | 6.7 | 7.4 | 7.0 | 7.8 | 7.8 | 6.9 |
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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)]
Intervention | mmol/L (Mean) |
---|
| GW 8-12 IDet (N)=130, NPH (N)=141 | GW 14 IDet (N)=125, NPH (N)=135 | GW 24 IDet (N)=129, NPH (N)=141 | GW 36 IDet (N)=129, NPH (N)=142 |
---|
Insulin Detemir | 5.0 | 5.0 | 5.2 | 4.7 |
,Neutral Protamine Hagedorn (NPH) Insulin | 5.8 | 5.7 | 6.3 | 5.4 |
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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)
Intervention | Percent (%) glycosylated haemoglobin (Mean) |
---|
| GW 8-12 IDet (N)=140, NPH (N)=146 | GW 14 IDet (N)=136, NPH (N)=146 | GW 24 IDet (N)=138, NPH (N)=146 | GW 36 IDet (N)=138, NPH (N)=146 | Delivery IDet (N)=138, NPH (N)=146 | Follow-up IDet (N)=138, NPH (N)=146 |
---|
Insulin Detemir | 6.6 | 6.3 | 6 | 6.2 | 6.3 | 6.5 |
,Neutral Protamine Hagedorn (NPH) Insulin | 6.8 | 6.5 | 6.1 | 6.3 | 6.5 | 6.6 |
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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)
Intervention | participants (Number) |
---|
| Acceleration in Any Eye | No Acceleration in Any Eye | Missing Data |
---|
Insulin Detemir | 12 | 120 | 20 |
,Neutral Protamine Hagedorn (NPH) Insulin | 14 | 120 | 24 |
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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)
Intervention | kg (Mean) |
---|
| GW (8-12) IDet(N)=139,NPH(N)=145 | Change 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 Detemir | 67.8 | 1.0 | 5.6 | 11.5 |
,Neutral Protamine Hagedorn (NPH) Insulin | 69.2 | 1.4 | 6.0 | 11.0 |
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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)
Intervention | mmHg (Mean) |
---|
| GW (8-12) IDet(N)=140,NPH(N)=146 | Change 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 Detemir | 70.5 | -0.2 | -1.6 | 3.2 | 1.3 |
,Neutral Protamine Hagedorn (NPH) Insulin | 70.7 | -0.5 | -1.2 | 2.6 | 1.8 |
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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)
Intervention | beats/minute (Mean) |
---|
| GW (8-12) IDet(N)=136,NPH(N)=142 | Change 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 Detemir | 77.4 | 1.5 | 3.5 | 5.2 | -3 |
,Neutral Protamine Hagedorn (NPH) Insulin | 76.8 | 2.2 | 4.5 | 4.9 | -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)
Intervention | mmHg (Mean) |
---|
| GW (8-12) IDet(N)=140,NPH(N)=146 | Change 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 Detemir | 114.1 | 0.8 | -0.7 | 3.1 | 2.6 |
,Neutral Protamine Hagedorn (NPH) Insulin | 116.2 | -2.8 | -1.6 | 2.3 | -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)
Intervention | U/L (Mean) |
---|
| Visit P1 IDet (N)=138, NPH (N)=145 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=136, 145) |
---|
Insulin Detemir | 16.12 | 27.06 | 10.88 |
,Neutral Protamine Hagedorn (NPH) Insulin | 17.97 | 26.16 | 8.16 |
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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)
Intervention | g/dL (Mean) |
---|
| Visit P1 IDet (N)=138, NPH (N)=145 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=136, 145) |
---|
Insulin Detemir | 4.05 | 4.19 | 0.13 |
,Neutral Protamine Hagedorn (NPH) Insulin | 4.04 | 4.12 | 0.09 |
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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)
Intervention | mg/mmol (Mean) |
---|
| Visit P1 IDet (N)=135, NPH (N)=143 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=133, 142) |
---|
Insulin Detemir | 0.82 | 2.65 | 1.88 |
,Neutral Protamine Hagedorn (NPH) Insulin | 0.85 | 4.81 | 4.07 |
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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)
Intervention | U/L (Mean) |
---|
| Visit P1 IDet (N)=137, NPH (N)=144 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=135, 144) |
---|
Insulin Detemir | 52.64 | 90.17 | 37.39 |
,Neutral Protamine Hagedorn (NPH) Insulin | 53.88 | 92.96 | 39.51 |
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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)
Intervention | mcmol/L (Mean) |
---|
| Visit P1 IDet (N)=138, NPH (N)=145 | FU Visit IDet (N)=138, NPH (N)=146 | Change from Visit P1-FU (N=136, 145) |
---|
Insulin Detemir | 52.04 | 62.98 | 11.18 |
,Neutral Protamine Hagedorn (NPH) Insulin | 54.01 | 66.57 | 12.52 |
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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
Intervention | hypoglycemic events per 30 days (Mean) |
---|
| Endpoint Hypogylcemic Rate | Overall Hypoglycemic Rate | Endpoint Nocturnal Hypoglycemic Rate | Overall Nocturnal Hypoglycemic Rate | Endpoint Non-Nocturnal Hypoglycemic Rate | Overall Non-Nocturnal Hypoglycemic Rate | Endpoint Severe Hypoglycemic Rate | Overall Severe Hypoglycemic Rate |
---|
Detemir | 4.32 | 5.03 | 0.46 | 0.49 | 3.85 | 4.50 | 0.01 | 0.02 |
,Insulin Lispro Protamine Suspension | 5.45 | 6.28 | 0.73 | 0.79 | 4.69 | 5.47 | 0.05 | 0.03 |
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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
Intervention | episodes of hypoglycemia (Number) |
---|
| Endpoint Hypoglycemic Episodes | Overall Hypoglycemic Episodes | Endpoint Nocturnal Hypoglycemic Episodes | Overall Nocturnal Episodes (N=191,N=186) | Endpoint Non-Nocturnal Hypoglycemic Episodes | Overall Non-Nocturnal Hypoglycemic Episodes | Endpoint Severe Hypoglycemic Episodes | Overall Severe Hypoglycemic Episodes (N=171,N=170) |
---|
Detemir | 135 | 173 | 55 | 111 | 129 | 172 | 3 | 13 |
,Insulin Lispro Protamine Suspension | 134 | 173 | 69 | 125 | 127 | 172 | 11 | 24 |
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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
Intervention | percentage 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% |
---|
Detemir | 18.7 | 81.3 | 15.4 | 84.6 | 9.9 | 90.1 | 8.2 | 91.8 |
,Insulin Lispro Protamine Suspension | 18.5 | 81.5 | 15.2 | 84.8 | 8.7 | 91.3 | 7.1 | 92.9 |
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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
Intervention | hypoglycemic events per 1 year (Mean) |
---|
| Endpoint Hypoglycemic Rate | Overall Hypoglycemic Rate | Endpoint Nocturnal Hypoglcemic Rate | Overall Nocturnal Hypoglycemic Rate | Endpoint Non-Nocturnal Hypoglycemic Rate | Overall Non-Nocturnal Hypoglycemic Rate | Endpoint Severe Hypoglycemic Rate | Overall Severe Hypoglycemic Rate |
---|
Detemir | 52.60 | 61.21 | 5.60 | 6.01 | 46.88 | 54.83 | 0.10 | 0.25 |
,Insulin Lispro Protamine Suspension | 66.41 | 76.45 | 8.90 | 9.65 | 57.08 | 66.58 | 0.63 | 0.42 |
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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
Intervention | millimoles 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) |
---|
Detemir | 8.48 | 8.56 | 8.58 | 8.75 | 8.62 | 8.56 | 8.19 | 8.61 | 8.87 | 8.60 | 8.29 | -0.12 | 0.46 | -0.24 | 0.01 |
,Insulin Lispro Protamine Suspension | 8.67 | 8.77 | 8.70 | 9.00 | 9.09 | 8.68 | 8.29 | 8.54 | 8.92 | 9.05 | 8.49 | -0.34 | 0.38 | 0.12 | 0.06 |
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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
Intervention | percent of HbA1c (Least Squares Mean) |
---|
| Baseline | 8 Week HbA1c (n=184, n=179) | 8 Week Change from Baseline | 16 Week HbA1c (n=174, n=173) | 16 Week Change from Baseline | 24 Week HbA1c (n=171, n=174) | 24 Week Change from Baseline | 32 Week HbA1c (n=165, n=165) | 32 Week Change from Baseline |
---|
Detemir | 8.68 | 8.11 | -0.64 | 8.08 | -0.67 | 8.11 | -0.65 | 8.14 | -0.62 |
,Insulin Lispro Protamine Suspension | 8.88 | 8.08 | -0.68 | 7.94 | -0.81 | 8.07 | -0.69 | 8.09 | -0.68 |
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Change From Baseline in Absolute Body Weight at 32 Week Endpoint
(NCT00487240)
Timeframe: Baseline, 32 Weeks
Intervention | kilograms (Mean) |
---|
| Baseline | Change from Baseline |
---|
Detemir | 72.69 | 0.58 |
,Insulin Lispro Protamine Suspension | 72.76 | 1.54 |
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Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
(NCT00487240)
Timeframe: baseline and 32 weeks
Intervention | percent of HbA1c (Least Squares Mean) |
---|
| Baseline | Change from Baseline |
---|
Detemir | 8.68 | -0.59 |
,Insulin Lispro Protamine Suspension | 8.88 | -0.69 |
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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
Intervention | millimoles 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) |
---|
Detemir | 2.30 | 32.19 | 2.78 |
,Insulin Lispro Protamine Suspension | 2.64 | 36.39 | 3.04 |
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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
Intervention | units 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) |
---|
Detemir | 73.84 | 33.32 | 40.70 |
,Insulin Lispro Protamine Suspension | 67.78 | 28.94 | 38.99 |
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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
Intervention | units 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) |
---|
Detemir | 0.99 | 0.45 | 0.55 |
,Insulin Lispro Protamine Suspension | 0.91 | 0.39 | 0.53 |
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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
Intervention | episodes per week by visit (Mean) |
---|
| Screening (week -2 to week 0) | Month 1 (weeks 1-4) | Difference (month 1-screening) |
---|
Insulin Detemir | 0.039 | 0.026 | -0.013 |
,Insulin NPH | 0.073 | 0.120 | 0.047 |
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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
Intervention | episodes per week by visit (Mean) |
---|
| Screening (week -2 to week 0) | Months 5-7 (weeks 17-28) | Difference (months 5-7 - screening) |
---|
Insulin Detemir | 0.039 | 0.018 | -0.022 |
,Insulin NPH | 0.058 | 0.041 | -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
Intervention | episodes per week by visit (Mean) |
---|
| Screening (week -2 to week 0) | Months 2-4 (weeks 5-16) | Difference (months 2-4 - screening) |
---|
Insulin Detemir | 0.039 | 0.015 | -0.024 |
,Insulin NPH | 0.076 | 0.072 | -0.004 |
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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
Intervention | kcal/day (Mean) |
---|
Insulin Detemir | 588.5 |
Insulin NPH | 542.7 |
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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
Intervention | kcal/day (Mean) |
---|
Insulin Detemir | 1932.5 |
Insulin NPH | 2034.5 |
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Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced in the study. (NCT00509925)
Timeframe: Weeks 0-32
Intervention | episodes (Number) |
---|
Insulin Detemir | 90 |
Insulin NPH | 109 |
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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
Intervention | kcal/day (Mean) |
---|
Insulin Detemir | 2017.9 |
Insulin NPH | 2181.0 |
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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
Intervention | kcal/day (Mean) |
---|
Insulin Detemir | 2942.2 |
Insulin NPH | 3007.2 |
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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
Intervention | kg (Mean) |
---|
| Treatment period 1, N=12, 10 | Treatment period 2, N=9, 12 |
---|
Insulin Detemir First, Then Insulin NPH | 58.9 | 59.9 |
,Insulin NPH First, Then Insulin Detemir | 63.7 | 64.3 |
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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
Intervention | episodes (Number) |
---|
| Diurnal | Nocturnal | Time of event not recorded |
---|
Insulin Detemir | 62 | 26 | 2 |
,Insulin NPH | 60 | 15 | 34 |
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Hormonal Assessment: Resistin
Resistin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30
Intervention | ng/ml (Mean) |
---|
| Treatment period 1, N=12, 10 | Treatment period 2, N=9, 11 |
---|
Insulin Detemir First, Then Insulin NPH | 8.2 | 8.4 |
,Insulin NPH First, Then Insulin Detemir | 10.2 | 16.2 |
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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
Intervention | kcal/day (Mean) |
---|
Insulin Detemir | 73.0 |
Insulin NPH | 74.3 |
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Hormonal Assessment: Leptin
Leptin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30
Intervention | ng/ml (Mean) |
---|
| Treatment period 1, N=12, 10 | Treatment period 2, N=9, 11 |
---|
Insulin Detemir First, Then Insulin NPH | 9.4 | 9.9 |
,Insulin NPH First, Then Insulin Detemir | 10.5 | 6.6 |
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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
Intervention | ng/ml (Mean) |
---|
| Treatment period 1, N=12, 9 | Treatment period 2, N=9, 10 |
---|
Insulin Detemir First, Then Insulin NPH | 212.3 | 179.8 |
,Insulin NPH First, Then Insulin Detemir | 206.8 | 168.4 |
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Hormonal Assessment: Adiponectin
Adiponectin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30
Intervention | ng/ml (Mean) |
---|
| Treatment period 1, N=12, 10 | Treatment period 2, N=9, 11 |
---|
Insulin Detemir First, Then Insulin NPH | 15978.3 | 15189.5 |
,Insulin NPH First, Then Insulin Detemir | 11361.0 | 11053.3 |
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Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated haemoglobin A1c (HbA1c) after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32
Intervention | percentage of total haemoglobin (Mean) |
---|
| Treatment period 1, N=11, 10 | Treatment period 2, N=10, 12 |
---|
Insulin Detemir First, Then Insulin NPH | 7.8 | 7.6 |
,Insulin NPH First, Then Insulin Detemir | 7.4 | 8.0 |
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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
Intervention | kg (Mean) |
---|
| Treatment period 1, N=12, 10 | Treatment period 2, N=9, 12 |
---|
Insulin Detemir First, Then Insulin NPH | 21.7 | 23.0 |
,Insulin NPH First, Then Insulin Detemir | 22.3 | 19.2 |
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Fasting Plasma Glucose
Fasting plasma glucose (FPG) after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32
Intervention | mmol/L (Mean) |
---|
| Treatment period 1, N=12, 9 | Treatment period 2, N=10, 12 |
---|
Insulin Detemir First, Then Insulin NPH | 13.3 | 9.1 |
,Insulin NPH First, Then Insulin Detemir | 10.5 | 13.3 |
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Body Weight
Body weight after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32
Intervention | kg (Mean) |
---|
| Treatment period 1, N= 12, 10 | Treatment period 2, N= 10, 12 |
---|
Insulin Detemir First, Then Insulin NPH | 80.6 | 82.9 |
,Insulin NPH First, Then Insulin Detemir | 86.0 | 84.8 |
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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
Intervention | kcal/day (Mean) |
---|
Insulin Detemir | 1163.7 |
Insulin NPH | 1170.0 |
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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
Intervention | percentage of hip circumference (Mean) |
---|
| Treatment period 1, N= 12, 10 | Treatment period 2, N= 10, 12 |
---|
Insulin Detemir First, Then Insulin NPH | 92.4 | 92.4 |
,Insulin NPH First, Then Insulin Detemir | 94.4 | 94.8 |
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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
Intervention | mg/L (Mean) |
---|
Advanced | 3.76 |
Basic | 4.67 |
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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
Intervention | U/L (Mean) |
---|
Advanced | 30.09 |
Basic | 27.04 |
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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
Intervention | episodes (Number) |
---|
| Major | Minor | Symptoms Only |
---|
Advanced | 1 | 531 | 283 |
,Basic | 4 | 567 | 344 |
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Glycosylated Haemoglobin A1c (HbA1c)
Measured for the Per Protocol analysis set. (NCT00537303)
Timeframe: week 36
Intervention | percentage (%) of total haemoglobin (Least Squares Mean) |
---|
Advanced | 7.55 |
Basic | 7.52 |
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Glycosylated Haemoglobin A1c (HbA1c)
Analysed for the full analysis set. (NCT00537303)
Timeframe: week 36
Intervention | percentage (%) of total haemoglobin (Least Squares Mean) |
---|
Advanced | 7.67 |
Basic | 7.61 |
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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
Intervention | mmol/L (Mean) |
---|
Advanced | 8.57 |
Basic | 8.58 |
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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
Intervention | episodes (Number) |
---|
Mixed Injection | 351 |
Separate Injection | 293 |
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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
Intervention | pmol.h/L (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 1546.3 | 2102.4 |
,Separate Injection | 1510.9 | 1540 |
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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
Intervention | pmol.h/L (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 36591.2 | 36055.0 |
,Separate Injection | 34653.4 | 39757.0 |
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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
Intervention | pmol/L (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 216 | 274 |
,Separate Injection | 167 | 186 |
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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
Intervention | pmol/L (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 557 | 662 |
,Separate Injection | 762 | 601 |
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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
Intervention | pmol/L (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 10700 | 12000 |
,Separate Injection | 10500 | 12600 |
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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
Intervention | hours (Median) |
---|
| Week 0, n=8, 9 | Week 8, n=11, 11 |
---|
Mixed Injection | 3.6 | 2.9 |
,Separate Injection | 2.3 | 2.0 |
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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
Intervention | hours (Median) |
---|
| Week 0, n=10, 11 | Week 8, n=13, 12 |
---|
Mixed Injection | 2.2 | 3.5 |
,Separate Injection | 2 | 1.7 |
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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
Intervention | hours (Median) |
---|
| Week 0, n=4, 3 | Week 8, n=3, 6 |
---|
Mixed Injection | 16.2 | 5.6 |
,Separate Injection | 8.2 | 20.8 |
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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
Intervention | hours (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 2.5 | 2.5 |
,Separate Injection | 3.0 | 1.8 |
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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
Intervention | hours (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 2 | 2 |
,Separate Injection | 2 | 1.5 |
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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
Intervention | hours (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 3.5 | 3.5 |
,Separate Injection | 3.5 | 3.3 |
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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
Intervention | Z-score (Mean) |
---|
| Week 0, n=13, 12 | Week 8, n=11, 12 |
---|
Mixed Injection | -0.42 | -0.29 |
,Separate Injection | 0.19 | 0.26 |
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Self-measured Plasma Glucose Profile (After Breakfast)
(NCT00542620)
Timeframe: Week 0 and Week 8
Intervention | mg/dL (Mean) |
---|
| Week 0, n=5, 6 | Week 8, n=4, 7 |
---|
Mixed Injection | 123.00 | 208.08 |
,Separate Injection | 164.89 | 167.98 |
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Self-measured Plasma Glucose Profile (After Dinner)
(NCT00542620)
Timeframe: Week 0 and Week 8
Intervention | mg/dL (Mean) |
---|
| Week 0, n=8, 5 | Week 8, n=7, 6 |
---|
Mixed Injection | 175.38 | 198.00 |
,Separate Injection | 201.80 | 187.67 |
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Self-measured Plasma Glucose Profile (Before Breakfast)
(NCT00542620)
Timeframe: Week 0 and Week 8
Intervention | mg/dL (Mean) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 190.31 | 162.96 |
,Separate Injection | 165.39 | 204.75 |
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Self-measured Plasma Glucose Profile (Before Dinner)
(NCT00542620)
Timeframe: Week 0 and Week 8
Intervention | mg/dL (Mean) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 199.14 | 185.23 |
,Separate Injection | 201.44 | 181.03 |
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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
Intervention | episodes (Number) |
---|
| With symptoms | Without (w/o) symptoms | W/o information on presence of symptoms |
---|
Mixed Injection | 49 | 131 | 5 |
,Separate Injection | 46 | 33 | 1 |
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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
Intervention | percentage of subjects (Number) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 27 | 81 |
,Separate Injection | 50 | 69 |
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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
Intervention | percentage of subjects (Number) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 45 | 0 |
,Separate Injection | 33 | 23 |
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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
Intervention | percentage of subjects (Number) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 27.3 | 18.2 |
,Separate Injection | 16.7 | 7.7 |
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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
Intervention | Z-score (Mean) |
---|
| Week 0, n=13, 12 | Week 8, n=11, 12 |
---|
Mixed Injection | -0.32 | -0.07 |
,Separate Injection | 0.04 | 0.26 |
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Fructosamine
(NCT00542620)
Timeframe: Week 0 and Week 8
Intervention | mmol/L (Mean) |
---|
| Week 0, n=13, 12 | Week 8, n=12, 12 |
---|
Mixed Injection | 334.8 | 316.4 |
,Separate Injection | 319.8 | 334.8 |
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Glycosylated Haemoglobin A1c (HbA1c)
Measured for the ITT (Intention-to-Treat) set (NCT00542620)
Timeframe: Week 0 and Week 8
Intervention | percentage of total haemoglobin (Mean) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 7.93 | 7.65 |
,Separate Injection | 7.77 | 8.15 |
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Glycosylated Haemoglobin A1c (HbA1c)
Measured for the Per Protocol (PP) set (NCT00542620)
Timeframe: Week 0 and Week 8
Intervention | percentage of total haemoglobin (Mean) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 8.00 | 7.63 |
,Separate Injection | 7.77 | 8.15 |
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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
Intervention | episodes (Number) |
---|
| With symptoms | Without (w/o) symptoms | W/o info on presence of symptoms |
---|
Mixed Injection | 68 | 75 | 23 |
,Separate Injection | 159 | 48 | 6 |
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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
Intervention | pmol.h/L (Median) |
---|
| Week 0, n=8, 9 | Week 8, n=11, 11 |
---|
Mixed Injection | 1441.3 | 1981.1 |
,Separate Injection | 752.1 | 672.8 |
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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
Intervention | pmol.h/L (Median) |
---|
| Week 0, n=10, 11 | Week 8, n=13, 12 |
---|
Mixed Injection | 3008.1 | 5674.3 |
,Separate Injection | 3006.3 | 3019.9 |
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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
Intervention | pmol.h/L (Median) |
---|
| Week 0, n=4, 3 | Week 8, n=3, 6 |
---|
Mixed Injection | 230728.2 | 123555.7 |
,Separate Injection | 68509.6 | 362313.5 |
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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
Intervention | pmol.h/L (Median) |
---|
| Week 0 | Week 8 |
---|
Mixed Injection | 638.4 | 819.6 |
,Separate Injection | 398.9 | 466.2 |
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C-peptide Area Under the Curve
We measured the insulin secretory capacity of the pancreas by measuring C-peptide levels (and calculating the C-peptide area under the curve (AUC) using the trapezoidal method following a mixed meal tolerance test (using Boost) at 1, 6 and 12 months after diagnosis. (NCT00564018)
Timeframe: Although measured at 1, 6 and 12 months, the primary outcomes was a comparison between treatment groups at 6 months after diagnosis
Intervention | ng*hr/mL (Median) |
---|
Detemir | 220 |
NPH Insulin | 144 |
Glargine | 51 |
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Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis
We assessed glycemic control via measurement of Hemoglobin A1c at each quarterly clinic visit after diagnosis of diabetes. Data on the 6 month time point are presented (NCT00564018)
Timeframe: 6 months
Intervention | percent (Mean) |
---|
Detemir | 7.6 |
NPH Insulin | 8.0 |
Glargine | 7.9 |
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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
Intervention | mmol*hr/L (Mean) |
---|
Insulin Detemir Mixed With RAI Injection | 457 |
Insulin Detemir and RAI Injection Separately | 469 |
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Hospital Length of Stay
hospital length of stay in days (NCT00591227)
Timeframe: from hospital admission to hospital discharge
Intervention | days (Mean) |
---|
Aspart Detemir | 2.7 |
Usual Care | 3.1 |
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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
Intervention | mmol/L (Mean) |
---|
| Sodium Serum (n=144) | Potassium serum (n=137) | Haemoglobin (n=144) |
---|
Insulin Detemir | 141.6 | 4.38 | 8.28 |
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Diabetic Ketoacidosis
Diabetic ketoacidosis requiring hospitalisation (NCT00623194)
Timeframe: At 104 weeks
Intervention | events (Number) |
---|
Insulin Detemir | 3 |
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Laboratory Values: Leukocytes and Thrombocytes
Leukocytes and Thrombocytes after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks
Intervention | 10^9/L (Mean) |
---|
| Leukocytes (n=144) | Thrombocytes (n=144) |
---|
Insulin Detemir | 6.72 | 301.90 |
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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
Intervention | participants (Number) |
---|
| Abnormal, clinically significant | Abnormal, not clinically significant | Normal | Missing | Abn CS baseline and 104 weeks |
---|
Insulin Detemir | 1 | 8 | 131 | 6 | 1 |
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Insulin Dose
Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104. (NCT00623194)
Timeframe: At 104 weeks
Intervention | U/kg (Mean) |
---|
| Insulin Detemir dose (Basal) | Insulin Aspart dose (Bolus) |
---|
Insulin Detemir | 0.66 | 0.51 |
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BMI (Body Mass Index)
BMI (Body Mass Index) after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks
Intervention | kg/m^2 (Mean) |
---|
Insulin Detemir | 18.88 |
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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
Intervention | U/L (Mean) |
---|
| Alkaline phosphatase serum (n=144) | Alanine Aminotransferase serum (n=144) | Lactate Dehydrogenase serum (n=137) |
---|
Insulin Detemir | 226.7 | 19.0 | 199.6 |
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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
Intervention | g/dL (Mean) |
---|
| Albumin serum (n=144) | Total Protein serum (n=144) |
---|
Insulin Detemir | 4.32 | 7.09 |
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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
Intervention | events (Number) |
---|
| Overall, Mild | Overall, Moderate | Overall, Severe | Overall, Biochemical | Overall, Unclassified | Daytime, Mild | Daytime, Moderate | Daytime, Severe | Daytime, Biochemical | Daytime, Unclassified | Night-time, Mild | Night-time, Moderate | Night-time, Severe | Night-time, Biochemical | Night-time, Unclassified | Total hypoglycaemic episodes | Total hypoglycaemic episodes, daytime | Total hypoglycaemic episodes, night-time |
---|
Insulin Detemir | 10530 | 450 | 7 | 5080 | 7 | 9080 | 396 | 3 | 4122 | 4 | 1450 | 54 | 4 | 958 | 3 | 16074 | 13605 | 2469 |
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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
Intervention | Percent 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 Detemir | 31.11 | 43.99 | 35.96 | 31.22 | 44.09 | 35.92 |
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Laboratory Values: Creatine Serum Umol/L
Creatine serum after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks
Intervention | Umol/L (Mean) |
---|
Insulin Detemir | 51.08 |
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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
Intervention | SD-scores (Mean) |
---|
Insulin Detemir | 0.13 |
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Vital Signs: Pulse
Pulse at week 104 (NCT00623194)
Timeframe: At 104 weeks
Intervention | beats/minute (Mean) |
---|
Insulin Detemir | 82.6 |
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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
Intervention | Percent bound of total (Mean) |
---|
| Insulin Detemir specific, week 0 | Insulin Detemir specific, week 52 | Insulin Detemir specific, week 104 | Insulin Aspart specific, week 0 | Insulin Aspart specific, week 52 | Insulin Aspart specific, week 104 |
---|
Insulin Detemir | 2.81 | 4.40 | 3.05 | 1.32 | 2.79 | 1.99 |
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Vital Signs: Blood Pressure
Blood pressure (Systolic and Diastolic) after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks
Intervention | mmHg (Mean) |
---|
| Systolic Blood Pressure | Diastolic Blood Pressure |
---|
Insulin Detemir | 109.5 | 66.6 |
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Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks
Intervention | Percent (%) glycosylated haemoglobin (Mean) |
---|
Insulin Detemir | 8.74 |
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Fasting Plasma Glucose Values
FPG (Fasting Plasma Glucose) values after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks
Intervention | mmol/L (Mean) |
---|
Insulin Detemir | 7.71 |
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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
Intervention | percentage of participants (Number) |
---|
FPG 70-90 mg/dL | 64.3 |
FPG 80-110 mg/dL | 54.5 |
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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
Intervention | percentage 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
Intervention | percentage of participants (Number) |
---|
FPG 70-90 mg/dL | 41.1 |
FPG 80-110 mg/dL | 26.8 |
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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
Intervention | number of events (Number) |
---|
| All | Major | Minor | Symptoms only |
---|
FPG 70-90 mg/dL | 333 | 1 | 225 | 107 |
,FPG 80-110 mg/dL | 227 | 0 | 136 | 91 |
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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
Intervention | kcal (Mean) |
---|
Insulin Detemir | 1418 |
Insulin Glargine | 1357 |
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Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians. (NCT00659295)
Timeframe: Months 0-12
Intervention | participants (Number) |
---|
| 3 months sub-group | 6 months sub-group | 12 months sub-group |
---|
Type 1 Diabetes | 186 | 208 | 109 |
,Type 2 Diabetes | 93 | 112 | 48 |
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Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)
Number of patients with hypoglycemia (defined as glucose <65 mg/dl) (NCT00717288)
Timeframe: 48 hours
Intervention | participants (Number) |
---|
50% Conversion Factor | 0 |
65% Conversion Factor | 6 |
80% Conversion Factor | 3 |
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Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3 (NCT00717288)
Timeframe: day 2, day 3
Intervention | participants (Number) |
---|
50% Conversion Factor | 10 |
65% Conversion Factor | 18 |
80% Conversion Factor | 14 |
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Reversion to Intravenous Insulin for Failure of Glycemic Control
Number of participants who went back on intravenous insulin for failure of glycemic control. (NCT00717288)
Timeframe: 72 hours
Intervention | participants (Number) |
---|
50% Conversion Factor | 2 |
65% Conversion Factor | 0 |
80% Conversion Factor | 1 |
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Change in BMI (Body Mass Index)
(NCT00789191)
Timeframe: Week 0, Week 26
Intervention | kg/m^2 (Mean) |
---|
Comb | -0.30 |
Sita | -0.58 |
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Change in Body Weight
(NCT00789191)
Timeframe: Week 0, Week 26
Intervention | kg (Mean) |
---|
Comb | -0.81 |
Sita | -1.66 |
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HbA1c (Glycosylated Haemoglobin A1c)
(NCT00789191)
Timeframe: Week 26
Intervention | Percent (%) glycosylated haemoglobin (Mean) |
---|
Comb | 7.08 |
Sita | 7.64 |
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Hypoglycemic Episodes
Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26
Intervention | episodes (Number) |
---|
| Overall | Minor | Symptoms Only | Unclassified |
---|
Comb | 1 | 0 | 0 | 0 |
,Sita | 1 | 0 | 0 | 0 |
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Hypoglycemic Episodes: Day Time
Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26
Intervention | episodes (Number) |
---|
| Overall | Minor | Symptoms Only | Unclassified |
---|
Comb | 1 | 0 | 0 | 0 |
,Sita | 1 | 0 | 0 | 0 |
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Hypoglycemic Episodes: Night Time
Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26
Intervention | episodes (Number) |
---|
| Overall | Minor | Symptoms Only | Unclassified |
---|
Comb | 0 | 0 | 0 | 0 |
,Sita | 0 | 0 | 0 | 0 |
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Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
(NCT00789191)
Timeframe: Week 26
Intervention | Subjects (Number) |
---|
| Target achieved | Target not achieved |
---|
Comb | 20 | 83 |
,Sita | 11 | 95 |
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Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia (NCT00789191)
Timeframe: Week 26
Intervention | Subjects (Number) |
---|
| Target achieved | Target not achieved |
---|
Comb | 15 | 88 |
,Sita | 8 | 98 |
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Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
(NCT00789191)
Timeframe: Week 26
Intervention | Subjects (Number) |
---|
| Target achieved | Target not achieved |
---|
Comb | 46 | 57 |
,Sita | 25 | 81 |
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Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia (NCT00789191)
Timeframe: Week 26
Intervention | Subjects (Number) |
---|
| Target achieved | Target not achieved |
---|
Comb | 37 | 66 |
,Sita | 21 | 85 |
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Self-measured 9-point Plasma Glucose Profile
(NCT00789191)
Timeframe: Week 26
Intervention | mmol/L (Mean) |
---|
| 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 03:00 A.M. | Before breakfast the following day |
---|
Comb | 6.16 | 8.82 | 6.99 | 8.69 | 7.85 | 9.30 | 8.38 | 6.85 | 6.07 |
,Sita | 8.17 | 10.50 | 8.01 | 9.99 | 8.61 | 10.20 | 9.42 | 8.02 | 7.87 |
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FPG (Fasting Plasma Glucose)
(NCT00789191)
Timeframe: Week 26
Intervention | mmol/L (Mean) |
---|
Comb | 6.08 |
Sita | 8.52 |
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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
Intervention | mg/dL (Least Squares Mean) |
---|
Insulin Detemir | -48.29 |
Insulin NPH | -37.36 |
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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
Intervention | mcg/dL (Least Squares Mean) |
---|
Insulin Detemir | 0.926 |
Insulin NPH | 2.844 |
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Absolute Change in Alanine Aminotransferase (ALAT)
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | IU/L (Mean) |
---|
Insulin Detemir | -3.59 |
Insulin NPH | -4.55 |
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Absolute Change in Albumin
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | -0.02 |
Insulin NPH | 0.01 |
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Absolute Change in Alkaline Phosphatase
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | IU/L (Mean) |
---|
Insulin Detemir | -7.10 |
Insulin NPH | -12.55 |
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Absolute Change in Aspartate Aminotransferase (ASAT)
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | IU/L (Mean) |
---|
Insulin Detemir | 0.23 |
Insulin NPH | -0.48 |
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Absolute Change in Basophils
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | 10^9 cells/L (Mean) |
---|
Insulin Detemir | 0.00 |
Insulin NPH | -0.01 |
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Absolute Change in Urea
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | 2.45 |
Insulin NPH | 0.50 |
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Absolute Change in Blood Volume (Haematocrit)
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | percentage (Mean) |
---|
Insulin Detemir | -1.17 |
Insulin NPH | -1.06 |
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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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | -0.535 |
Insulin NPH | 4.526 |
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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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | 1.480 |
Insulin NPH | 2.090 |
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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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | 0.366 |
Insulin NPH | 1.011 |
Insulin Detemir | 0.535 |
Insulin NPH | 1.126 |
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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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | 1.153 |
Insulin NPH | 5.743 |
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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
Intervention | percent 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
Intervention | ratio (Least Squares Mean) |
---|
Insulin Detemir | -0.032 |
Insulin NPH | -0.036 |
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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
Intervention | percent of whole body fat (%) (Least Squares Mean) |
---|
Insulin Detemir | 0.782 |
Insulin NPH | 0.291 |
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Absolute Change in Creatine Phosphokinase
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | IU/L (Mean) |
---|
Insulin Detemir | -19.86 |
Insulin NPH | 21.56 |
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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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | -2.632 |
Insulin NPH | -0.855 |
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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
Intervention | cm^2 (Least Squares Mean) |
---|
Insulin Detemir | -3.258 |
Insulin NPH | 5.658 |
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Absolute Change in Bilirubin Total
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | -0.07 |
Insulin NPH | -0.07 |
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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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | -4.092 |
Insulin NPH | -3.303 |
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Number of Non-serious Adverse Events
Number of episodes reported during the trial. (NCT00795600)
Timeframe: Weeks 0-26
Intervention | events (Number) |
---|
Insulin Detemir | 64 |
Insulin NPH | 103 |
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Number of Hypoglycaemic Episodes
Number of episodes reported during the trial. (NCT00795600)
Timeframe: Weeks 0-26
Intervention | episodes (Number) |
---|
Insulin Detemir | 17 |
Insulin NPH | 32 |
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Absolute Change in Creatinine
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | 0.03 |
Insulin NPH | -0.00 |
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Absolute Change in Eosinophils
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | 10^9 cells/L (Mean) |
---|
Insulin Detemir | 0.01 |
Insulin NPH | 0.01 |
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Absolute Change in Erythrocytes
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | percentage (Mean) |
---|
Insulin Detemir | 4.64 |
Insulin NPH | 4.38 |
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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
Intervention | grams (g) (Least Squares Mean) |
---|
Insulin Detemir | -54.20 |
Insulin NPH | 1097.2 |
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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
Intervention | grams (g) (Least Squares Mean) |
---|
Insulin Detemir | 1147.1 |
Insulin NPH | 858.88 |
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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
Intervention | cm (Least Squares Mean) |
---|
Insulin Detemir | 0.064 |
Insulin NPH | 0.609 |
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Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | 1.05 |
Insulin NPH | 1.54 |
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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
Intervention | grams (g) (Least Squares Mean) |
---|
Insulin Detemir | 359.43 |
Insulin NPH | 469.84 |
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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
Intervention | grams (g) (Least Squares Mean) |
---|
Insulin Detemir | 133.99 |
Insulin NPH | -62.37 |
Insulin Detemir | 153.38 |
Insulin NPH | 39.43 |
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Absolute Change in Triglycerides
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/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
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | -8.96 |
Insulin NPH | 7.77 |
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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
Intervention | kg (Least Squares Mean) |
---|
Insulin Detemir | 1.663 |
Insulin NPH | 2.293 |
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Absolute Change in Thrombocytes
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | percentage (Mean) |
---|
Insulin Detemir | 0.10 |
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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
Intervention | cm^2 (Least Squares Mean) |
---|
Insulin Detemir | 7.654 |
Insulin NPH | 12.616 |
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Absolute Change in Sodium
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mmol/L (Mean) |
---|
Insulin Detemir | 1.12 |
Insulin NPH | 0.69 |
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Absolute Change in Potassium
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mmol/L (Mean) |
---|
Insulin Detemir | -0.20 |
Insulin NPH | 0.21 |
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Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | ng/L (Least Squares Mean) |
---|
Insulin Detemir | -10.77 |
Insulin NPH | -12.50 |
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Absolute Change in Neutrophils
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | percentage (Mean) |
---|
Insulin Detemir | -0.29 |
Insulin NPH | 0.01 |
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Absolute Change in Monocytes
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | percentage (Mean) |
---|
Insulin Detemir | 0.10 |
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Absolute Change in Lymphocytes
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | percentage (Mean) |
---|
Insulin Detemir | -0.10 |
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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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | 1.607 |
Insulin NPH | 1.491 |
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Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | 2.39 |
Insulin NPH | 6.14 |
[back to top]
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
Intervention | ratio (Least Squares Mean) |
---|
Insulin Detemir | -0.044 |
Insulin NPH | -0.023 |
[back to top]
Absolute Change in Leucocytes
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | 10^9 cells/L (Mean) |
---|
Insulin Detemir | -0.01 |
Insulin NPH | -0.07 |
[back to top]
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
Intervention | mg/L (Least Squares Mean) |
---|
Insulin Detemir | 1.200 |
Insulin NPH | -0.862 |
[back to top]
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
Intervention | cm (Least Squares Mean) |
---|
Insulin Detemir | 0.577 |
Insulin NPH | 0.112 |
[back to top]
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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | 3.870 |
Insulin NPH | 4.047 |
[back to top]
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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | 0.051 |
Insulin NPH | 2.798 |
[back to top]
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
Intervention | percent change (Least Squares Mean) |
---|
Insulin Detemir | -1.543 |
Insulin NPH | 0.042 |
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Absolute Change in High Density Lipoprotein (HDL) Cholesterol
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | -0.95 |
Insulin NPH | 2.87 |
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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
Intervention | percentage of glycosylated haemoglobin (Least Squares Mean) |
---|
Insulin Detemir | -0.922 |
Insulin NPH | -0.792 |
[back to top]
Absolute Change in Haemoglobin
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | g/dL (Mean) |
---|
Insulin Detemir | -0.38 |
Insulin NPH | -0.35 |
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Absolute Change in Free Fatty Acids
(NCT00795600)
Timeframe: Week 0, week 26
Intervention | mg/dL (Mean) |
---|
Insulin Detemir | -0.03 |
Insulin NPH | -0.05 |
[back to top]
Diastolic Blood Pressure (BP)
Mean values at baseline (Week 0) and at Week 6 (NCT00841087)
Timeframe: Week 0, Week 6
Intervention | mmHg (Mean) |
---|
| Week 0 (Baseline) | Week 6 |
---|
Insulin Detemir | 73.8 | 73.0 |
,SIBA | 73.9 | 74.7 |
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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
Intervention | events (Number) |
---|
| Adverse events (AEs) | Serious AEs | Severe AEs | Moderate AEs | Mild AEs |
---|
Insulin Detemir | 15 | 0 | 0 | 2 | 13 |
,SIBA | 13 | 0 | 0 | 0 | 13 |
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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
Intervention | Episodes /year of patient exposure (Number) |
---|
| Major | Minor |
---|
Insulin Detemir | 0 | 80.84 |
,SIBA | 0 | 62.97 |
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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
Intervention | Episodes /year of patient exposure (Number) |
---|
| Major | Minor |
---|
Insulin Detemir | 0 | 15.83 |
,SIBA | 0 | 4.97 |
[back to top]
Systolic Blood Pressure (BP)
Mean values at baseline (Week 0) and at Week 6 (NCT00841087)
Timeframe: Week 0, Week 6
Intervention | mmHg (Mean) |
---|
| Week 0 (Baseline) | Week 6 |
---|
Insulin Detemir | 125.3 | 120.2 |
,SIBA | 125.0 | 125.5 |
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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
Intervention | kg (Mean) |
---|
SIBA | 0.22 |
Insulin Detemir | -0.20 |
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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
Intervention | participants (Number) |
---|
SIBA | 0 |
Insulin Detemir | 0 |
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Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C) (NCT00856986)
Timeframe: Week 0, Week 52
Intervention | mmol/L (Least Squares Mean) |
---|
| Change in Total Cholesterol | Change in LDL-C | Change in VLDL-C | Change in HDL-C |
---|
Insulin Detemir + Lira 1.8 | -0.03 | -0.1 | -0.03 | 0.07 |
,Lira 1.8 | -0.02 | -0.08 | 0.03 | 0.02 |
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Mean Change From Randomisation in Waist Circumference at Week 26.
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | cm (Least Squares Mean) |
---|
Lira 1.8 | -0.66 |
Insulin Detemir + Lira 1.8 | -0.78 |
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Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | mmol/L (Least Squares Mean) |
---|
Lira 1.8 | -0.03 |
Insulin Detemir + Lira 1.8 | -0.07 |
[back to top]
Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Lira 1.8 | -0.03 |
Insulin Detemir + Lira 1.8 | -0.11 |
[back to top]
Mean Change From Randomisation in Hip Circumference at Week 52
(NCT00856986)
Timeframe: Week 0, week 52
Intervention | cm (Least Squares Mean) |
---|
Lira 1.8 | -0.79 |
Insulin Detemir + Lira 1.8 | -0.28 |
[back to top]
Mean Change From Randomisation in Hip Circumference at Week 26
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | cm (Least Squares Mean) |
---|
Lira 1.8 | -0.36 |
Insulin Detemir + Lira 1.8 | -0.38 |
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Mean Change From Randomisation in Lipids: Triglycerides at Week 26
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Lira 1.8 | -0.24 |
Insulin Detemir + Lira 1.8 | -0.33 |
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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | Percentage point of total HbA1c (Least Squares Mean) |
---|
Lira 1.8 | 0.01 |
Insulin Detemir + Lira 1.8 | -0.5 |
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Mean Change From Randomisation in Waist to Hip Ratio at Week 26
Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | cm/cm (Least Squares Mean) |
---|
Lira 1.8 | -0.00356 |
Insulin Detemir + Lira 1.8 | -0.00332 |
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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | Percentage point of total HbA1c (Least Squares Mean) |
---|
Lira 1.8 | -0.1 |
Insulin Detemir + Lira 1.8 | -0.51 |
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Mean Change From Randomisation in Fasting Pro-insulin at Week 52
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | pmol/L (Least Squares Mean) |
---|
Lira 1.8 | 1.47 |
Insulin Detemir + Lira 1.8 | -4 |
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Mean Change From Randomisation in Fasting Pro-insulin at Week 26.
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | pmol/L (Least Squares Mean) |
---|
Lira 1.8 | -1.12 |
Insulin Detemir + Lira 1.8 | -9.78 |
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Mean Change From Randomisation in Body Weight at Week 52
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | kg (Least Squares Mean) |
---|
Lira 1.8 | -1.02 |
Insulin Detemir + Lira 1.8 | -0.05 |
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Mean Change From Randomisation in Fasting Plasma Glucose at Week 52
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | mmol/L (Least Squares Mean) |
---|
Lira 1.8 | -0.14 |
Insulin Detemir + Lira 1.8 | -1.91 |
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Mean Change From Randomisation in Fasting Plasma Glucose at Week 26
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Lira 1.8 | -0.39 |
Insulin Detemir + Lira 1.8 | -2.12 |
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Mean Change From Randomisation in Fasting C-peptide at Week 52.
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | mmol/L (Least Squares Mean) |
---|
Lira 1.8 | 0.02 |
Insulin Detemir + Lira 1.8 | -0.34 |
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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.
(NCT00856986)
Timeframe: Week 0 (Randomisation), week 26
Intervention | Percentage point of total HbA1c (Least Squares Mean) |
---|
Lira 1.8 | 0.02 |
Insulin Detemir + Lira 1.8 | -0.51 |
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Hypoglycaemic Episodes Weeks 0-52
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. (NCT00856986)
Timeframe: Week 0-52
Intervention | episodes (Number) |
---|
| Major | Minor | Symptoms only | Unknown |
---|
Insulin Detemir + Lira 1.8 | 0 | 33 | 57 | 1 |
,Intensified Group | 0 | 1 | 2 | 0 |
,Lira 1.8 | 0 | 4 | 14 | 0 |
,Non-Randomised Lira 1.8 | 0 | 53 | 42 | 2 |
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Mean Change From Randomisation in Fasting C-peptide at Week 26.
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Lira 1.8 | -0.08 |
Insulin Detemir + Lira 1.8 | -0.32 |
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Mean Change From Randomisation in Body Weight at Week 26
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | kg (Least Squares Mean) |
---|
Lira 1.8 | -0.95 |
Insulin Detemir + Lira 1.8 | -0.16 |
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Adverse Events From Run-in (Week -12) to Week 52
(NCT00856986)
Timeframe: Run-in (week -12) to Week 52
Intervention | events (Number) |
---|
Lira 1.8 | 716 |
Insulin Detemir + Lira 1.8 | 845 |
Non-Randomised Lira 1.8 | 2389 |
Early Withdrawals Lira 1.8 | 383 |
Intensified Group | 30 |
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Mean Change From Randomisation in Lipids: Triglycerides at Week 52
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | mmol/L (Least Squares Mean) |
---|
Lira 1.8 | -0.22 |
Insulin Detemir + Lira 1.8 | -0.37 |
[back to top]
Mean Change From Randomisation in Waist Circumference at Week 52.
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | participants (Least Squares Mean) |
---|
Lira 1.8 | -0.83 |
Insulin Detemir + Lira 1.8 | -0.83 |
[back to top]
Mean Change From Randomisation in Waist to Hip Ratio at Week 52
Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference (NCT00856986)
Timeframe: Week 0, Week 52
Intervention | cm/cm (Least Squares Mean) |
---|
Lira 1.8 | -0.00146 |
Insulin Detemir + Lira 1.8 | -0.00438 |
[back to top]
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
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. (NCT00856986)
Timeframe: weeks 0-26
Intervention | episodes (Number) |
---|
| Major | Minor | Symptoms only |
---|
Insulin Detemir + Lira 1.8 | 0 | 22 | 19 |
,Lira 1.8 | 0 | 2 | 9 |
,Non-Randomised Lira 1.8 | 0 | 31 | 26 |
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Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively. (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
| Change at Breakfast, N=133, 144 | Change at Lunch, N= 134, 143 | Change at Dinner, N= 133, 139 |
---|
Insulin Detemir + Lira 1.8 | -2.09 | -1.43 | -1.18 |
,Lira 1.8 | -0.97 | -0.83 | -0.48 |
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Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively. (NCT00856986)
Timeframe: Week 0, Week 52
Intervention | mmol/L (Least Squares Mean) |
---|
| Change at Breakfast, N=148, 135 | Change at Lunch, N= 145, 136 | Change at Dinner, N= 144, 135 |
---|
Insulin Detemir + Lira 1.8 | -2.43 | -1.14 | -1.4 |
,Lira 1.8 | -0.68 | -0.51 | -0.96 |
[back to top]
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | mmHg (Least Squares Mean) |
---|
| Systolic Blood Pressure | Diastolic Blood Pressure |
---|
Insulin Detemir + Lira 1.8 | 0.41 | -0.4 |
,Lira 1.8 | 1.11 | -1.1 |
[back to top]
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
(NCT00856986)
Timeframe: Week 0, Week 52
Intervention | mmHg (Least Squares Mean) |
---|
| Systolic Blood Pressure | Diastolic Blood Pressure |
---|
Insulin Detemir + Lira 1.8 | 0.16 | 0.11 |
,Lira 1.8 | -0.74 | -0.66 |
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Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C) (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
| Change in Total Cholesterol | Change in LDL-C | Change in VLDL-C | Change in HDL-C |
---|
Insulin Detemir + Lira 1.8 | 0.05 | -0.03 | 0.01 | 0.05 |
,Lira 1.8 | 0.04 | -0.04 | 0.05 | 0.02 |
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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
Intervention | episodes (Number) |
---|
| Major | Minor | Symptoms only |
---|
IDet | 0 | 5 | 6 |
,IGlar | 0 | 8 | 16 |
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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
Intervention | episodes (Number) |
---|
| All Events | Major | Minor | Symptoms only |
---|
IDet | 329 | 0 | 119 | 210 |
,IGlar | 457 | 2 | 156 | 299 |
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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
Intervention | mmol/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) |
---|
IDet | 5.8 | 9.1 | 7.2 | 9.7 | 8.2 | 10.3 | 9.5 | 6.6 | 5.7 |
,IGlar | 5.9 | 8.7 | 6.6 | 8.8 | 7.5 | 9.8 | 9 | 6.3 | 5.6 |
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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
Intervention | percentage of subjects (Number) |
---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All |
---|
IDet | 55 | 40 | 31 | 38 |
,IGlar | 70 | 40 | 47 | 53 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All |
---|
IDet | 48 | 33 | 25 | 32 |
,IGlar | 52 | 33 | 33 | 38 |
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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
Intervention | mmol/L (Median) |
---|
| Metformin Monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | Overall |
---|
IDet | 0.48 | 0.72 | 0.6 | 0.57 |
,IGlar | 0.67 | 0.84 | 0.71 | 0.71 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All |
---|
IDet | 22 | 13 | 5 | 11 |
,IGlar | 30 | 13 | 17 | 21 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All |
---|
IDet | 22 | 7 | 3 | 9 |
,IGlar | 21 | 13 | 13 | 15 |
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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
Intervention | Subjects (Number) |
---|
IDet | 12 |
IGlar | 24 |
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Change in Body Weight From Baseline
(NCT00909480)
Timeframe: Week 0, Week 26
Intervention | kg (Mean) |
---|
IDet | -0.49 |
IGlar | 1 |
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Change in HbA1c From Baseline
(NCT00909480)
Timeframe: Week 0, Week 26
Intervention | percentage point change (Mean) |
---|
IDet | -0.48 |
IGlar | -0.74 |
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Fasting Plasma Glucose (FPG)
(NCT00909480)
Timeframe: Week 26
Intervention | mmol/L (Mean) |
---|
IDet | 6.22 |
IGlar | 6.09 |
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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
Intervention | episodes (Number) |
---|
| Major | Minor | Symptoms only |
---|
IDet | 0 | 75 | 128 |
,IGlar | 2 | 118 | 222 |
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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
Intervention | episodes (Number) |
---|
| Major | Minor | Symptoms only |
---|
IDet | 0 | 39 | 76 |
,IGlar | 0 | 30 | 61 |
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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
Intervention | Episodes/100 years of patient exposure (Number) |
---|
IDegAsp OD | 371 |
IDet | 572 |
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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
Intervention | Events/100 years of patient exposure (Number) |
---|
| Adverse event (AE) | Serious AE | Severe AE | Moderate AE | Mild AE | Fatal AE |
---|
IDegAsp OD | 408 | 24 | 33 | 93 | 282 | 0 |
,IDet | 442 | 19 | 48 | 83 | 311 | 0 |
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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
Intervention | Episodes/100 years of patient exposure (Number) |
---|
IDegAsp OD | 3917 |
IDet | 4434 |
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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
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
IDegAsp OD | -0.73 |
IDet | -0.68 |
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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
Intervention | percentage 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
Intervention | mmol/L (Mean) |
---|
IDegAsp OD | -1.83 |
IDet | -2.40 |
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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
Intervention | Episodes/100 years of patient exposure (Number) |
---|
IDegAsp OD | 309 |
IDet | 541 |
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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
Intervention | Episodes/100 years of patient exposure (Number) |
---|
IDegAsp OD | 3183 |
IDet | 3673 |
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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
Intervention | mmol/L (Mean) |
---|
IDegAsp OD | 8.0 |
IDet | 8.4 |
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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
Intervention | mg/dL (Mean) |
---|
| 3-month - Day-long plasma glucose profile | 6-month - Day-long plasma glucose profile |
---|
Insulin Detemir Only (3 and 6 Months) | 168 | 153 |
,Insulin Detemir Plus Aspart | NA | 170 |
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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
Intervention | Percentage 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 Only | 18 | 65 | 32 | 30 | -6 | 34 | -4 | 2 | 1 | 14 |
,Insulin Detemir Plus Aspart | NA | 5 | NA | 49 | NA | 19 | NA | -1 | NA | 7 |
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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.
Intervention | mg/dL (Mean) |
---|
| 3-month total cholesterol | 3-month LDL-cholesterol | 3-month triglycerides | 3-month HDL-C | 6-month total cholesterol | 6-month LDL-cholesterol | 6-month triglycerides | 6-month HDL-C |
---|
Insulin Detemir Only | 136 | 76 | 154 | 33 | 147 | 86 | 150 | 31 |
,Insulin Detemir Plus Aspart | NA | NA | NA | NA | 145 | 80 | 144 | 33 |
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Advanced Lipid Testing
Change in lipoprotein particle number was determined using NMR. (NCT00998335)
Timeframe: 3 and 6 months
Intervention | Change 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 | -100 | 128 | 0 | 2 |
,Insulin Detemir Plus Aspart | NA | -2 | NA | 85 | NA | 1 |
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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
Intervention | Number of events (Number) |
---|
| 3-month rate of severe hypoglycemia | 6-month rate of severe hypoglycemia |
---|
Insulin Detemir Only | 0 | 0 |
,Insulin Detemir Plus Aspart | NA | 0 |
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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.
Intervention | Change from baseline (Kg) (Mean) |
---|
| 3-month total body weight | 6-month total body weight |
---|
Insulin Detemir Only | -0.8 | 0.8 |
,Insulin Detemir Plus Aspart | NA | 0.3 |
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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.
Intervention | ng/ml (Mean) |
---|
| 3-month C-peptide level increase in first phase | 3-month C-peptide level increase in second phase | 6-month C-peptide level increase in first phase | 6-month C-peptide level increase in second phase |
---|
Insulin Detemir Only (3 and 6 Months) | 0.5 | 1.6 | -0.1 | 0.6 |
,Insulin Detemir Plus Aspart | NA | NA | 0.2 | 0.2 |
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Hepatic Steatosis
Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS). (NCT00998335)
Timeframe: 3 and 6 months
Intervention | percentage of liver fat (Mean) |
---|
| Month 3 | Month 6 |
---|
Insulin Detemir Plus Aspart | NA | 5.9 |
,Insulin Detemir x 3 Months (All Pts Had Liver MRS) | 6.7 | 8.4 |
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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.
Intervention | Change from baseline (Kg/m2) (Mean) |
---|
| 3-month body mass index | 6-month body mass index |
---|
Insulin Detemir Only | -0.4 | 0.3 |
,Insulin Detemir Plus Aspart | NA | 0.2 |
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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 triglycerides | 6-month intramyocellular triglycerides |
---|
Insulin Detemir Only | 0.63 | 1.05 |
,Insulin Detemir Plus Aspart | NA | 0.49 |
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Change in Total Cholesterol From Baseline to Endpoint (Week 26).
Change in total cholesterol from baseline to endpoint (week 26). (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Exenatide Once Weekly | -0.09 |
Insulin Detemir | 0.06 |
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Change in Triglycerides From Baseline to Endpoint (Week 26).
Change in triglycerides from baseline to endpoint (week 26). (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Exenatide Once Weekly | -0.01 |
Insulin Detemir | -0.08 |
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Changes in Systolic Blood Pressure From Baseline to Week 26
Change in systolic blood pressure from baseline to Week 26 (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | mmHg (Least Squares Mean) |
---|
Exenatide Once Weekly | -7.37 |
Insulin Detemir | -2.65 |
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Percentage of Patients Achieving ≤6.5% at Endpoint
Percentage of patients achieving HbA1c ≤6.5% at endpoint (NCT01003184)
Timeframe: Week 26
Intervention | Percentage (Number) |
---|
Exenatide Once Weekly | 27.9 |
Insulin Detemir | 7.6 |
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Percentage of Patients Achieving ≤7.0% at Endpoint
Percentage of patients achieving ≤7.0% at endpoint. (NCT01003184)
Timeframe: Week 26
Intervention | Percentage (Number) |
---|
Exenatide Once Weekly | 51.4 |
Insulin Detemir | 34.3 |
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Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective. (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | Percentage (Number) |
---|
Exenatide Once Weekly | 44.1 |
Insulin Detemir | 11.4 |
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Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint
Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint (NCT01003184)
Timeframe: Week 26
Intervention | Percentage (Number) |
---|
Exenatide Once Weekly | 66.7 |
Insulin Detemir | 54.3 |
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Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26) (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | Percentage (Number) |
---|
Exenatide Once Weekly | 58.9 |
Insulin Detemir | 17.8 |
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Hypoglycemia Rate Per Year
All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account. (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | events per subject-year (Number) |
---|
Exenatide Once Weekly | 0.06 |
Insulin Detemir | 0.10 |
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Change in Body Weight From Baseline to Week 26
Change in body weight from baseline to week 26 (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | kilograms (Least Squares Mean) |
---|
Exenatide Once Weekly | -2.79 |
Insulin Detemir | 0.88 |
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Change in Diastolic Blood Pressure From Baseline to Week 26.
Change in diastolic blood pressure from baseline to week 26. (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | mmHg (Least Squares Mean) |
---|
Exenatide Once Weekly | -0.79 |
Insulin Detemir | -0.34 |
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Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).
Change in fasting serum glucose from baseline to endpoint (Week 26). (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Exenatide Once Weekly | -2.33 |
Insulin Detemir | -2.43 |
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Change in HbA1c From Baseline to Week 26
Change in HbA1c from baseline to week 26 (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | Percentage of total hemoglobin (Least Squares Mean) |
---|
Exenatide Once Weekly | -1.32 |
Insulin Detemir | -0.91 |
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Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).
Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26). (NCT01003184)
Timeframe: Baseline, Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Exenatide Once Weekly | 0.02 |
Insulin Detemir | 0.04 |
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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
Intervention | percentage 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 38 Weeks of Treatment
Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25) (NCT01068652)
Timeframe: Week 38
Intervention | mg/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 + Met | 110.86 | 139.38 | 118.30 | 158.45 | 129.10 | 142.82 | 132.45 | 117.42 |
,Detemir + Met | 110.14 | 146.70 | 130.63 | 145.91 | 132.26 | 155.47 | 146.37 | 124.57 |
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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
Intervention | mg/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 + Met | 110.76 | 132.45 | 115.02 | 149.90 | 126.76 | 138.08 | 130.10 | 113.14 |
,Detemir + Met | 108.78 | 140.05 | 120.43 | 139.48 | 128.28 | 144.19 | 137.13 | 118.60 |
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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
Intervention | mg/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 + Met | 128.31 | 176.31 | 156.12 | 199.75 | 168.09 | 173.95 | 156.65 | 139.93 |
,Detemir + Met | 136.44 | 181.89 | 157.61 | 199.40 | 169.69 | 212.23 | 200.15 | 158.69 |
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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
Intervention | Subjects (Number) |
---|
Detemir + Met | 73 |
BIAsp 30 + Met | 84 |
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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
Intervention | Subjects (Number) |
---|
Detemir + Met | 84 |
BIAsp 30 + Met | 103 |
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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
Intervention | mg/dL (Mean) |
---|
Detemir + Met | 25.44 |
BIAsp 30 + Met | 28.32 |
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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
Intervention | mg/dL (Mean) |
---|
Detemir + Met | 32.95 |
BIAsp 30 + Met | 31.71 |
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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
Intervention | mg/dL (Mean) |
---|
Detemir + Met | 43.19 |
BIAsp 30 + Met | 32.61 |
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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
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
Detemir + Met | -1.16 |
BIAsp 30 + Met | -1.34 |
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Glycosylated Haemoglobin (HbA1c)
Estimated mean difference in HbA1c after 50 weeks of treatment (NCT01068652)
Timeframe: Week 50
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
Detemir + Met | 7.34 |
BIAsp 30 + Met | 7.23 |
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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
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
Detemir + Met | -1.35 |
BIAsp 30 + Met | -1.56 |
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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
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
Detemir + Met | -1.05 |
BIAsp 30 + Met | -1.30 |
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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
Intervention | mg/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 + Met | 115.79 | 153.85 | 131.27 | 178.92 | 143.29 | 152.44 | 140.39 | 123.29 |
,Detemir + Met | 116.57 | 163.52 | 140.97 | 166.00 | 147.58 | 172.21 | 164.70 | 133.59 |
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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
Intervention | Subjects (Number) |
---|
Detemir + Met | 67 |
BIAsp 30 + Met | 77 |
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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
Intervention | Subjects (Number) |
---|
Detemir + Met | 15 |
BIAsp 30 + Met | 26 |
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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
Intervention | mg/dL (Mean) |
---|
Detemir + Met | 22.45 |
BIAsp 30 + Met | 23.66 |
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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
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
IDeg OD | -0.46 |
IDet OD | -0.47 |
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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
Intervention | Events/100 years of patient exposure (Number) |
---|
| Adverse events (AEs) | Serious AE | Severe AE | Moderate AE | Mild AE | Fatal AE |
---|
IDeg OD | 459 | 20 | 23 | 48 | 388 | 0 |
,IDet OD | 420 | 17 | 35 | 45 | 341 | 0 |
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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
Intervention | Episodes/100 years of patient exposure (Number) |
---|
IDeg OD | 414 |
IDet OD | 593 |
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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
Intervention | Episodes/100 years of patient exposure (Number) |
---|
IDeg OD | 4583 |
IDet OD | 4569 |
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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
Intervention | mmol/L (Mean) |
---|
IDeg OD | 7.9 |
IDet OD | 7.8 |
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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
Intervention | mmol/L (Mean) |
---|
IDeg OD | -2.60 |
IDet OD | -0.62 |
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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
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
IDeg OD | -0.73 |
IDet OD | -0.65 |
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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
Intervention | Episodes/100 years of patient exposure (Number) |
---|
IDeg OD | 338 |
IDet OD | 481 |
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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
Intervention | Episodes/100 years of patient exposure (Number) |
---|
IDeg OD | 3778 |
IDet OD | 3926 |
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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
Intervention | mmol/L (Mean) |
---|
IDeg OD | 7.8 |
IDet OD | 7.8 |
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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
Intervention | mmol/L (Mean) |
---|
IDeg OD | -2.19 |
IDet OD | -0.82 |
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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
Intervention | mmol/L (Mean) |
---|
Step-wise | 1.9 |
Basal-bolus | 1.5 |
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Fasting Plasma Glucose (FPG) at Week 10
Mean FPG at Week 10 (NCT01165684)
Timeframe: Week 10
Intervention | mmol/L (Mean) |
---|
Step-wise | 7.1 |
Basal-bolus | 6.7 |
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Body Mass Index (BMI) at Week 32
Estimated mean BMI after 32 Weeks of treatment (NCT01165684)
Timeframe: Week 32
Intervention | kg/m^2 (Mean) |
---|
Step-wise | 31.86 |
Basal-bolus | 32.03 |
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Body Weight at Week 32
Estimated mean body weight after 32 Weeks of treatment (NCT01165684)
Timeframe: Week 32
Intervention | kg (Mean) |
---|
Step-wise | 89.32 |
Basal-bolus | 89.80 |
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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
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
Step-wise | -0.45 |
Basal-bolus | -1.00 |
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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
Intervention | percentage 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
Intervention | percentage 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
Intervention | mmol/L (Mean) |
---|
Step-wise | 1.64 |
Basal-bolus | 1.28 |
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Fasting Plasma Glucose (FPG) at Week 21
Mean FPG at Week 21 (NCT01165684)
Timeframe: Week 21
Intervention | mmol/L (Mean) |
---|
Step-wise | 7.1 |
Basal-bolus | 7.0 |
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Fasting Plasma Glucose (FPG) at Week 32
Estimated Mean FPG at Week 32 (NCT01165684)
Timeframe: Week 32
Intervention | mmol/L (Mean) |
---|
Step-wise | 7.12 |
Basal-bolus | 7.01 |
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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
Intervention | Episodes /year of patient exposure (Number) |
---|
Step-wise | 33.47 |
Basal-bolus | 57.56 |
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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
Intervention | mmol/L (Mean) |
---|
Step-wise | 2.3 |
Basal-bolus | 1.4 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
Step-wise | 55.9 |
Basal-bolus | 63.3 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
Step-wise | 45.1 |
Basal-bolus | 65.4 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
Step-wise | 19.2 |
Basal-bolus | 56.3 |
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Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)
Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl) (NCT01186003)
Timeframe: within 48 hours of discontinuation
Intervention | Participants (Count of Participants) |
---|
Standard Insulin Drip Therapy | 14 |
Insulin Drip and Detemir | 3 |
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Rate of Treatment Emergent Adverse Events (TEAEs)
Corresponds to rate of adverse events (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 AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT01232491)
Timeframe: Week 0 to Week 26
Intervention | rate per 100 years of patient exposure (Number) |
---|
| All TEAEs | Serious TEAEs | Severe TEAEs | Moderate TEAEs | Mild TEAEs |
---|
Control | 437.1 | 16.6 | 11.3 | 108.3 | 317.5 |
,Dietician | 387.9 | 16.3 | 16.3 | 130.5 | 241.0 |
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Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes
Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. 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. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions. (NCT01232491)
Timeframe: Week 0 to Week 26
Intervention | rate per year of patient exposure (Number) |
---|
| All Events | Severe Events |
---|
Control | 5.51 | 0.01 |
,Dietician | 5.59 | 0.01 |
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Rate of All Treatment Emergent Hypoglycaemic Episodes
Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. 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, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions. (NCT01232491)
Timeframe: Week 0 to Week 26
Intervention | rate per year of patient exposure (Number) |
---|
| All Events | Severe Events |
---|
Control | 23.30 | 0.01 |
,Dietician | 25.47 | 0.01 |
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Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Estimated mean change from baseline in HbA1c after 26 weeks of treatment. (NCT01232491)
Timeframe: Week 0, Week 26
Intervention | percentage of glycosylated haemoglobin (Least Squares Mean) |
---|
Dietician | -0.93 |
Control | -0.80 |
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Change From Baseline in Fasting Plasma Glucose (FPG)
Estimated mean change from baseline in FPG after 26 weeks of treatment. (NCT01232491)
Timeframe: Week 0, Week 26
Intervention | mmol/L (Least Squares Mean) |
---|
Dietician | -3.00 |
Control | -2.93 |
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Change From Baseline in Body Weight
Estimated mean change from baseline in body weight after 26 weeks of treatment. (NCT01232491)
Timeframe: Week 0, Week 26
Intervention | kg (Least Squares Mean) |
---|
Dietician | -1.05 |
Control | -0.56 |
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Change From Baseline in Body Mass Index (BMI)
Estimated mean change from baseline in BMI after 26 weeks of treatment. (NCT01232491)
Timeframe: Week 0, Week 26
Intervention | kg/m^2 (Least Squares Mean) |
---|
Dietician | -0.37 |
Control | -0.20 |
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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
Intervention | umol/g/min (Median) |
---|
Iiraglutide | 0.055 |
Insulin Detemir | 0.0399 |
Liraglutide Plus Insulin Detemir | 0.0373 |
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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
Intervention | umol/g/min (Median) |
---|
Iiraglutide | 0.1019 |
Insulin Detemir | 0.1234 |
Liraglutide Plus Insulin Detemir | 0.0992 |
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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
Intervention | umol/g/min (Median) |
---|
Iiraglutide | 0.00274 |
Insulin Detemir | 0.00358 |
Liraglutide Plus Insulin Detemir | 0.00146 |
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Change From Baseline in Fructosamine After Two Weeks of Treatment
(NCT01486966)
Timeframe: Week 0, week 2
Intervention | Umol/L (Least Squares Mean) |
---|
Insulin Detemir + Insulin Aspart ± Metformin | -31.0 |
Insulin NPH + Human Soluble Insulin ± Metformin | -23.7 |
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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
Intervention | events (Number) |
---|
| All events | Severe | Nocturnal | Diurnal | Minor |
---|
Insulin Detemir + Insulin Aspart ± Metformin | 22 | 0 | 4 | 18 | 2 |
,Insulin NPH + Human Soluble Insulin ± Metformin | 54 | 0 | 11 | 43 | 11 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
Insulin Detemir + Insulin Aspart ± Metformin | 41.4 |
Insulin NPH + Human Soluble Insulin ± Metformin | 34.5 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
Insulin Detemir + Insulin Aspart ± Metformin | 41.4 |
Insulin NPH + Human Soluble Insulin ± Metformin | 34.5 |
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Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
(NCT01486966)
Timeframe: Week 2
Intervention | percentage (%) of subjects (Number) |
---|
Insulin Detemir + Insulin Aspart ± Metformin | 48.3 |
Insulin NPH + Human Soluble Insulin ± Metformin | 48.3 |
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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
Intervention | percentage (%) of subjects (Number) |
---|
Insulin Detemir + Insulin Aspart ± Metformin | 20.7 |
Insulin NPH + Human Soluble Insulin ± Metformin | 20.7 |
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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
Intervention | mmol/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
Intervention | mmol/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 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
Intervention | mmol/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 Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
The FPG referred to pre-breakfast plasma glucose. (NCT01486966)
Timeframe: Week 0, week 2
Intervention | mmol/L (Least Squares Mean) |
---|
Insulin Detemir + Insulin Aspart ± Metformin | -2.22 |
Insulin NPH + Human Soluble Insulin ± Metformin | -2.29 |
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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
Intervention | episodes (Number) |
---|
| 26 weeks | 52 weeks |
---|
IDeg + IAsp | 31264 | 58679 |
,IDet + IAsp | 31173 | 52831 |
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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
Intervention | events (Number) |
---|
| TEAEs -26 weeks | TEAEs -52 weeks |
---|
IDeg + IAsp | 810 | 1462 |
,IDet + IAsp | 761 | 1266 |
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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
Intervention | pmol/L (Mean) |
---|
| week 2 | week 12 | week 26 |
---|
IDeg + IAsp | 4540.4 | 4148.1 | 4105.6 |
,IDet + IAsp | 3972.2 | 5430.1 | 6377.0 |
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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
Intervention | mmol/L (Mean) |
---|
IDeg + IAsp | -0.67 |
IDet + IAsp | 0.50 |
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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
Intervention | percentage of glycosylated haemoglobin (Mean) |
---|
IDeg + IAsp | -0.27 |
IDet + IAsp | -0.22 |
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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
Intervention | mmol/L (Mean) |
---|
IDeg + IAsp | -1.29 |
IDet + IAsp | 1.10 |
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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
Intervention | percentage 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 antibodies | Insulin Detemir specific antibodies | Insulin Degludec specific antibodies | X-reacting AB Hu Insulin |
---|
IDeg + IAsp | 1.1 | NA | 0 | 17.2 |
,IDet + IAsp | 1.5 | 6.1 | NA | 26.0 |
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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
Intervention | episodes (Number) |
---|
| 26 weeks (entire day) | 26 weeks (nocturnal) | 52 weeks (entire day) | 52 weeks (nocturnal) |
---|
IDeg + IAsp | 11712 | 1261 | 21560 | 2336 |
,IDet + IAsp | 10991 | 1458 | 18373 | 2586 |
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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
Intervention | Change in Z score memory composite (Mean) |
---|
Saline | -.31247583 |
Insulin Detemir | .33390008 |
Insulin | -.05181561 |
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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
Intervention | pg/mL (Mean) |
---|
| Abeta42 Pre | Abeta 42 Post | Tau Pre | Tau Post | Tau-P181 Pre | Tau-P181 Post |
---|
Insulin | 305.5 | 325 | 132.3 | 152.2 | 74 | 68.5 |
,Insulin Detemir | 408.5 | 381.8 | 118.3 | 107.6 | 63.9 | 64.1 |
,Saline | 331.5 | 384 | 109.7 | 117.1 | 65.1 | 72.17 |
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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
Intervention | ratio (Mean) |
---|
| TTau-P181/Abeta42 ratio Pre | Tau-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
Intervention | units on a scale (Mean) |
---|
| Baseline | month 2 | month 4 |
---|
Insulin | 7.7 | 9.7 | 10.6 |
,Insulin Detemir | 8.7 | 9.7 | 9.1 |
,Saline | 7.3 | 7 | 6.9 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Month 2 | Month 4 |
---|
Insulin | 19.8 | 21.8 | 22.6 |
,Insulin Detemir | 21.6 | 23.4 | 19.5 |
,Saline | 20 | 18.5 | 20.4 |
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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
Intervention | Percentage of glycosylated haemoglobin (Mean) |
---|
| Week 0 (baseline) | Week 26 |
---|
Faster Aspart (Post) | 7.63 | 7.51 |
,NovoRapid (Meal) | 7.58 | 7.42 |
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Change in HbA1c
Change from baseline in HbA1c (%) after 52 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 52
Intervention | Percentage of glycosylated haemoglobin (Mean) |
---|
| Week 0 (baseline) | Week 52 |
---|
Faster Aspart (Meal) | 7.62 | 7.51 |
,NovoRapid (Meal) | 7.58 | 7.58 |
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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
Intervention | mmol/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) | 14.51 | 14.26 | 6.06 | 5.71 |
,NovoRapid (Meal) | 14.14 | 14.51 | 6.24 | 6.14 |
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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
Intervention | Kg (Mean) |
---|
| Week 0: Baseline | Week 26 |
---|
Faster Aspart (Meal) | 78.56 | 79.21 |
,Faster Aspart (Post) | 80.49 | 81.17 |
,NovoRapid (Meal) | 80.15 | 80.69 |
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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
Intervention | event /100 patient yrs of exposure (Number) |
---|
Faster Aspart (Meal) | 445.8 |
Faster Aspart (Post) | 441 |
NovoRapid (Meal) | 411 |
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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
Intervention | event rate/100 patient yrs of exposure (Number) |
---|
Faster Aspart (Meal) | 5899 |
Faster Aspart (Post) | 5443 |
NovoRapid (Meal) | 5865 |
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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
Intervention | mmol/L (Mean) |
---|
| Week 0: Baseline | Week 26 |
---|
Faster Aspart (Meal) | 6.06 | 5.88 |
,Faster Aspart (Post) | 6.06 | 6.73 |
,NovoRapid (Meal) | 6.24 | 6.55 |
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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
Intervention | Percentage of glycosylated haemoglobin (Mean) |
---|
| Week 0 (Baseline) | Week 26 |
---|
Faster Aspart (Meal) | 7.62 | 7.31 |
,Faster Aspart (Post) | 7.63 | 7.51 |
,NovoRapid (Meal) | 7.58 | 7.42 |
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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
Intervention | episodes (Number) |
---|
IDegAsp OD | 2532 |
IDet OD/BID | 2672 |
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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
Intervention | episodes (Number) |
---|
IDegAsp OD | 6 |
IDet OD/BID | 12 |
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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
Intervention | episodes (Number) |
---|
IDegAsp OD | 316 |
IDet OD/BID | 291 |
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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
Intervention | mmol/L (Mean) |
---|
IDegAsp OD | -0.3 |
IDet OD/BID | -0.1 |
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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
Intervention | percentage (%) (Mean) |
---|
IDegAsp OD | -0.3 |
IDet OD/BID | -0.3 |
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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
Intervention | number of events (Number) |
---|
IDegAsp OD | 501 |
IDet OD/BID | 460 |
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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
Intervention | episodes (Number) |
---|
IDegAsp OD | 599 |
IDet OD/BID | 449 |
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Proportion of Subjects Achieving HbA1c Below 7.0%
Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment. (NCT01868542)
Timeframe: Week 20
Intervention | percentage (%) of subjects (Number) |
---|
| week 20 (Yes) | week 20 (No) |
---|
Insulin Detemir (2-4-6-8 Algorithm ) | 14.3 | 85.7 |
,Insulin Detemir (3-0-3 Algorithm ) | 8.7 | 91.3 |
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Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms. (NCT01868542)
Timeframe: For 20 weeks of treatment and over 24 hours
Intervention | Episodes (Number) |
---|
| Hypoglycaemic episodes | Nocturnal hypoglycaemic episodes |
---|
Insulin Detemir (2-4-6-8 Algorithm ) | 119 | 17 |
,Insulin Detemir (3-0-3 Algorithm ) | 72 | 22 |
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Change in Fasting Plasma Glucose From Baseline
Change in fasting plasma glucose from baseline. (NCT01868542)
Timeframe: week 0, week 12
Intervention | mg/dL (Mean) |
---|
Insulin Detemir (3-0-3 Algorithm ) | -74.3 |
Insulin Detemir (2-4-6-8 Algorithm ) | -44.6 |
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Change in Fasting Plasma Glucose From Baseline
Change in fasting plasma glucose from baseline. (NCT01868542)
Timeframe: Week 0, week 20
Intervention | mg/dL (Mean) |
---|
Insulin Detemir (3-0-3 Algorithm ) | -60.4 |
Insulin Detemir (2-4-6-8 Algorithm ) | -70.0 |
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Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included. (NCT01868542)
Timeframe: Week 0, week 20
Intervention | Percent (%) glycosylated haemoglobin (Mean) |
---|
Insulin Detemir (3-0-3 Algorithm ) | -0.9 |
Insulin Detemir (2-4-6-8 Algorithm ) | -1.0 |
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Change in HbA1c
Change in HbA1c at 12 weeks of treatment from visit 2. (NCT01868542)
Timeframe: Week 0, week 12
Intervention | Percent (%) glycosylated haemoglobin (Mean) |
---|
Insulin Detemir (3-0-3 Algorithm ) | -0.8 |
Insulin Detemir (2-4-6-8 Algorithm ) | -0.9 |
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Incidence of 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 the day of visit 22.(week 20) (NCT01868542)
Timeframe: Week 20
Intervention | events (Number) |
---|
| Treatment Emergent Adverse Events (TEAEs) | Serious Adverse Events (SAEs) | Non Serious Adverse Events (NSAEs) |
---|
Insulin Detemir (2-4-6-8 Algorithm ) | 29 | 1 | 28 |
,Insulin Detemir (3-0-3 Algorithm ) | 24 | 0 | 24 |
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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
Intervention | percentage of participants (Number) |
---|
Control: Metformin, Insulin Detemir, Insulin Aspart | 16 |
Metformin, Insulin Determir, Liraglutide | 34 |
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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
Intervention | percentage of participants (Number) |
---|
Control: Metformin, Insulin Detemir, Insulin Aspart | 16.1 |
Metformin, Insulin Determir, Liraglutide | 7.4 |
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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
Intervention | score on a scale (Least Squares Mean) |
---|
| General Health Perception | Current Health Perception | Treatment Satisfaction | Diabetes Related Worry | Social or Vocational Worry | Hypoglycemia Fear | Glycemic Control Perception | Satisfaction with Insulin Treatment | Willingness to Continue Insulin Treatment | LifeStyle Flexibility | Social Stigma |
---|
Control: Metformin, Insulin Detemir, Insulin Aspart | -0.3 | -0.5 | -0.3 | 0.03 | -0.02 | 0.3 | -1.1 | -1.3 | -0.9 | -0.09 | 0.1 |
,Metformin, Insulin Determir, Liraglutide | -0.9 | -1.1 | -0.6 | -0.2 | -0.2 | -0.2 | -1.6 | -1.7 | -1.1 | -0.2 | 0.01 |
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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
Intervention | Percentage of glycosylated hemoglobin (Mean) |
---|
Control: Metformin, Insulin Detemir, Insulin Aspart | 3.4 |
Metformin, Insulin Determir, Liraglutide | 4.1 |
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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
Intervention | percentage of participants (Number) |
---|
Control: Metformin, Insulin Detemir, Insulin Aspart | 66.1 |
Metformin, Insulin Determir, Liraglutide | 35.2 |
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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
Intervention | kilogram (Mean) |
---|
Control: Metformin, Insulin Detemir, Insulin Aspart | 3.1 |
Metformin, Insulin Determir, Liraglutide | -0.6 |
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Percentage of Participants Reaching Target A1c of <7% at Week 26
(NCT01966978)
Timeframe: Week 26
Intervention | percentage of participants (Number) |
---|
Control: Metformin, Insulin Detemir, Insulin Aspart | 20 |
Metformin, Insulin Determir, Liraglutide | 44 |
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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
Intervention | Percent change (Least Squares Mean) |
---|
Placebo/Glimepiride | -0.69 |
Ertugliflozin 5 mg | -0.49 |
Ertugliflozin 15 mg | -0.44 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 17.2 |
Ertugliflozin 5 mg | 4.3 |
Ertugliflozin 15 mg | 1.5 |
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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
Intervention | Percent 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 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
Intervention | Percent 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 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
Intervention | Percentage change (Least Squares Mean) |
---|
Placebo/Glimepiride | 0.22 |
Ertugliflozin 5 mg | -0.01 |
Ertugliflozin 15 mg | 0.12 |
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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
Intervention | Percent change (Least Squares Mean) |
---|
Placebo/Glimepiride | -0.40 |
Ertugliflozin 5 mg | -0.10 |
Ertugliflozin 15 mg | 0.30 |
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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
Intervention | Percent change (Least Squares Mean) |
---|
Placebo/Glimepiride | 0.06 |
Ertugliflozin 5 mg | -0.15 |
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
Intervention | Percent 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 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
Intervention | Percent change (Least Squares Mean) |
---|
Placebo/Glimepiride | 0.09 |
Ertugliflozin 5 mg | -0.19 |
Ertugliflozin 15 mg | -0.13 |
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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
Intervention | mmHg (Mean) |
---|
Placebo/Glimepiride | 0.65 |
Ertugliflozin 5 mg | -2.63 |
Ertugliflozin 15 mg | -4.28 |
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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
Intervention | mmHg (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 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
Intervention | mmHg (Mean) |
---|
Placebo/Glimepiride | 0.05 |
Ertugliflozin 5 mg | -3.61 |
Ertugliflozin 15 mg | -3.13 |
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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
Intervention | mmHg (Mean) |
---|
Placebo/Glimepiride | 0.38 |
Ertugliflozin 5 mg | -1.40 |
Ertugliflozin 15 mg | -1.19 |
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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
Intervention | mmHg (Least Squares Mean) |
---|
Placebo/Glimepiride | 0.23 |
Ertugliflozin 5 mg | -1.59 |
Ertugliflozin 15 mg | -2.19 |
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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
Intervention | mmHg (Mean) |
---|
Placebo/Glimepiride | -0.46 |
Ertugliflozin 5 mg | -2.36 |
Ertugliflozin 15 mg | -1.52 |
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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
Intervention | mg/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 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
Intervention | mg/dL (Mean) |
---|
Placebo/Glimepiride | -10.9 |
Ertugliflozin 5 mg | -18.2 |
Ertugliflozin 15 mg | -28.2 |
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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
Intervention | Percent change (Least Squares Mean) |
---|
Placebo/Glimepiride | -1.23 |
Ertugliflozin 5 mg | -1.11 |
Ertugliflozin 15 mg | -0.96 |
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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
Intervention | Kilograms (Mean) |
---|
Placebo/Glimepiride | 0.07 |
Ertugliflozin 5 mg | -3.23 |
Ertugliflozin 15 mg | -3.35 |
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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
Intervention | Kilograms (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 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
Intervention | Kilograms (Mean) |
---|
Placebo/Glimepiride | -0.18 |
Ertugliflozin 5 mg | -3.77 |
Ertugliflozin 15 mg | -3.63 |
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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
Intervention | Percent A1C (Mean) |
---|
Placebo/Glimepiride | -0.68 |
Ertugliflozin 5 mg | -0.72 |
Ertugliflozin 15 mg | -0.96 |
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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
Intervention | Percent 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 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
Intervention | mg/dL (Mean) |
---|
Placebo/Glimepiride | -12.0 |
Ertugliflozin 5 mg | -22.4 |
Ertugliflozin 15 mg | -35.2 |
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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
Intervention | Percent A1C (Mean) |
---|
Placebo/Glimepiride | -0.58 |
Ertugliflozin 5 mg | -0.60 |
Ertugliflozin 15 mg | -0.89 |
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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
Intervention | Percent change (Mean) |
---|
Placebo/Glimepiride | -0.98 |
Ertugliflozin 5 mg | 0.28 |
Ertugliflozin 15 mg | 0.14 |
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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
Intervention | Percent Change (Mean) |
---|
Placebo/Glimepiride | 24.50 |
Ertugliflozin 5 mg | 8.41 |
Ertugliflozin 15 mg | 19.79 |
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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
Intervention | Percent change (Mean) |
---|
Placebo/Glimepiride | 0.5 |
Ertugliflozin 5 mg | 0.8 |
Ertugliflozin 15 mg | 0.5 |
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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
Intervention | Percent change (Mean) |
---|
Placebo/Glimepiride | 10.12 |
Ertugliflozin 5 mg | 8.16 |
Ertugliflozin 15 mg | 5.46 |
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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
Intervention | Percent Change (Mean) |
---|
Placebo/Glimepiride | 8.11 |
Ertugliflozin 5 mg | 11.09 |
Ertugliflozin 15 mg | 2.48 |
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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
Intervention | Percent change (Mean) |
---|
Placebo/Glimepiride | 19.38 |
Ertugliflozin 5 mg | 10.11 |
Ertugliflozin 15 mg | 24.21 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 2.4 |
Ertugliflozin 5 mg | 3.4 |
Ertugliflozin 15 mg | 3.9 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 77.5 |
Ertugliflozin 5 mg | 70.5 |
Ertugliflozin 15 mg | 75.6 |
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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
Intervention | Percentage of participants (Number) |
---|
Placebo/Glimepiride | 24.4 |
Ertugliflozin 5 mg | 11.1 |
Ertugliflozin 15 mg | 10.7 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 17.7 |
Ertugliflozin 5 mg | 2.9 |
Ertugliflozin 15 mg | 1.5 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 7.2 |
Ertugliflozin 5 mg | 10.6 |
Ertugliflozin 15 mg | 12.2 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 2.9 |
Ertugliflozin 5 mg | 8.7 |
Ertugliflozin 15 mg | 12.2 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 11.0 |
Ertugliflozin 5 mg | 10.6 |
Ertugliflozin 15 mg | 14.6 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 19.1 |
Ertugliflozin 5 mg | 24.6 |
Ertugliflozin 15 mg | 33.7 |
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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
Intervention | Percent change (Least Squares Mean) |
---|
Placebo/Glimepiride | -0.58 |
Ertugliflozin 5 mg | -0.40 |
Ertugliflozin 15 mg | -0.64 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 30.6 |
Ertugliflozin 5 mg | 34.8 |
Ertugliflozin 15 mg | 36.6 |
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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
Intervention | Days (Median) |
---|
Placebo/Glimepiride | 105 |
Ertugliflozin 5 mg | 112 |
Ertugliflozin 15 mg | 139 |
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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
Intervention | ng/mL (Mean) |
---|
| Week 6:Pre-dose | Week 12:Pre-dose | Week 12:60 mins post-dose | Week 18:Pre-dose | Week 18:60 mins post-dose | Week 30:Pre-dose |
---|
Ertugliflozin 15 mg | 38.38 | 29.23 | 228.13 | 24.46 | 214.96 | 30.55 |
,Ertugliflozin 5 mg | 14.89 | 12.34 | 74.84 | 9.91 | 74.39 | 12.66 |
,Placebo/Glimepiride | NA | NA | NA | 0.01 | 0.01 | 0.15 |
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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
Intervention | Percent change (Mean) |
---|
Placebo/Glimepiride | 15.54 |
Ertugliflozin 5 mg | 34.36 |
Ertugliflozin 15 mg | 41.57 |
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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
Intervention | Percent change (Mean) |
---|
Placebo/Glimepiride | 19.29 |
Ertugliflozin 5 mg | 26.94 |
Ertugliflozin 15 mg | 32.53 |
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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
Intervention | Percent change (Mean) |
---|
Placebo/Glimepiride | 10.8 |
Ertugliflozin 5 mg | 51.9 |
Ertugliflozin 15 mg | 80.2 |
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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
Intervention | Percent change (Least Squares Mean) |
---|
Placebo/Glimepiride | -0.82 |
Ertugliflozin 5 mg | -1.04 |
Ertugliflozin 15 mg | -1.32 |
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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
Intervention | Percent change (Least Squares Mean) |
---|
Placebo/Glimepiride | -0.10 |
Ertugliflozin 5 mg | -0.28 |
Ertugliflozin 15 mg | 0.07 |
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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
Intervention | Percentage of Participants (Number) |
---|
Placebo/Glimepiride | 15.8 |
Ertugliflozin 5 mg | 35.3 |
Ertugliflozin 15 mg | 40.0 |
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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
Intervention | Percentage of subjects (Number) |
---|
Insulin Detemir + Metformin + Diet/Exercise | 25.0 |
Insulin NPH + Metformin + Diet/Exercise | 33.3 |
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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
Intervention | Number of events (Number) |
---|
Insulin Detemir + Metformin + Diet/Exercise | 30 |
Insulin NPH + Metformin + Diet/Exercise | 41 |
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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
Intervention | Percentage of glycosylated haemoglobin (Least Squares Mean) |
---|
Insulin Detemir + Metformin + Diet/Exercise | -0.64 |
Insulin NPH + Metformin + Diet/Exercise | -0.81 |
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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
Intervention | standard deviation score (Mean) |
---|
Insulin Detemir + Metformin + Diet/Exercise | 0.006 |
Insulin NPH + Metformin + Diet/Exercise | 0.098 |
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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
Intervention | Percentage of subjects (Number) |
---|
Insulin Detemir + Metformin + Diet/Exercise | 30.0 |
Insulin NPH + Metformin + Diet/Exercise | 38.1 |
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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
Intervention | Number of episodes (Number) |
---|
| Severe | Blood glucose confirmed symptomatic |
---|
Insulin Detemir + Metformin + Diet/Exercise | 0 | 0 |
,Insulin NPH + Metformin + Diet/Exercise | 0 | 1 |
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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
Intervention | Number of episodes (Number) |
---|
| Severe | Blood glucose confirmed symptomatic |
---|
Insulin Detemir + Metformin + Diet/Exercise | 0 | 4 |
,Insulin NPH + Metformin + Diet/Exercise | 0 | 12 |
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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
Intervention | percentage of participants (Number) |
---|
Toujeo | 37.3 |
Standard of Care | 34.3 |
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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
Intervention | Medication Possession ratio (Mean) |
---|
| Month 6 | Month 12 |
---|
Standard of Care | 63.14 | 57.82 |
,Toujeo | 62.06 | 58.21 |
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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
Intervention | score on a scale (Mean) |
---|
| Total treatment satisfaction score:Baseline | Total treatment satisfaction score: Month 6 | Total treatment satisfaction score: Month 12 | Perceived frequencyof hyperglycemia score:Baseline | Perceived frequency of hyperglycemia score:Month 6 | Perceived frequency of hyperglycemia score:Month12 | Perceived frequency of hypoglycemia score:Baseline | Perceived frequency of hypoglycemia score: Month 6 | Perceived frequency of hypoglycemia score:Month 12 |
---|
Standard of Care | 26.4 | 31.1 | 30.7 | 4.3 | 2.8 | 2.6 | 0.8 | 1.0 | 1.0 |
,Toujeo | 26.5 | 31.0 | 30.9 | 4.3 | 2.8 | 2.6 | 0.9 | 0.9 | 0.9 |
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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
Intervention | score on a scale (Least Squares Mean) |
---|
| Total satisfaction score | Perceived frequency of hyperglycemia score | Perceived frequency of hypoglycemia |
---|
Standard of Care | 13.79 | 0.21 | -0.82 |
,Toujeo | 13.81 | 0.14 | -0.82 |
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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
Intervention | percentage of participants (Number) |
---|
| Hospitalizations: Month 6 | Emergency Room Visits: Month 6 | Specialty Visits: Month 6 | Hospitalizations: Month 12 | Emergency Room Visits: Month 12 | Specialty Visits: Month 12 |
---|
Standard of Care | 7.5 | 10.3 | 74.0 | 8.0 | 11.1 | 75.9 |
,Toujeo | 8.1 | 11.3 | 78.3 | 9.1 | 12.7 | 80.1 |
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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
Intervention | percentage of participants (Number) |
---|
| Any hypoglycemia: Any time: Month 6 | Any hypoglycemia: Nocturnal: Month 6 | Any hypoglycemia: Any time: Month 12 | Any hypoglycemia: Nocturnal: Month 12 | Severe hypoglycemia: Any time: Month 6 | Severe hypoglycemia:Nocturnal: Month 6 | Documented Symptomatic <=70 mg/dL:Any time:Month 6 | Documented Symptomatic <54 mg/dL:Any time:Month 6 | Documented Symptomatic <=70mg/dL:Nocturnal:Month 6 | Documented Symptomatic <54 mg/dL:Nocturnal:Month 6 | Severe hypoglycemia: Any time: Month 12 | Severe hypoglycemia:Nocturnal: Month 12 | Documented Symptomatic<=70 mg/dL:Any time:Month 12 | Documented Symptomatic <54 mg/dL:Any time:Month 12 | Documented Symptomatic<=70mg/dL:Nocturnal:Month 12 | Documented Symptomatic <54mg/dL:Nocturnal:Month 12 |
---|
Standard of Care | 30.4 | 10.0 | 41.8 | 14.9 | 1.0 | 0.6 | 14.9 | 3.1 | 5.6 | 0.8 | 1.9 | 0.7 | 20.8 | 5.6 | 8.3 | 1.7 |
,Toujeo | 28.9 | 8.9 | 39.1 | 13.6 | 1.0 | 0.5 | 13.9 | 3.6 | 4.5 | 0.8 | 1.2 | 0.5 | 19.9 | 5.6 | 6.5 | 1.2 |
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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
Intervention | percentage of participants (Number) |
---|
| Month 12: <=70 mg/dL | Month 12: <54 mg/dL |
---|
Standard of Care | 23.7 | 29.5 |
,Toujeo | 26.1 | 33.0 |
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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
Intervention | mg/dL (Least Squares Mean) |
---|
| Month 6 | Month 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
Intervention | kilogram (kg) (Least Squares Mean) |
---|
| Month 6 | Month 12 |
---|
Standard of Care | 1.14 | 1.40 |
,Toujeo | 1.02 | 1.51 |
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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
Intervention | Unit/kg (U/kg) (Mean) |
---|
| Month 6 | Month 12 |
---|
Standard of Care | 0.183 | 0.224 |
,Toujeo | 0.179 | 0.222 |
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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
Intervention | percentage of responders (Number) |
---|
| Percentage of Participants: Month 6 | Percentage of Providers: Month 6 | Percentage of Participants: Month 12 | Percentage of Providers: Month 12 |
---|
Standard of Care | 65.6 | 57.7 | 64.2 | 56.3 |
,Toujeo | 67.2 | 62.1 | 64.7 | 58.8 |
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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
Intervention | percentage of HbA1c (Least Squares Mean) |
---|
| Month 6 | Month 12 |
---|
Standard of Care | -1.36 | -1.24 |
,Toujeo | -1.40 | -1.29 |
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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
Intervention | days (Median) |
---|
Placebo | 9 |
Sitagliptin | 11 |
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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
Intervention | Participants (Count of Participants) |
---|
| Mild hypoglycemia | Clinically significant hypoglycemia |
---|
Placebo | 2 | 0 |
,Sitagliptin | 5 | 0 |
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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
Intervention | days (Median) |
---|
Placebo | 2.0 |
Sitagliptin | 1.5 |
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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
Intervention | Participants (Count of Participants) |
---|
Placebo | 7 |
Sitagliptin | 5 |
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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)
Intervention | Participants (Count of Participants) |
---|
Placebo | 0 |
Sitagliptin | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
Placebo | 0 |
Sitagliptin | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
Placebo | 0 |
Sitagliptin | 1 |
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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
Intervention | international units of insulin (Number) |
---|
Sitagliptin | 5 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Wound infection | Respiratory failure | Pneumonia | Acute kidney injury | Cardiac event | Bacterial septic infection |
---|
Placebo | 0 | 0 | 0 | 1 | 0 | 0 |
,Sitagliptin | 0 | 0 | 0 | 1 | 0 | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Left eye72577228 | Left eye72577227 | Right eye72577227 | Right eye72577228 |
---|
| Yes | No | Missing |
---|
IDet | 2 |
IDeg | 79 |
IDeg | 2 |
IDet | 79 |
IDeg | 10 |
IDet | 13 |
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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
Intervention | Events (Number) |
---|
IDeg | 164 |
IDet | 150 |
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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)
Intervention | Events (Number) |
---|
IDeg | 429 |
IDet | 328 |
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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
Intervention | mmol/L (Mean) |
---|
IDeg | 7.37 |
IDet | 6.96 |
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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)
Intervention | Kilogram (Kg) (Mean) |
---|
IDeg | 11.97 |
IDet | 10.81 |
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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
Intervention | Standard Deviation score (Mean) |
---|
IDeg | 1.7 |
IDet | 1.2 |
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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
Intervention | grams (g) (Mean) |
---|
IDeg | 3691.0 |
IDet | 3490.2 |
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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
Intervention | Participants (Count of Participants) |
---|
| Spontaneous vaginal birth | Planned caesarean section | Operative vaginal birth | Non planned caesarean section | Missing |
---|
IDeg | 11 | 42 | 8 | 23 | 7 |
,IDet | 18 | 45 | 9 | 15 | 7 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No | Unaddressed |
---|
IDeg | 4 | 87 | 1 |
,IDet | 5 | 87 | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No |
---|
IDeg | 36 | 48 |
,IDet | 31 | 53 |
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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
Intervention | mmol/L (Mean) |
---|
IDeg | 6.17 |
IDet | 6.79 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No |
---|
IDeg | 58 | 26 |
,IDet | 53 | 31 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No | Unaddressed |
---|
IDeg | 86 | 5 | 1 |
,IDet | 85 | 7 | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No |
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IDeg | 12 | 79 |
,IDet | 7 | 87 |
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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
Intervention | Participants (Count of Participants) |
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| Yes | No | Unaddressed |
---|
IDeg | 34 | 57 | 1 |
,IDet | 26 | 66 | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No |
---|
IDeg | 8 | 84 |
,IDet | 8 | 88 |
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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
Intervention | Participants (Count of Participants) |
---|
| During the first 24 hours after birth72577228 | During the first 24 hours after birth72577227 | Between 24 hours and 48 hours after birth72577227 | Between 24 hours and 48 hours after birth72577228 |
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| Yes | No | Unaddressed category |
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IDeg | 20 |
IDet | 19 |
IDeg | 64 |
IDet | 65 |
IDeg | 2 |
IDet | 1 |
IDeg | 4 |
IDet | 5 |
IDeg | 77 |
IDet | 78 |
IDeg | 5 |
IDet | 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)
Intervention | Participants (Count of Participants) |
---|
| Left eye72577227 | Left eye72577228 | Right eye72577227 | Right eye72577228 |
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| Missing | Yes | No |
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IDet | 13 |
IDeg | 2 |
IDet | 2 |
IDeg | 79 |
IDet | 79 |
IDeg | 10 |
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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
Intervention | Participants (Count of Participants) |
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| Yes | No | Unaddressed |
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IDeg | 1 | 84 | 1 |
,IDet | 3 | 81 | 1 |
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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
Intervention | Percentage glycosylated hemoglobin (Mean) |
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| in-trial | on-treatment |
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IDeg | 6.30 | 6.32 |
,IDet | 6.26 | 6.26 |
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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)
Intervention | Episodes (Number) |
---|
IDeg | 5431 |
IDet | 5982 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No | Unaddressed |
---|
IDeg | 55 | 30 | 1 |
,IDet | 43 | 41 | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No | Unaddressed |
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IDeg | 0 | 91 | 1 |
,IDet | 0 | 92 | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
| Yes | No | Unaddressed |
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IDeg | 0 | 91 | 1 |
,IDet | 0 | 92 | 4 |
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