insulin, isophane profile

Insulin, Isophane: An intermediate-acting INSULIN preparation with onset time of 2 hours and duration of 24 hours. It is produced by crystallizing ZINC-insulin-PROTAMINES at neutral pH 7. Thus it is called neutral protamine Hagedorn for inventor Hans Christian Hagedorn. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ID Source	ID
PubMed CID	24839622
MeSH ID	M0011436

Synonym
ultra lente iszilin
insulin lente
insulin, ultralente
insulini cum zinco (crystallisati) [inn-latin]
insulin zinc suspension
insulin zinc
novolin u
insulini zinco amorphi aquosuspensa
zinc insulin
insulin novo lente
insulina-zinco sospensione composta [dcit]
suspension d'insuline zinc (amorphe) [inn-french]
insulini zinci amorphi suspensio
insulini zinci cristallisati suspensio
insulini zinco cristallisati aquosuspensa
suspension de insulina cinc (amorfa) [inn-spanish]
insulina-zinco sospensione (amorfa) [dcit]
suspension injectable d'insuline zinc amorphe
prompt insulin zinc suspension
injectio insulini cum zinco neutralis
insulin semilente
suspension injectable d'insuline zinc cristallisee
insulini cum zinco (amorphi) suspensio [inn-latin]
iletin u 40
insulin, lente
ultralenta zinc insulin
suspensio zinc-insulini
iniectabile insulini zinci compositum
izsab
monotard
nph iletin
insulin lente mc
ultralente insulin
suspension d'insuline zinc (composee) [inn-french]
insulini cum zinco suspensio compositacompound [inn-latin]
nph insulin
insulin nph
insulina-zinco sospensione (crisstallina) [dcit]
extended zinc insulin suspension
lente insulin
semilente insulin
caninsulin
zinc-insulinum
insulin, crystalline zinc
suspension injectable d'insuline zinc mixte
insulini zinci suspensio mixta
suspension d'insuline zinc (cristallisee) [inn-french]
suspension de insulina cinc (compuesta) [inn-spanish]
insulin, semi-lente
iniectabile insulini zinci cristallisati
suspension de insulina cinc (cristal.) [inn-spanish]
iniectabile insulini zinci amorphi
einecs 232-469-4
insulin, crystalline
NPH ,
lente
8049-62-5
insulini cum zinco (amorphi) suspensio
insulin zinc injection (aqueous suspension)
insulini cum zinco suspensio compositacompound
insulin zinc purified porcine (suspension)
insulin human zinc
suspension d'insuline zinc (composee)
insulina-zinco sospensione composta
suspension d'insuline zinc (amorphe)
insulina-zinco sospensione (crisstallina)
insulin human zinc [usp]
suspension de insulina cinc (compuesta)
insulina-zinco sospensione (amorfa)
insulin zinc purified porcine (suspension) [jan]
insulin zinc injection (aqueous suspension) [jan]
suspension d'insuline zinc (cristallisee)
suspension de insulina cinc (amorfa)
lente iletin
insulin zinc [usp:ban]
insulin zinc suspension, compound [inn]
insulin, isophane
insulini cum zinco (crystallisati)
insulin zinc suspension, compound
suspension de insulina cinc (cristal.)
insulin isophane

Excerpt	Reference	Relevance
"A retrospective analysis was conducted to determine the effects of metformin on glycosylated hemoglobin (HbA1c), body weight, and adverse events in an African-American population."	( A retrospective analysis of the efficacy and safety of metformin in the African-American patient. Anderson, D; Briscoe, TA; Cooper, GS; Usifo, OS, 1997)	0.3
" There were no serious adverse events during the study."	( Safety and efficacy of [Lys(B28), Pro(B29)]-human insulin in patients with diabetes mellitus. Akalin, S; Bagriacik, N; Damci, T; Erbas, T; Ersanli, Z; Ilkova, H; Karsidag, K; Satman, I; Yilmaz, MT, 1997)	0.3
" The pattern of adverse events and injection site reactions with HOE 901 was similar to that with NPH."	( Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes. The European Study Group of HOE 901 in type 1 diabetes. Derobert, E; Eugène-Jolchine, I; Pieber, TR, 2000)	0.31
" Adverse incidents between 30 days and 6 months were the same for both groups."	( Safety of heparin reversal with protamin and immediate sheath removal after coronary angioplasty. Brekke, M; Hoffmann, P; Kløw, NE; Lohne, F; Pettersen, MS; Stavnes, S; Stensaeth, KH; Søvik, E, 2004)	0.32
" The adverse event (AE) profile, weight gain during treatment, and formation of cross-reactive antibodies were not different between BIAsp 30 and BHI 30."	( Biphasic insulin aspart 30: literature review of adverse events associated with treatment. Cucinotta, D; Davidson, J; Kawamori, R; Vaz, J; Vexiau, P, 2005)	0.33
"The combination of repaglinide, metformin and bedtime NPH is safe and effective and it provides better postprandial blood glucose control."	( Safety and efficacy of repaglinide in combination with metformin and bedtime NPH insulin as an insulin treatment regimen in type 2 diabetes. Civera, M; Martínez, I; Merchante, A; Salvador, M; Sanz, J, 2008)	0.35
" Data on adverse events, hypoglycaemia and glycaemic parameters were obtained from patients' diaries and medical notes."	( Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Benroubi, M; Borzi, V; Gumprecht, J; Kawamori, R; Shaban, J; Shah, S; Shestakova, M; Valensi, P; Wenying, Y, 2009)	0.35
" Demographic data, efficacy end-points (HbA(1c), fasting blood glucose and postprandial blood glucose) and safety end-points (serious adverse drug reactions, hypoglycaemia and adverse events) were collected at baseline and final visit."	( Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study. Benroubi, M; Borzi, V; Gumprecht, J; Kawamori, R; Shaban, J; Shah, S; Shestakova, M; Valensi, P; Wenying, Y, 2009)	0.35
" Except for two serious adverse drug reactions (ADRs) reported by one patient at 3 months, there were no reports of ADRs during the treatment period."	( Efficacy, safety and acceptability of biphasic insulin aspart 30 in Indian patients with type 2 diabetes: results from the PRESENT study. Chakkarwar, PN; Hoskote, SS; Joshi, SR; Kumar, A; Moharana, AK; Sharma, SK; Unnikrishnan, AG; Vaz, JA, 2008)	0.35
"The use of BIAsp 30 monotherapy or in combination with OADs in clinical practice was effective and safe in poorly controlled Indian type 2 diabetes patients."	( Efficacy, safety and acceptability of biphasic insulin aspart 30 in Indian patients with type 2 diabetes: results from the PRESENT study. Chakkarwar, PN; Hoskote, SS; Joshi, SR; Kumar, A; Moharana, AK; Sharma, SK; Unnikrishnan, AG; Vaz, JA, 2008)	0.35
"Efficacy measurements included haemoglobin A(1c) (HbA(1c)) and eight-point plasma glucose (PG); safety included adverse events (AEs) and hypoglycaemic episodes."	( Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. Christiansen, JS; Cucinotta, D; Kanc, K; le Devehat, C; Liebl, A; López de la Torre, M; Smirnova, O; Wojciechowska, M, 2009)	0.35
" Metformin plus glargine or plus neutral protamine Hagedorn is a safe and effective therapeutic choice for type 2 diabetes mellitus cases with poor glycaemic control; moreover, metformin plus neutral protamine is a cheaper and effective choice."	( [Comparison on efficacy and safety of two regimens for treatment of type 2 diabetes mellitus: glargine plus metformin versus neutral protamine hagedorn plus metformin]. Hu, M; Luo, Y; Yang, X; Zhang, H; Zhang, L, 2010)	0.36
"BIAsp 30 therapy appeared safe and effective and improved quality of life in Iranian patients with type 2 diabetes after 26 weeks of treatment."	( The safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in Iranians with type 2 diabetes: an open-label, non-randomised, multi-centre observational study--the Iran subgroup of the IMPROVE™ study. Afkhami-Ardekani, M; Amini, M; Bahrami, A; Esteghamati, A; Khamseh, ME; Rajabian, R; Rizi, EP, )	0.13
"Once or twice daily NPH insulin is a safe and tolerable option for pregnant diabetics who wish to fast during Ramadan."	( Safety and tolerability of once or twice daily neutral protamine hagedorn insulin in fasting pregnant women with diabetes during Ramadan. Adam, R; Jamil, MA; Kamaruddin, NA; Mustafa, N; Nor Azlin, MI; Sufian, SS; Wahab, NA, 2011)	0.37
"No evidence has been documented for increased adverse fetal outcomes with the use of insulin glargine in pregnancy compared to the use of NPH insulin."	( Safety of insulin glargine use in pregnancy: a systematic review and meta-analysis. Feig, DS; Koren, G; Moretti, ME; Pollex, E, 2011)	0.37
"Both insulin glargine and detemir improved HbA(1c) at short-term and proved to be safe and well tolerated in children and adolescents with type 1 DM."	( Comparison of the efficacy and safety of insulin glargine and insulin detemir with NPH insulin in children and adolescents with type 1 diabetes mellitus receiving intensive insulin therapy. Dündar, BN; Dündar, N; Eren, E, 2009)	0.35
" Safety endpoints included hypoglycemia rates (events/patient-year) and adverse events."	( Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Bhargava, A; Brett, J; Chu, PL; Coulter, FC; Oyer, DS; Shepherd, MD; Trippe, BS, 2012)	0.38
" Five serious adverse drug reactions (hypoglycaemia) were reported by five individuals (0."	( Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: results from the A₁chieve study. Chen, JW; El Naggar, NK; Haddad, J; Khamseh, ME; Soewondo, P, 2012)	0.38
" The primary outcome was evaluation of serious adverse drug reactions including major hypoglycaemia over 24 weeks."	( Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN cohort of the A₁chieve study. Bebakar, WM; Jain, AB; Lim-Abrahan, MA; Seah, D; Soewondo, P, 2013)	0.39
" The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia."	( Safety and effectiveness of biphasic insulin aspart 30 in a Bangladeshi subgroup of type 2 diabetic patients switched from biphasic human insulin 30: a sub-analysis of the A₁chieve study. Ashrafuzzaman, SM; Latif, ZA; Pathan, MF; Rahman, MM; Siddiqui, MN; Sobhan, MJ, 2013)	0.39
" No serious adverse drug reactions were reported."	( Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: results from the Filipino cohort of the A₁chieve study. Jain, AB; Lim-Abrahan, MA; Racho, VA; Sobrepena, LM; Yu-Gan, S, 2013)	0.39
" No serious adverse drug reactions were reported throughout the study."	( Clinical safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: results from the Indonesian cohort of the A₁chieve study. Dalem-Pemayun, TG; Lindarto, D; Renaldi, O; Soewondo, P; Wibisono, S, 2013)	0.39
" No serious adverse drug reactions were reported."	( Safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes switching from basal-bolus insulin regimens in the A1chieve study. Almaghamsi, A; Chen, JW; Chuang, LM; Dieuzeide, G; Lavalle-González, FJ; Zilov, A, 2014)	0.4
"Exenatide, metformin (MET), and biphasic insulin aspart 30 (BIA30) have been widely used in the treatment of patients with type 2 diabetes mellitus (T2DM); however, each of these medications has significant adverse effects, which limit their utilization."	( Phase III Study on Efficacy and Safety of Triple Combination (Exenatide/Metformin/Biphasic Insulin Aspart) Therapy for Type 2 Diabetes Mellitus. Bai, Y; Ji, Z; Liu, Y; Lv, C; Su, K; Wang, H; Wang, Y, )	0.13
"BIAsp 30 administered either TID or BID with metformin was a safe and effective option when intensifying treatment after failure of basal insulin and OADs in patients with T2DM."	( Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs. Asirvatham, A; Chow, F; Ersoy, C; Kadu, P; Liu, J; Miao, H; Wang, G; Werther, S; Yang, W; Ye, S, 2019)	0.51
" The adverse drug reactions were rare and similar between the two groups."	( Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: a randomized, controlled study. Gao, J; Guo, N; Han, Z; He, Z; Ji, J; Luo, X; Ma, Z; Mi, Y; Yang, Z; Zhao, H, 2020)	0.56
" Compared with NPH, IDet could control blood glucose and reached the targets faster and more effectively, thus reducing the number of insulin injections and the incidence of hypoglycemia in pregnant women without increasing adverse birth outcomes."	( Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: a randomized, controlled study. Gao, J; Guo, N; Han, Z; He, Z; Ji, J; Luo, X; Ma, Z; Mi, Y; Yang, Z; Zhao, H, 2020)	0.56
"A well-known metabolic side effect from treatment with glucocorticoids is glucocorticoid-induced diabetes mellitus (GIDM)."	( Study rationale and design of the EANITIATE study (EmpAgliflozin compared to NPH Insulin for sTeroId diAbeTEs) - a randomized, controlled, multicenter trial of safety and efficacy of treatment with empagliflozin compared with NPH-insulin in patients with Almdal, TP; Bagge Hansen, K; Holm Schultz, H; Klarskov, CK; Lommer Kristensen, P; Møller Christensen, T; Pedersen-Bjergaard, U; Persson, F; Snorgaard, O, 2020)	0.56
" More research should be conducted to reach a safe conclusion about the optimal insulin regimen for women with diabetes in pregnancy."	( Safety and efficacy of insulin detemir versus NPH in the treatment of diabetes during pregnancy: Systematic review and meta-analysis of randomized controlled trials. Athanasiadou, KI; Goulis, DG; Haidich, AB; Papakonstantinou, E; Paschou, SA; Stamatopoulos, T, 2022)	0.72

Excerpt	Reference	Relevance
" Pharmacokinetic measurements were calculated from insulin data corrected for C-peptide, including maximum insulin concentration (Cmax), time to maximum insulin concentration (tmax), terminal rate constant (beta), area under the curve from 0 to infinity (AUCinfinity0), and mean residence time (MRT)."	( Comparative pharmacokinetics and glucodynamics of two human insulin mixtures. 70/30 and 50/50 insulin mixtures. Bowsher, RR; Brunelle, RL; Cerimele, B; Compton, J; Howey, DC; Rowe, HM; Woodworth, JR, 1994)	0.29
"For the pharmacokinetic assessment, statistically greater values of insulin Cmax and beta were found for the 50/50 mixture, whereas the 70/30 mixture had a greater MRT."	( Comparative pharmacokinetics and glucodynamics of two human insulin mixtures. 70/30 and 50/50 insulin mixtures. Bowsher, RR; Brunelle, RL; Cerimele, B; Compton, J; Howey, DC; Rowe, HM; Woodworth, JR, 1994)	0.29
"0%), respectively, subsequently participated in a pharmacokinetic study."	( The influence of insulin antibodies on the pharmacokinetics of NPH insulin in patients with type 1 diabetes treated with human insulin. Hefty, R; Keck, F; Kerner, W; Klose, O; Peters, A, 1995)	0.29
" We investigated the pharmacokinetic and pharmacodynamic properties of insulin analogue NN304 (0."	( Pharmacokinetic and pharmacodynamic properties of long-acting insulin analogue NN304 in comparison to NPH insulin in humans. Brunner, GA; Ellmerer, M; Hirschberger, S; Krejs, GJ; Pieber, TR; Sendhofer, G; Siebenhofer, A; Søgaard, B; Wutte, A, 2000)	0.31
"This trial aimed to characterize for the first time the pharmacokinetic profile of insulin detemir, the novel soluble basal insulin analog, in children and adolescents compared with adults."	( Insulin detemir is characterized by a consistent pharmacokinetic profile across age-groups in children, adolescents, and adults with type 1 diabetes. Danne, T; Gall, MA; Lüpke, K; Von Schuetz, W; Walte, K, 2003)	0.32
"The mean pharmacokinetic profile of insulin detemir was similar across all three age-groups."	( Insulin detemir is characterized by a consistent pharmacokinetic profile across age-groups in children, adolescents, and adults with type 1 diabetes. Danne, T; Gall, MA; Lüpke, K; Von Schuetz, W; Walte, K, 2003)	0.32
"To compare pharmacokinetic characteristics of two biphasic insulin aspart (BIAsp) formulations: BIAsp30 and BIAsp70 (30% and 70%, respectively, of fast-acting insulin aspart) during 15 days of multiple dosing (thrice daily)."	( Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study. Chen, JW; Christiansen, JJ; Christiansen, JS; Clausen, WH; Jensen, LH; Lauritzen, T, 2005)	0.33
" CONCLUSIONS The pharmacokinetic properties of BIAsp30 and 70 remain constant during 2 weeks of daily administration in patients with Type 1 diabetes."	( Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study. Chen, JW; Christiansen, JJ; Christiansen, JS; Clausen, WH; Jensen, LH; Lauritzen, T, 2005)	0.33
"To investigate the pharmacodynamic profile and duration of action for five subcutaneous doses of insulin detemir (0."	( A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Bodenlenz, M; Draeger, E; Endahl, LA; Görzer, E; Magnes, C; Pieber, TR; Plank, J; Regittnig, W; Sinner, F; Zdravkovic, M, 2005)	0.33
"This study shows that insulin detemir provides a flat and protracted pharmacodynamic profile."	( A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Bodenlenz, M; Draeger, E; Endahl, LA; Görzer, E; Magnes, C; Pieber, TR; Plank, J; Regittnig, W; Sinner, F; Zdravkovic, M, 2005)	0.33
" At the end of the treatment period, all patients attended two 24-h profile days 1 week apart for pharmacokinetic and pharmacodynamic assessments."	( Impact of insulin antibodies on insulin aspart pharmacokinetics and pharmacodynamics after 12-week treatment with multiple daily injections of biphasic insulin aspart 30 in patients with type 1 diabetes. Chen, JW; Christiansen, JS; Frystyk, J; Lauritzen, T, 2005)	0.33
"The pharmacokinetic and pharmacodynamic properties of biphasic insulin aspart (BIAsp 30) (30% soluble, 70% protaminated insulin aspart [IAsp]) and insulin glargine (IGlarg) were compared."	( Comparison of the pharmacokinetics and pharmacodynamics of biphasic insulin aspart and insulin glargine in people with type 2 diabetes. Dunseath, G; Luzio, S; Owens, DR; Pauvaday, V; Peter, R, 2006)	0.33
"The pharmacodynamic and pharmacokinetic profiles were 34 and 28%, respectively, higher following equivalent doses (0."	( Comparison of the pharmacokinetics and pharmacodynamics of biphasic insulin aspart and insulin glargine in people with type 2 diabetes. Dunseath, G; Luzio, S; Owens, DR; Pauvaday, V; Peter, R, 2006)	0.33
"The aim of this study was to compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of BIAsp50 (test) and BIAsp30 (reference) after single-dose SC injection in patients with type 2 diabetes mellitus."	( Comparison of the pharmacokinetic and pharmacodynamic profiles of biphasic insulin aspart 50 and 30 in patients with type 2 diabetes mellitus: a single-center, randomized, double-blind, two-period, crossover trial in Japan. Hirao, K; Hirao, S; Maeda, H; Sasaki, T; Sasako, T; Takisawa, Y; Urata, S, 2007)	0.34
"The purpose of this study was to evaluate pharmacokinetic and pharmacodynamic profiles of pure insulin aspart and three different formulations of insulin aspart and protaminated insulin aspart: biphasic insulin aspart 30 (BIAsp30), biphasic insulin aspart 50 (BIAsp50) and biphasic insulin aspart 70 (BIAsp70)."	( A comparison of pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30, 50, 70 and pure insulin aspart: a randomized, quadruple crossover study. Chen, JW; Christiansen, JS; Ejskjaer, N; Parkner, T; Thorisdottir, RL, 2009)	0.35
"This pedagogical review illustrates the differences between pharmacokinetic (PK) and pharmacodynamic (PD) measures, using insulin therapy as the primary example."	( How pharmacokinetic and pharmacodynamic principles pave the way for optimal basal insulin therapy in type 2 diabetes. Arnolds, S; Heise, T; Kapitza, C; Kuglin, B, 2010)	0.36
" The aim was to directly compare the pharmacodynamic properties of the long-acting insulin analogues and NPH insulin after a single subcutaneous injection."	( Similarity of pharmacodynamic effects of a single injection of insulin glargine, insulin detemir and NPH insulin on glucose metabolism assessed by 24-h euglycaemic clamp studies in healthy humans. Brock, B; Mengel, A; Moller, N; Nielsen, S; Rungby, J; Schmitz, O; Sørensen, LP; Vølund, A, 2010)	0.36
"In this experimental design, only minor pharmacodynamic differences were demonstrated between insulin detemir, insulin glargine and NPH insulin."	( Similarity of pharmacodynamic effects of a single injection of insulin glargine, insulin detemir and NPH insulin on glucose metabolism assessed by 24-h euglycaemic clamp studies in healthy humans. Brock, B; Mengel, A; Moller, N; Nielsen, S; Rungby, J; Schmitz, O; Sørensen, LP; Vølund, A, 2010)	0.36
"With the aim to improve current therapeutic and monitoring options for diabetic cats, the present study compared pharmacodynamic parameters of protamine zinc insulin (PZI) and insulin degludec and validated the continuous glucose monitoring system (CGMS) iPro2 with Sof-sensor and Enlite-sensor focusing on the low glycemic range."	( Comparison of the pharmacodynamics of protamine zinc insulin and insulin degludec and validation of the continuous glucose monitoring system iPro2 in healthy cats. Lutz, TA; Reusch, CE; Riederer, A; Salesov, E; Zini, E, 2018)	0.48
"To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin-70/30) and HUMULIN® 70/30 (HUMULIN-70/30; Eli Lilly and Company, IN)."	( Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US-licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE-3 (Recombinant Human INsulin Equivalence-3) study. Athalye, SN; Klein, O; Lakshmi, GC; Loganathan, S; Marwah, A; Murugesan, SMN; Panda, J; Plum-Mörschel, L; Sharma, N; Singh, G, 2022)	0.72
"To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin N (Biocon's Insulin-N; Biocon Biologics Ltd."	( Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar insulin N with US-licensed Humulin® N formulation in healthy subjects: Results from the RHINE-2 (Recombinant Human INsulin Equivalence-2) study. Andersen, G; Athalye, SN; Gogineni, R; Loganathan, S; Marwah, A; Murugesan, SMN; Panda, J; Sharma, N; Singh, G, 2023)	0.91

Excerpt	Reference	Relevance
"To compare the effect of morning and bedtime NPH insulin combined with daytime sulfonylurea on glycemic control in non-insulin-dependent diabetes mellitus (NIDDM) patients no longer responding to treatment with sulfonylureas alone."	( Morning or bedtime NPH insulin combined with sulfonylurea in treatment of NIDDM. Ekstrand, A; Eriksson, JG; Franssila-Kallunki, A; Groop, LC; Saloranta, C; Schalin-Jäntti, C; Widén, E, 1992)	0.28
"Morning and bedtime NPH insulin combined with glibenclamide are equipotent in the treatment of NIDDM patients with secondary failure to sulfonylurea."	( Morning or bedtime NPH insulin combined with sulfonylurea in treatment of NIDDM. Ekstrand, A; Eriksson, JG; Franssila-Kallunki, A; Groop, LC; Saloranta, C; Schalin-Jäntti, C; Widén, E, 1992)	0.28
"To compare the effect of bedtime NPH insulin or preprandial regular insulin combined with glibenclamide on metabolic control in non-insulin-dependent diabetes mellitus (NIDDM) patients with secondary failure to sulfonylurea therapy."	( Comparison of bedtime NPH or preprandial regular insulin combined with glibenclamide in secondary sulfonylurea failure. Adamson, U; Arner, P; Bolinder, J; Landstedt-Hallin, L; Lins, PE, 1995)	0.29
"Eighty NIDDM patients were randomized to treatment with either three preprandial doses of regular insulin (daytime group D) or a bedtime dose of NPH insulin (nocturnal insulinization, group N), both regimens being combined with 10."	( Comparison of bedtime NPH or preprandial regular insulin combined with glibenclamide in secondary sulfonylurea failure. Adamson, U; Arner, P; Bolinder, J; Landstedt-Hallin, L; Lins, PE, 1995)	0.29
" In 707 randomized patients, 379 with IDDM and 328 with NIDDM, we studied the effect of twice-daily insulin lispro or regular human insulin in combination with NPH human insulin (isophane insulin) on premeal, 2-hour postprandial, and bedtime glycemic control."	( Efficacy of insulin lispro in combination with NPH human insulin twice per day in patients with insulin-dependent or non-insulin-dependent diabetes mellitus. Multicenter Insulin Lispro Study Group. Anderson, JH; Iversen, PW; Vignati, L, )	0.13
"To compare the effect on glycemic control and weight gain of repaglinide versus metformin combined with bedtime NPH insulin in patients with type 2 diabetes."	( Repaglinide versus metformin in combination with bedtime NPH insulin in patients with type 2 diabetes established on insulin/metformin combination therapy. Furlong, NJ; Hardy, KJ; Hulme, SA; O'Brien, SV, 2002)	0.31
"To investigate the efficacy and safety of glimepiride combined with either morning or bedtime insulin glargine or bedtime neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes."	( Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Fritsche, A; Häring, HU; Schweitzer, MA, 2003)	0.32
"The risk for nocturnal hypoglycemia was lower with glimepiride in combination with morning and bedtime insulin glargine than with glimepiride in combination with bedtime NPH insulin in patients with type 2 diabetes."	( Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Fritsche, A; Häring, HU; Schweitzer, MA, 2003)	0.32
"), or biphasic human insulin 70/30 (30 min before dinner) in combination with metformin."	( Starting patients with type 2 diabetes on insulin therapy using once-daily injections of biphasic insulin aspart 70/30, biphasic human insulin 70/30, or NPH insulin in combination with metformin. Jain, R; Kilo, C; McGill, J; Mersey, J; Mezitis, N; Raskin, P, )	0.13
" gliclazide combined with bedtime NPH insulin in patients with Type 2 diabetes inadequately controlled with oral hypoglycaemic therapy [HbA1c>7."	( Comparison of repaglinide vs. gliclazide in combination with bedtime NPH insulin in patients with Type 2 diabetes inadequately controlled with oral hypoglycaemic agents. Furlong, NJ; Hardy, KJ; Hulme, SA; O'Brien, SV, 2003)	0.32
"Over 13 weeks, both repaglinide and gliclazide, when combined with bedtime NPH insulin produce similar significant improvements in glycaemic control (-1%) and similar weight gain."	( Comparison of repaglinide vs. gliclazide in combination with bedtime NPH insulin in patients with Type 2 diabetes inadequately controlled with oral hypoglycaemic agents. Furlong, NJ; Hardy, KJ; Hulme, SA; O'Brien, SV, 2003)	0.32
"In type 2 diabetic patients we compared 9 months of combination therapy with insulin glargine and metformin with 9 months of NPH insulin combined with metformin."	( Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Hänninen, J; Hardy, K; Hulme, S; Kauppinen-Mäkelin, R; Lahdenperä, S; Lehtonen, R; Levänen, H; McNulty, S; Nikkilä, K; Ryysy, L; Tiikkainen, M; Tulokas, T; Vähätalo, M; Virtamo, H; Yki-Järvinen, H, 2006)	0.33
" This study compared the efficacy and safety of insulin glargine and NPH insulin, both in combination with a once-daily fixed dose of glimepiride, in terms of glycemic control and incidence of hypoglycemia."	( Therapy in type 2 diabetes: insulin glargine vs. NPH insulin both in combination with glimepiride. Aschner, P; Calvo, C; Eliaschewitz, FG; Jimenez, J; Ramirez, LA; Ruiz, M; Valbuena, H; Villena, J, 2006)	0.33
" Biphasic insulin aspart 30 in combination with metformin administered twice a day may be recommended as a starting insulin treatment in obese diabetic persons whose glycaemic control remained poor while on oral metformin therapy alone."	( Effect of biphasic insulin aspart 30 combined with metformin on glycaemic control in obese people with type 2 diabetes. Ascić-Buturović, B, 2007)	0.34
"Saxagliptin in combination with MET or SU is likely to represent a cost-effective treatment option in Polish patients with type 2 diabetes failing first-line treatment."	( The cost-effectiveness of saxagliptin versus NPH insulin when used in combination with other oral antidiabetes agents in the treatment of type 2 diabetes mellitus in Poland. Czupryniak, L; Grzeszczak, W; Kolasa, K; Lomon, ID; McEwan, P; Sciborski, C, 2012)	0.38
" PZI combined with Se decreased the body weight and fasting blood glucose levels."	( Protamine zinc insulin combined with sodium selenite improves glycometabolism in the diabetic KKAy mice. Chen, L; Chen, M; Ji, W; Lu, J; Ren, S; Wang, B; Wang, M; Yan, W; Yuan, B; Zhao, M, 2016)	0.43

Excerpt	Reference	Relevance
" In conclusion, the results of this study confirm that the mixtures of regular + isophane insulins (Actrapid HM + Protaphane HM) and regular + lente insulins (Actrapid HM + Monotard HM) give the same guaranties of safety and efficacy, that the former shows a more rapid absorption rate and, finally, indicate that the ratio 30:70 between regular and intermediate insulins is that more frequently used."	( [Advances in insulin treatment. Evaluation of isophane or lente insulin, mixed with rapid insulin and injected twice-a-day]. Cucinotta, D; Lunetta, M, )	0.13
" Regular insulin administered subcutaneously was better absorbed than NPH and PZI insulins (mean bioavailability index 45."	( Absorption kinetics of regular, isophane, and protamine zinc insulin in normal cats. Nichols, CE; Peterson, ME; Wallace, MS, 1990)	0.28
"In order to determine the effect of exercise on the rate of absorption of an isophane (NPH) insulin, 7 normal men were studied on two separate occasions using the euglycaemic clamp technique."	( Exercise augments the absorption of isophane (NPH) insulin. Antsiferov, M; Home, PD; Johnson, AB; Thow, JC, )	0.13
" Regular insulin was better absorbed than NPH insulin (mean bioavailability index 64."	( Absorption kinetics of regular and isophane (NPH) insulin in the normal dog. Esposito, LA; Goeders, LA; Peterson, ME, 1987)	0.27
" However, an increase in the injected dose from 6 to 24 IU resulted in a decrease of approximately 30% in the absorption rate of all NPH insulins."	( Dose-dependent subcutaneous absorption of porcine, bovine and human NPH insulins. Birch, K; Hildebrandt, P; Sestoft, L; Vølund, A, 1984)	0.27
"Higher insulin concentrations and a greater initial response were present with the 50/50 mixture, but the two mixtures had equivalent bioavailability and cumulative effects."	( Comparative pharmacokinetics and glucodynamics of two human insulin mixtures. 70/30 and 50/50 insulin mixtures. Bowsher, RR; Brunelle, RL; Cerimele, B; Compton, J; Howey, DC; Rowe, HM; Woodworth, JR, 1994)	0.29
" As such, it's rate of absorption from subcutaneous sites of injection is greater that of regular insulin."	( [Spanish experience with insulin lispro]. Reviriego Fernández, J, 1998)	0.3
"In study 1, the time in hours for 25% of the administered radioactivity to disappear after bolus subcutaneous injection (T75%) for NPH insulin indicated a significantly faster absorption rate compared with the 2 insulin glargine formulations (3."	( Pharmacokinetics of 125I-labeled insulin glargine (HOE 901) in healthy men: comparison with NPH insulin and the influence of different subcutaneous injection sites. Coates, PA; Kurzhals, R; Luzio, SD; Owens, DR; Tinbergen, JP, 2000)	0.31
" There is little or no difference in the absorption rate of insulin glargine between the main subcutaneous injection sites."	( Pharmacokinetics of 125I-labeled insulin glargine (HOE 901) in healthy men: comparison with NPH insulin and the influence of different subcutaneous injection sites. Coates, PA; Kurzhals, R; Luzio, SD; Owens, DR; Tinbergen, JP, 2000)	0.31
"Insulin glargine (HOE 901, 21(A)-Gly-30(B)a-L-Arg-30(B)b-L-Arg human insulin) is a novel recombinant analog of human insulin with a shift in the isoelectric point producing a retarded absorption rate and an increased duration of action that closely mimics normal basal insulin secretion."	( Basal insulin glargine (HOE 901) versus NPH insulin in patients with type 1 diabetes on multiple daily insulin regimens. U.S. Insulin Glargine (HOE 901) Type 1 Diabetes Investigator Group. Park, G; Rosenstock, J; Zimmerman, J, 2000)	0.31
" Previous studies have shown poor bioavailability (less than 15%) with nasal insulin administration with various absorption enhancers."	( Six month administration of gelified intranasal insulin in 16 type 1 diabetic patients under multiple injections: efficacy vs subcutaneous injections and local tolerance. Bardin, C; Boillot, J; Chast, F; Coste, A; Escudier, E; Lalej-Bennis, D; Peynegre, R; Selam, JL; Slama, G; Zirinis, P, 2001)	0.31
"Insulin-like growth factor binding protein-1 (IGFBP-1) is known to regulate the bioavailability of insulin-like growth factor (IGF) and the levels of IGFBP-1 are increased in the morning in patients with type 1 diabetes mellitus."	( Nocturnal blood glucose and IGFBP-1 changes in type 1 diabetes: Differences in the dawn phenomenon between insulin regimens. Amemiya, S; Cho, H; Kobayashi, K; Mitsui, Y; Mochizuki, M; Nagamine, K; Nakazawa, S; Ohyama, K; Saitou, T; Yagasaki, H, 2010)	0.36
" This requires that the bioavailability of the different insulins is considered."	( Bioavailability and variability of biphasic insulin mixtures. Colding-Jørgensen, M; Mosekilde, E; Rasmussen, CH; Søeborg, T, 2012)	0.38
"Manufacturers of insulin products for diabetes therapy have long sought ways to modify the absorption rate of exogenously administered insulins in an effort to better reproduce the naturally occurring pharmacokinetics of endogenous insulin secretion."	( Impact of the mode of protraction of basal insulin therapies on their pharmacokinetic and pharmacodynamic properties and resulting clinical outcomes. Heise, T; Mathieu, C, 2017)	0.46

Excerpt	Relevance	Reference
" The improved accuracy in dosing with premixed insulin might explain the previously observed improved glycemic control in patients taking premixed insulin."	( Dosage accuracy of self-mixed vs premixed insulin. Bell, DS; Clements, RS; Perentesis, G; Roddam, R; Wagenknecht, L, 1991)	0.28
" Total insulin dosage was similar (NPH 56."	( Double-blind crossover trial of isophane (NPH)- and lente-based insulin regimens. Alberti, KG; Burrin, JM; Davis, SN; Home, PD; Jensen, I; Murphy, M; Newens, A; Tunbridge, FK, 1989)	0.28
" Diet, exercise, and insulin dosage remained constant."	( Twice-daily mixed regular and NPH insulin injections with new jet injector versus conventional syringes: pharmacokinetics of insulin absorption. Coutu, F; Hallé, JP; Lalumière, G; Lambert, J; Legault, C; Legendre, L; Lindmayer, I; Menassa, K; Moghrabi, A, )	0.13
" While insulin dosage did not change, there was a slight increase in fasting serum glucose and a statistically significant increase in fasting ketonuria."	( The U.S. "new patient" and "transfer" studies. Allemenos, D; Fineberg, SE; Galloway, JA; Ingulli-Fattic, J; Marsden, JH; Peck, FB; Spradlin, CT, )	0.13
" This implies that minor adjustments of intermediate insulin dosage are probably futile."	( Absorption of isophane (NPH) insulin and its clinical implications. Binder, C; Deckert, T; Gale, EA; Lauritzen, T; Pramming, S, 1982)	0.26
" The insulin dosage was increased until the FPG level was normalized."	( Safety and efficacy of normalizing fasting glucose with bedtime NPH insulin alone in NIDDM. Comstock, JP; Cunningham, GR; Cusi, K, 1995)	0.29
" No change of the insulin dosage was performed during the study period."	( Improvement of basal hepatic glucose production and fasting hyperglycemia of type I diabetic patients treated with human recombinant ultralente insulin. Avogaro, A; Del Prato, S; Riccio, A; Tiengo, A; Valerio, A; Zappella, A, 1994)	0.29
" Daily, two-thirds of the total dosage was given before breakfast (63."	( [Insulin combinations: improving the treatment of juvenile diabetes]. Durá Travé, T; Gúrpide Arraya, N; Moya Benavent, M, )	0.13
" Earlier basal NPH dosage alone does not ameliorate the nighttime hyperglycemia of short-acting insulin analog regimens."	( Optimization of evening insulin dose in patients using the short-acting insulin analog lispro. Ahmed, AB; Home, PD; Mallias, J, 1998)	0.3
" The bedtime NPH dosage was no different."	( Long-term intensive treatment of type 1 diabetes with the short-acting insulin analog lispro in variable combination with NPH insulin at mealtime. Bartocci, L; Bolli, GB; Brunetti, P; Cartechini, MG; Ciofetta, M; Compagnucci, P; Del Sindaco, P; Lalli, C; Pampanelli, S; Torlone, E, 1999)	0.3
"001), suggesting a clear dose-response relationship for both NPH insulin and NN304."	( Pharmacokinetic and pharmacodynamic properties of long-acting insulin analogue NN304 in comparison to NPH insulin in humans. Brunner, GA; Ellmerer, M; Hirschberger, S; Krejs, GJ; Pieber, TR; Sendhofer, G; Siebenhofer, A; Søgaard, B; Wutte, A, 2000)	0.31
" Patients were managed by a specialist nurse using a dosage adjustment protocol."	( Appropriate insulin regimes for type 2 diabetes: a multicenter randomized crossover study. Davies, R; Fox, C; Sampson, M; Taylor, R; Weaver, JU; Wood, L, 2000)	0.31
" Although the dosage of NPH insulin at bedtime was increased to 32 U/day, there was no improvement in the FPG level."	( Type-1 diabetes mellitus with insufficient serum immunoreactive insulin elevation after subcutaneous NPH-insulin injection. Fujimoto, S; Kurose, T; Matsushima, A; Oya, M; Seino, Y; Shimono, D; Takeda, T; Yamada, Y; Yoshitani, K, 2003)	0.32
" Other drawbacks include inter- and intra-patient variability that compromises dosing reproducibility and unsuitability for single daily dosing."	( A review of basal insulins. Barnett, AH, 2003)	0.32
"Preprandial dosing (within 5 min before meal) and postprandial dosing (15-20 min after meal onset) of NovoLog Mix 70/30 (BIAsp 30, a biphasic formulation of insulin aspart, 30% soluble and 70% protamine-crystallized) were compared in elderly (> or =65 years) type 2 diabetes patients in this open-label, 12-week, crossover study."	( Postprandial versus preprandial dosing of biphasic insulin aspart in elderly type 2 diabetes patients. Allen, E; Conway, MJ; Klaff, LJ; Rosenstock, J; Warren, ML, 2004)	0.32
" The convenience of dosing immediately before the meal contributed 37%."	( Patient preference and willingness-to-pay for Humalog Mix25 relative to Humulin 30/70: a multicountry application of a discrete choice experiment. Aristides, M; FitzGerald, P; Le Reun, C; Maniadakis, N; Weston, AR, )	0.13
" Insufficient data are available to conclude whether insulin glargine is different from each of the commonly used NPH dosing regimens: once daily and more than once daily."	( Systematic review and economic evaluation of a long-acting insulin analogue, insulin glargine. Beverley, C; Chilcott, J; Warren, E; Weatherley-Jones, E, 2004)	0.32
"To compare pharmacokinetic characteristics of two biphasic insulin aspart (BIAsp) formulations: BIAsp30 and BIAsp70 (30% and 70%, respectively, of fast-acting insulin aspart) during 15 days of multiple dosing (thrice daily)."	( Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study. Chen, JW; Christiansen, JJ; Christiansen, JS; Clausen, WH; Jensen, LH; Lauritzen, T, 2005)	0.33
"The medical literature supports the fact that sliding scale dosing of insulin is an ineffective means to control blood glucose concentrations."	( 70/30 insulin algorithm versus sliding scale insulin. Gresham, DG; Rice, DA; Schoeffler, JM, 2005)	0.33
"To compare the efficacy of an algorithm using 70/30 insulin with traditional SSI dosing for glycemic control in hospitalized patients with type 2 diabetes."	( 70/30 insulin algorithm versus sliding scale insulin. Gresham, DG; Rice, DA; Schoeffler, JM, 2005)	0.33
" Patients were screened for enrollment based on orders received in the pharmacy for sliding scale dosing of insulin."	( 70/30 insulin algorithm versus sliding scale insulin. Gresham, DG; Rice, DA; Schoeffler, JM, 2005)	0.33
" Total daily insulin dosage was significantly lower in patients with high than moderate levels of insulin antibodies."	( Impact of insulin antibodies on insulin aspart pharmacokinetics and pharmacodynamics after 12-week treatment with multiple daily injections of biphasic insulin aspart 30 in patients with type 1 diabetes. Chen, JW; Christiansen, JS; Frystyk, J; Lauritzen, T, 2005)	0.33
" In both groups the total insulin dosage was reduced."	( The effect of resistance versus aerobic training on metabolic control in patients with type-1 diabetes mellitus. Abrantes, V; Andrade, A; Aragão, C; Barbosa, C; Cambuí, Z; de Lourdes Lima, M; Martins, M; Nunes, F; Ramalho, AC; Temístocles, M; Viana, A, 2006)	0.33
"To evaluate the time-action profiles and the dose-response relationship of the long-acting insulin analogues insulin detemir (IDet) and NPH insulin (NPH) in type 2 diabetic patients belonging to different ethnic groups."	( Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups. Elbroend, B; Endahl, L; Haahr, H; Heinemann, L; Heise, T; Hompesch, M; Troupin, B, 2006)	0.33
"These results confirm a linear dose-response relationship of IDet, without any relevant differences between ethnic groups."	( Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups. Elbroend, B; Endahl, L; Haahr, H; Heinemann, L; Heise, T; Hompesch, M; Troupin, B, 2006)	0.33
"The pharmacology, pharmacokinetics, efficacy and tolerability, safety, drug interactions, dosage and administration, cost, and place in therapy of insulin detemir are reviewed."	( Insulin detemir: a long-acting insulin product. Jones, MC; Patel, M, 2006)	0.33
" In most trials, patients were randomized to receive insulin on three different dosing schedules: basal insulin twice daily before breakfast and at bedtime, basal insulin at 12-hour intervals, or basal insulin before breakfast and dinner."	( Insulin detemir: a long-acting insulin product. Jones, MC; Patel, M, 2006)	0.33
" Mean daily dosage for glargine at 12 weeks were (0."	( [Post-hoc analyses of type 2 diabetes patients switch from premixed insulin regimen to basal insulin plus oral hypoglycemic agents regimen]. Bu, S; Gao, Y; Guo, XH; Lu, GZ; Ren, TT; Yang, WY; Yang, ZJ, 2007)	0.34
" Glycated haemoglobin (HbA1C), 1,5-anhydroglucitol (1,5-AG), blood plasma glucose level, body mass index (BMI), daily total insulin dosage and insulin therapy-related QOL (ITR-QOL) were studied."	( Comparison of twice-daily injections of biphasic insulin lispro and basal-bolus therapy: glycaemic control and quality-of-life of insulin-naïve type 2 diabetic patients. Atsuda, K; Inoue, G; Irie, J; Kitaoka, A; Masuda, H; Sakamoto, M; Shiono, K; Yamada, S, 2008)	0.35
" The data recorded at baseline included demographic characteristics, detailed medical histories, physician-cited reasons for starting BIAsp 30 treatment, and the chosen dosage regimens."	( Baseline characteristics of the Indian cohort from the IMPROVE study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes. Baruah, MP; Das, AK; Ganapathi, B; Kalra, S; Kumar, A; Sahay, RK; Shah, S; Unnikrishnan, AG, 2009)	0.35
" In contrast, serial dosing with NPH elevated CRH and GCK, diminished OT, but did not alter VP gene transcripts."	( Impact of recurring intermediate insulin-induced hypoglycemia on hypothalamic paraventricular corticotropin-releasing hormone, oxytocin, vasopressin and glucokinase gene profiles: role of type II glucocorticoid receptors. Briski, KP; Kale, AY; Vavaiya, KV, 2009)	0.35
" BIAsp 30 dosage was determined by the patient's attending physician; coadministration of hypotensive agents and antilipemic agents was permitted, but OAD coadministration was limited to patients already receiving such drugs at the start of the study."	( Step-up therapy with biphasic insulin aspart-70/30--Sapporo 1-2-3 study. Aoki, S; Kato, M; Kijima, H; Koike, T; Komori, K; Kurihara, Y; Manda, N; Ono, Y; Wada, N; Yanagisawa, K; Yoshioka, N, 2009)	0.35
" However, at present, international recommendations for intensification of insulin therapy using premix analogues are limited and specific guidance on dosing is not available for many scenarios."	( Practical guidance on intensification of insulin therapy with BIAsp 30: a consensus statement. Damci, T; Gero, L; Gumprecht, J; Hadley-Brown, M; Krentz, AJ; Ligthelm, R; Mu, Y; Raz, I; Tibaldi, J; Unnikrishnan, AG, 2009)	0.35
" ARH InsRb gene profiles were decreased, relative to baseline, after either one or four NPH injections in OVX + EB rats; mean mRNA levels were significantly lower after serial dosing since basal InsRb transcripts were diminished by precedent NPH treatment."	( Adaptation of arcuate insulin receptor, estrogen receptor-alpha, estrogen receptor-beta, and type-II glucocorticoid receptor gene profiles to chronic intermediate insulin-induced hypoglycemia in estrogen-treated ovariectomized female rats. Briski, KP; Genabai, NK, 2010)	0.36
" Individual NPY-immunoreactive neurones were laser-microdissected from the caudal arcuate nucleus after single or serial dosing with neutral protamine Hagedorn insulin (NPH), and evaluated by quantitative real-time reverse transcriptase-polymerase chain reaction for the assessment of neurotransmitter and receptor gene expression."	( Effects of hypoglycaemia on neurotransmitter and hormone receptor gene expression in laser-dissected arcuate neuropeptide Y/agouti-related peptide neurones. Briski, KP; Koshy Cherian, A; Nedungadi, TP, 2010)	0.36
" While data presented by Kaiser and colleagues demonstrated that the issue of proper mixing is not trivial, the modest differences observed between and within products both at the initial dose and with repeated dosing may indicate that the clinical relevance of these findings is most applicable to those requiring large doses or, alternatively, those who have otherwise unexplained hypoglycemic episodes."	( An analysis of the mixing efficiency of neutral protamine Hagedorn cartridges. Comerford, P; Dearing, N; Monte, SV, 2010)	0.36
" Furthermore, intensive glycemic control was achieved with insulin detemir in insulin dependent diabetic dogs, using a lower dosage than NPH insulin and insulin glargine therapeutic doses."	( Time-action profiles of insulin detemir in normal and diabetic dogs. Arai, T; Ishioka, K; Kurishima, M; Lee, P; Makino, Y; Miki, Y; Mimura, K; Mizutani, H; Mori, A; Nozawa, S; Oda, H; Saeki, K; Sako, T, 2011)	0.37
" Adjustments in dosage of rhPZI were made as needed to control glycemia."	( Efficacy of protamine zinc recombinant human insulin for controlling hyperglycemia in dogs with diabetes mellitus. Dennis, J; Johnson, E; Kass, PH; Maggiore, AD; Nelson, RW, )	0.13
" Insulin glargine was replaced with the same dosage of NPH insulin."	( Insulin glargine or neutral protamine Hagedorn in patients with severe insulin resistance: Is there a benefit? Bota, VM; Hirsch, IB, )	0.13
" An expected reduction in dosing frequency, as well as in the basal insulin dose was reported for glargine vs."	( Outcomes with insulin glargine in patients with type 2 diabetes previously on NPH insulin: evidence from clinical practice in Spain. Delgado, E, 2012)	0.38
"4% were dosing BHI twice daily (bid)."	( Switching from biphasic human insulin to biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN subgroup of the A₁chieve study. Goh, SY; Hussein, Z; Jain, AB; Lim-Abrahan, MA; Soewondo, P, 2013)	0.39
" The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins."	( Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes. Bolli, GB; Candelas, C; Dain, MP; Deerochanawong, C; Home, PD; Landgraf, W; Mathieu, C; Pilorget, V; Riddle, MC, 2015)	0.42
"The strategies that aim at preventing diabetic retinopathy by treating T2DM patients with long-acting insulin analogues remain further prospective studies with longer follow-up period to validate our observations within an appropriate dosage range and to further evaluate the safety of long-acting insulin analogues on reducing the progression of diabetic retinopathy."	( Long-acting insulin analogues and diabetic retinopathy: a retrospective cohort study. Lai, MS; Lin, JC; Shau, WY, 2014)	0.4
" Significant differences were observed between the basal insulin groups for glycated hemoglobin level and dosing frequency."	( Use of basal insulin and the associated clinical outcomes among elderly nursing home residents with type 2 diabetes mellitus: a retrospective chart review study. Davis, KL; Kilpatrick, BS; Meyers, JL; Pandya, N; Wei, W, 2014)	0.4
" Differences in glycated hemoglobin and dosing frequencies between types of basal insulin warrant further comparative effectiveness studies."	( Use of basal insulin and the associated clinical outcomes among elderly nursing home residents with type 2 diabetes mellitus: a retrospective chart review study. Davis, KL; Kilpatrick, BS; Meyers, JL; Pandya, N; Wei, W, 2014)	0.4
" Data regarding blood glucose control, insulin dosage adjustment and recording of hypoglycemia episodes were obtained through telephone calls; office visits were conducted to measure weight, glycated hemoglobin, fasting plasma glucose and blood glucose profile."	( Replacing Insulin Glargine with Neutral Protamine Hagedorn (NPH) Insulin in a Subpopulation of Study Subjects in the Action to Control Cardiovascular Risk in Diabetes (ACCORD): Effects on Blood Glucose Levels, Hypoglycemia and Patient Satisfaction. Berard, L; Cameron, B; Stewart, J; Woo, V, 2015)	0.42
" The patients were enrolled to take BIAsp 30 according to physician's clinical judgments, who was also responsible for the treatment regimen and dosage adjustment."	( [The predictive factors of good glycaemic control in Chinese patients receiving biphasic insulin as part 30: a subgroup analyses from the A1 chieve study]. Chang, B; Chen, B; Gao, Z; Hong, J; Lei, M; Wang, Z; Xu, M; Yang, W; Zhang, X; Zhuang, X, 2015)	0.42
"Long-term, high dosage protamine zinc insulin (PZI) treatments produce adverse reactions."	( Protamine zinc insulin combined with sodium selenite improves glycometabolism in the diabetic KKAy mice. Chen, L; Chen, M; Ji, W; Lu, J; Ren, S; Wang, B; Wang, M; Yan, W; Yuan, B; Zhao, M, 2016)	0.43
" Indeed, NPH insulin remains widely used today despite a frequent need for a twice-daily dosing and a relatively high incidence of hypoglycaemia."	( Impact of the mode of protraction of basal insulin therapies on their pharmacokinetic and pharmacodynamic properties and resulting clinical outcomes. Heise, T; Mathieu, C, 2017)	0.46
" For BBIT, owners were instructed to continue NPH insulin administration at the usual dosage at home (q 12 h, with feeding) and to administer lispro insulin (0."	( Effects of treatment with lispro and neutral protamine Hagedorn insulins on serum fructosamine and postprandial blood glucose concentrations in dogs with clinically well-controlled diabetes mellitus and postprandial hyperglycemia. Bertalan, AV; Drobatz, KJ; Hess, RS, 2020)	0.56
" More aggressive dosing initiation of NPH based on steroid dose may allow for earlier achievement of euglycemia without a difference in hypoglycemia."	( Insulin NPH for steroid-induced hyperglycemia: Predictors for success. Dungan, K; Gaborcik, JW; Stone, AC, 2021)	0.62
" The model was built via Monolix software, taking into account the weight-based dosing and the dose and body-weight effects on the parameters."	( Modeling of Pharmacokinetic Profiles of Insulin Aspart and Biphasic Insulin Aspart 30/70. Drai, RV; Khokhlov, AL; Kulesh, VS; Makarenko, IE; Pilyus, FG; Zinnatulina, BR, 2022)	0.72
" The lag time between dosing and peak concentration, as well as intra- and inter-subject variability, render prandial glucose control and dose consistency difficult."	( Accelerated absorption of regular insulin administered via a vascularizing permeable microchamber implanted subcutaneously in diabetic Rattus norvegicus. Cocchi, K; Drew, D; Huey, B; Johnson, R; Papas, KK; Price, ND; Putnam, CW; Steyn, LV; Vlachos, D, 2023)	0.91

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	234 (22.76)	18.7374
1990's	89 (8.66)	18.2507
2000's	359 (34.92)	29.6817
2010's	302 (29.38)	24.3611
2020's	44 (4.28)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	362 (32.26%)	5.53%
Reviews	104 (9.27%)	6.00%
Case Studies	68 (6.06%)	4.05%
Observational	27 (2.41%)	0.25%
Other	561 (50.00%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (121)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes [NCT01134224]	Phase 1	39 participants (Actual)	Interventional	2010-05-31	Completed
"Is Beta Cell Rest by Insulin Treatment Beneficial Compared to State-of-the Art Enhancers of Insulin Secretion in Preserving Beta Cell Function in Subjects With Latent Autoimmune Diabetes of the Adult (LADA)?" [NCT01140438]		64 participants (Actual)	Interventional	2009-03-31	Completed
Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily N [NCT01562561]	Phase 3	213 participants (Actual)	Interventional	2001-06-01	Completed
A Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated With Differing Baseline D [NCT01068860]	Phase 2	246 participants (Actual)	Interventional	2010-02-28	Completed
Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial Study to Test Bioequivalence Between Two Recombinant Human Mixed Insulins-Wockhardt's Human/Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects [NCT01358435]	Phase 1	53 participants (Actual)	Interventional	2011-01-31	Completed
Insulin Scheme for Glycemic Control in Non-critical Hospitalized Patients With Type 2 Diabetes in the Context of a Health System in Mexico. [NCT03350984]	Phase 4	75 participants (Actual)	Interventional	2017-11-02	Completed
National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure. [NCT01122979]	Phase 4	72 participants (Actual)	Interventional	2010-07-31	Completed
A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years [NCT01223131]	Phase 3	162 participants (Actual)	Interventional	2011-02-28	Completed
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novol [NCT00593255]	Phase 4	220 participants (Actual)	Interventional	2004-07-31	Completed
Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus [NCT00597233]	Phase 4	91 participants (Actual)	Interventional	2002-10-31	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 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
An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on [NCT01215435]	Phase 4	245 participants (Actual)	Interventional	2011-03-31	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
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
Comparative Pharmacokinetics and Pharmacodynamics of Human Regular U-500 Insulin Administered Subcutaneously as a Bolus Via Syringe Versus Continuous Subcutaneous Insulin Infusion and Characterization of TID and BID Dosing at Steady State in High-Dose Ins [NCT02588950]	Phase 1	11 participants (Actual)	Interventional	2016-01-12	Terminated(stopped due to Slow enrollment)
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy [NCT00574405]		24 participants (Actual)	Interventional	2005-04-30	Completed
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
Intravenous Insulin Protocol in Diabetes and Renal Transplantation Study [NCT00609986]		104 participants (Actual)	Interventional	2007-07-31	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)
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 Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes [NCT00993096]	Phase 1	33 participants (Actual)	Interventional	2009-09-30	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
"A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of GP-40081 (LLC GEROPHARM, Russia) Versus NovoMix® 30 Penfill® (Novo Nordisk) in Healthy Subjects Using the Euglycemic Clamp Technique" [NCT04184492]		34 participants (Actual)	Interventional	2019-04-15	Completed
Single-center, Randomized, Double-blind, 2-treatment, 2-period Crossover Trial in Healthy Subjects to Demonstrate PK Bioequivalence and to Compare the PD Properties of Julphar Insulin N and Huminsulin® Basal [NCT02634528]	Phase 1	85 participants (Actual)	Interventional	2016-11-16	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 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
Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia (TIP): Efficacy and Safety of a Novel Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based Immunosuppression [NCT00830297]	Phase 2	50 participants (Actual)	Interventional	2009-01-31	Completed
Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study [NCT00841919]	Phase 4	60 participants (Anticipated)	Interventional	2006-12-31	Completed
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin [NCT00941369]	Phase 4	345 participants (Actual)	Interventional	2009-06-30	Completed
Short and Long Term Effects of a Dypeptidil-peptidase-4 Versus Bedtime NPH Insulin as add-on Therapy in Patients With Type 2 Diabetes [NCT02607410]	Phase 4	40 participants (Actual)	Interventional	2010-01-31	Completed
Pilot Study for Evaluation of the Impact of Pulsatile Insulin Infusion Therapy on Vascular Function in Patients With Type 1 and Type 2 Diabetes Mellitus [NCT04030091]	Phase 4	24 participants (Actual)	Interventional	2019-09-06	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
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
The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy [NCT00686712]	Phase 4	108 participants (Actual)	Interventional	2003-02-28	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
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
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
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents [NCT00925977]		44 participants (Actual)	Interventional	2009-07-31	Terminated
28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/ [NCT00783744]	Phase 3	375 participants (Actual)	Interventional	2001-12-31	Completed
ANALYSIS OF THE EFFECTIVENESS OF A STAGED MANAGEMENT PROGRAM AIMED AT CONTROLLING BLOOD PRESSURE AND BLOOD GLUCOSE OF TYPE 2 DIABETIC PATIENTS USING EXCLUSIVELY THE RESOURCES AVAILABLE IN A PRIMARY CARE SETTING IN BRAZIL [NCT00935805]		124 participants (Anticipated)	Observational	2006-07-31	Active, not recruiting
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
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis [NCT00590044]	Phase 4	74 participants (Actual)	Interventional	2007-12-31	Completed
An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen [NCT00832182]	Phase 3	75 participants (Actual)	Interventional	1999-12-22	Completed
A 24-week, National, Single-centre, Open-labelled, Randomised, Parallel-group Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-bolus Regimen With Insulin Aspart as the Mealtime Insulin in Subjects With Type 2 Diabet [NCT00788840]	Phase 4	30 participants (Actual)	Interventional	2008-01-31	Completed
Evaluation of the Effects of Oral Anti-Hyperglycemic Agents, Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion on Glycemic Control, B-Cell Function and the Remission Rate in Newly-Diagnosed Type 2 Diabetic Patients [NCT00147836]		436 participants (Actual)	Interventional	2004-09-30	Completed
Multi-centre, Open, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled With SU +/ Biguanide Therapy, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin vs. Insulin Alone [NCT00799448]	Phase 4	40 participants (Actual)	Interventional	2003-09-16	Terminated(stopped due to Low recruitment status)
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
The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control [NCT00279201]	Phase 4	2,091 participants (Actual)	Interventional	2005-12-31	Completed
Device Study for Intranasal Delivery of Insulin [NCT03857321]	Phase 2	30 participants (Anticipated)	Interventional	2019-04-12	Active, not recruiting
Safety/Efficacy Trial Using Stored Serum Samples to Investigate the Immunogenicity of Insulin Aspart and Soluble Human Insulin in Children and Adolescents From Onset of Type 1 Diabetes [NCT00410033]		74 participants (Actual)	Interventional	1989-12-31	Completed
The Effect of Long- and Intermediate-acting Insulins on Glycemic Control and Risk of Hypoglycemia Among Toddlers and Preschool Children With Newly Onset Type 1 Diabetes Mellitus: A Randomized Three Armed Trial [NCT04664764]	Phase 4	60 participants (Anticipated)	Interventional	2019-02-21	Recruiting
A Comparison of Premixed and Basal-Bolus Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Twice-daily Premixed Insulin [NCT01175811]	Phase 4	402 participants (Actual)	Interventional	2011-02-28	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
Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin in a Limited Resources Setting: a Multicenter Randomized Controlled Crossover Clinical Trial [NCT05768191]	Phase 4	20 participants (Anticipated)	Interventional	2023-06-15	Recruiting
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
Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes (HEART2D) [NCT00191282]	Phase 4	1,116 participants (Actual)	Interventional	2002-10-31	Completed
Treat-To-Target Trial of Continuous Subcutaneous, Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation (SAPT-NODAT) [NCT01680185]	Phase 3	85 participants (Actual)	Interventional	2012-08-31	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 Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus [NCT00600626]	Phase 3	394 participants (Actual)	Interventional	2004-01-31	Completed
A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes [NCT00725036]	Phase 3	305 participants (Actual)	Interventional	2002-09-02	Completed
Assessment of Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation on Glycaemic Control in Subjects With Type 2 Diabetes [NCT00660374]	Phase 2	402 participants (Actual)	Interventional	2008-02-29	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
Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin. [NCT00653341]	Phase 3	764 participants (Actual)	Interventional	2000-01-31	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
Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study. [NCT00329615]	Phase 4	135 participants	Interventional	2000-01-31	Completed
Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin [NCT01854723]	Phase 4	0 participants (Actual)	Interventional	2013-04-30	Withdrawn
A Randomised, Double-blind, Placebo-controlled Single Dose, Dose Escalation Trial With Insulin 454 in Healthy Male Subjects, Followed by a Two-period Cross-over Trial With Insulin 454 and Insulatard® in Male Subjects With Type 1 and Type 2 Diabetes Mellit [NCT01865279]	Phase 1	64 participants (Actual)	Interventional	2005-12-31	Completed
A Randomised, Double-blind, Multiple Period Crossover Trial Comparing Insulin 454 and Insulin Aspart Premixes With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared With Biphasic Insulin Aspart 30 (NovoMix® 30) in Male Su [NCT01865305]	Phase 1	59 participants (Actual)	Interventional	2006-09-30	Completed
A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Bioequivalence Study Comparing Two Formulations of Insulin Glulisine (Insulin Glulisine 300 Units/mL Versus Insulin Glulisine 100 Units/mL Marketed as Apidra® 100 Units/m [NCT02910518]	Phase 1	44 participants (Actual)	Interventional	2017-02-17	Completed
A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia [NCT01492153]		1,981 participants (Actual)	Observational	2003-02-11	Completed
A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents [NCT00490854]	Phase 2/Phase 3	129 participants (Actual)	Interventional	2007-07-31	Completed
Self-control Trial to Evaluate the Remission Rate and Safety in Newly Diagnosed Type 2 Diabetes Patients After Short-term Intensive Insulin Aspart and Insulin NPH Treatment [NCT00494988]	Phase 4	33 participants (Actual)	Interventional	2004-12-31	Completed
SNIFF Multi-Device Study 2 - Study of Nasal Insulin to Fight Forgetfulness [NCT04199767]	Phase 2	30 participants (Anticipated)	Interventional	2020-07-16	Active, not recruiting
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 Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects [NCT01486901]	Phase 1	44 participants (Actual)	Interventional	2006-05-31	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
Effects of Pulsatile IV Insulin on Cognitive Deficits in Diabetic Patients [NCT00228865]	Phase 2/Phase 3	75 participants (Actual)	Interventional	2003-06-30	Terminated(stopped due to Administrative)
"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
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 Carbohydrate Metabolism During the Night and at Hypoglycemia in Type-2 Diabetic Patients Either on Glargine or NPH Insulin [NCT00468364]		12 participants (Actual)	Observational	2003-07-31	Completed
Comparative Trial Between Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Type 2 Diabetes [NCT00590226]	Phase 4	130 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 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
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 and Safety of Insulin Glulisine Compared With Insulin Lispro in Children and Adolescents With Type 1 Diabetes Mellitus: A 26 Week, Multicenter, Open, Parallel Clinical Trial [NCT00115570]	Phase 3	572 participants (Actual)	Interventional	2005-04-30	Completed
South Danish Diabetes Study: A Prospective Randomised Multi-Centre Study for the Evaluation of the Optimal Pharmacological Antidiabetic Treatment of Type 2 Diabetes Mellitus [NCT00121966]	Phase 4	400 participants	Interventional	2003-01-31	Completed
Morning LANTUS v. Intermediate-acting Insulin 2x/Day as Basal Insulin in a Multiple Daily Inj. w/ Humalog in Adolescents w/ Type 1 Diabetes Mellitus: an Active-controlled, Open, Randomized, Gender-stratified, Two-arm, Parallel-group Study [NCT00046501]	Phase 3	250 participants	Interventional	2002-11-30	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
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes [NCT00065130]	Phase 3	27 participants (Actual)	Interventional	2000-04-30	Completed
Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices [NCT04726657]		36 participants (Actual)	Interventional	2016-01-18	Completed
Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD) [NCT00835861]	Phase 2	31 participants (Actual)	Interventional	2008-08-31	Completed
Cost Effectiveness of Glargine Insulin Versus NPH Insulin in Diabetic Patients in Iran [NCT01832935]	Phase 4	200 participants (Actual)	Interventional	2011-07-31	Completed
A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy [NCT01720303]	Phase 4	159 participants (Actual)	Interventional	2002-09-19	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
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 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
Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use. [NCT01500850]	Phase 4	60 participants (Anticipated)	Interventional	2011-10-31	Recruiting
Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia [NCT01648218]	Phase 4	5 participants (Actual)	Interventional	2012-08-31	Terminated(stopped due to Poor enrollment)
An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic [NCT01707134]	Phase 3	753 participants (Actual)	Interventional	1997-09-30	Completed
Gestational Diabetes in Non Obese Women and Metformine [NCT01756105]	Phase 2	84 participants (Anticipated)	Interventional	2012-06-30	Terminated
The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients [NCT01810952]	Phase 4	37 participants (Actual)	Interventional	2010-09-30	Completed
Use of Neutral Protamine Hagedorn (NPH) Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia [NCT03511521]	Phase 4	3 participants (Actual)	Interventional	2018-03-27	Terminated(stopped due to Unable to recruit sufficient number of patients)
A 24 Week Randomised, Open Label, 3 Parallel-group Comparison of Once and Twice Daily Biphasic Insulin Aspart (BIAsp) 30 Plus Sitagliptin and Twice Daily BIAsp 30, All in Combination With Metformin in Insulin naïve Type 2 Diabetic Subjects Inadequately Co [NCT01519674]	Phase 4	582 participants (Actual)	Interventional	2012-06-30	Completed
[NCT01446120]	Phase 1	7 participants (Anticipated)	Interventional		Not yet recruiting
Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial [NCT01467141]	Phase 4	26 participants (Actual)	Interventional	2002-06-19	Completed
Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1 [NCT02580877]	Phase 2	92 participants (Actual)	Interventional	2016-01-31	Completed
Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia [NCT01184014]	Phase 4	72 participants (Actual)	Interventional	2010-08-31	Completed
A Pilot Study to Describe the Glycaemic Variability of Insulin Glargine 300U/ml Versus NPH (Neutral Protamine Hagedorn) in the Insulin-naïve Type 2 Diabetes Patients Following a Patient-adjusted Insulin Algorithm in Hong Kong [NCT03389490]	Phase 4	50 participants (Actual)	Interventional	2018-01-01	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
Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT) [NCT01963728]	Phase 4	2 participants (Actual)	Interventional	2013-11-27	Terminated(stopped due to Blood sugar status of the enrolled subjects wasn't evaluable)
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
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)
Effects of New Longacting Insulin Analogs on Metabolic Control, Endogenous Insulin Production, GH/IGF-I Axis and Quality of Life - Comparison of NPH, Glargine Och Detemir Insulin From the Debut of Type 1 Diabetes Mellitus in Adolescents [NCT01271517]	Phase 4	120 participants (Actual)	Interventional	2005-09-30	Active, not recruiting
A Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study [NCT01790438]	Phase 3	641 participants (Actual)	Interventional	2013-03-31	Completed
An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients [NCT01278160]	Phase 4	179 participants (Actual)	Interventional	2011-01-31	Completed
A 20-week Study Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients Uncontrolled on NPH Insulin [NCT01589653]	Phase 4	155 participants (Actual)	Interventional	2012-05-26	Completed
Insulin Therapy for the Prevention of New Onset Diabetes After Transplantation (ITP-NODAT) Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients [NCT03507829]	Phase 3	263 participants (Actual)	Interventional	2012-11-21	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.)
Subcutaneous Insulin Glargine Versus NPH Insulin in Patients With Chronic Kidney Disease Stages III and IV: Randomized Controlled Trial. [NCT02451917]	Phase 4	34 participants (Actual)	Interventional	2013-12-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00191282 (27) [back to overview]	Number of Participants With Self-Reported Hypoglycemia During Month 18
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors
NCT00191282 (27) [back to overview]	Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18
NCT00191282 (27) [back to overview]	Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced a Primary Combined Outcome
NCT00191282 (27) [back to overview]	Summary of Reasons for Deaths
NCT00191282 (27) [back to overview]	Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9
NCT00191282 (27) [back to overview]	Number of Participants With Self-Reported Hypoglycemia During Month 9
NCT00191282 (27) [back to overview]	Number of Participants With Self-Reported Hypoglycemia During Month 6
NCT00191282 (27) [back to overview]	Number of Participants With Self-Reported Hypoglycemia During Month 3
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization
NCT00191282 (27) [back to overview]	Number of Participants With Self-Reported Hypoglycemia During Month 12
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Stroke
NCT00191282 (27) [back to overview]	Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6
NCT00191282 (27) [back to overview]	Number of Participants With Self-Reported Hypoglycemia During Month 1
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Cardiovascular (CV) Death
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Congestive Heart Failure
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Coronary Angiography Planned After Randomization
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Coronary Revascularization Procedures
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Death From Any Cause
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)
NCT00191282 (27) [back to overview]	Number of Participants Who Experienced Myocardial Infarction (MI)
NCT00191282 (27) [back to overview]	Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12
NCT00191282 (27) [back to overview]	Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1
NCT00279201 (56) [back to overview]	MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
NCT00279201 (56) [back to overview]	MAINTENANCE: Body Weight
NCT00279201 (56) [back to overview]	MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
NCT00279201 (56) [back to overview]	INITIATION: Rate of Self-reported Hypoglycemic Episodes
NCT00279201 (56) [back to overview]	INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
NCT00279201 (56) [back to overview]	INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
NCT00279201 (56) [back to overview]	INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
NCT00279201 (56) [back to overview]	INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
NCT00279201 (56) [back to overview]	INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
NCT00279201 (56) [back to overview]	INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
NCT00279201 (56) [back to overview]	INITIATION: Insulin Dose
NCT00279201 (56) [back to overview]	INITIATION: Incremental Change From Baseline in Body Weight
NCT00279201 (56) [back to overview]	INITIATION: HbA1c
NCT00279201 (56) [back to overview]	INITIATION: Body Weight
NCT00279201 (56) [back to overview]	INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
NCT00279201 (56) [back to overview]	ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
NCT00279201 (56) [back to overview]	ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
NCT00279201 (56) [back to overview]	ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
NCT00279201 (56) [back to overview]	ADDENDUM: Insulin Dose
NCT00279201 (56) [back to overview]	ADDENDUM: Incremental Change From Baseline in Body Weight
NCT00279201 (56) [back to overview]	ADDENDUM: HbA1c at Specified Visits and Endpoint
NCT00279201 (56) [back to overview]	ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
NCT00279201 (56) [back to overview]	ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
NCT00279201 (56) [back to overview]	ADDENDUM: Body Weight
NCT00279201 (56) [back to overview]	ADDENDUM: 7-point SMPG Profiles
NCT00279201 (56) [back to overview]	MAINTENANCE: Rate of Increase in HbA1c
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
NCT00279201 (56) [back to overview]	MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
NCT00279201 (56) [back to overview]	ADDENDUM: 24-Week Endpoint HbA1c
NCT00279201 (56) [back to overview]	INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)
NCT00279201 (56) [back to overview]	INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
NCT00279201 (56) [back to overview]	INITIATION: Change in HbA1c From Baseline to 24 Weeks
NCT00279201 (56) [back to overview]	INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
NCT00279201 (56) [back to overview]	INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
NCT00279201 (56) [back to overview]	INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
NCT00279201 (56) [back to overview]	MAINTENANCE: Incremental Change From Baseline in Body Weight
NCT00279201 (56) [back to overview]	MAINTENANCE: HbA1c at Specified Visits and Endpoint
NCT00279201 (56) [back to overview]	MAINTENANCE: Change From Baseline to Endpoint in HbA1c
NCT00279201 (56) [back to overview]	MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
NCT00279201 (56) [back to overview]	MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
NCT00279201 (56) [back to overview]	MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
NCT00279201 (56) [back to overview]	MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
NCT00279201 (56) [back to overview]	MAINTENANCE: Insulin Dose
NCT00279201 (56) [back to overview]	INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
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)
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]	8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36
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]	Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36
NCT00474045 (47) [back to overview]	Ratio Between Detemir 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 Aspart Specific Antibodies in Cord Blood and Maternal Antibodies
NCT00474045 (47) [back to overview]	Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood
NCT00474045 (47) [back to overview]	Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]	Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]	Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]	Maternal Safety - Nocturnal Hypoglycaemic Episodes
NCT00474045 (47) [back to overview]	Maternal Safety - Electrocardiogram (ECG)
NCT00474045 (47) [back to overview]	Maternal Safety - Acceleration of Nephropathy
NCT00474045 (47) [back to overview]	Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36
NCT00474045 (47) [back to overview]	Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36
NCT00474045 (47) [back to overview]	Maternal Safety - Change in Sodium Serum Level (Biochemistry)
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 - Change in Insulin Detemir Specific Antibodies
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 - Acceleration of Retinopathy in Any Eye
NCT00474045 (47) [back to overview]	Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)
NCT00474045 (47) [back to overview]	Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]	Maternal Safety - Change in Creatinine Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]	Maternal Safety - Change in Haemoglobin Level (Haematology)
NCT00474045 (47) [back to overview]	Maternal Safety - Change in Insulin Aspart Specific Antibodies
NCT00474045 (47) [back to overview]	Maternal Safety - Change in Albumin Serum Level (Biochemistry)
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 2-4
NCT00506662 (3) [back to overview]	Mean Number of Total Hypoglycaemic Episodes, Months 5-7
NCT00509925 (18) [back to overview]	Hormonal Assessment: Insulin-like Growth Factor-1
NCT00509925 (18) [back to overview]	Hormonal Assessment: Leptin
NCT00509925 (18) [back to overview]	Hormonal Assessment: Resistin
NCT00509925 (18) [back to overview]	Hypoglycaemic Episodes, Diurnal/Nocturnal
NCT00509925 (18) [back to overview]	Lean Body Mass
NCT00509925 (18) [back to overview]	Waist:Hip Ratio
NCT00509925 (18) [back to overview]	Fasting Plasma Glucose
NCT00509925 (18) [back to overview]	Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)
NCT00509925 (18) [back to overview]	Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)
NCT00509925 (18) [back to overview]	Component of Total Energy Expenditure: Physical Activity Thermogenesis
NCT00509925 (18) [back to overview]	Component of Total Energy Expenditure: Resting Energy Expenditure (REE)
NCT00509925 (18) [back to overview]	Hypoglycaemic Episodes
NCT00509925 (18) [back to overview]	Total Energy Expenditure, Dietary Record Method
NCT00509925 (18) [back to overview]	Total Energy Expenditure, Double-labelled Water Method
NCT00509925 (18) [back to overview]	Body Weight
NCT00509925 (18) [back to overview]	Fat Mass
NCT00509925 (18) [back to overview]	Glycosylated Haemoglobin A1c (HbA1c)
NCT00509925 (18) [back to overview]	Hormonal Assessment: Adiponectin
NCT00574405 (1) [back to overview]	Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
NCT00590044 (4) [back to overview]	Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin
NCT00590044 (4) [back to overview]	Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups
NCT00590044 (4) [back to overview]	Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups
NCT00590044 (4) [back to overview]	Difference in Time in Hours to Resolution of DKA Between the 2 Groups
NCT00590226 (2) [back to overview]	Mean AM BG (mg/dl)
NCT00590226 (2) [back to overview]	Number of Patients With Hypoglycemic Events
NCT00609986 (4) [back to overview]	Acute/Active Rejection
NCT00609986 (4) [back to overview]	Delayed Graft Function
NCT00609986 (4) [back to overview]	Severe Hyperglycemia
NCT00609986 (4) [back to overview]	Severe Hypoglycemia
NCT00686712 (7) [back to overview]	Body Mass Index Change From Baseline
NCT00686712 (7) [back to overview]	Any Adverse Event Other Than Hypoglycemia
NCT00686712 (7) [back to overview]	Total Daily Insulin Dose
NCT00686712 (7) [back to overview]	Hemoglobin A1c Change From Baseline
NCT00686712 (7) [back to overview]	Frequency of Total Hypoglycemic Reactions
NCT00686712 (7) [back to overview]	Frequency of Severe Hypoglycemic Reactions
NCT00686712 (7) [back to overview]	Frequency of Glucose Readings < 130 mg/dL
NCT00795600 (56) [back to overview]	Absolute Change in Blood Volume (Haematocrit)
NCT00795600 (56) [back to overview]	Absolute Change in Adiponectin
NCT00795600 (56) [back to overview]	Absolute Change in Bilirubin Total
NCT00795600 (56) [back to overview]	Absolute Change in Basophils
NCT00795600 (56) [back to overview]	Absolute Change in Aspartate Aminotransferase (ASAT)
NCT00795600 (56) [back to overview]	Absolute Change in Alkaline Phosphatase
NCT00795600 (56) [back to overview]	Absolute Change in Albumin
NCT00795600 (56) [back to overview]	Absolute Change in Alanine Aminotransferase (ALAT)
NCT00795600 (56) [back to overview]	Absolute Change in Haemoglobin
NCT00795600 (56) [back to overview]	Absolute Change in Free Fatty Acids
NCT00795600 (56) [back to overview]	Absolute Change in Fasting Plasma Glucose (FPG)
NCT00795600 (56) [back to overview]	Absolute Change in Whole Body Fat Mass
NCT00795600 (56) [back to overview]	Absolute Change in Eosinophils
NCT00795600 (56) [back to overview]	Absolute Change in Creatinine
NCT00795600 (56) [back to overview]	Absolute Change in Creatine Phosphokinase
NCT00795600 (56) [back to overview]	Absolute Change in Calculated Whole Body Fat Percentage
NCT00795600 (56) [back to overview]	Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
NCT00795600 (56) [back to overview]	Absolute Change in Waist Circumference
NCT00795600 (56) [back to overview]	Percentual Change in Calculated Whole Body Fat Percentage
NCT00795600 (56) [back to overview]	Percentual Change in Calculated Trunk Fat Percentage
NCT00795600 (56) [back to overview]	Percentage Change in Whole Body Lean Mass
NCT00795600 (56) [back to overview]	Percentage Change in Whole Body Fat Mass
NCT00795600 (56) [back to overview]	Percentage Change in Visceral Adipose Tissue Area
NCT00795600 (56) [back to overview]	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]	Percentage Change in Liver/Spleen Attenuation Ratio
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 Whole Body Lean Mass
NCT00795600 (56) [back to overview]	Absolute Change in Erythrocytes
NCT00795600 (56) [back to overview]	Absolute Change in Visceral Adipose Tissue Area
NCT00795600 (56) [back to overview]	Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
NCT00795600 (56) [back to overview]	Absolute Change in Urea
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 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 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]	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 Potassium
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]	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 Calculated Trunk Fat Percentage
NCT00795600 (56) [back to overview]	Absolute Change in Body Weight
NCT00835861 (9) [back to overview]	Number of Babies With Adverse Neonatal Outcomes
NCT00835861 (9) [back to overview]	Maternal Weight Gain
NCT00835861 (9) [back to overview]	Number of Babies With Neonatal Hypoglycemia
NCT00835861 (9) [back to overview]	Number of Episodes Maternal Hypoglycemia
NCT00835861 (9) [back to overview]	Number of Patients With Obstetric Complications
NCT00835861 (9) [back to overview]	Blood Glucose Measurements
NCT00835861 (9) [back to overview]	Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
NCT00835861 (9) [back to overview]	Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
NCT00835861 (9) [back to overview]	Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
NCT01068860 (16) [back to overview]	Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Fructosamine, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.
NCT01068860 (16) [back to overview]	Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.
NCT01068860 (16) [back to overview]	Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks
NCT01068860 (16) [back to overview]	Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks
NCT01175811 (10) [back to overview]	The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
NCT01175811 (10) [back to overview]	The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
NCT01175811 (10) [back to overview]	Percentage of Participants With Hypoglycemic Episodes (Incidence)
NCT01175811 (10) [back to overview]	Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
NCT01175811 (10) [back to overview]	Change in HbA1c From Baseline to 12 Week Endpoint
NCT01175811 (10) [back to overview]	Percentage of Participants Experiencing a Severe Hypoglycemic Episode
NCT01175811 (10) [back to overview]	The Rate of Hypoglycemic Episodes
NCT01175811 (10) [back to overview]	Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks
NCT01175811 (10) [back to overview]	Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
NCT01175811 (10) [back to overview]	Daily Dose of Insulin: Total, Basal, and Prandial
NCT01184014 (1) [back to overview]	Mean Blood Glucose of All Readings
NCT01215435 (3) [back to overview]	Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36
NCT01215435 (3) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes
NCT01215435 (3) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
NCT01278160 (5) [back to overview]	Percentage of Subjects Achieving HbA1c Below 7.0%
NCT01278160 (5) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes
NCT01278160 (5) [back to overview]	9-point SMPG (Self Measured Plasma Glucose) Profile
NCT01278160 (5) [back to overview]	Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
NCT01278160 (5) [back to overview]	Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline
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 Fructosamine 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 Mean 8-point Plasma Glucose (PG) 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]	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]	Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
NCT01519674 (11) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01519674 (11) [back to overview]	Prandial Plasma Glucose (PPG) Increments at Breakfast
NCT01519674 (11) [back to overview]	Prandial Plasma Glucose (PPG) Increments at Dinner.
NCT01519674 (11) [back to overview]	Prandial Plasma Glucose (PPG) Increments at Lunch.
NCT01519674 (11) [back to overview]	Prandial Plasma Glucose (PPG) Overall Mean Increment.
NCT01519674 (11) [back to overview]	Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
NCT01519674 (11) [back to overview]	Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)
NCT01519674 (11) [back to overview]	Adverse Events (AEs)
NCT01519674 (11) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.
NCT01519674 (11) [back to overview]	Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.
NCT01519674 (11) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01589653 (5) [back to overview]	Change in HbA1c From Baseline
NCT01589653 (5) [back to overview]	Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden
NCT01589653 (5) [back to overview]	Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
NCT01589653 (5) [back to overview]	Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline
NCT01589653 (5) [back to overview]	Number of Hypoglycaemic Episodes During the Trial From Baseline
NCT01790438 (23) [back to overview]	Percentage of Participants With Severe Hypoglycemic Events
NCT01790438 (23) [back to overview]	Rate of Severe Hypoglycemic Events
NCT01790438 (23) [back to overview]	Time to Steady-State (Stable Maximum Dose)
NCT01790438 (23) [back to overview]	30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
NCT01790438 (23) [back to overview]	6-Point Self-Monitored Blood Glucose (SMBG)
NCT01790438 (23) [back to overview]	Change From Baseline to 26 Weeks in Lipid Profile
NCT01790438 (23) [back to overview]	Percentage of Participants With HbA1c ≤6.5% and <7.0%
NCT01790438 (23) [back to overview]	Percentage of Participants With Total and Nocturnal Hypoglycemic Events
NCT01790438 (23) [back to overview]	Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores
NCT01790438 (23) [back to overview]	Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
NCT01790438 (23) [back to overview]	Change From Baseline to 26 Weeks in Body Weight
NCT01790438 (23) [back to overview]	Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index
NCT01790438 (23) [back to overview]	Percentage of Participants With Insulin Antibodies
NCT01790438 (23) [back to overview]	Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
NCT01790438 (23) [back to overview]	Fasting Blood Glucose (FBG) (by Self Monitoring)
NCT01790438 (23) [back to overview]	Fasting Serum Glucose (FSG) (by Laboratory)
NCT01790438 (23) [back to overview]	HbA1c
NCT01790438 (23) [back to overview]	Insulin Dose Per Kilogram (kg) of Body Weight
NCT01790438 (23) [back to overview]	Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
NCT01790438 (23) [back to overview]	Intra-Participant Variability in FBG by Standard Deviation
NCT01790438 (23) [back to overview]	Intra-Participant Variability in FBG by the Coefficient of Variation
NCT01790438 (23) [back to overview]	Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
NCT01790438 (23) [back to overview]	Percentage of Participants With Injection Site Reactions
NCT01810952 (5) [back to overview]	Glucose Values <70 mg/dL.
NCT01810952 (5) [back to overview]	Percent of Glucose Determinations >180 mg/dL
NCT01810952 (5) [back to overview]	Daily Insulin Dose/Kg Body Weight
NCT01810952 (5) [back to overview]	Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
NCT01810952 (5) [back to overview]	Percent of Participants With Average Glucose >70 and <180 mg/dL
NCT02131272 (7) [back to overview]	Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02131272 (7) [back to overview]	Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02131272 (7) [back to overview]	Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment
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)
NCT02451917 (7) [back to overview]	Total Daily Insulin Dose
NCT02451917 (7) [back to overview]	Body Mass Index (BMI)
NCT02451917 (7) [back to overview]	Difference in A1c Levels
NCT02451917 (7) [back to overview]	Estimated Glomerular Filtration Rate (eGFR) Calculated by CKD-EPI
NCT02451917 (7) [back to overview]	Glycemic Variability
NCT02451917 (7) [back to overview]	Number of Hypoglycemic Events
NCT02451917 (7) [back to overview]	Serum Creatinine
NCT02580877 (2) [back to overview]	Change in mIAA Autoantibody Titer From Baseline
NCT02580877 (2) [back to overview]	Change in GAD65 Autoantibody Titer (DK Units/mL)
NCT02588950 (9) [back to overview]	Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R
NCT02588950 (9) [back to overview]	Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R
NCT02588950 (9) [back to overview]	Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R
NCT02588950 (9) [back to overview]	Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R
NCT02588950 (9) [back to overview]	Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R
NCT02588950 (9) [back to overview]	Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R
NCT02588950 (9) [back to overview]	Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R
NCT02588950 (9) [back to overview]	Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R
NCT02588950 (9) [back to overview]	Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R
NCT03350984 (3) [back to overview]	the Number of Participants With Mild and Severe Hypoglycemic Events
NCT03350984 (3) [back to overview]	Number of Participants With Sustained Glycemic Control During Hospital Stay
NCT03350984 (3) [back to overview]	Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.
NCT03511521 (3) [back to overview]	Percentage of Glucose Values Within Therapeutic Range
NCT03511521 (3) [back to overview]	Percentage of Glucose Values Within the Hypoglycemic Range
NCT03511521 (3) [back to overview]	Glycemic Control

Number of Participants With Self-Reported Hypoglycemia During Month 18

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

Intervention	participants (Number)
Postprandial	143
Fasting	129

Intervention	participants (Number)
	Fatal MI	Fatal Stroke	CV Death other than Stroke/MI	Non-CV Death	Unknown
Fasting	12	2	28	8	1
Postprandial	12	3	29	7	0

Intervention	ug/dL (Mean)
	Baseline	Endpoint	Change
Insulin Glargine	5.66	10.48	4.82
Lispro Low Mix	5.87	11.71	5.84

Intervention	kilograms (Mean)
	Baseline (n=419,473)	Week 24 (n=417, 470)	Week 36 (n=411, 465)	Week 48 (n=399,460)	Week 60 (n=362,414)	Week 72 (n=315,372)	Week 84 (n=281,327)	Week 96 (n=248, 297)	Week 108 (n=228,268)	Week 120 (n=204,253)	Endpoint (n=414,470)
Insulin Glargine	90.56	92.64	93.13	93.23	93.17	93.62	93.46	93.33	93.39	93.99	94.14
Lispro Low Mix	88.62	92.35	93.24	93.57	94.57	95.50	95.63	95.34	95.07	94.82	94.01

Intervention	mg/dL (Mean)
	Baseline mean fasting blood glucose (n=403,456)	Endpoint mean fasting blood glucose (n=372,426)	Baseline AM 2-hour (hr) postprandial (n=398,455)	Endpoint AM 2-hour postprandial (n=368,426)	Baseline midday premeal blood glucose (n=400,454)	Endpoint midday premeal blood glucose (n=370,425)	Baseline midday 2hr postprandial (n=397,456)	Endpoint midday 2hr postprandial (n=370,424)	Baseline PM pre-meal blood glucose (n=402,455)	Endpoint PM pre-meal blood glucose (n=371,425)	Baseline PM 2hr postprandial (n=399,455)	Endpoint PM 2hr postprandial (n=369,425)	Baseline 3AM blood glucose (n=393,450)	Endpoint 3AM blood glucose (n=363,419)	Baseline AM 2hr excursion (n=397,455)	Endpoint AM 2hr excursion (n=368,426)	Baseline midday 2hr excursion (n=395,452)	Endpoint midday 2hr excursion (n=370,423)	Baseline PM 2hr excursion (n=398,453)	Endpoint PM 2hr excursion (n=369,424)	Baseline mean all meal time excursions (n=402,455)	Endpoint mean all meal time excursions (n=370,426)	Baseline mean of all 2hr postprandial (n=402,457)	Endpoint mean of all 2hr postprandial (n=370,426)	Baseline mean all premeal (n=404,456)	Endpoint mean all premeal (n=372,426)	Baseline combined AM/PM 2hr postprandial (402,457)	Endpoint combined AM/PM 2hr postprandial (370,426)	Baseline AM/PM 2hr postprandial excursion (402,455	Endpoint AM/PM 2hr postprandial excursion (370,426	Baseline mean all blood glucose values (n=405,457)	Endpoint mean all blood glucose values (n=372,426)
Insulin Glargine	190.90	119.50	243.62	164.94	193.21	132.25	217.67	159.81	190.06	131.58	223.83	167.66	189.36	126.05	52.63	45.69	25.13	27.78	33.87	36.24	37.36	36.32	228.52	164.17	191.46	127.61	233.82	166.34	43.46	40.76	207.01	142.94
Lispro Low Mix	187.12	127.92	243.55	161.37	192.02	126.42	218.54	158.58	187.92	133.15	223.02	156.48	183.18	123.43	56.96	33.61	27.02	32.03	34.78	23.45	39.65	29.81	228.39	158.91	188.95	129.16	233.25	158.97	45.80	28.69	205.17	141.01

Intervention	Episodes/participant/year (Mean)
	Nocturnal episodes Endpoint	Nocturnal episodes Overall	Severe episodes Endpoint	Severe episodes Overall	Hypoglycemia episodes Endpoint	Hypoglycemia episodes Overall
Insulin Glargine	11.42	9.80	0.02	0.03	20.28	18.14
Lispro Low Mix	8.86	9.22	0.09	0.10	24.96	25.49

Intervention	percentage of participants (Number)
	Hypoglycemic episodes endpoint	Overall hypoglycemic episodes	Nocturnal hypoglycemic episodes endpoint	Nocturnal hypoglycemic episodes overall	Severe hypoglycemic episodes endpoint	Severe hypoglycemic episodes overall
Insulin Glargine	51.8	76.7	34.3	58.4	0.2	1.2
Lispro Low Mix	57.1	80.5	33.9	59.6	0.6	2.1

Intervention	percentage of participants (Number)
	<=7.0%	<7.0%	<=6.5%
Insulin Glargine	45.8	40.3	22.2
Lispro Low Mix	52.5	47.5	24.6

Intervention	milligrams per deciliter (mg/dL) (Mean)
	Pre Meals Blood Glucose (n=892,866)	Post Meals Blood Glucose (n=891,865)	Average of All Blood Glucose (n=894,866)	Fasting Blood Glucose (n=891,864)
Did Not Meet Goal	209.86	252.90	227.77	201.22
Met Goal	190.47	228.87	206.43	189.04

Intervention	participants (Number)
	Caucasian	African Descent	East/Southeast Asian	Hispanic	Other	Western Asian
Did Not Meet Goal	521	44	28	102	36	175
Met Goal	680	50	11	96	20	70

Intervention	participants (Number)
	<8.5% HbA1c	>=8.5% HbA1c
Did Not Meet Goal	220	665
Met Goal	464	451

Intervention	participants (Number)
	Sulfonylurea/Metformin	TZD/Metformin	Sulfonylurea/TZD	Patients with 3 drugs (Sulfonylurea/TZD/Metformin)
Did Not Meet Goal	631	35	51	184
Met Goal	563	95	51	208

Intervention	units/kg/day (Mean)
	Week 1 (n=994,1001)	Week 2 (n=991, 987)	Week 3 (n=990,968)	Week 4 (n=971,958)	Week 5 (n=958,930)	Week 6 (n=998,1023)	Week 8 (n=949,933)	Week 10 (n=925,916)	Week 12 (n=970,972)	Week 18 (n=943,943)	Week 24 (n=915,920)	Endpoint (n=1029,1036)
Insulin Glargine	0.13	0.18	0.23	0.26	0.30	0.32	0.34	0.37	0.38	0.39	0.41	0.40
Lispro Low Mix	0.24	0.28	0.32	0.35	0.38	0.39	0.42	0.44	0.45	0.46	0.48	0.47

Intervention	kilograms (kg) (Mean)
	Change from baseline at Week 6 (n=1008,995)	Change from baseline at Week 12 (n=970, 960)	Change from baseline at Week 18 (n=943,927)	Change from baseline at Week 24 (n=925,911)	Change from baseline at endpoint (n=1016,1008)
Insulin Gargine	0.97	1.60	2.24	2.59	2.45
Lispro Low Mix	1.66	2.63	3.44	3.76	3.60

Intervention	percent glycosylated hemoglobin (Mean)
	Baseline (n=1030,1017)	Week 12 (n=952,953)	Week 24 (n=922,911)	Endpoint (LOCF) (n=990,986)
Insulin Glargine	9.02	7.42	7.28	7.33
Lispro Low Mix	9.06	7.27	7.19	7.23

Intervention	kilograms (Mean)
	Actual weight at Baseline (n=1046,1044)	Actual weight at Week 6 (n=1008,995)	Actual weight at Week 12 (n=970,960)	Actual weight at Week 18 (n=943,927)	Actual weight at Week 24 (n=925,911)	Actual weight Endpoint (n=1016,1008)
Insulin Glargine	88.23	89.24	89.80	90.33	90.78	90.74
Lispro Low Mix	88.84	90.63	91.79	92.46	92.63	92.67

Intervention	milligrams per 100 Milliliters (mg/dL) (Mean)
	Baseline mean fasting blood glucose (n=986,993)	Mean fasting blood glucose (n=938,922)	Baseline AM 2-hour postprandial BG (n=977,989)	AM 2-hour postprandial blood glucose (n=932,920)	Baseline midday premeal BG (n=976,988)	Midday premeal blood glucose (BG) (n=934,919)	Baseline midday 2-hour postprandial BG (n=974,988)	Midday 2-hour postprandial BG (n=929,916)	Baseline evening pre-meal BG (n=983,993)	Evening pre-meal blood glucose (n=936,922)	Baseline evening 2hour postprandial BG (n=983,991)	Evening 2-hour postprandial BG (n=932,921)	Baseline 3 AM blood glucose (n=955,975)	3 AM blood glucose (n=912,899)	Baseline AM 2-hour BG excursion (n=975,987)	AM 2-hour blood glucose excursion (n=932,920)	Baseline midday 2-hour BG excursion (n=966,981)	Midday 2-hour blood glucose excursion (n=928,916)	Baseline PM 2-hour BG excursion (n=979,988)	PM 2-hour blood glucose excursion (n=929,921)	Baseline mean all meal time excursions (n=985,991)	Mean of all meal time excursions (n=935,921)	Baseline mean all 2hour PP BG (n=986,993)	Mean of all 2-hour postprandial BG (n=935,921)	Baseline AM/PM 2-hour postprandial BG (n=986,993)	AM/PM 2-hour postprandial BG (n=935,921)	Baseline mean all premeal BG (n=988,994)	Mean of all premeal blood glucose (n=938,922)	Baseline AM/PM 2-hour BG excursion (n=985,991)	AM/PM 2-hour blood glucose excursion (n=935,921)	Baseline mean of all BG values (n=989,995)	Mean of all blood glucose values (n=938,922)
Insulin Glargine	196.16	121.52	251.45	171.79	203.87	137.43	232.73	169.38	203.33	141.86	239.73	175.73	197.99	131.08	55.32	50.57	26.60	32.21	36.50	34.17	40.80	38.96	241.58	172.28	245.67	173.73	201.29	133.62	46.05	42.42	218.05	149.89
Lispro Low Mix	192.91	133.54	252.46	167.40	203.76	130.36	231.53	167.91	200.36	143.44	236.33	163.20	194.11	129.70	60.06	34.01	28.08	37.46	36.31	19.51	41.63	30.34	240.08	166.17	244.36	165.19	198.97	135.80	48.11	26.74	216.12	147.96

Intervention	percentage of participants (Number)
	Hypoglycemia episodes endpoint	Overall hypoglycemia episodes	Severe episodes endpoint	Severe episodes overall	Nocturnal episodes endpoint	Nocturnal episodes overall
Basal Bolus Prior Glargine Addendum	34.9	47.9	0.0	0.0	19.3	27.1
Basal Bolus Prior Lispro LM Addendum	40.9	53.7	0.0	0.0	25.0	31.1
Lispro Low Mix Prior Glargine Addendum	40.9	56.1	0.0	1.0	23.7	36.9
Lispro Mid Mix Prior Lispro Low Mix Addendum	41.5	56.1	0.0	1.2	20.5	31.0

Intervention	units/kg/day (Mean)
	Baseline (n=171,174,199,200)	Week 1 (n=152,158,183,183)	Week 2 (n=147,159,180,187)	Week 3 (n=149,158,179,184)	Week 4 (n=145,157,178,178)	Week 5 (n=148,153,172,173)	Week 6 (n=162,168,190,196)	Week 8 (n=139,154,164,174)	Week 10 (n=141,152,158,174)	Week 12 (n=152,161,177,190)	Week 24 (n=147,151,166,179)	Endpoint (n=165,170,199,200)
Basal Bolus Prior Glargine Addendum	0.46	0.49	0.54	0.57	0.63	0.65	0.68	0.71	0.76	0.77	0.79	0.77
Basal Bolus Prior Lispro LM Addendum	0.55	0.58	0.63	0.65	0.69	0.73	0.73	0.76	0.78	0.80	0.82	0.81
Lispro Low Mix Prior Glargine Addendum	0.46	0.49	0.53	0.58	0.61	0.65	0.66	0.69	0.73	0.74	0.76	0.76
Lispro Mid Mix Prior Lispro Low Mix Addendum	0.55	0.57	0.59	0.64	0.67	0.70	0.72	0.75	0.77	0.79	0.80	0.79

Intervention	kilograms (Mean)
	Baseline (n=170,173,198,200)	Week 6 change (n=161,162,183,193)	Week 12 change (n=150,158,173,187)	Week 24 change (n=144,151,163,176)	Endpoint change (n=163,169,191,198)
Basal Bolus Prior Glargine Addendum	89.25	0.32	0.27	1.03	0.86
Basal Bolus Prior Lispro LM Addendum	91.85	0.38	0.43	0.77	0.85
Lispro Low Mix Prior Glargine Addendum	90.09	0.64	0.83	1.51	1.42
Lispro Mid Mix Prior Lispro Low Mix Addendum	93.63	0.28	0.54	0.73	0.55

Intervention	percent glycosylated hemoglobin (Mean)
	Baseline (n=174,200,171,199)	Week 12 (n=150,175,151,161)	Week 24 (n=145,171,144,159)	Endpoint (n=160, 187,159,176)
Basal Bolus Prior Glargine Addendum	7.98	8.19	8.14	8.14
Basal Bolus Prior Lispro Low Mix Addendum	8.00	8.13	8.19	8.16
Lispro LM Prior Glargine Addendum	8.03	8.07	8.05	8.03
Lispro Mid Mix Prior Lispro Low Mix Addendum	8.01	8.11	8.19	8.19

insulin, isophane

Description

Cross-References

Synonyms (81)

Research Excerpts

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Research

Studies (1,028)

Market Indicators

Research Demand Index: 72.63

Study Types

Clinical Trials (121)

Trial Overview

Trial Outcomes

Number of Participants With Self-Reported Hypoglycemia During Month 18

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

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

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

Number of Participants Who Experienced a Primary Combined Outcome

Summary of Reasons for Deaths

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

Number of Participants With Self-Reported Hypoglycemia During Month 9

Number of Participants With Self-Reported Hypoglycemia During Month 6

Number of Participants With Self-Reported Hypoglycemia During Month 3

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

Number of Participants With Self-Reported Hypoglycemia During Month 12

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

Number of Participants Who Experienced Stroke

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

Number of Participants With Self-Reported Hypoglycemia During Month 1

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

Number of Participants Who Experienced Cardiovascular (CV) Death

Number of Participants Who Experienced Congestive Heart Failure

Number of Participants Who Experienced Coronary Angiography Planned After Randomization

Number of Participants Who Experienced Coronary Revascularization Procedures

Number of Participants Who Experienced Death From Any Cause

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

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

Number of Participants Who Experienced Myocardial Infarction (MI)

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

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

MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol

MAINTENANCE: Body Weight

MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions

INITIATION: Rate of Self-reported Hypoglycemic Episodes

INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes

INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint

INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose

INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin

INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group

INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline

INITIATION: Insulin Dose

INITIATION: Incremental Change From Baseline in Body Weight

INITIATION: HbA1c

INITIATION: Body Weight

INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions

ADDENDUM: Rate of Self-reported Hypoglycemic Episodes

ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes

ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%

ADDENDUM: Insulin Dose

ADDENDUM: Incremental Change From Baseline in Body Weight

ADDENDUM: HbA1c at Specified Visits and Endpoint

ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint

ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24

ADDENDUM: Body Weight

ADDENDUM: 7-point SMPG Profiles

MAINTENANCE: Rate of Increase in HbA1c

MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes

MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c

MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG

MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes

MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c

MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose

MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG

MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)

ADDENDUM: 24-Week Endpoint HbA1c

Intervention	percent (Mean)
	Baseline (n=174,200,171,199)	Endpoint (n=160,187,159,176)
Basal Bolus Prior Glargine Addendum	7.98	0.18
Basal Bolus Prior Lispro Low Mix Addendum	8.00	0.19
Lispro LM Prior Glargine Addendum	8.03	0.04
Lispro Mid Mix Prior Lispro Low Mix Addendum	8.01	0.19

Intervention	ug/mL (Mean)
	Baseline (n=166,172,197,199)	Endpoint (n=142,150,165,171)	Change (n=142,150,165,171)
Basal Bolus Prior Glargine Addendum	7.31	8.43	0.90
Basal Bolus Prior Lispro LM Addendum	7.84	8.18	0.26
Lispro Low Mix Prior Glargine Addendum	7.37	8.14	0.53
Lispro Mid Mix Prior Lispro Low Mix Addendum	7.77	7.73	-0.18

Intervention	kilograms (Mean)
	Baseline (n=170,173,198,200)	Week 6 (n=162,163,184,193)	Week 12 (n=151,158,174,187)	Week 24 (n=145,151,164,176)	Endpoint (n=164,170,192,198)
Basal Bolus Prior Glargine Addendum	89.25	89.66	89.62	89.80	90.09
Basal Bolus Prior Lispro LM Addendum	91.85	91.53	91.59	91.92	92.40
Lispro Low Mix Prior Glargine Addendum	90.09	89.85	91.19	91.22	91.45
Lispro Mid Mix Prior Lispro Low Mix Addendum	93.63	93.71	94.60	94.18	94.09

Intervention	mg/dL (Mean)
	Mean fast blood glucose (BG) (n=135,150,161,178)	AM 2-hour postprandial (PP) BG (n=135,149,160,176)	Midday premeal blood glucose (n=135,150,161,177)	Midday 2-hour (hr) PP BG (n=135,149,160,176))	PM premeal blood glucose (n=135,150,161,178)	PM 2-hour postprandial BG (n=134,150,161,178)	3 AM blood glucose (n=132,146,153,171)	AM 2-hour BG excursion (n=135,149,160,176)	Midday 2-hour BG excursion (n=135,148,160,176)	PM 2-hour BG excursion (n=134,150,161,178)	Mean all mealtime excursions (n=135,150,161,178)	Mean all 2-hour PP BG (n=135,150,161,178)	Mean all premeal blood glucose (n=135,150,161,178)	Mean combined AM/PM 2hr PP BG (n=135,150,161,178)	Mean AM/PM 2hr BG excursion (n=135,150,161,178)	Mean all BG values (n=135,150,161,178)	Baseline mean all premeals BG (n=152,161,183,187)	Baseline mean of postmeal BG (n=152,161,182,187)	Baseline average of all BG (n=152,161,183,187)	Baseline fasting glucose (n=152,161,183,187)
Basal Bolus Prior Glargine Addendum	126.22	170.14	144.61	167.45	157.15	175.34	147.14	24.35	23.30	18.58	21.82	170.95	149.04	172.73	21.42	158.33	146.64	186.19	163.19	131.54
Basal Bolus Prior Lispro LM Addendum	145.33	168.71	144.08	165.24	153.62	171.51	146.50	23.30	20.71	17.88	20.61	168.55	147.68	170.04	20.74	156.41	149.91	183.82	164.02	147.93
Lispro Low Mix Prior Glargine Addendum	139.45	171.40	141.87	181.46	153.19	174.94	139.86	31.33	39.40	21.59	30.38	175.61	144.85	172.88	26.45	157.41	146.01	185.62	163.20	131.02
Lispro Mid Mix Prior Lispro Low Mix Addendum	151.15	170.36	145.89	164.13	151.96	172.98	146.30	18.97	18.97	21.14	19.64	169.14	149.67	171.65	20.06	157.52	149.50	181.18	162.18	143.99

Intervention	years (Mean)
Lispro LM Participants Who Maintained Goal	9.42
Lispro LM Participants Who Did Not Maintain Goal	9.87

Intervention	percent glycosylated hemoglobin (Mean)
Lispro LM Participants Who Maintained Goal	8.54
Lispro LM Participants Who Did Not Maintain Goal	8.80

Intervention	ug/ml (Mean)
Lispro LM Participants Who Maintained Goal	5.93
Lispro LM Participants Who Did Not Maintain Goal	5.73

Intervention	years (Mean)
Insulin Glargine Participants Who Maintained Goal	8.44
Insulin Glargine Participants Who Did Not Maintain Goal	9.70

Intervention	percent glycosylated hemoglobin (Mean)
Insulin Glargine Participants Who Maintained Goal	8.27
Insulin Glargine Participants Who Did Not Maintain Goal	8.77

Intervention	mg/dL (Mean)
	Mean of post meals blood glucose	Average of all blood glucose
Lispro LM Participants Who Did Not Maintain Goal	231.66	207.96
Lispro LM Participants Who Maintained Goal	223.98	201.42