Page last updated: 2024-11-12

insulin detemir

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Description

Insulin Detemir: A recombinant long-acting insulin and hypoglycemic agent in which a MYRISTIC ACID is conjugated to a LYSINE at position B29. It is used to manage BLOOD GLUCOSE levels in patients with DIABETES MELLITUS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID16137271
CHEMBL ID2104391
MeSH IDM0274330

Synonyms (20)

Synonym
169148-63-4
insulin,detemir,human
insulin detemir recombinant
detemir
insulin detemir
29(sup b)-(n(sup 6)-(1-oxotetradecyl)-l-lysine)-(1(sup a)-21(sup a)),(1(sup b)-29(sup b))-insulin (human)
nn304
nn 304
levemir
29(sup b)-(n(sup 6)-myristoyl-l-lysine)-30(sup b)-de-l-threonineinsulin (human)
29b-(n6-myristoyl-l-lysine)-30b-de-l-threonineinsulin (human)
CHEMBL2104391
unii-4ft78t86xv
nn-304
levemir innolet
levemir penfill
levemir flexpen
4ft78t86xv ,
insulin detemir [usan:inn:ban]
levemir insulin

Research Excerpts

Overview

Insulin detemir (IDet) is a slow-acting, synthetic analogue characterised by the conjugation of a C14 fatty acid. It has significant weight-gain-sparing effects in diabetic patients.

ExcerptReferenceRelevance
"Insulin detemir (IDet) is an insulin analog used to treat diabetes. "( Probing the mechanism of reduced
Brand, CL; Sturis, J, 2023
)
2.35
"Insulin detemir is a lipidated insulin analogue that obtains a half-life extension by oligomerization and reversible binding to human serum albumin. "( Investigations of Albumin-Insulin Detemir Complexes Using Molecular Dynamics Simulations and Free Energy Calculations.
Bukrinski, JT; Harris, P; Peters, GHJ; Ryberg, LA; Sønderby, P, 2020
)
2.3
"Insulin detemir (IDet) is a clinically available, slow-acting, synthetic analogue characterised by the conjugation of a C14 fatty acid."( Exploration of temperature and shelf-life dependency of the therapeutically available Insulin Detemir.
Adams, GG; Agugini, G; Beji, O; Dinu, V; Fedele, F; Fisk, ID; Gillis, RB; Gyasi-Antwi, P; Harding, SE; Huang, S; Jiwani, SI; Meal, A; Morgan, PS, 2020
)
1.5
"Insulin detemir (DET) is a basal insulin analog that, in contrast to other long-acting forms of insulin, has significant weight-gain-sparing effects in diabetic patients. "( Central effects of insulin detemir on feeding, body weight, and metabolism in rats.
Chapman, CD; Currie, PJ; John, CS; Pi-Sunyer, FX; Vasselli, JR; Wall, DG, 2017
)
2.23
"Insulin detemir is a basal insulin analog that causes less weight gain than other basal insulin formulations, including the current standard intermediate-long acting Neutral Protamine Hagedorn (NPH) insulin."( Effects of insulin detemir and NPH insulin on body weight and appetite-regulating brain regions in human type 1 diabetes: a randomized controlled trial.
Barkhof, F; Deijen, JB; Diamant, M; Drent, ML; Heijboer, AC; van Golen, LW; Veltman, DJ; IJzerman, RG, 2014
)
1.51
"Insulin detemir is a long-acting insulin analogue and may represent a valuable treatment option for diabetic cats. "( Insulin detemir treatment in diabetic cats in a practice setting.
Bjornvad, CR; Hoelmkjaer, KM; Spodsberg, EM, 2015
)
3.3
"Insulin detemir is a new basal insulin analogue with superiority to NPH insulin similar to that demonstrated by insulin glargine, though its duration of action appears to be shorter."( New insulin analogues and routes of delivery: pharmacodynamic and clinical considerations.
Roach, P, 2008
)
1.07
"Insulin detemir is a basal insulin analog designed to produce a superior pharmacokinetic profile to basal formulations of human insulin. "( Insulin detemir improves glycemic control and reduces hypoglycemia in children with type 1 diabetes: findings from the Turkish cohort of the PREDICTIVE observational study.
Atabek, ME; Dizdarer, C; Emek, S; Isguven, P; Kurtoglu, S; Pirgon, O, 2009
)
3.24
"Insulin detemir (Levemir) is a soluble human insulin analogue acylated with a 14-carbon fatty acid, which reversibly binds to albumin, thereby providing a more prolonged metabolic effect with lower variability as compared to NPH insulin taken as reference. "( [Insulin detemir in the predictive study: results in patients with type 1 diabetes in the Belgian cohort].
Philips, JC; Scheen, AJ, 2009
)
2.71
"Insulin detemir is a novel human insulin analog that does not show the usual propensity for weight gain in diabetic patients. "( Evaluation of the lack of anorectic effect of intracerebroventricular insulin in rats.
Bouman, SD; Clegg, DJ; Jessen, L, 2010
)
1.8
"Insulin detemir is a basal insulin analog that provides effective therapeutic options for patients with type 1 and type 2 diabetes."( An update on the treatment of type 1 and type 2 diabetes mellitus: focus on insulin detemir, a long-acting human insulin analog.
Raslova, K, 2010
)
1.31
"Insulin detemir (Levemir®) is a long-acting insulin analogue indicated for use as basal insulin therapy in patients with type 1 or 2 diabetes mellitus. "( Insulin detemir: a review of its use in the management of diabetes mellitus.
Keating, GM, 2012
)
3.26
"Insulin detemir is a soluble basal insulin analog with a unique mechanism of protracted action designed to reduce the variability associated with conventional basal insulins. "( Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart.
De Leeuw, I; Draeger, E; Elte, JW; Haahr, H; Kristensen, A; Selam, JL; Skeie, S; Vague, P, 2003
)
3.2
"Insulin detemir (NN-304) is a soluble, long-acting insulin analog being developed by Novo Nordisk for the potential treatment of type 1 and 2 diabetes. "( Insulin detemir. Novo Nordisk.
Barlocco, D, 2003
)
3.2
"Insulin detemir is a soluble long-acting basal insulin analog designed to overcome the limitations of conventional basal insulin formulations. "( Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial.
Abrams, P; Bartley, P; Draeger, E; Hanaire-Broutin, H; Heeg, JE; Home, P; Hylleberg, B; Landin-Olsson, M; Lang, H; Russell-Jones, D, 2004
)
3.21
"Insulin detemir is a novel long-acting analogue of human insulin designed to overcome these practical limitations."( Can we reduce hypoglycaemia with insulin detemir?
Mathieu, C, 2004
)
1.33
"Insulin detemir is a new long-acting soluble insulin analogue where protraction is achieved by reversible binding to albumin."( At last, a weight neutral insulin?
Fritsche, A; Häring, H, 2004
)
1.04
"Insulin detemir (Levemir) is a soluble long-acting human insulin analogue acylated with a 14-carbon fatty acid. "( Insulin detemir: a review of its use in the management of type 1 and 2 diabetes mellitus.
Chapman, TM; Perry, CM, 2004
)
3.21
"Insulin detemir is a basal insulin analog that has been shown to improve glycemic control in patients with type 1 and type 2 diabetes."( Insulin detemir--a new basal insulin analog.
Goldman-Levine, JD; Lee, KW, 2005
)
3.21
"Insulin detemir (Levemir) is a soluble long-acting human insulin analog acylated with a 14-carbon fatty acid. "( Spotlight on insulin detemir in type 1 and 2 diabetes mellitus.
Chapman, TM; Perry, CM, 2005
)
2.14
"Insulin detemir (Levemir) is a soluble long acting human insulin analogue acylated with a 14-carbon fatty acid. "( [Insulin detemir (Levemir)].
Paquot, N; Philips, JC; Radermecker, RP; Scheen, AJ, 2005
)
2.68
"Insulin detemir is a new basal insulin analogue recently available for commercial use in the UK."( Insulin detemir: a new basal insulin analogue.
Soran, H; Younis, N, 2006
)
2.5
"Insulin detemir (Levemir) is a soluble long-acting human insulin analogue acylated with a 14-carbon fatty acid. "( [Insulin analogues: place of detemir (levemir)].
Dorchy, H; Sternon, J,
)
1.57
"Insulin detemir (Levemir) is a soluble long-acting human insulin analogue acylated with a 14-carbon fatty acid. "( [Insulin analogues: place of detemir (Levemir)].
Dorchy, H; Sternon, J, 2006
)
1.78
"Insulin detemir is a long-acting, neutral, and soluble insulin analogue with a lower within-subject variability of fasting plasma glucose levels than isophane insulin human (NPH insulin) and insulin glargine. "( Insulin detemir: a long-acting insulin product.
Jones, MC; Patel, M, 2006
)
3.22
"Insulin detemir is a soluble long-acting human insulin analogue at neutral pH with a unique mechanism of action. "( Insulin detemir in the treatment of type 1 and type 2 diabetes.
Philips, JC; Scheen, A, 2006
)
3.22
"Insulin detemir is a novel basal insulin analogue that has consistently been shown in randomized, controlled trials to have a weight-sparing effect (i.e."( Does insulin detemir have a role in reducing risk of insulin-associated weight gain?
Davies, M; Hermansen, K, 2007
)
1.57
"Insulin detemir is a basal insulin analog that can help patients move safely toward glycemic targets with less weight gain."( Intensive diabetes therapy and body weight: focus on insulin detemir.
Bush, MA, 2007
)
1.31
"Insulin detemir is a novel long-acting insulin analogue with a unique mechanism underlying its prolonged duration of action. "( Defining the role of insulin detemir in Basal insulin therapy.
Morales, J, 2007
)
2.1
"Insulin detemir (NN304) is a soluble basal insulin analog developed to cover basal insulin requirements. "( Comparison of the soluble basal insulin analog insulin detemir with NPH insulin: a randomized open crossover trial in type 1 diabetic subjects on basal-bolus therapy.
Axelsen, M; Hermansen, K; Kristensen, A; Madsbad, S; Perrild, H, 2001
)
2.01

Effects

Insulin detemir has a more predictable, protracted and consistent effect on blood glucose than neutral protamine Hagedorn (NPH) insulin. It has a less variable pharmacokinetic profile than insulin suspension isophane or insulin ultralente.

Insulin detemir has been found in clinical trials to be absorbed with very low variability. It has shown weight neutrality in patients with type 1 diabetes and is associated with less weight gain than NPH insulin.

ExcerptReferenceRelevance
"Insulin detemir has a different profile of action on the central nervous system (CNS) than human insulin. "( Insulin detemir is not transported across the blood-brain barrier.
Banks, WA; Lynch, JL; Lynch, KM; Mooradian, AD; Morley, JE, 2010
)
3.25
"Insulin detemir has a more predictable, protracted and consistent effect on blood glucose than neutral protamine Hagedorn (NPH) insulin, with less intrapatient variability in glycaemic control, compared with NPH insulin or insulin glargine."( Insulin detemir: a review of its use in the management of type 1 and 2 diabetes mellitus.
Chapman, TM; Perry, CM, 2004
)
2.49
"Insulin detemir has a more predictable, protracted, and consistent effect on blood glucose than neutral protamine Hagedorn (NPH) insulin, with less intrapatient variability in glycemic control than NPH insulin or insulin glargine."( Spotlight on insulin detemir in type 1 and 2 diabetes mellitus.
Chapman, TM; Perry, CM, 2005
)
1.42
"Insulin detemir has a less variable pharmacokinetic profile than insulin suspension isophane or insulin ultralente."( Insulin detemir in the treatment of type 1 and type 2 diabetes.
Philips, JC; Scheen, A, 2006
)
2.5
"Insulin detemir has been increasingly studied in basal-only insulin regimens in type 2 diabetes, in which an understanding of how to optimize its use has been built incrementally."( Insulin detemir: A historical perspective on a modern basal insulin analogue.
Abrahamson, MJ; Liebl, A; Meneghini, L, 2010
)
2.52
"Insulin detemir has been found in clinical trials to be absorbed with very low variability. "( The mechanism of protraction of insulin detemir, a long-acting, acylated analog of human insulin.
Havelund, S; Jonassen, I; Kurtzhals, P; Markussen, J; Plum, A; Ribel, U; Vølund, A, 2004
)
2.05
"Insulin detemir has shown weight neutrality in patients with type 1 diabetes and is associated with less weight gain than NPH insulin in clinical studies."( Defining the role of insulin detemir in Basal insulin therapy.
Morales, J, 2007
)
1.38

Actions

Insulin detemir displays reduced induction of the Pparg2 adipocyte master gene. diminished effects on adipocyte differentiation and lipogenesis in human subcutaneous and visceral ASC.

ExcerptReferenceRelevance
"Insulin detemir dosages were lower than reported dosages of other insulin types needed to maintain glycemic control, suggesting that insulin detemir should be used with caution, especially in small dogs."( Detemir insulin for the treatment of diabetes mellitus in dogs.
Boretti, FS; Corradini, S; Fracassi, F; Hafner, M; Reusch, CE; Sieber-Ruckstuhl, NS, 2015
)
1.14
"Insulin detemir displays reduced induction of the Pparg2 adipocyte master gene and diminished effects on adipocyte differentiation and lipogenesis in human subcutaneous and visceral ASC, in spite of normal activation of proximal insulin signaling reactions. "( Long-acting insulin analog detemir displays reduced effects on adipocyte differentiation of human subcutaneous and visceral adipose stem cells.
Barbaro, M; Cignarelli, A; Ficarella, R; Giorgino, F; Laviola, L; Natalicchio, A; Nigro, P; Perrini, S; Peschechera, A; Porro, S; Puglisi, F, 2016
)
1.88

Treatment

Insulin detemir compared to NPH insulin found an RR for severe hypoglycaemia of 0.45 (95% CI 0.17 to 1.20) Weight loss was paralleled by increased CBF in appetite-related brain regions in the resting state.

ExcerptReferenceRelevance
"Treatment with insulin detemir compared to NPH insulin found an RR for severe hypoglycaemia of 0.45 (95% CI 0.17 to 1.20; P = 0.11; ARR -0.9%, 95% CI -1.4 to 0.4; 5 trials, 1804 participants; very low-certainty evidence)."( (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus.
Berghold, A; Engler, J; Horvath, K; Jeitler, K; Semlitsch, T; Siebenhofer, A, 2020
)
0.9
"Treatment with insulin detemir also reduced the incidence of serious hypoglycaemia."( (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus.
Berghold, A; Engler, J; Horvath, K; Jeitler, K; Semlitsch, T; Siebenhofer, A, 2020
)
0.9
"Treatment with insulin detemir versus NPH insulin resulted in weight loss, paralleled by increased CBF in appetite-related brain regions in the resting state, in men with well-controlled type 1 diabetes. "( Cerebral blood flow and glucose metabolism in appetite-related brain regions in type 1 diabetic patients after treatment with insulin detemir and NPH insulin: a randomized controlled crossover trial.
Diamant, M; Drent, ML; Hensbergen, JF; Hoogma, RP; Huisman, MC; Lammertsma, AA; van Golen, LW; IJzerman, RG, 2013
)
0.95
"Treatment with insulin detemir and aspart in patients with type 1 diabetes and recurrent severe hypoglycaemia resulted in a clinically significant reduced rate of severe hypoglycaemia compared with human insulin. "( Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial.
Beck-Nielsen, H; Christiansen, JS; Hougaard, P; Jensen, T; Kristensen, PL; Nørgaard, K; Parving, HH; Pedersen-Bjergaard, U; Perrild, H; Tarnow, L; Thorsteinsson, B, 2014
)
0.76
"Treatment with insulin detemir was associated with fewer mild hypoglycaemic events than NPH insulin (mean rates of 26.3 vs. "( Evaluating the cost-effectiveness of reduced mild hypoglycaemia in subjects with Type 1 diabetes treated with insulin detemir or NPH insulin in Denmark, Sweden, Finland and the Netherlands.
Jendle, J; Lammert, M; Pollock, RF; Saraheimo, M; Thorsteinsson, B; Valentine, WJ, 2012
)
0.94
"Treatment with insulin detemir for 6 months resulted in substantial benefits, including reduced HbA(1c), FPG and body weight, and improvements in nocturnal quality of life, without increasing hypoglycaemia."( Observational 6-month open-label study of Japanese type 2 diabetes patients switching from NPH insulin to insulin detemir in basal-bolus regimen: 23rd article of the Japan Diabetes Clinical Data Management Study Group (JDDM23).
Abe, N; Kobayashi, M; Kuribayashi, N; Matoba, K; Oishi, M; Tomonaga, O; Yokoyama, H, 2012
)
0.95
"Treatment with insulin detemir appears to require more frequent administration and higher insulin doses compared with insulin glargine in patients with type 2 diabetes, with 33% higher doses, on average, observed in this study. "( Evaluation of dosing and clinical outcomes in patients undergoing conversion of insulin glargine to insulin detemir.
Bryant, GA; Farris, KB; Horner, KE; McDanel, DL; Newkirk, EN, 2013
)
0.96
"Treatment with insulin detemir resulted in more predictable glycemic control, with smoother plasma glucose profiles than NPH insulin and a significant reduction in the risk of hypoglycemia. "( Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart.
De Leeuw, I; Draeger, E; Elte, JW; Haahr, H; Kristensen, A; Selam, JL; Skeie, S; Vague, P, 2003
)
2.11
"Treatment with insulin detemir+/-OHA was associated with increases in quality-adjusted life expectancy of 0.309, 0.350, and 0.333 quality-adjusted life-years (QALYs) versus treatment with OHA alone, NPH+/-OHA, and insulin glargine+/-OHA, respectively."( Therapy conversion to insulin detemir among patients with type 2 diabetes treated with oral agents: a modeling study of cost-effectiveness in the United States.
Cobden, D; Erny-Albrecht, KM; Palmer, AJ; Ray, JA; Roze, S; Valentine, WJ,
)
0.79
"Treatment with insulin detemir (+/- OADs) significantly reduced mean haemoglobin A(1c) (HbA(1c)) (-1.3%; p < 0.0001), fasting glucose (-3.7 mmol/l; p < 0.0001), and within-patient fasting glucose variability (-0.5 mmol/l; p < 0.0001)."( Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study.
Dornhorst, A; Hansen, JB; Kozlovski, P; Looij, BJ; Lüddeke, HJ; Meneghini, L; Sreenan, S, 2008
)
2.13

Toxicity

Once-daily insulin detemir therapy was safe and effective, and rates of hypoglycemia were low.

ExcerptReferenceRelevance
" Six subjects discontinued the study, 2 as a result of adverse events (blood draw-related ecchymosis and hypoglycemia)."( Similarity of insulin detemir pharmacokinetics, safety, and tolerability profiles in healthy caucasian and Japanese american subjects.
Jacobsen, LV; Jhee, SS; Leibowitz, MT; Lyness, WH; Rojas, PB; Zarotsky, V, 2004
)
0.68
" The primary endpoint was incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia."( Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort.
Dornhorst, A; Hansen, JB; Koenen, C; Landstedt-Hallin, L; Lüddeke, HJ; Sreenan, S; Tsur, A, 2007
)
0.65
" The primary endpoint was serious adverse drug reactions (SADRs), including major hypoglycaemia."( Safety and efficacy of insulin detemir basal-bolus therapy in type 1 diabetes patients: 14-week data from the European cohort of the PREDICTIVE study.
Ackermann, RW; Dornhorst, A; Gallwitz, B; Honka, M; Lüddeke, HJ; Meriläinen, M; Sreenan, S, 2008
)
0.66
" Safety endpoints included adverse events (AEs) and hypoglycaemia."( Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial.
Hollander, P; Liutkus, JF; Raslova, K; Råstam, J; Skjøth, TV, 2011
)
0.68
"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
)
0.59
" Adverse event data (including hypoglycaemia) and glycaemic control were recorded before and 24 weeks following insulin initiation while patients continued routine clinical management."( The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries.
Caputo, S; Damci, T; Dzida, GJ; Ji, Q; Kaiser, M; Karnieli, E; Khunti, K; Liebl, A; Ligthelm, RJ; Meneghini, LF; Nazeri, A; Orozco-Beltran, D; Pan, C; Ross, SA; Svendsen, AL; Vora, J; Yale, JF, 2012
)
0.64
" During the study, 27 patients experienced serious adverse drug reaction, severe hypoglycaemic events or both; and there were 31 episodes of severe hypoglycaemia in 21 patients."( The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries.
Caputo, S; Damci, T; Dzida, GJ; Ji, Q; Kaiser, M; Karnieli, E; Khunti, K; Liebl, A; Ligthelm, RJ; Meneghini, LF; Nazeri, A; Orozco-Beltran, D; Pan, C; Ross, SA; Svendsen, AL; Vora, J; Yale, JF, 2012
)
0.64
"Addition of once-daily insulin detemir to patients with type 2 diabetes mellitus on OHA therapy resulted in few adverse events, significant improvements in glycaemic control, small reductions in weight and low rates of hypoglycaemia."( The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries.
Caputo, S; Damci, T; Dzida, GJ; Ji, Q; Kaiser, M; Karnieli, E; Khunti, K; Liebl, A; Ligthelm, RJ; Meneghini, LF; Nazeri, A; Orozco-Beltran, D; Pan, C; Ross, SA; Svendsen, AL; Vora, J; Yale, JF, 2012
)
0.95
" Gastrointestinal-related and injection site-related adverse events occurred more frequently with EQW than with detemir."( Once-weekly exenatide versus once- or twice-daily insulin detemir: randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas.
Adetunji, O; Davies, M; Heller, S; Sapin, H; Sreenan, S; Tahbaz, A; Vora, J, 2013
)
0.64
" The primary outcome measure was the incidence of severe adverse drug reactions; just one major hypoglycemic event occurred in a patient in the ND stratum during the study and one patient was withdrawn due to injection-site reactions."( A multicenter observational safety study in Swedish children and adolescents using insulin detemir for the treatment of type 1 diabetes.
Carlsson, A; Forsander, G; Larsen, S; Ludvigsson, J; Ortqvist, E, 2013
)
0.61
" The primary outcome was the incidence of serious adverse drug reactions including major hypoglycaemia over 24 weeks."( Safety and effectiveness of insulin detemir in type 2 diabetes: results from the ASEAN cohort of the A₁chieve study.
Jain, AB; Khoo, CM; Mohamed, M; Soewondo, P; Sy, RA, 2013
)
0.68
" The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia."( Safety and effectiveness of insulin analogues in type 2 diabetic patients from Algeria: a sub-analysis of the A₁chieve study.
Arbouche, Z; Bachaoui, M; Dahaoui, A; Malek, R, 2013
)
0.39
" The primary outcome was the evaluation of serious adverse drug reactions including major hypoglycaemic events."( Safety and effectiveness of insulin analogues in Moroccan patients with type 2 diabetes: a sub-analysis of the A₁chieve study.
Ajdi, F; Belkhadir, J; Chraibi, A; El Ansari, N; Farouqi, A; Marouan, F, 2013
)
0.39
" The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events."( Exploring insulin analogue safety and effectiveness in a Maghrebian cohort with type 2 diabetes: results from the A₁chieve study.
Belhadj, M; Dahaoui, A; Farouqi, A; Jamoussi, H, 2013
)
0.39
"Once-daily insulin detemir therapy was safe and effective, and rates of hypoglycemia were low."( Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice.
Dzida, G; Ji, Q; Kaiser, M; Ligthelm, R; Meneghini, L; Nazeri, A; Orozco-Beltran, D; Pan, C; Ross, S; Svendsen, AL, 2014
)
1.11
" Both treatments were well tolerated with comparable rates of adverse events."( Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes.
Danne, T; Deeb, L; Iotova, V; Kawamura, T; Kinduryte, O; Klingensmith, G; Ocampo Francisco, AM; Philotheou, A; Silverstein, J; Thalange, N; Tumini, S, 2015
)
0.42
" Insulin is the most effective pharmacological treatment for controlling hyperglycemia during gestation and can limit adverse outcomes."( The use of insulin detemir during pregnancy: a safety evaluation.
Hod, M; Koren, R; Toledano, Y, 2015
)
0.81
"Aspart, glargine, and detemir are safe treatment options for diabetes during pregnancy; these insulin analogs did not increase complications for the mothers or fetuses in our study."( Safety of insulin analogs during pregnancy: a meta-analysis.
Lv, S; Wang, J; Xu, Y, 2015
)
0.42
" The primary endpoint was to assess the incidence of serious adverse drug reactions (SADRs) including in the specific major hypoglycemic events during 24 weeks of once-daily insulin detemir treatment."( Safety and effectiveness of insulin detemir in combination with oral antidiabetic agents in an outpatient specialist setting: results of the Italian SOLVE™ observational study.
Caputo, S; Lastoria, G; Mannino, D; Maran, A; Morano, S; Nicoziani, P, 2015
)
0.9
" Serious adverse events (SAEs) were recorded at 3 and 6 months."( Observational Registry of Basal Insulin Treatment in Patients with Type 2 Diabetes in China: Safety and Hypoglycemia Predictors.
Gao, Y; Guo, X; Ji, J; Ji, L; Li, X; Zhang, H; Zhang, P; Zhang, T; Zhao, F; Zhu, D, 2017
)
0.46
" There was no difference in overall severe or blood glucose-confirmed hypoglycaemic episodes or treatment-emergent adverse events between treatments."( Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial.
Birk Østerskov, A; Bode, BW; Franek, E; Graungaard, T; Mathieu, C; Philis-Tsimikas, A; Rose, L; Russell-Jones, D, 2018
)
0.48
" This treatment strategy is an effective and safe alternative to a basal-bolus insulin regimen."( A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study.
Abreu, M; Adams-Huet, B; Dimachkie, P; Elhassan, A; Gunasekaran, U; Li, X; Lingvay, I; Meneghini, LF; Papacostea, O; Peicher, K; Pop, LM; Siddiqui, MS; Tumyan, A, 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
)
0.83
" 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
)
0.83
"This study aimed to compare the rate of hypoglycemic events from all spontaneously reported adverse events (AEs) between insulin detemir and insulin degludec using the Korea Adverse Event Reporting System (KAERS) database."( Disproportionality analysis of spontaneously reported hypoglycemia events due to insulin use: A comparison between insulin detemir and insulin degludec using the Korea Adverse Event Reporting System.
Jeong, D; Kim, W; Shin, JY, 2021
)
1.04
"We analyzed data on the reported hypoglycemia events retrieved from adverse drug reactions (ADR) on the use of different insulin types from 2016 to 2017 in the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD)."( Disproportionality analysis of spontaneously reported hypoglycemia events due to insulin use: A comparison between insulin detemir and insulin degludec using the Korea Adverse Event Reporting System.
Jeong, D; Kim, W; Shin, JY, 2021
)
0.83
" 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
)
1.03

Pharmacokinetics

The pharmacodynamic characteristics of the basal insulin analogues insulin detemir (IDet) and insulin glargine (IGlar) have been examined extensively via euglycaemic clamp studies. This study shows that insulin Detemir provides a flat and protracted pharmacodynamic profile.

ExcerptReferenceRelevance
" 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
)
1.99
"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
)
2.04
" For pharmacokinetic evaluations, serial blood sampling was performed over a period of 30 hours after dosing."( Similarity of insulin detemir pharmacokinetics, safety, and tolerability profiles in healthy caucasian and Japanese american subjects.
Jacobsen, LV; Jhee, SS; Leibowitz, MT; Lyness, WH; Rojas, PB; Zarotsky, V, 2004
)
0.68
"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
)
0.55
"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
)
0.64
" The two analogues are popularly perceived to differ from each other in their pharmacodynamic (PD) profiles, in particular with regard to 'flatness' and duration of action."( Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies.
Heise, T; Pieber, TR, 2007
)
0.34
" Insulin aspart and insulin lispro have nearly identical pharmacokinetic and pharmacodynamic profiles and provide better postprandial glucose control and less hypoglycaemia (primarily nocturnal and severe hypoglycaemia in type 1 diabetes mellitus) than regular insulin."( New insulin analogues and routes of delivery: pharmacodynamic and clinical considerations.
Roach, P, 2008
)
0.35
" This randomized, double-blind, crossover trial compared the within-subject variability of detemir and insulin glargine (glargine) in pharmacokinetic properties in children and adolescents with T1DM."( Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial.
Danne, T; Datz, N; Endahl, L; Fjording, MS; Haahr, H; Kordonouri, O; Nestoris, C; Westergaard, L, 2008
)
1.79
"8 U/kg) and evaluate pharmacokinetic (PK) and pharmacodynamic (PD) dose responses of ILPS."( Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes.
Campaigne, BN; Hompesch, M; Jacober, SJ; Kollmeier, AP; Morrow, LA; Ocheltree, SM; Wondmagegnehu, ET, 2009
)
0.56
"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
)
0.59
"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
)
0.81
"To compare the pharmacokinetic (PK) [area under the curve (AUC₀(-)₂₄ (h), C(max))] and pharmacodynamic (PD) (AUC(GIR) ₀(-)₂₄ (h), GIR(max)) properties of single-dose insulin detemir in the presence or absence of steady-state liraglutide (1."( Co-administration of liraglutide with insulin detemir demonstrates additive pharmacodynamic effects with no pharmacokinetic interaction.
Chang, D; Chatterjee, DJ; Guthrie, H; Hompesch, M; Morrow, L, 2011
)
0.84
"To compare the pharmacodynamic properties of insulin detemir (detemir) and neutral protamine lispro (NPL) insulin using a euglycaemic glucose clamp."( A direct comparison of the pharmacodynamic properties of insulin detemir and neutral protamine lispro insulin in patients with type 1 diabetes.
Bock, G; Glettler, K; Koehler, G; Korsatko, S; Mader, JK; Olsen, KJ; Pieber, TR; Semlitsch, B; Wutte, A, 2013
)
0.89
" Using glucose infusion rate (GIR) parameters, detemir showed a flatter pharmacodynamic profile versus NPL: area under the curve, AUC(GIR) ((0-32))  = 1326 vs."( A direct comparison of the pharmacodynamic properties of insulin detemir and neutral protamine lispro insulin in patients with type 1 diabetes.
Bock, G; Glettler, K; Koehler, G; Korsatko, S; Mader, JK; Olsen, KJ; Pieber, TR; Semlitsch, B; Wutte, A, 2013
)
0.64
"The pharmacodynamic characteristics of the basal insulin analogues insulin detemir (IDet) and insulin glargine (IGlar) have been examined extensively via euglycaemic clamp studies."( Pharmacodynamics of the long-acting insulin analogues detemir and glargine following single-doses and under steady-state conditions in patients with type 1 diabetes.
Koehler, G; Korsatko, S; Mader, JK; Pieber, TR; Semlitsch, B; Treiber, G; Wutte, A, 2014
)
0.64
"Pharmacokinetic and pharmacodynamic profiles of exogenous insulin may be affected by intrinsic factors, such as age, ethnicity/race, and hepatic and renal function."( Pharmacokinetic and pharmacodynamic responses of insulin degludec in African American, white, and Hispanic/Latino patients with type 2 diabetes mellitus.
Haahr, H; Hompesch, M; Morrow, L; Roepstorff, C; Thomsen, HF; Watkins, E, 2014
)
0.4
"The purpose of this study was to investigate whether the pharmacokinetic and pharmacodynamic responses to IDeg at steady state vary according to patient race/ethnicity."( Pharmacokinetic and pharmacodynamic responses of insulin degludec in African American, white, and Hispanic/Latino patients with type 2 diabetes mellitus.
Haahr, H; Hompesch, M; Morrow, L; Roepstorff, C; Thomsen, HF; Watkins, E, 2014
)
0.4
" Differences in pharmacokinetic and pharmacodynamic variables among groups were analyzed using an ANOVA with treatment period, an interaction between race/ethnicity, and treatment as fixed factors, subject as a random effect, and residual variance, depending on treatment."( Pharmacokinetic and pharmacodynamic responses of insulin degludec in African American, white, and Hispanic/Latino patients with type 2 diabetes mellitus.
Haahr, H; Hompesch, M; Morrow, L; Roepstorff, C; Thomsen, HF; Watkins, E, 2014
)
0.4
"The similar pharmacokinetic and pharmacodynamic responses to IDeg in 3 racial/ethnic groups of patients with type 2 diabetes mellitus suggest that the flat, stable, and ultralong pharmacokinetic and pharmacodynamic profiles of IDeg are preserved irrespective of race/ethnicity."( Pharmacokinetic and pharmacodynamic responses of insulin degludec in African American, white, and Hispanic/Latino patients with type 2 diabetes mellitus.
Haahr, H; Hompesch, M; Morrow, L; Roepstorff, C; Thomsen, HF; Watkins, E, 2014
)
0.4
"Despite their widespread use in this population, data on the pharmacodynamic (PD) properties of the insulin analogs detemir and glargine in severely obese patients with type 2 diabetes are lacking."( Comparison of the dose-response pharmacodynamic profiles of detemir and glargine in severely obese patients with type 2 diabetes: A single-blind, randomised cross-over trial.
Bilz, S; Falconnier, C; Flückiger, M; Keller, U; Meienberg, F; Puder, JJ, 2018
)
0.48
" Model specific parameters are identified using data from a range of published clinical studies on the pharmacokinetic of insulin Detemir."( A subcutaneous insulin pharmacokinetic model for insulin Detemir.
Chase, JG; Knopp, JL; van Noorden, B, 2019
)
0.98
"A first model of insulin Detemir including its unique albumin binding kinetics is derived and provisionally validated against clinical pharmacokinetic data."( A subcutaneous insulin pharmacokinetic model for insulin Detemir.
Chase, JG; Knopp, JL; van Noorden, B, 2019
)
1.11

Compound-Compound Interactions

The aim of this trial was to evaluate the efficacy and safety of the combination of once-daily insulin detemir (IDet) and sitagliptin (SITA) versus SITA ± sulphonylurea (SU) in insulin-naive subjects.

ExcerptReferenceRelevance
"The aim of this trial was to evaluate the efficacy and safety of the combination of once-daily insulin detemir (IDet) and sitagliptin (SITA) versus SITA ± sulphonylurea (SU), both in combination with metformin (MET) in insulin-naive subjects."( Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial.
Hollander, P; Liutkus, JF; Raslova, K; Råstam, J; Skjøth, TV, 2011
)
0.9
"The combination of once-daily IDet with SITA showed a clinically and significantly better improvement in glycaemic control than SITA in combination with or without SUs."( Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial.
Hollander, P; Liutkus, JF; Raslova, K; Råstam, J; Skjøth, TV, 2011
)
0.68
" The Italian arm of the Solve™ Study aimed to evaluate the safety and the effectiveness of once-daily insulin detemir in combination with OAD agents for the treatment of patients with T2DM in the Italian outpatient specialist setting."( Safety and effectiveness of insulin detemir in combination with oral antidiabetic agents in an outpatient specialist setting: results of the Italian SOLVE™ observational study.
Caputo, S; Lastoria, G; Mannino, D; Maran, A; Morano, S; Nicoziani, P, 2015
)
0.93

Bioavailability

ExcerptReferenceRelevance
"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

Dosage Studied

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. The pharmacology, pharmacokinetics, efficacy and tolerability, safety, drug interactions, dosage and administration, cost, and place in therapy are reviewed.

ExcerptRelevanceReference
"Injection of NN304 at different doses resulted in an increase in total NN304 concentration in a linear dose-response effect and a more even metabolic effect than NPH-insulin."( Time-action profile of the soluble, fatty acid acylated, long-acting insulin analogue NN304.
Heinemann, L; Heise, T; Hirschberger, S; Loftager, M; Sinha, K; Weyer, C, 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
" 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
" There was a linear dose-response relationship between the three ascending insulin detemir doses and serum insulin detemir AUC values for both the Japanese and Caucasian subjects."( Similarity of insulin detemir pharmacokinetics, safety, and tolerability profiles in healthy caucasian and Japanese american subjects.
Jacobsen, LV; Jhee, SS; Leibowitz, MT; Lyness, WH; Rojas, PB; Zarotsky, V, 2004
)
0.91
"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
)
0.86
"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
)
0.64
"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
)
1.98
" 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
)
1.78
"8 dosing units (DU) (1 DU corresponds to 6 nmol NN344) per kilogram of body weight."( Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes.
Damholt, B; Endahl, L; Heise, T; Klein, O; Lynge, J; Nosek, L, 2007
)
0.61
" The information provided is tailored to diabetes educators and includes mechanism of action, pharmacokinetics, drug interactions, clinical trials, dosage and administration guidelines, side effects, and educational pearls for each insulin discussed."( Update in the pharmacologic treatment of diabetes: focus on insulin detemir, insulin glulisine, and inhaled dry powdered insulin.
Campbell, RK; Iltz, JL; Odegard, PS; Setter, SM,
)
0.37
" Attention was paid to dosing schedules and 24-h glycaemic profiles."( Refining basal insulin therapy: what have we learned in the age of analogues?
Devries, JH; Nattrass, M; Pieber, TR, 2007
)
0.34
" Morning administration tends to require higher dosing than evening administration."( Refining basal insulin therapy: what have we learned in the age of analogues?
Devries, JH; Nattrass, M; Pieber, TR, 2007
)
0.34
"Forty-three case reports of patients with type 2 diabetes who were treated with insulin detemir (Levemir, Novo Nordisk A/S, Bagsvaerd, Denmark) were collected from doctors' offices for the purpose of analyzing 4 parameters: (1) effectiveness of glycemic control (fasting blood glucose [FBG] readings and glycosylated hemoglobin [A1C]); (2) tolerability (hypoglycemic episodes and weight gain); (3) dosing regimen; and (4) treatment discontinuations."( Levemir Early Clinical Experience Case Series.
Mayerson, AB, 2007
)
0.57
"The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation 303 (PREDICTIVE 303) Study (n = 5604) evaluated the effectiveness of insulin detemir, a long-acting basal insulin analogue, using a simplified patient self-adjusted dosing algorithm (303 Algorithm group) compared with standard-of-care physician-driven adjustments (Standard-of-care group) in a predominantly primary care setting, over a period of 6 months."( The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study.
Koenen, C; Meneghini, L; Selam, JL; Weng, W, 2007
)
0.76
" With detemir, 45% of participants completed the study on once daily dosing and 55% on twice daily dosing, with no difference in HbA(1c)."( A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes.
Davies, M; Home, PD; Koenen, C; Larsen, J; Rosenstock, J; Schernthaner, G, 2008
)
0.59
"Basal bolus insulin dosing (BBD) may be defined as the physiological replacement of basal and bolus insulin to achieve near normal glycemia without hypoglycemia and loss of life quality."( Basal bolus dosing: a clinical experience.
Armstrong, DU; King, AB, 2005
)
0.33
" The results of both glucose clamp studies and clinical trials support initiation of detemir at a once-daily dosing regimen."( An update on the use of insulin detemir, with a focus on type 2 diabetes (drug evaluation update).
Philis-Tsimikas, A, 2008
)
0.65
"4 U/kg of detemir and glargine was injected subcutaneously 24 h apart at each of two dosing visits."( Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial.
Danne, T; Datz, N; Endahl, L; Fjording, MS; Haahr, H; Kordonouri, O; Nestoris, C; Westergaard, L, 2008
)
1.79
"Once-daily dosing with insulin detemir and insulin glargine were compared in a double-blind, randomised, crossover study in type 2 diabetes subjects previously treated with other antihyperglycaemic medications."( Once-daily insulin detemir is comparable to once-daily insulin glargine in providing glycaemic control over 24 h in patients with type 2 diabetes: a double-blind, randomized, crossover study.
King, AB, 2009
)
1.05
"The aim was to compare clinical outcomes by different dosing frequencies of insulin detemir (detemir) used over 52 weeks in various regimens."( Effect of insulin detemir dose frequency on clinical outcomes in patients with diabetes in PREDICTIVE.
Fontaine, P; Gin, H; Hanaire, H; Marre, M; Pinget, M; Robert, JJ; Thivolet, C; Venkatanarasimhachar, S, 2009
)
0.98
" In each cohort, data were stratified according to detemir dosing frequency at the beginning and end of 52 weeks: once daily (o."( Effect of insulin detemir dose frequency on clinical outcomes in patients with diabetes in PREDICTIVE.
Fontaine, P; Gin, H; Hanaire, H; Marre, M; Pinget, M; Robert, JJ; Thivolet, C; Venkatanarasimhachar, S, 2009
)
0.76
" We found no dose-response relationship between end-of-study insulin dose and hypoglycaemia or weight gain."( Contact frequency determines outcome of basal insulin initiation trials in type 2 diabetes.
DeVries, JH; Swinnen, SGHA, 2009
)
0.35
" These results potentially support once-daily dosing of ILPS in T2DM."( Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes.
Campaigne, BN; Hompesch, M; Jacober, SJ; Kollmeier, AP; Morrow, LA; Ocheltree, SM; Wondmagegnehu, ET, 2009
)
0.56
" In this study, injection force requirements and dosage scale displays were evaluated for NovoPen 3 and NovoPen 4 (both from Novo Nordisk A/S, Copenhagen, Denmark)."( A comparison of injection force and dosage scale size between NovoPen 3 and NovoPen 4.
Donsmark, M; Herold, L; Kristensen, CM, 2009
)
0.35
" To compare dosage scale displays, digital images of multiple settings were made, and the total inked areas of digits were converted to mm(2)."( A comparison of injection force and dosage scale size between NovoPen 3 and NovoPen 4.
Donsmark, M; Herold, L; Kristensen, CM, 2009
)
0.35
" A higher dosage was chosen for detemir to compensate for its delay in impact relative to human insulin and to elicit similar systemic effects."( Euglycemic infusion of insulin detemir compared with human insulin appears to increase direct current brain potential response and reduces food intake while inducing similar systemic effects.
Born, J; Hallschmid, M; Jauch-Chara, K; Kern, W; Korn, O; Mölle, M; Rasch, B; Schultes, B, 2010
)
0.67
" Further, the mean dosage to achieve this glucose goal was the same with both insulins."( No higher dose requirements with insulin detemir than glargine in type 2 diabetes: a crossover, double-blind, and randomized study using continuous glucose monitoring.
King, AB, 2010
)
0.64
" Previous studies have demonstrated noninferiority of insulin detemir, dosed once or twice daily, and insulin glargine, dosed once daily."( An analysis of dosing equivalence of insulin detemir and insulin glargine: more evidence?
True, MW, 2010
)
0.88
" More ILPS patients used twice-daily dosing (59% vs."( A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes.
Dharmalingam, M; Fogelfeld, L; Jacober, S; Jones, C; Robling, K; Swanson, D, 2010
)
0.58
"To compare the properties of insulin detemir with human insulin or insulin aspart in various in vitro and in vivo experiments, thereby highlighting the importance of performing dose-response studies when investigating insulin analogues, in this study specifically insulin detemir."( Insulin detemir is a fully efficacious, low affinity agonist at the insulin receptor.
Bouman, SD; Brand, CL; Jonassen, I; Kurtzhals, P; Nishimura, E; Ribel, U; Stidsen, CE; Sturis, J; Sørensen, AR, 2010
)
2.09
" The hyperinsulinaemic euglycaemic clamp technique in rats is used to establish dose-response curves for multiple metabolic endpoints and to investigate the effects of the simultaneous presence of insulin detemir and human insulin."( Insulin detemir is a fully efficacious, low affinity agonist at the insulin receptor.
Bouman, SD; Brand, CL; Jonassen, I; Kurtzhals, P; Nishimura, E; Ribel, U; Stidsen, CE; Sturis, J; Sørensen, AR, 2010
)
1.99
"Both in vitro and in vivo, insulin detemir shows full efficacy and right-shifted parallel dose-response curves compared with human insulin."( Insulin detemir is a fully efficacious, low affinity agonist at the insulin receptor.
Bouman, SD; Brand, CL; Jonassen, I; Kurtzhals, P; Nishimura, E; Ribel, U; Stidsen, CE; Sturis, J; Sørensen, AR, 2010
)
2.1
" The fact that the potency estimates are method-dependent emphasizes the importance of establishing full dose-response relationships when characterizing insulin detemir."( Insulin detemir is a fully efficacious, low affinity agonist at the insulin receptor.
Bouman, SD; Brand, CL; Jonassen, I; Kurtzhals, P; Nishimura, E; Ribel, U; Stidsen, CE; Sturis, J; Sørensen, AR, 2010
)
2
" 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
)
0.92
"A pooled analysis of randomized controlled trials of individuals with type 2 diabetes mellitus (T2DM) was conducted to compare dosing and impact of two basal insulin analogs, insulin glargine (glargine) and insulin detemir (detemir), on weight and hemoglobin A1c (A1c)."( Relationship of insulin dose, A1c lowering, and weight in type 2 diabetes: comparing insulin glargine and insulin detemir.
Admane, K; Dailey, G; Mercier, F; Owens, D, 2010
)
0.76
" There was no loss of glycemic control by the end of the once-daily dosing interval."( Comparison of 3 algorithms for Basal insulin in transitioning from intravenous to subcutaneous insulin in stable patients after cardiothoracic surgery.
Dungan, K; Hall, C; Osei, K; Schuster, D,
)
0.13
" After 12 weeks of basal insulin detemir dosage optimization, participants with a hemoglobin A1c level of 7% or greater entered three 12-week treatment periods with stepwise addition of a first insulin aspart bolus, then a second, and then a third, if hemoglobin A1c remained at 7% or greater after 12 and 24 weeks of treatment, respectively."( Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study.
Hermansen, K; Kumar, S; Meneghini, L; Mersebach, H; Svendsen, AL,
)
0.64
" Insulin glargine was dosed once-daily in the evening."( Insulin detemir versus insulin glargine for type 2 diabetes mellitus.
Devries, JH; Hoekstra, JB; Holleman, F; Simon, AC; Swinnen, SG, 2011
)
1.81
" This was unaffected by adjustment for initial dosing group."( Differential response between diabetes and stress-induced hyperglycaemia to algorithmic use of detemir and flexible mealtime aspart among stable postcardiac surgery patients requiring intravenous insulin.
Dungan, K; Hall, C; Osei, K; Schuster, D, 2011
)
0.37
" Insulin dosage was titrated according to fasting capillary blood glucose levels, and treatment was stopped after 2 weeks."( Noninferiority effects on glycemic control and β-cell function improvement in newly diagnosed type 2 diabetes patients: basal insulin monotherapy versus continuous subcutaneous insulin infusion treatment.
Deng, H; Li, X; Lu, H; Mu, P; Wang, M; Zeng, L, 2012
)
0.38
" Incomplete resuspension and precipitation appear to be important issues with regard to unpredictability in this action, while an inadequate duration of action relative to the dosing interval results in a fluctuating action profile."( Variability of glucose-lowering effect as a limiting factor in optimizing basal insulin therapy: a review.
Heise, T; Vora, J, 2013
)
0.39
" During the first 9 months, the insulin dosage to reach the postprandial blood glucose <140 mg/dl, were significantly lower in the IA-group, but approached the following the RHI-group without significant changes after 24 months."( Comparison of insulin aspart vs. regular human insulin with or without insulin detemir concerning adipozytokines and metabolic effects in patients with type 2 diabetes mellitus.
Dette, H; Herrmann, BL; Huptas, M; Kasser, C; Keuthage, W; Klute, A, 2013
)
0.62
" The importance of patient education in overcoming barriers to insulin is discussed, as well as the choice of available basal insulins and the necessity to optimize basal insulin dosage by self-titration."( Initiating basal insulin therapy in type 2 diabetes: practical steps to optimize glycemic control.
Philis-Tsimikas, A, 2013
)
0.39
"To review the available evidence regarding dosing conversion between glargine and detemir in an effort to assist clinicians in performing dosing conversion."( Comparing dosing of basal insulin analogues detemir and glargine: is it really unit-per-unit and dose-per-dose?
McFarland, MS; Wallace, JL; Wallace, JP, 2014
)
0.4
"All English-language clinical trials were reviewed for inclusion of dosing and/or pharmacokinetic data."( Comparing dosing of basal insulin analogues detemir and glargine: is it really unit-per-unit and dose-per-dose?
McFarland, MS; Wallace, JL; Wallace, JP, 2014
)
0.4
"A total of 7 large (n ≥ 258) randomized controlled trials (RCTs) comparing glargine and detemir in patients with type 1 and 2 diabetes had dosing equivalency data available."( Comparing dosing of basal insulin analogues detemir and glargine: is it really unit-per-unit and dose-per-dose?
McFarland, MS; Wallace, JL; Wallace, JP, 2014
)
0.4
" Patients were allocated randomly to a sequence of 2 treatment periods, separated by a 7- to 21-day washout period, with once-daily IDeg or insulin detemir dosing for 6 days at a predefined fixed dose level (0."( Pharmacokinetic and pharmacodynamic responses of insulin degludec in African American, white, and Hispanic/Latino patients with type 2 diabetes mellitus.
Haahr, H; Hompesch, M; Morrow, L; Roepstorff, C; Thomsen, HF; Watkins, E, 2014
)
0.6
"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
" Insulin dose (intervention) was 60% of the usual, of this 40% was dosed as Levemir at sunrise and 60% as NovoMix 70 before dinner."( Effect of a new insulin treatment regimen on glycaemic control and quality of life of Muslim patients with type 2 diabetes mellitus during Ramadan fast - an open label, controlled, multicentre, cluster randomised study.
Maor, Y; Shehadeh, N, 2015
)
0.42
" 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
"A clear dose-response relationship can be demonstrated for both insulin analogs, even at very high doses in severely obese patients with type 2 diabetes."( Comparison of the dose-response pharmacodynamic profiles of detemir and glargine in severely obese patients with type 2 diabetes: A single-blind, randomised cross-over trial.
Bilz, S; Falconnier, C; Flückiger, M; Keller, U; Meienberg, F; Puder, JJ, 2018
)
0.48
"Medical records were retrospectively analyzed to investigate the effect of a hospital formulary change at a semi-urban underserved hospital that substituted detemir for glargine on a 1:1 dosing basis."( Detemir vs Glargine: Comparison of Inpatient Glycemic Control.
Avanesyan, A; Cade, K; Capson, J, 2019
)
0.51
" Multiple randomized control trials and real-world evidence studies have demonstrated that the newer second-generation basal insulin analogs, insulin glargine 300 units/mL and insulin degludec 100 or 200 units/mL, provide stable glycemic control with once-daily dosing and are associated with a reduced risk of hypoglycemia compared with previous-generation basal insulin analogs insulin glargine 100 units/mL and insulin detemir."( Differentiating Basal Insulin Preparations: Understanding How They Work Explains Why They Are Different.
Cheng, AYY; Patel, DK; Reid, TS; Wyne, K, 2019
)
0.68
"In patients with HbA1c ≥10% treatment with GLP1RA plus basal insulin, compared with basal-bolus insulin, resulted in better glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life."( A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study.
Abreu, M; Adams-Huet, B; Dimachkie, P; Elhassan, A; Gunasekaran, U; Li, X; Lingvay, I; Meneghini, LF; Papacostea, O; Peicher, K; Pop, LM; Siddiqui, MS; Tumyan, A, 2019
)
0.51
" Thus, there is a strong potential motivation to develop models of long-acting insulin analogues to enable safe, effective use in model-based dosing systems."( A subcutaneous insulin pharmacokinetic model for insulin Detemir.
Chase, JG; Knopp, JL; van Noorden, B, 2019
)
0.77
" We present results from 4 nonclinical rat studies evaluating effects of repeated dosing with insulin detemir (≤26 weeks) or degludec (52 weeks) in mammary glands."( Evaluation of Cell Proliferation in Rat Mammary Glands Is Not Predictive of the Carcinogenic Potential of Insulin In Vivo.
Brinck, PR; Jensen, VFH; Mølck, AM; Nowak, J; Sjögren, I; Thorup, I,
)
0.35
" Clinical evaluations occurred on days 7 to 14, day 30, and then every 60 to 90 days, and dosage adjustments of detemir occurred as needed to control glycemia."( Detemir improves diabetic regulation in poorly controlled diabetic dogs with concurrent diseases.
Ford, SL; Harris-Samson, AR; Rand, J, 2023
)
0.91
"The mean, peak, nadir, morning, and evening preinsulin daily blood glucose concentrations were significantly lower after dosing with detemir for 1, 3, or 6 months and during the last month of treatment compared to the final month of treatment with intermediate-acting insulin."( Detemir improves diabetic regulation in poorly controlled diabetic dogs with concurrent diseases.
Ford, SL; Harris-Samson, AR; Rand, J, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (557)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's6 (1.08)18.2507
2000's192 (34.47)29.6817
2010's322 (57.81)24.3611
2020's37 (6.64)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 74.85

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index74.85 (24.57)
Research Supply Index6.63 (2.92)
Research Growth Index6.27 (4.65)
Search Engine Demand Index128.91 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (74.85)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials172 (29.40%)5.53%
Reviews129 (22.05%)6.00%
Case Studies27 (4.62%)4.05%
Observational29 (4.96%)0.25%
Other228 (38.97%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (179)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effect of 50-week Treatment With Stepwise Insulin Intensification of Basal-bolus Insulin Analogues (Insulin Detemir and Aspart) or Biphasic Insulin Aspart 30 (NovoMix 30) All in Combination With Fixed Dose of Metformin on Glycaemic Control (Measured as Hb [NCT01068652]Phase 4403 participants (Actual)Interventional2010-03-31Completed
Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes [NCT00626080]40 participants (Anticipated)Interventional2009-01-31Completed
A Multi-centre, Open-labeled, Randomized, Parallel Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After 26 Weeks Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily [NCT01310452]50 participants (Anticipated)Interventional2011-01-31Active, not recruiting
Evaluation of Insulin Detemir in Combination With OADs in Type 2 Diabetes Mellitus [NCT00592527]Phase 3132 participants (Actual)Interventional2004-04-30Completed
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus [NCT00655200]2,286 participants (Actual)Observational2008-02-29Completed
Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised [NCT00322257]Phase 3596 participants (Actual)Interventional2006-05-01Terminated(stopped due to See termination reason in detailed description)
A Trial Comparing the Effect and Safety of Insulin Degludec Versus Insulin Detemir, Both in Combination With Insulin Aspart, in the Treatment of Pregnant Women With Type 1 Diabetes [NCT03377699]Phase 3225 participants (Actual)Interventional2017-11-22Completed
A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus [NCT01377155]20 participants (Actual)Interventional2011-06-30Completed
Retrospective Cohort Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine [NCT03960814]12,847 participants (Actual)Observational2019-05-21Completed
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus [NCT00706017]2,282 participants (Actual)Observational2007-09-30Completed
"Making an ObeseBrain(and Body)Lean: Insulin Detemir,Monoamines,and Reward" [NCT01239550]240 participants (Anticipated)Interventional2011-04-30Active, not recruiting
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 1 Diabetes [NCT01135927]Phase 122 participants (Actual)Interventional2010-06-30Completed
Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients [NCT01281605]181 participants (Actual)Interventional2011-01-31Completed
Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary [NCT00865397]1,032 participants (Actual)Observational2009-02-28Completed
NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficac [NCT01074268]Phase 3456 participants (Actual)Interventional2010-02-28Completed
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study [NCT05124457]Phase 2336 participants (Anticipated)Interventional2022-02-01Recruiting
Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) to Improve Insulin Secretion and Action in Subjects With Type 2 Diabetes [NCT00998335]Phase 430 participants (Actual)Interventional2007-06-30Completed
Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea [NCT01003184]Phase 3222 participants (Actual)Interventional2009-10-31Completed
Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes [NCT00715351]342 participants (Actual)Observational2007-05-31Completed
A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen [NCT00604344]Phase 3401 participants (Actual)Interventional2003-04-30Completed
Randomized, Long-Term Study About the Effects of Analogue Versus Human Insulin Based Regimens (Insulin Detemir and Aspart Versus NPH- and Regular Human Insulin) on Metabolic Control and Myocardial Function in People With Type 2 Diabetes. [NCT00747409]Phase 4120 participants (Anticipated)Interventional2004-07-31Active, not recruiting
Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation. [NCT00793273]1,074 participants (Actual)Observational2008-11-30Completed
A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial to Compare the Pharmacodynamic Effects of Single Doses of Insulin Detemir and Neutral Protamin Lispro (NPL) Insulin in Subjects With Type 1 Diabetes [NCT00810589]Phase 130 participants (Actual)Interventional2008-11-30Completed
A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes [NCT00825643]18,481 participants (Actual)Observational2008-04-30Completed
Insulin Detemir Co-administered With Liraglutide: An Open Label Trial to Assess Insulin Detemir and Liraglutide Pharmacokinetics and Pharmacodynamics Following Liraglutide Therapy in Subjects With Type 2 Diabetes [NCT00873223]Phase 133 participants (Actual)Interventional2009-03-31Completed
The Metabolic and Glycaemic Effects of a Combined Basal-Bolus Insulin Reduction And Carbohydrate Feeding Strategy For Evening Exercise in Type 1 Diabetes Mellitus [NCT02204839]10 participants (Actual)Interventional2014-01-31Completed
Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes: Study of Insulin Sensitivity in the 2 Types of Treatment [NCT02048189]Phase 460 participants (Anticipated)Interventional2012-03-31Recruiting
A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen. [NCT03220425]Phase 3752 participants (Actual)Interventional2001-02-01Completed
A Randomised, Three-period Crossover Trial in Healthy Subjects Investigating the Relationship Between the Pharmacodynamic Steady State and the Pharmacokinetic Steady State in the Interstitial Fluid Following iv Infusion of Insulin Detemir and Human Insuli [NCT02162407]Phase 113 participants (Actual)Interventional1999-10-31Completed
Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes [NCT00487240]Phase 3387 participants (Actual)Interventional2007-06-30Completed
Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus [NCT00709475]747 participants (Actual)Observational2008-05-31Completed
A 32-week National, Single-centre, Open-labelled, Randomised, Crossover Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-Bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes [NCT00509925]Phase 423 participants (Actual)Interventional2007-07-31Terminated(stopped due to See detailed description)
Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents [NCT00740519]882 participants (Actual)Observational2008-09-30Completed
A 12-months Multi-national, Multi-centre, Double Blind, Randomised, Parallel Safety and Efficacy Comparison of Insulin Detemir Produced by the Current Process and Insulin Detemir Produced by the NN729 Process in Subjects With Type 1 Diabetes on a Basal-bo [NCT00447382]Phase 3330 participants (Actual)Interventional2007-03-31Completed
Prospective, Multicentre, Open Label, Non-controlled, 24-week Observation in Type 2 Diabetics Using Once Daily Levemir® (Insulin Detemir) as Part of Their ITT Regimen [NCT00806897]74 participants (Actual)Observational2009-01-31Completed
A Randomised, Parallel-group, Open-labelled, Multinational Trial Comparing the Efficacy and Safety of Insulin Detemir (Levemir®) Versus Human Insulin (NPH Insulin), Used in Combination With Insulin Aspart as Bolus Insulin, in the Treatment of Pregnant Wom [NCT00474045]Phase 3470 participants (Actual)Interventional2007-05-31Completed
A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes [NCT00467649]Phase 4112 participants (Actual)Interventional2007-05-31Completed
Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus [NCT00604253]Phase 3362 participants (Actual)Interventional2003-12-31Completed
RAndomized SubCutaneous Insulin in INpatients (RASCIN) Trial: Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin [NCT00906529]Phase 40 participants (Actual)Interventional2009-05-31Withdrawn
Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia [NCT00490893]Phase 412 participants (Actual)Interventional2006-03-31Terminated
Safety and Efficacy of Insulin Detemir (Levemir® FlexPen®) in Patients With Diabetes Mellitus [NCT00670683]797 participants (Actual)Observational2007-07-31Completed
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus [NCT00655044]3,637 participants (Actual)Observational2007-05-31Completed
Evaluation on Glycaemic Control and Weight Change of Once Daily Levemir® (Insulin Detemir) in Type 2 Diabetes Mellitus Treated by an Intensive Insulin Treatment (ICT) [NCT00657930]2,289 participants (Actual)Observational2008-03-31Completed
Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-related and General Health-related Quality of Li [NCT00665808]8,125 participants (Actual)Observational2007-10-31Completed
Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus [NCT00670722]6,500 participants (Actual)Observational2008-01-31Completed
Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents [NCT00715780]1,667 participants (Actual)Observational2008-06-30Completed
Cystic Fibrosis - Insulin Deficiency, Early Action [NCT01100892]Phase 3100 participants (Anticipated)Interventional2010-12-31Completed
Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes [NCT00564395]Phase 418 participants (Actual)Interventional2007-08-31Completed
Effects of Different Insulin Regimens on Artery Compliance, Endothelium Function and Autonomic Cardiac Function in Patients With Poorly Controlled Type 2 Diabetes: a Pilot Study [NCT01022658]42 participants (Actual)Interventional2010-01-31Completed
A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin [NCT00623194]Phase 3146 participants (Actual)Interventional2008-02-29Completed
Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus. [NCT00687284]2,188 participants (Actual)Observational2008-02-29Completed
Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus [NCT00700830]1,976 participants (Actual)Observational2008-01-31Completed
Effects of Optimized Glycemic Control Achieved With add-on Basal Insulin Therapy on Indexes of Endothelial Damage and Regeneration in Type 2 Diabetic Patients With Macroangiopathy. A Randomized Cross-over Trial Comparing Detemir vs Glargine [NCT00699686]Phase 450 participants (Anticipated)Interventional2008-05-31Completed
Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth) [NCT00704574]159 participants (Actual)Observational2008-01-31Completed
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia [NCT00665093]1,569 participants (Actual)Observational2007-05-31Completed
Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus [NCT00789191]Phase 3222 participants (Actual)Interventional2008-11-30Completed
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes [NCT00435019]Phase 3348 participants (Actual)Interventional2007-02-28Completed
Safety of Levemir® (Insulin Detemir) Treatment in Patients With Type 2 Diabetes [NCT00735501]314 participants (Actual)Observational2008-03-31Completed
Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus [NCT00738153]798 participants (Actual)Observational2008-06-30Completed
A Multi-centre, Open-labelled, Randomised, Two-group Parallel Trial Comparing the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After 26 Weeks of Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily, B [NCT00795600]Phase 460 participants (Actual)Interventional2009-04-30Completed
Use of Levemir® Improves Metabolic and Clinical Status in CFRD [NCT00639626]Phase 2/Phase 36 participants (Actual)Interventional2008-08-31Terminated(stopped due to PI left the institution)
A Multicentre, Open-label, Nonrandomised, Non-interventional, Observational Study to Compare Safety and Effectiveness of Biphasic Insulin Aspart 30 (NovoMix 30) and Insulin Detemir (Levemir) for the Treatment of Diabetes Mellitus [NCT00789711]3,131 participants (Actual)Observational2008-11-30Completed
The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Stu [NCT00869908]66,726 participants (Actual)Observational2008-11-30Completed
Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus [NCT00698269]5,926 participants (Actual)Observational2008-02-29Completed
Doubleblind, Randomised, Single Centre Investigator Sponsored Study of Applications Site Reactions After Deep and Superficial Subcutaneous and Intradermal Injection of Insulin Detemir and Saline in Subjects With Diabetes Mellitus [NCT00607737]Phase 440 participants (Actual)Interventional2008-01-31Completed
Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine [NCT00656422]Phase 366 participants (Actual)Interventional2007-11-30Terminated
A Randomised, Controlled, Open Label, Multicentre, Multinational, Treat-to-target Trial Investigating the Efficacy and Safety of Intensification With Addition of Bolus Insulin Aspart in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insuli [NCT01165684]Phase 4401 participants (Actual)Interventional2010-10-31Completed
Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism [NCT00862875]Phase 442 participants (Actual)Interventional2009-03-31Completed
Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients [NCT00742976]Phase 424 participants (Actual)Interventional2008-06-30Completed
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania [NCT00873639]417 participants (Actual)Observational2009-04-30Completed
Impact of Insulin (I.)Glargine Compared to NPH I. and to I. Detemir in Combination With Metformin on Prandial ß-cell Function and Overall Metabolic Control in Type 2 Diabetic Patients With Insufficient Metabolic Control During OAD Treatment [NCT00941148]Phase 430 participants (Actual)Interventional2008-04-30Completed
Observational Study Evaluating the Body Weight Progress During the Treatment With Insulin Detemir (Levemir®) in Type 2 Patients, Previously Treated With Other Basal Insulins [NCT00697450]206 participants (Actual)Observational2008-07-31Completed
A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes [NCT00909480]Phase 4457 participants (Actual)Interventional2009-05-31Completed
Trial Investigating the Hypoglycaemic Response to Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes [NCT00760448]Phase 125 participants (Actual)Interventional2004-04-30Completed
Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes. [NCT00771680]10,408 participants (Actual)Observational2008-10-31Completed
A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins [NCT00849342]580 participants (Actual)Observational2008-12-31Completed
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes. [NCT00184665]Phase 3501 participants (Actual)Interventional2004-06-30Completed
A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy [NCT00455858]Phase 487 participants (Actual)Interventional2007-11-30Completed
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 at Steady State Conditions in Subjects With Type 2 Diabetes of Different Race and/or Ethnicity [NCT01043510]Phase 163 participants (Actual)Interventional2010-01-31Completed
A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes In [NCT00184600]Phase 3708 participants (Actual)Interventional2004-11-30Completed
INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza® Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric [NCT04974528]Phase 3264 participants (Anticipated)Interventional2021-09-29Recruiting
The Effect of Detemir Compared to Exenatide and/or the Combination of Detemir and Exenatide on Glycemic Control and Weight in Patients With Type 2 Diabetes Mellitus Who Have Failed Oral Hypoglycemic Agents [NCT01076842]Phase 475 participants (Anticipated)Interventional2008-04-30Completed
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus [NCT01892319]2,446 participants (Actual)Observational2013-09-30Completed
Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir. [NCT00717288]Phase 482 participants (Actual)Interventional2008-07-31Completed
Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus [NCT00605137]Phase 383 participants (Actual)Interventional2004-05-21Completed
No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans [NCT00566124]Phase 410 participants (Actual)Interventional2005-01-31Completed
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus [NCT00595374]Phase 3114 participants (Actual)Interventional2003-12-02Completed
Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes [NCT00537303]Phase 4296 participants (Actual)Interventional2007-10-31Completed
A Prospective, Multicentre, Multinational, Open Label, Non-controlled, Observational, 24-week Study in Patients Using Oral Anti-Diabetic (OAD) Drugs + Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Near East Region Countries [NCT00842192]2,155 participants (Actual)Observational2009-04-30Completed
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extensio [NCT00856986]Phase 3987 participants (Actual)Interventional2009-03-31Completed
Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus [NCT00604396]Phase 3477 participants (Actual)Interventional2003-03-31Completed
Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus [NCT00605020]Phase 3719 participants (Actual)Interventional2003-12-02Completed
NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401- [NCT00978627]Phase 3548 participants (Actual)Interventional2009-08-31Completed
The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial [NCT00657943]Phase 4415 participants (Actual)Interventional2008-04-30Completed
Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus [NCT00658099]699 participants (Actual)Observational2007-11-30Completed
Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart) or Levemir® (Insulin Detemir) - for Treatment of Diabetes Mellitus [NCT00676741]3,809 participants (Actual)Observational2008-02-29Completed
Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy [NCT04222348]Phase 3200 participants (Actual)Interventional2016-10-26Active, not recruiting
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus [NCT00700765]1,531 participants (Actual)Observational2008-01-31Completed
Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs Given as a Bolus by Continuous Subcutaneous Insulin Infusion (CSII) and in MDI Basal-Bolus Therapy in Pediatric Subjects With Type 1 Diabetes (TID) [NCT00652288]Phase 136 participants (Actual)Interventional2007-04-30Completed
Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes [NCT00104182]Phase 3503 participants (Actual)Interventional2005-02-28Completed
Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus [NCT00671008]400 participants (Actual)Observational2007-12-31Completed
Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections in Children and Adolescence With Type 1 Diabetes Mellitus. [NCT00542399]Phase 450 participants (Anticipated)Interventional2007-11-30Completed
Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy [NCT00331604]Phase 3618 participants (Actual)Interventional2006-08-31Terminated(stopped due to See termination reason in detailed description)
The Effects of Insulin Detemir and Gliclazide-MR Treatments in Addition to Life-style Modification and Metformin Therapy on Endothelial Functions in Patients With Type 2 Diabetes : An Open-labelled Randomized Prospective Study [NCT01420692]64 participants (Actual)Interventional2010-06-30Completed
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes [NCT00097084]Phase 3324 participants (Actual)Interventional2004-09-30Completed
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia [NCT00842894]3,421 participants (Actual)Observational2009-05-31Completed
Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH [NCT00564018]33 participants (Actual)Interventional2006-09-30Terminated(stopped due to Presumed loss of clinical equipoise between the agents being investigated)
Observational Study on Efficacy on Glycaemic Control of Slow-acting Insulin Analogue in Type 2 Diabetes [NCT00700960]2,745 participants (Actual)Observational2007-06-30Completed
The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed [NCT01487421]2,134 participants (Actual)Observational2003-07-31Completed
A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects [NCT01490099]Phase 137 participants (Actual)Interventional2006-08-31Completed
The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies [NCT00467246]0 participants InterventionalWithdrawn(stopped due to Ethics approval denied)
Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics [NCT02922179]103,951 participants (Actual)Observational2011-01-01Completed
A 26-week Randomised, Controlled, Open Label, Multicentre, Multinational, Treat to Target Trial Investigating the Impact of Dietary Intervention on Weight Change and the Relationship Between Weight Change and Baseline Body Mass Index (BMI) in Subjects Wit [NCT01232491]Phase 4611 participants (Actual)Interventional2010-10-29Completed
A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen [NCT01486940]Phase 3598 participants (Actual)Interventional2002-03-31Completed
"A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to Standard of Care Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Unco [NCT02967224]Phase 4705 participants (Actual)Interventional2015-11-05Completed
Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (PREDICTIVE™ 303) [NCT00264901]Phase 45,652 participants (Actual)Interventional2005-10-31Completed
The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients [NCT00346996]Phase 4179 participants (Actual)Interventional2007-05-31Completed
Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes [NCT00117780]Phase 4520 participants (Actual)Interventional2005-06-30Completed
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake [NCT01232946]30 participants (Actual)Interventional2012-01-31Completed
Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus [NCT00701155]3,593 participants (Actual)Observational2007-07-31Completed
An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus. [NCT00687063]10,008 participants (Actual)Observational2008-04-30Completed
Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment [NCT00521690]Phase 425 participants (Actual)Interventional2006-12-31Completed
Comparison of the Effect of Insulin Detemir Versus Insulin NPH Both With Insulin Aspart on Weight Change in Overweight and Obese Subjects With Type 2 Diabetes [NCT00504673]Phase 3277 participants (Actual)Interventional2005-04-30Completed
An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and [NCT00313742]Phase 451 participants (Actual)Interventional2006-04-30Completed
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia [NCT01542424]1,889 participants (Actual)Observational2006-03-31Completed
A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir) and NPH Human Insulin in Japanese Subjects With Type 1 Diabetes Mellitus [NCT01542450]Phase 123 participants (Actual)Interventional2002-08-31Completed
Levemir®: the Physiological Basal Insulin. Documentation of Safety Aspects, Glycaemic Control and Weight [NCT01542463]4,464 participants (Actual)Observational2004-09-30Completed
An Observational Study in Dutch Type 1 and Type 2 Diabetes Patients: The Impact of Initiation of/Switching to Levemir® on Emotional Well-being, Insulin Perceptions and Treatment Satisfaction - CONFIDENCE (Clinical ObservatioNs oF Levemir® In Dutch Experie [NCT01542476]299 participants (Actual)Observational2006-08-31Completed
An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes [NCT01542489]480 participants (Actual)Observational2006-10-31Completed
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Patients Using Insulin Detemir for the Treatment of Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study - Predictable Results and Experience in Diabetes Thr [NCT01545791]1,037 participants (Actual)Observational2006-05-31Completed
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days [NCT01547169]Phase 260 participants (Actual)Interventional2011-03-31Completed
An Observational 3-months Study to Evaluate Efficacy and Safety of Insulin Levemir® Used as Basal Insulin on the Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes [NCT01548248]631 participants (Actual)Observational2006-01-31Completed
Efficacy and Safety Comparison of Insulin Detemir and Insulin Glargine Plus Insulin Aspart in Patients With Type 2 Diabetes [NCT00106366]Phase 3389 participants (Actual)Interventional2005-03-31Completed
Action to Control Cardiovascular Risk in Diabetes (ACCORD) [NCT00000620]Phase 310,251 participants (Actual)Interventional1999-09-30Completed
"A Twenty-six Week, Randomized, Open-label, 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to Standard of Care Insulin in Basal Insulin Treated Patients With Uncontrolled [NCT02967211]Phase 4609 participants (Actual)Interventional2015-12-21Completed
Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or Insulin Detemir. [NCT00405418]Phase 4973 participants (Actual)Interventional2006-11-30Completed
A Randomised Study Comparing Continuous Intravenous Insulin Infusion With Subcutaneous Insulin Analogues in Hospitalised Patients With Type II Diabetes and Hyperglycaemia [NCT00135070]Phase 441 participants (Actual)Interventional2005-07-31Terminated(stopped due to No documentation with MHRA to support clinical trial of a medicinal product.)
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen. [NCT00184639]Phase 371 participants (Actual)Interventional2004-08-16Completed
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes [NCT00095082]Phase 3447 participants (Actual)Interventional2004-09-30Completed
Exploration of the Weight Neutral Effects of Insulin Detemir Compared to Insulin Glargine: A Measure of Satiety and Calories Consumed in Type 1 Diabetes [NCT00659165]10 participants (Actual)Interventional2008-04-30Completed
A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIBA Once Daily + NovoRapid® Compared to Insulin Detemir Once Daily + NovoRapid®, All in a Basal-bolus Regimen in Subjects With Type 1 Diabet [NCT00841087]Phase 265 participants (Actual)Interventional2009-01-31Completed
A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients [NCT00271284]Phase 388 participants (Actual)Interventional2005-10-31Completed
Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes [NCT00274274]Phase 4373 participants (Actual)Interventional2005-09-30Completed
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes [NCT00283751]Phase 3583 participants (Actual)Interventional2003-03-31Completed
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes [NCT00312156]Phase 3347 participants (Actual)Interventional2002-08-31Completed
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes. [NCT00312104]Phase 3325 participants (Actual)Interventional2002-04-30Completed
A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties [NCT01497535]Phase 140 participants (Actual)Interventional2004-05-27Completed
A Randomised, Double-blind, Four-period, Cross-over, Dose Response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 2 Diabetes [NCT01497561]Phase 115 participants (Actual)Interventional2003-03-31Completed
A Single-centre, Randomised, Double-blind, Cross-over Trial Comparing the Within-subject Variability of the Pharmacokinetic Profiles of Insulin Detemir and Insulin Glargine in Children and Adolescents With Type 1 Diabetes [NCT01497574]Phase 132 participants (Actual)Interventional2005-05-31Completed
A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese Subjects [NCT01497587]Phase 120 participants (Actual)Interventional2005-08-31Completed
A Randomised, Double-blind, Six-period, Cross-over, Dose-response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects of Blacks or African American, Whites of Hispanic or Latino Orig [NCT01497600]Phase 150 participants (Actual)Interventional2004-02-29Completed
A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects [NCT01498926]Phase 134 participants (Actual)Interventional2005-11-30Completed
A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the 24-hour Pharmacokinetics After Single Dose of Insulin Detemir in Healthy Chinese Male Subjects [NCT01498939]Phase 120 participants (Actual)Interventional2007-08-31Completed
A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen [NCT01697657]Phase 3131 participants (Actual)Interventional2001-09-30Completed
A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus [NCT01709929]Phase 32,287 participants (Actual)Interventional2005-10-31Completed
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabet [NCT01835431]Phase 3362 participants (Actual)Interventional2013-10-17Completed
Impact of Insulin Detemir Versus Insulin Glargine on Glycaemic Control and Metabolism During Exercise in Type 1 Diabetes [NCT01440439]Phase 430 participants (Anticipated)Interventional2011-11-30Recruiting
Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on IGFBP-1 Production and Serum IGF-I in Subjects With Type 1 Diabetes Mellitus: An Open-label, Randomised, Triple Cross-over Trial [NCT01461616]Phase 319 participants (Actual)Interventional2012-02-29Completed
New Onset Type 1 Diabetes: Role of Exenatide [NCT01269034]Phase 413 participants (Actual)Interventional2010-12-31Completed
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120) [NCT01595646]Phase 237 participants (Actual)Interventional2011-11-30Completed
A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes [NCT05134987]Phase 130 participants (Actual)Interventional2021-12-01Completed
The Relative Effectiveness of Pumps Over Multiple Dose Injections and Structured Education Trial [NCT01616784]Phase 3267 participants (Actual)Interventional2011-11-30Completed
Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents [NCT00634842]Phase 4244 participants (Actual)Interventional2008-02-29Completed
The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients [NCT02496780]Phase 2/Phase 366 participants (Actual)Interventional2015-08-31Completed
A 26-week Open Label, Randomised, 2-armed, Parallel Group, Multi-centre Trial Investigating Efficacy and Safety of Insulin Detemir Versus Insulin Neutral Protamine Hagedorn in Combination With the Maximum Tolerated Dose of Metformin and Diet/Exercise on G [NCT02131272]Phase 342 participants (Actual)Interventional2014-06-11Terminated
A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabete [NCT02451137]Phase 43,304 participants (Actual)Interventional2015-06-16Completed
Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes [NCT00383877]Phase 3263 participants (Actual)Interventional2006-09-30Completed
Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study [NCT02741687]Phase 480 participants (Actual)Interventional2016-06-30Completed
The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes. [NCT00506662]Phase 486 participants (Actual)Interventional2007-07-31Terminated(stopped due to See termination reason in detailed description)
Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care [NCT00591227]Phase 4176 participants (Actual)Interventional2008-05-31Completed
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study: Predictable Results and Experienc [NCT00659295]51,170 participants (Actual)Observational2004-06-30Completed
A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen [NCT01513473]Phase 3350 participants (Actual)Interventional2012-01-16Completed
A Randomised, Multicentric, Open Labelled, Parallel Group Trial With Insulin Aspart and Insulin Detemir, Investigating the Glycaemic Effect and Profile in Children With Type 1 Diabetes, of Two Separate Levemir® + NovoRapid® Injections and Extemporaneous M [NCT00542620]Phase 425 participants (Actual)Interventional2007-09-30Completed
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes [NCT01831765]Phase 31,290 participants (Actual)Interventional2013-08-26Completed
The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, P [NCT01966978]Phase 4157 participants (Actual)Interventional2014-11-30Completed
Effectiveness of a Subcutaneously Administered Long-Acting Insulin Detemir Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment [NCT01186003]30 participants (Actual)Interventional2010-08-31Completed
A 2-week, Randomised, Controlled, Open-label, Two-group Parallel, Multi-centre Trial Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin Both in a Basal Bolus Regimen With or Without Metformin in [NCT01486966]Phase 458 participants (Actual)Interventional2011-11-30Terminated(stopped due to Trial terminated prematurely due to slow recruitment.)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monothe [NCT02033889]Phase 3621 participants (Actual)Interventional2013-12-13Completed
A 20-week, Randomised, Multi-centre, Open-labelled Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Titration Algorithms (3-0-3 Algorithm and 2-4-6-8 Algorithm) After 20 Weeks in Subjects With Type 2 Diabetes Mell [NCT01868542]Phase 446 participants (Actual)Interventional2013-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00000620 (6) [back to overview]Stroke in the Blood Pressure Trial.
NCT00000620 (6) [back to overview]First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.
NCT00000620 (6) [back to overview]First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.
NCT00000620 (6) [back to overview]First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.
NCT00000620 (6) [back to overview]First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.
NCT00000620 (6) [back to overview]Death From Any Cause in the Glycemia Trial.
NCT00184600 (15) [back to overview]Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months
NCT00184600 (15) [back to overview]Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%
NCT00184600 (15) [back to overview]Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
NCT00184600 (15) [back to overview]HbA1c (Glycosylated Haemoglobin) at Month 12
NCT00184600 (15) [back to overview]Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
NCT00184600 (15) [back to overview]HbA1c (Glycosylated Haemoglobin) at Month 36
NCT00184600 (15) [back to overview]Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months
NCT00184600 (15) [back to overview]Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months
NCT00184600 (15) [back to overview]Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months
NCT00184600 (15) [back to overview]Percentage of Participants Who Required A Second Insulin Therapy by Month 36
NCT00184600 (15) [back to overview]Percentage of Participants Who Required A Second Insulin Therapy by Month 12
NCT00184600 (15) [back to overview]Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%
NCT00184600 (15) [back to overview]Number of Participants Having an 'Other' Adverse Event
NCT00184600 (15) [back to overview]Change From Baseline in Body Weight at Month 36
NCT00184600 (15) [back to overview]Change From Baseline in Body Weight at Month 12
NCT00435019 (3) [back to overview]Observed Insulin Antibody Values
NCT00435019 (3) [back to overview]Number of Subjects Reporting Adverse Events
NCT00435019 (3) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Leucocytes)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Lymphocytes)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Monocytes)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Thrombocytes)
NCT00447382 (24) [back to overview]Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
NCT00447382 (24) [back to overview]Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
NCT00447382 (24) [back to overview]Glycaemic Control Parameters (Change in HbA1c)
NCT00447382 (24) [back to overview]Hypoglycaemic Episodes
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Neutrophils)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Sodium)
NCT00447382 (24) [back to overview]Adverse Events
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Albumin)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Creatinine)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Potassium)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Biochemistry - Total Protein)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Basophilis)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Eosinophils)
NCT00447382 (24) [back to overview]Clinical Laboratory Values (Change in Haematology - Haemoglobin)
NCT00447382 (24) [back to overview]Change From Baseline in Total Antibodies
NCT00447382 (24) [back to overview]Change From Baseline in Detemir Specific Antibodies
NCT00447382 (24) [back to overview]Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
NCT00455858 (5) [back to overview]Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%
NCT00455858 (5) [back to overview]Occurence of Hypoglycaemic Episodes
NCT00455858 (5) [back to overview]Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
NCT00455858 (5) [back to overview]Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12
NCT00455858 (5) [back to overview]Change in Fasting Plasma Glucose (FPG)
NCT00467649 (12) [back to overview]Change in Body Weight From Baseline at Week 24
NCT00467649 (12) [back to overview]Phase 2: Change in HbA1c at Week 36
NCT00467649 (12) [back to overview]Phase 2: Change in Body Weight at Week 36
NCT00467649 (12) [back to overview]Hypoglycemia Adverse Events
NCT00467649 (12) [back to overview]Fasting Serum Lipids Change From Baseline to Week 24
NCT00467649 (12) [back to overview]The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
NCT00467649 (12) [back to overview]Percentage of Patients With a Severe Hypoglycemia Adverse Event
NCT00467649 (12) [back to overview]Percentage of Patients Achieving HbA1c <=7% at Week 24
NCT00467649 (12) [back to overview]Change in Waist Circumference From Baseline at Week 24
NCT00467649 (12) [back to overview]Change in HbA1c From Baseline at Week 24
NCT00467649 (12) [back to overview]Change in Fasting Plasma Glucose From Baseline at Week 24
NCT00467649 (12) [back to overview]Percentage of Patients With no Weight Gain at Week 24
NCT00474045 (47) [back to overview]Maternal Safety - Change in Haemoglobin Level (Haematology)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Insulin Aspart Specific Antibodies
NCT00474045 (47) [back to overview]Maternal Safety - Change in Insulin Detemir Specific Antibodies
NCT00474045 (47) [back to overview]Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies
NCT00474045 (47) [back to overview]Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Leukocytes Level (Haematology)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Potassium Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Sodium Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Thrombocytes Level (Haematology)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Total Protein Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Urine Albumin Level (Urinalysis)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)
NCT00474045 (47) [back to overview]Maternal Safety - Hypoglycaemic Episodes
NCT00474045 (47) [back to overview]Maternal Safety - Mode of Delivery
NCT00474045 (47) [back to overview]Maternal Safety - Number of Subjects With Adverse Events (AEs)
NCT00474045 (47) [back to overview]Pregnancy Outcome at Delivery
NCT00474045 (47) [back to overview]Pregnancy Outcome at Follow-Up
NCT00474045 (47) [back to overview]Safety - Composite Pregnancy Outcome
NCT00474045 (47) [back to overview]Safety - Total Daily Insulin Dose During Pregnancy
NCT00474045 (47) [back to overview]Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events
NCT00474045 (47) [back to overview]Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36
NCT00474045 (47) [back to overview]Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36
NCT00474045 (47) [back to overview]Maternal Safety - Acceleration of Nephropathy
NCT00474045 (47) [back to overview]Maternal Safety - Electrocardiogram (ECG)
NCT00474045 (47) [back to overview]Maternal Safety - Nocturnal Hypoglycaemic Episodes
NCT00474045 (47) [back to overview]Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36
NCT00474045 (47) [back to overview]Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood
NCT00474045 (47) [back to overview]Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood
NCT00474045 (47) [back to overview]Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies
NCT00474045 (47) [back to overview]Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies
NCT00474045 (47) [back to overview]Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies
NCT00474045 (47) [back to overview]Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36
NCT00474045 (47) [back to overview]8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24
NCT00474045 (47) [back to overview]Fasting Plasma Glucose (FPG)
NCT00474045 (47) [back to overview]Glycosylated Haemoglobin (HbA1c) During Pregnancy
NCT00474045 (47) [back to overview]Maternal Safety - Acceleration of Retinopathy in Any Eye
NCT00474045 (47) [back to overview]Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit
NCT00474045 (47) [back to overview]Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit
NCT00474045 (47) [back to overview]Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up
NCT00474045 (47) [back to overview]Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit
NCT00474045 (47) [back to overview]Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Albumin Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)
NCT00474045 (47) [back to overview]Maternal Safety - Change in Creatinine Serum Level (Biochemistry)
NCT00487240 (11) [back to overview]30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
NCT00487240 (11) [back to overview]Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint
NCT00487240 (11) [back to overview]Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%
NCT00487240 (11) [back to overview]1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
NCT00487240 (11) [back to overview]7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint
NCT00487240 (11) [back to overview]Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values
NCT00487240 (11) [back to overview]Change From Baseline in Absolute Body Weight at 32 Week Endpoint
NCT00487240 (11) [back to overview]Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
NCT00487240 (11) [back to overview]Glycemic Variability at Endpoint
NCT00487240 (11) [back to overview]Insulin Dose (Total and By Component [Basal and Bolus])
NCT00487240 (11) [back to overview]Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])
NCT00506662 (3) [back to overview]Mean Number of Total Hypoglycaemic Episodes, Month 1
NCT00506662 (3) [back to overview]Mean Number of Total Hypoglycaemic Episodes, Months 5-7
NCT00506662 (3) [back to overview]Mean Number of Total Hypoglycaemic Episodes, Months 2-4
NCT00509925 (18) [back to overview]Component of Total Energy Expenditure: Physical Activity Thermogenesis
NCT00509925 (18) [back to overview]Component of Total Energy Expenditure: Resting Energy Expenditure (REE)
NCT00509925 (18) [back to overview]Hypoglycaemic Episodes
NCT00509925 (18) [back to overview]Total Energy Expenditure, Dietary Record Method
NCT00509925 (18) [back to overview]Total Energy Expenditure, Double-labelled Water Method
NCT00509925 (18) [back to overview]Lean Body Mass
NCT00509925 (18) [back to overview]Hypoglycaemic Episodes, Diurnal/Nocturnal
NCT00509925 (18) [back to overview]Hormonal Assessment: Resistin
NCT00509925 (18) [back to overview]Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)
NCT00509925 (18) [back to overview]Hormonal Assessment: Leptin
NCT00509925 (18) [back to overview]Hormonal Assessment: Insulin-like Growth Factor-1
NCT00509925 (18) [back to overview]Hormonal Assessment: Adiponectin
NCT00509925 (18) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00509925 (18) [back to overview]Fat Mass
NCT00509925 (18) [back to overview]Fasting Plasma Glucose
NCT00509925 (18) [back to overview]Body Weight
NCT00509925 (18) [back to overview]Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)
NCT00509925 (18) [back to overview]Waist:Hip Ratio
NCT00537303 (6) [back to overview]Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide
NCT00537303 (6) [back to overview]Biochemistry: Serum Alanine Aminotransferase
NCT00537303 (6) [back to overview]Hypoglycaemic Episodes
NCT00537303 (6) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00537303 (6) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00537303 (6) [back to overview]Haematology: Haemoglobin Measured in Blood
NCT00542620 (30) [back to overview]Incidence of Hypoglycaemic Episodes - All Episodes
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir
NCT00542620 (30) [back to overview]Pharmacokinetics: Cmax of Free Insulin
NCT00542620 (30) [back to overview]Pharmacokinetics: Cmax of Insulin Aspart
NCT00542620 (30) [back to overview]Pharmacokinetics: Cmax of Insulin Detemir
NCT00542620 (30) [back to overview]Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin
NCT00542620 (30) [back to overview]Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart
NCT00542620 (30) [back to overview]Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir
NCT00542620 (30) [back to overview]Pharmacokinetics: Tmax of Free Insulin
NCT00542620 (30) [back to overview]Pharmacokinetics: Tmax of Insulin Aspart
NCT00542620 (30) [back to overview]Pharmacokinetics: Tmax of Insulin Detemir
NCT00542620 (30) [back to overview]Weight Z Score
NCT00542620 (30) [back to overview]Self-measured Plasma Glucose Profile (After Breakfast)
NCT00542620 (30) [back to overview]Self-measured Plasma Glucose Profile (After Dinner)
NCT00542620 (30) [back to overview]Self-measured Plasma Glucose Profile (Before Breakfast)
NCT00542620 (30) [back to overview]Self-measured Plasma Glucose Profile (Before Dinner)
NCT00542620 (30) [back to overview]Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
NCT00542620 (30) [back to overview]"Percentage of Children Assessing Insulin Therapy Injection Pain as Happy Face"
NCT00542620 (30) [back to overview]"Percentage of Children Assessing Insulin Therapy Injection Pain as Sad Face"
NCT00542620 (30) [back to overview]"Percentage of Children Assessing Insulin Therapy Injection Pain as Very Happy Face"
NCT00542620 (30) [back to overview]Body Mass Index (BMI) Z Score
NCT00542620 (30) [back to overview]Fructosamine
NCT00542620 (30) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00542620 (30) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00542620 (30) [back to overview]Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir
NCT00542620 (30) [back to overview]Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin
NCT00564018 (2) [back to overview]C-peptide Area Under the Curve
NCT00564018 (2) [back to overview]Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis
NCT00564395 (1) [back to overview]Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections
NCT00591227 (1) [back to overview]Hospital Length of Stay
NCT00623194 (17) [back to overview]Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)
NCT00623194 (17) [back to overview]Diabetic Ketoacidosis
NCT00623194 (17) [back to overview]Laboratory Values: Leukocytes and Thrombocytes
NCT00623194 (17) [back to overview]Fundoscopy/Fundus Photography
NCT00623194 (17) [back to overview]Insulin Dose
NCT00623194 (17) [back to overview]BMI (Body Mass Index)
NCT00623194 (17) [back to overview]Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)
NCT00623194 (17) [back to overview]Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)
NCT00623194 (17) [back to overview]Hypoglycaemic Episodes
NCT00623194 (17) [back to overview]Insulin Detemir-insulin Aspart Cross-reacting Antibodies
NCT00623194 (17) [back to overview]Laboratory Values: Creatine Serum Umol/L
NCT00623194 (17) [back to overview]SD-score (Z-score) for Body Weight
NCT00623194 (17) [back to overview]Vital Signs: Pulse
NCT00623194 (17) [back to overview]Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies
NCT00623194 (17) [back to overview]Vital Signs: Blood Pressure
NCT00623194 (17) [back to overview]Glycosylated Haemoglobin A1c (HbA1c)
NCT00623194 (17) [back to overview]Fasting Plasma Glucose Values
NCT00634842 (4) [back to overview]Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
NCT00634842 (4) [back to overview]Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
NCT00634842 (4) [back to overview]Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
NCT00634842 (4) [back to overview]Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
NCT00659165 (1) [back to overview]Calories Consumed After Fast.
NCT00659295 (1) [back to overview]Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
NCT00717288 (3) [back to overview]Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)
NCT00717288 (3) [back to overview]Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
NCT00717288 (3) [back to overview]Reversion to Intravenous Insulin for Failure of Glycemic Control
NCT00789191 (12) [back to overview]Change in BMI (Body Mass Index)
NCT00789191 (12) [back to overview]Change in Body Weight
NCT00789191 (12) [back to overview]HbA1c (Glycosylated Haemoglobin A1c)
NCT00789191 (12) [back to overview]Hypoglycemic Episodes
NCT00789191 (12) [back to overview]Hypoglycemic Episodes: Day Time
NCT00789191 (12) [back to overview]Hypoglycemic Episodes: Night Time
NCT00789191 (12) [back to overview]Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
NCT00789191 (12) [back to overview]Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
NCT00789191 (12) [back to overview]Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
NCT00789191 (12) [back to overview]Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
NCT00789191 (12) [back to overview]Self-measured 9-point Plasma Glucose Profile
NCT00789191 (12) [back to overview]FPG (Fasting Plasma Glucose)
NCT00795600 (56) [back to overview]Absolute Change in Fasting Plasma Glucose (FPG)
NCT00795600 (56) [back to overview]Absolute Change in Adiponectin
NCT00795600 (56) [back to overview]Absolute Change in Alanine Aminotransferase (ALAT)
NCT00795600 (56) [back to overview]Absolute Change in Albumin
NCT00795600 (56) [back to overview]Absolute Change in Alkaline Phosphatase
NCT00795600 (56) [back to overview]Absolute Change in Aspartate Aminotransferase (ASAT)
NCT00795600 (56) [back to overview]Absolute Change in Basophils
NCT00795600 (56) [back to overview]Absolute Change in Urea
NCT00795600 (56) [back to overview]Absolute Change in Blood Volume (Haematocrit)
NCT00795600 (56) [back to overview]Percentage Change in Visceral Adipose Tissue Area
NCT00795600 (56) [back to overview]Percentage Change in Trunk Lean Mass
NCT00795600 (56) [back to overview]Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
NCT00795600 (56) [back to overview]Percentage Change in Subcutaneous Adipose Tissue Area
NCT00795600 (56) [back to overview]Absolute Change in Calculated Trunk Fat Percentage
NCT00795600 (56) [back to overview]Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
NCT00795600 (56) [back to overview]Absolute Change in Calculated Whole Body Fat Percentage
NCT00795600 (56) [back to overview]Absolute Change in Creatine Phosphokinase
NCT00795600 (56) [back to overview]Percentage Change in Liver/Spleen Attenuation Ratio
NCT00795600 (56) [back to overview]Absolute Change in Visceral Adipose Tissue Area
NCT00795600 (56) [back to overview]Absolute Change in Bilirubin Total
NCT00795600 (56) [back to overview]Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
NCT00795600 (56) [back to overview]Number of Non-serious Adverse Events
NCT00795600 (56) [back to overview]Number of Hypoglycaemic Episodes
NCT00795600 (56) [back to overview]Absolute Change in Creatinine
NCT00795600 (56) [back to overview]Absolute Change in Eosinophils
NCT00795600 (56) [back to overview]Absolute Change in Erythrocytes
NCT00795600 (56) [back to overview]Absolute Change in Whole Body Lean Mass
NCT00795600 (56) [back to overview]Absolute Change in Whole Body Fat Mass
NCT00795600 (56) [back to overview]Absolute Change in Waist Circumference
NCT00795600 (56) [back to overview]Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
NCT00795600 (56) [back to overview]Absolute Change in Trunk Lean Mass
NCT00795600 (56) [back to overview]Absolute Change in Trunk Fat Mass
NCT00795600 (56) [back to overview]Absolute Change in Triglycerides
NCT00795600 (56) [back to overview]Absolute Change in Total Cholesterol
NCT00795600 (56) [back to overview]Absolute Change in Body Weight
NCT00795600 (56) [back to overview]Absolute Change in Thrombocytes
NCT00795600 (56) [back to overview]Absolute Change in Subcutaneous Adipose Tissue Area
NCT00795600 (56) [back to overview]Absolute Change in Sodium
NCT00795600 (56) [back to overview]Absolute Change in Potassium
NCT00795600 (56) [back to overview]Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
NCT00795600 (56) [back to overview]Absolute Change in Neutrophils
NCT00795600 (56) [back to overview]Absolute Change in Monocytes
NCT00795600 (56) [back to overview]Absolute Change in Lymphocytes
NCT00795600 (56) [back to overview]Percentual Change in Calculated Whole Body Fat Percentage
NCT00795600 (56) [back to overview]Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
NCT00795600 (56) [back to overview]Absolute Change in Liver/Spleen Attenuation Ratio
NCT00795600 (56) [back to overview]Absolute Change in Leucocytes
NCT00795600 (56) [back to overview]Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
NCT00795600 (56) [back to overview]Absolute Change in Hip Circumference
NCT00795600 (56) [back to overview]Percentage Change in Whole Body Fat Mass
NCT00795600 (56) [back to overview]Percentage Change in Whole Body Lean Mass
NCT00795600 (56) [back to overview]Percentual Change in Calculated Trunk Fat Percentage
NCT00795600 (56) [back to overview]Absolute Change in High Density Lipoprotein (HDL) Cholesterol
NCT00795600 (56) [back to overview]Absolute Change in HbA1c (Glycosylated Haemoglobin)
NCT00795600 (56) [back to overview]Absolute Change in Haemoglobin
NCT00795600 (56) [back to overview]Absolute Change in Free Fatty Acids
NCT00841087 (7) [back to overview]Diastolic Blood Pressure (BP)
NCT00841087 (7) [back to overview]Number of Treatment Emergent Adverse Events (AEs)
NCT00841087 (7) [back to overview]Rate of Major and Minor Hypoglycaemic Episodes
NCT00841087 (7) [back to overview]Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
NCT00841087 (7) [back to overview]Systolic Blood Pressure (BP)
NCT00841087 (7) [back to overview]Change in Body Weight
NCT00841087 (7) [back to overview]Electrocardiogram (ECG)
NCT00856986 (30) [back to overview]Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Waist Circumference at Week 26.
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Hip Circumference at Week 52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Hip Circumference at Week 26
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Lipids: Triglycerides at Week 26
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Waist to Hip Ratio at Week 26
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Fasting Pro-insulin at Week 52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Fasting Pro-insulin at Week 26.
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Body Weight at Week 52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Fasting Plasma Glucose at Week 52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Fasting Plasma Glucose at Week 26
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Fasting C-peptide at Week 52.
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.
NCT00856986 (30) [back to overview]Hypoglycaemic Episodes Weeks 0-52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Fasting C-peptide at Week 26.
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Body Weight at Week 26
NCT00856986 (30) [back to overview]Adverse Events From Run-in (Week -12) to Week 52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Lipids: Triglycerides at Week 52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Waist Circumference at Week 52.
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Waist to Hip Ratio at Week 52
NCT00856986 (30) [back to overview]Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
NCT00856986 (30) [back to overview]Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
NCT00856986 (30) [back to overview]Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
NCT00856986 (30) [back to overview]Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
NCT00856986 (30) [back to overview]Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
NCT00909480 (14) [back to overview]Hypoglycemic Episodes, Unclassifiable
NCT00909480 (14) [back to overview]Incidence of Hypoglycaemic Episodes During the Trial
NCT00909480 (14) [back to overview]Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
NCT00909480 (14) [back to overview]Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
NCT00909480 (14) [back to overview]Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
NCT00909480 (14) [back to overview]Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
NCT00909480 (14) [back to overview]Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
NCT00909480 (14) [back to overview]Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
NCT00909480 (14) [back to overview]"Number of Subjects Having the Adverse Event Incorrect Dose Administered"
NCT00909480 (14) [back to overview]Change in Body Weight From Baseline
NCT00909480 (14) [back to overview]Change in HbA1c From Baseline
NCT00909480 (14) [back to overview]Fasting Plasma Glucose (FPG)
NCT00909480 (14) [back to overview]Hypoglycaemic Episodes, Diurnal
NCT00909480 (14) [back to overview]Hypoglycaemic Episodes, Nocturnal
NCT00978627 (9) [back to overview]Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00978627 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
NCT00978627 (9) [back to overview]Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00978627 (9) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
NCT00978627 (9) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT00978627 (9) [back to overview]Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
NCT00978627 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT00978627 (9) [back to overview]Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT00978627 (9) [back to overview]Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
NCT00998335 (12) [back to overview]Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.
NCT00998335 (12) [back to overview]Percent Change From Baseline in Vascular Inflammatory Markers
NCT00998335 (12) [back to overview]Plasma Lipid Concentration.
NCT00998335 (12) [back to overview]Advanced Lipid Testing
NCT00998335 (12) [back to overview]Number of Hypoglycemic Events
NCT00998335 (12) [back to overview]Change in Anthropometric Measure (Body Weight).
NCT00998335 (12) [back to overview]Change in Insulin Secretion
NCT00998335 (12) [back to overview]Hepatic Steatosis
NCT00998335 (12) [back to overview]Change in Anthropometric Measure (Body Mass Index [BMI]).
NCT00998335 (12) [back to overview]Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).
NCT00998335 (12) [back to overview]Metabolic Control as Measured by the A1c
NCT00998335 (12) [back to overview]Metabolic Control as Measured by the Fasting Plasma Glucose Concentration
NCT01003184 (14) [back to overview]Change in Total Cholesterol From Baseline to Endpoint (Week 26).
NCT01003184 (14) [back to overview]Change in Triglycerides From Baseline to Endpoint (Week 26).
NCT01003184 (14) [back to overview]Changes in Systolic Blood Pressure From Baseline to Week 26
NCT01003184 (14) [back to overview]Percentage of Patients Achieving ≤6.5% at Endpoint
NCT01003184 (14) [back to overview]Percentage of Patients Achieving ≤7.0% at Endpoint
NCT01003184 (14) [back to overview]Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
NCT01003184 (14) [back to overview]Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint
NCT01003184 (14) [back to overview]Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
NCT01003184 (14) [back to overview]Hypoglycemia Rate Per Year
NCT01003184 (14) [back to overview]Change in Body Weight From Baseline to Week 26
NCT01003184 (14) [back to overview]Change in Diastolic Blood Pressure From Baseline to Week 26.
NCT01003184 (14) [back to overview]Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).
NCT01003184 (14) [back to overview]Change in HbA1c From Baseline to Week 26
NCT01003184 (14) [back to overview]Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).
NCT01068652 (17) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
NCT01068652 (17) [back to overview]Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment
NCT01068652 (17) [back to overview]Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment
NCT01068652 (17) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) at Week 50
NCT01068652 (17) [back to overview]Glycosylated Haemoglobin (HbA1c)
NCT01068652 (17) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment
NCT01068652 (17) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
NCT01068652 (17) [back to overview]Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment
NCT01068652 (17) [back to overview]Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment
NCT01068652 (17) [back to overview]Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
NCT01074268 (11) [back to overview]Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
NCT01074268 (11) [back to overview]Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01074268 (11) [back to overview]Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT01074268 (11) [back to overview]Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
NCT01074268 (11) [back to overview]Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
NCT01074268 (11) [back to overview]Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
NCT01074268 (11) [back to overview]Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
NCT01165684 (15) [back to overview]Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21
NCT01165684 (15) [back to overview]Fasting Plasma Glucose (FPG) at Week 10
NCT01165684 (15) [back to overview]Body Mass Index (BMI) at Week 32
NCT01165684 (15) [back to overview]Body Weight at Week 32
NCT01165684 (15) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10
NCT01165684 (15) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21
NCT01165684 (15) [back to overview]Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32
NCT01165684 (15) [back to overview]Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32
NCT01165684 (15) [back to overview]Fasting Plasma Glucose (FPG) at Week 21
NCT01165684 (15) [back to overview]Fasting Plasma Glucose (FPG) at Week 32
NCT01165684 (15) [back to overview]Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)
NCT01165684 (15) [back to overview]Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10
NCT01165684 (15) [back to overview]Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32
NCT01165684 (15) [back to overview]Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21
NCT01165684 (15) [back to overview]Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10
NCT01186003 (1) [back to overview]Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)
NCT01232491 (7) [back to overview]Rate of Treatment Emergent Adverse Events (TEAEs)
NCT01232491 (7) [back to overview]Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes
NCT01232491 (7) [back to overview]Rate of All Treatment Emergent Hypoglycaemic Episodes
NCT01232491 (7) [back to overview]Change From Baseline in Glycosylated Haemoglobin (HbA1c)
NCT01232491 (7) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01232491 (7) [back to overview]Change From Baseline in Body Weight
NCT01232491 (7) [back to overview]Change From Baseline in Body Mass Index (BMI)
NCT01232946 (3) [back to overview]Myocardial Glucose Uptake
NCT01232946 (3) [back to overview]Myocardial Fatty Acid Oxidation Rate
NCT01232946 (3) [back to overview]Myocardial Fatty Acid Esterification Rate
NCT01486966 (10) [back to overview]Change From Baseline in Fructosamine After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Incidence of Hypoglycaemic Episodes
NCT01486966 (10) [back to overview]Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment
NCT01486966 (10) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
NCT01513473 (10) [back to overview]Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))
NCT01513473 (10) [back to overview]Number of Treatment Emergent Adverse Events (TEAEs)
NCT01513473 (10) [back to overview]Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
NCT01513473 (10) [back to overview]Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
NCT01513473 (10) [back to overview]Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
NCT01513473 (10) [back to overview]Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
NCT01513473 (10) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
NCT01513473 (10) [back to overview]Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
NCT01513473 (10) [back to overview]Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))
NCT01513473 (10) [back to overview]Number of Hypoglycaemic Episodes
NCT01595646 (5) [back to overview]Verbal Memory Composite
NCT01595646 (5) [back to overview]Cerebral Spinal Fluid (CSF) Biomarkers of AD
NCT01595646 (5) [back to overview]Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio
NCT01595646 (5) [back to overview]Functional Ability
NCT01595646 (5) [back to overview]The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision
NCT01831765 (8) [back to overview]Change From Baseline in HbA1c (Post Meal Arm)
NCT01831765 (8) [back to overview]Change in HbA1c
NCT01831765 (8) [back to overview]Change in PPG (Postprandial Glucose)
NCT01831765 (8) [back to overview]Change From Baseline in Body Weight
NCT01831765 (8) [back to overview]Frequency of Adverse Events
NCT01831765 (8) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
NCT01831765 (8) [back to overview]Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)
NCT01831765 (8) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01835431 (7) [back to overview]Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)
NCT01835431 (7) [back to overview]Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)
NCT01835431 (7) [back to overview]Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
NCT01835431 (7) [back to overview]Change From Baseline in Fasting Plasma Glucose
NCT01835431 (7) [back to overview]Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
NCT01835431 (7) [back to overview]Incidence of Treatment Emergent Adverse Events (TEAEs)
NCT01835431 (7) [back to overview]Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill
NCT01868542 (7) [back to overview]Proportion of Subjects Achieving HbA1c Below 7.0%
NCT01868542 (7) [back to overview]Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.
NCT01868542 (7) [back to overview]Change in Fasting Plasma Glucose From Baseline
NCT01868542 (7) [back to overview]Change in Fasting Plasma Glucose From Baseline
NCT01868542 (7) [back to overview]Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.
NCT01868542 (7) [back to overview]Change in HbA1c
NCT01868542 (7) [back to overview]Incidence of Adverse Events
NCT01966978 (8) [back to overview]Composite End-point
NCT01966978 (8) [back to overview]"Percentage of Participants Reaching Pre-specified Treatment Failure Outcome"
NCT01966978 (8) [back to overview]Change in Short Form-36 (SF-36) Questionnaire Score
NCT01966978 (8) [back to overview]Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means
NCT01966978 (8) [back to overview]Mean Change From Randomization in A1c at Week 26
NCT01966978 (8) [back to overview]Hypoglycemic Episodes
NCT01966978 (8) [back to overview]Mean Change From Randomization in Body Weight
NCT01966978 (8) [back to overview]Percentage of Participants Reaching Target A1c of <7% at Week 26
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 52
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Systolic Blood Pressure at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Systolic Blood Pressure at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Diastolic Blood Pressure at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Sitting Diastolic Blood Pressure at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Fasting Plasma Glucose at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Body Weight at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Body Weight at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in A1C at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in A1C at Week 26 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Change From Baseline in Fasting Plasma Glucose at Week 52 (Excluding Rescue Therapy)
NCT02033889 (49) [back to overview]Change From Baseline in A1C at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker Parathyroid Hormone (PTH) at Week 26 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker P1NP at Week 52 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker Procollagen Type I N-terminal Propeptide (P1NP) at Week 26 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker PTH at Week 104 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker PTH at Week 52 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker P1NP at Week 104 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 104
NCT02033889 (49) [back to overview]Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 26
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 104 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From BMD at Week 104 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 52 (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Time to Glycemic Rescue Therapy at Week 26
NCT02033889 (49) [back to overview]Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker CTX at Week 52 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker CTX at Week 104 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in Bone Biomarker Carboxy-Terminal Cross-Linking Telopeptides of Type I Collagen (CTX) at Week 26 (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)
NCT02033889 (49) [back to overview]Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)
NCT02131272 (7) [back to overview]Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment.
NCT02131272 (7) [back to overview]Incidence of Adverse Events (AEs)
NCT02131272 (7) [back to overview]Change in HbA1c (Glycosylated Haemoglobin)
NCT02131272 (7) [back to overview]Change in Body Weight Standard Deviation Score (SDS)
NCT02131272 (7) [back to overview]Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment
NCT02131272 (7) [back to overview]Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02131272 (7) [back to overview]Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02451137 (13) [back to overview]Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia
NCT02451137 (13) [back to overview]Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period
NCT02451137 (13) [back to overview]Treatment Persistence Measured by Medication Possession Ratio (MPR)
NCT02451137 (13) [back to overview]Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12
NCT02451137 (13) [back to overview]Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12
NCT02451137 (13) [back to overview]Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12
NCT02451137 (13) [back to overview]Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period
NCT02451137 (13) [back to overview]Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period
NCT02451137 (13) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12
NCT02451137 (13) [back to overview]Change From Baseline in Body Weight at Month 6 and Month 12
NCT02451137 (13) [back to overview]Change From Baseline in Basal Insulin Dose at Month 6 and Month 12
NCT02451137 (13) [back to overview]"Percentage of Responders (Participants and Provider) Who Reported Excellent or Good Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12"
NCT02451137 (13) [back to overview]Change From Baseline in HbA1c at Month 6 and Month 12
NCT02741687 (10) [back to overview]Length of Hospital Stay
NCT02741687 (10) [back to overview]Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization
NCT02741687 (10) [back to overview]Number of Participants With Hypoglycemic Events
NCT02741687 (10) [back to overview]Number of Days in the ICU
NCT02741687 (10) [back to overview]Number of Participants Experiencing Stress Hyperglycemia
NCT02741687 (10) [back to overview]Number of Participants With Emergency Room Visits After Discharge
NCT02741687 (10) [back to overview]Number of Participants With Hospital Readmissions After Discharge
NCT02741687 (10) [back to overview]Number of Patients Requiring Supplemental, Subcutaneous Insulin
NCT02741687 (10) [back to overview]Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin
NCT02741687 (10) [back to overview]Number of Participants Experiencing Complications
NCT03377699 (24) [back to overview]Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
NCT03377699 (24) [back to overview]Number of Adverse Events in the Infant
NCT03377699 (24) [back to overview]Number of Adverse Events During Pregnancy Period
NCT03377699 (24) [back to overview]Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)
NCT03377699 (24) [back to overview]Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery
NCT03377699 (24) [back to overview]Birth Weight Standard Deviation (SD) Score for Live Birth Infants
NCT03377699 (24) [back to overview]Birth Weight for Live Birth Infants
NCT03377699 (24) [back to overview]Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
NCT03377699 (24) [back to overview]Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)
NCT03377699 (24) [back to overview]Last Planned Fasting Plasma Glucose Prior to Delivery
NCT03377699 (24) [back to overview]Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants With Live Born Infants (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants With Pre-term Delivery
NCT03377699 (24) [back to overview]Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants
NCT03377699 (24) [back to overview]Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
NCT03377699 (24) [back to overview]Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)
NCT03377699 (24) [back to overview]Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
NCT03377699 (24) [back to overview]Number of Hypoglycaemic Episodes During the Pregnancy Period
NCT03377699 (24) [back to overview]Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]
NCT03377699 (24) [back to overview]Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)
NCT03377699 (24) [back to overview]Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)

Stroke in the Blood Pressure Trial.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Death From Any Cause in the Glycemia Trial.

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

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

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

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

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

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

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

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

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

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

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

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HbA1c (Glycosylated Haemoglobin) at Month 12

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

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

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

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

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

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HbA1c (Glycosylated Haemoglobin) at Month 36

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Number of Participants Having an 'Other' Adverse Event

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

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

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Change From Baseline in Body Weight at Month 36

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

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

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Change From Baseline in Body Weight at Month 12

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

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

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Observed Insulin Antibody Values

Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies. (NCT00435019)
Timeframe: at 0 and 52 weeks

,
InterventionPercent bound of total (Mean)
Insulin detemir specific, week 0 (n=127, 112)Insulin detemir specific, week 52 (n=125, 128)Cross-reacting insulin, week 0 (n=130, 113)Cross-reacting insulin, week 52 (n=132, 135)Insulin aspart specific, week 0 (n=126, 111)Insulin aspart specific, week 52 (n=128, 133)
Insulin Detemir3.235.1527.0643.702.264.20
NPH Insulin2.953.0127.2630.192.242.68

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Number of Subjects Reporting Adverse Events

"Number of subjects reporting adverse events during the trial (from week -2 to week 52).~For details, please refer to the adverse events section." (NCT00435019)
Timeframe: from week -2 to week 52

Interventionparticipants (Number)
Insulin Detemir132
NPH Insulin135

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Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory. (NCT00435019)
Timeframe: after 52 weeks of treatment

InterventionPercent (%) glycosylated haemoglobin (Mean)
Insulin Detemir8.75
NPH Insulin8.64

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Clinical Laboratory Values (Change in Haematology - Leucocytes)

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3046.226.240.03
NN7296.35.96-0.32

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Clinical Laboratory Values (Change in Haematology - Lymphocytes)

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30433.8028.12-3.25
NN72937.4536.675.33

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Clinical Laboratory Values (Change in Haematology - Monocytes)

"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3043.403.59-2.50
NN7294.003.420.67

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Clinical Laboratory Values (Change in Haematology - Thrombocytes)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (NCT00447382)
Timeframe: Week 0, week 52

,
Intervention10^9/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN304254.0242.2-12.8
NN729267.1247.2-18.6

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Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])

"point is Before Breakfast~point is 120 minutes after Breakfast~point is Before Lunch~point is 120 minutes after Lunch~point is Before Dinner~point is 120 minutes after Dinner~point is at Bedtime~point is At 03:00 A.M.~point is Before Breakfast the Following Day" (NCT00447382)
Timeframe: week 0, 26 and 52

,
Interventionmmol/L (Mean)
Baseline 1. pointBaseline 2. pointBaseline 3. pointBaseline 4. pointBaseline 5. pointBaseline 6. pointBaseline 7. pointBaseline 8. pointBaseline 9. pointWeek 26 change. 1. pointWeek 26 change. 2. pointWeek 26 change. 3. pointWeek 26 change. 4. pointWeek 26 change. 5. pointWeek 26 change. 6. pointWeek 26 change. 7. pointWeek 26 change. 8. pointWeek 26 change. 9. pointWeek 52 change. 1. pointWeek 52 change. 2. pointWeek 52 change. 3. pointWeek 52 change. 4. pointWeek 52 change. 5. pointWeek 52 change. 6. pointWeek 52 change. 7. pointWeek 52 change. 8. pointWeek 52 change. 9. point
NN3048.178.957.668.608.298.438.697.978.05-0.64-0.61-0.49-0.34-0.36-0.35-0.350.18-0.64-0.60-0.54-0.36-0.78-0.41-0.31-0.34-0.24-0.44
NN7298.179.037.348.188.168.608.607.727.56-0.44-0.610.08-0.22-0.000.070.200.080.24-0.67-0.99-0.28-0.29-0.59-0.51-0.47-0.31-0.09

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Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])

(NCT00447382)
Timeframe: week 0, week 52

,
Interventionmmol/L (Mean)
Week 52Change from Baseline to week 52
NN3049.730.07
NN7299.64-0.02

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Glycaemic Control Parameters (Change in HbA1c)

HbA1c (Glycosylated haemoglobin). (NCT00447382)
Timeframe: week 0, week 52

,
InterventionPercent (%) glycosylated haemoglobin (Mean)
Week 52Change from Baseline to week 52
NN3047.88-0.08
NN7297.85-0.11

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Hypoglycaemic Episodes

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal. (NCT00447382)
Timeframe: Weeks 0-52

,
Interventionepisodes (Number)
All events - MajorAll events - MinorAll events - Symptoms OnlyDaytime - MajorDaytime - MinorDaytime - Symptoms OnlyNocturnal - MajorNocturnal - MinorNocturnal - Symptoms OnlyUnclassified - Minor
NN3042132154459274138112472642
NN7292129963181525902586404602

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Clinical Laboratory Values (Change in Haematology - Neutrophils)

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30460.0065.596.25
NN72956.3657.50-6.00

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Clinical Laboratory Values (Change in Biochemistry - Sodium)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
Interventionmmol/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN304138.9140.31.4
NN729139.2140.00.8

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Adverse Events

(NCT00447382)
Timeframe: Weeks 0-52

,
Interventionevents (Number)
Serious Adverse EventsNon-Serious Adverse Events
NN30425259
NN72910346

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Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALAT = alanine aminotransferase)" (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionU/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30429.2130.721.34
NN72925.9827.811.76

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Clinical Laboratory Values (Change in Biochemistry - Albumin)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
Interventiong/dL (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3044.304.28-0.02
NN7294.274.300.02

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Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])

"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALP = alkaline phosphatase)" (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionU/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30475.4082.356.77
NN72975.5580.424.53

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Clinical Laboratory Values (Change in Biochemistry - Creatinine)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionUmol/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN30473.172.5-0.5
NN72972.373.10.8

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Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase) (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionU/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN304161.1164.93.2
NN729159.4162.72.6

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Clinical Laboratory Values (Change in Biochemistry - Potassium)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
Interventionmmol/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3044.464.490.02
NN7294.374.430.06

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Clinical Laboratory Values (Change in Biochemistry - Total Protein)

Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (NCT00447382)
Timeframe: Week 0, week 52

,
Interventiong/dL (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3047.237.13-0.11
NN7297.247.19-0.06

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Clinical Laboratory Values (Change in Haematology - Basophilis)

"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory." (NCT00447382)
Timeframe: week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3040.300.24-0.25
NN7290.360.330.00

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Clinical Laboratory Values (Change in Haematology - Eosinophils)

Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (NCT00447382)
Timeframe: Week 0, week 52

,
InterventionPercent (%) of white blood cells (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3042.502.47-0.25
NN7291.822.080.00

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Clinical Laboratory Values (Change in Haematology - Haemoglobin)

Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (NCT00447382)
Timeframe: Week 0, week 52

,
Interventionmmol/L (Mean)
BaselineWeek 52Change from Baseline to week 52
NN3048.858.54-0.30
NN7298.808.47-0.31

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Change From Baseline in Total Antibodies

Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir - human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. (NCT00447382)
Timeframe: Week 0, week 52

Interventionratio (Mean)
NN3041.55
NN7291.55

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Change From Baseline in Detemir Specific Antibodies

Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. (NCT00447382)
Timeframe: Week 0, week 52

Interventionratio (Mean)
NN3041.14
NN7291.06

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Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies

Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. (NCT00447382)
Timeframe: week 0, week 52

Interventionratio (Mean)
NN3041.81
NN7291.89

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Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%

Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0% (NCT00455858)
Timeframe: week 12, week 20

Interventionpercentage of participants (Number)
Achieving HbA1c < 7% after 12 weeks, N=82Not achieving HbA1c < 7% after 12 weeks, N=82Achieving HbA1c < 7% after 20 weeks, N=81Not achieving HbA1c < 7% after 20 weeks, N=81
Insulin Detemir14.685.412.387.7

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Occurence of Hypoglycaemic Episodes

Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment. (NCT00455858)
Timeframe: weeks 0-20

Interventionepisodes (Number)
Occurence of hypoglycaemic episodes: DiurnalOccurence of hypoglycaemic episodes: NocturnalOccurence of hypoglycaemic episodes: Total
Insulin Detemir9278170

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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20

Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20 (NCT00455858)
Timeframe: week 0, week 20

Interventionpercentage change in HbA1c (Mean)
HbA1c at baselineHbA1c at week 20Change in HbA1c from baseline to week 20
Insulin Detemir9.38.2-1.2

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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12

Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline (NCT00455858)
Timeframe: week 0, week 12

Interventionpercentage change in HbA1c (Mean)
HbA1c at baselineHbA1c at week 12Change in HbA1c from baseline to week 12
Insulin Detemir9.38.2-1.2

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Change in Fasting Plasma Glucose (FPG)

Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20 (NCT00455858)
Timeframe: week 0, week 12, week 20

Interventionmg/dL (Mean)
FPG at baseline, N=81FPG at week 12, N=77FPG at week 20, N=78Change in FPG from baseline to week 12, N=75Change in FPG from baseline to week 20, N=73
Insulin Detemir178118116-60-62

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Change in Body Weight From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section (NCT00467649)
Timeframe: From Baseline to Week 24

Interventionkg (Least Squares Mean)
Group A (Phase 1 SYMLIN)0.02
Group B (Phase 1 RA Insulin)4.65

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Phase 2: Change in HbA1c at Week 36

Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only). (NCT00467649)
Timeframe: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

,,,
InterventionPercent (Mean)
Phase 1 BaselineChange From Phase 1 Baseline to Week 36Phase 2 Baseline at Week 24Change From Phase 2 Baseline to Week 36
Group C (Phase 2 SYMLIN)8.35-1.966.260.14
Group D (Phase 2 SYMLIN+RA)8.03-0.687.57-0.23
Group E (Phase 2 RA Insulin)7.85-1.496.140.22
Group F (Phase 2 RA Insulin + SYMLIN)8.38-0.997.320.07

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Phase 2: Change in Body Weight at Week 36

Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only). (NCT00467649)
Timeframe: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

,,,
Interventionkg (Mean)
Phase 1 BaselineChange From Phase 1 Baseline to Week 36Phase 2 Baseline at Week 24Change From Phase 2 Baseline to Week 36
Group C (Phase 2 SYMLIN)109.98-0.80108.500.69
Group D (Phase 2 SYMLIN+RA)104.831.34105.670.50
Group E (Phase 2 RA Insulin)104.423.90107.870.44
Group F (Phase 2 RA Insulin + SYMLIN)105.304.51110.68-0.86

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Hypoglycemia Adverse Events

"MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating.~MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion).~SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention." (NCT00467649)
Timeframe: 36 weeks

,,,,,
Interventionparticipants (Number)
MildModerateSevere
Group A (Phase 1 SYMLIN)31120
Group B (Phase 1 RA Insulin)46130
Group C (Phase 2 SYMLIN)700
Group D (Phase 2 SYMLIN+RA)1810
Group E (Phase 2 RA Insulin)920
Group F (Phase 2 RA Insulin + SYMLIN)1930

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Fasting Serum Lipids Change From Baseline to Week 24

(NCT00467649)
Timeframe: Baseline, week 24

,
Interventionmg/dL (Mean)
Total CholesterolHDLLDLTriglycerides
Group A (Phase 1 SYMLIN)-1.811.112.36-28.96
Group B (Phase 1 RA Insulin)5.271.659.12-31.98

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The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia

A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention. (NCT00467649)
Timeframe: 24 Weeks

InterventionPercent (Number)
Group A (Phase 1 SYMLIN)30.4
Group B (Phase 1 RA Insulin)10.7

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Percentage of Patients With a Severe Hypoglycemia Adverse Event

This is a component of the primary endpoint. (NCT00467649)
Timeframe: 24 Weeks

InterventionPercent (Number)
Group A (Phase 1 SYMLIN)0.0
Group B (Phase 1 RA Insulin)0.0

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Percentage of Patients Achieving HbA1c <=7% at Week 24

This is a component of the primary endpoint (NCT00467649)
Timeframe: 24 Weeks

InterventionPercent (Number)
Group A (Phase 1 SYMLIN)44.6
Group B (Phase 1 RA Insulin)55.4

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Change in Waist Circumference From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section (NCT00467649)
Timeframe: From Baseline to Week 24

Interventioncm (Least Squares Mean)
Group A (Phase 1 SYMLIN)-0.63
Group B (Phase 1 RA Insulin)2.17

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Change in HbA1c From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section (NCT00467649)
Timeframe: From Baseline to Week 24

InterventionPercent (Least Squares Mean)
Group A (Phase 1 SYMLIN)-1.11
Group B (Phase 1 RA Insulin)-1.27

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Change in Fasting Plasma Glucose From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section (NCT00467649)
Timeframe: From Baseline to Week 24

Interventionmg/dL (Mean)
Group A (Phase 1 SYMLIN)-29.0
Group B (Phase 1 RA Insulin)-37.8

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Percentage of Patients With no Weight Gain at Week 24

This is a component of the primary endpoint (NCT00467649)
Timeframe: 24 Weeks

InterventionPercent (Number)
Group A (Phase 1 SYMLIN)46.4
Group B (Phase 1 RA Insulin)14.3

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Maternal Safety - Change in Haemoglobin Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in haemoglobin level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmmol/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=146FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir7.647.810.16
Neutral Protamine Hagedorn (NPH) Insulin7.647.690.05

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Maternal Safety - Change in Insulin Aspart Specific Antibodies

Change in concentrations values for insulin aspart specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing. (NCT00474045)
Timeframe: Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.

,
Intervention%B/T (Median)
Baseline IDet (N)=145, NPH (N)=154Visit P4 IDet (N)=109, NPH (N)=110Change from Baseline-Visit P4(N=104,109)
Insulin Detemir0.440.43-0.12
Neutral Protamine Hagedorn (NPH) Insulin0.460.36-0.21

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Maternal Safety - Change in Insulin Detemir Specific Antibodies

Change in concentrations of values for insulin detemir specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing. (NCT00474045)
Timeframe: Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.

,
Intervention%B/T (Median)
Baseline IDet (N)=145, NPH (N)=155Visit P4 IDet (N)=110, NPH (N)=110Change from Baseline-Visit P4(N=105,109)
Insulin Detemir1.131.360.04
Neutral Protamine Hagedorn (NPH) Insulin1.091.250.09

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Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies

Change in concentrations values for insulin detemir/aspart cross-reacting antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing (NCT00474045)
Timeframe: Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.

,
Intervention%B/T (Median)
Baseline IDet (N)=146, NPH (N)=155Visit P4 IDet (N)=110, NPH (N)=110Change from Baseline-Visit P4(N=106,109)
Insulin Detemir5.215.40-0.43
Neutral Protamine Hagedorn (NPH) Insulin5.364.28-1.12

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Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in lactate dehydrogenase serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionU/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir145.1167.521.82
Neutral Protamine Hagedorn (NPH) Insulin144.1169.525.46

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Maternal Safety - Change in Leukocytes Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in leukocytes level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Intervention10^9 cells/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=146FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir8.016.68-1.36
Neutral Protamine Hagedorn (NPH) Insulin8.26.55-1.65

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Maternal Safety - Change in Potassium Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in potassium serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmmol/L (Mean)
Visit P1 IDet (N)=137, NPH (N)=144FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=135, 144)
Insulin Detemir4.134.300.15
Neutral Protamine Hagedorn (NPH) Insulin4.124.310.20

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Maternal Safety - Change in Sodium Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in sodium serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmmol/L (Mean)
Visit P1 IDet (N)=137, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=135, 145)
Insulin Detemir138.0141.63.59
Neutral Protamine Hagedorn (NPH) Insulin137.8141.23.36

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Maternal Safety - Change in Thrombocytes Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in thrombocytes level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Intervention10^9 cells/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=146FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir245.3270.624.25
Neutral Protamine Hagedorn (NPH) Insulin247.2263.116.16

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Maternal Safety - Change in Total Protein Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in total protein serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventiong/dL (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir6.847.080.24
Neutral Protamine Hagedorn (NPH) Insulin6.897.110.22

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Maternal Safety - Change in Urine Albumin Level (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in urine albumin level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventiong/dL (Mean)
Visit P1 IDet (N)=135, NPH (N)=143FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=133, 142)
Insulin Detemir0.010.020.01
Neutral Protamine Hagedorn (NPH) Insulin0.010.030.02

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Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in Urine-N (creatinine) level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmg/dL (Mean)
Visit P1 IDet (N)=135, NPH (N)=144FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=133, 143)
Insulin Detemir114.8106.2-6.62
Neutral Protamine Hagedorn (NPH) Insulin103.198.61-6.34

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Maternal Safety - Hypoglycaemic Episodes

All episodes include major, minor and symptoms only. Major episode : unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. Diurnal: Episode occurring between 06.00 - 00.00, both including. (NCT00474045)
Timeframe: Participants were followed during the pregnancy period, an average of 9.6 months

,
Interventionepisodes (Number)
All EpisodesDiurnal
Insulin Detemir94968045
Neutral Protamine Hagedorn (NPH) Insulin94537810

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Maternal Safety - Mode of Delivery

Non-Planned Caesarean Section is a procedure which takes place ≤8h prior to delivery. Planned Caesarean Section takes place >8h prior to delivery. (NCT00474045)
Timeframe: At Delivery Visit

,
Interventionpercentage (%) of subjects (Number)
Spontaneous onset of labour (N)=130,136Induction of labour (N)=130,136Normal Vaginal Delivery(N)=54,50Instrumental Vaginal Delivery(N)=54,50Non-Planned Caesarean Section(N)=76,86Planned Caesarean Section(N)=76,86
Insulin Detemir193976243665
Neutral Protamine Hagedorn (NPH) Insulin283680204357

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Maternal Safety - Number of Subjects With Adverse Events (AEs)

AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. Serious adverse event (SAE) =any undesirable serious medical event as defined in protocol. (NCT00474045)
Timeframe: Participants were followed during the pregnancy period, an average of 9.6 months

,
Interventionparticipants (Number)
Subjects with (w.) adverse eventsSubjects with serious adverse eventsSubjects with severe adverse eventsSubjects w. AEs related to basal insulinSubjects w. AEs related to bolus insulinSubjects with AEs leading to withdrawal
Insulin Detemir1386138181213
Neutral Protamine Hagedorn (NPH) Insulin141493216146

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Pregnancy Outcome at Delivery

Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Stillbirth indicates death between at or after 22 GW and at or before delivery. (NCT00474045)
Timeframe: Delivery Visit

,
Interventionparticipants (Number)
Live BirthEarly Foetal Death (Spont. Abortion)Early Foetal Death (Ectopic Pregnancy)Induced AbortionStillbirth
Insulin Detemir12810112
Neutral Protamine Hagedorn (NPH) Insulin1368100

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Pregnancy Outcome at Follow-Up

Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Perinatal Death means death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal Death means death between at or after 7 completed days and before 28 completed days after delivery. Death During Follow-Up means death between at or after 28 days after delivery and at or before Follow-Up. (NCT00474045)
Timeframe: Follow-Up (6 weeks after delivery)

,
Interventionparticipants (Number)
Live ChildrenEarly Foetal Death (Spont. Abortion)Early Foetal Death (Ectopic Pregnancy)Induced AbortionPerinatal DeathNeonatal DeathDeath During Follow-Up
Insulin Detemir1281011200
Neutral Protamine Hagedorn (NPH) Insulin135810100

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Safety - Composite Pregnancy Outcome

Wt. corresponds to weight of live-born infants. Pre-term delivery: delivery before 37 completed GWs including abortions. Early foetal death: death before 22 completed GWs. Perinatal mortality: death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal mortality: post-partum after 7 completed days and before 28 completed days after delivery. Major-malformation: a life threatening structural anomaly or one likely to cause significant impairment of health or functional capacity and needs medical or surgical treatment. (NCT00474045)
Timeframe: End of Pregnancy

,
Interventionparticipants (Number)
Wt. below the 10th percentile(N)=128,136Wt. above the 90th percentile(N)=128,136Pre-term delivery (N)=142,145Major malformations (N)=142,145Early foetal death (N)=142,145Perinatal mortality (N)=130,136Neonatal mortality (N)=126,135Compiled(at least 1 of above)(N)=142,145
Insulin Detemir359395112089
Neutral Protamine Hagedorn (NPH) Insulin17345191096

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Safety - Total Daily Insulin Dose During Pregnancy

(NCT00474045)
Timeframe: Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (6 weeks after delivery)

,
InterventionU/kg (Mean)
GW 14 IDet (N)=129, NPH (N)=141GW 24 IDet (N)=128, NPH (N)=137GW 36 IDet (N)=119, NPH (N)=121Follow-Up IDet (N)=124, NPH (N)=133
Insulin Detemir0.730.851.170.53
Neutral Protamine Hagedorn (NPH) Insulin0.740.841.050.57

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Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events

AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. SAE=any undesirable serious medical event as defined in protocol. (NCT00474045)
Timeframe: Foetuses/Newborns were followed during the pregnancy period, an average of 9.6 months and Follow-Up period (6 weeks after delivery)

,
InterventionFoetus/Newborns (1 per pregnant woman) (Number)
Subjects with adverse eventsSubjects with serious adverse eventsSubjects with severe adverse eventsSubjects w. AEs related to Basal insulinSubjects w. AEs related to Bolus insulinSubjects with AEs leading to withdrawal
Insulin Detemir563615110
Neutral Protamine Hagedorn (NPH) Insulin553212001

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Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36

(NCT00474045)
Timeframe: At gestational week (GW) 36

InterventionPercent (%) glycosylated haemoglobin (Least Squares Mean)
Insulin Detemir6.27
Neutral Protamine Hagedorn (NPH) Insulin6.33

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Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36

(NCT00474045)
Timeframe: At gestational week (GW) 36

InterventionPercent (%) glycosylated haemoglobin (Least Squares Mean)
Insulin Detemir6.22
Neutral Protamine Hagedorn (NPH) Insulin6.37

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Maternal Safety - Acceleration of Nephropathy

Acceleration of nephropathy was defined as a change from a low U-albumin:U-creatinine ratio ≤33.93 mg/mmol to a high U-albumin:U-creatinine ratio > 33.93 mg/mmol from GW 8-12 (Visit P1) to the follow-up visit. (NCT00474045)
Timeframe: From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)

Interventionparticipants (Number)
Insulin Detemir2
Neutral Protamine Hagedorn (NPH) Insulin1

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Maternal Safety - Electrocardiogram (ECG)

The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' (at Visit 1, 3 weeks before randomisation) to 'Abnormal, clinically significant' (at Follow-Up). 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. (NCT00474045)
Timeframe: Follow-Up (6 weeks after delivery)

Interventionparticipants (Number)
Insulin Detemir0
Neutral Protamine Hagedorn (NPH) Insulin0

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Maternal Safety - Nocturnal Hypoglycaemic Episodes

A nocturnal episode is any episode occurring between 0.01 - 5.59, both including. It includes major, minor and symptoms only episodes. Major: unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. (NCT00474045)
Timeframe: Participants were followed during the pregnancy period, an average of 9.6 months

Interventionepisodes (Number)
Insulin Detemir1451
Neutral Protamine Hagedorn (NPH) Insulin1643

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Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T) (NCT00474045)
Timeframe: At Delivery (End of Pregnancy)

Intervention%B/T (Median)
Insulin Detemir0.38
Neutral Protamine Hagedorn (NPH) Insulin0.32

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Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T). (NCT00474045)
Timeframe: At Delivery (End of Pregnancy)

Intervention%B/T (Median)
Insulin Detemir5.99
Neutral Protamine Hagedorn (NPH) Insulin4.12

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8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36

8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit. (NCT00474045)
Timeframe: Visit P4 (GW 36)

,
Interventionmmol/L (Mean)
Before Breakfast (N=131,141)120 mins after breakfast (N=130,139)Before Lunch (N=131,141)120 mins after lunch (N=130,140)Before Dinner (N=131,140)120 mins after Dinner (N=117,132)Bedtime (N=126,137)At 2.00 A.M. (N=122,135)
Insulin Detemir67.45.96.96.57.476
Neutral Protamine Hagedorn (NPH) Insulin6.37.56.17.16.57.47.26.4

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Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T). (NCT00474045)
Timeframe: At Delivery (End of Pregnancy)

Intervention%B/T (Median)
Insulin Detemir1.31
Neutral Protamine Hagedorn (NPH) Insulin0.90

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Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood

(NCT00474045)
Timeframe: At Delivery

Interventionpmol/L (Median)
Insulin Detemir25.00

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Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36) (NCT00474045)
Timeframe: At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

Interventionratio (Median)
Insulin Detemir0.84
Neutral Protamine Hagedorn (NPH) Insulin0.64

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Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36) (NCT00474045)
Timeframe: At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

Interventionratio (Median)
Insulin Detemir1.29
Neutral Protamine Hagedorn (NPH) Insulin0.90

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Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36) (NCT00474045)
Timeframe: At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

Interventionratio (Median)
Insulin Detemir1.10
Neutral Protamine Hagedorn (NPH) Insulin0.77

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Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36

(NCT00474045)
Timeframe: At both Visit P3 (GW 24) and Visit P4 (GW 36)

Interventionparticipants (Number)
Insulin Detemir57
Neutral Protamine Hagedorn (NPH) Insulin46

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8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24

8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit. (NCT00474045)
Timeframe: Visit P3 (GW 24)

,
Interventionmmol/L (Mean)
Before Breakfast (N=131,141)120 mins after breakfast (N=130,141)Before Lunch (N=131,141)120 mins after lunch (N=130,140)Before Dinner (N=130,140)120 mins after Dinner (N=117,133)Bedtime (N=125,137)At 2.00 A.M. (N=125,134)
Insulin Detemir6.47.76.17.26.87.27.66.7
Neutral Protamine Hagedorn (NPH) Insulin7.38.06.77.47.07.87.86.9

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Fasting Plasma Glucose (FPG)

(NCT00474045)
Timeframe: During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]

,
Interventionmmol/L (Mean)
GW 8-12 IDet (N)=130, NPH (N)=141GW 14 IDet (N)=125, NPH (N)=135GW 24 IDet (N)=129, NPH (N)=141GW 36 IDet (N)=129, NPH (N)=142
Insulin Detemir5.05.05.24.7
Neutral Protamine Hagedorn (NPH) Insulin5.85.76.35.4

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Glycosylated Haemoglobin (HbA1c) During Pregnancy

(NCT00474045)
Timeframe: During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Delivery Visit (end of pregnancy)] and Follow-Up Visit ( 6 weeks after delivery)

,
InterventionPercent (%) glycosylated haemoglobin (Mean)
GW 8-12 IDet (N)=140, NPH (N)=146GW 14 IDet (N)=136, NPH (N)=146GW 24 IDet (N)=138, NPH (N)=146GW 36 IDet (N)=138, NPH (N)=146Delivery IDet (N)=138, NPH (N)=146Follow-up IDet (N)=138, NPH (N)=146
Insulin Detemir6.66.366.26.36.5
Neutral Protamine Hagedorn (NPH) Insulin6.86.56.16.36.56.6

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Maternal Safety - Acceleration of Retinopathy in Any Eye

Acceleration of Retinopathy is defined as worsening of fundoscopy/fundusphotography findings from GW 8-12 (Visit P1) to follow-up on one or both eyes. (NCT00474045)
Timeframe: From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)

,
Interventionparticipants (Number)
Acceleration in Any EyeNo Acceleration in Any EyeMissing Data
Insulin Detemir1212020
Neutral Protamine Hagedorn (NPH) Insulin1412024

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Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit

Change in the body weight was summarised by treatment. (NCT00474045)
Timeframe: Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)

,
Interventionkg (Mean)
GW (8-12) IDet(N)=139,NPH(N)=145Change from GW(8-12)-GW 14 (N=128,139)Change from GW(8-12)-GW 24 (N=130,139)Change from GW(8-12)-GW 36(N=130,139)
Insulin Detemir67.81.05.611.5
Neutral Protamine Hagedorn (NPH) Insulin69.21.46.011.0

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Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit

Change in the diastolic blood pressure was summarised by treatment. (NCT00474045)
Timeframe: Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionmmHg (Mean)
GW (8-12) IDet(N)=140,NPH(N)=146Change from GW(8-12)-GW 14 (N=137,145)Change from GW(8-12)-GW 24(N=138,145)Change from GW(8-12)-GW 36(N=138,145)Change from GW(8-12)-FU(N=138,145)
Insulin Detemir70.5-0.2-1.63.21.3
Neutral Protamine Hagedorn (NPH) Insulin70.7-0.5-1.22.61.8

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Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up

Change in the pulse was summarised by treatment. (NCT00474045)
Timeframe: Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up Visit (6 weeks after delivery)

,
Interventionbeats/minute (Mean)
GW (8-12) IDet(N)=136,NPH(N)=142Change from GW(8-12)-GW 14 (N=133,139)Change from GW(8-12)-GW 24(N=134,141)Change from GW(8-12)-GW 36(N=134,141)Change from GW(8-12)-FU(N=134,141)
Insulin Detemir77.41.53.55.2-3
Neutral Protamine Hagedorn (NPH) Insulin76.82.24.54.9-2.3

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Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit

Change in the systolic blood pressure was summarised by treatment. (NCT00474045)
Timeframe: Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionmmHg (Mean)
GW (8-12) IDet(N)=140,NPH(N)=146Change from GW(8-12)-GW 14 (N=137,145)Change from GW(8-12)-GW 24(N=138,145)Change from GW(8-12)-GW 36(N=138,145)Change from GW(8-12)-FU(N=138,145)
Insulin Detemir114.10.8-0.73.12.6
Neutral Protamine Hagedorn (NPH) Insulin116.2-2.8-1.62.3-0

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Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alanine aminotransferase level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionU/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir16.1227.0610.88
Neutral Protamine Hagedorn (NPH) Insulin17.9726.168.16

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Maternal Safety - Change in Albumin Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in albumin level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventiong/dL (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir4.054.190.13
Neutral Protamine Hagedorn (NPH) Insulin4.044.120.09

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Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in albumin/creatinine ratio at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmg/mmol (Mean)
Visit P1 IDet (N)=135, NPH (N)=143FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=133, 142)
Insulin Detemir0.822.651.88
Neutral Protamine Hagedorn (NPH) Insulin0.854.814.07

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Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alkaline phosphatase level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
InterventionU/L (Mean)
Visit P1 IDet (N)=137, NPH (N)=144FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=135, 144)
Insulin Detemir52.6490.1737.39
Neutral Protamine Hagedorn (NPH) Insulin53.8892.9639.51

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Maternal Safety - Change in Creatinine Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in creatinine serum level at Follow-Up Visit (6 weeks after delivery). (NCT00474045)
Timeframe: Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

,
Interventionmcmol/L (Mean)
Visit P1 IDet (N)=138, NPH (N)=145FU Visit IDet (N)=138, NPH (N)=146Change from Visit P1-FU (N=136, 145)
Insulin Detemir52.0462.9811.18
Neutral Protamine Hagedorn (NPH) Insulin54.0166.5712.52

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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint

(NCT00487240)
Timeframe: baseline to 32 weeks

,
Interventionhypoglycemic events per 30 days (Mean)
Endpoint Hypogylcemic RateOverall Hypoglycemic RateEndpoint Nocturnal Hypoglycemic RateOverall Nocturnal Hypoglycemic RateEndpoint Non-Nocturnal Hypoglycemic RateOverall Non-Nocturnal Hypoglycemic RateEndpoint Severe Hypoglycemic RateOverall Severe Hypoglycemic Rate
Detemir4.325.030.460.493.854.500.010.02
Insulin Lispro Protamine Suspension5.456.280.730.794.695.470.050.03

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Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint

Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. (NCT00487240)
Timeframe: Baseline to 32 Weeks

,
Interventionepisodes of hypoglycemia (Number)
Endpoint Hypoglycemic EpisodesOverall Hypoglycemic EpisodesEndpoint Nocturnal Hypoglycemic EpisodesOverall Nocturnal Episodes (N=191,N=186)Endpoint Non-Nocturnal Hypoglycemic EpisodesOverall Non-Nocturnal Hypoglycemic EpisodesEndpoint Severe Hypoglycemic EpisodesOverall Severe Hypoglycemic Episodes (N=171,N=170)
Detemir13517355111129172313
Insulin Lispro Protamine Suspension134173691251271721124

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Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%

(NCT00487240)
Timeframe: 32 Weeks

,
Interventionpercentage of participants (Number)
With HbA1c ≤7.0%With HbA1c >7.0%With HbA1c <7.0%With HbA1c ≥7.0%With HbA1c ≤6.5%With HbA1c >6.5%With HbA1c <6.5%With HbA1c ≥6.5%
Detemir18.781.315.484.69.990.18.291.8
Insulin Lispro Protamine Suspension18.581.515.284.88.791.37.192.9

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1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint

Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. (NCT00487240)
Timeframe: baseline to 32 weeks

,
Interventionhypoglycemic events per 1 year (Mean)
Endpoint Hypoglycemic RateOverall Hypoglycemic RateEndpoint Nocturnal Hypoglcemic RateOverall Nocturnal Hypoglycemic RateEndpoint Non-Nocturnal Hypoglycemic RateOverall Non-Nocturnal Hypoglycemic RateEndpoint Severe Hypoglycemic RateOverall Severe Hypoglycemic Rate
Detemir52.6061.215.606.0146.8854.830.100.25
Insulin Lispro Protamine Suspension66.4176.458.909.6557.0866.580.630.42

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7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint

Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals. (NCT00487240)
Timeframe: 32 Weeks

,
Interventionmillimoles per Liter (mmol/L) (Mean)
Daily Mean 7-Point SMBG (N=164,N=172)Daily Mean Pre-Meal (N=174,N=181)Daily Mean Postprandial Meal (N=168,N=176)Daily Mean Morning+Evening Pre-Meal (N=174,N=181)Actual Morning Pre-Meal (N=175,N=182)Actual Morning Postprandial Meal (N=171,N=178)Actual Midday Pre-Meal (N=175,N=181)Actual Midday Postprandial Meal (N=170,N=177)Actual Evening Pre-Meal (N=174,N=181)Actual Evening Postprandial Meal (N=172,N=181)Actual 0300 Hours (N=167,N=173)Actual Morning SMBG Excursion (N=171,N=178)Actual Midday SMBG Excursion (N=170,N=176)Actual Evening SMBG Excursion (N=172,N=181)Actual Daily Mean SMBG Excursion (N=168,N=176)
Detemir8.488.568.588.758.628.568.198.618.878.608.29-0.120.46-0.240.01
Insulin Lispro Protamine Suspension8.678.778.709.009.098.688.298.548.929.058.49-0.340.380.120.06

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Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values

"The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the mean change from baseline is calculated by averaging out for all subjects. [Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline." (NCT00487240)
Timeframe: Baseline, 8,16, 24, 32 Weeks

,
Interventionpercent of HbA1c (Least Squares Mean)
Baseline8 Week HbA1c (n=184, n=179)8 Week Change from Baseline16 Week HbA1c (n=174, n=173)16 Week Change from Baseline24 Week HbA1c (n=171, n=174)24 Week Change from Baseline32 Week HbA1c (n=165, n=165)32 Week Change from Baseline
Detemir8.688.11-0.648.08-0.678.11-0.658.14-0.62
Insulin Lispro Protamine Suspension8.888.08-0.687.94-0.818.07-0.698.09-0.68

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Change From Baseline in Absolute Body Weight at 32 Week Endpoint

(NCT00487240)
Timeframe: Baseline, 32 Weeks

,
Interventionkilograms (Mean)
BaselineChange from Baseline
Detemir72.690.58
Insulin Lispro Protamine Suspension72.761.54

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Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

(NCT00487240)
Timeframe: baseline and 32 weeks

,
Interventionpercent of HbA1c (Least Squares Mean)
BaselineChange from Baseline
Detemir8.68-0.59
Insulin Lispro Protamine Suspension8.88-0.69

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Glycemic Variability at Endpoint

Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose [SMBG] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values. (NCT00487240)
Timeframe: 32 Weeks

,
Interventionmillimoles per Liter (mmol/L) (Mean)
Standard Deviation (SD) Value (N=172, N=180)Mean Value (M-Value) (N=175, N=182)Mean Daily Difference (MODD) Value (N=172, N=180)
Detemir2.3032.192.78
Insulin Lispro Protamine Suspension2.6436.393.04

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Insulin Dose (Total and By Component [Basal and Bolus])

Total daily insulin dose (U/day) was assessed. (NCT00487240)
Timeframe: 32 weeks

,
Interventionunits of insulin per day (U/day) (Mean)
Total Insulin (N=192, N=188)Total Bolus Insulin (N=191, N=187)Total Basal Insulin (N=192, N=188)
Detemir73.8433.3240.70
Insulin Lispro Protamine Suspension67.7828.9438.99

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Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])

Total daily insulin dose adjusted for body weight (U/kg/day) was assessed. (NCT00487240)
Timeframe: 32 Weeks

,
Interventionunits of insulin per kilogram per day (Mean)
Total Insulin (N=192, N=188)Total Bolus Insulin (N=191, N=187)Total Basal Insulin (N=192, N=188)
Detemir0.990.450.55
Insulin Lispro Protamine Suspension0.910.390.53

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Mean Number of Total Hypoglycaemic Episodes, Month 1

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. (NCT00506662)
Timeframe: weeks -2-0, month 1

,
Interventionepisodes per week by visit (Mean)
Screening (week -2 to week 0)Month 1 (weeks 1-4)Difference (month 1-screening)
Insulin Detemir0.0390.026-0.013
Insulin NPH0.0730.1200.047

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Mean Number of Total Hypoglycaemic Episodes, Months 5-7

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. (NCT00506662)
Timeframe: weeks -2-0, months 5-7

,
Interventionepisodes per week by visit (Mean)
Screening (week -2 to week 0)Months 5-7 (weeks 17-28)Difference (months 5-7 - screening)
Insulin Detemir0.0390.018-0.022
Insulin NPH0.0580.041-0.017

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Mean Number of Total Hypoglycaemic Episodes, Months 2-4

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. (NCT00506662)
Timeframe: weeks -2-0, months 2-4

,
Interventionepisodes per week by visit (Mean)
Screening (week -2 to week 0)Months 2-4 (weeks 5-16)Difference (months 2-4 - screening)
Insulin Detemir0.0390.015-0.024
Insulin NPH0.0760.072-0.004

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Component of Total Energy Expenditure: Physical Activity Thermogenesis

Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32). (NCT00509925)
Timeframe: Week 16, week 32

Interventionkcal/day (Mean)
Insulin Detemir588.5
Insulin NPH542.7

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Component of Total Energy Expenditure: Resting Energy Expenditure (REE)

Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation. (NCT00509925)
Timeframe: Week 14, week 30

Interventionkcal/day (Mean)
Insulin Detemir1932.5
Insulin NPH2034.5

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Hypoglycaemic Episodes

Total number of hypoglycaemic episodes experienced in the study. (NCT00509925)
Timeframe: Weeks 0-32

Interventionepisodes (Number)
Insulin Detemir90
Insulin NPH109

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Total Energy Expenditure, Dietary Record Method

The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE. (NCT00509925)
Timeframe: Weeks 14-16, weeks 30-32

Interventionkcal/day (Mean)
Insulin Detemir2017.9
Insulin NPH2181.0

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Total Energy Expenditure, Double-labelled Water Method

Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure. (NCT00509925)
Timeframe: Weeks 14-16, weeks 30-32

Interventionkcal/day (Mean)
Insulin Detemir2942.2
Insulin NPH3007.2

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Lean Body Mass

Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionkg (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 12
Insulin Detemir First, Then Insulin NPH58.959.9
Insulin NPH First, Then Insulin Detemir63.764.3

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Hypoglycaemic Episodes, Diurnal/Nocturnal

Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study. (NCT00509925)
Timeframe: Weeks 0-32

,
Interventionepisodes (Number)
DiurnalNocturnalTime of event not recorded
Insulin Detemir62262
Insulin NPH601534

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Hormonal Assessment: Resistin

Resistin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30

,
Interventionng/ml (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 11
Insulin Detemir First, Then Insulin NPH8.28.4
Insulin NPH First, Then Insulin Detemir10.216.2

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Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)

Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual's average daily food intake. (NCT00509925)
Timeframe: Week 14, week 30

Interventionkcal/day (Mean)
Insulin Detemir73.0
Insulin NPH74.3

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Hormonal Assessment: Leptin

Leptin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30

,
Interventionng/ml (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 11
Insulin Detemir First, Then Insulin NPH9.49.9
Insulin NPH First, Then Insulin Detemir10.56.6

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Hormonal Assessment: Insulin-like Growth Factor-1

Insulin-like growth factor-1 (IGF-1) levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30

,
Interventionng/ml (Mean)
Treatment period 1, N=12, 9Treatment period 2, N=9, 10
Insulin Detemir First, Then Insulin NPH212.3179.8
Insulin NPH First, Then Insulin Detemir206.8168.4

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Hormonal Assessment: Adiponectin

Adiponectin levels after each treatment period. (NCT00509925)
Timeframe: Week 14, week 30

,
Interventionng/ml (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 11
Insulin Detemir First, Then Insulin NPH15978.315189.5
Insulin NPH First, Then Insulin Detemir11361.011053.3

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Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated haemoglobin A1c (HbA1c) after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionpercentage of total haemoglobin (Mean)
Treatment period 1, N=11, 10Treatment period 2, N=10, 12
Insulin Detemir First, Then Insulin NPH7.87.6
Insulin NPH First, Then Insulin Detemir7.48.0

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Fat Mass

Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionkg (Mean)
Treatment period 1, N=12, 10Treatment period 2, N=9, 12
Insulin Detemir First, Then Insulin NPH21.723.0
Insulin NPH First, Then Insulin Detemir22.319.2

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Fasting Plasma Glucose

Fasting plasma glucose (FPG) after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionmmol/L (Mean)
Treatment period 1, N=12, 9Treatment period 2, N=10, 12
Insulin Detemir First, Then Insulin NPH13.39.1
Insulin NPH First, Then Insulin Detemir10.513.3

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Body Weight

Body weight after each treatment period. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionkg (Mean)
Treatment period 1, N= 12, 10Treatment period 2, N= 10, 12
Insulin Detemir First, Then Insulin NPH80.682.9
Insulin NPH First, Then Insulin Detemir86.084.8

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Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)

Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT. (NCT00509925)
Timeframe: Week 16, week 32

Interventionkcal/day (Mean)
Insulin Detemir1163.7
Insulin NPH1170.0

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Waist:Hip Ratio

At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100. (NCT00509925)
Timeframe: Week 16, week 32

,
Interventionpercentage of hip circumference (Mean)
Treatment period 1, N= 12, 10Treatment period 2, N= 10, 12
Insulin Detemir First, Then Insulin NPH92.492.4
Insulin NPH First, Then Insulin Detemir94.494.8

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Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide

High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory. (NCT00537303)
Timeframe: week 36

Interventionmg/L (Mean)
Advanced3.76
Basic4.67

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Biochemistry: Serum Alanine Aminotransferase

Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory. (NCT00537303)
Timeframe: week 36

InterventionU/L (Mean)
Advanced30.09
Basic27.04

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Hypoglycaemic Episodes

Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00537303)
Timeframe: Weeks 0-36

,
Interventionepisodes (Number)
MajorMinorSymptoms Only
Advanced1531283
Basic4567344

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Glycosylated Haemoglobin A1c (HbA1c)

Measured for the Per Protocol analysis set. (NCT00537303)
Timeframe: week 36

Interventionpercentage (%) of total haemoglobin (Least Squares Mean)
Advanced7.55
Basic7.52

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Glycosylated Haemoglobin A1c (HbA1c)

Analysed for the full analysis set. (NCT00537303)
Timeframe: week 36

Interventionpercentage (%) of total haemoglobin (Least Squares Mean)
Advanced7.67
Basic7.61

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Haematology: Haemoglobin Measured in Blood

Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory. (NCT00537303)
Timeframe: week 36

Interventionmmol/L (Mean)
Advanced8.57
Basic8.58

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Incidence of Hypoglycaemic Episodes - All Episodes

Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator's judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00542620)
Timeframe: Weeks 0-8

Interventionepisodes (Number)
Mixed Injection351
Separate Injection293

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0Week 8
Mixed Injection1546.32102.4
Separate Injection1510.91540

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0Week 8
Mixed Injection36591.236055.0
Separate Injection34653.439757.0

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Pharmacokinetics: Cmax of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol/L (Median)
Week 0Week 8
Mixed Injection216274
Separate Injection167186

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Pharmacokinetics: Cmax of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol/L (Median)
Week 0Week 8
Mixed Injection557662
Separate Injection762601

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Pharmacokinetics: Cmax of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol/L (Median)
Week 0Week 8
Mixed Injection1070012000
Separate Injection1050012600

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Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0, n=8, 9Week 8, n=11, 11
Mixed Injection3.62.9
Separate Injection2.32.0

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Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0, n=10, 11Week 8, n=13, 12
Mixed Injection2.23.5
Separate Injection21.7

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Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0, n=4, 3Week 8, n=3, 6
Mixed Injection16.25.6
Separate Injection8.220.8

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Pharmacokinetics: Tmax of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0Week 8
Mixed Injection2.52.5
Separate Injection3.01.8

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Pharmacokinetics: Tmax of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0Week 8
Mixed Injection22
Separate Injection21.5

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Pharmacokinetics: Tmax of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionhours (Median)
Week 0Week 8
Mixed Injection3.53.5
Separate Injection3.53.3

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Weight Z Score

Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex (NCT00542620)
Timeframe: Week 0 and Week 8

,
InterventionZ-score (Mean)
Week 0, n=13, 12Week 8, n=11, 12
Mixed Injection-0.42-0.29
Separate Injection0.190.26

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Self-measured Plasma Glucose Profile (After Breakfast)

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmg/dL (Mean)
Week 0, n=5, 6Week 8, n=4, 7
Mixed Injection123.00208.08
Separate Injection164.89167.98

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Self-measured Plasma Glucose Profile (After Dinner)

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmg/dL (Mean)
Week 0, n=8, 5Week 8, n=7, 6
Mixed Injection175.38198.00
Separate Injection201.80187.67

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Self-measured Plasma Glucose Profile (Before Breakfast)

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmg/dL (Mean)
Week 0Week 8
Mixed Injection190.31162.96
Separate Injection165.39204.75

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Self-measured Plasma Glucose Profile (Before Dinner)

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmg/dL (Mean)
Week 0Week 8
Mixed Injection199.14185.23
Separate Injection201.44181.03

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Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L

"Number of symptoms only hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself." (NCT00542620)
Timeframe: Weeks 0-8

,
Interventionepisodes (Number)
With symptomsWithout (w/o) symptomsW/o information on presence of symptoms
Mixed Injection491315
Separate Injection46331

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"Percentage of Children Assessing Insulin Therapy Injection Pain as Happy Face"

Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face. (NCT00542620)
Timeframe: Week 0 and week 8

,
Interventionpercentage of subjects (Number)
Week 0Week 8
Mixed Injection2781
Separate Injection5069

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"Percentage of Children Assessing Insulin Therapy Injection Pain as Sad Face"

Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face. (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpercentage of subjects (Number)
Week 0Week 8
Mixed Injection450
Separate Injection3323

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"Percentage of Children Assessing Insulin Therapy Injection Pain as Very Happy Face"

Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face. (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpercentage of subjects (Number)
Week 0Week 8
Mixed Injection27.318.2
Separate Injection16.77.7

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Body Mass Index (BMI) Z Score

Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex (NCT00542620)
Timeframe: Week 0 and Week 8

,
InterventionZ-score (Mean)
Week 0, n=13, 12Week 8, n=11, 12
Mixed Injection-0.32-0.07
Separate Injection0.040.26

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Fructosamine

(NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionmmol/L (Mean)
Week 0, n=13, 12Week 8, n=12, 12
Mixed Injection334.8316.4
Separate Injection319.8334.8

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Glycosylated Haemoglobin A1c (HbA1c)

Measured for the ITT (Intention-to-Treat) set (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpercentage of total haemoglobin (Mean)
Week 0Week 8
Mixed Injection7.937.65
Separate Injection7.778.15

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Glycosylated Haemoglobin A1c (HbA1c)

Measured for the Per Protocol (PP) set (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpercentage of total haemoglobin (Mean)
Week 0Week 8
Mixed Injection8.007.63
Separate Injection7.778.15

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Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L

Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself. (NCT00542620)
Timeframe: Weeks 0-8

,
Interventionepisodes (Number)
With symptomsWithout (w/o) symptomsW/o info on presence of symptoms
Mixed Injection687523
Separate Injection159486

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0, n=8, 9Week 8, n=11, 11
Mixed Injection1441.31981.1
Separate Injection752.1672.8

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0, n=10, 11Week 8, n=13, 12
Mixed Injection3008.15674.3
Separate Injection3006.33019.9

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0, n=4, 3Week 8, n=3, 6
Mixed Injection230728.2123555.7
Separate Injection68509.6362313.5

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Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin

The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs (NCT00542620)
Timeframe: Week 0 and Week 8

,
Interventionpmol.h/L (Median)
Week 0Week 8
Mixed Injection638.4819.6
Separate Injection398.9466.2

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C-peptide Area Under the Curve

We measured the insulin secretory capacity of the pancreas by measuring C-peptide levels (and calculating the C-peptide area under the curve (AUC) using the trapezoidal method following a mixed meal tolerance test (using Boost) at 1, 6 and 12 months after diagnosis. (NCT00564018)
Timeframe: Although measured at 1, 6 and 12 months, the primary outcomes was a comparison between treatment groups at 6 months after diagnosis

Interventionng*hr/mL (Median)
Detemir220
NPH Insulin144
Glargine51

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Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis

We assessed glycemic control via measurement of Hemoglobin A1c at each quarterly clinic visit after diagnosis of diabetes. Data on the 6 month time point are presented (NCT00564018)
Timeframe: 6 months

Interventionpercent (Mean)
Detemir7.6
NPH Insulin8.0
Glargine7.9

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Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections

Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections. (NCT00564395)
Timeframe: 0-48 hours post-dose

Interventionmmol*hr/L (Mean)
Insulin Detemir Mixed With RAI Injection457
Insulin Detemir and RAI Injection Separately469

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Hospital Length of Stay

hospital length of stay in days (NCT00591227)
Timeframe: from hospital admission to hospital discharge

Interventiondays (Mean)
Aspart Detemir2.7
Usual Care3.1

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Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)

Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Interventionmmol/L (Mean)
Sodium Serum (n=144)Potassium serum (n=137)Haemoglobin (n=144)
Insulin Detemir141.64.388.28

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Diabetic Ketoacidosis

Diabetic ketoacidosis requiring hospitalisation (NCT00623194)
Timeframe: At 104 weeks

Interventionevents (Number)
Insulin Detemir3

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Laboratory Values: Leukocytes and Thrombocytes

Leukocytes and Thrombocytes after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Intervention10^9/L (Mean)
Leukocytes (n=144)Thrombocytes (n=144)
Insulin Detemir6.72301.90

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Fundoscopy/Fundus Photography

"Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant~Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant" (NCT00623194)
Timeframe: at 52 weeks and at 104 weeks

Interventionparticipants (Number)
Abnormal, clinically significantAbnormal, not clinically significantNormalMissingAbn CS baseline and 104 weeks
Insulin Detemir1813161

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Insulin Dose

Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104. (NCT00623194)
Timeframe: At 104 weeks

InterventionU/kg (Mean)
Insulin Detemir dose (Basal)Insulin Aspart dose (Bolus)
Insulin Detemir0.660.51

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BMI (Body Mass Index)

BMI (Body Mass Index) after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Interventionkg/m^2 (Mean)
Insulin Detemir18.88

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Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)

Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

InterventionU/L (Mean)
Alkaline phosphatase serum (n=144)Alanine Aminotransferase serum (n=144)Lactate Dehydrogenase serum (n=137)
Insulin Detemir226.719.0199.6

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Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)

Albumin Serum and Total Protein Serum after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Interventiong/dL (Mean)
Albumin serum (n=144)Total Protein serum (n=144)
Insulin Detemir4.327.09

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Hypoglycaemic Episodes

"Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.~Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment." (NCT00623194)
Timeframe: Weeks 0-104

Interventionevents (Number)
Overall, MildOverall, ModerateOverall, SevereOverall, BiochemicalOverall, UnclassifiedDaytime, MildDaytime, ModerateDaytime, SevereDaytime, BiochemicalDaytime, UnclassifiedNight-time, MildNight-time, ModerateNight-time, SevereNight-time, BiochemicalNight-time, UnclassifiedTotal hypoglycaemic episodesTotal hypoglycaemic episodes, daytimeTotal hypoglycaemic episodes, night-time
Insulin Detemir1053045075080790803963412241450544958316074136052469

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Insulin Detemir-insulin Aspart Cross-reacting Antibodies

Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection. (NCT00623194)
Timeframe: week 0, 52 and 104

InterventionPercent bound of total (Mean)
Week 0 (3 hours)Week 52 (3 hours)Week 104 (3 hours)Week 0 (2.5 hours)Week 52 (2.5 hours)Week 104 (2.5 hours)
Insulin Detemir31.1143.9935.9631.2244.0935.92

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Laboratory Values: Creatine Serum Umol/L

Creatine serum after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

InterventionUmol/L (Mean)
Insulin Detemir51.08

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SD-score (Z-score) for Body Weight

Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. (NCT00623194)
Timeframe: At 104 weeks

InterventionSD-scores (Mean)
Insulin Detemir0.13

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Vital Signs: Pulse

Pulse at week 104 (NCT00623194)
Timeframe: At 104 weeks

Interventionbeats/minute (Mean)
Insulin Detemir82.6

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Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies

Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks. (NCT00623194)
Timeframe: At 0, 52 and 104 weeks

InterventionPercent bound of total (Mean)
Insulin Detemir specific, week 0Insulin Detemir specific, week 52Insulin Detemir specific, week 104Insulin Aspart specific, week 0Insulin Aspart specific, week 52Insulin Aspart specific, week 104
Insulin Detemir2.814.403.051.322.791.99

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Vital Signs: Blood Pressure

Blood pressure (Systolic and Diastolic) after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

InterventionmmHg (Mean)
Systolic Blood PressureDiastolic Blood Pressure
Insulin Detemir109.566.6

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Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

InterventionPercent (%) glycosylated haemoglobin (Mean)
Insulin Detemir8.74

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Fasting Plasma Glucose Values

FPG (Fasting Plasma Glucose) values after 104 weeks. (NCT00623194)
Timeframe: At 104 weeks

Interventionmmol/L (Mean)
Insulin Detemir7.71

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Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%

Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment (NCT00634842)
Timeframe: week 20

Interventionpercentage of participants (Number)
FPG 70-90 mg/dL64.3
FPG 80-110 mg/dL54.5

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Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline

Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20 (NCT00634842)
Timeframe: week -2, week 20

Interventionpercentage point change (Least Squares Mean)
FPG 70-90 mg/dL-1.229
FPG 80-110 mg/dL-0.958

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Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%

Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment (NCT00634842)
Timeframe: week 20

Interventionpercentage of participants (Number)
FPG 70-90 mg/dL41.1
FPG 80-110 mg/dL26.8

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Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)

"Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:~If subject was unable to treat himself: Major incidence.~If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.~If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only." (NCT00634842)
Timeframe: weeks 0-20

,
Interventionnumber of events (Number)
AllMajorMinorSymptoms only
FPG 70-90 mg/dL3331225107
FPG 80-110 mg/dL227013691

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Calories Consumed After Fast.

Total energy ingested following the 24 hour fast. (NCT00659165)
Timeframe: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks

Interventionkcal (Mean)
Insulin Detemir1418
Insulin Glargine1357

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Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events

The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians. (NCT00659295)
Timeframe: Months 0-12

,
Interventionparticipants (Number)
3 months sub-group6 months sub-group12 months sub-group
Type 1 Diabetes186208109
Type 2 Diabetes9311248

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Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)

Number of patients with hypoglycemia (defined as glucose <65 mg/dl) (NCT00717288)
Timeframe: 48 hours

Interventionparticipants (Number)
50% Conversion Factor0
65% Conversion Factor6
80% Conversion Factor3

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Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3

Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3 (NCT00717288)
Timeframe: day 2, day 3

Interventionparticipants (Number)
50% Conversion Factor10
65% Conversion Factor18
80% Conversion Factor14

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Reversion to Intravenous Insulin for Failure of Glycemic Control

Number of participants who went back on intravenous insulin for failure of glycemic control. (NCT00717288)
Timeframe: 72 hours

Interventionparticipants (Number)
50% Conversion Factor2
65% Conversion Factor0
80% Conversion Factor1

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Change in BMI (Body Mass Index)

(NCT00789191)
Timeframe: Week 0, Week 26

Interventionkg/m^2 (Mean)
Comb-0.30
Sita-0.58

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Change in Body Weight

(NCT00789191)
Timeframe: Week 0, Week 26

Interventionkg (Mean)
Comb-0.81
Sita-1.66

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HbA1c (Glycosylated Haemoglobin A1c)

(NCT00789191)
Timeframe: Week 26

InterventionPercent (%) glycosylated haemoglobin (Mean)
Comb7.08
Sita7.64

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Hypoglycemic Episodes

Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
OverallMinorSymptoms OnlyUnclassified
Comb1000
Sita1000

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Hypoglycemic Episodes: Day Time

Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
OverallMinorSymptoms OnlyUnclassified
Comb1000
Sita1000

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Hypoglycemic Episodes: Night Time

Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
OverallMinorSymptoms OnlyUnclassified
Comb0000
Sita0000

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Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%

(NCT00789191)
Timeframe: Week 26

,
InterventionSubjects (Number)
Target achievedTarget not achieved
Comb2083
Sita1195

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Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia

Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia (NCT00789191)
Timeframe: Week 26

,
InterventionSubjects (Number)
Target achievedTarget not achieved
Comb1588
Sita898

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

(NCT00789191)
Timeframe: Week 26

,
InterventionSubjects (Number)
Target achievedTarget not achieved
Comb4657
Sita2581

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Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia

Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia (NCT00789191)
Timeframe: Week 26

,
InterventionSubjects (Number)
Target achievedTarget not achieved
Comb3766
Sita2185

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Self-measured 9-point Plasma Glucose Profile

(NCT00789191)
Timeframe: Week 26

,
Interventionmmol/L (Mean)
Before breakfast120 minutes after start of breakfastBefore Lunch120 minutes after start of lunchBefore dinner120 minutes after start of dinnerBedtimeAt 03:00 A.M.Before breakfast the following day
Comb6.168.826.998.697.859.308.386.856.07
Sita8.1710.508.019.998.6110.209.428.027.87

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FPG (Fasting Plasma Glucose)

(NCT00789191)
Timeframe: Week 26

Interventionmmol/L (Mean)
Comb6.08
Sita8.52

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Absolute Change in Fasting Plasma Glucose (FPG)

Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Least Squares Mean)
Insulin Detemir-48.29
Insulin NPH-37.36

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Absolute Change in Adiponectin

Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionmcg/dL (Least Squares Mean)
Insulin Detemir0.926
Insulin NPH2.844

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Absolute Change in Alanine Aminotransferase (ALAT)

(NCT00795600)
Timeframe: Week 0, week 26

InterventionIU/L (Mean)
Insulin Detemir-3.59
Insulin NPH-4.55

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Absolute Change in Albumin

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-0.02
Insulin NPH0.01

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Absolute Change in Alkaline Phosphatase

(NCT00795600)
Timeframe: Week 0, week 26

InterventionIU/L (Mean)
Insulin Detemir-7.10
Insulin NPH-12.55

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Absolute Change in Aspartate Aminotransferase (ASAT)

(NCT00795600)
Timeframe: Week 0, week 26

InterventionIU/L (Mean)
Insulin Detemir0.23
Insulin NPH-0.48

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Absolute Change in Basophils

(NCT00795600)
Timeframe: Week 0, week 26

Intervention10^9 cells/L (Mean)
Insulin Detemir0.00
Insulin NPH-0.01

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Absolute Change in Urea

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir2.45
Insulin NPH0.50

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Absolute Change in Blood Volume (Haematocrit)

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir-1.17
Insulin NPH-1.06

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Percentage Change in Visceral Adipose Tissue Area

Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir-0.535
Insulin NPH4.526

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Percentage Change in Trunk Lean Mass

Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir1.480
Insulin NPH2.090

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Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)

Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor. (NCT00795600)
Timeframe: week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir0.366
Insulin NPH1.011
Insulin Detemir0.535
Insulin NPH1.126

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Percentage Change in Subcutaneous Adipose Tissue Area

Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir1.153
Insulin NPH5.743

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Absolute Change in Calculated Trunk Fat Percentage

Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent of trunk fat (%) (Least Squares Mean)
Insulin Detemir-0.600
Insulin NPH-0.321

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Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio

Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionratio (Least Squares Mean)
Insulin Detemir-0.032
Insulin NPH-0.036

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Absolute Change in Calculated Whole Body Fat Percentage

Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent of whole body fat (%) (Least Squares Mean)
Insulin Detemir0.782
Insulin NPH0.291

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Absolute Change in Creatine Phosphokinase

(NCT00795600)
Timeframe: Week 0, week 26

InterventionIU/L (Mean)
Insulin Detemir-19.86
Insulin NPH21.56

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Percentage Change in Liver/Spleen Attenuation Ratio

Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir-2.632
Insulin NPH-0.855

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Absolute Change in Visceral Adipose Tissue Area

Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventioncm^2 (Least Squares Mean)
Insulin Detemir-3.258
Insulin NPH5.658

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Absolute Change in Bilirubin Total

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-0.07
Insulin NPH-0.07

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Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio

Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir-4.092
Insulin NPH-3.303

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Number of Non-serious Adverse Events

Number of episodes reported during the trial. (NCT00795600)
Timeframe: Weeks 0-26

Interventionevents (Number)
Insulin Detemir64
Insulin NPH103

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Number of Hypoglycaemic Episodes

Number of episodes reported during the trial. (NCT00795600)
Timeframe: Weeks 0-26

Interventionepisodes (Number)
Insulin Detemir17
Insulin NPH32

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Absolute Change in Creatinine

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir0.03
Insulin NPH-0.00

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Absolute Change in Eosinophils

(NCT00795600)
Timeframe: Week 0, week 26

Intervention10^9 cells/L (Mean)
Insulin Detemir0.01
Insulin NPH0.01

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Absolute Change in Erythrocytes

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir4.64
Insulin NPH4.38

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Absolute Change in Whole Body Lean Mass

Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventiongrams (g) (Least Squares Mean)
Insulin Detemir-54.20
Insulin NPH1097.2

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Absolute Change in Whole Body Fat Mass

Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventiongrams (g) (Least Squares Mean)
Insulin Detemir1147.1
Insulin NPH858.88

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Absolute Change in Waist Circumference

Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventioncm (Least Squares Mean)
Insulin Detemir0.064
Insulin NPH0.609

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Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir1.05
Insulin NPH1.54

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Absolute Change in Trunk Lean Mass

Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventiongrams (g) (Least Squares Mean)
Insulin Detemir359.43
Insulin NPH469.84

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Absolute Change in Trunk Fat Mass

Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate. (NCT00795600)
Timeframe: week 0, week 26

Interventiongrams (g) (Least Squares Mean)
Insulin Detemir133.99
Insulin NPH-62.37
Insulin Detemir153.38
Insulin NPH39.43

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Absolute Change in Triglycerides

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-14.71
Insulin NPH-20.97

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Absolute Change in Total Cholesterol

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-8.96
Insulin NPH7.77

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Absolute Change in Body Weight

Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable. (NCT00795600)
Timeframe: Week 0, week 26

Interventionkg (Least Squares Mean)
Insulin Detemir1.663
Insulin NPH2.293

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Absolute Change in Thrombocytes

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir0.10

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Absolute Change in Subcutaneous Adipose Tissue Area

Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate (NCT00795600)
Timeframe: Week 0, week 26

Interventioncm^2 (Least Squares Mean)
Insulin Detemir7.654
Insulin NPH12.616

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Absolute Change in Sodium

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Detemir1.12
Insulin NPH0.69

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Absolute Change in Potassium

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
Insulin Detemir-0.20
Insulin NPH0.21

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Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)

(NCT00795600)
Timeframe: Week 0, week 26

Interventionng/L (Least Squares Mean)
Insulin Detemir-10.77
Insulin NPH-12.50

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Absolute Change in Neutrophils

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir-0.29
Insulin NPH0.01

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Absolute Change in Monocytes

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir0.10

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Absolute Change in Lymphocytes

(NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage (Mean)
Insulin Detemir-0.10

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Percentual Change in Calculated Whole Body Fat Percentage

Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir1.607
Insulin NPH1.491

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Absolute Change in Low Density Lipoprotein (LDL) Cholesterol

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir2.39
Insulin NPH6.14

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Absolute Change in Liver/Spleen Attenuation Ratio

Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionratio (Least Squares Mean)
Insulin Detemir-0.044
Insulin NPH-0.023

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Absolute Change in Leucocytes

(NCT00795600)
Timeframe: Week 0, week 26

Intervention10^9 cells/L (Mean)
Insulin Detemir-0.01
Insulin NPH-0.07

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Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)

Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/L (Least Squares Mean)
Insulin Detemir1.200
Insulin NPH-0.862

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Absolute Change in Hip Circumference

Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventioncm (Least Squares Mean)
Insulin Detemir0.577
Insulin NPH0.112

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Percentage Change in Whole Body Fat Mass

Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir3.870
Insulin NPH4.047

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Percentage Change in Whole Body Lean Mass

Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir0.051
Insulin NPH2.798

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Percentual Change in Calculated Trunk Fat Percentage

Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercent change (Least Squares Mean)
Insulin Detemir-1.543
Insulin NPH0.042

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Absolute Change in High Density Lipoprotein (HDL) Cholesterol

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-0.95
Insulin NPH2.87

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Absolute Change in HbA1c (Glycosylated Haemoglobin)

Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate. (NCT00795600)
Timeframe: Week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Least Squares Mean)
Insulin Detemir-0.922
Insulin NPH-0.792

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Absolute Change in Haemoglobin

(NCT00795600)
Timeframe: Week 0, week 26

Interventiong/dL (Mean)
Insulin Detemir-0.38
Insulin NPH-0.35

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Absolute Change in Free Fatty Acids

(NCT00795600)
Timeframe: Week 0, week 26

Interventionmg/dL (Mean)
Insulin Detemir-0.03
Insulin NPH-0.05

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Diastolic Blood Pressure (BP)

Mean values at baseline (Week 0) and at Week 6 (NCT00841087)
Timeframe: Week 0, Week 6

,
InterventionmmHg (Mean)
Week 0 (Baseline)Week 6
Insulin Detemir73.873.0
SIBA73.974.7

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Number of Treatment Emergent Adverse Events (AEs)

Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00841087)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
Interventionevents (Number)
Adverse events (AEs)Serious AEsSevere AEsModerate AEsMild AEs
Insulin Detemir1500213
SIBA1300013

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Rate of Major and Minor Hypoglycaemic Episodes

Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. (NCT00841087)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
InterventionEpisodes /year of patient exposure (Number)
MajorMinor
Insulin Detemir080.84
SIBA062.97

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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00-05:59 (both inclusive). (NCT00841087)
Timeframe: Week 0 to Week 6 + 5 days follow up

,
InterventionEpisodes /year of patient exposure (Number)
MajorMinor
Insulin Detemir015.83
SIBA04.97

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Systolic Blood Pressure (BP)

Mean values at baseline (Week 0) and at Week 6 (NCT00841087)
Timeframe: Week 0, Week 6

,
InterventionmmHg (Mean)
Week 0 (Baseline)Week 6
Insulin Detemir125.3120.2
SIBA125.0125.5

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Change in Body Weight

Observed change from baseline in body weight after 6 weeks of treatment (NCT00841087)
Timeframe: Week 0, Week 6

Interventionkg (Mean)
SIBA0.22
Insulin Detemir-0.20

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Electrocardiogram (ECG)

The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. (NCT00841087)
Timeframe: Week 0, Week 6

Interventionparticipants (Number)
SIBA0
Insulin Detemir0

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Mean Changes From Randomisation in Cholesterol Lipids at Week 52.

Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C) (NCT00856986)
Timeframe: Week 0, Week 52

,
Interventionmmol/L (Least Squares Mean)
Change in Total CholesterolChange in LDL-CChange in VLDL-CChange in HDL-C
Insulin Detemir + Lira 1.8-0.03-0.1-0.030.07
Lira 1.8-0.02-0.080.030.02

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Mean Change From Randomisation in Waist Circumference at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventioncm (Least Squares Mean)
Lira 1.8-0.66
Insulin Detemir + Lira 1.8-0.78

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Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Interventionmmol/L (Least Squares Mean)
Lira 1.8-0.03
Insulin Detemir + Lira 1.8-0.07

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Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventionmmol/L (Least Squares Mean)
Lira 1.8-0.03
Insulin Detemir + Lira 1.8-0.11

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Mean Change From Randomisation in Hip Circumference at Week 52

(NCT00856986)
Timeframe: Week 0, week 52

Interventioncm (Least Squares Mean)
Lira 1.8-0.79
Insulin Detemir + Lira 1.8-0.28

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Mean Change From Randomisation in Hip Circumference at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventioncm (Least Squares Mean)
Lira 1.8-0.36
Insulin Detemir + Lira 1.8-0.38

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Mean Change From Randomisation in Lipids: Triglycerides at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventionmmol/L (Least Squares Mean)
Lira 1.8-0.24
Insulin Detemir + Lira 1.8-0.33

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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)

(NCT00856986)
Timeframe: Week 0, Week 52

InterventionPercentage point of total HbA1c (Least Squares Mean)
Lira 1.80.01
Insulin Detemir + Lira 1.8-0.5

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Mean Change From Randomisation in Waist to Hip Ratio at Week 26

Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventioncm/cm (Least Squares Mean)
Lira 1.8-0.00356
Insulin Detemir + Lira 1.8-0.00332

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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)

(NCT00856986)
Timeframe: Week 0, Week 52

InterventionPercentage point of total HbA1c (Least Squares Mean)
Lira 1.8-0.1
Insulin Detemir + Lira 1.8-0.51

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Mean Change From Randomisation in Fasting Pro-insulin at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Interventionpmol/L (Least Squares Mean)
Lira 1.81.47
Insulin Detemir + Lira 1.8-4

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Mean Change From Randomisation in Fasting Pro-insulin at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventionpmol/L (Least Squares Mean)
Lira 1.8-1.12
Insulin Detemir + Lira 1.8-9.78

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Mean Change From Randomisation in Body Weight at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Interventionkg (Least Squares Mean)
Lira 1.8-1.02
Insulin Detemir + Lira 1.8-0.05

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Mean Change From Randomisation in Fasting Plasma Glucose at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Interventionmmol/L (Least Squares Mean)
Lira 1.8-0.14
Insulin Detemir + Lira 1.8-1.91

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Mean Change From Randomisation in Fasting Plasma Glucose at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventionmmol/L (Least Squares Mean)
Lira 1.8-0.39
Insulin Detemir + Lira 1.8-2.12

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Mean Change From Randomisation in Fasting C-peptide at Week 52.

(NCT00856986)
Timeframe: Week 0, Week 52

Interventionmmol/L (Least Squares Mean)
Lira 1.80.02
Insulin Detemir + Lira 1.8-0.34

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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), week 26

InterventionPercentage point of total HbA1c (Least Squares Mean)
Lira 1.80.02
Insulin Detemir + Lira 1.8-0.51

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Hypoglycaemic Episodes Weeks 0-52

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00856986)
Timeframe: Week 0-52

,,,
Interventionepisodes (Number)
MajorMinorSymptoms onlyUnknown
Insulin Detemir + Lira 1.8033571
Intensified Group0120
Lira 1.804140
Non-Randomised Lira 1.8053422

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Mean Change From Randomisation in Fasting C-peptide at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventionmmol/L (Least Squares Mean)
Lira 1.8-0.08
Insulin Detemir + Lira 1.8-0.32

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Mean Change From Randomisation in Body Weight at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Interventionkg (Least Squares Mean)
Lira 1.8-0.95
Insulin Detemir + Lira 1.8-0.16

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Adverse Events From Run-in (Week -12) to Week 52

(NCT00856986)
Timeframe: Run-in (week -12) to Week 52

Interventionevents (Number)
Lira 1.8716
Insulin Detemir + Lira 1.8845
Non-Randomised Lira 1.82389
Early Withdrawals Lira 1.8383
Intensified Group30

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Mean Change From Randomisation in Lipids: Triglycerides at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Interventionmmol/L (Least Squares Mean)
Lira 1.8-0.22
Insulin Detemir + Lira 1.8-0.37

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Mean Change From Randomisation in Waist Circumference at Week 52.

(NCT00856986)
Timeframe: Week 0, Week 52

Interventionparticipants (Least Squares Mean)
Lira 1.8-0.83
Insulin Detemir + Lira 1.8-0.83

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Mean Change From Randomisation in Waist to Hip Ratio at Week 52

Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference (NCT00856986)
Timeframe: Week 0, Week 52

Interventioncm/cm (Least Squares Mean)
Lira 1.8-0.00146
Insulin Detemir + Lira 1.8-0.00438

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Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00856986)
Timeframe: weeks 0-26

,,
Interventionepisodes (Number)
MajorMinorSymptoms only
Insulin Detemir + Lira 1.802219
Lira 1.8029
Non-Randomised Lira 1.803126

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Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26

Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively. (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

,
Interventionmmol/L (Least Squares Mean)
Change at Breakfast, N=133, 144Change at Lunch, N= 134, 143Change at Dinner, N= 133, 139
Insulin Detemir + Lira 1.8-2.09-1.43-1.18
Lira 1.8-0.97-0.83-0.48

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Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52

Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively. (NCT00856986)
Timeframe: Week 0, Week 52

,
Interventionmmol/L (Least Squares Mean)
Change at Breakfast, N=148, 135Change at Lunch, N= 145, 136Change at Dinner, N= 144, 135
Insulin Detemir + Lira 1.8-2.43-1.14-1.4
Lira 1.8-0.68-0.51-0.96

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Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

,
InterventionmmHg (Least Squares Mean)
Systolic Blood PressureDiastolic Blood Pressure
Insulin Detemir + Lira 1.80.41-0.4
Lira 1.81.11-1.1

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Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.

(NCT00856986)
Timeframe: Week 0, Week 52

,
InterventionmmHg (Least Squares Mean)
Systolic Blood PressureDiastolic Blood Pressure
Insulin Detemir + Lira 1.80.160.11
Lira 1.8-0.74-0.66

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Mean Changes From Randomisation in Cholesterol Lipids at Week 26.

Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C) (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

,
Interventionmmol/L (Least Squares Mean)
Change in Total CholesterolChange in LDL-CChange in VLDL-CChange in HDL-C
Insulin Detemir + Lira 1.80.05-0.030.010.05
Lira 1.80.04-0.040.050.02

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Hypoglycemic Episodes, Unclassifiable

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
MajorMinorSymptoms only
IDet056
IGlar0816

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Incidence of Hypoglycaemic Episodes During the Trial

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
All EventsMajorMinorSymptoms only
IDet3290119210
IGlar4572156299

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Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)

Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am. (NCT00909480)
Timeframe: Week 26

,
Interventionmmol/L (Mean)
Before breakfast (N=200, N=197)2 hours after breakfast (N=192, N=188)Before Lunch (N=193, N=189)2 hours After Lunch (N=194, N=186)Before Dinner (N=194, N=186)2 hours after dinner (N=192, N=190)Bedtime (N=190, N=183)At 3AM (N=193, N=186)Before Breakfast Next Day (N=197, N=195)
IDet5.89.17.29.78.210.39.56.65.7
IGlar5.98.76.68.87.59.896.35.6

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Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%

The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% (NCT00909480)
Timeframe: Week 26

,
Interventionpercentage of subjects (Number)
Metformin monotherapyMetformin+TZDMetformin+2nd OAD other than TZDAll
IDet55403138
IGlar70404753

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Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia

The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. (NCT00909480)
Timeframe: Week 26

,
Interventionpercentage (%) of subjects (Number)
Metformin monotherapyMetformin+TZDMetformin+2nd OAD other than TZDAll
IDet48332532
IGlar52333338

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Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast

The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. (NCT00909480)
Timeframe: Week 26

,
Interventionmmol/L (Median)
Metformin MonotherapyMetformin+TZDMetformin+2nd OAD other than TZDOverall
IDet0.480.720.60.57
IGlar0.670.840.710.71

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Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%

The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less (NCT00909480)
Timeframe: Week 26

,
Interventionpercentage (%) of subjects (Number)
Metformin monotherapyMetformin+TZDMetformin+2nd OAD other than TZDAll
IDet2213511
IGlar30131721

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Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia

The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. (NCT00909480)
Timeframe: Week 26

,
Interventionpercentage (%) of subjects (Number)
Metformin monotherapyMetformin+TZDMetformin+2nd OAD other than TZDAll
IDet22739
IGlar21131315

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"Number of Subjects Having the Adverse Event Incorrect Dose Administered"

"Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications" (NCT00909480)
Timeframe: Weeks 0-26

InterventionSubjects (Number)
IDet12
IGlar24

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Change in Body Weight From Baseline

(NCT00909480)
Timeframe: Week 0, Week 26

Interventionkg (Mean)
IDet-0.49
IGlar1

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Change in HbA1c From Baseline

(NCT00909480)
Timeframe: Week 0, Week 26

Interventionpercentage point change (Mean)
IDet-0.48
IGlar-0.74

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Fasting Plasma Glucose (FPG)

(NCT00909480)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDet6.22
IGlar6.09

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Hypoglycaemic Episodes, Diurnal

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
MajorMinorSymptoms only
IDet075128
IGlar2118222

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Hypoglycaemic Episodes, Nocturnal

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26

,
Interventionepisodes (Number)
MajorMinorSymptoms only
IDet03976
IGlar03061

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Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. (NCT00978627)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD371
IDet572

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Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT00978627)
Timeframe: Week 0 to Week 53 + 7 days of follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse event (AE)Serious AESevere AEModerate AEMild AEFatal AE
IDegAsp OD4082433932820
IDet4421948833110

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Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. (NCT00978627)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD3917
IDet4434

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment (NCT00978627)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp OD-0.73
IDet-0.68

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment (NCT00978627)
Timeframe: Week 0, Week 53

Interventionpercentage of glycosylated haemoglobin (Mean)
IDegAsp OD-0.65
IDet-0.56

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Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

Change from baseline in FPG after 52 weeks of treatment. (NCT00978627)
Timeframe: Week 0, Week 53

Interventionmmol/L (Mean)
IDegAsp OD-1.83
IDet-2.40

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Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. (NCT00978627)
Timeframe: Week 0 to Week 53 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD309
IDet541

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Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L. (NCT00978627)
Timeframe: Week 0 to Week 53 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDegAsp OD3183
IDet3673

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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Overall mean of 9-point SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT00978627)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDegAsp OD8.0
IDet8.4

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Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.

(NCT00998335)
Timeframe: 3 and 6 months

,
Interventionmg/dL (Mean)
3-month - Day-long plasma glucose profile6-month - Day-long plasma glucose profile
Insulin Detemir Only (3 and 6 Months)168153
Insulin Detemir Plus AspartNA170

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Percent Change From Baseline in Vascular Inflammatory Markers

Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM (NCT00998335)
Timeframe: 3 and 6 months

,
InterventionPercentage of change (Mean)
Adiponectin (3 months)Adiponectin (6 months)MMP-9 (3 months)MMP-9 (6 months)E-selectin (3 months)E-selectin (6 months)sICAM (3 months)sICAM (6 months)sVCAM (3 months)sVCAM (6 months)
Insulin Detemir Only18653230-634-42114
Insulin Detemir Plus AspartNA5NA49NA19NA-1NA7

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Plasma Lipid Concentration.

Fasting plasma lipid concentration on day of admission at 3 and 6 months. (NCT00998335)
Timeframe: 3 and 6 months.

,
Interventionmg/dL (Mean)
3-month total cholesterol3-month LDL-cholesterol3-month triglycerides3-month HDL-C6-month total cholesterol6-month LDL-cholesterol6-month triglycerides6-month HDL-C
Insulin Detemir Only13676154331478615031
Insulin Detemir Plus AspartNANANANA1458014433

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Advanced Lipid Testing

Change in lipoprotein particle number was determined using NMR. (NCT00998335)
Timeframe: 3 and 6 months

,
InterventionChange in number of particles (nmol/L) (Mean)
VLDL particles (3 months)VLDL particles (6 months)LDL particles (3 months)LDL particles (6 months)HDL particles (3 months)HDL particles (6 months)
Insulin Detemir Only (3 and 6 Months)-15-5-10012802
Insulin Detemir Plus AspartNA-2NA85NA1

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Number of Hypoglycemic Events

Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial. (NCT00998335)
Timeframe: 3 and 6 months

,
InterventionNumber of events (Number)
3-month rate of severe hypoglycemia6-month rate of severe hypoglycemia
Insulin Detemir Only00
Insulin Detemir Plus AspartNA0

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Change in Anthropometric Measure (Body Weight).

Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months. (NCT00998335)
Timeframe: 3 and 6 months.

,
InterventionChange from baseline (Kg) (Mean)
3-month total body weight6-month total body weight
Insulin Detemir Only-0.80.8
Insulin Detemir Plus AspartNA0.3

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Change in Insulin Secretion

Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase). (NCT00998335)
Timeframe: 3 and 6 months.

,
Interventionng/ml (Mean)
3-month C-peptide level increase in first phase3-month C-peptide level increase in second phase6-month C-peptide level increase in first phase6-month C-peptide level increase in second phase
Insulin Detemir Only (3 and 6 Months)0.51.6-0.10.6
Insulin Detemir Plus AspartNANA0.20.2

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Hepatic Steatosis

Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS). (NCT00998335)
Timeframe: 3 and 6 months

,
Interventionpercentage of liver fat (Mean)
Month 3Month 6
Insulin Detemir Plus AspartNA5.9
Insulin Detemir x 3 Months (All Pts Had Liver MRS)6.78.4

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Change in Anthropometric Measure (Body Mass Index [BMI]).

Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months. (NCT00998335)
Timeframe: 3 and 6 months.

,
InterventionChange from baseline (Kg/m2) (Mean)
3-month body mass index6-month body mass index
Insulin Detemir Only-0.40.3
Insulin Detemir Plus AspartNA0.2

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Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).

Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS). (NCT00998335)
Timeframe: 3 and 6 months.

,
Intervention% of intramyocellular triglyceride (Mean)
3-month intramyocellular triglycerides6-month intramyocellular triglycerides
Insulin Detemir Only0.631.05
Insulin Detemir Plus AspartNA0.49

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Metabolic Control as Measured by the A1c

(NCT00998335)
Timeframe: 3 and 6 months

,
Interventionpercentage of A1c (Mean)
3-month - A1c6-month - A1c
Insulin Detemir Only (3 and 6 Months)7.46.9
Insulin Detemir Plus AspartNA6.7

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Metabolic Control as Measured by the Fasting Plasma Glucose Concentration

(NCT00998335)
Timeframe: 3 and 6 months

,
Interventionmg/dL (Mean)
3-month - Fasting plasma glucose6-month - Fasting plasma glucose
Insulin Detemir Only (3 and 6 Months)10589
Insulin Detemir Plus AspartNA116

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Change in Total Cholesterol From Baseline to Endpoint (Week 26).

Change in total cholesterol from baseline to endpoint (week 26). (NCT01003184)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
Exenatide Once Weekly-0.09
Insulin Detemir0.06

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Change in Triglycerides From Baseline to Endpoint (Week 26).

Change in triglycerides from baseline to endpoint (week 26). (NCT01003184)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
Exenatide Once Weekly-0.01
Insulin Detemir-0.08

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Changes in Systolic Blood Pressure From Baseline to Week 26

Change in systolic blood pressure from baseline to Week 26 (NCT01003184)
Timeframe: Baseline, Week 26

InterventionmmHg (Least Squares Mean)
Exenatide Once Weekly-7.37
Insulin Detemir-2.65

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Percentage of Patients Achieving ≤6.5% at Endpoint

Percentage of patients achieving HbA1c ≤6.5% at endpoint (NCT01003184)
Timeframe: Week 26

InterventionPercentage (Number)
Exenatide Once Weekly27.9
Insulin Detemir7.6

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Percentage of Patients Achieving ≤7.0% at Endpoint

Percentage of patients achieving ≤7.0% at endpoint. (NCT01003184)
Timeframe: Week 26

InterventionPercentage (Number)
Exenatide Once Weekly51.4
Insulin Detemir34.3

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Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)

The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective. (NCT01003184)
Timeframe: Baseline, Week 26

InterventionPercentage (Number)
Exenatide Once Weekly44.1
Insulin Detemir11.4

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Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint

Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint (NCT01003184)
Timeframe: Week 26

InterventionPercentage (Number)
Exenatide Once Weekly66.7
Insulin Detemir54.3

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Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)

Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26) (NCT01003184)
Timeframe: Baseline, Week 26

InterventionPercentage (Number)
Exenatide Once Weekly58.9
Insulin Detemir17.8

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Hypoglycemia Rate Per Year

All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account. (NCT01003184)
Timeframe: Baseline, Week 26

Interventionevents per subject-year (Number)
Exenatide Once Weekly0.06
Insulin Detemir0.10

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Change in Body Weight From Baseline to Week 26

Change in body weight from baseline to week 26 (NCT01003184)
Timeframe: Baseline, Week 26

Interventionkilograms (Least Squares Mean)
Exenatide Once Weekly-2.79
Insulin Detemir0.88

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Change in Diastolic Blood Pressure From Baseline to Week 26.

Change in diastolic blood pressure from baseline to week 26. (NCT01003184)
Timeframe: Baseline, Week 26

InterventionmmHg (Least Squares Mean)
Exenatide Once Weekly-0.79
Insulin Detemir-0.34

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Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).

Change in fasting serum glucose from baseline to endpoint (Week 26). (NCT01003184)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
Exenatide Once Weekly-2.33
Insulin Detemir-2.43

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Change in HbA1c From Baseline to Week 26

Change in HbA1c from baseline to week 26 (NCT01003184)
Timeframe: Baseline, Week 26

InterventionPercentage of total hemoglobin (Least Squares Mean)
Exenatide Once Weekly-1.32
Insulin Detemir-0.91

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Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).

Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26). (NCT01003184)
Timeframe: Baseline, Week 26

Interventionmmol/L (Least Squares Mean)
Exenatide Once Weekly0.02
Insulin Detemir0.04

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Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment

Observed mean change from baseline in HbA1c at Week 14 (visit 11) (NCT01068652)
Timeframe: Week 0, Week 14

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met-0.18
BIAsp 30 + Met-0.64

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Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment

Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25) (NCT01068652)
Timeframe: Week 38

,
Interventionmg/dL (Mean)
Before Breakfast (n=193, 194)120 min After Breakfast (n=191, 192)Before Lunch (n=193, 194)120 min After Lunch (n=191, 192)Before Dinner (n=193, 194)120 min After Dinner (n=192,192)Bedtime (n=193, 194)At 2 AM - 3 AM (n=187, 190)
BIAsp 30 + Met110.86139.38118.30158.45129.10142.82132.45117.42
Detemir + Met110.14146.70130.63145.91132.26155.47146.37124.57

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Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment

Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32) (NCT01068652)
Timeframe: Week 50

,
Interventionmg/dL (Mean)
Before Breakfast (n=193, 194)120 min After Breakfast (n=191, 192)Before Lunch (n=193, 194)120 min After Lunch (n=191, 192)Before Dinner (n=193, 194)120 min After Dinner (n=192, 192)Bedtime (n=193, 194)At 2 AM - 3 AM (n=187, 190)
BIAsp 30 + Met110.76132.45115.02149.90126.76138.08130.10113.14
Detemir + Met108.78140.05120.43139.48128.28144.19137.13118.60

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Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment

Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11) (NCT01068652)
Timeframe: Week 14

,
Interventionmg/dL (Mean)
Before Breakfast (n=193, 194)120 min After Breakfast (n=187, 184)Before Lunch (n=192, 193)120 min After Lunch (n=186, 185)Before Dinner (n=191, 192)120 min After Dinner (n=183, 185)Bedtime (n=187, 192)At 2 AM - 3 AM (n=172, 177)
BIAsp 30 + Met128.31176.31156.12199.75168.09173.95156.65139.93
Detemir + Met136.44181.89157.61199.40169.69212.23200.15158.69

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Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment

Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32) (NCT01068652)
Timeframe: Week 50

InterventionSubjects (Number)
Detemir + Met73
BIAsp 30 + Met84

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Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment

Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25) (NCT01068652)
Timeframe: Week 38

InterventionSubjects (Number)
Detemir + Met84
BIAsp 30 + Met103

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Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment

Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}. (NCT01068652)
Timeframe: Week 38

Interventionmg/dL (Mean)
Detemir + Met25.44
BIAsp 30 + Met28.32

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Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment

Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)} (NCT01068652)
Timeframe: Week 26

Interventionmg/dL (Mean)
Detemir + Met32.95
BIAsp 30 + Met31.71

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Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment

Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)} (NCT01068652)
Timeframe: Week 14

Interventionmg/dL (Mean)
Detemir + Met43.19
BIAsp 30 + Met32.61

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Change in Glycosylated Haemoglobin (HbA1c) at Week 50

Observed mean change from baseline in HbA1c at Week 50 (visit 32) (NCT01068652)
Timeframe: Week 0, Week 50

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met-1.16
BIAsp 30 + Met-1.34

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Glycosylated Haemoglobin (HbA1c)

Estimated mean difference in HbA1c after 50 weeks of treatment (NCT01068652)
Timeframe: Week 50

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met7.34
BIAsp 30 + Met7.23

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Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment

Observed mean change from baseline in HbA1c at Week 38 (visit 25) (NCT01068652)
Timeframe: Week 0, Week 38

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met-1.35
BIAsp 30 + Met-1.56

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Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Observed mean change in from baseline in HbA1c at Week 26 (visit 18) (NCT01068652)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
Detemir + Met-1.05
BIAsp 30 + Met-1.30

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Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment

Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18) (NCT01068652)
Timeframe: Week 26

,
Interventionmg/dL (Mean)
Before Breakfast (n=193, 194)120 min After Breakfast (n=191, 191)Before Lunch (n=193, 194)120 min After Lunch (n=191, 191)Before Dinner (n=192, 194)120 min After Dinner (n=188, 191)Bedtime (n=190, 194)At 2 AM - 3 AM (n=181, 187)
BIAsp 30 + Met115.79153.85131.27178.92143.29152.44140.39123.29
Detemir + Met116.57163.52140.97166.00147.58172.21164.70133.59

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Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment

Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18) (NCT01068652)
Timeframe: Week 26

InterventionSubjects (Number)
Detemir + Met67
BIAsp 30 + Met77

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Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment

Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11) (NCT01068652)
Timeframe: Week 14

InterventionSubjects (Number)
Detemir + Met15
BIAsp 30 + Met26

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Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment

Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}. (NCT01068652)
Timeframe: Week 50

Interventionmg/dL (Mean)
Detemir + Met22.45
BIAsp 30 + Met23.66

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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment (NCT01074268)
Timeframe: Week 0, Week 52

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-0.46
IDet OD-0.47

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Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect or important medical issues (NCT01074268)
Timeframe: Week 0 to Week 52 + 7 days follow up

,
InterventionEvents/100 years of patient exposure (Number)
Adverse events (AEs)Serious AESevere AEModerate AEMild AEFatal AE
IDeg OD4592023483880
IDet OD4201735453410

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Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT01074268)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD414
IDet OD593

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Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. (NCT01074268)
Timeframe: Week 0 to Week 26 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD4583
IDet OD4569

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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day. (NCT01074268)
Timeframe: Week 26

Interventionmmol/L (Mean)
IDeg OD7.9
IDet OD7.8

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Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment

Change from baseline in FPG after 26 weeks of treatment (NCT01074268)
Timeframe: Week 0, Week 26

Interventionmmol/L (Mean)
IDeg OD-2.60
IDet OD-0.62

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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment (NCT01074268)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg OD-0.73
IDet OD-0.65

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Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT01074268)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD338
IDet OD481

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Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms (NCT01074268)
Timeframe: Week 0 to Week 52 + 7 days follow up

InterventionEpisodes/100 years of patient exposure (Number)
IDeg OD3778
IDet OD3926

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Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day. (NCT01074268)
Timeframe: Week 52

Interventionmmol/L (Mean)
IDeg OD7.8
IDet OD7.8

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Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

Change from baseline in FPG after 52 weeks of treatment (NCT01074268)
Timeframe: Week 0, Week 52

Interventionmmol/L (Mean)
IDeg OD-2.19
IDet OD-0.82

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Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21

Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21 (NCT01165684)
Timeframe: Week 21

Interventionmmol/L (Mean)
Step-wise1.9
Basal-bolus1.5

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Fasting Plasma Glucose (FPG) at Week 10

Mean FPG at Week 10 (NCT01165684)
Timeframe: Week 10

Interventionmmol/L (Mean)
Step-wise7.1
Basal-bolus6.7

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Body Mass Index (BMI) at Week 32

Estimated mean BMI after 32 Weeks of treatment (NCT01165684)
Timeframe: Week 32

Interventionkg/m^2 (Mean)
Step-wise31.86
Basal-bolus32.03

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Body Weight at Week 32

Estimated mean body weight after 32 Weeks of treatment (NCT01165684)
Timeframe: Week 32

Interventionkg (Mean)
Step-wise89.32
Basal-bolus89.80

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10

Estimated mean change from baseline in HbA1c after 10 Weeks of treatment (NCT01165684)
Timeframe: Week 0, Week 10

Interventionpercentage of glycosylated haemoglobin (Mean)
Step-wise-0.45
Basal-bolus-1.00

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21

Estimated mean change from baseline in HbA1c after 21 Weeks of treatment (NCT01165684)
Timeframe: Week 0, Week 21

Interventionpercentage of glycosylated haemoglobin (Mean)
Step-wise-0.78
Basal-bolus-1.15

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32

Estimated mean change from baseline in HbA1c after 32 Weeks of treatment (NCT01165684)
Timeframe: Week 0, Week 32

Interventionpercentage of glycosylated haemoglobin (Mean)
Step-wise-0.98
Basal-bolus-1.12

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Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32

Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32 (NCT01165684)
Timeframe: Week 32

Interventionmmol/L (Mean)
Step-wise1.64
Basal-bolus1.28

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Fasting Plasma Glucose (FPG) at Week 21

Mean FPG at Week 21 (NCT01165684)
Timeframe: Week 21

Interventionmmol/L (Mean)
Step-wise7.1
Basal-bolus7.0

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Fasting Plasma Glucose (FPG) at Week 32

Estimated Mean FPG at Week 32 (NCT01165684)
Timeframe: Week 32

Interventionmmol/L (Mean)
Step-wise7.12
Basal-bolus7.01

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Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. (NCT01165684)
Timeframe: Week 0 to Week 32

InterventionEpisodes /year of patient exposure (Number)
Step-wise33.47
Basal-bolus57.56

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Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10

Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10 (NCT01165684)
Timeframe: Week 10

Interventionmmol/L (Mean)
Step-wise2.3
Basal-bolus1.4

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Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32

Proportion of subjects reaching HbA1c below 7.0% at Week 32 (NCT01165684)
Timeframe: Week 32

Interventionpercentage (%) of subjects (Number)
Step-wise55.9
Basal-bolus63.3

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Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21

Proportion of subjects reaching HbA1c below 7.0% at Week 21 (NCT01165684)
Timeframe: Week 21

Interventionpercentage (%) of subjects (Number)
Step-wise45.1
Basal-bolus65.4

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Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10

Proportion of subjects reaching HbA1c below 7.0% at Week 10 (NCT01165684)
Timeframe: Week 10

Interventionpercentage (%) of subjects (Number)
Step-wise19.2
Basal-bolus56.3

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Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)

Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl) (NCT01186003)
Timeframe: within 48 hours of discontinuation

InterventionParticipants (Count of Participants)
Standard Insulin Drip Therapy14
Insulin Drip and Detemir3

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Rate of Treatment Emergent Adverse Events (TEAEs)

Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT01232491)
Timeframe: Week 0 to Week 26

,
Interventionrate per 100 years of patient exposure (Number)
All TEAEsSerious TEAEsSevere TEAEsModerate TEAEsMild TEAEs
Control437.116.611.3108.3317.5
Dietician387.916.316.3130.5241.0

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Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes

Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions. (NCT01232491)
Timeframe: Week 0 to Week 26

,
Interventionrate per year of patient exposure (Number)
All EventsSevere Events
Control5.510.01
Dietician5.590.01

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Rate of All Treatment Emergent Hypoglycaemic Episodes

Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions. (NCT01232491)
Timeframe: Week 0 to Week 26

,
Interventionrate per year of patient exposure (Number)
All EventsSevere Events
Control23.300.01
Dietician25.470.01

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Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Estimated mean change from baseline in HbA1c after 26 weeks of treatment. (NCT01232491)
Timeframe: Week 0, Week 26

Interventionpercentage of glycosylated haemoglobin (Least Squares Mean)
Dietician-0.93
Control-0.80

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Change From Baseline in Fasting Plasma Glucose (FPG)

Estimated mean change from baseline in FPG after 26 weeks of treatment. (NCT01232491)
Timeframe: Week 0, Week 26

Interventionmmol/L (Least Squares Mean)
Dietician-3.00
Control-2.93

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Change From Baseline in Body Weight

Estimated mean change from baseline in body weight after 26 weeks of treatment. (NCT01232491)
Timeframe: Week 0, Week 26

Interventionkg (Least Squares Mean)
Dietician-1.05
Control-0.56

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Change From Baseline in Body Mass Index (BMI)

Estimated mean change from baseline in BMI after 26 weeks of treatment. (NCT01232491)
Timeframe: Week 0, Week 26

Interventionkg/m^2 (Least Squares Mean)
Dietician-0.37
Control-0.20

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Myocardial Glucose Uptake

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Interventionumol/g/min (Median)
Iiraglutide0.055
Insulin Detemir0.0399
Liraglutide Plus Insulin Detemir0.0373

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Myocardial Fatty Acid Oxidation Rate

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Interventionumol/g/min (Median)
Iiraglutide0.1019
Insulin Detemir0.1234
Liraglutide Plus Insulin Detemir0.0992

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Myocardial Fatty Acid Esterification Rate

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Interventionumol/g/min (Median)
Iiraglutide0.00274
Insulin Detemir0.00358
Liraglutide Plus Insulin Detemir0.00146

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Change From Baseline in Fructosamine After Two Weeks of Treatment

(NCT01486966)
Timeframe: Week 0, week 2

InterventionUmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-31.0
Insulin NPH + Human Soluble Insulin ± Metformin-23.7

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Incidence of Hypoglycaemic Episodes

"All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.~Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) < 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value < 3.1 mmol/l (56 mg/dl).~A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal." (NCT01486966)
Timeframe: Weeks 0-2

,
Interventionevents (Number)
All eventsSevereNocturnalDiurnalMinor
Insulin Detemir + Insulin Aspart ± Metformin2204182
Insulin NPH + Human Soluble Insulin ± Metformin540114311

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Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment

(NCT01486966)
Timeframe: Week 2

Interventionpercentage (%) of subjects (Number)
Insulin Detemir + Insulin Aspart ± Metformin41.4
Insulin NPH + Human Soluble Insulin ± Metformin34.5

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Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment

FPG target was < 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included). (NCT01486966)
Timeframe: Week 2

Interventionpercentage (%) of subjects (Number)
Insulin Detemir + Insulin Aspart ± Metformin41.4
Insulin NPH + Human Soluble Insulin ± Metformin34.5

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Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment

(NCT01486966)
Timeframe: Week 2

Interventionpercentage (%) of subjects (Number)
Insulin Detemir + Insulin Aspart ± Metformin48.3
Insulin NPH + Human Soluble Insulin ± Metformin48.3

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Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment

FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L. (NCT01486966)
Timeframe: Week 2

Interventionpercentage (%) of subjects (Number)
Insulin Detemir + Insulin Aspart ± Metformin20.7
Insulin NPH + Human Soluble Insulin ± Metformin20.7

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Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment

The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime. (NCT01486966)
Timeframe: Week 0, week 2

Interventionmmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-2.47
Insulin NPH + Human Soluble Insulin ± Metformin-2.87

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Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment

Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile. (NCT01486966)
Timeframe: Week 0, week 2

Interventionmmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-2.84
Insulin NPH + Human Soluble Insulin ± Metformin-2.80

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Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment

The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal. (NCT01486966)
Timeframe: Week 0, week 2

Interventionmmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-4.00
Insulin NPH + Human Soluble Insulin ± Metformin-3.47

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Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment

The FPG referred to pre-breakfast plasma glucose. (NCT01486966)
Timeframe: Week 0, week 2

Interventionmmol/L (Least Squares Mean)
Insulin Detemir + Insulin Aspart ± Metformin-2.22
Insulin NPH + Human Soluble Insulin ± Metformin-2.29

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Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))

Episodes of PG >11.1mmol/L (200mg/dL) (NCT01513473)
Timeframe: After 26 weeks and 52 weeks of treatment

,
Interventionepisodes (Number)
26 weeks52 weeks
IDeg + IAsp3126458679
IDet + IAsp3117352831

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Number of Treatment Emergent Adverse Events (TEAEs)

TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT01513473)
Timeframe: After 26 weeks and 52 weeks of treatment

,
Interventionevents (Number)
TEAEs -26 weeksTEAEs -52 weeks
IDeg + IAsp8101462
IDet + IAsp7611266

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Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment

Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial. (NCT01513473)
Timeframe: Between week 1 and week 26

,
Interventionpmol/L (Mean)
week 2week 12week 26
IDeg + IAsp4540.44148.14105.6
IDet + IAsp3972.25430.16377.0

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Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)

Change from baseline in FPG after 26 weeks of treatment. (NCT01513473)
Timeframe: Week 0, week 26

Interventionmmol/L (Mean)
IDeg + IAsp-0.67
IDet + IAsp0.50

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Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)

Change from baseline in HbA1c (%) after 52 weeks of treatments. (NCT01513473)
Timeframe: Week 0, week 52

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg + IAsp-0.27
IDet + IAsp-0.22

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Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)

Change from baseline in FPG after 52 weeks of treatment. (NCT01513473)
Timeframe: Week 0, week 52

Interventionmmol/L (Mean)
IDeg + IAsp-1.29
IDet + IAsp1.10

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)

Change from baseline in HbA1c (%) after 26 weeks of treatment. (NCT01513473)
Timeframe: Week 0, week 26

Interventionpercentage of glycosylated haemoglobin (Mean)
IDeg + IAsp-0.20
IDet + IAsp-0.31

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Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)

Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below) (NCT01513473)
Timeframe: After 52 weeks of treatment

,
Intervention%B/T (Mean)
Insulin aspart specific antibodiesInsulin Detemir specific antibodiesInsulin Degludec specific antibodiesX-reacting AB Hu Insulin
IDeg + IAsp1.1NA017.2
IDet + IAsp1.56.1NA26.0

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Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))

Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment (NCT01513473)
Timeframe: After 26 weeks and 52 weeks of treatment

,
Interventionepisodes (Number)
26 weeks52 weeks
IDeg + IAsp44109
IDet + IAsp86161

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Number of Hypoglycaemic Episodes

Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours) (NCT01513473)
Timeframe: After 26 weeks and 52 weeks of treatment

,
Interventionepisodes (Number)
26 weeks (entire day)26 weeks (nocturnal)52 weeks (entire day)52 weeks (nocturnal)
IDeg + IAsp117121261215602336
IDet + IAsp109911458183732586

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Verbal Memory Composite

The composite will consist of the sum of Z scores for Delayed Story Recall and Buschke Selective Reminding Test. In the Story Recall test subjects listen to a story containing 44 informational bits that is read once. Subjects will be asked to recall the story immediately after the reading and after a 20-min delay. Credit is awarded for each bit recalled verbatim or accurately paraphrased. The Buschke Selective Reminding Test measures verbal memory through multiple trials of a list learning task. A list of 12 words is audibly presented to the subject, and subjects recall as many words as possible. On subsequent trials, subjects are only told those words they omitted on the previous trial. The procedure continues until the subject recalls all words on two successive trials or to the twelfth trial. After a 30-minute delay, subjects recall as many items as possible. Number of items recalled after the delay will be summed. Higher scores indicate better performance. (NCT01595646)
Timeframe: Change from Baseline in Verbal Memory at 16 weeks

InterventionChange in Z score memory composite (Mean)
Saline-.31247583
Insulin Detemir.33390008
Insulin-.05181561

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Cerebral Spinal Fluid (CSF) Biomarkers of AD

CSF Abeta (Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject. (NCT01595646)
Timeframe: Change from Baseline in CSF Biomarkers at 16 Weeks

,,
Interventionpg/mL (Mean)
Abeta42 PreAbeta 42 PostTau PreTau PostTau-P181 PreTau-P181 Post
Insulin305.5325132.3152.27468.5
Insulin Detemir408.5381.8118.3107.663.964.1
Saline331.5384109.7117.165.172.17

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Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio

CSF Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject. A pre and post ratio of TTau-P181/Abeta42 will be given. (NCT01595646)
Timeframe: Change from Baseline in CSF Biomarkers at 16 Weeks

,,
Interventionratio (Mean)
TTau-P181/Abeta42 ratio PreTau-P181/Abeta42 ratio Post
Insulin.27.23
Insulin Detemir.23.23
Saline.27.30

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Functional Ability

Subjects will have a collateral informant (i.e., spouse or friend) rate the subjects' ability to carry out activities of daily living on the Dementia Severity Rating Scale. The Dementia Severity Rating Scale is made up of sub-scales and the scores from each are summed to produce one score. The scale assess memory, ability to get from place to place, and speech and language each with a range from 0-6; recognition of family members and social and community both having a range from 0-5; orientation of time, orientation to place, ability to make decisions, home activities and responsibilities, and control of urination and bowels each having a range of 0-4; personal care- cleanliness and eating both with a range of 0-3. The total score range is from 0-54 and lower scores denotes better outcomes. (NCT01595646)
Timeframe: baseline, month 2, and month 4

,,
Interventionunits on a scale (Mean)
Baselinemonth 2month 4
Insulin7.79.710.6
Insulin Detemir8.79.79.1
Saline7.376.9

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The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision

This cognitive screening measure contains measures of confrontational naming, following commands, constructional praxis, ideational praxis, orientation, and language production and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment. (NCT01595646)
Timeframe: Baseline, Month 2 and Month 4

,,
Interventionunits on a scale (Mean)
BaselineMonth 2Month 4
Insulin19.821.822.6
Insulin Detemir21.623.419.5
Saline2018.520.4

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Change From Baseline in HbA1c (Post Meal Arm)

Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 26

,
InterventionPercentage of glycosylated haemoglobin (Mean)
Week 0 (baseline)Week 26
Faster Aspart (Post)7.637.51
NovoRapid (Meal)7.587.42

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Change in HbA1c

Change from baseline in HbA1c (%) after 52 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 52

,
InterventionPercentage of glycosylated haemoglobin (Mean)
Week 0 (baseline)Week 52
Faster Aspart (Meal)7.627.51
NovoRapid (Meal)7.587.58

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Change in PPG (Postprandial Glucose)

Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 52

,
Interventionmmol/L (Mean)
PPG at 120 minutes (Baseline)PPG at 120 minutes (Week 52)PPG increment at 120 mins (Baseline)PPG increment at 120 mins(Week 52)
Faster Aspart (Meal)14.5114.266.065.71
NovoRapid (Meal)14.1414.516.246.14

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Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 26

,,
InterventionKg (Mean)
Week 0: BaselineWeek 26
Faster Aspart (Meal)78.5679.21
Faster Aspart (Post)80.4981.17
NovoRapid (Meal)80.1580.69

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Frequency of Adverse Events

All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment. (NCT01831765)
Timeframe: After 52 weeks of randomised treatment

Interventionevent /100 patient yrs of exposure (Number)
Faster Aspart (Meal)445.8
Faster Aspart (Post)441
NovoRapid (Meal)411

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. (NCT01831765)
Timeframe: From baseline until week 26

Interventionevent rate/100 patient yrs of exposure (Number)
Faster Aspart (Meal)5899
Faster Aspart (Post)5443
NovoRapid (Meal)5865

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Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)

Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test). (NCT01831765)
Timeframe: Week 0, week 26

,,
Interventionmmol/L (Mean)
Week 0: BaselineWeek 26
Faster Aspart (Meal)6.065.88
Faster Aspart (Post)6.066.73
NovoRapid (Meal)6.246.55

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of randomised treatment. (NCT01831765)
Timeframe: Week 0, week 26

,,
InterventionPercentage of glycosylated haemoglobin (Mean)
Week 0 (Baseline)Week 26
Faster Aspart (Meal)7.627.31
Faster Aspart (Post)7.637.51
NovoRapid (Meal)7.587.42

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)

"Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia).~Confirmed hypoglycaemic episodes were defined as episodes that were either:~Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or~An episode biochemically confirmed by PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia." (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionepisodes (Number)
IDegAsp OD2532
IDet OD/BID2672

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Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)

The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionepisodes (Number)
IDegAsp OD6
IDet OD/BID12

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Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes

The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionepisodes (Number)
IDegAsp OD316
IDet OD/BID291

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Change From Baseline in Fasting Plasma Glucose

Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment. (NCT01835431)
Timeframe: week 0, week 16

Interventionmmol/L (Mean)
IDegAsp OD-0.3
IDet OD/BID-0.1

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)

Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment. (NCT01835431)
Timeframe: Week 0 to week 16

Interventionpercentage (%) (Mean)
IDegAsp OD-0.3
IDet OD/BID-0.3

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Incidence of Treatment Emergent Adverse Events (TEAEs)

A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment. (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionnumber of events (Number)
IDegAsp OD501
IDet OD/BID460

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Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill

The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. (NCT01835431)
Timeframe: After 16 weeks of treatment

Interventionepisodes (Number)
IDegAsp OD599
IDet OD/BID449

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Proportion of Subjects Achieving HbA1c Below 7.0%

Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment. (NCT01868542)
Timeframe: Week 20

,
Interventionpercentage (%) of subjects (Number)
week 20 (Yes)week 20 (No)
Insulin Detemir (2-4-6-8 Algorithm )14.385.7
Insulin Detemir (3-0-3 Algorithm )8.791.3

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Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms. (NCT01868542)
Timeframe: For 20 weeks of treatment and over 24 hours

,
InterventionEpisodes (Number)
Hypoglycaemic episodesNocturnal hypoglycaemic episodes
Insulin Detemir (2-4-6-8 Algorithm )11917
Insulin Detemir (3-0-3 Algorithm )7222

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Change in Fasting Plasma Glucose From Baseline

Change in fasting plasma glucose from baseline. (NCT01868542)
Timeframe: week 0, week 12

Interventionmg/dL (Mean)
Insulin Detemir (3-0-3 Algorithm )-74.3
Insulin Detemir (2-4-6-8 Algorithm )-44.6

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Change in Fasting Plasma Glucose From Baseline

Change in fasting plasma glucose from baseline. (NCT01868542)
Timeframe: Week 0, week 20

Interventionmg/dL (Mean)
Insulin Detemir (3-0-3 Algorithm )-60.4
Insulin Detemir (2-4-6-8 Algorithm )-70.0

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Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.

Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included. (NCT01868542)
Timeframe: Week 0, week 20

InterventionPercent (%) glycosylated haemoglobin (Mean)
Insulin Detemir (3-0-3 Algorithm )-0.9
Insulin Detemir (2-4-6-8 Algorithm )-1.0

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Change in HbA1c

Change in HbA1c at 12 weeks of treatment from visit 2. (NCT01868542)
Timeframe: Week 0, week 12

InterventionPercent (%) glycosylated haemoglobin (Mean)
Insulin Detemir (3-0-3 Algorithm )-0.8
Insulin Detemir (2-4-6-8 Algorithm )-0.9

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Incidence of Adverse Events

A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20) (NCT01868542)
Timeframe: Week 20

,
Interventionevents (Number)
Treatment Emergent Adverse Events (TEAEs)Serious Adverse Events (SAEs)Non Serious Adverse Events (NSAEs)
Insulin Detemir (2-4-6-8 Algorithm )29128
Insulin Detemir (3-0-3 Algorithm )24024

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Composite End-point

Percentage of participants with glycosylated Hemoglobin A1c (A1c)<8% AND no documented severe hypoglycemia (<56 mg/dL) during the study AND no significant weight gain (>3% from baseline) (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

Interventionpercentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart16
Metformin, Insulin Determir, Liraglutide34

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"Percentage of Participants Reaching Pre-specified Treatment Failure Outcome"

Treatment Failure defined as A1c>10% at week 13 (visit 5) (NCT01966978)
Timeframe: week 13

Interventionpercentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart16.1
Metformin, Insulin Determir, Liraglutide7.4

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Change in Short Form-36 (SF-36) Questionnaire Score

Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. SF-36 is scored on a 1-100 scale; a higher score represents a better self-assessed health - for all domains. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

,
Interventionscore on a scale (Least Squares Mean)
Physical Component SummaryMental Component Summary
Control: Metformin, Insulin Detemir, Insulin Aspart-0.10.04
Metformin, Insulin Determir, Liraglutide0.0070.09

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Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means

Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

,
Interventionscore on a scale (Least Squares Mean)
General Health PerceptionCurrent Health PerceptionTreatment SatisfactionDiabetes Related WorrySocial or Vocational WorryHypoglycemia FearGlycemic Control PerceptionSatisfaction with Insulin TreatmentWillingness to Continue Insulin TreatmentLifeStyle FlexibilitySocial Stigma
Control: Metformin, Insulin Detemir, Insulin Aspart-0.3-0.5-0.30.03-0.020.3-1.1-1.3-0.9-0.090.1
Metformin, Insulin Determir, Liraglutide-0.9-1.1-0.6-0.2-0.2-0.2-1.6-1.7-1.1-0.20.01

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Mean Change From Randomization in A1c at Week 26

Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy (NCT01966978)
Timeframe: Baseline and Week 26

InterventionPercentage of glycosylated hemoglobin (Mean)
Control: Metformin, Insulin Detemir, Insulin Aspart3.4
Metformin, Insulin Determir, Liraglutide4.1

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Hypoglycemic Episodes

Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of <70 mg/dl (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 2, week 4, week 13, Week 26

Interventionpercentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart66.1
Metformin, Insulin Determir, Liraglutide35.2

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Mean Change From Randomization in Body Weight

Change in body weight from randomization to end of study. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

Interventionkilogram (Mean)
Control: Metformin, Insulin Detemir, Insulin Aspart3.1
Metformin, Insulin Determir, Liraglutide-0.6

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Percentage of Participants Reaching Target A1c of <7% at Week 26

(NCT01966978)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart20
Metformin, Insulin Determir, Liraglutide44

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Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.69
Ertugliflozin 5 mg-0.49
Ertugliflozin 15 mg-0.44

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Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 52

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 52

InterventionPercentage of Participants (Number)
Placebo/Glimepiride17.2
Ertugliflozin 5 mg4.3
Ertugliflozin 15 mg1.5

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Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.44
Ertugliflozin 5 mg-0.59
Ertugliflozin 15 mg-0.39

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Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.63
Ertugliflozin 5 mg-0.55
Ertugliflozin 15 mg-0.36

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Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercentage change (Least Squares Mean)
Placebo/Glimepiride0.22
Ertugliflozin 5 mg-0.01
Ertugliflozin 15 mg0.12

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Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.40
Ertugliflozin 5 mg-0.10
Ertugliflozin 15 mg0.30

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Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride0.06
Ertugliflozin 5 mg-0.15
Ertugliflozin 15 mg-0.13

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Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-1.18
Ertugliflozin 5 mg-1.72
Ertugliflozin 15 mg-2.02

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Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride0.09
Ertugliflozin 5 mg-0.19
Ertugliflozin 15 mg-0.13

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Change From Baseline in Sitting Systolic Blood Pressure at Week 52 (Excluding Rescue Approach)

This change from baseline reflects the Week 52 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionmmHg (Mean)
Placebo/Glimepiride0.65
Ertugliflozin 5 mg-2.63
Ertugliflozin 15 mg-4.28

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Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)

This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionmmHg (Least Squares Mean)
Placebo/Glimepiride-0.70
Ertugliflozin 5 mg-4.38
Ertugliflozin 15 mg-5.20

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Change From Baseline in Sitting Systolic Blood Pressure at Week 104 (Excluding Rescue Approach)

This change from baseline reflects the Week 104 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionmmHg (Mean)
Placebo/Glimepiride0.05
Ertugliflozin 5 mg-3.61
Ertugliflozin 15 mg-3.13

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Change From Baseline in Sitting Diastolic Blood Pressure at Week 52 (Excluding Rescue Approach)

This change from baseline reflects the Week 52 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionmmHg (Mean)
Placebo/Glimepiride0.38
Ertugliflozin 5 mg-1.40
Ertugliflozin 15 mg-1.19

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Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)

This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionmmHg (Least Squares Mean)
Placebo/Glimepiride0.23
Ertugliflozin 5 mg-1.59
Ertugliflozin 15 mg-2.19

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Change From Baseline in Sitting Diastolic Blood Pressure at Week 104 (Excluding Rescue Approach)

This change from baseline reflects the Week 104 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionmmHg (Mean)
Placebo/Glimepiride-0.46
Ertugliflozin 5 mg-2.36
Ertugliflozin 15 mg-1.52

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Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo/Glimepiride-0.85
Ertugliflozin 5 mg-27.54
Ertugliflozin 15 mg-39.10

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Change From Baseline in Fasting Plasma Glucose at Week 104 (Excluding Rescue Approach)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 104 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 104 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

Interventionmg/dL (Mean)
Placebo/Glimepiride-10.9
Ertugliflozin 5 mg-18.2
Ertugliflozin 15 mg-28.2

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Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-1.23
Ertugliflozin 5 mg-1.11
Ertugliflozin 15 mg-0.96

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Change From Baseline in Body Weight at Week 52 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionKilograms (Mean)
Placebo/Glimepiride0.07
Ertugliflozin 5 mg-3.23
Ertugliflozin 15 mg-3.35

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Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionKilograms (Least Squares Mean)
Placebo/Glimepiride-1.33
Ertugliflozin 5 mg-3.01
Ertugliflozin 15 mg-2.93

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Change From Baseline in Body Weight at Week 104 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 104 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionKilograms (Mean)
Placebo/Glimepiride-0.18
Ertugliflozin 5 mg-3.77
Ertugliflozin 15 mg-3.63

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Change From Baseline in A1C at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 52 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent A1C (Mean)
Placebo/Glimepiride-0.68
Ertugliflozin 5 mg-0.72
Ertugliflozin 15 mg-0.96

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Change From Baseline in A1C at Week 26 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent A1C (Least Squares Mean)
Placebo/Glimepiride-0.03
Ertugliflozin 5 mg-0.73
Ertugliflozin 15 mg-0.91

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Change From Baseline in Fasting Plasma Glucose at Week 52 (Excluding Rescue Therapy)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

Interventionmg/dL (Mean)
Placebo/Glimepiride-12.0
Ertugliflozin 5 mg-22.4
Ertugliflozin 15 mg-35.2

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Change From Baseline in A1C at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 104 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent A1C (Mean)
Placebo/Glimepiride-0.58
Ertugliflozin 5 mg-0.60
Ertugliflozin 15 mg-0.89

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Percent Change From Baseline in Bone Biomarker Parathyroid Hormone (PTH) at Week 26 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Mean)
Placebo/Glimepiride-0.98
Ertugliflozin 5 mg0.28
Ertugliflozin 15 mg0.14

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Percent Change From Baseline in Bone Biomarker P1NP at Week 52 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent Change (Mean)
Placebo/Glimepiride24.50
Ertugliflozin 5 mg8.41
Ertugliflozin 15 mg19.79

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Percent Change From Baseline in Bone Biomarker Procollagen Type I N-terminal Propeptide (P1NP) at Week 26 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Mean)
Placebo/Glimepiride0.5
Ertugliflozin 5 mg0.8
Ertugliflozin 15 mg0.5

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Percent Change From Baseline in Bone Biomarker PTH at Week 104 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Mean)
Placebo/Glimepiride10.12
Ertugliflozin 5 mg8.16
Ertugliflozin 15 mg5.46

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Percent Change From Baseline in Bone Biomarker PTH at Week 52 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent Change (Mean)
Placebo/Glimepiride8.11
Ertugliflozin 5 mg11.09
Ertugliflozin 15 mg2.48

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Percent Change From Baseline in Bone Biomarker P1NP at Week 104 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Mean)
Placebo/Glimepiride19.38
Ertugliflozin 5 mg10.11
Ertugliflozin 15 mg24.21

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Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 104

InterventionPercentage of Participants (Number)
Placebo/Glimepiride2.4
Ertugliflozin 5 mg3.4
Ertugliflozin 15 mg3.9

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Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 106

InterventionPercentage of Participants (Number)
Placebo/Glimepiride77.5
Ertugliflozin 5 mg70.5
Ertugliflozin 15 mg75.6

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Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 104

Per protocol participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 104

InterventionPercentage of participants (Number)
Placebo/Glimepiride24.4
Ertugliflozin 5 mg11.1
Ertugliflozin 15 mg10.7

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Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 26

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 26

InterventionPercentage of Participants (Number)
Placebo/Glimepiride17.7
Ertugliflozin 5 mg2.9
Ertugliflozin 15 mg1.5

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Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 104

InterventionPercentage of Participants (Number)
Placebo/Glimepiride7.2
Ertugliflozin 5 mg10.6
Ertugliflozin 15 mg12.2

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Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 26

InterventionPercentage of Participants (Number)
Placebo/Glimepiride2.9
Ertugliflozin 5 mg8.7
Ertugliflozin 15 mg12.2

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Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Placebo/Glimepiride11.0
Ertugliflozin 5 mg10.6
Ertugliflozin 15 mg14.6

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Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 104

InterventionPercentage of Participants (Number)
Placebo/Glimepiride19.1
Ertugliflozin 5 mg24.6
Ertugliflozin 15 mg33.7

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Percent Change From BMD at Week 104 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.58
Ertugliflozin 5 mg-0.40
Ertugliflozin 15 mg-0.64

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Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Placebo/Glimepiride30.6
Ertugliflozin 5 mg34.8
Ertugliflozin 15 mg36.6

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Time to Glycemic Rescue Therapy at Week 26

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Week 26

InterventionDays (Median)
Placebo/Glimepiride105
Ertugliflozin 5 mg112
Ertugliflozin 15 mg139

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Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach)

Pharmacokinetic samples were collected at approximately 24 hours following the prior day's dose and before administration of the current day's dose. The lower limit of quantitation (LLOQ) was 0.500 mg/mL. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Pre-dose and/or 60 minutes post-dose on Weeks 6, 12, 18, and 30

,,
Interventionng/mL (Mean)
Week 6:Pre-doseWeek 12:Pre-doseWeek 12:60 mins post-doseWeek 18:Pre-doseWeek 18:60 mins post-doseWeek 30:Pre-dose
Ertugliflozin 15 mg38.3829.23228.1324.46214.9630.55
Ertugliflozin 5 mg14.8912.3474.849.9174.3912.66
Placebo/GlimepirideNANANA0.010.010.15

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Percent Change From Baseline in Bone Biomarker CTX at Week 52 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Mean)
Placebo/Glimepiride15.54
Ertugliflozin 5 mg34.36
Ertugliflozin 15 mg41.57

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Percent Change From Baseline in Bone Biomarker CTX at Week 104 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

InterventionPercent change (Mean)
Placebo/Glimepiride19.29
Ertugliflozin 5 mg26.94
Ertugliflozin 15 mg32.53

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Percent Change From Baseline in Bone Biomarker Carboxy-Terminal Cross-Linking Telopeptides of Type I Collagen (CTX) at Week 26 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

InterventionPercent change (Mean)
Placebo/Glimepiride10.8
Ertugliflozin 5 mg51.9
Ertugliflozin 15 mg80.2

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Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.82
Ertugliflozin 5 mg-1.04
Ertugliflozin 15 mg-1.32

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Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

InterventionPercent change (Least Squares Mean)
Placebo/Glimepiride-0.10
Ertugliflozin 5 mg-0.28
Ertugliflozin 15 mg0.07

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Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 26

InterventionPercentage of Participants (Number)
Placebo/Glimepiride15.8
Ertugliflozin 5 mg35.3
Ertugliflozin 15 mg40.0

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Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment.

Proportion of subjects achieving HbA1c <7.0% is presented as percentage of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment. (NCT02131272)
Timeframe: At week 26

InterventionPercentage of subjects (Number)
Insulin Detemir + Metformin + Diet/Exercise25.0
Insulin NPH + Metformin + Diet/Exercise33.3

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Incidence of Adverse Events (AEs)

The total number of treatment emergent adverse events (the onset of the adverse event is on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration) reported during the 26 weeks of treatment. (NCT02131272)
Timeframe: weeks 0 - 26

InterventionNumber of events (Number)
Insulin Detemir + Metformin + Diet/Exercise30
Insulin NPH + Metformin + Diet/Exercise41

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Change in HbA1c (Glycosylated Haemoglobin)

Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26. (NCT02131272)
Timeframe: week 0, week 26

InterventionPercentage of glycosylated haemoglobin (Least Squares Mean)
Insulin Detemir + Metformin + Diet/Exercise-0.64
Insulin NPH + Metformin + Diet/Exercise-0.81

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Change in Body Weight Standard Deviation Score (SDS)

Change in body weight standard deviation score (SDS) from baseline to week 26. In order to reduce the variability in body weight measurements, SDS were calculated. SDS for weight was derived by comparing the actual measurements with standard growth charts for the United States. Standard values provided by the standard growth charts according to the subject's sex and age at the time of the measurement were used to calculate the SDS. (NCT02131272)
Timeframe: week 0, week 26

Interventionstandard deviation score (Mean)
Insulin Detemir + Metformin + Diet/Exercise0.006
Insulin NPH + Metformin + Diet/Exercise0.098

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Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment

Proportion of subjects achieving HbA1c below 7.5% is presented as percentage of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment. (NCT02131272)
Timeframe: At week 26

InterventionPercentage of subjects (Number)
Insulin Detemir + Metformin + Diet/Exercise30.0
Insulin NPH + Metformin + Diet/Exercise38.1

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Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

The total number of blood glucose confirmed symptomatic nocturnal (time of onset between 23:00 and 06.59 both inclusive) severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial. (NCT02131272)
Timeframe: Weeks 0 - 26

,
InterventionNumber of episodes (Number)
SevereBlood glucose confirmed symptomatic
Insulin Detemir + Metformin + Diet/Exercise00
Insulin NPH + Metformin + Diet/Exercise01

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Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Total number of treatment emergent severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial. (NCT02131272)
Timeframe: Weeks 0 - 26

,
InterventionNumber of episodes (Number)
SevereBlood glucose confirmed symptomatic
Insulin Detemir + Metformin + Diet/Exercise04
Insulin NPH + Metformin + Diet/Exercise012

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Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia

HEDIS criteria: Individualized HbA1c target <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 milligrams per deciliter (mg/dL) (<=3.9 millimoles per litre [mmol/L]). Analysis was performed using all post-baseline data available on the 6 month randomized period (defined as time from randomization up to Day 180 or discontinuation date, whichever comes earlier). (NCT02451137)
Timeframe: Baseline to Month 6

Interventionpercentage of participants (Number)
Toujeo31.3
Standard of Care27.9

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Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period

HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (3.0 mmol/L). (NCT02451137)
Timeframe: Baseline to Month 6

Interventionpercentage of participants (Number)
Toujeo37.3
Standard of Care34.3

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Treatment Persistence Measured by Medication Possession Ratio (MPR)

Treatment persistence was determined based on vendor claims database that would be responsible for managing and administration of the study drugs. Medication use was assessed by MPR and persistence measures based on data collected by the smart card vendor (date of fill or refill and quantity of medication dispensed for 30-day supply). The MPR was assessed based on total number of days of supply divided by the total number of days in 6 or 12 months period. (NCT02451137)
Timeframe: At Month 6 and Month 12

,
InterventionMedication Possession ratio (Mean)
Month 6Month 12
Standard of Care63.1457.82
Toujeo62.0658.21

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Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12

DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items, each answered on a Likert scale of 0 to 6. Responses of 6 questions (Items 1, 4, 5, 6, 7 and 8) were summarized to derive total treatment satisfaction score, such that a higher score was indicative of better satisfaction. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (improvement in treatment satisfaction). Item 2 and Item 3 scores were used for hyperglycemia perception and hypoglycemia perception respectively, where lower scores indicated better health outcome. Perceived frequency of hyperglycemia score (Item 2) and perceived frequency of hypoglycemia score (Item 3) range from 0 (none of the time) to 6 (most of time), where lower scores indicated more satisfaction/better health outcome. (NCT02451137)
Timeframe: At Baseline, Month 6, Month 12

,
Interventionscore on a scale (Mean)
Total treatment satisfaction score:BaselineTotal treatment satisfaction score: Month 6Total treatment satisfaction score: Month 12Perceived frequencyof hyperglycemia score:BaselinePerceived frequency of hyperglycemia score:Month 6Perceived frequency of hyperglycemia score:Month12Perceived frequency of hypoglycemia score:BaselinePerceived frequency of hypoglycemia score: Month 6Perceived frequency of hypoglycemia score:Month 12
Standard of Care26.431.130.74.32.82.60.81.01.0
Toujeo26.531.030.94.32.82.60.90.90.9

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Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12

DTSQc version evaluates the change in treatment satisfaction at Month 12 as compared to the start of the study . It consists of 8 items, each answered on a Likert scale from -3 to +3. The sum of treatment satisfaction scores (items 1, 4, 5, 6, 7,and 8) ranged from score -18 (deterioration in treatment satisfaction) to +18 (improvement in treatment satisfaction). Perceived frequency of hypoglycemia and perceived frequency of hyperglycemia score ranges from score -3 (fewer problems) to +3 (more problems). (NCT02451137)
Timeframe: At Month 12

,
Interventionscore on a scale (Least Squares Mean)
Total satisfaction scorePerceived frequency of hyperglycemia scorePerceived frequency of hypoglycemia
Standard of Care13.790.21-0.82
Toujeo13.810.14-0.82

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Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12

Percentage of participants with hospitalizations, emergency room visits, and specialty visits during the 6-month and 12-month randomized period were reported. The 12-month randomized period was defined as the time from randomization up to Day 365 or discontinuation date, whichever comes earlier. (NCT02451137)
Timeframe: From Baseline to Month 6 and Month 12

,
Interventionpercentage of participants (Number)
Hospitalizations: Month 6Emergency Room Visits: Month 6Specialty Visits: Month 6Hospitalizations: Month 12Emergency Room Visits: Month 12Specialty Visits: Month 12
Standard of Care7.510.374.08.011.175.9
Toujeo8.111.378.39.112.780.1

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Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period

Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (<=3.9 mmol/L) or <54 mg/dL (3.0 mmol/L). (NCT02451137)
Timeframe: Up to Month 6 and Month 12

,
Interventionpercentage of participants (Number)
Any hypoglycemia: Any time: Month 6Any hypoglycemia: Nocturnal: Month 6Any hypoglycemia: Any time: Month 12Any hypoglycemia: Nocturnal: Month 12Severe hypoglycemia: Any time: Month 6Severe hypoglycemia:Nocturnal: Month 6Documented Symptomatic <=70 mg/dL:Any time:Month 6Documented Symptomatic <54 mg/dL:Any time:Month 6Documented Symptomatic <=70mg/dL:Nocturnal:Month 6Documented Symptomatic <54 mg/dL:Nocturnal:Month 6Severe hypoglycemia: Any time: Month 12Severe hypoglycemia:Nocturnal: Month 12Documented Symptomatic<=70 mg/dL:Any time:Month 12Documented Symptomatic <54 mg/dL:Any time:Month 12Documented Symptomatic<=70mg/dL:Nocturnal:Month 12Documented Symptomatic <54mg/dL:Nocturnal:Month 12
Standard of Care30.410.041.814.91.00.614.93.15.60.81.90.720.85.68.31.7
Toujeo28.98.939.113.61.00.513.93.64.50.81.20.519.95.66.51.2

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Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period

HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) and < 3.0 mmol/L (< 54 mg/dL). (NCT02451137)
Timeframe: Baseline to Month 12

,
Interventionpercentage of participants (Number)
Month 12: <=70 mg/dLMonth 12: <54 mg/dL
Standard of Care23.729.5
Toujeo26.133.0

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Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12

Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline FPG (as continuous) and baseline FPG-by-visit interaction. (NCT02451137)
Timeframe: Baseline, Month 6, Month 12

,
Interventionmg/dL (Least Squares Mean)
Month 6Month 12
Standard of Care-50.4-47.3
Toujeo-48.9-48.0

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Change From Baseline in Body Weight at Month 6 and Month 12

Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline weight (as continuous) and baseline weight-by-visit interaction. (NCT02451137)
Timeframe: Baseline, Month 6, Month 12

,
Interventionkilogram (kg) (Least Squares Mean)
Month 6Month 12
Standard of Care1.141.40
Toujeo1.021.51

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Change From Baseline in Basal Insulin Dose at Month 6 and Month 12

Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values. (NCT02451137)
Timeframe: Baseline, Month 6, Month 12

,
InterventionUnit/kg (U/kg) (Mean)
Month 6Month 12
Standard of Care0.1830.224
Toujeo0.1790.222

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"Percentage of Responders (Participants and Provider) Who Reported Excellent or Good Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12"

"Participant and Physician (Provider) reported GES for this diabetes study. The GES assessed impact of treatment on scale ranges as: excellent (complete control of diabetes), good (marked improvement of diabetes), moderate (discernible, but limited improvement in diabetes), poor (no appreciable change in diabetes), or worsening of condition (worsening of diabetes). There was no score expressed by numbers and no change measured over the time of the study. Percentage of participants and providers who reported excellent or good on the GES at Month 6 and Month 12 are reported here." (NCT02451137)
Timeframe: At Month 6, Month 12

,
Interventionpercentage of responders (Number)
Percentage of Participants: Month 6Percentage of Providers: Month 6Percentage of Participants: Month 12Percentage of Providers: Month 12
Standard of Care65.657.764.256.3
Toujeo67.262.164.758.8

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Change From Baseline in HbA1c at Month 6 and Month 12

Change in HbA1c was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted Least Squares (LS) means and Standard Errors (SE) were obtained using Mixed Effect Model with Repeated Measures (MMRM ) with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline HbA1c (as continuous) and baseline HbA1c-by-visit interaction. (NCT02451137)
Timeframe: Baseline, Month 6, Month 12

,
Interventionpercentage of HbA1c (Least Squares Mean)
Month 6Month 12
Standard of Care-1.36-1.24
Toujeo-1.40-1.29

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Length of Hospital Stay

Total length of hospital stay (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

Interventiondays (Median)
Placebo9
Sitagliptin11

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Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization

The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery. (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

InterventionParticipants (Count of Participants)
Placebo1
Sitagliptin2

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Number of Participants With Hypoglycemic Events

Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL) (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

,
InterventionParticipants (Count of Participants)
Mild hypoglycemiaClinically significant hypoglycemia
Placebo20
Sitagliptin50

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Number of Days in the ICU

The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required. (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

Interventiondays (Median)
Placebo2.0
Sitagliptin1.5

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Number of Participants Experiencing Stress Hyperglycemia

The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL. (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

InterventionParticipants (Count of Participants)
Placebo7
Sitagliptin5

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Number of Participants With Emergency Room Visits After Discharge

Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known. (NCT02741687)
Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

InterventionParticipants (Count of Participants)
Placebo0
Sitagliptin0

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Number of Participants With Hospital Readmissions After Discharge

Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known. (NCT02741687)
Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

InterventionParticipants (Count of Participants)
Placebo0
Sitagliptin1

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Number of Patients Requiring Supplemental, Subcutaneous Insulin

Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

InterventionParticipants (Count of Participants)
Placebo0
Sitagliptin1

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Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin

Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo (NCT02741687)
Timeframe: Up to time of discharge from hospital, an average of 10 days

Interventioninternational units of insulin (Number)
Sitagliptin5

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Number of Participants Experiencing Complications

The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented. (NCT02741687)
Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

,
InterventionParticipants (Count of Participants)
Wound infectionRespiratory failurePneumoniaAcute kidney injuryCardiac eventBacterial septic infection
Placebo000100
Sitagliptin000100

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Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)

Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. Eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between pregnancy baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy. (NCT03377699)
Timeframe: From pregnancy baseline (corresponding to GW 8-13) to end of treatment (28 days after delivery)

InterventionParticipants (Count of Participants)
Left eye72577228Left eye72577227Right eye72577227Right eye72577228
YesNoMissing
IDet2
IDeg79
IDeg2
IDet79
IDeg10
IDet13

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Number of Adverse Events in the Infant

AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs in foetus/infant with particular focus on the AEs from delivery to follow-up are presented. (NCT03377699)
Timeframe: From delivery to final follow-up 30 days after delivery

InterventionEvents (Number)
IDeg164
IDet150

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Number of Adverse Events During Pregnancy Period

Number of adverse events (AEs) during pregnancy period is reported. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs presented are treatment-emergent AEs (TEAEs). The TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT03377699)
Timeframe: From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)

InterventionEvents (Number)
IDeg429
IDet328

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Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)

Mean of post-prandial glucose (PPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. Average PPG is defined as the average of the available blood glucouse (BG) measurements 90 minutes after breakfast, lunch and main evening meal respectively. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: From GW 16 to GW 36

Interventionmmol/L (Mean)
IDeg7.37
IDet6.96

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Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery

Change in body weight from pregnancy baseline to last planned visit prior to delivery is presented. (NCT03377699)
Timeframe: From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth)

InterventionKilogram (Kg) (Mean)
IDeg11.97
IDet10.81

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Birth Weight Standard Deviation (SD) Score for Live Birth Infants

Mean of birth weight SD score for live infants is presented. Birth weight SD score indicates how far an infant's score deviates from the mean of the reference population of same age and same sex born at the same gestational week as per local normal curves. The SD score of 0 indicates that the infants born weigh approximately the same, negative score indicates that the infants born weigh lesser and positive score indicates that the infants born weigh more when compared with the reference population. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

InterventionStandard Deviation score (Mean)
IDeg1.7
IDet1.2

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Birth Weight for Live Birth Infants

Mean birth weight for live birth infants is presented. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

Interventiongrams (g) (Mean)
IDeg3691.0
IDet3490.2

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Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery

Number of participants who had delivered by which mode of delivery (vaginal, operative vaginal, planned caesarean section or unplanned caesarean section delivery) is presented. Planned caesarean section: decision taken > 8 hours prior to delivery. Unplanned caesarean section: decision taken ≤ 8 hours prior to delivery. In case of 'early foetal death' or if the participant did not fill the pregnancy outcome form then mode of delivery was reported as 'missing'. (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
Spontaneous vaginal birthPlanned caesarean sectionOperative vaginal birthNon planned caesarean sectionMissing
IDeg11428237
IDet18459157

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Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)

Number of participants who had early foetal death (delivery before 20 completed GWs) is presented. In the reported data, 'Yes' infers early foetal deaths whereas 'No' infers no foetal deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg4871
IDet5874

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Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)

Number of participants who achieved pre-defined HbA1c targets ≤ 6.0% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.0% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.0% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: From GW 16 to GW 36

,
InterventionParticipants (Count of Participants)
YesNo
IDeg3648
IDet3153

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Last Planned Fasting Plasma Glucose Prior to Delivery

Mean of fasting plasma glucose (FPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from in-trial observation period. The in-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: From GW 16 to GW 36

Interventionmmol/L (Mean)
IDeg6.17
IDet6.79

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Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)

Number of participants who achieved pre-defined HbA1c targets ≤ 6.5% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.5% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.5% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: From GW 16 to GW 36

,
InterventionParticipants (Count of Participants)
YesNo
IDeg5826
IDet5331

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Number of Participants With Live Born Infants (Yes/no)

Number of participants with live born infants is presented. In the reported data, 'Yes' infers number of live infants whereas 'No' infers early foetal death or termination of pregnancy (induced/elective abortion). The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg8651
IDet8574

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Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no)

Number of participants with one or more events of pre-eclampsia during pregnancy period is reported. Pre-eclampsia was defined as new-onset hypertension (greater than or equal to) ≥ 140 millimeters of mercury (mmHg) systolic or ≥ 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart) occurring from GW 20 to delivery and simultaneous proteinuria (defined as ≥ 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of ≥ 300 mg/g in a urine sample or a urine dipstick protein of 1+) or presence of eclampsia, haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, or other severe organ involvement. In the reported data, 'Yes' infers number of participants who had pre-eclampsia events whereas 'No' infers number of participants who have not had pre-eclampsia events. (NCT03377699)
Timeframe: From GW 20 to delivery

,
InterventionParticipants (Count of Participants)
YesNo
IDeg1279
IDet787

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Number of Participants With Pre-term Delivery

Number of pregnant women who had pre-term delivery is presented. Pre-term delivery refers to delivery in < 37 completed GWs. In the reported data, 'Yes' infers number of participants who had pre-term delivery whereas 'No' infers number of participants who has not had pre-term delivery. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion,up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery+58 days). For participants who had not attended the follow-up visit,the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg34571
IDet26664

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Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants

Number of participants who delivered foetuses/infants with abnormalities (classified according to EUROCAT) is presented. Presence of major abnormalities were based on adjudicated data, as after adjudication congenital anomalies were classified into major or minor anomalies or in other categories. In reported data, 'Yes' infers presence of major abnormalities whereas 'No' infers absence of major abnormalities in foetus/infant. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion up to 24 months. Date of trial completion : final scheduled follow-up visit (delivery + 58 days). (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNo
IDeg884
IDet888

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Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)

Number of infants with neonatal hypoglycaemic episodes is presented. Neonatal hypoglycaemic episodes defined as plasma glucose ≤ 1.7 mmol/L (31 mg/dL) during the first 24 hours after birth or below or equal to 2.5 mmol/L (45 mg/dl) between 24 hours and 48 hours after birth. In the reported data, 'Yes' infers number of infants with neonatal hypoglycaemic episodes whereas 'No' infers number of infants with no neonatal hypoglycaemic episodes. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. (NCT03377699)
Timeframe: During between 24 and 48 hours after birth

InterventionParticipants (Count of Participants)
During the first 24 hours after birth72577228During the first 24 hours after birth72577227Between 24 hours and 48 hours after birth72577227Between 24 hours and 48 hours after birth72577228
YesNoUnaddressed category
IDeg20
IDet19
IDeg64
IDet65
IDeg2
IDet1
IDeg4
IDet5
IDeg77
IDet78
IDeg5
IDet2

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Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)

Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. For pregnant women, eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between treatment baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy. (NCT03377699)
Timeframe: From treatment baseline (week 0) to end of treatment (28 days after delivery)

InterventionParticipants (Count of Participants)
Left eye72577227Left eye72577228Right eye72577227Right eye72577228
MissingYesNo
IDet13
IDeg2
IDet2
IDeg79
IDet79
IDeg10

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Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)

Number of live born infants with birth weight <10th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants.In the reported data,'Yes' infers number of live born infants with birth weight <10th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not <10th percentile for gestational age and sex.Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.Endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion,up to 24 months.Date of trial completion:final scheduled follow-up visit (delivery + 58 days). (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg1841
IDet3811

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Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery

Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months. (NCT03377699)
Timeframe: From GW 16 to GW 36

,
InterventionPercentage glycosylated hemoglobin (Mean)
in-trialon-treatment
IDeg6.306.32
IDet6.266.26

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Number of Hypoglycaemic Episodes During the Pregnancy Period

Number of treatment emergent hypoglycaemic episodes during the pregnancy period is presented. Hypoglycaemic episode (plasma glucose <= 3.9 mmol/L (70 milligrams per decilitre (mg/dL)) Or > 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs on or after the first day of trial product administration, and no later than 7 days from the last day on trial product. The endpoint was evaluated based on the data from pregnancy period. Pregnancy period started from first day of pregnancy (date of conception corresponding to the first day in GW 2) or randomisation (whichever comes last) to the date of delivery. (NCT03377699)
Timeframe: From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)

InterventionEpisodes (Number)
IDeg5431
IDet5982

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Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]

Number of live born infants with birth weight >90th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants. In the reported data,'Yes' infers number of live born infants with birth weight >90th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not >90th percentile for gestational age and sex.Unaddressed category refers to cases where either parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if THE participants did not fill the pregnancy outcome form.The endpoint was evaluated based on the data from in-trial observation period:started at randomization and ended at the date of trial completion,up to 24 months. Date of trial completion:final scheduled follow-up visit (delivery + 58 days). (NCT03377699)
Timeframe: At birth

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg55301
IDet43411

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Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)

Number of participants who had infant loss after delivery is presented. Neonatal mortality: death of infant between ≥7 completed days after delivery and < 28 completed days after delivery. In the reported data, 'Yes' infers infant deaths whereas 'No' infers no infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. (NCT03377699)
Timeframe: Between at least 7 completed days after delivery and before 28 completed days after delivery

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg0911
IDet0924

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Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)

Number of participants who had foetal/infant loss at delivery is presented. Perinatal mortality: death of foetus/infant between ≥ 20 completed GWs before delivery and <1 completed week after delivery). In the reported data, 'Yes' infers early foetal/infant deaths whereas 'No' infers no foetal/infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion, up to 24 months. Date of trial completion: final scheduled follow-up visit (delivery + 58 days). (NCT03377699)
Timeframe: Between at least 20 completed GWs before delivery and before 7 completed days after delivery

,
InterventionParticipants (Count of Participants)
YesNoUnaddressed
IDeg0911
IDet0924

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