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Randomized, double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 3.


ABSTRACT: To compare the efficacy and safety of basal insulin peglispro (BIL), which has a flat pharmacokinetic and pharmacodynamic profile and a long duration of action, with insulin glargine (GL) in patients with type 1 diabetes.In this phase III, 52-week, blinded study, we randomized 1114 adults with type 1 diabetes in a 3?:?2 distribution to receive either BIL (n?=?664) or GL (n?=?450) at bedtime, with preprandial insulin lispro, using intensive insulin management. The primary objective was to compare glycated haemoglobin (HbA1c) in the groups at 52?weeks, with a non-inferiority margin of 0.4%.At 52?weeks, mean (standard error) HbA1c was 7.38 (0.03)% with BIL and 7.61 (0.04)% with GL {difference -0.22% [95% confidence interval (CI) -0.32, -0.12]; p?

SUBMITTER: Bergenstal RM 

PROVIDER: S-EPMC5096008 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Randomized, double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 3.

Bergenstal R M RM   Lunt H H   Franek E E   Travert F F   Mou J J   Qu Y Y   Antalis C J CJ   Hartman M L ML   Rosilio M M   Jacober S J SJ   Bastyr E J EJ  

Diabetes, obesity & metabolism 20160803 11


<h4>Aims</h4>To compare the efficacy and safety of basal insulin peglispro (BIL), which has a flat pharmacokinetic and pharmacodynamic profile and a long duration of action, with insulin glargine (GL) in patients with type 1 diabetes.<h4>Materials and methods</h4>In this phase III, 52-week, blinded study, we randomized 1114 adults with type 1 diabetes in a 3 : 2 distribution to receive either BIL (n = 664) or GL (n = 450) at bedtime, with preprandial insulin lispro, using intensive insulin manag  ...[more]

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