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