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
| Autor: | R M, Bergenstal, H, Lunt, E, Franek, F, Travert, J, Mou, Y, Qu, C J, Antalis, M L, Hartman, M, Rosilio, S J, Jacober, E J, Bastyr |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Blood Glucose Male type 1 diabetes Endocrinology Diabetes and Metabolism Insulin Glargine 030209 endocrinology & metabolism Drug Administration Schedule Polyethylene Glycols 03 medical and health sciences 0302 clinical medicine Endocrinology Double-Blind Method randomized trial Internal Medicine Humans basal insulin 030212 general & internal medicine Meals Glycated Hemoglobin Insulin Lispro Middle Aged Themed Section‐bil Diabetes Mellitus Type 1 glycaemic control Drug Therapy Combination Female Original Article hypoglycaemia |
| Zdroj: | Diabetes, Obesity & Metabolism |
| ISSN: | 1463-1326 1462-8902 |
| DOI: | 10.1111/dom.12698 |
| Popis: | Aims 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. Materials and methods 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%. Results 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 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text