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A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 841 |
| Start date | 2010-05 |
| Completion | 2011-09 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- albiglutide
- liraglutide
Primary outcomes
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 — Baseline and Week 32
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Countries
United States, Australia, Israel, Peru, Philippines, South Korea, Spain, United Kingdom