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A Dose Finding Study of GSK716155 Versus Placebo in the Treatment of Type 2 Diabetes Mellitus
This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 215 |
| Start date | 2010-04 |
| Completion | 2011-05 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- albiglutide
- placebo
Primary outcomes
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 — Baseline and Week 16
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 was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. 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
Japan