A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.

NCT00838916 Phase 3 COMPLETED Results posted

A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	COMPLETED
Enrolment	779
Start date	2009-02
Completion	2013-05

Conditions

• Diabetes Mellitus, Type 2

Interventions

• albiglutide
• insulin glargine

Primary outcomes

• Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 — Baseline and Week 52
  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 BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.

Countries

United States, Russia, South Africa, United Kingdom