Conditions: Diabetes Mellitus, Type 2
Keywords: albiglutide Japanese GSK716155 Type 2 diabetes mellitus glucagon-like peptide 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 494
Healthy volunteers: no

Brief summary:
This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus.

Detailed description:

Arms:
arm 1: Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks arm 2: Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52 arm 3: Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52 arm 4: Subjects will be randomly assigned to open-label liraglutide for 52 weeks

Interventions: intervention 1: Albiglutide 30 mg weekly intervention 2: Albiglutide 50 mg weekly intervention 3: Placebo intervention 4: Liraglutide 0.9 mg daily
Intervention descriptions: intervention 1: Albiglutide will be available as a pen injector that delivers 30mg of albiglutide intervention 2: Albiglutide will be available as a pen injector that delivers 50mg of albiglutide intervention 3: Albiglutide matching placebo will be available as a pen injector intervention 4: Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose

Protocol document: