A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

Sponsor
GlaxoSmithKline
Study ID
NCT01733758
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Albiglutide 30 mg weekly — DRUG
    Albiglutide will be available as a pen injector that delivers 30mg of albiglutide
  • Albiglutide 50 mg weekly — DRUG
    Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
  • Placebo — DRUG
    Albiglutide matching placebo will be available as a pen injector
  • Liraglutide 0.9 mg daily — DRUG
    Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose

Study Details

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.

Key Dates

Start date
Feb 28, 2013
Status verified
Aug 2016
Primary completion
Jun 30, 2014
Completion
Feb 28, 2015

Study Design

Enrollment
494 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Albiglutide 30 mg weekly
    Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks
  • Experimental: Albiglutide 50 mg weekly
    Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52
  • Placebo Comparator: Placebo
    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
  • Active Comparator: Liraglutide 0.9 mg daily
    Subjects will be randomly assigned to open-label liraglutide for 52 weeks

Primary Outcome Measure

Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline and Week 24 ]

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