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

NCT01733758 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2016-09-22

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Albiglutide 30 mg weekly

Albiglutide will be available as a pen injector that delivers 30mg of albiglutide

DRUG

Albiglutide 50 mg weekly

Albiglutide will be available as a pen injector that delivers 50mg of albiglutide

DRUG

Placebo

Albiglutide matching placebo will be available as a pen injector

DRUG

Liraglutide 0.9 mg daily

Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-06-30
Completion
2015-02-28

Countries

  • Japan

Study Locations

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Entities

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01733758 on ClinicalTrials.gov