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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)

NCT ID: NCT01733758

Last Updated: 2016-09-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Albiglutide 30 mg weekly

Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks

Group Type EXPERIMENTAL

Albiglutide 30 mg weekly

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Albiglutide matching placebo will be available as a pen injector

Albiglutide 50 mg weekly

Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52

Group Type EXPERIMENTAL

Albiglutide 50 mg weekly

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Albiglutide matching placebo will be available as a pen injector

Liraglutide 0.9 mg daily

Subjects will be randomly assigned to open-label liraglutide for 52 weeks

Group Type ACTIVE_COMPARATOR

Liraglutide 0.9 mg daily

Intervention Type DRUG

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

Interventions

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Albiglutide 30 mg weekly

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

Intervention Type DRUG

Albiglutide 50 mg weekly

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

Intervention Type DRUG

Placebo

Albiglutide matching placebo will be available as a pen injector

Intervention Type DRUG

Liraglutide 0.9 mg daily

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
* Body mass index (BMI) 17 to 40 kg/ m\^2 inclusive
* Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
* Creatinine clearance \>30 mL/min (calculated using the Cockcroft-Gault formula)

Exclusion Criteria

* History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or \<6 weeks postpartum•
* Clinically significant cardiovascular and/or cerebrovascular disease
* Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
* Serum amylase \>=3 ×ULN and/or serum lipase \>=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
* Prior use of a TZD or GLP-1R agonist within 4 months before Screening
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Aichi, , Japan

Site Status

GSK Investigational Site

Chiba, , Japan

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GSK Investigational Site

Ehime, , Japan

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Ehime, , Japan

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Ehime, , Japan

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GSK Investigational Site

Fukuoka, , Japan

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GSK Investigational Site

Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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GSK Investigational Site

Fukushima, , Japan

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Fukushima, , Japan

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Fukushima, , Japan

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Fukushima, , Japan

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GSK Investigational Site

Gunma, , Japan

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Gunma, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Ibaraki, , Japan

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Ibaraki, , Japan

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Ibaraki, , Japan

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Kagawa, , Japan

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Kagawa, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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GSK Investigational Site

Kanagawa, , Japan

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GSK Investigational Site

Kanagawa, , Japan

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GSK Investigational Site

Kanagawa, , Japan

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GSK Investigational Site

Kanagawa, , Japan

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Kanagawa, , Japan

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GSK Investigational Site

Kochi, , Japan

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Kumamoto, , Japan

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Kumamoto, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Miyagi, , Japan

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Miyagi, , Japan

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Nagano, , Japan

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Nagano, , Japan

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Nagano, , Japan

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Nara, , Japan

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Okinawa, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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GSK Investigational Site

Ōita, , Japan

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Ōita, , Japan

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GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Shizuoka, , Japan

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GSK Investigational Site

Tochigi, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Yamaguchi, , Japan

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Countries

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Japan

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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113121

Identifier Type: -

Identifier Source: org_study_id

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