A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00839527

First received: February 5, 2009

Last updated: January 21, 2013

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 5, 2009

Last Updated Date

January 21, 2013

Start Date ^ICMJE

February 2009

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HbA1c change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]

change from baseline

Original Primary Outcome Measures ^ICMJE

HbA1c change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00839527 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

FPG change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
change from baseline
body weight change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
change from baseline

Original Secondary Outcome Measures ^ICMJE

FPG change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
body weight change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes

Official Title ^ICMJE

A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone.

Brief Summary

The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: metformin + glimepiride + pioglitazone + albiglutide placebo
metformin + open-label glimepiride + pioglitazone + albiglutide matching placebo
Biological: metformin + glimepiride + pioglitazone placebo + albiglutide
metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide matching placebo

Study Arm (s)

Active Comparator: metformin + glimepiride + pioglitazone + albiglutide placebo
Metformin + glimepiride + pioglitazone + matching albiglutide placebo

Intervention: Drug: metformin + glimepiride + pioglitazone + albiglutide placebo
Experimental: metformin + glimepiride + pioglitazone placebo + albiglutide
Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide

Intervention: Biological: metformin + glimepiride + pioglitazone placebo + albiglutide
Active Comparator: met + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo

Intervention: Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

685

Estimated Completion Date

March 2013

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

type 2 diabetes
BMI 20-45kg/m2 inclusive

Exclusion Criteria:

females who are pregnant, lactating, or less than 6 weeks post-partum
current symptomatic heart failure (NYHA Class II-IV)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany, Hong Kong, India, Peru, Philippines, Russian Federation, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00839527

Other Study ID Numbers ^ICMJE

112757

Has Data Monitoring Committee

Yes

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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