Safety and Efficacy of Albiglutide in Type 2 Diabetes - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00849056

Purpose

The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Biological: albiglutide Biological: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Metformin

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	300
Study Start Date:	January 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo + pioglitazone (with or without metformin): Placebo Comparator Placebo albiglutide weekly injection + pioglitazone (with or without metformin)	Biological: placebo placebo albiglutide weekly injection + pioglitazone (with or without metformin)
albiglutide + pioglitazone (with or without metformin): Experimental albiglutide weekly injection + pioglitazone (+/- meformin)	Biological: albiglutide albiglutide weekly injection + pioglitazone (with or without metformin)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849056

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	112755
Study First Received:	February 19, 2009
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00849056 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

diabetes

Study placed in the following topic categories:

Metabolic Diseases
Pioglitazone
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 30, 2009