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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00849017

Purpose

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Biological: albiglutide uptitration Biological: placebo Biological: albiglutide	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 Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	315
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: Placebo Comparator albiglutide matching placebo	Biological: placebo matching albiglutide placebo weekly injection
albiglutide up-titration: Experimental albiglutide weekly injection uptitration at week 12	Biological: albiglutide uptitration albiglutide uptitration at week 12
albiglutide: Experimental albiglutide weekly injection	Biological: albiglutide albiglutide weekly injection

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849017

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	112756
Study First Received:	February 19, 2009
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00849017 History of Changes
Health Authority:	United States: Food and Drug Administration; Mexico: Ministry of Health; South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:

diabetes
albiglutide
monotherapy
placebo

Study placed in the following topic categories:

Metabolic Diseases
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