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

This study is currently recruiting participants.

Verified by GlaxoSmithKline, April 2009

First Received: February 5, 2009 Last Updated: April 30, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00838916

Purpose

A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Biological: albiglutide Drug: insulin glargine	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Long-Term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.

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:	750
Study Start Date:	February 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
insulin glargine: Active Comparator	Drug: insulin glargine insulin glargine
albiglutide weekly injection: Experimental	Biological: albiglutide albiglutide weekly injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

type 2 diabetes
BMI 20-45kg/m2 inclusive

Exclusion Criteria:

females who are pregnant, lactating or within <6 weeks post-partum
current symptomatic heart failure (NYHA Class III-IV)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838916

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 277 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	112754
Study First Received:	February 5, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00838916 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

diabetes

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 06, 2009