A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes. - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00839527

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo Drug: metformin + glimepiride + pioglitazone + albiglutide placebo Biological: metformin + glimepiride + pioglitazone placebo + albiglutide	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride

U.S. FDA Resources

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:	600
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
metformin + glimepiride + pioglitazone + albiglutide placebo: Active Comparator Metformin + glimepiride + pioglitazone + matching albiglutide placebo	Drug: metformin + glimepiride + pioglitazone + albiglutide placebo metformin + open-label glimepiride + pioglitazone + albiglutide matching placebo
met + glimepiride + pioglitazone placebo + albiglutide placebo: Active Comparator metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo	Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide matching placebo
metformin + glimepiride + pioglitazone placebo + albiglutide: Experimental Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide	Biological: metformin + glimepiride + pioglitazone placebo + albiglutide metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide

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 less than 6 weeks post-partum
current symptomatic heart failure (NYHA Class II-IV)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839527

Show 359 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:	112757
Study First Received:	February 5, 2009
Last Updated:	February 25, 2010
ClinicalTrials.gov Identifier:	NCT00839527 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

diabetes

Additional relevant MeSH terms:

Metabolic Diseases
Pioglitazone
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents

Immunosuppressive Agents
Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on March 18, 2010