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

Sponsor:	GlaxoSmithKline
Information provided by (Responsible Party):	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
Diabetes Mellitus, Type 2	Drug: metformin + glimepiride + pioglitazone + albiglutide placebo Biological: metformin + glimepiride + pioglitazone placebo + albiglutide Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo	Phase 3

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Glimepiride Pioglitazone Pioglitazone 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 ]
change from baseline

Secondary Outcome Measures:

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

Enrollment:	685
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2013
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

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 355 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00839527 History of Changes
Other Study ID Numbers:	112757
Study First Received:	February 5, 2009
Last Updated:	May 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

diabetes

Additional relevant MeSH terms:

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

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012