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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00839527
First received: February 5, 2009
Last updated: January 21, 2013
Last verified: November 2012
History of Changes
  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:

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 359 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: January 21, 2013
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 June 18, 2013