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Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838903
First received: February 5, 2009
Last updated: January 21, 2013
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
 Biological: albiglutide
Drug: sitagliptin
Drug: glimepiride
Drug: metformin
 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 When Used in Combination With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HbA1 c change from baseline [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG change from baseline [ Time Frame: two years ] [ Designated as safety issue: No ]
  • body weight change from baseline [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: February 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albiglutide + metformin
Albiglutide + metformin + placebo sitagliptin + placebo glimepiride
 Biological: albiglutide
albiglutide + metformin + placebo sitagliptin + placebo glimepiride
Active Comparator: sitagliptin + metformin
Sitagliptin + metformin + placebo albiglutide + placebo glimepiride
 Drug: sitagliptin
sitagliptin + metformin + placebo albiglutide + placebo glimepiride
Active Comparator: glimepiride + metformin
Glimepiride + metformin + placebo albiglutide + placebo sitagliptin
 Drug: glimepiride
Glimepiride + metformin + placebo albiglutide + placebo sitagliptin
Active Comparator: metformin + placebo
Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride
 Drug: metformin
Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepride

  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 <6 weeks post-partum
  • current symptomatic heart failure (NYHA Class III or IV)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838903

  Show 389 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00838903     History of Changes
Other Study ID Numbers: 112753
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
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013