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Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849017
First received: February 19, 2009
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Biological: albiglutide
Biological: albiglutide uptitration
Biological: 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-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With 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:
  • 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: 309
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albiglutide
albiglutide weekly injection
 Biological: albiglutide
albiglutide weekly injection
Placebo Comparator: placebo
albiglutide matching placebo
 Biological: placebo
matching albiglutide placebo weekly injection
Experimental: albiglutide up-titration
albiglutide weekly injection uptitration at week 12
 Biological: albiglutide uptitration
albiglutide uptitration at week 12

  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
  • CHF NYHA class III-IV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849017

  Show 269 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849017     History of Changes
Other Study ID Numbers: 112756
Study First Received: February 19, 2009
Last Updated: January 31, 2013
Health Authority: South Africa: Medicines Control Council
Mexico: Ministry of Health
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
placebo
albiglutide
monotherapy
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013