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

February 19, 2009
January 31, 2013
January 2009
October 2010   (final data collection date for primary outcome measure)
HbA1c change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
change from baseline
HbA1c change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00849017 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Albiglutide in Type 2 Diabetes
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Biological: albiglutide
    albiglutide weekly injection
  • Biological: albiglutide uptitration
    albiglutide uptitration at week 12
  • Biological: placebo
    matching albiglutide placebo weekly injection
  • Experimental: albiglutide
    albiglutide weekly injection
    Intervention: Biological: albiglutide
  • Placebo Comparator: placebo
    albiglutide matching placebo
    Intervention: Biological: placebo
  • Experimental: albiglutide up-titration
    albiglutide weekly injection uptitration at week 12
    Intervention: Biological: albiglutide uptitration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
309
January 2013
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico,   South Africa
 
NCT00849017
112756
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP