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

February 5, 2009
January 21, 2013
February 2009
December 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 NCT00839527 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
 
A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
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.

The purpose of this study is to determine the safety and efficacy of albiglutide in subjects 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
  • Drug: metformin + glimepiride + pioglitazone + albiglutide placebo
    metformin + open-label glimepiride + pioglitazone + albiglutide matching placebo
  • Biological: metformin + glimepiride + pioglitazone placebo + albiglutide
    metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
  • Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo
    metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide matching placebo
  • Active Comparator: metformin + glimepiride + pioglitazone + albiglutide placebo
    Metformin + glimepiride + pioglitazone + matching albiglutide placebo
    Intervention: Drug: metformin + glimepiride + pioglitazone + albiglutide placebo
  • Experimental: metformin + glimepiride + pioglitazone placebo + albiglutide
    Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
    Intervention: Biological: metformin + glimepiride + pioglitazone placebo + albiglutide
  • Active Comparator: met + glimepiride + pioglitazone placebo + albiglutide placebo
    metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
    Intervention: Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
685
March 2013
December 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 less than 6 weeks post-partum
  • current symptomatic heart failure (NYHA Class II-IV)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Hong Kong,   India,   Peru,   Philippines,   Russian Federation,   Spain,   United Kingdom
 
NCT00839527
112757
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

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