Safety and Efficacy of Albiglutide in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849056
First received: February 19, 2009
Last updated: February 7, 2013
Last verified: February 2013

February 19, 2009
February 7, 2013
January 2009
January 2013   (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 NCT00849056 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 ]
Not Provided
Not Provided
 
Safety and Efficacy of Albiglutide in Type 2 Diabetes
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes.

The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of 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 + pioglitazone with or without metfomin
    albiglutide weekly injection + pioglitazone (with or without metformin)
  • Biological: placebo + pioglitazone with or without metformin
    placebo albiglutide weekly injection + pioglitazone (with or without metformin)
  • Placebo Comparator: placebo + pioglitazone (with or without metformin)
    Placebo albiglutide weekly injection + pioglitazone (with or without metformin)
    Intervention: Biological: placebo + pioglitazone with or without metformin
  • Experimental: albiglutide + pioglitazone (with or without metformin)
    albiglutide weekly injection + pioglitazone (+/- meformin)
    Intervention: Biological: albiglutide + pioglitazone with or without metfomin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetes
  • BMI 20-45kg/m2

Exclusion Criteria:

  • NYHA Class II to IV heart failure
  • females who are pregnant, lactating, or less than 6 weeks post-partum
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Korea, Republic of,   Peru,   South Africa,   United Kingdom
 
NCT00849056
112755
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

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