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
  Purpose

The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Biological: albiglutide + pioglitazone with or without metfomin
Biological: placebo + pioglitazone with or without 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-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.

Resource links provided by NLM:


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: 310
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo + pioglitazone (with or without metformin)
Placebo albiglutide weekly injection + pioglitazone (with or without metformin)
Biological: placebo + pioglitazone with or without metformin
placebo albiglutide weekly injection + pioglitazone (with or without metformin)
Experimental: albiglutide + pioglitazone (with or without metformin)
albiglutide weekly injection + pioglitazone (+/- meformin)
Biological: albiglutide + pioglitazone with or without metfomin
albiglutide weekly injection + pioglitazone (with or without metformin)

  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

Exclusion Criteria:

  • NYHA Class II to IV heart failure
  • females who are pregnant, lactating, or less than 6 weeks post-partum
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849056

  Show 331 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849056     History of Changes
Other Study ID Numbers: 112755
Study First Received: February 19, 2009
Last Updated: February 7, 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
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014