AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00241605
First received: October 17, 2005
Last updated: July 11, 2013
Last verified: July 2012
  Purpose

This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: rosiglitazone/metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in HbA1c at week 48.

Secondary Outcome Measures:
  • Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.

Estimated Enrollment: 600
Study Start Date: June 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rosiglitazone/metformin
    Other Name: rosiglitazone/metformin
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
  • Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
  • Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.

Exclusion Criteria:

  • Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
  • Have a known hypersensitivity to thiazolidinediones or biguanides.
  • Currently using insulin or any oral anti-diabetic agent other than metformin.
  • History of metabolic acidosis.
  • History of substance abuse.
  • Have active cancer other than localized squamous or basal cell carcinoma.
  • Chronic disease requiring treatment with corticosteroids.
  • Other criteria will be evaluated at the screening visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241605

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00241605     History of Changes
Other Study ID Numbers: 712753/008
Study First Received: October 17, 2005
Last Updated: July 11, 2013
Health Authority: Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Metformin
AVANDAMET
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014