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.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2005

Intervention(s) in this Clinical Trial

• Drug: rosiglitazone/metformin

Primary Measures

• Change from baseline in HbA1c at week 48.

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00241605

Study ID Number: 712753/008

ClinicalTrials.gov Identifier: NCT00241605

Health Authority: Canada: Health Canada