AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2005-12-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Metformin; Rosiglitazone

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.