Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

• Status: Completed
• Trial end date: 2006-06-19
• Target enrollment: 0
• Participant gender: All

Summary

The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Glyburide; Metformin; Rosiglitazone

Criteria

Inclusion criteria:

• Newly diagnosed patients (< 3years) with type 2 diabetes.

• Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.

• No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

• History of lactic acidosis.

• Anemia (<11g for males, <10 g for females).

• Unstable or severe NY Heart Association-class 3 or 4.

• Any NY Heart Association congestive heart failure.

• Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.