Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: glyburide; Drug: metformin; Drug: Rosiglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00279045

49653/048

Details and patient eligibility

About

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.

Enrollment: 4,426 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.