Resumen:
Background: Largest head-to-head, double-blind study of metformin, glyburide and rosiglitazone (N = 4,360).
Primary objective: To compare the durability of glycemic control using rosiglitazone versus metformin or glyburide as initial monotherapy in patients with recently diagnosed type 2 diabetes.
Design: Double-blind, randomized, controlled trial.
Inclusion criteria: Type 2 diabetes ≤ 3 years, drug-naive, male and female, aged 30–75 years, FPG 126–180 mg/dl (7–10 mmol/l).
Exclusion criteria: Previous use of glucose-lowering therapy, women of child-bearing potential, significant hepatic disease, renal impairment, unstable or severe angina, known CHF (NYHA Class I–IV), uncontrolled hypertension.
Treatment duration: Treatment period: 4 to 6 years. Median duration of treatment: 4 years (rosiglitazone and metformin); 3.3 years (glyburide).
Interventions: Rosiglitazone, metformin, glyburide.
