Effect of Metformin and Rosiglitazone Combination Therapy in Patients With Type 2 Diabetes Mellitus
Abstract
CONTEXT: Most antidiabetic agents target only 1 of several underlying causes of diabetes. The complementary actions of the antidiabetic agents metformin hydrochloride and rosiglitazone maleate may maintain optimal glycemic control in patients with type 2 diabetes; therefore, their combined use may be indicated for patients whose diabetes is poorly controlled by metformin alone. OBJECTIVE: To evaluate the efficacy of metformin-rosiglitazone therapy in patients whose type 2 diabetes is inadequately controlled with metformin alone. DESIGN: Randomized, double-blind, placebo-controlled trial from April 1997 and March 1998. SETTING: Thirty-six outpatient centers in the United States. PATIENTS: Three hundred forty-eight patients aged 40 to 80 years with a mean fasting plasma glucose level of 12.0 mmol/L (216 mg/dL), a mean glycosylated hemoglobin level of 8.8%, and a mean body mass index of 30.1 kg/m2 were randomized. INTERVENTIONS: Patients were assigned to receive 2.5 g/d of metformin plus placebo (n = 116); 2.5 g/d of metformin plus 4 mg/d of rosiglitazone (n = 119); or 2.5 g/d of metformin and 8 mg/d of rosiglitazone (n = 113) for 26 weeks. MAIN OUTCOME MEASURES: Glycosylated hemoglobin levels, fasting plasma glucose levels, insulin sensitivity, and beta-cell function, compared between baseline and week 26, by treatment group. RESULTS: Glycosylated hemoglobin levels, fasting plasma glucose levels, insulin sensitivity, and beta-cell function improved significantly with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 119 participants or records.
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