PURPOSE: To evaluate the efficacy and tolerability of pioglitazone in combination with a sulfonylurea in the treatment of type 2 diabetes mellitus. SUBJECTS AND METHODS: This 16-week, double-blind study included patients on a stable regimen of a sulfonylurea for ≥30 days and with a glycosylated hemoglobin (HbA1C) level ≥8.0%. Patients were randomly assigned to receive once daily pioglitazone 15 mg (n = 184), pioglitazone 30 mg (n = 189), or placebo plus sulfonylurea (n = 187). RESULTS: Patients receiving pioglitazone + sulfonylurea had significant (P 1C and fasting plasma glucose levels compared with patients treated with placebo + sulfonylurea. As compared with placebo, HbA1C decreased by 0.9% (95% confidence interval [CI]: 0.06% to 1.2%) with pioglitazone 15 mg and 1.3% (CI: 1% to 1.6%) with 30 mg pioglitazone; fasting plasma glucose levels decreased by 39 mg/dL (95% CI: 27 to 52 mg/dL) with pioglitazone 15 mg and by 58 mg/dL (95% CI: 46-70 mg/dL) with 30 mg pioglitazone. Both pioglitazone + sulfonylurea groups had significant (P 1C and fasting plasma glucose levels with beneficial effects on serum triglyceride and HDL-cholesterol levels.
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