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To assess the efficacy, safety, and dose-response relationship of glimepiride in patients with NIDDM.After a 21-day placebo washout period, 304 patients were randomized to receive either placebo or glimepiride, 1, 4, or 8 mg once daily. Fasting plasma glucose (FPG), 2-h postprandial glucose (PPG), and HbA1c were measured at predetermined intervals during the washout period and the 14-week study. Adverse events were tabulated.At each patient visit, reduction from baseline FPG was greater in each glimepiride group than in the placebo group (P less than 0.001). Changes from baseline to endpoint after 1, 4, and 8 mg glimepiride exceeded those after placebo (P less than 0.001) by 2.4, 3.9, and 4.1 mmol/l, respectively, for FPG; by 1.2, 1.8, and 1.9 percentage points, respectively, for HbA1c; and by 3.5, 5.1, and 5.2 mmol/l, respectively, for 2-h PPG. Greater reductions in these parameters were observed with 8 and 4 mg than with 1 mg (P less than 0.05), indicating a dose-response relationship. When patients with baseline HbA1c levels greater or equal to 8 percent were assessed, more patients who received 8 mg glimepiride had HbA1c values less than 8 percent at endpoint compared with patients receiving 4 mg. Glimepiride had a favorable safety profile.Glimepiride in 1-, 4-, or 8-mg once-daily doses was effective and well tolerated. Although the 4- and 8-mg doses were significantly more potent than the 1-mg dose, all greater number of patients with high baseline HbA1c levels than did the 4-mg dose, this higher dose might be beneficial for patients who are difficult to treat.