LONG-TERM EFFICACY AND SAFETY OF ACARBOSE IN THE TREATMENT OF OBESE SUBJECTS WITH NON-INSULIN-DEPENDENT DIABETES-MELLITUS

Background: Acarbose delays the release of glucose from complex carbohydrates and disaccharides by inhibiting intestinal cr-glucosidases, attenuating postprandial increments in blood glucose and insulin. This multicenter double-blind study compared the efficacy and safety of acarbose with placebo in the treatment of obese subjects with non-insulin-dependent diabetes mellitus (NIDDM) managed by diet. Methods: Two hundred twelve obese subjects with NIDDM who had not received any diabetic medication for at least 12 weeks were randomized to receive acarbose or placebo. The subjects were stratified by fasting glucose level above or below 11.1 mmol/L (200 mg/dL). Based on the subject's therapeutic response and tolerance, the acarbose dosage was titrated from 50 to 300 mg three times per day. This 36-week study consisted of a 6-week pretreatment period, a 24-week double-blind treatment period, and a 6-week posttreatment period. Results: Ninety-one subjects given acarbose and 98 subjects who received placebo were evaluable for efficacy. During a standard meal tolerance test at the double-blind end point, the differences between treatment groups in mean change from baseline were as follows: 0.9 mmol/L (16 mg/dL) for fasting plasma glucose level, approximately 2.8 mmol/L (50 mg/dL) for postprandial plasma glucose level, and 0.59% (P < .0001) for hemoglobin A(1c) concentration (for all three measurements, values decreased in the acarbose group and increased in the placebo group). Conclusions: Acarbose improved both fasting and postprandial hyperglycemia and improved overall glycemic control as measured by the hemoglobin A(1c) level. These findings suggest a beneficial role for acarbose in combination with diet in the treatment of obese subjects with NIDDM.