EFFICACY AND SAFETY OF ACARBOSE IN METFORMIN-TREATED PATIENTS WITH TYPE-2 DIABETES

OBJECTIVE - To demonstrate the efficacy, tolerability, and safety of a carbose compared with placebo in patients with type 2 diabetes inadequ ately controlled with diet and metformin (2,000 or 2,500 mg/day in div ided doses). RESEARCH DESIGN AND METHODS - This study had a multicente r randomized double-blind placebo-controlled parallel-group comparison design. The trial lasted 31 weeks and consisted of a 1-week screening period, a 6-week placebo pretreatment period, and a 24-week period of acarbose or placebo, with a forced titration from 25-50 mg t,i.d. and a titration of 50-100 mg tid that was based on glucose control. The p rimary efficacy variable was the mean change from baseline in HbA(1c). Secondary efficacy variables included mean changes from baseline in f asting and postprandial plasma glucose, serum insulin, and triglycerid e levels. RESULTS - The addition of acarbose to patients on background metformin and diet therapy showed a statistically significant reducti on in mean HbA(1c) of 0.65%. There were statistically significant redu ctions in fasting and postprandial plasma glucose and serum insulin le vels compared with placebo. Gastrointestinal side effects were more fr equently reported in the acarbose-treated patients. No significant dif ferences in liver transaminase elevations were observed between patien ts treated with acarbose and those treated with placebo. CONCLUSIONS - The results of this study demonstrate that the addition of acarbose t o patients with type 2 diabetes who are inadequately controlled with m etformin and diet is safe and generally well tolerated and that it sig nificantly lowers HbA(1c) and fasting and postprandial glucose and ins ulin levels.