A DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL EVALUATING THE SAFETY AND EFFICACY OF ACARBOSE FOR THE TREATMENT OF PATIENTS WITH INSULIN-REQUIRING TYPE-II DIABETES

OBJECTIVE-To determine whether a forced titration of acarbose (from 50 to 300 mg three times daily) administered over a 24-week period, in conjunction with diet and insulin therapy, improves glycemic control and reduces daily insulin requirements in insulin-requiring type II diabetes. RESEARCH DESIGN AND METHODS-This multicenter, randomized, double-blind, placebo-controlled trial was 36 weeks in duration. The trial consisted of a 6-week pretreatment period, a 24-week double-blind treatment period, and a 6-week post-treatment follow-up period. The primary efficacy variables were the mean change from baseline in HbA(1c) levels and the mean percentage change from baseline in total daily insulin dose. RESULTS-Treatment with acarbose was associated with significant reductions in HbA(1c) levels of 0.40% (P = 0.0001) and in total daily insulin dose of 8.3% (P = 0.0015). There were also significant reductions in all plasma glucose variables measured, including a 0.9 mmol/l reduction in fasting glucose (P = 0.0440), a 2.6 mmol/l reduction in glucose C-max (P = 0.0001) and a 270 mmol . min(-1). l(-1) reduction in glucose area under the curve (P = 0.0002). Although acarbose treatment was associated with a greater incidence of adverse events than was placebo treatment, primarily flatulence and diarrhea, these events did not generally prevent patients from completing the study. CONCLUSIONS-The results of this study suggest that acarbose is a safe and effective adjunct to diet and insulin therapy for the management of insulin-requiring type II diabetes.