Efficacy and safety of acarbose add-on therapy in the treatment of overweight patients with Type 2 diabetes inadequately controlled with metformin: adouble-blind, placebo-controlled study

This 6-month, double-blind, placebo-controlled, randomised, parallel-group study investigated the potential of acarbose add-on therapy for improving t he glycaemic control of overweight patients with Type 2 diabetes and was in adequately controlled with metformin monotherapy. Patients were randomised to receive acarbose titrated up to 100 mg three times daily (n = 74) or pla cebo (n = 78). All patients were receiving metformin 850 mg twice or thrice daily before the study and continued to receive this dose throughout the s tudy. The mean difference in glycated haemoglobin (HbA(1c)) (+/- S.D.) from baseline to endpoint was - 0.7 +/- 1.2% U in the acarbose intention-to-tre at (ITT) group, compared with + 0.2 +/- 1.3% in the placebo ITT group (P = 0.0001). Significantly, more patients in the acarbose group were classified as 'responders', with an HbA(1c) at the end of treatment of less than 7.0% or a decrease by at least 15% relative to baseline (acarbose vs, placebo; 42 vs. 17%; P = 0.002). The difference in fasting blood glucose level from baseline to endpoint was - 1.0 +/- 2.8 (S.D.) mmol/l in the acarbose ITT gr oup, compared with + 1.3 +/- 2.8 mmol/l in the placebo ITT group (P = 0.000 1), and for 2-h postprandial blood glucose level - 1.4 +/- 3.8 vs. + 1.1 +/ - 3.5 mmol/l (P = 0.0001). In all, 60% of patients in the acarbose group an d 33% in the placebo group had an adverse event considered to be possibly o r probably related to drug therapy, leading to withdrawal by 15 and 3%, res pectively. The results indicate that acarbose has potential clinical utilit y for improving glycaemic control in overweight patients with Type 2 diabet es inadequately controlled with metformin. (C) 2000 Published by Elsevier S cience ireland Ltd.