Details

Autor(en) / Beteiligte

• Halimi, S
• Le Berre, M.A
• Grangé, V

Titel

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

Ist Teil von

• Diabetes research and clinical practice, 2000-09, Vol.50 (1), p.49-56

Ort / Verlag

Shannon: Elsevier Ireland Ltd

Erscheinungsjahr

2000

Quelle

Elsevier Journal Backfiles on ScienceDirect (DFG Nationallizenzen)

Beschreibungen/Notizen

• This 6-month, double-blind, placebo-controlled, randomised, parallel-group study investigated the potential of acarbose add-on therapy for improving the glycaemic control of overweight patients with Type 2 diabetes and was inadequately controlled with metformin monotherapy. Patients were randomised to receive acarbose titrated up to 100 mg three times daily ( n=74) or placebo ( n=78). All patients were receiving metformin 850 mg twice or thrice daily before the study and continued to receive this dose throughout the study. 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-treat (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 group, compared with +1.3±2.8 mmol/l in the placebo ITT group ( P=0.0001), 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 and 33% in the placebo group had an adverse event considered to be possibly or probably related to drug therapy, leading to withdrawal by 15 and 3%, respectively. The results indicate that acarbose has potential clinical utility for improving glycaemic control in overweight patients with Type 2 diabetes inadequately controlled with metformin.