Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus: a placebo-controlled, double-blind, multicentre study

Aims The aim of the study was to evaluate the efficacy and safety of acarbo se in patients with Type 1 diabetes mellitus (DM). Methods A multicentre double-blind, randomized, placebo-controlled study wa s performed. After a 6-week run-in, 121 patients were randomized to acarbos e or placebo and to high- or low-fibre diet for 24 weeks. Acarbose dose was 50 mg t.d.s. for the first 2 weeks and 100 mg r.d.s. for the subsequent we eks. Results At the end of 24 weeks of treatment the intention to treat analysis showed that acarbose compared with placebo decreased 2 h postprandial plas ma glucose levels (12.23 +/- 0.83 vs. 14.93 +/- 0.87 mmol/l; F = 6.1, P < 0 .02) (least square means +/- SEM). No significant effect of acarbose was re corded on HbA(1c) or on the number of hypoglycaemic episodes. The effect of acarbose on blood glucose control was not influenced by the amount of carb ohydrate and/or fibre intake. The incidence of adverse events were 75% and 39% in acarbose and placebo groups, respectively; they were mild and confin ed to the gastrointestinal tract. Conclusions The use of acarbose in combination with insulin reduces postpra ndial plasma glucose levels in Type 1 diabetic patients who are not satisfa ctorily controlled with insulin alone but without significant effect on HbA (1c).