LONG-TERM EFFECTIVENESS OF A NEW ALPHA-GLUCOSIDASE INHIBITOR (BAY M1099-MIGLITOL) IN INSULIN-TREATED TYPE-2 DIABETES-MELLITUS

In a double-blind, randomized study, miglitol (BAY m 1099), an alpha-g lucosidase inhibitor, 100 mg tds or placebo was given orally with meal s for a period of 24 weeks in 117 patients with Type 2 (non-insulin-de pendent) diabetes mellitus (DM) treated with insulin. Easting and 1 h postprandial plasma glucose and C-peptide were measured at the beginni ng and at the end of each 4-week interval and glycosylated haemoglobin was determined at day 0 and at the end of the 12th and 24th week. One hour postprandial plasma glucose was significantly lower in the migli tol group at the end of the 24th week (placebo: 11.6 +/- 1.5 vs miglit ol: 8.2 +/- 1.5 mmol l(-1), mean +/- SD, p = 0.001). Diabetes control improved in the same group as the HbA(1) was lowered by 16 % (p = <0.0 001) at the end of the treatment. Mild reversible adverse effects were observed in 37 patients of the miglitol group (mainly flatulence and mild hypoglycaemia) and 2 of the placebo group. Urinary glucose was re ndered negative in 41 patients in the miglitol group only. Thus miglit ol appears to be a safe and effective adjunct in the management of Typ e 2 DM, in association with insulin. (C) 1998 John Wiley & Sons, Ltd.