Long‐term effectiveness of a new α‐glucosidase inhibitor (BAY m1099‐miglitol) in insulin‐treated Type 2 diabetes mellitus

In a double-blind, randomized study, miglitol (BAY m 1099), an α-glucosidase inhibitor, 100 mg tds or placebo was given orally with meals for a period of 24 weeks in 117 patients with Type 2 (non-insulin-dependent) diabetes mellitus (DM) treated with insulin. Fasting and 1 h postprandial plasma glucose and C-peptide were measured at the beginning 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 miglitol group at the end of the 24th week (placebo: 11.6 ± 1.5 vs miglitol: 8.2 ± 1.5 mmol l−1, mean ± SD, p = 0.001). Diabetes control improved in the same group as the HbA1 was lowered by 16 % (p = <0.0001) 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 rendered negative in 41 patients in the miglitol group only. Thus miglitol appears to be a safe and effective adjunct in the management of Type 2 DM, in association with insulin. © 1998 John Wiley & Sons, Ltd.