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Background: The efficacy and safety of aglucosidase inhibitor, acarbose, was investigated in patients with non-insulin-dependent diabetes mellitus (NIDDM) who could not achieve satisfactory glycemic control by sulfonylurea or sulfonylurea/metformin combination. Methods: This randomized placebo-controlled double-blind cross-over study comprised a 4 week run-in period, a 12 week test period, a 4 week wash-out period and a 12 week crossover-test period. Thirty NIDDM patients, insufficiently treated with sulfonylurea (n=10) or sulfonylurea plus metformin (n=20) were randomized into two groups. During the test periods, l00mg of acrbose or placebo were given three times per day just before each meal to each group respectively. Before and after 12 weeks of test and crossover-test period, levels of hemoglobin A(HbA), serum lipids, fasting and postprandial lh & 2h glucose and insulin were measured. Results: Two patients were dropped out during acarbose period due to gastrointestinal side effects. Additional two patients were dropped out during placebo period due to personal problems not associated with side effects. Of 26 patients who completed the study, 9 were being treated with sulfonylurea and 17 with sulfonylurea plus metformin. Compared with baseline, acarbose treatment caused a significant decrease in the mean fasting and postprandial lh & 2h serum glucose (208+34 vs 176 +39, 315+48 vs 261+58, 297+53 vs 252+ 68mg/dL respectively, p<0.05), and HbA> levels (11.8+1.5 vs 10.6+2.0%, p<0.05). The incidence of side effects (mainly gastrointestinal symptoms such as flatulence and abdominal pain) was higher in acarbose treatment period than in placebo treatment period (48% vs 11%, p<0.05). However in most cases, these side-effects faded away with prolonged use of the drug. Conclusion: Acarbose significantly improved glycemic control of NIDDM patients when combined with sulfonylurea or sulfonylurea/metformin.