Dutch Acarbose Intervention Trial (DAISI).

A total of 171 subjects were screened and 121 subjects with impaired glucose tolerance were included in the randomized, double-blind and placebo-controlled treatment phase over 3 years (60 placebo and 61 acarbose).

33 subjects under placebo and 27 subjects under acarbose completed the study. All randomized subjects were included in the safety population, 118 subjects (58 placebo, 60 acarbose) in the ITT population and 71 subjects (39 placebo, 32 acarbose) in the PP population.

Median age of subjects in the safety population was 56 years (placebo) and 61 years (acarbose), respectively. The sex ratio in each of the treatment groups was nearly 1:1.

Descriptively, the mean post-load glucose value after 3 years of treatment was slightly lower among subjects under acarbose compared with placebo, but in all analyzed parameters of glucose metabolism - including the oGGT data, the results derived from the hyperglycemic clamp, and the conversion rates- there appeared to be no clear and relevant differences between treatment groups.

Approximately 1/3 of persons with IGT develops type 2 diabetes mellitus in 5-10 years time. Acarbose is an alpha-glucosidase inhibitor decreasing post-prandial glucose levels, without the risk of hypoglycemia. The prevention of diabetes with acarbose in this study was considered a feasible approach.

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Acarbose used at a fixed dose of 50 mg. The daily maintenance dose was 50 mg tid, which was reached as from Week 3 after 2 weeks of up-titration with 50 mg od (Week 1) and 50 mg bid (Week 2).