薬理と治療

Abstract

Aim We performed a dose-ranging study of anagliptin, a novel dipeptidyl peptidase-4 inhibitor, with multi-centre, randomized, placebo-controlled, double-blind, parallel-group design, to investigate its efficacy and safety in Japanese patients with type 2 diabetes mellitus. Methods A total of 358 subjects with type 2 diabetes treated with 25 to 200 mg of anagliptin twice a day(BID)or a placebo for 12 weeks. The markers for glycemic control were measured and investigated, and the change in HbA1c levels from baseline to week 12 was assessed as the primary endpoint. Results At week 12, HbA1c significantly decreased in anagliptin-treated groups, but not in the placebo group, in a dose-dependent manner. The difference of HbA1c reduction between the groups treated with 100 and 200 mg BID was only 0.07%. In the subgroup with baseline HbA1c level at 8.4% or more, HbA1c reduction was much greater in the group with 200 mg BID than the group with 100 mg BID. Any clinically important adverse events were not observed. Conclusions The results showed that anagliptin was efficacious for the treatment of the patients with type 2 diabetes, and that its optimum dose was 100 mg twice a day. The results from subgroup analysis suggested that the dose escalation of anagliptin to 200 mg twice a day is useful for the treatment of the patients with a high level of HbA1c.