日本人2型糖尿病患者に対するAnagliptinのインスリン製剤との併用療法における有効性および安全性の検討一多施設共同，ランダム化，プラセボ対照二重盲検群間比較およびオープンラベル長期投与試験一

摘要

Background and Aim Anagliptin, a novel dipeptidyl peptidase-4 inhibitor, has been used in monotherapy and combination therapy with a-glucosidase inhibitors, biguanides, sulfonylureas, or thiazolidinediones for patients with type 2 diabetes in Japan. We investigated the efficacy and safety of anagliptin add to insulin therapy in a multi-center, randomized, placebo controlled, double-blind, parallel-group study with an open-label,40 weeks extension in Japanese patients with type 2 diabetes mellitus. Methods A total of123 subjects with type 2 diabetes receiving insulin therapy were treated with100 mg of anagliptin or placebo twice a day for12 weeks. Thereafter, all subjects continued on anagliptin100 mg twice a day in an open-label extension for 40 weeks. Patients who did not achieve the HbAlc goal (less than 7.0%) at either visit from week 28 to week 40 were placed on anagliptin 200 mg twice a day. The primary endpoint was the change in HbAlc from baseline to the end of the double-blind period (week12). Results After12 weeks, HbAlc in anagliptin-treated group were significantly decreased compared to those in placebo-treated group. This significant reduction of HbAlc was observed with any type of insulin therapy. Postprandial glucose, area under the curve (AUC) of glucose, 1,5 -AG, glycoalbumin in anagliptin-treated group were also significantly improved compared to those in the placebo-treated group. Significant reductions of HbAlc from baseline were sustained through 52 weeks. The most frequent adverse event is hypoglycemia which was not statistically different in the placebo-treated group and anagliptin—treated group. We did not observe any clinically important adverse events else.Conclusions We demonstrated that anagliptin was effective and well tolerated in the treatment of the patients with type 2 diabetes mellitus receiving insulin therapy. These results suggest that anagliptin is a useful add-on insulin therapy in type 2 diabetes.