日本人2型糖尿病患者に対するAnagliptinの 速効型インスリン分泌促進薬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 as an add-on to glinides in a multi-center, single-group, open-label, 52 week long-term study in Japanese patients with type 2 diabetes. Methods A total of 63 subjects with type 2 diabetes receiving glinide therapy were treated with100 mg of anagliptin twice a day. Patients who did not achieve the HbAlc goal (less than 6.9%) at any visit from week 24 to week 36 were placed on anagliptin 200 mg twice a day. The primary endpoint was the change in HbAlc relative to baseline to the end of the study (week 52). Results Significant reductions of HbAlc were continuously observed from week 4 to week 52. The fasting plasma glucose, postprandial glucose (0.5-h, l_h， 2_h), area under the curve of glucose, 1,5-AG, and glycoalbumin were also significantly improved, compared with baseline. Hypoglycemia occurred in 9.5% of subjects; however, all cases were slight and not serious. No other clinically important adverse events were observed. Conclusions We demonstrated that anagliptin was effective and well-tolerated in the treatment of patients with type 2 diabetes receiving glinide therapy. These results suggest that anagliptin, used as an add-on to glinides is useful for the treatment of type 2 diabetes.