薬理と治療

Abstract

Background and aim Anagliptin, a novel dipeptidyl peptidase-4 inhibitor, has been used in monotherapy and combination therapy with α-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 with 100 mg of anagliptin twice a day. Patients who did not achieve the HbA1c 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 HbA1c relative to baseline to the end of the study（week 52）. Results Significant reductions of HbA1c were continuously observed from week 4 to week 52. The fasting plasma glucose, postprandial glucose（0.5-h, 1-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.