Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open-label, multicenter study.

AIM/INTRODUCTION: To assess the overall safety and efficacy of lixisenatide in combination with background oral antidiabetic drug treatment in Japanese patients with type 2 diabetes, as required by Japanese guidelines. MATERIALS AND METHODS: A phase 3, multicenter, uncontrolled, open-label, four-arm, parallel-group study of Japanese outpatients with type 2 diabetes was carried out; patients received once-daily lixisenatide in combination with biguanide, thiazolidinedione, alpha-glucosidase inhibitors or glinide (NCT01940965). The primary end-point was safety over 52 weeks; secondary end-points included absolute change from baseline in glycated hemoglobin A1c at weeks 24 and 52. RESULTS: A total of 294 patients were enrolled (biguanide, thiazolidinedione, alpha-glucosidase groups: 73 patients each; glinide group: 75 patients). Overall, 90.4% of patients in the biguanide group, 83.6% in the thiazolidinedione group, 83.6% in the alpha-glucosidase group and 85.3% in the glinide group reported one or more treatment-emergent adverse event, the most common of which were nasopharingitis, nausea and constipation. Symptomatic hypoglycemia was reported in 5.5, 0, 1.4, and 10.7% of patients in the biguanide, thiazolidinedione, alpha-glucosidase and glinide groups, respectively. No severe hypoglycemia was observed. Hemoglobin A1c decreased from baseline at weeks 24 and 52, with mean changes ranging from -0.98 to -1.22%, and from -0.80 to -1.08%, respectively, across all groups. CONCLUSIONS: Lixisenatide treatment administered daily over 52 weeks was well tolerated and effective in improving glycemic control in Japanese patients with type 2 diabetes uncontrolled with existing oral antidiabetic drug therapies. The use of lixisenatide in combination with oral antidiabetic drugs is a valuable treatment option for Japanese patients with type 2 diabetes after failure of oral antidiabetic treatment alone.