Safety of exenatide once weekly for 52weeks in Japanese patients with type 2 diabetes mellitus

Abstract

Aims/Introduction: An initial 26-week, randomized, open-label study compared the efficacy and safety of exenatide 10mcg twice daily with exenatide 2mg once weekly in Asian patients with type 2 diabetes who experienced inadequate glycemic control with oral antidiabetes medications. The aim of this study was to evaluate the safety of exenatide once weekly in Japanese patients, a subset of the initial patient population, who continued into this extension study for an additional 26weeks of therapy on exenatide once weekly, followed by 10weeks without exenatide once weekly. Materials and Methods: Japanese patients initially assigned to exenatide twice daily (n=62) switched to exenatide once weekly for the extended 26weeks, and patients initially assigned to exenatide once weekly (n=74) continued on this regimen for the remainder of the study (total treatment of 52weeks). Results: A total of 68% of patients reported one or more treatment-emergent adverse events during the extension period; the most common of these were nasopharyngitis (14%) and vomiting (6%). No major hypoglycemic episodes were reported. Improvements in glycated hemoglobin, fasting plasma glucose and postprandial glucose were maintained over 52weeks of treatment. At week52, bodyweight remained reduced from baseline. Conclusions: Exenatide once weekly added to oral antidiabetes medication was well tolerated in Japanese patients with type 2 diabetes, and was associated with glycemic control and weight loss through to 52weeks, supporting the use of exenatide once weekly as an adjunctive treatment for type 2 diabetes in this patient population. The initial 26-week portion of this trial was registered with ClinicalTrials.gov (no. NCT00917267). © 2012 Asian Association for the Study of Diabetes and Wiley Publishing Asia Pty Ltd.