Efficacy and tolerability of exenatide twice daily and exenatide once weekly in Asian versus White patients with type 2 diabetes mellitus: A pooled analysis

Aims: The efficacy and safety of exenatide twice daily (BID) and once weekly (QW) were assessed in Asian versus White patients with type 2 diabetes mellitus (T2DM). Methods: This post-hoc pooled analysis evaluated patients receiving 10 mu g exenatide BID for 12-30 weeks or 2 mg exenatide QW for 24-30 weeks in exenatide clinical development program trials. Race was self-identified. Results: A total of 4625 patients were included (exenatide BID: Asian, n = 787; White, n = 2223; exenatide QW: Asian, n = 511; White, n = 1104). At study end, glycated hemoglobin (HbA1c), fasting glucose (FG), body weight, post-prandial glucose (PPG), and PPG excursions were significantly reduced (all P < 0.0001 vs baseline). For exenatide BID, HbA1c reduction was greater in Asians (P < 0.0001 vs Whites), whereas HbA1c reduction did not differ by race for exenatide QW. FG reduction did not differ by race for either exenatide formulation. Weight reduction was significantly greater in Whites (P < 0.0001 vs Asians), regardless of exenatide formulation. PPG reduction was greater in Asians (P < 0.0001 vs Whites) for exenatide BID but did not differ by race for exenatide QW. For exenatide BID, reductions in PPG excursions for all meals were significantly greater in Asians (P < 0.0001 vs Whites), whereas only post-breakfast and post-lunch excursions were significantly greater in Asians for exenatide QW (P = 0.0009 and P = 0.0189 vs Whites, respectively). Common adverse events included nausea, headache, and diarrhea. Conclusions: Exenatide BID and QW improved glycemic control, including PPG, in Asian and White patients with T2DM. With exenatide BID, Asian patients exhibited significantly greater reductions in HbA1c and PPG than White patients. Both exenatide formulations were well tolerated in both groups. (C) 2016 The Authors. Published by Elsevier Ireland Ltd.