Efficacy and Tolerability of Exenatide Once Weekly over 7 Years in Patients with Type 2 Diabetes: an Open-Label Extension of the DURATION-1 Study.

Aims: To investigate the glycemic efficacy, effects on cardiovascular risk factors, and safety of exenatide once weekly (QW) in patients with type 2 diabetes over 7 years in the DURATION-1 study. Methods: Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years. Efficacy analyses included changes from baseline in glycated hemoglobin (HbA(1c)) and cardiovascular risk factors. Results: Of 295 patients in the intention-to-treat population, 122 (41%) completed 7 years of treatment. Patients in the 7-year completer population showed sustained glycemic improvements from baseline (7-year least-squares mean [ISM] change in HbA(1c), -1.53%) and significant improvements in several cardiovascular risk factors, including body weight, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Seven-year completers who received no additional glucose-lowering therapies (n = 65 [53%]) had similar improvements in HbA(1c), and numerically greater reductions in body weight (7-year ISM change, -6.46 kg vs -3.87 kg), compared with the overall cohort. There were no unexpected safety findings. Conclusions: Treatment with exenatide QW for 7 years was associated with sustained improvements in glycemic control and several cardiovascular risk factors. (C) 2018 The Authors.