Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

Summary

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus. To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Timeline

Start

2013-01

Primary completion

2014-08

Completion

2014-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Experimental: Exenatide QWS Suspension vs Active Comparator: Exenatide BID; p = 0.0072; LS Mean Difference -0.37 (95% CI -0.63 to -0.10); Mixed model for repeated measure (MMRM) NCT01652716 ↗

Publications

• Wysham CH, Rosenstock J, Vetter ML, Wang H, Hardy E, Iqbal N. Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e000773. doi: 10.1136/bmjdrc-2019-000773.
• Wysham CH, Rosenstock J, Vetter ML, Dong F, Ohman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):165-172. doi: 10.1111/dom.13056. Epub 2017 Aug 22.

Drugs

Indications