Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
Summary
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
Timeline
- Start
- 2014-09-04
- Primary completion
- 2016-04-26
- Completion
- 2017-12-28
Outcome
Met primary endpoint
registry analysis (superiority or other test); Exenatide + Dapagliflozin vs Exenatide + Placebo; p = 0.003; Mean Difference (Final Values) -0.38 (95% CI -0.63 to -0.13) NCT02229396 ↗
registry analysis (superiority or other test); Dapagliflozin + Placebo vs Exenatide + Dapagliflozin; p <0.001; Mean Difference (Final Values) -0.59 (95% CI -0.84 to -0.34) NCT02229396 ↗
release “DURATION-8 trial met primary and secondary endpoints” astrazeneca.com ↗
release “DURATION-8 trial met primary and secondary endpoints, significantly reducing blood sugar (HbA1c), weight and systolic blood pressure versus either medicine alone” astrazeneca.com ↗
Publications
- Jabbour SA, Frias JP, Ahmed A, Hardy E, Choi J, Sjostrom CD, Guja C. Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial. Diabetes Care. 2020 Oct;43(10):2528-2536. doi: 10.2337/dc19-1350. Epub 2020 Aug 18.
- Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
- Jabbour SA, Frias JP, Hardy E, Ahmed A, Wang H, Ohman P, Guja C. Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the DURATION-8 Randomized Controlled Trial. Diabetes Care. 2018 Oct;41(10):2136-2146. doi: 10.2337/dc18-0680. Epub 2018 Aug 6.
- Frias JP, Guja C, Hardy E, Ahmed A, Dong F, Ohman P, Jabbour SA. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Dec;4(12):1004-1016. doi: 10.1016/S2213-8587(16)30267-4. Epub 2016 Sep 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Subject | Exenatide | Peptide | 2 mg | Subcutaneous |