drugset / Trial / NCT02597049
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in participants with type 2 diabetes mellitus.
Timeline
- Start
- 2015-11
- Primary completion
- 2017-02
- Completion
- 2017-02
Outcome
Met primary endpoint
registry analysis (superiority test); 1.5 mg Dulaglutide vs Placebo; p <.001; Mean Difference (Final Values) -0.79 (95% CI -0.97 to -0.61) NCT02597049 ↗
registry analysis (superiority test); 0.75 mg Dulaglutide vs Placebo; p < .001; Mean Difference (Final Values) -0.66 (95% CI -0.84 to -0.49) NCT02597049 ↗
Publications
- Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
- Ludvik B, Frias JP, Tinahones FJ, Wainstein J, Jiang H, Robertson KE, Garcia-Perez LE, Woodward DB, Milicevic Z. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 May;6(5):370-381. doi: 10.1016/S2213-8587(18)30023-8. Epub 2018 Feb 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dulaglutide | Peptide | 0.75 mg | Subcutaneous |
| Subject | Dulaglutide | Peptide | 1.5 mg | Subcutaneous |
| Background | CANAGLIFLOZIN ANHYDROUS | Small molecule | — | — |
| Background | Dapagliflozin | Small molecule | — | — |
| Background | Empagliflozin | Small molecule | — | — |
| Background | Metformin | Small molecule | — | — |