drugset / Trial / NCT03951753
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)
RandomizedParallel-groupDouble-blindBasic science
Summary
This is a study for participants with type 2 diabetes mellitus. The main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks, including a 28-week treatment period.
Timeline
- Start
- 2019-06-28
- Primary completion
- 2021-04-08
- Completion
- 2021-04-08
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN Tirzepatide 15 mg: 1.9 (Standard Error 0.16) pmol*m-2*L*min-2*kg-1 NCT03951753 ↗
registry analysis (other test); Tirzepatide 15 mg vs Placebo; p <0.001; Least Squares Mean Difference 1.92 (95% CI 1.59 to 2.24); ANCOVA NCT03951753 ↗
Publications
- Heise T, DeVries JH, Urva S, Li J, Pratt EJ, Thomas MK, Mather KJ, Karanikas CA, Dunn J, Haupt A, Milicevic Z, Coskun T. Tirzepatide Reduces Appetite, Energy Intake, and Fat Mass in People With Type 2 Diabetes. Diabetes Care. 2023 May 1;46(5):998-1004. doi: 10.2337/dc22-1710.
- Heise T, Mari A, DeVries JH, Urva S, Li J, Pratt EJ, Coskun T, Thomas MK, Mather KJ, Haupt A, Milicevic Z. Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):418-429. doi: 10.1016/S2213-8587(22)00085-7. Epub 2022 Apr 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Semaglutide | Peptide | 1 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 15 mg | Subcutaneous |