drugset / Trial / NCT07139405
TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessed
Timeline
- Start
- 2026-09-01
- Primary completion
- 2027-09-01
- Completion
- 2027-12-30
Publications
- Background Donath MY, Shoelson SE. Type 2 diabetes as an inflammatory disease. Nat Rev Immunol. 2011 Feb;11(2):98-107. doi: 10.1038/nri2925. Epub 2011 Jan 14.
- Background Seferovic JP, Claggett B, Seidelmann SB, Seely EW, Packer M, Zile MR, Rouleau JL, Swedberg K, Lefkowitz M, Shi VC, Desai AS, McMurray JJV, Solomon SD. Effect of sacubitril/valsartan versus enalapril on glycaemic control in patients with heart failure and diabetes: a post-hoc analysis from the PARADIGM-HF trial. Lancet Diabetes Endocrinol. 2017 May;5(5):333-340. doi: 10.1016/S2213-8587(17)30087-6. Epub 2017 Mar 18.
- Background El-Bahrawy H, Hegazy S, Farrag W, Werida R. Targeting inflammation using celecoxib with glimepiride in the treatment of obese type 2 diabetic Egyptian patients. Int J Diabetes Dev Ctries. 2015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 100 mg | Oral |
| Subject | Celecoxib | Other / unclassified | 200 mg | Oral |
| Subject | Metformin | Small molecule | 1000 mg | Oral |
| Subject | Metformin | Small molecule | 2000 mg | Oral |
| Subject | Valsartan | Small molecule | 40 mg | Oral |
| Subject | Valsartan | Small molecule | 80 mg | Oral |