drugset / Trial / NCT07254572
Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
Phase 4
Recruiting
300 enrolled
National Institute of Cardiology, Warsaw, Poland
Medical Research Agency, Poland · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to compare the anti-atherosclerotic efficacy of oral treatment with a GLP-1 analogue (semaglutide) or an SGLT-2 (so-called "flozin") inhibitor (dapagliflozin) versus routine treatment (metformin) in patients with pre-diabetes and diagnosed coronary artery disease at 24 months. The diagnosis of coronary artery disease will be defined as the presence of coronary atherosclerosis confirmed by coronary artery computed tomography (coronary CT). The study will evaluate the effect of treatment with flozin vs. semaglutide compared to treatment with metformin on the progression/regression of coronary atherosclerosis, change in plaque character, and control of cardiovascular risk factors.
Timeline
- Start
- 2025-07-10
- Primary completion
- 2029-08-01
- Completion
- 2029-08-01
Publications
- Results https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-22/diabetes-total-risk-benefit-of-sglt2-inhibitors-and-glp1-agonists#.ZC8_KhOdj2E.link
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Comparator | Metformin | Small molecule | 1000 mg | — |
| Subject | Semaglutide | Peptide | 14 mg | Oral |