NCT07254572

Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes

A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: National Institute of Cardiology, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• PreDiabetes

Interventions

Type	Name	Description
DRUG	Semaglutide 14 MG [Rybelsus]	Semaglutide 3 mg daily - up-titrated to 7 mg daily if well tolerated - up-titrated to 14 mg daily if well tolerated
DRUG	Dapagliflozin (Forxiga)	Dapagliflozin 10 mg daily
DRUG	Metformin	Metformin 500 mg daily (up-titrated to 1000 mg daily if indicated)
BEHAVIORAL	Optimal Medical Therapy (OMT) And Lifestyle Intervention	* cardiological counselling aiming to reduce risk factors of atherosclerosis progression (LDL target, optimal medical therapy, comorbidities management, electrocardiogram) in accordance with current European Society of Cardiology guidelines * dietary counselling * body weight management * advice on optimizing physical activity levels * advice on how to quit smoking if applicable * psychological counselling

Timeline

• Start date: 2025-07-10
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: Poland