Comparing diabetes drugs for coronary artery plaque in people with pre-diabetes
Tests semaglutide or dapagliflozin against metformin for artery plaque in pre-diabetes.
Plain-language title generated from the registry record
Registry title: Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
Key facts
- Where
- Warsaw, PolandSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07254572, who can take part
Where in Poland
- National Institute of Cardiology, Department of Coronary Artery and Structural Heart DiseasesWarsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Institute of Cardiology, Warsaw, Poland
- Trial code
- NCT07254572
- Record updated
- 28 November 2025
- Original description
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.Read full original descriptionShow less
A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
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.
Inclusion: Age 18 - 80; Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of >2.5 mm or status after percutaneous coronary revascularization procedure found on coronary CT scan); Coronary CT scan performed <3 months after inclusion in the study, at least of good quality; Pre-diabetic status defined as fasting blood glucose 100-125 mg% or Hba1c 5.70-6.49% (measurement documented at the screening/randomization appointment or within 30 days prior to the screening/randomization appointment) or documented, positive result of an oral glucose load test (fasting blood glucose 100-125 mg% and 140-199 mg% 2h after a 75 g oral glucose load) performed up to 30 days before the screening/randomization appointment; Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks; Willing and able to give informed consent to participate in the study; Willing and able, according to the researcher, to comply with all the requirements of the study.
Exclusion: Status after coronary artery bypass surgery; Use of weight-loss drugs; Other known contraindications to treatment with metformin, dapagliflozin or semaglutide; Clinical condition requiring surgical treatment of coronary artery disease; Other severe medical conditions requiring scheduled hospital treatment at the time of the study; Severe musculoskeletal conditions requiring specific rehabilitation recommendations; Diagnosed heart failure; Presence of an artificial valve, cardiac pacing system or other implantable device (such as a cardioverter defibrillator); Severe arrhythmia/unexplained loss of consciousness; Condition after bariatric surgery; Pancreatic cancer; Medullary thyroid cancer; History of anaphylactic shock after iodine contrast administration; History of pancreatitis or active pancreatitis; Diagnosed diabetes or Hba1c>=6.5% at screening/randomization appointment; Use of glucose-lowering drugs other than metformin; Diagnosed liver disease or ALT, AST above three times the upper limit of normal at screening appointment; Chronic kidney disease (eGFR <45 ml/min/1.73 m2); Severe valvular defect; Other contraindications to physical activity; No consent to participate in the study; Uncompensated hyperthyroidism; Body mass index (BMI) >40 kg/m2; Pregnancy/lactation; Participation in another clinical trial.