Dapagliflozin to slow coronary plaque progression in type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study examines if the SGLT2 inhibitor dapagliflozin can modify coronary plaque progression in people with type 2 diabetes and stable coronary artery disease. Participants are randomized to dapagliflozin 10 mg daily plus standard care or standard care alone for 18 months, with imaging and biomarkers tracked to assess changes in plaque volume, hemodynamics, perivascular fat characteristics, and inflammation. Imaging analyses are performed by blinded core laboratories to ensure objective assessment. Primary assessments include serial coronary CT angiography and CT-derived metrics, along with metabolic and quality-of-life measures. The trial aims to determine if SGLT2 inhibition can reduce cardiovascular risk in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 75 years.
* Confirmed diagnosis of type 2 diabetes mellitus with SCORE2-Diabetes risk score \>10%.
* Stable angina pectoris.
* Coronary CT angiography (CCTA) demonstrating 50%-90% stenosis in at least one coronary vessel with diameter ≥2.5 mm.
* CT-derived fractional flow reserve (CT-FFR) \>0.8 in the target vessel.
* Stable standard therapy for diabetes and cardiovascular disease, with no changes in SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors within the past 4 weeks.
* Able and willing to provide written informed consent.

Exclusion Criteria:

* History of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) with stenting, prosthetic valve replacement, or permanent pacemaker implantation.
* New York Heart Association (NYHA) functional class III or IV heart failure. Acute myocardial infarction within the previous 30 days.
* Known allergy to iodinated contrast media or other contraindications to CCTA. Severe arrhythmia or coronary artery calcium (CAC) score \>400.
* Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². History of serious adverse reactions to SGLT2 inhibitors.
* Pregnancy, lactation, or planned pregnancy during the study period. Severe liver dysfunction (Child-Pugh class C).
* Any other condition that, in the investigator's opinion, makes the participant unsuitable for the trial.

Where it's running

• The First Medical Center of Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting
• The Sixth Medical Center of Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Junjie Yang, MD
• Email: fearlessyang@126.com
• Phone: 010-55499209

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.