NCT07614230

Brief Summary

This study is a multicenter, randomized controlled trial to test whether an SGLT2 inhibitor (dapagliflozin), a type of diabetes medication, can slow down or even reverse the progression of coronary atherosclerosis (plaque buildup in the coronary arteries) in patients with type 2 diabetes. The effect may be mediated by improving the function of perivascular adipose tissue. A total of 144 adults with type 2 diabetes and stable coronary artery disease will be randomly assigned to receive either dapagliflozin plus standard diabetes and cardiovascular care (intervention group) or standard care alone (control group) for 18 months. Serial coronary CT angiography and other assessments will be performed to evaluate changes in coronary plaque volume, CT-derived fractional flow reserve, perivascular fat radiomics score, and various metabolic and inflammatory markers, to determine whether SGLT2 inhibition reduces cardiovascular risk.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
31mo left

Started Jan 2026

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Dec 2028

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

April 22, 2026

Last Update Submit

May 25, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)Coronary Artery DiseaseAtherosclerosis

Keywords

SGLT2 InhibitorsDapagliflozinPerivascular Adipose TissueCoronary AtherosclerosisType 2 DiabetesPlaque ProgressionCoronary CT AngiographyCardiovascular RiskPVATRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Progression of Coronary Plaque Volume and Proportion from Baseline to the 18-Month Follow-Up

    Progression of total plaque volume (TPV) （mm³）from baseline or appearance of new plaques, assessed by coronary CT angiography (CCTA). Includes changes in plaque components (e.g., necrotic core, fibrous cap, calcification)（mm³）.

    Baseline to 18 months

Secondary Outcomes (18)

  • Change in the Coronary Perivascular Fat Radiomics Score (FRS) from Baseline to 18 Months

    Baseline to 18 months

  • Change in CT-derived fractional flow reserve (CT-FFR) from Baseline to 18 Months

    Baseline to 18 months

  • Change in Fat Attenuation Index （FAI）from Baseline to 18 Months

    Baseline to 18 months

  • Change in the Degree of Coronary Artery Stenosis from Baseline to 18 Months

    Baseline to 18 months

  • Change in C-reactive protein (CRP) from baseline to 18 months

    Baseline to 18 months

  • +13 more secondary outcomes

Study Arms (2)

SGLT2 Inhibitor Group

EXPERIMENTAL

Participants with type 2 diabetes and coronary atherosclerosis receive dapagliflozin 10 mg orally once daily in addition to standard diabetes care for 18 months.

Drug: Dapagliflozin (DAPA)Other: Standard Care (Treatment as Usual)

Control Group

ACTIVE COMPARATOR

Participants receive standard diabetes care without SGLT2 inhibitors for 18 months.

Other: Standard Care (Treatment as Usual)

Interventions

Dapagliflozin (DAPA)DRUG

Dapagliflozin 10 mg tablet administered orally once daily for 18 months, in addition to standard diabetes and cardiovascular care, to evaluate its effects on coronary atherosclerosis progression mediated by perivascular adipose tissue in patients with type 2 diabetes.

SGLT2 Inhibitor Group
Standard Care (Treatment as Usual)OTHER

Standard glycemic and cardiovascular management according to clinical guidelines, excluding SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors, for 18 months.

Control GroupSGLT2 Inhibitor Group

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery DiseaseAtherosclerosis

Interventions

dapagliflozinStandard of CareTherapeutics

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Junjie Yang, MD

CONTACT

010-55499209fearlessyang@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective, multicenter, 1:1 randomized, open-label trial where participants are assigned to parallel groups: one receiving dapagliflozin 10 mg daily plus standard diabetes care, and the other receiving standard care alone, for 18 months to assess effects on coronary atherosclerosis progression.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Associate Chief Physician

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 29, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant privacy and confidentiality.

Locations

CN(2)