Type 2 Diabetes Mellitus (T2DM)Phase 4SCOPENCT07614230
SGLT2 Inhibitors on Coronary Atherosclerosis Progression Via Perivascular Adipose Tissue in Diabetes
A Phase 4 study testing Dapagliflozin (DAPA) in people with Type 2 Diabetes Mellitus (T2DM) and Coronary Artery Disease, run by Junjie Yang at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Coronary Artery Disease, Atherosclerosis
- What is being tested?
- Dapagliflozin (DAPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality
Junjie Yang, 010-55499345, fearlessyang@126.com
- Recruiting
The Sixth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality
Junjie Yang, MD, 010-55499209, fearlessyang@126.com
About this study
Official title: Effects of SGLT2 Inhibitors on Coronary Atherosclerosis Progression in Diabetes Mediated by Perivascular Adipose Tissue: The SCOPE Trial
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.
Read the detailed description
Randomization and blinding: Eligible participants will be randomly assigned in a 1:1 ratio to either the dapagliflozin group or the standard care control group using a centralized, computer-generated randomization sequence. This is an open-label trial; however, all outcome assessments will be performed by core laboratories blinded to treatment allocation. Imaging analyses for plaque volume, hemodynamic parameters, and perivascular adipose tissue metrics will be conducted by investigators masked to group assignment.
Intervention: Participants in the intervention group receive dapagliflozin 10 mg once daily in addition to their standard diabetes and cardiovascular care. Participants in the control group receive standard glycemic management according to current clinical guidelines, with the exclusion of SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors. The total study duration is 18 months.
Study procedures: At baseline, participants will undergo coronary computed tomography angiography (CCTA) using a standardized protocol. Blood samples will be collected for lipid panels and inflammatory markers. Quality of life will be assessed using the Seattle Angina Questionnaire (SAQ-7). Follow-up visits are scheduled at 6, 12, and 18 months. At each visit, adverse events, concomitant medications, and medication adherence will be recorded. The 18-month visit will include a repeat CCTA and blood sampling.
Imaging core laboratory: All CCTA images will be transferred to an independent core laboratory for quantitative analysis. Plaque volume and composition will be assessed using semi-automated software. CT-derived fractional flow reserve (CT-FFR) will be computed using a dedicated algorithm. Wall shear stress (WSS) will be derived from computational fluid dynamics. Perivascular adipose tissue parameters, including fat attenuation index (FAI) and fat volume, will be measured using a validated software tool.
Data and safety monitoring: An independent Data and Safety Monitoring Board (DSMB) will review unblinded safety data every 6 months. The DSMB will monitor for serious adverse events, including volume depletion, genital infections, hypoglycemia, diabetic ketoacidosis, and acute kidney injury. Protocol-defined stopping rules include a significant increase in any of these events in the intervention arm.
- Being tested
- Dapagliflozin (DAPA), Standard Care (Treatment as Usual)
- Keywords
- SGLT2 Inhibitors, Dapagliflozin, Perivascular Adipose Tissue, Coronary Atherosclerosis, Type 2 Diabetes, Plaque Progression, Coronary CT Angiography, Cardiovascular Risk, PVAT, Randomized Controlled Trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dapagliflozin (DAPA); Other: Standard Care (Treatment as Usual) |
| Control Group | Active comparator | Participants receive standard diabetes care without SGLT2 inhibitors for 18 months. Receives: Other: Standard Care (Treatment as Usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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）.
Measured: Baseline to 18 months
Secondary outcomes (18)
Change in the Coronary Perivascular Fat Radiomics Score (FRS) from Baseline to 18 Months
Change from baseline to the 18-month follow-up in the coronary perivascular fat radiomics score (FRS), measured in "points", where a higher score indicates a higher inflammatory activity state and a stronger correlation with the risk of major adverse cardiovascular events.
Measured: Baseline to 18 months
Change in CT-derived fractional flow reserve (CT-FFR) from Baseline to 18 Months
Change from baseline to the 18-month follow-up in CT-derived fractional flow reserve (CT-FFR), expressed as a pure number between 0 and 1 (no units), where a higher value indicates a lower likelihood of ischemia.
Measured: Baseline to 18 months
Change in Fat Attenuation Index （FAI）from Baseline to 18 Months
Change from baseline to the 18-month follow-up in fat attenuation index (FAI)(HU) .FAI is defined as the mean attenuation value of pericoronary adipose tissue observed on CT scan, ranging from approximately -190 to -30 HU. Higher values indicating increased perivascular adipose tissue inflammation and coronary vulnerability, and lower values suggesting a more stable, anti-inflammatory vascular state.
Measured: Baseline to 18 months
Change in the Degree of Coronary Artery Stenosis from Baseline to 18 Months
Change from baseline to the 18-month follow-up in the degree of coronary artery stenosis, expressed as CAD-RADS category or quantitatively measured percent stenosis. CAD-RADS grades range from 0 to 5, with higher grades indicating greater stenosis severity. Quantitatively measured percent stenosis ranges from 0% to 100%, with higher percentages indicating greater stenosis severity.
Measured: Baseline to 18 months
Change in C-reactive protein (CRP) from baseline to 18 months
Change from baseline to the 18-month follow-up in C-reactive protein (CRP). Reference range: 0-0.8 mg/L; Unit: mg/dL.
Measured: Baseline to 18 months
Change in Quality of Life Score as Assessed by the Seattle Angina Questionnaire (SAQ-7) from Baseline to 18 Months
Change from baseline to the 18-month follow-up in quality of life score measured by the Seattle Angina Questionnaire (SAQ-7). The total score ranges from 0 to 100, with higher scores indicating better quality of life and better angina control.
Measured: Baseline to 18 months
Occurrence of Major Adverse Cardiovascular Events (MACE) from Baseline to 18 Months
Occurrence of major adverse cardiovascular events (MACE), including but not limited to cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, from baseline to the 18-month follow-up.
Measured: Baseline to 18 months
Change in Self-Rating Anxiety Scale（SAS） Score from Baseline to 18 Months
Change from baseline to the 18-month follow-up in the Self-Rating Anxiety Scale (SAS) score. The SAS is a 20-item self-reported scale with 4-point scoring, designed to assess the subjective experience of anxiety in patients. Total scores range from 0 to 60, with higher scores indicating greater anxiety severity. The scores are interpreted as follows:
A (0-8): no anxiety disorder B (9-21): occasional anxiety C (22-32): mild anxiety disorder D (33-44): moderate anxiety disorder E (45-60): severe anxiety disorder
Measured: Baseline to 18 months
Change in Hamilton Anxiety Scale (HAMA) Score from Baseline to 18 Months
Change from baseline to the 18-month follow-up in the Hamilton Anxiety Scale (HAMA) score. HAMA is a clinician-rated scale consisting of 14 items, each scored from 0 to 4, where:
0 = asymptomatic
- = mild symptoms
- = moderate symptoms (clearly present but does not affect daily life)
- = severe symptoms (significantly affects daily life)
- = extremely severe symptoms (unable to function normally)
Total scores range from 0 to 56, with higher scores indicating more severe anxiety. The score is interpreted as follows:
<7: no anxiety symptoms 7-13: possible anxiety 14-20: mild anxiety 21-28: marked anxiety 29: severe anxiety
Measured: Baseline to 18 months
Change in wall shear stress (WSS) from Baseline to 18 Months
Change from baseline to the 18-month follow-up in wall shear stress (WSS)(Pa).Both excessively high and abnormally low WSS are pathological: high WSS promotes plaque destabilization and rupture, while low WSS accelerates atherogenesis and plaque growth.
Measured: Baseline to 18 months
Change in Pericoronary Adipose Tissue Volume from Baseline to 18 Months
Change from baseline to the 18-month follow-up in Pericoronary Adipose Tissue Volume (mm³).Larger volume indicates higher inflammatory activity or greater disease burden, whereas smaller volume indicates the opposite.
Measured: Baseline to 18 months
Change in lipoprotein(a) (Lp(a)) from baseline to 18 months
Change from baseline to the 18-month follow-up in lipoprotein(a) (Lp(a)). Reference range: <30 mg/dL; Unit: mg/dL.
Measured: Baseline to 18 months
Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 18 months
Change from baseline to the 18-month follow-up in low-density lipoprotein cholesterol (LDL-C). Reference range: 0-3.4; Unit: mmol/L.
Measured: Baseline to 18 months
Change in high-density lipoprotein cholesterol (HDL-C) from baseline to 18 months
Change from baseline to the 18-month follow-up in high-density lipoprotein cholesterol (HDL-C). Reference range: 1-1.6 ; Unit: mmol/L.
Measured: Baseline to 18 months
Change in triglycerides (TG) from baseline to 18 months
Change from baseline to the 18-month follow-up in triglycerides (TG). Reference range: 0.4-1.7; Unit: mmol/L.
Measured: Baseline to 18 months
Change in total cholesterol (TC) from baseline to 18 months
Change from baseline to the 18-month follow-up in total cholesterol (TC). Reference range: 3.1-5.7; Unit: mmol/L.
Measured: Baseline to 18 months
Change in interleukin-6 (IL-6) from baseline to 18 months
Change from baseline to the 18-month follow-up in interleukin-6 (IL-6). Reference range: 0-5.9 pg/mL; Unit: pg/mL.
Measured: Baseline to 18 months
Change in tumor necrosis factor-alpha (TNF-α) from baseline to 18 months
Change from baseline to the 18-month follow-up in tumor necrosis factor-alpha (TNF-α). Reference range: <20; Unit: ng/L.
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junjie Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junjie Yang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614230
- Sponsor's protocol ID
- S2025-052-01
- Other IDs
- 82470342
- Acronym
- SCOPE
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SGLT2 Inhibitors on Coronary Atherosclerosis Progression in Diabetes Mediated by Perivascular Adipose Tissue: The SCOPE Trial
- ClinicalTrials.gov ID
- NCT07614230
- Acronym / sponsor ID
- SCOPE / S2025-052-01
- Keywords
- SGLT2 Inhibitors, Dapagliflozin, Perivascular Adipose Tissue, Coronary Atherosclerosis, Type 2 Diabetes, Plaque Progression, Coronary CT Angiography, Cardiovascular Risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Junjie YangUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomization and blinding: Eligible participants will be randomly assigned in a 1:1 ratio to either the dapagliflozin group or the standard care control group using a centralized, computer-generated randomization sequence. This is an open-label trial; however, all outcome assessments will be performed by core laboratories blinded to treatment allocation. Imaging analyses for plaque volume, hemodynamic parameters, and perivascular adipose tissue metrics will be conducted by investigators masked to group assignment.
Intervention: Participants in the intervention group receive dapagliflozin 10 mg once daily in addition to their standard diabetes and cardiovascular care. Participants in the control group receive standard glycemic management according to current clinical guidelines, with the exclusion of SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors. The total study duration is 18 months.
Study procedures: At baseline, participants will undergo coronary computed tomography angiography (CCTA) using a standardized protocol. Blood samples will be collected for lipid panels and inflammatory markers. Quality of life will be assessed using the Seattle Angina Questionnaire (SAQ-7). Follow-up visits are scheduled at 6, 12, and 18 months. At each visit, adverse events, concomitant medications, and medication adherence will be recorded. The 18-month visit will include a repeat CCTA and blood sampling.
Imaging core laboratory: All CCTA images will be transferred to an independent core laboratory for quantitative analysis. Plaque volume and composition will be assessed using semi-automated software. CT-derived fractional flow reserve (CT-FFR) will be computed using a dedicated algorithm. Wall shear stress (WSS) will be derived from computational fluid dynamics. Perivascular adipose tissue parameters, including fat attenuation index (FAI) and fat volume, will be measured using a validated software tool.
Data and safety monitoring: An independent Data and Safety Monitoring Board (DSMB) will review unblinded safety data every 6 months. The DSMB will monitor for serious adverse events, including volume depletion, genital infections, hypoglycemia, diabetic ketoacidosis, and acute kidney injury. Protocol-defined stopping rules include a significant increase in any of these events in the intervention arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SGLT2 Inhibitor Group | Experimental | Drug: Dapagliflozin (DAPA), Other: Standard Care (Treatment as Usual)Participants with type 2 diabetes and coronary atherosclerosis receive dapagliflozin 10 mg orally once daily in addition to standard diabetes care for 18 months. |
| Control Group | Active comparator | Other: Standard Care (Treatment as Usual)Participants receive standard diabetes care without SGLT2 inhibitors for 18 months. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin (DAPA)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. | Drug | SGLT2 Inhibitor Group |
| Standard Care (Treatment as Usual)Standard glycemic and cardiovascular management according to clinical guidelines, excluding SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors, for 18 months. | Other | Control Group, SGLT2 Inhibitor Group |
Primary outcome
Progression of Coronary Plaque Volume and Proportion from Baseline to the 18-Month Follow-Up
Time frame: Baseline to 18 months
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）.
18 secondary outcomes
Change in the Coronary Perivascular Fat Radiomics Score (FRS) from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in CT-derived fractional flow reserve (CT-FFR) from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in Fat Attenuation Index （FAI）from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in the Degree of Coronary Artery Stenosis from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in C-reactive protein (CRP) from baseline to 18 months
Time frame: Baseline to 18 months
Change in Quality of Life Score as Assessed by the Seattle Angina Questionnaire (SAQ-7) from Baseline to 18 Months
Time frame: Baseline to 18 months
Occurrence of Major Adverse Cardiovascular Events (MACE) from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in Self-Rating Anxiety Scale（SAS） Score from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in Hamilton Anxiety Scale (HAMA) Score from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in wall shear stress (WSS) from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in Pericoronary Adipose Tissue Volume from Baseline to 18 Months
Time frame: Baseline to 18 months
Change in lipoprotein(a) (Lp(a)) from baseline to 18 months
Time frame: Baseline to 18 months
Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 18 months
Time frame: Baseline to 18 months
Change in high-density lipoprotein cholesterol (HDL-C) from baseline to 18 months
Time frame: Baseline to 18 months
Change in triglycerides (TG) from baseline to 18 months
Time frame: Baseline to 18 months
Change in total cholesterol (TC) from baseline to 18 months
Time frame: Baseline to 18 months
Change in interleukin-6 (IL-6) from baseline to 18 months
Time frame: Baseline to 18 months
Change in tumor necrosis factor-alpha (TNF-α) from baseline to 18 months
Time frame: Baseline to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality.
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin (DAPA) in people with Type 2 Diabetes Mellitus (T2DM) and Coronary Artery Disease, run by Junjie Yang at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junjie Yang, MD (010-55499209, fearlessyang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of Coronary Plaque Volume and Proportion from Baseline to the 18-Month Follow-Up (time frame: Baseline to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.