Type 2 Diabetes Mellitus (T2DM)NCT07770737
Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus (T2DM) and Cardiovascular Diseases, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists) in Korean adults with type 2 diabetes. The study consists of two phases. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Cardiovascular Diseases, Stage B Heart Failure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2026to 31 Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Phase 1 will include adults with type 2 diabetes identified from de-identified electronic health records mapped to the OMOP Common Data Model at participating Korean hospitals. New users of SGLT2 inhibitors, GLP-1 receptor agonists, or eligible comparator glucose-lowering medications will be included. Phase 2 will consecutively screen adults aged 50 years or older with type 2 diabetes and cardiovascular or renal risk factors who are scheduled to initiate an SGLT2 inhibitor during routine clinical care at Dongtan Sacred Heart Hospital. Approximately 100 participants will undergo baseline screening, and approximately 50 participants meeting the protocol-defined criteria for the stage B heart failure longitudinal cohort will complete 6-month follow-up assessments.
Who may be able to join
- Adults aged 19 years or older.
- Diagnosis of type 2 diabetes mellitus.
- New initiation of a study medication, including an SGLT2 inhibitor, a GLP-1 receptor agonist, or another eligible glucose-lowering medication.
- At least 180 days of observable data before the index date, defined as the date of the first eligible prescription.
- Adults aged 50 years or older receiving outpatient care at Dongtan Sacred Heart Hospital.
- Diagnosis of type 2 diabetes mellitus.
Show all 10Show fewer
- No current or previous signs or symptoms of heart failure and New York Heart Association functional class I.
- At least one of the following high-risk characteristics: diabetes duration of 5 years or longer, hypertension, body mass index of 25 kg/m² or higher, urinary albumin-to-creatinine ratio of 30 mg/g or higher, estimated glomerular filtration rate below 60 mL/min/1.73 m², or diabetic microvascular complications.
- No previous treatment with an SGLT2 inhibitor and scheduled to initiate an SGLT2 inhibitor based on the treating physician's clinical judgment.
- Ability and willingness to provide written informed consent.
Who cannot join
- Type 1 diabetes mellitus or secondary diabetes mellitus.
- Use of a medication from the same drug class within 90 days before the index date.
- Pregnancy recorded during the relevant study period.
- A history of the outcome being evaluated during the baseline period, applied separately for each outcome analysis.
- Phase 2: Prospective SGLT2 Inhibitor Validation Cohort
- Current or previous diagnosis of heart failure, hospitalization for heart failure, clinically suspected signs or symptoms of heart failure, or screening left ventricular ejection fraction below 50%.
Show all 15Show fewer
- Moderate or severe valvular heart disease, known hypertrophic, dilated, or infiltrative cardiomyopathy, complex congenital heart disease, or clinically significant pericardial disease.
- Acute coronary syndrome, coronary revascularization, or stroke within 3 months before enrollment.
- Presence of a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device.
- Atrial fibrillation, sustained tachycardia, frequent premature contractions, or another arrhythmia that prevents reliable comparison of ECG or global longitudinal strain measurements.
- Type 1 diabetes mellitus, secondary diabetes mellitus, diabetic ketoacidosis within the previous year, or another clinical condition making SGLT2 inhibitor treatment inappropriate.
- Estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis.
- Echocardiographic image quality insufficient for reliable 3-view global longitudinal strain or stage B heart failure assessment.
- Pregnancy or breastfeeding.
- Unwillingness to undergo study assessments or inability to complete the 6-month follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
Eun-Gyoung Hong, MD, PhD, +82-31-8086-2492, hegletter@hanmail.net
Kyungyoon Na, +82-31-8086-3491, yoonique555@naver.com
About this study
Official title: Evaluation of Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes: A Multicenter CDM-Based Retrospective Cohort Study With Prospective AI-ECG Validation
This observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists) in Korean adults with type 2 diabetes.
The study consists of two phases. Phase 1 will use de-identified electronic health record data from multiple Korean hospitals organized in a common data model. Cardiovascular outcomes, including myocardial infarction, ischemic stroke, and hospitalization for heart failure, will be compared among patients who started an SGLT2 inhibitor or a GLP-1 receptor agonist. Fractures, metabolic changes, and real-world medication use will also be evaluated.
Read more
Phase 2 will prospectively enroll approximately 100 adults with type 2 diabetes who are starting an SGLT2 inhibitor as part of routine clinical care at Dongtan Sacred Heart Hospital. Participants will undergo electrocardiography, AI-based ECG analysis, echocardiography, blood and urine tests, and body composition assessment at baseline. Approximately 50 participants with stage B heart failure, defined as structural or functional heart abnormalities without heart failure symptoms, will undergo the same assessments after 6 months. The primary outcome of Phase 2 is the change in echocardiographic global longitudinal strain from baseline to 6 months. The study will also examine whether changes detected by AI-based ECG are associated with changes in echocardiographic measures of cardiac function.
The study does not assign medications or alter routine treatment. All treatment decisions are made by the participants' treating physicians.
Read the detailed description
This is an investigator-initiated, two-phase observational study integrating a multicenter retrospective cohort analysis with a single-center prospective validation cohort. The two phases involve different study populations and data sources and will be analyzed independently. Their findings will be interpreted together to provide complementary evidence regarding long-term clinical cardiovascular outcomes and short-term changes in cardiac function among Korean patients with type 2 diabetes.
In Phase 1, de-identified electronic health record data mapped to the Observational Medical Outcomes Partnership Common Data Model will be obtained from participating Korean hospitals through a distributed data network. A new-user, active-comparator cohort design will be used to compare patients initiating an SGLT2 inhibitor with those initiating a GLP-1 receptor agonist. Medication exposure, cardiovascular events, safety outcomes, metabolic measures, and treatment patterns will be identified using prespecified common data model definitions. Confounding will be addressed using propensity score methods, stratified analyses, and sensitivity analyses. Participating institutions will execute a common analytic protocol locally and provide only aggregated, non-identifiable results for multicenter analysis.
In Phase 2, adults with type 2 diabetes who are scheduled to start an SGLT2 inhibitor during routine clinical care at Dongtan Sacred Heart Hospital will be consecutively screened. Baseline assessments will include standard 12-lead electrocardiography, portable 6-lead electrocardiography, AI-based ECG analysis, advanced echocardiography, laboratory testing, body composition assessment, and research blood sampling. Participants will be classified according to prespecified echocardiographic criteria for stage B heart failure. Approximately 50 participants who meet the protocol-defined criteria for the longitudinal cohort will undergo repeat assessments 6 months after baseline. Baseline data from other consented screening participants may be included in cross-sectional analyses.
Phase 2 will evaluate whether AI-based ECG measurements reflect echocardiographic cardiac dysfunction at baseline and whether changes in AI-based ECG measurements correspond to changes in cardiac function after SGLT2 inhibitor treatment. Analyses will focus on changes within participants, correlations and agreement between AI-ECG and echocardiographic measurements, and the feasibility of AI-ECG for monitoring subclinical cardiac dysfunction.
Medication selection, dose, continuation, and modification are determined solely by the treating physicians according to routine clinical practice. The protocol does not assign treatment, require medication changes, or use AI-ECG results to guide clinical care. No individual-level data will be combined across Phase 1 and Phase 2.
- Keywords
- SGLT2 Inhibitor, GLP-1 Receptor Agonist, Cardiovascular Protection, Artificial Intelligence Electrocardiography, AI-ECG, Global Longitudinal Strain, Diabetic Cardiomyopathy, Stage B Heart Failure, Pre-Heart Failure, OMOP Common Data Model, Real-World Data
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective SGLT2 Inhibitor Cohort | Patients with type 2 diabetes who initiated an SGLT2 inhibitor and were identified retrospectively from multicenter OMOP Common Data Model databases. | |
| Retrospective GLP-1 Receptor Agonist Cohort | Patients with type 2 diabetes who initiated a GLP-1 receptor agonist and were identified retrospectively from multicenter OMOP Common Data Model databases. | |
| Prospective SGLT2 Inhibitor Validation Cohort | Adults with type 2 diabetes who are newly starting an SGLT2 inhibitor and undergo baseline cardiovascular assessments. Approximately 50 participants meeting the protocol-defined criteria for stage B heart failure will undergo repeat AI-ECG, electrocardiographic, echocardiographic, laboratory, and body composition assessments after 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Atherosclerotic Cardiovascular Disease Composite Event
Time from the index date to the first occurrence of acute myocardial infarction or ischemic stroke, identified using prespecified OMOP Common Data Model phenotype definitions. The outcome will be compared between treatment cohorts using hazard ratios with 95% confidence intervals.
Measured: From the index date until the first occurrence of acute myocardial infarction or ischemic stroke, loss to follow-up, death, or the end of available database records, whichever occurs first, assessed up to 12 years
Time to First Hospitalization for Heart Failure
Time from the index date to the first hospitalization accompanied by a diagnosis of heart failure, identified using prespecified OMOP Common Data Model phenotype definitions. The outcome will be compared between treatment cohorts using hazard ratios with 95% confidence intervals.
Measured: From the index date until the first hospitalization for heart failure, loss to follow-up, death, or the end of available database records, whichever occurs first, assessed up to 12 years
Change in Echocardiographic Global Longitudinal Strain
Change in signed left ventricular global longitudinal strain from baseline to 6 months, calculated as GLS at 6 months minus GLS at baseline. A more negative change indicates improvement in left ventricular systolic function.
Measured: Baseline and 6 months after SGLT2 inhibitor initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dongtan Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp.
- Responsible party
- Principal investigator, Eun Gyoung Hong, Dongtan Sacred Heart Hospital
- Investigators
- Eun-Gyoung Hong, MD, PhD, Principal investigator, Hallym University Dongtan Sacred Heart HospitalHun Jee Choe, Study director, Hallym University Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770737
- Sponsor's protocol ID
- 2026-07-014
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be publicly shared because the study includes institutionally governed electronic health record data, electrocardiographic and echocardiographic data, and clinical information that are subject to participant consent, institutional review board requirements, and data-use restrictions. Phase 1 analyses will be conducted within each participating institution, and only aggregated, non-identifiable results will be shared across institutions.
Publications
Choi HM, Kim J, Park J, Park JB, Kim HK, Choi HJ, Yoon YE, Cho GY, Cho Y, Hwang IC. AI derived ECG global longitudinal strain compared to echocardiographic measurements. Sci Rep. 2024 Nov 2;14(1):26458. doi: 10.1038/s41598-024-78268-8.
PubMed 39488646Marwick TH, Halabi A, Soh CH, Curtin A, Sherrif AG, Azad A, Wright L. Effects of dapagliflozin on the progression of left ventricular dysfunction in type 2 diabetes mellitus: a randomized controlled trial. Cardiovasc Diabetol. 2025 May 30;24(1):232. doi: 10.1186/s12933-025-02796-4.
PubMed 40448135Lim S, Bae JH, Oh H, Hwang IC, Yoon YE, Cho GY. Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial. Cardiovasc Diabetol. 2024 Oct 22;23(1):373. doi: 10.1186/s12933-024-02463-0.
PubMed 39438942
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes: A Multicenter CDM-Based Retrospective Cohort Study With Prospective AI-ECG Validation
- ClinicalTrials.gov ID
- NCT07770737
- Acronym / sponsor ID
- 2026-07-014
- Keywords
- SGLT2 Inhibitor, GLP-1 Receptor Agonist, Cardiovascular Protection, Artificial Intelligence Electrocardiography, AI-ECG, Global Longitudinal Strain, Diabetic Cardiomyopathy, Stage B Heart Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dongtan Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp.
- Study start
- Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Aug 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 observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists) in Korean adults with type 2 diabetes.
The study consists of two phases. Phase 1 will use de-identified electronic health record data from multiple Korean hospitals organized in a common data model. Cardiovascular outcomes, including myocardial infarction, ischemic stroke, and hospitalization for heart failure, will be compared among patients who started an SGLT2 inhibitor or a GLP-1 receptor agonist. Fractures, metabolic changes, and real-world medication use will also be evaluated.
Phase 2 will prospectively enroll approximately 100 adults with type 2 diabetes who are starting an SGLT2 inhibitor as part of routine clinical care at Dongtan Sacred Heart Hospital. Participants will undergo electrocardiography, AI-based ECG analysis, echocardiography, blood and urine tests, and body composition assessment at baseline. Approximately 50 participants with stage B heart failure, defined as structural or functional heart abnormalities without heart failure symptoms, will undergo the same assessments after 6 months. The primary outcome of Phase 2 is the change in echocardiographic global longitudinal strain from baseline to 6 months. The study will also examine whether changes detected by AI-based ECG are associated with changes in echocardiographic measures of cardiac function.
The study does not assign medications or alter routine treatment. All treatment decisions are made by the participants' treating physicians.
Detailed description
This is an investigator-initiated, two-phase observational study integrating a multicenter retrospective cohort analysis with a single-center prospective validation cohort. The two phases involve different study populations and data sources and will be analyzed independently. Their findings will be interpreted together to provide complementary evidence regarding long-term clinical cardiovascular outcomes and short-term changes in cardiac function among Korean patients with type 2 diabetes.
In Phase 1, de-identified electronic health record data mapped to the Observational Medical Outcomes Partnership Common Data Model will be obtained from participating Korean hospitals through a distributed data network. A new-user, active-comparator cohort design will be used to compare patients initiating an SGLT2 inhibitor with those initiating a GLP-1 receptor agonist. Medication exposure, cardiovascular events, safety outcomes, metabolic measures, and treatment patterns will be identified using prespecified common data model definitions. Confounding will be addressed using propensity score methods, stratified analyses, and sensitivity analyses. Participating institutions will execute a common analytic protocol locally and provide only aggregated, non-identifiable results for multicenter analysis.
In Phase 2, adults with type 2 diabetes who are scheduled to start an SGLT2 inhibitor during routine clinical care at Dongtan Sacred Heart Hospital will be consecutively screened. Baseline assessments will include standard 12-lead electrocardiography, portable 6-lead electrocardiography, AI-based ECG analysis, advanced echocardiography, laboratory testing, body composition assessment, and research blood sampling. Participants will be classified according to prespecified echocardiographic criteria for stage B heart failure. Approximately 50 participants who meet the protocol-defined criteria for the longitudinal cohort will undergo repeat assessments 6 months after baseline. Baseline data from other consented screening participants may be included in cross-sectional analyses.
Phase 2 will evaluate whether AI-based ECG measurements reflect echocardiographic cardiac dysfunction at baseline and whether changes in AI-based ECG measurements correspond to changes in cardiac function after SGLT2 inhibitor treatment. Analyses will focus on changes within participants, correlations and agreement between AI-ECG and echocardiographic measurements, and the feasibility of AI-ECG for monitoring subclinical cardiac dysfunction.
Medication selection, dose, continuation, and modification are determined solely by the treating physicians according to routine clinical practice. The protocol does not assign treatment, require medication changes, or use AI-ECG results to guide clinical care. No individual-level data will be combined across Phase 1 and Phase 2.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective SGLT2 Inhibitor Cohort | – | –Patients with type 2 diabetes who initiated an SGLT2 inhibitor and were identified retrospectively from multicenter OMOP Common Data Model databases. |
| Retrospective GLP-1 Receptor Agonist Cohort | – | –Patients with type 2 diabetes who initiated a GLP-1 receptor agonist and were identified retrospectively from multicenter OMOP Common Data Model databases. |
| Prospective SGLT2 Inhibitor Validation Cohort | – | –Adults with type 2 diabetes who are newly starting an SGLT2 inhibitor and undergo baseline cardiovascular assessments. Approximately 50 participants meeting the protocol-defined criteria for stage B heart failure will undergo repeat AI-ECG, electrocardiographic, echocardiographic, laboratory, and body composition assessments after 6 months. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Phase 1 will include adults with type 2 diabetes identified from de-identified electronic health records mapped to the OMOP Common Data Model at participating Korean hospitals. New users of SGLT2 inhibitors, GLP-1 receptor agonists, or eligible comparator glucose-lowering medications will be included. Phase 2 will consecutively screen adults aged 50 years or older with type 2 diabetes and cardiovascular or renal risk factors who are scheduled to initiate an SGLT2 inhibitor during routine clinical care at Dongtan Sacred Heart Hospital. Approximately 100 participants will undergo baseline screening, and approximately 50 participants meeting the protocol-defined criteria for the stage B heart failure longitudinal cohort will complete 6-month follow-up assessments.
Key inclusion criteria (10 listed)
- Adults aged 19 years or older.
- Diagnosis of type 2 diabetes mellitus.
- New initiation of a study medication, including an SGLT2 inhibitor, a GLP-1 receptor agonist, or another eligible glucose-lowering medication.
- At least 180 days of observable data before the index date, defined as the date of the first eligible prescription.
- Adults aged 50 years or older receiving outpatient care at Dongtan Sacred Heart Hospital.
Key exclusion criteria (15 listed)
- Type 1 diabetes mellitus or secondary diabetes mellitus.
- Use of a medication from the same drug class within 90 days before the index date.
- Pregnancy recorded during the relevant study period.
- A history of the outcome being evaluated during the baseline period, applied separately for each outcome analysis.
- Phase 2: Prospective SGLT2 Inhibitor Validation Cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to First Atherosclerotic Cardiovascular Disease Composite Event
Time frame: From the index date until the first occurrence of acute myocardial infarction or ischemic stroke, loss to follow-up, death, or the end of available database records, whichever occurs first, assessed up to 12 years
Time from the index date to the first occurrence of acute myocardial infarction or ischemic stroke, identified using prespecified OMOP Common Data Model phenotype definitions. The outcome will be compared between treatment cohorts using hazard ratios with 95% confidence intervals.
Time to First Hospitalization for Heart Failure
Time frame: From the index date until the first hospitalization for heart failure, loss to follow-up, death, or the end of available database records, whichever occurs first, assessed up to 12 years
Time from the index date to the first hospitalization accompanied by a diagnosis of heart failure, identified using prespecified OMOP Common Data Model phenotype definitions. The outcome will be compared between treatment cohorts using hazard ratios with 95% confidence intervals.
Change in Echocardiographic Global Longitudinal Strain
Time frame: Baseline and 6 months after SGLT2 inhibitor initiation
Change in signed left ventricular global longitudinal strain from baseline to 6 months, calculated as GLS at 6 months minus GLS at baseline. A more negative change indicates improvement in left ventricular systolic function.
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 18 Aug 2026.
- Background: PubMed 39488646Choi HM, Kim J, Park J, Park JB, Kim HK, Choi HJ, Yoon YE, Cho GY, Cho Y, Hwang IC. AI derived ECG global longitudinal strain compared to echocardiographic measurements. Sci Rep. 2024 Nov 2;14(1):26458. doi: 10.1038/s41598-024-78268-8.
- Background: PubMed 40448135Marwick TH, Halabi A, Soh CH, Curtin A, Sherrif AG, Azad A, Wright L. Effects of dapagliflozin on the progression of left ventricular dysfunction in type 2 diabetes mellitus: a randomized controlled trial. Cardiovasc Diabetol. 2025 May 30;24(1):232. doi: 10.1186/s12933-025-02796-4.
- Background: PubMed 39438942Lim S, Bae JH, Oh H, Hwang IC, Yoon YE, Cho GY. Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial. Cardiovasc Diabetol. 2024 Oct 22;23(1):373. doi: 10.1186/s12933-024-02463-0.
- Individual participant dataSharing planned: No. Individual participant-level data will not be publicly shared because the study includes institutionally governed electronic health record data, electrocardiographic and echocardiographic data, and clinical information that are subject to participant consent, institutional review board requirements, and data-use restrictions. Phase 1 analyses will be conducted within each participating institution, and only aggregated, non-identifiable results will be shared across institutions.
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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.
Eun-Gyoung Hong, MD, PhD principal investigator
Hallym University Dongtan Sacred Heart Hospital
Hun Jee Choe study director
Hallym University Dongtan Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Cardiovascular Diseases, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
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 Hun Jee Choe, MD, PhD (+821094935703, hunjeechoe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Atherosclerotic Cardiovascular Disease Composite Event (time frame: From the index date until the first occurrence of acute myocardial infarction or ischemic stroke, loss to follow-up, death, or the end of available database records, whichever occurs first, assessed up to 12 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07770737, which also lists 3 linked publications.
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 18 Aug 2026.