An observational study in Type 2 Diabetes Mellitus (T2DM), Cardiovascular Diseases and Stage B Heart Failure, sponsored by Dongtan Sacred Heart Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Dongtan Sacred Heart Hospital · Observational
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Among 571 studies in Diabetes Mellitus, Type 2 with a site in Korea, Republic of — 70 open to participants now, 84 under way, 26 of them phase 3. Diabetes Mellitus, Type 2 · Korea, Republic of.
Among the 571 studies in Diabetes Mellitus, Type 2 with a site in Korea, Republic of, this one is the 69th largest by planned enrollment of the 78 observational ones that give a count, is one of 30 that started in 2026, is one of 78 observational ones, reaches primary completion later than 61 of the 83 other live ones, and was the 566th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →70 of the 571 studies in Diabetes Mellitus, Type 2 with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Korea, Republic of, United States, Brazil and 7 more countries
Ages 18+
AstraZeneca · Sites in Korea, Republic of, United States, Argentina and 13 more countries
Ages 18+
AstraZeneca · Sites in Korea, Republic of, United States, Australia and 10 more countries
Ages 18+
Eli Lilly and Company · Sites in Korea, Republic of, United States, Belgium and 8 more countries
Ages 10–17
AstraZeneca · Sites in Korea, Republic of, United States, Argentina and 10 more countries
Ages 18+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
571 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 95 · Phase 2 34 · Phase 3 206 · Phase 4 116
First in 2001; this study’s year is marked. 30 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 174 across the 493 interventional studies, 1,470 across the 78 observational. Of the 432 that completed or were terminated, 159 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
435 of 571 have an industry lead sponsor. The 10 most frequent:
Dongtan Sacred Heart Hospital is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Dongtan Sacred Heart Hospital has 1 study filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
22 of the studies in Diabetes Mellitus, Type 2 with a site in Korea, Republic of that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06220773Phase 3Boryung Pharmaceutical Co., LtdA Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy | 2026-12 |
| NCT07093476Phase 3CelltrionEfficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin | 2026-12 |
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT07220759Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | 2027-05-12 |
| NCT07619833Phase 3Daewoong Pharmaceutical Co. LTD.To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus | 2027-11 |
Add all 22 to your calendar (.ics) → With an account.
Among the 571 studies in Diabetes Mellitus, Type 2 with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Phase 1: Retrospective Cohorts
Inclusion Criteria:
Exclusion Criteria:
Phase 2: Prospective SGLT2 Inhibitor Validation Cohort
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with type 2 diabetes who initiated an SGLT2 inhibitor and were identified retrospectively from multicenter OMOP Common Data Model databases.
Patients with type 2 diabetes who initiated a GLP-1 receptor agonist and were identified retrospectively from multicenter OMOP Common Data Model databases.
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.
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.
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 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.
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
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.
Time frame: Baseline and 6 months after SGLT2 inhibitor initiation
Plan to share: 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.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 15 months is below that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Dongtan Sacred Heart Hospital