A Phase 4 interventional study of Cilostazol and Aspirin in Type 2 Diabetes Mellitus (T2DM) and Atherosclerosis, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Seoul National University Bundang Hospital · Phase 4, Interventional, and Treatment
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Among 21 studies in Diabetes Mellitus, Type 2 by Seoul National University Bundang Hospital — 11 open to participants now, 11 under way, 1 of them phase 3. Diabetes Mellitus, Type 2 · Seoul National University Bundang Hospital.
Among the 21 studies in Diabetes Mellitus, Type 2 by Seoul National University Bundang Hospital, this one has the largest planned enrollment of the 19 interventional ones that give a count, is the only one that started in 2026, is one of 15 in phase 4, reaches primary completion later than 9 of the 10 other live ones, and was the 21st registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →11 of the 21 studies in Diabetes Mellitus, Type 2 by Seoul National University Bundang Hospital are open now, in 1 country. Recruiting first, the newest first:
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Ages 20+
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Ages 19+
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Ages 20–80
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Ages 20+
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Ages 20+
By country, each count listing its studies:
Of the 883 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; 205 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.
21 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,200 is above the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 105 across the 19 interventional studies, 8,250 across the 2 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Seoul National University Bundang Hospital is the lead sponsor of 377 studies on the registry; 56 are open to participants now.
5 of the studies in Diabetes Mellitus, Type 2 by Seoul National University Bundang Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05365425Seoul National University Bundang HospitalCholine Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia | 2026-12-31 |
| NCT06399835Seoul National University Bundang HospitalEnavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis | 2026-12-31 |
| NCT05365438Seoul National University Bundang HospitalAtmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia | 2026-12-31 |
| NCT06402747Seoul National University Bundang HospitalClopidogrel Versus Cilostazol on Vessels | 2026-12-31 |
| NCT06989723Seoul National University Bundang HospitalPioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes | 2026-12-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 21 studies in Diabetes Mellitus, Type 2 by Seoul National University Bundang Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Patients with type 2 diabetes and cardiovascular risk factors are at increased risk of cardiovascular events. Therefore, a multi-center prospective randomized study will be conducted to compare the efficacy and safety of cilostazol and aspirin for the prevention of major adverse cardiac and cerebrovascular events (MACCE) in high-risk patients with type 2 diabetes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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 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.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
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.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cilostazol
Drug: Aspirin
Drug: Cilostazol Other Name: Pletaal SR Capsule
Drug: AspirinOther Name: ASA
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as myocardial infarction, stroke, cardiac or peripheral revascularization, hospitalization for symptomatic vascular ischemia, amputation, hospitalization for heart failure, or cardiovascular disease-related death
Time frame: Up to 156 weeks
Incidence of Three-Point Major Adverse Cardiovascular Events
Incidence of three-point major adverse cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death
Time frame: Up to 156 weeks
Incidence of Heart Failure Events
Incidence of heart failure events during the study period
Time frame: Up to 156 weeks
Incidence of Peripheral Vascular Events
Incidence of peripheral vascular events, including limb ischemia, amputation, and revascularization.
Time frame: Up to 156 weeks
Change in CK-MB Level
Change from baseline in serum creatine kinase-MB level.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Troponin-I Level
Change from baseline in serum troponin-I level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Fasting Glucose Level
Change from baseline in fasting glucose level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in HbA1c Level
Change from baseline in HbA1c level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Insulin Level
Change from baseline in insulin level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Total Cholesterol Level
Change from baseline in serum total cholesterol level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Triglyceride(TG) Level
Change from baseline in serum TG level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in HDL Cholesterol Level
Change from baseline in serum high-density lipoprotein (HDL) cholesterol level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in LDL Cholesterol Level
Change from baseline in serum LDL(low-density lipoprotein) cholesterol level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in hsCRP Level
Change from baseline in high-sensitivity C-reactive protein level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Body Composition
Change in body composition measured by BIA
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in the Number of Metabolic Syndrome Components
Change in the number of metabolic syndrome components.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Framingham Risk Score
Change in Framingham Risk Score. Higher scores indicate a higher estimated risk of cardiovascular disease.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in PREVENT Risk Score
Change in Predicting Risk of Cardiovascular Disease EVENTs (PREVENT) risk score. Higher scores indicate a higher estimated risk of cardiovascular disease.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in SCORE2
Change in in Systematic COronary Risk Evaluation 2 (SCORE2). Higher scores indicate a higher estimated risk of cardiovascular disease.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in coronary artery calcium score
Change in coronary artery calcium score (CACS) measured by coronary computed tomography angiography The coronary artery calcium score is measured using the Agatston method; the minimum value is 0, there is no fixed maximum value, and higher scores indicate greater coronary artery calcification.
Time frame: Baseline and 156 weeks
Change in Coronary Artery Stenosis
Change in coronary artery stenosis measured by coronary computed tomography angiography
Time frame: Baseline and 156 weeks
Plan to share: Undecided — The plan to share de-identified individual participant data has not yet been determined. Any future sharing will require approval from the Institutional Review Board of the coordinating institution and appropriate data sharing agreements with participating institutions.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2028, 31 months after the start.
Of 320 non-industry phase 4 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 31 months is close to that.
Counting every sponsor, half of 452 studies reached it within 24 months; a quarter within 13 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Cilostazol
Seoul National University Bundang Hospital →