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Can common diabetes drugs shield the heart? AI and Real-World data seek answers

NCT ID NCT07770737

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This observational study looks at whether two classes of diabetes medications—SGLT2 inhibitors and GLP-1 receptor agonists—help protect the heart in Korean adults with type 2 diabetes. Researchers will analyze health records from multiple hospitals to compare heart attack, stroke, and heart failure rates among patients taking these drugs. In a smaller phase, about 100 patients starting an SGLT2 inhibitor will undergo heart imaging, AI-based ECG, and blood tests to see if early changes in heart function can be detected. The study does not assign any treatments; patients receive their usual care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SGLT2 inhibitors and GLP-1 receptor agonists (medications for type 2 diabetes)
What this could lead to
If successful, this could clarify which diabetes medications best protect the heart, potentially guiding treatment choices to reduce heart attacks, strokes, and heart failure in people with type 2 diabetes.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may be influenced by other factors, and the small prospective phase may not be generalizable to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Phase 1: Retrospective Cohorts Inclusion Criteria: * 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. Exclusion Criteria: * 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 Inclusion Criteria: * Adults aged 50 years or older receiving outpatient care at Dongtan Sacred Heart Hospital. * Diagnosis of type 2 diabetes mellitus. * 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. Exclusion Criteria: * 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%. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, Gyeonggi-do, 18450, South Korea

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