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.
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.
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 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.
Cohort
Other
Not listed
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 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.
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.
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Dongtan Sacred Heart Hospital
Lead sponsor
Chong Kun Dang Pharmaceutical Corp.
Collaborator
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