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.
Dongtan Sacred Heart Hospital
Lead sponsor
Chong Kun Dang Pharmaceutical Corp.
Collaborator