Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes

Prior treatment

• Use of a medication from the same drug class within 90 days before the index date.
• Acute coronary syndrome, coronary revascularization, or stroke within 3 months before enrollment.
• Type 1 diabetes mellitus, secondary diabetes mellitus, diabetic ketoacidosis within the previous year, or another clinical condition making SGLT2 inhibitor treatment inappropriate.

Other illness

• Type 1 diabetes mellitus or secondary diabetes mellitus.
• A history of the outcome being evaluated during the baseline period, applied separately for each outcome analysis.
  • Phase 2: Prospective SGLT2 Inhibitor Validation Cohort
• Moderate or severe valvular heart disease, known hypertrophic, dilated, or infiltrative cardiomyopathy, complex congenital heart disease, or clinically significant pericardial disease.
• 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.
• Echocardiographic image quality insufficient for reliable 3-view global longitudinal strain or stage B heart failure assessment.

Lab values

• 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%.

Other

• Pregnancy recorded during the relevant study period.
• Estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis.
• Pregnancy or breastfeeding.
• Unwillingness to undergo study assessments or inability to complete the 6-month follow-up.

• 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.
• 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.

Criteria the registry did not label

• Phase 1: Retrospective Cohorts