SGLT2 Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Cohort Study

NCT07198191 | Active Not Recruiting

• 1 other identifier: IRB No. 9-2023-0049
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, retrospective cohort study aims to evaluate the impact of sodium-glucose cotransporter 2 (SGLT2) inhibitor use after acute myocardial infarction (AMI) in patients with type 2 diabetes mellitus (T2DM). Using the nationwide database from the Korean National Health Insurance Service, the investigators will compare cardiovascular outcomes between patients treated with SGLT2 inhibitors and those treated with dipeptidyl peptidase-4 (DPP4) inhibitors after AMI. The study period includes patients diagnosed with AMI between September 2014 and June 2021, with follow-up data available through June 2022. The primary outcomes include major cardiovascular events (death, myocardial infarction, stroke) and bleeding events. This study will provide real-world evidence on the effectiveness and safety of SGLT2 inhibitors in routine clinical practice following AMI among patients with T2DM in Korea.

Conditions

Acute Myocardial Infarction (AMI); Type 2 Diabetes Mellitus (T2DM)

Keywords

SGLT2 inhibitor; Dapagliflozin; Empagliflozin; DPP4 inhibitor; Cardiovascular Outcomes; Heart Failure; Real-world Evidence; NHIS; South Korea

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  MACE defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke.

  From index date (hospitalization for AMI), upto 365 days

Secondary Outcomes (5)

• Incidence of Cardiovascular Death

  From index hospitalization for acute myocardial infarction, upto 365 days

• Incidence of All-cause Death

  From index hospitalization for acute myocardial infarction, upto 365 days

• Incidence of Non-fatal Myocardial Infarction

  From index hospitalization for acute myocardial infarction, upto 365 days

• Incidence of Non-fatal Ischemic Stroke

  From index hospitalization for acute myocardial infarction, upto 365 days

• Incidence of Hospital Admission for Heart Failure

  From index hospitalization for acute myocardial infarction, upto 365 days

Study Arms (2)

SGLT2 Inhibitor Group

Patients with type 2 diabetes mellitus (T2DM) who were prescribed SGLT2 inhibitors after acute myocardial infarction.

Drug: SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin)

DPP4 Inhibitor Group

Patients with type 2 diabetes mellitus (T2DM) who were prescribed DPP4 inhibitors after acute myocardial infarction.

Drug: DPP4 inhibitors

Interventions

SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) DRUG

Exposure to SGLT2 inhibitors following AMI in patients with T2DM

SGLT2 Inhibitor Group

DPP4 inhibitors DRUG

Exposure to DPP4 inhibitors following AMI in patients with T2DM

DPP4 Inhibitor Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥19 years) with type 2 diabetes mellitus who were hospitalized for acute myocardial infarction in South Korea between September 2014 and June 2021. Eligible patients were identified from the Korean National Health Insurance Service database, with follow-up available through June 2022.

You may qualify if:

• Adults aged ≥19 years
• Hospitalization with a primary diagnosis of acute myocardial infarction between September 2014 and June 2021
• Diagnosis of type 2 diabetes mellitus (T2DM)
• Prescription of either an SGLT2 inhibitor or a DPP4 inhibitor after index AMI

You may not qualify if:

• Diagnosis of type 1 diabetes mellitus
• Gestational diabetes mellitus
• End-stage renal disease (ESRD) or history of kidney transplantation
• No use of either SGLT2 inhibitor or DPP4 inhibitor after index AMI
• Short-term use of SGLT2 inhibitor or DPP4 inhibitor (less than 30 days)
• Concomitant use of SGLT2 inhibitor and DPP4 inhibitor
• Incomplete or missing data for key study variables

Sponsors & Collaborators

• Yonsei University: lead
• Chong Kun Dang Pharmaceutical Corp.: collaborator
• Health Insurance Review & Assessment Service: collaborator

Study Sites (1)

Yongin Severance Hospital, Yonsei University Health System

Yongin, Gyeonggi-do, 16995, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Heart Failure

Interventions

Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin; empagliflozin; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Protease Inhibitors; Enzyme Inhibitors

Study Officials

• Yongcheol Kim, MD, PhD

  Yonsei University Health System, Yongin Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 30, 2025
• Study Start: September 1, 2014
• Primary Completion: June 30, 2022
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)