Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction

NCT07621380 | Not Yet Recruiting Phase 4

• 1 other identifier: B2026-325
• Study Type: interventional
• Target: 476
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluates the efficacy of early ertugliflozin initiation (10 mg daily) compared to standard care alone on cardiac function in 476 adult patients with type 2 diabetes mellitus (T2DM) following a first acute myocardial infarction (AMI). The primary objective is to assess the change in NT-proBNP levels from baseline to 26 weeks, while secondary endpoints explore echocardiographic parameters (such as LVEF and LAVi) and metabolic indices including blood ketone levels, HbA1c, and body weight. Eligible participants are randomized in a 1:1 ratio within 72 hours of AMI onset and followed for a total of 30 weeks to monitor both efficacy outcomes and safety events, with a specific focus on serious adverse events like severe hypoglycemia, genital infections, and ketoacidosis.

Conditions

Type 2 Diabetes Mellitus Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Percent change in NT-proBNP from baseline

  Percent change in serum NT-proBNP levels from baseline to week 26, assessed by mixed-effects model for repeated measures (MMRM)

  26 weeks

Study Arms (2)

Ertugliflozin

EXPERIMENTAL

Drug: Ertugliflozin 10 mg

Control

ACTIVE COMPARATOR

Standard AMI pharmacotherapy alone for 26 weeks, without Ertugliflozin or any placebo.

Other: Standard AMI Care

Interventions

Ertugliflozin 10 mg DRUG

Ertugliflozin 10mg, oral, once daily

Ertugliflozin

Standard AMI Care OTHER

Standard pharmacotherapy for acute myocardial infarction without Ertugliflozin

Control

Eligibility Criteria

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

You may qualify if:

• Adults aged 19 years or older
• Clinically confirmed type 2 diabetes mellitus (T2DM)
• First acute myocardial infarction (AMI) with planned randomization within 72 hours of AMI onset
• Ability to understand and voluntarily sign written informed consent

You may not qualify if:

• Type 1 diabetes mellitus or history of diabetic ketoacidosis
• Gestational diabetes, pregnancy, or breastfeeding
• End-stage renal disease (ESRD), dialysis, or prior kidney transplantation
• Use of any SGLT2 inhibitor within 4 weeks prior to enrollment
• Hemodynamic instability or investigator judgment that participation is not in the patient's best interest
• Systolic blood pressure \< 90 mmHg at enrollment or requiring vasopressors to maintain blood pressure

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Interventions

ertugliflozin

Central Study Contacts

Junbo Ge

CONTACT

+86-13901977506; ge.junbo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share