Type 2 Diabetes Mellitus Myocardial InfarctionPhase 4NCT07621380
Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction
A Phase 4 study testing Ertugliflozin 10 mg and Standard AMI Care in people with Type 2 Diabetes Mellitus Myocardial Infarction, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus Myocardial Infarction
- What is being tested?
- Ertugliflozin 10 mg and Standard AMI Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai
Junbo Ge, MD, +86-13901977506, ge.junbo@zs-hospital.sh.cn
Junbo Ge, MD
About this study
Official title: Effect of Ertugliflozin on NT-proBNP and Cardiac Function After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded Endpoint (PROBE) Trial
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 study is supported by scientific rationale suggesting potential effects of ertugliflozin on cardiac resident macrophages in the heart after myocardial infarction.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.
- Being tested
- Ertugliflozin 10 mg, Standard AMI Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ertugliflozin 10 mgDrug
Ertugliflozin 10mg, oral, once daily
Standard AMI CareOther
Standard pharmacotherapy for acute myocardial infarction without Ertugliflozin
| Study group | Role | What they receive |
|---|---|---|
| Ertugliflozin | Experimental | Not described Receives: Drug: Ertugliflozin 10 mg |
| Control | Active comparator | Standard AMI pharmacotherapy alone for 26 weeks, without Ertugliflozin or any placebo. Receives: Other: Standard AMI Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621380
- Sponsor's protocol ID
- B2026-325
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ertugliflozin on NT-proBNP and Cardiac Function After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded Endpoint (PROBE) Trial
- ClinicalTrials.gov ID
- NCT07621380
- Acronym / sponsor ID
- B2026-325
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 study is supported by scientific rationale suggesting potential effects of ertugliflozin on cardiac resident macrophages in the heart after myocardial infarction.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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertugliflozin | Experimental | Drug: Ertugliflozin 10 mg |
| Control | Active comparator | Other: Standard AMI CareStandard AMI pharmacotherapy alone for 26 weeks, without Ertugliflozin or any placebo. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ertugliflozin 10 mgErtugliflozin 10mg, oral, once daily | Drug | Ertugliflozin |
| Standard AMI CareStandard pharmacotherapy for acute myocardial infarction without Ertugliflozin | Other | Control |
Primary outcome
Percent change in NT-proBNP from baseline
Time frame: 26 weeks
Percent change in serum NT-proBNP levels from baseline to week 26, assessed by mixed-effects model for repeated measures (MMRM)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertugliflozin 10 mg and Standard AMI Care in people with Type 2 Diabetes Mellitus Myocardial Infarction, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junbo Ge (+86-13901977506, ge.junbo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in NT-proBNP from baseline (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.