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Heart showdown: which diabetes drug wins?

NCT ID NCT07203677

Disease control Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed study looked at two diabetes drugs, tirzepatide and sitagliptin, to see which one better prevents heart attacks, strokes, or death in people with type 2 diabetes and heart disease. Researchers analyzed data from over 49,000 patients. The goal was to learn how well real-world data can mimic clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirzepatide and sitagliptin
What this could lead to
If tirzepatide proves better, it could become a preferred option for managing diabetes and reducing heart risks.
What could go wrong
This is an observational study using existing data, not a controlled trial, so results may be less reliable. It also cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

49,065 people

The number who actually took part.

Started

Sep 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals aged 40 years or older with T2DM and and atherosclerotic cardiovascular disease.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * History of MI or stroke, surgical or percutaneous coronary/carotid peripheral artery revascularization, amputation, diagnosis of coronary/carotid/peripheral artery disease * BMI ≥25.0kg/m2 * Type 2 diabetes * Age ≥40 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2, malignancy * Treatment for diabetic retinopathy/macular edema, heart failure NYHA IV, gastric emptying abnormality/bariatric surgery, end-stage renal disease or dialysis, pregnancy * Prior use of pramlintide or any GLP-1-RA except tirzepatide, * Pancreatitis, liver disease * Cardiovascular event or intervention, hospitalization for heart failure * Concurrent use of both drugs i.e. tirzepatide and sitagliptin

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerotic cardiovascular disease TYPE2 diabetes mellitus

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

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