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Which diabetes drug best protects your heart? 60,000-person study aims to find out.

NCT ID NCT07417618

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 3 times

Summary

This large study looks at real-world data from 60,000 people with type 2 diabetes and obesity to compare four diabetes drugs—dulaglutide, semaglutide, tirzepatide, and sitagliptin—in preventing heart attacks, strokes, and death. Researchers are analyzing insurance claims to see which drug works best, both in people with and without existing heart disease. The goal is to guide doctors in choosing the most effective treatment for heart protection.

What this could mean

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

Active substance
dulaglutide, semaglutide, tirzepatide, sitagliptin
What this could lead to
If successful, this could show which diabetes drug is best at preventing heart attacks and strokes in people with type 2 diabetes and obesity.
What could go wrong
This is an observational study using existing data, not a controlled experiment, so results may be less reliable. It also compares drugs already on the market, so no new treatment is being tested.

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

60,000 people

The number who actually took part.

Started

Jan 2026

Finished

Jun 2026

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 with T2DM and overweight with (or without) ASCVD.

Ages

18 years and older

Sex

Anyone

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.

The database analyses will be new-user active-comparative studies, conducted using 3 national United States claims databases, where we compare the effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on preventing atherosclerotic cardiovascular events. Optum: Eligible cohort entry period from September 18, 2014 to August 31, 2025. Marketscan: Eligible cohort entry from October 1, 2016 to October 31, 2023. Medicare: Eligible cohort entry from September 18, 2014 to October 31, 2020. POPULATION WITH ASCVD Inclusion Criteria: * History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease) * BMI \>= 25.0kg/m2 * Type 2 Diabetes Exclusion Criteria: * Medullary thyroid carcinoma * MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * End-stage renal disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Bariatric surgery * Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin * CV-event or intervention * Concurrent use of both study drugs POPULATION WITHOUT ASCVD Inclusion Criteria: * BMI \>=25.0kg/m2 * Type 2 diabetes Exclusion Criteria: * History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease) * Medullary thyroid carcinoma * MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * End-stage renal disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Bariatric surgery * Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin * Concurrent use of both study drugs

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

ASCVD Overweight Type 2 diabetes

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.