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Which diabetes pill is better for your heart? huge study aims to find out

NCT ID NCT07390110

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Updated 4 times

Summary

This large study compares two diabetes drugs—oral semaglutide and sitagliptin—in over 25,000 people with type 2 diabetes and heart failure. Researchers want to see which drug better prevents heart failure worsening or death. The study uses existing medical records to mimic a clinical trial.

What this could mean

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

Active substance
oral semaglutide and sitagliptin
What this could lead to
If this study shows one drug works better, it could guide doctors to a more effective treatment for heart failure in people with diabetes.
What could go wrong
This is an observational study using existing data, not a controlled trial. Results may be affected by unmeasured differences between groups, so they 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

25,664 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 aged 18 years or older with heart failure with preserved ejection fraction.

Ages

18 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.

Eligible Cohort Entry Dates: * Optum: Eligible cohort entry period from September 20, 2019 to November 30, 2025. * Marketscan: Eligible cohort entry from September 20, 2019 to December 31, 2023. * Medicare: Eligible cohort entry from September 20, 2019 to December 31, 2020. Inclusion Criteria: * Heart failure * BMI \> 27.0kg/m2 * Type 2 diabetes mellitus * LVEF \> 45% * Age \> 18 years * Sex: male or female Exclusion Criteria: * Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, other malignancy * Type 1 diabetes mellitus, uncontrolled diabetic retinopathy or maculopathy, bariatric surgery, end-stage renal disease or dialysis, nursing home admission * Any use of GLP-1-RA including injectable semaglutide except oral semaglutide, pregnancy, treatment with continuous subcutaneous insulin infusion * Concurrent use of both study drugs

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure type 2 diabetes mellitus

As listed by the trial registrant

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

Heart failure 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.