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Massive diabetes trial aims to find which drug saves hearts and kidneys best

NCT ID NCT05390892

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study compares two common diabetes drug classes—SGLT2 inhibitors and GLP-1 receptor agonists—to see which better prevents heart attacks, strokes, kidney failure, and death in 6,000 people with type 2 diabetes and heart disease or high risk. Participants are randomly assigned to one drug class and followed for years. The goal is to guide doctors on the best treatment to reduce serious complications.

What this could mean

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

Active substance
SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) or GLP-1 receptor agonists (dulaglutide, liraglutide, semaglutide)
What this could lead to
If it works, this could show which drug class is better at preventing serious heart and kidney complications in people with type 2 diabetes.
What could go wrong
This is a large, late-stage trial, but it's open-label (no placebo), so results may be influenced by patient or doctor expectations. Also, individual responses vary.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 6,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Mar 2029

An estimate. End dates often move.

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.

Ages

40 to 80 years

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: * Type 2 diabetes based on clinical diagnosis * HbA1c ≥6% measured within 12 months prior to screening * Secondary prevention cohort (at least 70% of cohort): * Age 40 to 80 years * Evidence of established atherosclerotic cardiovascular disease (ASCVD), as defined by one or more of the following * Coronary heart disease defined by at least one of the following: prior myocardial infarction, prior coronary percutaneous coronary intervention, ≥50% stenosis of a coronary artery documented by invasive or non-invasive imaging (including CT coronary angiography), positive stress test, or coronary artery calcium score \>400 Agatston units; * Cerebrovascular disease defined by at least one of the following: prior ischemic stroke, prior carotid revascularization procedure, carotid stenosis ≥ 50% documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound; * Symptomatic peripheral artery disease defined by at least one of the following: leg symptoms with an ABI ≤ 0.9, leg symptoms with imaging evidence of a stenosis ≥50% in a peripheral artery documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound, or prior amputation for atherosclerotic disease. * Primary prevention cohort (capped at 30% of cohort): * Age 60-80 years and at least 1 additional high-risk feature: * Cardiovascular risk factors/high-risk features: * Active smoking (combustible tobacco or marijuana) * HbA1c ≥ 8% measured within 12 months prior to screening. The most recent value available at the time of screening will be used for screening and to determine eligibility. * Stage 3a CKD, eGFR 45-59 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility. * Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety * Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider. * If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes * Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities Exclusion Criteria: * Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.) * Any background diabetes medication regimen will be allowed in this pragmatic trial with the following proviso: o Participants taking basal-bolus, prandial, or multiple daily injection insulin (MDI) regimens (e.g., short-acting in combination with long-acting insulin, called MDI regimens) are eligible only if the research staff attests that there has been communication with the usual diabetes care provider and that the provider has agreed to manage insulin adjustment with initiation of study medications. If such agreement has not been obtained, participants taking MDI regimens are excluded. * History of diabetic ketoacidosis * Active diabetic foot ulcer * History of pancreatitis * Heart failure as a primary reason for hospitalization within the past year * Known left ventricular ejection fraction \<40% * Known urinary albumin-to-creatinine ratio \>200 mg/g at screening * Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility. * Known inability to afford study medication through current insurance coverage. * If a woman of child-bearing potential, the patient or partner is unwilling to use birth control * Active treatment for cancer, planned treatment for cancer, or recent active cancer with likelihood of recurrence or progression, which, in the opinion of the site investigator, has a likelihood of recurrence that would interfere with study therapy prior to 2028 * Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy is allowed. Examples of allowable cancers include: * Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy * Prostate cancer being observed * Stage 0 or 1 tumors status post resection or other definitive treatment * Other similarly stable cancer comorbidities * History of solid organ or bone marrow transplant * Allergy to SGLT2 inhibitor or GLP-1 receptor agonist

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease type 2 diabetes mellitus

As listed by the trial registrant

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

ASCVD TYPE2DIABETES

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    36 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Family Medicine Research Department

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Eastside Clinical Research Associates

    RECRUITING

    Los Angeles, California, 90022, United States

  • Essentia Health

    RECRUITING

    Duluth, Minnesota, 55805, United States

  • Family Care Center at Kent Hospital

    RECRUITING

    Pawtucket, Rhode Island, 02860, United States

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17821, United States

  • Herman Clinical Research

    RECRUITING

    Suwanee, Georgia, 30024, United States

  • HonorHealth Research & Innovation Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

    Contact Email: •••••@•••••

  • Johns Hopkins School of Medicine

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Kendall South Medical Center, Inc

    RECRUITING

    Miami, Florida, 33185, United States

  • Kidney and Hypertension Specialists, PLLC

    RECRUITING

    Manassas, Virginia, 20110, United States

    Contact Email: •••••@•••••

  • Longwood Research LLC

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • MedStar Health Research Institute - Good Samaritan Hospital

    RECRUITING

    Baltimore, Maryland, 21239, United States

  • MedStar Union Memorial Hospital

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NSC Research, Inc.

    RECRUITING

    Johns Creek, Georgia, 30024, United States

    Contact Email: •••••@•••••

  • Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • North Dallas Research Associates

    RECRUITING

    McKinney, Texas, 75069, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Premier Internal Medicine Associates of Houston

    RECRUITING

    Katy, Texas, 77493, United States

    Contact Email: •••••@•••••

  • Rush University Medical Center

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • South Carolina Clinical Research, LLC

    RECRUITING

    Orangeburg, South Carolina, 29118, United States

  • South Florida Research Solutions, LLC

    RECRUITING

    Pembroke Pines, Florida, 33028, United States

  • Temple University Lewis Katz School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • UMass Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Illinois Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Missouri-Columbia

    RECRUITING

    Columbia, Missouri, 65212, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wooster Heart Group

    RECRUITING

    Wooster, Ohio, 44691, United States

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