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Type2DiabetesPhase 4PRECIDENTDNCT05390892

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

A Phase 4 study testing SGLT2 inhibitor and GLP-1 receptor agonist in people with Type2Diabetes and ASCVD, run by Brigham and Women's Hospital at 36 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Type2Diabetes, ASCVD
What is being tested?
SGLT2 inhibitor and GLP-1 receptor agonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,000 participants
Where
36 sitesUnited States
Study dates
26 Sep 2022to 1 Mar 2029
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Brendan Everett, MD, MPH contact

617-732-8790

PRECIDENTDccc@bwh.harvard.edu

Maureen Malloy contact

617-732-8773

PRECIDENTDccc@bwh.harvard.edu

36 sites in 1 country

United States36 sites, 36 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Brittany Williams, 734-998-2497, briplunk@med.umich.edu

    David Broome, MD

    Recruiting

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21205

    Jamie Hyman, 443-927-8723, PRECIDENTD@jhmi.edu

    Maya Venkataramani, MD

    Recruiting

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

    Flossine Brown, BS, CRC, 410-554-4451, flossine.brown@medstar.net

    Adline Ghazi, MD

    Recruiting

  • MedStar Health Research Institute - Good Samaritan Hospital

    Baltimore, Maryland, 21239

    Sariat Ibrahim, 443-444-2263, Sariat.Ibrahim@medstar.net

    Jean Park, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Krista Scartozzi, 617-278-0659, bwhprecidentd@bwh.harvard.edu

    Marie McDonnell, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Audra Wiser, (843) 876-9928, wisera@musc.edu

    Harsha Karanchi, MD

    Recruiting

  • Atrium Health Family Medicine Research Department

    Charlotte, North Carolina, 28207

    Andrea Price, 704-304-7176, precidentd@advocatehealth.org

    Hazel Tapp, PhD

    Recruiting

  • University of Illinois Chicago

    Chicago, Illinois, 60612

    Julia Law, 773-505-0169, julielaw@uic.edu

    Brian Layden, MD

    Recruiting

  • University of Missouri-Columbia

    Columbia, Missouri, 65212

    Katelyn Smith, 833-970-0046, MUPRECIDENTD@health.missouri.edu

    Camilla Manrique Acevedo, MD

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17821

    Megan Oliveri, 1-866-219-5148, Option 2, meoliveri@geisinger.edu

    Alexander Chang, MD, MS, FAHA, FASN

    Recruiting

  • Essentia Health

    Duluth, Minnesota, 55805

    Leah Tatelovich, 218-576-0480, PrecidentdEH@Essentia.org

    Catherine Benziger, MD, MPH

    Recruiting

  • Duke University Hospital

    Durham, North Carolina, 27710

    Chad Harrell, 919-668-9049, DukePRECIDENTD@duke.edu

    W. Schuyler Jones, MD

    Recruiting

  • University of Kansas Medical Center

    Fairway, Kansas, 66205

    Erica Lower, CCRP, 913-588-6052, elower@kumc.edu

    Kristin K Grdinovac, MD

    Recruiting

  • Rush University Medical Center

    Hinsdale, Illinois, 60521

    Sharon Glinski, 630-724-1792, sharon_glinski@rush.edu

    Ankitaben Han, MD, MS

    Recruiting

  • Longwood Research LLC

    Huntsville, Alabama, 35801

    Jeff Dunlap, 256-489-2879, jdunlap@longwoodresearch.net

    Saadat Ansari, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Laura Seegmiller, (319) 331-8773, laura-seegmiller@uiowa.edu

    Jeffrey D Quinlan, MD

    Recruiting

  • NSC Research, Inc.

    Johns Creek, Georgia, 30024

    Charlotte Mall, 678-507-0838, info@nscresearch.org

    Narendra Singh, MD

    Recruiting

  • Premier Internal Medicine Associates of Houston

    Katy, Texas, 77493

    Nausheen Mujeeb, 281-398-8044, IMresearch5@medacro.com

    Nadia Abbasi, MD

    Recruiting

  • Eastside Clinical Research Associates

    Los Angeles, California, 90022

    Mayra Vazquez, 323-261-4706, mvazquez@eastsideclinicalresearch.org

    Enrique J Gonzalez, MD

    Recruiting

  • Kidney and Hypertension Specialists, PLLC

    Manassas, Virginia, 20110

    Hanan Ebjad, MD, MHSA, 703-361-7341, Research@NovaKidney.Com

    Rashida Rahman, MD

    Recruiting

  • North Dallas Research Associates

    McKinney, Texas, 75069

    Samina Ahsanullah, 972-529-6939, samina@ndresearch.com

    Muhammad Akram Khan, MD

    Recruiting

  • Kendall South Medical Center, Inc

    Miami, Florida, 33185

    Denise Moreno, 305-388-1118, frontdesk@floridatrials.org

    Rafael Chiong, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Kailie Roth, 414-805-8104, kroth@mcw.edu

    Jake Decker, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Sarah Manser, 612-301-3105, PRECIDENTD@umn.edu

    Elizabeth Rogers, MD, MAS

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Alesia Pruitt, 615-421-3082, alesia.l.pruitt@vumc.org

    Leslee Matheny, MD

    Recruiting

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

    New York, New York, 10032

    Angel Suzana, 212-851-5492, precidentd@cumc.columbia.edu

    Jacqueline Lonier, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Khadieja M Abuzaho, 402-559-4815, kabuzaho@unmc.edu

    Cyrus Desouza, MBBS

    Recruiting

  • South Carolina Clinical Research, LLC

    Orangeburg, South Carolina, 29118

    Payton Padgett, 803-531-2220, ppadgett@scnephrology.net

    Moustafa A Moustafa, MD

    Recruiting

  • Family Care Center at Kent Hospital

    Pawtucket, Rhode Island, 02860

    Angela Larkin, 401-921-9066, ALarkin@kentri.org

    Caroline Richardson, MD

    Recruiting

  • South Florida Research Solutions, LLC

    Pembroke Pines, Florida, 33028

    Smelda Ferrin, 954-986-3067, sferrin@sfresearch.net

    Dennis Spiller, DO

    Recruiting

  • Temple University Lewis Katz School of Medicine

    Philadelphia, Pennsylvania, 19140

    Jackson Weiler, 267-225-4836, jackson.weiler@temple.edu

    Daniel J Rubin, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Aly Carlson, 971-610-3005, precidentd@ohsu.edu

    Rodica Busui, MD, PhD

    Recruiting

  • HonorHealth Research & Innovation Institute

    Scottsdale, Arizona, 85258

    Nadia Madias, 480-323-1046, heartclinicaltrials@honorhealth.com

    Tabitha Moe, MD FACC

    Recruiting

  • Herman Clinical Research

    Suwanee, Georgia, 30024

    Morgan Echols, 678-739-2765, mechols.hcr@gmail.com

    Lee Herman, MD

    Recruiting

  • Wooster Heart Group

    Wooster, Ohio, 44691

    John Roof, 330-202-5700, jroof@bloomingtonmedical.org

    Cyril S Ofori, MD

    Recruiting

  • UMass Chan Medical School

    Worcester, Massachusetts, 01655

    Xhenifer Mele, 508-334-3206, precidentd@umassmed.edu

    Mark O'Connor, MD

    Recruiting

Other trials in United States

About this study

Official title: PRECIDENTD: PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.

Conditions
Type2Diabetes, ASCVD
Being tested
SGLT2 inhibitor, GLP-1 receptor agonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGLT2 inhibitorDrug

    Empagliflozin, dapagliflozin, or canagliflozin

  • GLP-1 receptor agonistDrug

    Dulaglutide, liraglutide, semaglutide

Study groups in NCT05390892
Study groupRoleWhat they receive
Sodium-glucose cotransporter-2 inhibitor (SGLT2i)Active comparatorTherapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin
Receives: Drug: SGLT2 inhibitor
Glucagon-like peptide-1 receptor agonist (GLP-1 RA)Active comparatorTherapy with a GLP-1 RA with proven cardiovascular benefit. This means either dulaglutide, liraglutide, or semaglutide.
Receives: Drug: GLP-1 receptor agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total (first and recurrent) cardiovascular, kidney, and death events

    total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality

    Measured: Through study completion, with an average follow up of approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start26 Sep 2022
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390892
Sponsor's protocol ID
2022p001160
Acronym
PRECIDENTD
Status last verified
Apr 2026
First submitted
19 May 2022
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Wexler DJ, Mayberry LS, Nelson LA, Lema-Driscoll J, Flores LC, Malloy M, MacFadyen JG, Shen J, Zaharris E, Karanchi H, Chatterjee R, Benziger CP, Decker JE, Kalyani R, Manrique-Acevedo C, Lonier J, Simeone E, Mieras K, Siqueira ARO, Rothman RL, Jones WS, Glynn RJ, Everett BM. Dual versus monotherapy with SGLT2 inhibitor and GLP-1 receptor agonist: PRECIDENTD pragmatic randomized trial. Am Heart J. 2026 Apr;294:107332. doi: 10.1016/j.ahj.2025.107332. Epub 2025 Dec 26.

    PubMed 41456635

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SGLT2 inhibitor and GLP-1 receptor agonist in people with Type2Diabetes and ASCVD, run by Brigham and Women's Hospital at 36 sites in United States.

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 18 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. 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 Brendan Everett, MD, MPH (617-732-8790, PRECIDENTDccc@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total (first and recurrent) cardiovascular, kidney, and death events (time frame: Through study completion, with an average follow up of approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05390892, which also lists 1 linked publication.

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 13 Apr 2026.

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