PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes (PRECIDENTD)

April 7, 2026 updated by: Brendan M. Everett, Brigham and Women's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Longwood Research LLC
        • Contact:
        • Principal Investigator:
          • Saadat Ansari, MD
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth Research & Innovation Institute
        • Contact:
        • Principal Investigator:
          • Tabitha Moe, MD FACC
    • California
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Eastside Clinical Research Associates
        • Contact:
        • Principal Investigator:
          • Enrique J Gonzalez, MD
    • Florida
      • Miami, Florida, United States, 33185
        • Recruiting
        • Kendall South Medical Center, Inc
        • Contact:
        • Principal Investigator:
          • Rafael Chiong, MD
        • Sub-Investigator:
          • Enrique Vazquez Escarpanter, MD
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • South Florida Research Solutions, LLC
        • Contact:
        • Principal Investigator:
          • Dennis Spiller, DO
        • Sub-Investigator:
          • Julio Tallet, MD
    • Georgia
      • Johns Creek, Georgia, United States, 30024
        • Recruiting
        • NSC Research, Inc.
        • Principal Investigator:
          • Narendra Singh, MD
        • Contact:
        • Sub-Investigator:
          • Taylor Mabe, NP-C
        • Sub-Investigator:
          • Dhaval Shah, MD
      • Suwanee, Georgia, United States, 30024
        • Recruiting
        • Herman Clinical Research
        • Principal Investigator:
          • Lee Herman, MD
        • Contact:
        • Sub-Investigator:
          • Amit Narayan, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Chicago
        • Principal Investigator:
          • Brian Layden, MD
        • Contact:
        • Sub-Investigator:
          • Yuval Eisenberg, MD
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Ankitaben Han, MD, MS
        • Sub-Investigator:
          • Sameer Panjwani, MD
        • Sub-Investigator:
          • Jill K Marcus, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Jeffrey D Quinlan, MD
        • Sub-Investigator:
          • Hussain Banu, MBBS
        • Sub-Investigator:
          • Korey Kennelty, PharmD, MS, PhD, BCGP
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Kristin K Grdinovac, MD
        • Sub-Investigator:
          • Ethan Alexander, MD
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • MedStar Union Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Adline Ghazi, MD
        • Sub-Investigator:
          • Sadaf Mustafa, MD
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins School of Medicine
        • Sub-Investigator:
          • Dan Ford, MD
        • Contact:
        • Principal Investigator:
          • Maya Venkataramani, MD
      • Baltimore, Maryland, United States, 21239
        • Recruiting
        • MedStar Health Research Institute - Good Samaritan Hospital
        • Sub-Investigator:
          • Adline Ghazi, MD
        • Principal Investigator:
          • Jean Park, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Marie McDonnell, MD
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Chan Medical School
        • Contact:
        • Principal Investigator:
          • Mark O'Connor, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • David Broome, MD
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health
        • Principal Investigator:
          • Catherine Benziger, MD, MPH
        • Contact:
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Elizabeth Rogers, MD, MAS
        • Sub-Investigator:
          • Anne Bantle, MD, MS
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri-Columbia
        • Principal Investigator:
          • Camilla Manrique Acevedo, MD
        • Contact:
        • Sub-Investigator:
          • Katherine Pierce, PhD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Cyrus Desouza, MBBS
        • Sub-Investigator:
          • Amber Brown Keebler, MD
        • Sub-Investigator:
          • Shubham Agarwal, MBBS
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University
        • Principal Investigator:
          • Jacqueline Lonier, MD
        • Contact:
        • Sub-Investigator:
          • Nina Suda, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Atrium Health Family Medicine Research Department
        • Contact:
        • Principal Investigator:
          • Hazel Tapp, PhD
        • Sub-Investigator:
          • Emily Manlove Manlove, MD
        • Sub-Investigator:
          • May Royer, MD
        • Sub-Investigator:
          • Lindsay Shade, PA-C
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Hospital
        • Sub-Investigator:
          • Ranee Chatterjee, MD
        • Contact:
        • Principal Investigator:
          • W. Schuyler Jones, MD
    • Ohio
      • Wooster, Ohio, United States, 44691
        • Recruiting
        • Wooster Heart Group
        • Contact:
        • Principal Investigator:
          • Cyril S Ofori, MD
        • Sub-Investigator:
          • Toni King, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Principal Investigator:
          • Rodica Busui, MD, PhD
        • Contact:
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17821
        • Recruiting
        • Geisinger Medical Center
        • Sub-Investigator:
          • Eric Wright, PharmD, MPH
        • Contact:
        • Principal Investigator:
          • Alexander Chang, MD, MS, FAHA, FASN
        • Sub-Investigator:
          • Anthony Olson, PharmD, PhD, FAPhA
        • Sub-Investigator:
          • Waleed Zafar, MD
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Lewis Katz School of Medicine
        • Contact:
        • Principal Investigator:
          • Daniel J Rubin, MD
        • Sub-Investigator:
          • Ajaykumar D Rao, MD
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Recruiting
        • Family Care Center at Kent Hospital
        • Principal Investigator:
          • Caroline Richardson, MD
        • Contact:
        • Sub-Investigator:
          • Charles Eaton, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Harsha Karanchi, MD
        • Contact:
        • Sub-Investigator:
          • Mary Leigh Goodman, DNP, APRN, FNP-C
      • Orangeburg, South Carolina, United States, 29118
        • Recruiting
        • South Carolina Clinical Research, LLC
        • Contact:
        • Principal Investigator:
          • Moustafa A Moustafa, MD
        • Sub-Investigator:
          • Radames Zuquello, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Leslee Matheny, MD
        • Sub-Investigator:
          • Russell Rothman, MD
        • Contact:
    • Texas
      • Katy, Texas, United States, 77493
        • Recruiting
        • Premier Internal Medicine Associates of Houston
        • Contact:
        • Principal Investigator:
          • Nadia Abbasi, MD
        • Sub-Investigator:
          • Christina Bolin
      • McKinney, Texas, United States, 75069
        • Recruiting
        • North Dallas Research Associates
        • Contact:
        • Principal Investigator:
          • Muhammad Akram Khan, MD
        • Sub-Investigator:
          • Ambreen Ashfaque, MD
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Recruiting
        • Kidney and Hypertension Specialists, PLLC
        • Contact:
        • Principal Investigator:
          • Rashida Rahman, MD
        • Sub-Investigator:
          • Hanan Ebjad Ebjad, MD, MHSA
        • Sub-Investigator:
          • Priya Chaddah, PA-C
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Jake Decker, MD
        • Sub-Investigator:
          • Jeffrey Whittle, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium-glucose cotransporter-2 inhibitor (SGLT2i)
Therapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin
Drug: SGLT2 inhibitor
Empagliflozin, dapagliflozin, or canagliflozin
Active Comparator: Glucagon-like peptide-1 receptor agonist (GLP-1 RA)
Therapy with a GLP-1 RA with proven cardiovascular benefit. This means either dulaglutide, liraglutide, or semaglutide.
Drug: GLP-1 receptor agonist
Dulaglutide, liraglutide, semaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total (first and recurrent) cardiovascular, kidney, and death events
Time Frame: Through study completion, with an average follow up of approximately 3 years
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
Through study completion, with an average follow up of approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Patient-Centered Outcomes Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022p001160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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