Recruiting

PRECardiovascular & Diabetic Kidney DiseasePREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Sponsor:

Brigham and Women's Hospital

Code:

NCT05390892

Conditions

Type2Diabetes

ASCVD

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

SGLT2 inhibitor

GLP-1 receptor agonist

Study Details

Brief 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 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

Study ID

NCT05390892

Start date

Sep 26, 2022

Status verified date

Apr, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

6000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Sodium-glucose cotransporter-2 inhibitor (SGLT2i)

Therapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin

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.

Interventions

SGLT2 inhibitor

Empagliflozin, dapagliflozin, or canagliflozin

GLP-1 receptor agonist

Dulaglutide, liraglutide, semaglutide

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 ]

Central Contacts and Locations

Central contacts

Brendan Everett, MD, MPH

617-732-8790 PRECIDENTDccc@bwh.harvard.edu

Maureen Malloy

617-732-8773 PRECIDENTDccc@bwh.harvard.edu

Locations

Longwood Research LLC

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Jeff Dunlap

256-489-2879 jdunlap@longwoodresearch.net

Principal Investigator:

Saadat Ansari, MD

HonorHealth Research & Innovation Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Nadia Madias

480-323-1046 heartclinicaltrials@honorhealth.com

Principal Investigator:

Tabitha Moe, MD FACC

Eastside Clinical Research Associates

Recruiting

Los Angeles, California, United States, 90022

Contacts

Mayra Vazquez

323-261-4706 mvazquez@eastsideclinicalresearch.org

Principal Investigator:

Enrique J Gonzalez, MD

Kendall South Medical Center, Inc

Recruiting

Miami, Florida, United States, 33185

Contacts

Denise Moreno

305-388-1118 frontdesk@floridatrials.org

Principal Investigator:

Rafael Chiong, MD

South Florida Research Solutions, LLC

Recruiting

Pembroke Pines, Florida, United States, 33028

Contacts

Smelda Ferrin

954-986-3067 sferrin@sfresearch.net

Principal Investigator:

Dennis Spiller, DO

NSC Research, Inc.

Recruiting

Johns Creek, Georgia, United States, 30024

Contacts

Charlotte Mall

678-507-0838 info@nscresearch.org

Principal Investigator:

Narendra Singh, MD

Herman Clinical Research

Recruiting

Suwanee, Georgia, United States, 30024

Contacts

Morgan Echols

678-739-2765 mechols.hcr@gmail.com

Principal Investigator:

Lee Herman, MD

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Julia Law

773-505-0169 julielaw@uic.edu

Principal Investigator:

Brian Layden, MD

Rush University Medical Center

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

Sharon Glinski

630-724-1792 sharon_glinski@rush.edu

Principal Investigator:

Ankitaben Han, MD, MS

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Laura Seegmiller

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

Principal Investigator:

Jeffrey D Quinlan, MD

University of Kansas Medical Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Erica Lower, CCRP

913-588-6052 elower@kumc.edu

Principal Investigator:

Kristin K Grdinovac, MD

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Jamie Hyman

443-927-8723 PRECIDENTD@jhmi.edu

Principal Investigator:

Maya Venkataramani, MD

MedStar Union Memorial Hospital

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Flossine Brown, BS, CRC

410-554-4451 flossine.brown@medstar.net

Principal Investigator:

Adline Ghazi, MD

MedStar Health Research Institute - Good Samaritan Hospital

Recruiting

Baltimore, Maryland, United States, 21239

Contacts

Sariat Ibrahim

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

Principal Investigator:

Jean Park, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Krista Scartozzi

617-278-0659 bwhprecidentd@bwh.harvard.edu

Principal Investigator:

Marie McDonnell, MD

UMass Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Xhenifer Mele

508-334-3206 precidentd@umassmed.edu

Principal Investigator:

Mark O'Connor, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Brittany Williams

734-998-2497 briplunk@med.umich.edu

Principal Investigator:

David Broome, MD

Essentia Health

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Leah Tatelovich

218-576-0480 PrecidentdEH@Essentia.org

Principal Investigator:

Catherine Benziger, MD, MPH

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Sarah Manser

612-301-3105 PRECIDENTD@umn.edu

Principal Investigator:

Elizabeth Rogers, MD, MAS

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Katelyn Smith

833-970-0046 MUPRECIDENTD@health.missouri.edu

Principal Investigator:

Camilla Manrique Acevedo, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Khadieja M Abuzaho

402-559-4815 kabuzaho@unmc.edu

Principal Investigator:

Cyrus Desouza, MBBS

Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Angel Suzana

212-851-5492 precidentd@cumc.columbia.edu

Principal Investigator:

Jacqueline Lonier, MD

Atrium Health Family Medicine Research Department

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Andrea Price

704-304-7176 precidentd@advocatehealth.org

Principal Investigator:

Hazel Tapp, PhD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Chad Harrell

919-668-9049 DukePRECIDENTD@duke.edu

Principal Investigator:

W. Schuyler Jones, MD

Wooster Heart Group

Recruiting

Wooster, Ohio, United States, 44691

Contacts

John Roof

330-202-5700 jroof@bloomingtonmedical.org

Principal Investigator:

Cyril S Ofori, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Aly Carlson

971-610-3005 precidentd@ohsu.edu

Principal Investigator:

Rodica Busui, MD, PhD

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17821

Contacts

Megan Oliveri

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

Principal Investigator:

Alexander Chang, MD, MS, FAHA, FASN

Temple University Lewis Katz School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Jackson Weiler

267-225-4836 jackson.weiler@temple.edu

Principal Investigator:

Daniel J Rubin, MD

Family Care Center at Kent Hospital

Recruiting

Pawtucket, Rhode Island, United States, 02860

Contacts

Angela Larkin

401-921-9066 ALarkin@kentri.org

Principal Investigator:

Caroline Richardson, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Audra Wiser

(843) 876-9928 wisera@musc.edu

Principal Investigator:

Harsha Karanchi, MD

South Carolina Clinical Research, LLC

Recruiting

Orangeburg, South Carolina, United States, 29118

Contacts

Payton Padgett

803-531-2220 ppadgett@scnephrology.net

Principal Investigator:

Moustafa A Moustafa, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Alesia Pruitt

615-421-3082 alesia.l.pruitt@vumc.org

Principal Investigator:

Leslee Matheny, MD

Premier Internal Medicine Associates of Houston

Recruiting

Katy, Texas, United States, 77493

Contacts

Nausheen Mujeeb

281-398-8044 IMresearch5@medacro.com

Principal Investigator:

Nadia Abbasi, MD

North Dallas Research Associates

Recruiting

McKinney, Texas, United States, 75069

Contacts

Samina Ahsanullah

972-529-6939 samina@ndresearch.com

Principal Investigator:

Muhammad Akram Khan, MD

Kidney and Hypertension Specialists, PLLC

Recruiting

Manassas, Virginia, United States, 20110

Contacts

Hanan Ebjad, MD, MHSA

703-361-7341 Research@NovaKidney.Com

Principal Investigator:

Rashida Rahman, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kailie Roth

414-805-8104 kroth@mcw.edu

Principal Investigator:

Jake Decker, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-04-13.