PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

NCT05390892 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2022p001160
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 36

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

Outcome Measures

Primary Outcomes (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

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

Study Arms (2)

Sodium-glucose cotransporter-2 inhibitor (SGLT2i)

ACTIVE COMPARATOR

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

Drug: SGLT2 inhibitor

Glucagon-like peptide-1 receptor agonist (GLP-1 RA)

ACTIVE COMPARATOR

Therapy with a GLP-1 RA with proven cardiovascular benefit. This means either dulaglutide, liraglutide, or semaglutide.

Drug: GLP-1 receptor agonist

Interventions

SGLT2 inhibitor DRUG

Empagliflozin, dapagliflozin, or canagliflozin

Sodium-glucose cotransporter-2 inhibitor (SGLT2i)

GLP-1 receptor agonist DRUG

Dulaglutide, liraglutide, semaglutide

Glucagon-like peptide-1 receptor agonist (GLP-1 RA)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (36)

Longwood Research LLC

Huntsville, Alabama, 35801, United States

RECRUITING

HonorHealth Research & Innovation Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Eastside Clinical Research Associates

Los Angeles, California, 90022, United States

RECRUITING

Kendall South Medical Center, Inc

Miami, Florida, 33185, United States

RECRUITING

South Florida Research Solutions, LLC

Pembroke Pines, Florida, 33028, United States

RECRUITING

NSC Research, Inc.

Johns Creek, Georgia, 30024, United States

RECRUITING

Herman Clinical Research

Suwanee, Georgia, 30024, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Rush University Medical Center

Hinsdale, Illinois, 60521, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Medical Center

Fairway, Kansas, 66205, United States

RECRUITING

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

RECRUITING

MedStar Health Research Institute - Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Essentia Health

Duluth, Minnesota, 55805, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University

New York, New York, 10032, United States

RECRUITING

Atrium Health Family Medicine Research Department

Charlotte, North Carolina, 28207, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

Wooster Heart Group

Wooster, Ohio, 44691, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17821, United States

RECRUITING

Temple University Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Family Care Center at Kent Hospital

Pawtucket, Rhode Island, 02860, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

South Carolina Clinical Research, LLC

Orangeburg, South Carolina, 29118, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Premier Internal Medicine Associates of Houston

Katy, Texas, 77493, United States

RECRUITING

North Dallas Research Associates

McKinney, Texas, 75069, United States

RECRUITING

Kidney and Hypertension Specialists, PLLC

Manassas, Virginia, 20110, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41456635 DERIVED

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

Brendan Everett, MD, MPH

CONTACT

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

Maureen Malloy

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician and Associate Professor

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 25, 2022
• Study Start: September 26, 2022
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (36)