PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

NCT ID: NCT05390892

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2029-03-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sodium-glucose cotransporter-2 inhibitor (SGLT2i)

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

Group Type: ACTIVE_COMPARATOR

SGLT2 inhibitor

Intervention Type: DRUG

Empagliflozin, dapagliflozin, or canagliflozin

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.

Group Type: ACTIVE_COMPARATOR

GLP-1 receptor agonist

Intervention Type: DRUG

Dulaglutide, liraglutide, semaglutide

Interventions

SGLT2 inhibitor

Empagliflozin, dapagliflozin, or canagliflozin

Intervention Type: DRUG

GLP-1 receptor agonist

Dulaglutide, liraglutide, semaglutide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brendan M. Everett

Associate Physician and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Essentia Health

Duluth, Minnesota, United States

Site Status: RECRUITING

University of Missouri-Columbia

Columbia, Missouri, United States

Site Status: RECRUITING

Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University

New York, New York, United States

Site Status: RECRUITING

Duke University Hospital

Durham, North Carolina, United States

Site Status: RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brendan Everett, MD, MPH

Role: CONTACT

PRECIDENTDccc@bwh.harvard.edu

617-732-8790

Maureen Malloy

Role: CONTACT

PRECIDENTDccc@bwh.harvard.edu

617-732-8773

Facility Contacts

Jamie Hyman

Role: primary

PRECIDENTD@jhmi.edu

443-927-8723

Leah Tatelovich

Role: primary

PrecidentdEH@Essentia.org

218-576-0480

Tea Goletiani

Role: primary

MUPRECIDENTD@health.missouri.edu

833-970-0046

Jacqueline Lonier, MD

Role: primary

precidentd@cumc.columbia.edu

212-851-5492

Chad Harrell

Role: primary

DukePRECIDENTD@duke.edu

919-668-9049

Ebony Panaccione

Role: primary

panacceb@musc.edu

843-792-4675

Lance Roller

Role: primary

Lance.j.roller@vumc.org

615-875-6811

Kailie Roth

Role: primary

kroth@mcw.edu

414-805-8104

Other Identifiers

2022p001160

Identifier Type: -

Identifier Source: org_study_id