RecruitingPhase 4NCT05390892

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

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


Sponsor

Brigham and Women's Hospital

Enrollment

6,000 participants

Start Date

Sep 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two classes of diabetes medications — SGLT2 inhibitors (like empagliflozin) and GLP-1 receptor agonists (like semaglutide) — to see which better protects the heart and kidneys in adults with type 2 diabetes who are at elevated risk. You may be eligible if: you have type 2 diabetes; your HbA1c has been at least 6% in the past year; you are between 40 and 80 years old with established heart or blood vessel disease, OR you are 60–80 with high-risk features; and you are willing to be randomly assigned to one of the medication classes. You may NOT be eligible if: you have type 1 diabetes or another form of diabetes; you have a history of pancreatitis, diabetic ketoacidosis, or severe kidney disease; you are actively being treated for cancer with likely recurrence; or you are pregnant or unwilling to use birth control. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSGLT2 inhibitor

Empagliflozin, dapagliflozin, or canagliflozin

DRUGGLP-1 receptor agonist

Dulaglutide, liraglutide, semaglutide


Locations(36)

Longwood Research LLC

Huntsville, Alabama, United States

HonorHealth Research & Innovation Institute

Scottsdale, Arizona, United States

Eastside Clinical Research Associates

Los Angeles, California, United States

Kendall South Medical Center, Inc

Miami, Florida, United States

South Florida Research Solutions, LLC

Pembroke Pines, Florida, United States

NSC Research, Inc.

Johns Creek, Georgia, United States

Herman Clinical Research

Suwanee, Georgia, United States

University of Illinois Chicago

Chicago, Illinois, United States

Rush University Medical Center

Hinsdale, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Fairway, Kansas, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

MedStar Health Research Institute - Good Samaritan Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

UMass Chan Medical School

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Essentia Health

Duluth, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Missouri-Columbia

Columbia, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University

New York, New York, United States

Atrium Health Family Medicine Research Department

Charlotte, North Carolina, United States

Duke University Hospital

Durham, North Carolina, United States

Wooster Heart Group

Wooster, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Temple University Lewis Katz School of Medicine

Philadelphia, Pennsylvania, United States

Family Care Center at Kent Hospital

Pawtucket, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

South Carolina Clinical Research, LLC

Orangeburg, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Premier Internal Medicine Associates of Houston

Katy, Texas, United States

North Dallas Research Associates

McKinney, Texas, United States

Kidney and Hypertension Specialists, PLLC

Manassas, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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