Actively Recruiting
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Led by Brigham and Women's Hospital · Updated on 2026-04-13
6000
Participants Needed
36
Research Sites
335 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of type 2 diabetes
- HbA1c of 6% or higher measured within 12 months before screening
- For secondary prevention cohort (at least 70% of participants): age 40 to 80 years and established atherosclerotic cardiovascular disease defined by documented coronary heart disease, cerebrovascular disease, or symptomatic peripheral artery disease
- For primary prevention cohort (up to 30% of participants): age 60 to 80 years with at least one high-risk feature such as active smoking, HbA1c of 8% or higher, or stage 3a chronic kidney disease (eGFR 45-59 ml/min/1.73m2) measured within 12 months before screening
- Willingness to be randomly assigned to either SGLT2 inhibitor or GLP-1 receptor agonist medication class and fill prescriptions through personal pharmacy benefits
- Willingness to avoid starting therapy in the alternative medication group unless strongly recommended by usual care provider
- If already taking one of the study medication classes, willingness to stop and be randomly assigned to one of the two classes
- Consent to data collection using electronic health records and signing medical release for future records
You will not qualify if you...
- Known or suspected diabetes of other types such as type 1, pancreatogenic, or monogenic diabetes
- Taking multiple daily insulin injections without diabetes care provider's agreement to manage insulin adjustments with study medications
- History of diabetic ketoacidosis
- Active diabetic foot ulcer
- History of pancreatitis
- Heart failure hospitalization as primary reason within the past year
- Left ventricular ejection fraction less than 40%
- Urinary albumin-to-creatinine ratio greater than 200 mg/g at screening
- Estimated glomerular filtration rate less than 45 ml/min/1.73m2 measured within 12 months prior to screening
- Inability to afford study medication through current insurance
- Women of child-bearing potential unwilling to use birth control
- Active, planned, or recent active cancer likely to interfere with study therapy before 2028 (except stable cancers without progression)
- History of solid organ or bone marrow transplant
- Allergy to SGLT2 inhibitors or GLP-1 receptor agonists
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Longwood Research LLC
Huntsville, Alabama, United States, 35801
Actively Recruiting
2
HonorHealth Research & Innovation Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Eastside Clinical Research Associates
Los Angeles, California, United States, 90022
Actively Recruiting
4
Kendall South Medical Center, Inc
Miami, Florida, United States, 33185
Actively Recruiting
5
South Florida Research Solutions, LLC
Pembroke Pines, Florida, United States, 33028
Actively Recruiting
6
NSC Research, Inc.
Johns Creek, Georgia, United States, 30024
Actively Recruiting
7
Herman Clinical Research
Suwanee, Georgia, United States, 30024
Actively Recruiting
8
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Rush University Medical Center
Hinsdale, Illinois, United States, 60521
Actively Recruiting
10
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
University of Kansas Medical Center
Fairway, Kansas, United States, 66205
Actively Recruiting
12
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
13
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Actively Recruiting
14
MedStar Health Research Institute - Good Samaritan Hospital
Baltimore, Maryland, United States, 21239
Actively Recruiting
15
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
17
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Essentia Health
Duluth, Minnesota, United States, 55805
Actively Recruiting
19
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
20
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Actively Recruiting
21
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
22
Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University
New York, New York, United States, 10032
Actively Recruiting
23
Atrium Health Family Medicine Research Department
Charlotte, North Carolina, United States, 28207
Actively Recruiting
24
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
25
Wooster Heart Group
Wooster, Ohio, United States, 44691
Actively Recruiting
26
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
27
Geisinger Medical Center
Danville, Pennsylvania, United States, 17821
Actively Recruiting
28
Temple University Lewis Katz School of Medicine
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
29
Family Care Center at Kent Hospital
Pawtucket, Rhode Island, United States, 02860
Actively Recruiting
30
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
31
South Carolina Clinical Research, LLC
Orangeburg, South Carolina, United States, 29118
Actively Recruiting
32
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
33
Premier Internal Medicine Associates of Houston
Katy, Texas, United States, 77493
Actively Recruiting
34
North Dallas Research Associates
McKinney, Texas, United States, 75069
Actively Recruiting
35
Kidney and Hypertension Specialists, PLLC
Manassas, Virginia, United States, 20110
Actively Recruiting
36
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
B
Brendan Everett, MD, MPH
CONTACT
M
Maureen Malloy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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