Dual versus monotherapy with SGLT2 inhibitor and GLP-1 receptor agonist: PRECIDENTD pragmatic randomized trial.
Deborah J Wexler, Lindsay S Mayberry, Lyndsay A Nelson...
https://pubmed.ncbi.nlm.nih.gov/41456635Actively Recruiting
Phase 4
Age: 40Years - 80Years
All Genders
ID05390892
PRECIDENTD: 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
N/A
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
Researchers are evaluating two treatment options for people with type 2 diabetes who also have established or high-risk atherosclerotic cardiovascular disease (ASCVD). This clinical trial aims to compare the total number of heart, kidney, and death events between treatments using sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA). The study involves 6,000 participants and seeks to better understand how these medications affect health outcomes in this population. Participants will be randomly assigned to receive either an SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin) or a GLP-1 receptor agonist (dulaglutide, liraglutide, or semaglutide), all of which have shown cardiovascular benefits. The study is open label, meaning both participants and researchers know which treatment is given. Treatment assignment is balanced evenly between the two groups, and participants will continue their assigned therapy throughout the study. During the trial, researchers will monitor participants for events including heart attacks, strokes, arterial revascularization, hospitalizations for heart failure, kidney failure, kidney transplants, and death. Follow-up will last for an average of about three years. Data will be collected through medical records and electronic health information, with ongoing tracking of health status and treatment adherence to assess the total number of these cardiovascular and kidney-related events.
CONDITIONS
Brief Title
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Who Can Participate
Age: 40Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 2 diabetes based on clinical evaluation
- HbA1c of 6% or higher measured within 12 months before screening
- Age between 40 and 80 years
- Established atherosclerotic cardiovascular disease defined by coronary heart disease, cerebrovascular disease, or symptomatic peripheral artery disease
- For primary prevention group (up to 30% of participants): age 60 to 80 years with at least one high-risk feature including active smoking, HbA1c 8% or higher, or stage 3a chronic kidney disease
- Willingness to be randomly assigned to either SGLT2 inhibitor or GLP-1 receptor agonist medication class
- Willingness to fill prescriptions through personal pharmacy and adjust other medications for safety
- Willingness to avoid starting therapy from the alternative treatment group unless recommended by usual care provider
- If currently taking one of the study medication classes, willingness to stop and be reassigned
- Consent to data collection from electronic health records and medical releases
You will not qualify if you...
- Diagnosis of diabetes types other than type 2 (such as type 1, pancreatogenic, or monogenic diabetes)
- Use of multiple daily insulin injections without agreement from diabetes care provider to manage insulin adjustments
- History of diabetic ketoacidosis
- Presence of active diabetic foot ulcer
- History of pancreatitis
- Hospitalization for heart failure as primary reason within the past year
- Left ventricular ejection fraction below 40%
- Urinary albumin-to-creatinine ratio above 200 mg/g at screening
- Estimated glomerular filtration rate below 45 ml/min/1.73m2 within 12 months before screening
- Known inability to afford study medications through insurance
- Women of child-bearing potential unwilling to use birth control
- Active or planned cancer treatment, or recent cancer likely to interfere with study therapy before 2028, except stable cancers with no 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
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 3 years
Participants receive therapy with either an SGLT2 inhibitor or a GLP-1 receptor agonist medication class to prevent cardiovascular and diabetic kidney disease.
Regular visits as needed to fill prescriptions and adjust medications for safety
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
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Research Team
B
Brendan Everett, MD, MPH
M
Maureen Malloy
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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