PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
NCT05390892 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6000
Last updated 2026-04-13
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
Interventions
- DRUG
-
SGLT2 inhibitor
Empagliflozin, dapagliflozin, or canagliflozin
- DRUG
-
GLP-1 receptor agonist
Dulaglutide, liraglutide, semaglutide
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Brigham and Women's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-26
- Primary Completion
- 2029-03-01
- Completion
- 2029-03-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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