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PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Study acronym: PRECIDENTD
StatusRecruiting
PhasePhase 4
Started2022-09-26
View on ClinicalTrials.gov ↗

Amendment history

2026-04-07
Study Status, Contacts/Locations v8
Study sites8→36
2025-11-18
Study Status, Sponsor/Collaborators v7
Re-verified, no change to tracked fields
2024-05-20
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2028-04-30→2029-03-01
Completion date2028-04-30→2029-03-01
Enrollment target9000→6000
Study sites7→8
Study arms3→2
InterventionsCombination drug (Drug), GLP-1 receptor agonist (Drug), SGLT2 inhibitor (Drug)→GLP-1 receptor agonist (Drug), SGLT2 inhibitor (Drug)
Eligibility criteria+2,355 characters
Inclusion Criteria: Type 2 diabetes based on clinical diagnosis HbA1c ≥6.5% if on no medication or >6% if on glucose-lowering medication, measured within 612 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: History ofprior myocardial infarction, prior coronary percutaneous coronary intervention, ≥50% stenosis of a coronary artery documented by invasive or non-invasi [...] [...]
2023-07-25
Study Status, Contacts/Locations v5
Study sites2→7
2022-12-19
Study Status, Contacts/Locations v4
Start dateestimated 2022-09→confirmed 2022-09-26
Study sitesdetails revised at 1 of 2 sites
Show 3 earlier versions
2022-09-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites1→2
2022-09-19
Study Status, Contacts/Locations v2
Start date2022-08-01→2022-09
Study sites0→1
2022-07-18
Study Status v1
Start date2022-07-01→2022-08-01
2022-05-23
Original filing
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.
Trial Details
NCT Number NCT05390892
Lead Sponsor Brigham and Women's Hospital
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Type2Diabetes, ASCVD
Enrollment 6,000 participants
Start Date 2022-09-26
Primary Completion 2029-03-01 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-13