NCT05390892

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	SGLT2 inhibitor	Empagliflozin, dapagliflozin, or canagliflozin
DRUG	GLP-1 receptor agonist	Dulaglutide, liraglutide, semaglutide

Timeline

• Start date: 2022-09-26
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2022-05-25
• Last updated: 2026-04-13

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study