Trial · Interventional
RecruitingPhase 4Registry dataPREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Short name PRECIDENTD
Overview
- Status
- Recruiting
- Phase
- Phase 4
- Enrollment
- 6,000 participants (estimated)
- Sponsor
- Brigham and Women's Hospital · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 26 Sept 2022
- Primary completion
- 1 Mar 2029 (estimated)
- Completion
- 1 Mar 2029 (estimated)
- First posted
- 25 May 2022
- Last update posted
- 13 Apr 2026
- Conditions
- Type2Diabetes · ASCVD
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SGLT2 inhibitorDrug
- GLP-1 receptor agonistDrug
Arms2
Active comparator
Sodium-glucose cotransporter-2 inhibitor (SGLT2i)
Therapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin
Active comparator
Glucagon-like peptide-1 receptor agonist (GLP-1 RA)
Therapy with a GLP-1 RA with proven cardiovascular benefit. This means either dulaglutide, liraglutide, or semaglutide.
Primary outcomes1
Outcomes the sponsor listed as primary.
Total (first and recurrent) cardiovascular, kidney, and death events
Time frame · Through study completion, with an average follow up of approximately 3 years
Registry description
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedWexler DJ, Mayberry LS, Nelson LA, Lema-Driscoll J, Flores LC, Malloy M, MacFadyen JG, Shen J, Zaharris E, Karanchi H, Chatterjee R, Benziger CP, Decker JE, Kalyani R, Manrique-Acevedo C, Lonier J, Simeone E, Mieras K, Siqueira ARO, Rothman RL, Jones WS, Glynn RJ, Everett BM. Dual versus monotherapy with SGLT2 inhibitor and GLP-1 receptor agonist: PRECIDENTD pragmatic randomized trial. Am Heart J. 2026 Apr;294:107332. doi: 10.1016/j.ahj.2025.107332. Epub 2025 Dec 26. PMID 41456635
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 40 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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