PRECIDENTD: Preventing Heart and Kidney Disease in Type 2 Diabetes
This study, called PRECIDENTD, is for people aged 40 to 80 with type 2 diabetes and existing heart disease (atherosclerotic cardiovascular disease, or ASCVD) or a high risk for it. It aims to compare two types of medications: SGLT2 inhibitors (like empagliflozin, dapagliflozin, or canagliflozin) and GLP-1 receptor agonists (like dulaglutide, liraglutide, or semaglutide). Researchers want to see which treatment is better at preventing heart problems, kidney issues, and death. You would need to have an HbA1c (a measure of blood sugar control) of 6% or higher within the last year to be eligible. The study plans to enroll 6,000 participants.
- Study design
- This is a randomized, open-label study comparing two different drug treatments. It plans to include 6,000 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed through study completion, with an average follow-up of approximately 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05390892
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Recruiting
PHASE4Ages 40–80InterventionalPreventionBrigham and Women's HospitalInvestigator-initiated
~6,000 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:SGLT2 inhibitorGLP-1 receptor agonist
At a glance
Recruiting sites
36 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total (first and recurrent) cardiovascular, kidney, and death events
Measured over Through study completion, with an average follow up of approximately 3 years
Conditions
Where it's being run
36 sites across 25 statesMaryland3
Florida2
Georgia2
Illinois2
Massachusetts2
Minnesota2
North Carolina2
Pennsylvania2
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Type 2 diabetes based on clinical diagnosis
HbA1c ≥6% measured within 12 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: prior myocardial infarction, prior coronary percutaneous coronary intervention, ≥50% stenosis of a coronary artery documented by invasive or non-invasive imaging (including CT coronary angiography), positive stress test, or coronary artery calcium score \>400 Agatston units;
Cerebrovascular disease defined by at least one of the following: prior ischemic stroke, prior carotid revascularization procedure, carotid stenosis ≥ 50% documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound;
Symptomatic peripheral artery disease defined by at least one of the following: leg symptoms with an ABI ≤ 0.9, leg symptoms with imaging evidence of a stenosis ≥50% in a peripheral artery documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound, or prior amputation for atherosclerotic disease.
Primary prevention cohort (capped at 30% of cohort):
Age 60-80 years and at least 1 additional high-risk feature:
Cardiovascular risk factors/high-risk features:
Active smoking (combustible tobacco or marijuana)
HbA1c ≥ 8% measured within 12 months prior to screening. The most recent value available at the time of screening will be used for screening and to determine eligibility.
Stage 3a CKD, eGFR 45-59 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.
Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety
Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider.
If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes
Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities
Exclusion
Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)
Any background diabetes medication regimen will be allowed in this pragmatic trial with the following proviso:
History of diabetic ketoacidosis
Active diabetic foot ulcer
History of pancreatitis
Heart failure as a primary reason for hospitalization within the past year
Known left ventricular ejection fraction \<40%
Known urinary albumin-to-creatinine ratio \>200 mg/g at screening
Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.
Known inability to afford study medication through current insurance coverage.
If a woman of child-bearing potential, the patient or partner is unwilling to use birth control
Active treatment for cancer, planned treatment for cancer, or recent active cancer with likelihood of recurrence or progression, which, in the opinion of the site investigator, has a likelihood of recurrence that would interfere with study therapy prior to 2028
Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy is allowed. Examples of allowable cancers include:
Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy
Prostate cancer being observed
Stage 0 or 1 tumors status post resection or other definitive treatment
Other similarly stable cancer comorbidities
History of solid organ or bone marrow transplant
Allergy to SGLT2 inhibitor or GLP-1 receptor agonist
What this trial measures
- Total (first and recurrent) cardiovascular, kidney, and death eventsThrough study completion, with an average follow up of approximately 3 years
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