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Preventing cardiovascular and kidney disease in patients with type 2 diabetes

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

Phase 4 Interventional Brigham and Women's Hospital · NCT05390892

This study is testing which of two diabetes treatments can better prevent heart and kidney problems in people with type 2 diabetes who are at high risk for cardiovascular disease.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment6000 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorBrigham and Women's Hospital Academic / other
Locations36 sites (Huntsville, Alabama and 35 other locations)
Trial IDNCT05390892 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the effectiveness of two treatments, sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA), in reducing cardiovascular and kidney-related events in patients with type 2 diabetes and established or high-risk atherosclerotic cardiovascular disease (ASCVD). A total of 6,000 participants will be randomly assigned to one of the two treatment groups and monitored for various health outcomes, including heart attacks, strokes, and kidney disease. The study aims to determine which treatment is more effective in preventing serious health complications associated with diabetes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 with type 2 diabetes and established or high-risk ASCVD.

Not a fit: Patients without type 2 diabetes or those who do not have established or high-risk ASCVD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of cardiovascular and kidney complications in patients with type 2 diabetes.

How similar studies have performed: Previous studies have shown promising results with SGLT2 inhibitors and GLP-1 receptor agonists in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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:

  o Participants taking basal-bolus, prandial, or multiple daily injection insulin (MDI) regimens (e.g., short-acting in combination with long-acting insulin, called MDI regimens) are eligible only if the research staff attests that there has been communication with the usual diabetes care provider and that the provider has agreed to manage insulin adjustment with initiation of study medications. If such agreement has not been obtained, participants taking MDI regimens are excluded.
* 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

Where this trial is running

Huntsville, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type2DiabetesASCVD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.