What this trial means for you
This study is recruiting now at 36 US sites. It's studying SGLT2 inhibitor, GLP-1 receptor agonist for type2diabetes, ascvd.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Alabama
- Longwood Research LLC — Huntsville · Recruiting now
Arizona
- HonorHealth Research & Innovation Institute — Scottsdale · Recruiting now
California
- Eastside Clinical Research Associates — Los Angeles · Recruiting now
Florida
- Kendall South Medical Center, Inc — Miami · Recruiting now
- South Florida Research Solutions, LLC — Pembroke Pines · Recruiting now
Georgia
- NSC Research, Inc. — Johns Creek · Recruiting now
- Herman Clinical Research — Suwanee · Recruiting now
Illinois
- University of Illinois Chicago — Chicago · Recruiting now
- Rush University Medical Center — Hinsdale · Recruiting now
Iowa
- University of Iowa — Iowa City · Recruiting now
Kansas
- University of Kansas Medical Center — Fairway · Recruiting now
Maryland
- Johns Hopkins School of Medicine — Baltimore · Recruiting now
- MedStar Union Memorial Hospital — Baltimore · Recruiting now
- MedStar Health Research Institute - Good Samaritan Hospital — Baltimore · Recruiting now
Massachusetts
- Brigham and Women's Hospital — Boston · Recruiting now
- UMass Chan Medical School — Worcester · Recruiting now
Michigan
- University of Michigan — Ann Arbor · Recruiting now
Minnesota
- Essentia Health — Duluth · Recruiting now
- University of Minnesota — Minneapolis · Recruiting now
Missouri
- University of Missouri-Columbia — Columbia · Recruiting now
Nebraska
- University of Nebraska Medical Center — Omaha · Recruiting now
New York
- Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University — New York · Recruiting now
North Carolina
- Atrium Health Family Medicine Research Department — Charlotte · Recruiting now
- Duke University Hospital — Durham · Recruiting now
Ohio
- Wooster Heart Group — Wooster · Recruiting now
Oregon
- Oregon Health & Science University — Portland · Recruiting now
Pennsylvania
- Geisinger Medical Center — Danville · Recruiting now
- Temple University Lewis Katz School of Medicine — Philadelphia · Recruiting now
Rhode Island
- Family Care Center at Kent Hospital — Pawtucket · Recruiting now
South Carolina
- Medical University of South Carolina — Charleston · Recruiting now
- South Carolina Clinical Research, LLC — Orangeburg · Recruiting now
Tennessee
- Vanderbilt University Medical Center — Nashville · Recruiting now
Texas
- Premier Internal Medicine Associates of Houston — Katy · Recruiting now
- North Dallas Research Associates — McKinney · Recruiting now
Virginia
- Kidney and Hypertension Specialists, PLLC — Manassas · Recruiting now
Wisconsin
- Medical College of Wisconsin — Milwaukee · Recruiting now
View the official record on ClinicalTrials.gov →
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