RecruitingPhase 4

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two types of diabetes medicines, called SGLT2 inhibitors and GLP-1 receptor agonists. It looks at heart problems, kidney problems, and deaths in adults with type 2 diabetes who have artery disease or a high risk of it. People are assigned to a treatment group by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 2 diabetes and an HbA1c of at least 6% in the past 12 months. HbA1c measures average blood sugar.
  • Meet one of two age and health groups: ages 40–80 with artery disease, or ages 60–80 with at least one listed high-risk feature.
  • For the artery disease group: have qualifying heart, brain, or leg artery disease. Examples include a past heart attack or stroke, certain artery procedures or test results, or leg symptoms with poor blood flow.
  • For the high-risk group: currently smoke tobacco or marijuana, have an HbA1c of at least 8%, or have reduced kidney filtering with an eGFR of 45–59. Blood sugar and kidney tests must be from the past 12 months.
  • Agree to treatment assigned by chance, fill prescriptions using your own pharmacy coverage, and have other medicines changed for safety.
  • Agree not to start the other study medicine type unless your usual care provider strongly recommends it.
  • If already taking a study medicine type, agree to stop it and be assigned to a treatment group by chance.
  • Allow the study to collect electronic health records and get future records from other health care centers.

Who can't join

  • Have or may have a type of diabetes other than type 2; or use mealtime or multiple daily insulin shots without your usual diabetes provider agreeing to manage insulin changes.
  • Have a history of diabetic ketoacidosis, a dangerous acid buildup in the blood; an active diabetic foot sore; or past pancreatitis, which is swelling of the pancreas.
  • Were hospitalized mainly for heart failure in the past year, or have a heart pumping measure called ejection fraction below 40%.
  • Have a urine albumin-to-creatinine ratio above 200 mg/g, showing protein leakage, or a latest kidney filtering test called eGFR below 45 within the past 12 months.
  • Cannot afford study medicines through your current insurance, or have an allergy to either study medicine type.
  • Can become pregnant, but you or your partner are unwilling to use birth control.
  • Have active or planned cancer treatment, or recent cancer likely to return or worsen and interfere with study treatment before 2028. Some treated or stable cancers are allowed.
  • Have had an organ or bone marrow transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (36)

AL

AZ

CA

FL

GA

IA

IL

KS

MA

MD

MI

MN

MO

NC

NE

  • University of Nebraska Medical Center · Omaha, NE 68198Khadieja M Abuzaho · Study contact · 402-559-4815 · kabuzaho@unmc.eduCyrus Desouza, MBBS · Principal investigatorAmber Brown Keebler, MD · Sub-investigatorShubham Agarwal, MBBS · Sub-investigatorMore trials in Omaha

NY

OH

OR

PA

RI

SC

TN

TX

VA

  • Kidney and Hypertension Specialists, PLLC · Manassas, VA 20110Hanan Ebjad, MD, MHSA · Study contact · 703-361-7341 · Research@NovaKidney.ComRashida Rahman, MD · Principal investigatorHanan Ebjad Ebjad, MD, MHSA · Sub-investigatorPriya Chaddah, PA-C · Sub-investigatorMore trials in Manassas

WI