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Clinical Trial NCT05390892 (PRECIDENTD) for Type2Diabetes, ASCVD is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Brigham and Women's HospitalPREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes (PRECIDENTD) Phase 4 6,000 Randomized Open-Label Prevention
PRECIDENTD: PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
- PRECIDENTD
- 2022p001160
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorSodium-glucose cotransporter-2 inhibitor (SGLT2i) Therapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin | SGLT2 inhibitor Empagliflozin, dapagliflozin, or canagliflozin |
Active ComparatorGlucagon-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. | GLP-1 receptor agonist Dulaglutide, liraglutide, semaglutide |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Total (first and recurrent) cardiovascular, kidney, and death events | 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 | Through study completion, with an average follow up of approximately 3 years |
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
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
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