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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2028
  • participants needed
    9000
  • sponsor
    Brigham and Women's Hospital
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Updated on 15 October 2022
See if I qualify
atherosclerosis
diabetes
peripheral artery disease
stroke
heart failure
heart disease
myocardial infarction
infarct
primary prevention
atherosclerotic cardiovascular disease

Summary

PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among three 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 9,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1:1 allocation to SGLT2i, GLP-1RA, or the combination. 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.

Details
Condition Type2Diabetes, ASCVD
Treatment SGLT2 inhibitor, GLP-1 receptor agonist, Combination drug
Clinical Study IdentifierNCT05390892
SponsorBrigham and Women's Hospital
Last Modified on15 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Type 2 diabetes based on clinical diagnosis
HbA1c ≥6.5% if on no medication or >6% if on glucose-lowering medication, measured within 6 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: History of myocardial infarction or ischemic stroke or established coronary heart disease, or established peripheral artery disease, or established carotid artery atherosclerosis, or history of an arterial revascularization procedure of the coronary, peripheral, or cerebrovascular circulation
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), or HbA1c ≥ 8%, or Stage 3a CKD (eGFR 45-59 ml/min/1.73m2)
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 or to combination therapy
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.)
Use of prandial or short-acting insulin in combination with basal insulin
History of diabetic ketoacidosis
Active diabetic foot ulcer
History of pancreatitis
Heart failure as a primary reason for hospitalization within the past year OR known left ventricular ejection fraction <40%
Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2
Known inability to afford study medication through current insurance coverage
If a woman of child-bearing potential, patient, or partner unwilling to use birth control
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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