RecruitingType2DiabetesASCVD

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Eligible age

40–80 yrs

Accepts

All genders

Locations

25 states

Healthy volunteers

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About this study

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.

Sponsor: Brigham and Women's Hospital

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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%