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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
6,000
Empagliflozin, dapagliflozin, or canagliflozin
Dulaglutide, liraglutide, semaglutide
Longwood Research LLC
Huntsville, Alabama, United States
RECRUITINGHonorHealth Research & Innovation Institute
Scottsdale, Arizona, United States
RECRUITINGEastside Clinical Research Associates
Los Angeles, California, United States
RECRUITINGKendall South Medical Center, Inc
Miami, Florida, United States
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
Time frame: Through study completion, with an average follow up of approximately 3 years
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South Florida Research Solutions, LLC
Pembroke Pines, Florida, United States
RECRUITINGNSC Research, Inc.
Johns Creek, Georgia, United States
RECRUITINGHerman Clinical Research
Suwanee, Georgia, United States
RECRUITINGUniversity of Illinois Chicago
Chicago, Illinois, United States
RECRUITINGRush University Medical Center
Hinsdale, Illinois, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITING...and 26 more locations