PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Type 2 diabetes based on clinical diagnosis
HbA1c ≥6% measured within 12 months prior to screening
Age 40 to 80 years
Evidence of established atherosclerotic cardiovascular disease (ASCVD), as defined by one or more of the following
Disqualifiers
Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)
History of diabetic ketoacidosis
Active diabetic foot ulcer
History of pancreatitis
Trial design
Treatments tested in this trial
- SGLT2 inhibitor
- GLP-1 receptor agonist
Treatment groups
6,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov