PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Conditions

• ASCVD
• Type2Diabetes

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• SGLT2 inhibitor — DRUG
  Empagliflozin, dapagliflozin, or canagliflozin
• GLP-1 receptor agonist — DRUG
  Dulaglutide, liraglutide, semaglutide

Study Details

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.

Key Dates

Start date

Sep 26, 2022

Status verified

Apr 2026

Primary completion

Mar 1, 2029

Completion

Mar 1, 2029

Study Design

Enrollment

6,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Sodium-glucose cotransporter-2 inhibitor (SGLT2i)
  Therapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin
• Active Comparator: Glucagon-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.

Primary Outcome Measure

Total (first and recurrent) cardiovascular, kidney, and death events [ Time Frame: Through study completion, with an average follow up of approximately 3 years ]

Central Contacts

• Brendan Everett, MD, MPH
  617-732-8790
  [email protected]
• Maureen Malloy
  617-732-8773
  [email protected]

Locations (36)

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