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NCT05390892 · ClinicalTrials.gov registry record · Phase 4

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

A Phase 4 study of Type2diabetes and ASCVD, sponsored by Brigham and Women's Hospital.

Recruiting
Registry status
Phase 4
Development phase
6,000
Enrollment target
8
Study locations

NCT05390892 is a Phase 4 study of Type2diabetes and ASCVD that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 6,000 participants, above the 179-participant average among 19 other Type2diabetes trials with a reported enrollment target (3252% higher). The trial reports 8 study locations across 8 states.

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The verdict

NCT05390892, a Phase 4 study of Type2diabetes and ASCVD, is actively recruiting participants, sponsored by Brigham and Women's Hospital.

RECRUITING
Registry status
Phase 4
Development phase
6,000 participants
Enrollment target
8
Study locations

Study 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 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.

Conditions Studied

Type2diabetes ASCVD

Interventions

  • DRUG SGLT2 inhibitor
  • DRUG GLP-1 receptor agonist

Study Locations (8)

Maryland

  • Johns Hopkins School of Medicine - Baltimore

Minnesota

  • Essentia Health - Duluth

Missouri

  • University of Missouri-Columbia - Columbia

New York

  • Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University - New York

North Carolina

  • Duke University Hospital - Durham

South Carolina

  • Medical University of South Carolina - Charleston

Tennessee

  • Vanderbilt University Medical Center - Nashville

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 6,000 participants
Start Date 2022-09-26
Est. Completion 2029-03-01
Phase Phase 4

Sponsor

Brigham and Women's Hospital

937 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05390892

The ClinicalTrials.gov registry entry for NCT05390892 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 6,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 179-participant average among 19 other Type2diabetes trials with a reported enrollment target (3252% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Type2diabetes appearing as the primary indexed condition, and to 2 interventions - of which SGLT2 inhibitor is the first listed.

NCT05390892 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Maryland, Minnesota, Missouri.

Frequently Asked Questions

What is clinical trial NCT05390892 about?

NCT05390892 is a clinical study titled "PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes". 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...

What is the current status of trial NCT05390892?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 6,000 participants. The study started on 2022-09-26. Estimated completion is 2029-03-01.

What conditions does trial NCT05390892 study?

This clinical trial studies the following conditions: Type2diabetes, ASCVD.

What interventions are being tested in trial NCT05390892?

The interventions under investigation include: SGLT2 inhibitor (DRUG), GLP-1 receptor agonist (DRUG).

Who is sponsoring clinical trial NCT05390892?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05390892 being conducted?

This trial has 8 study locations across Maryland, Minnesota, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.