RECRUITING

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PRECIDENTD: PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Quick Facts

Study Start:2022-09-26

Study Completion:2029-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05390892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Primary prevention cohort (capped at 30% of cohort): * Age 60-80 years and at least 1 additional high-risk feature: * Cardiovascular risk factors/high-risk features: * Active smoking (combustible tobacco or marijuana) * HbA1c ≥ 8% measured within 12 months prior to screening. The most recent value available at the time of screening will be used for screening and to determine eligibility. * Stage 3a CKD, eGFR 45-59 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility. * Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety * Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider. * If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes * Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities	* 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: * 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% * Known urinary albumin-to-creatinine ratio \>200 mg/g at screening * Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility. * Known inability to afford study medication through current insurance coverage. * If a woman of child-bearing potential, the patient or partner is unwilling to use birth control * Active treatment for cancer, planned treatment for cancer, or recent active cancer with likelihood of recurrence or progression, which, in the opinion of the site investigator, has a likelihood of recurrence that would interfere with study therapy prior to 2028 * Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy is allowed. Examples of allowable cancers include: * Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy * Prostate cancer being observed * Stage 0 or 1 tumors status post resection or other definitive treatment * Other similarly stable cancer comorbidities * History of solid organ or bone marrow transplant * Allergy to SGLT2 inhibitor or GLP-1 receptor agonist

Inclusion Criteria

Exclusion Criteria

* 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.
* Primary prevention cohort (capped at 30% of cohort):
* Age 60-80 years and at least 1 additional high-risk feature:
* Cardiovascular risk factors/high-risk features:
* Active smoking (combustible tobacco or marijuana)
* HbA1c ≥ 8% measured within 12 months prior to screening. The most recent value available at the time of screening will be used for screening and to determine eligibility.
* Stage 3a CKD, eGFR 45-59 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.
* Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety
* Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider.
* If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes
* Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities

* 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:
* 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%
* Known urinary albumin-to-creatinine ratio \>200 mg/g at screening
* Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.
* Known inability to afford study medication through current insurance coverage.
* If a woman of child-bearing potential, the patient or partner is unwilling to use birth control
* Active treatment for cancer, planned treatment for cancer, or recent active cancer with likelihood of recurrence or progression, which, in the opinion of the site investigator, has a likelihood of recurrence that would interfere with study therapy prior to 2028
* Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy is allowed. Examples of allowable cancers include:
* Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy
* Prostate cancer being observed
* Stage 0 or 1 tumors status post resection or other definitive treatment
* Other similarly stable cancer comorbidities
* History of solid organ or bone marrow transplant
* Allergy to SGLT2 inhibitor or GLP-1 receptor agonist

Contacts and Locations

Study Contact

Brendan Everett, MD, MPH

CONTACT

617-732-8790

PRECIDENTDccc@bwh.harvard.edu

Maureen Malloy

CONTACT

617-732-8773

PRECIDENTDccc@bwh.harvard.edu

Study Locations (Sites)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205

United States

Essentia Health

Duluth, Minnesota, 55805

United States

University of Missouri-Columbia

Columbia, Missouri, 65212

United States

Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University

New York, New York, 10032

United States

Duke University Hospital

Durham, North Carolina, 27710

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-26

Study Completion Date2029-03-01

Study Record Updates

Study Start Date2022-09-26

Study Completion Date2029-03-01

Terms related to this study

Additional Relevant MeSH Terms

Type2Diabetes
ASCVD