Clinical trial

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Recruiting now · Phase 4 · 1 countries · Registry ID NCT05390892

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 80 Years
SexAll
Healthy volunteersNot accepted
ConditionType2Diabetes, ASCVD

Full registry criteria

Inclusion 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 Exclusion Criteria: * 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: o Participants taking basal-bolus, prandial, or multiple daily injection insulin (MDI) regimens (e.g., short-acting in combination with long-acting insulin, called MDI regimens) are eligible only if the research staff attests that there has been communication with the usual diabetes care provider and that the provider has agreed to manage insulin adjustment with initiation of study medications. If such agreement has not been obtained, participants taking MDI regimens are excluded. * 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

Treatments and study arms

SGLT2 inhibitor

Drug

Empagliflozin, dapagliflozin, or canagliflozin

GLP-1 receptor agonist

Drug

Dulaglutide, liraglutide, semaglutide

Primary outcomes

Total (first and recurrent) cardiovascular, kidney, and death eventsThrough study completion, with an average follow up of approximately 3 years

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

Study locations

36 locations were listed when this page was built. The first 40 are shown.

University of Michigan🇺🇸 Ann Arbor, Michigan, United States
Brittany WilliamsContact
David Broome, MDPrincipal Investigator
Johns Hopkins School of Medicine🇺🇸 Baltimore, Maryland, United States
Jamie HymanContact
Maya Venkataramani, MDPrincipal Investigator
Dan Ford, MDSub Investigator
MedStar Health Research Institute - Good Samaritan Hospital🇺🇸 Baltimore, Maryland, United States
Sariat IbrahimContact
Jean Park, MDPrincipal Investigator
Adline Ghazi, MDSub Investigator
MedStar Union Memorial Hospital🇺🇸 Baltimore, Maryland, United States
Flossine Brown, BS, CRCContact
Adline Ghazi, MDPrincipal Investigator
Sadaf Mustafa, MDSub Investigator
Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States
Krista ScartozziContact
Marie McDonnell, MDPrincipal Investigator
Medical University of South Carolina🇺🇸 Charleston, South Carolina, United States
Audra WiserContact
Harsha Karanchi, MDPrincipal Investigator
Mary Leigh Goodman, DNP, APRN, FNP-CSub Investigator
Atrium Health Family Medicine Research Department🇺🇸 Charlotte, North Carolina, United States
Andrea PriceContact
Hazel Tapp, PhDPrincipal Investigator
Emily Manlove Manlove, MDSub Investigator
University of Illinois Chicago🇺🇸 Chicago, Illinois, United States
Julia LawContact
Brian Layden, MDPrincipal Investigator
Yuval Eisenberg, MDSub Investigator
University of Missouri-Columbia🇺🇸 Columbia, Missouri, United States
Katelyn SmithContact
Camilla Manrique Acevedo, MDPrincipal Investigator
Katherine Pierce, PhDSub Investigator
Geisinger Medical Center🇺🇸 Danville, Pennsylvania, United States
Megan OliveriContact
Alexander Chang, MD, MS, FAHA, FASNPrincipal Investigator
Anthony Olson, PharmD, PhD, FAPhASub Investigator
Essentia Health🇺🇸 Duluth, Minnesota, United States
Leah TatelovichContact
Catherine Benziger, MD, MPHPrincipal Investigator
Duke University Hospital🇺🇸 Durham, North Carolina, United States
Chad HarrellContact
W. Schuyler Jones, MDPrincipal Investigator
Ranee Chatterjee, MDSub Investigator
University of Kansas Medical Center🇺🇸 Fairway, Kansas, United States
Erica Lower, CCRPContact
Kristin K Grdinovac, MDPrincipal Investigator
Ethan Alexander, MDSub Investigator
Rush University Medical Center🇺🇸 Hinsdale, Illinois, United States
Sharon GlinskiContact
Ankitaben Han, MD, MSPrincipal Investigator
Sameer Panjwani, MDSub Investigator
Longwood Research LLC🇺🇸 Huntsville, Alabama, United States
Jeff DunlapContact
Saadat Ansari, MDPrincipal Investigator
University of Iowa🇺🇸 Iowa City, Iowa, United States
Laura SeegmillerContact
Jeffrey D Quinlan, MDPrincipal Investigator
Hussain Banu, MBBSSub Investigator
NSC Research, Inc.🇺🇸 Johns Creek, Georgia, United States
Charlotte MallContact
Narendra Singh, MDPrincipal Investigator
Taylor Mabe, NP-CSub Investigator
Premier Internal Medicine Associates of Houston🇺🇸 Katy, Texas, United States
Nausheen MujeebContact
Nadia Abbasi, MDPrincipal Investigator
Christina BolinSub Investigator
Eastside Clinical Research Associates🇺🇸 Los Angeles, California, United States
Mayra VazquezContact
Enrique J Gonzalez, MDPrincipal Investigator
Kidney and Hypertension Specialists, PLLC🇺🇸 Manassas, Virginia, United States
Hanan Ebjad, MD, MHSAContact
Rashida Rahman, MDPrincipal Investigator
Hanan Ebjad Ebjad, MD, MHSASub Investigator
North Dallas Research Associates🇺🇸 McKinney, Texas, United States
Samina AhsanullahContact
Muhammad Akram Khan, MDPrincipal Investigator
Ambreen Ashfaque, MDSub Investigator
Kendall South Medical Center, Inc🇺🇸 Miami, Florida, United States
Denise MorenoContact
Rafael Chiong, MDPrincipal Investigator
Enrique Vazquez Escarpanter, MDSub Investigator
Medical College of Wisconsin🇺🇸 Milwaukee, Wisconsin, United States
Kailie RothContact
Jake Decker, MDPrincipal Investigator
Jeffrey Whittle, MDSub Investigator
University of Minnesota🇺🇸 Minneapolis, Minnesota, United States
Sarah ManserContact
Elizabeth Rogers, MD, MASPrincipal Investigator
Anne Bantle, MD, MSSub Investigator
Vanderbilt University Medical Center🇺🇸 Nashville, Tennessee, United States
Alesia PruittContact
Leslee Matheny, MDPrincipal Investigator
Russell Rothman, MDSub Investigator
Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University🇺🇸 New York, New York, United States
Angel SuzanaContact
Jacqueline Lonier, MDPrincipal Investigator
Nina Suda, MDSub Investigator
University of Nebraska Medical Center🇺🇸 Omaha, Nebraska, United States
Khadieja M AbuzahoContact
Cyrus Desouza, MBBSPrincipal Investigator
Amber Brown Keebler, MDSub Investigator
South Carolina Clinical Research, LLC🇺🇸 Orangeburg, South Carolina, United States
Payton PadgettContact
Moustafa A Moustafa, MDPrincipal Investigator
Radames Zuquello, MDSub Investigator
Family Care Center at Kent Hospital🇺🇸 Pawtucket, Rhode Island, United States
Angela LarkinContact
Caroline Richardson, MDPrincipal Investigator
Charles Eaton, MDSub Investigator
South Florida Research Solutions, LLC🇺🇸 Pembroke Pines, Florida, United States
Smelda FerrinContact
Dennis Spiller, DOPrincipal Investigator
Julio Tallet, MDSub Investigator
Temple University Lewis Katz School of Medicine🇺🇸 Philadelphia, Pennsylvania, United States
Jackson WeilerContact
Daniel J Rubin, MDPrincipal Investigator
Ajaykumar D Rao, MDSub Investigator
Oregon Health & Science University🇺🇸 Portland, Oregon, United States
Aly CarlsonContact
Rodica Busui, MD, PhDPrincipal Investigator
HonorHealth Research & Innovation Institute🇺🇸 Scottsdale, Arizona, United States
Nadia MadiasContact
Tabitha Moe, MD FACCPrincipal Investigator
Herman Clinical Research🇺🇸 Suwanee, Georgia, United States
Morgan EcholsContact
Lee Herman, MDPrincipal Investigator
Amit Narayan, MDSub Investigator
Wooster Heart Group🇺🇸 Wooster, Ohio, United States
John RoofContact
Cyril S Ofori, MDPrincipal Investigator
Toni King, MDSub Investigator
UMass Chan Medical School🇺🇸 Worcester, Massachusetts, United States
Xhenifer MeleContact
Mark O'Connor, MDPrincipal Investigator