DelfaGLP-1 Atlas

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PRECIDENTD

RecruitingPhase 4

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

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

Assets

Dulaglutide / GLP-1 / incretin class catch-all / Liraglutide / Semaglutide

Listed sites

36

Recruiting sites

36

Enrollment

6,000

estimated

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criteria

•Established ASCVD/CKD•HbA1c ≥6%•eGFR 45-59

Primary endpoint

•CV events (total recurrent) (Myocardial infarction (any), Stroke (any), Coronary revascularization, Cerebrovascular revascularization)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05390892
Org study ID2022p001160

Timeline

Milestones

Study first posted2022-05-25actual
Study start2022-09-26actual
Last update posted2026-04-13actual
Primary completion2029-03-01estimated
Study completion2029-03-01estimated

Assets

Investigational agents

DulaglutideGLP-1 / incretin class catch-allLiraglutideSemaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint

Total (first and recurrent) cardiovascular, kidney, and death events

Time frame:Through study completion, with an average follow up of approximately 3 years

CV events (total recurrent)

event count, event

componentsMyocardial infarction (any), Stroke (any), Coronary revascularization, Cerebrovascular revascularization, Peripheral revascularization, Heart-failure hospitalization, End-stage renal disease, Kidney-replacement therapy, All-cause death

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.