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Emulation of the SOUL Diabetes Trial in Healthcare Claims

Emulation of the Effects of Oral Semaglutide on Cardiovascular Outcomes in Individuals With Type 2 Diabetes and Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease: SOUL Trial

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

43,650

actual

Study population

Cardiovascular disease, Chronic kidney disease, Type 2 diabetes

Key I/E criterion

•eGFR ≤60

Primary endpoint

•Expanded / custom MACE composite (Myocardial infarction (any), Stroke (any), All-cause death)

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 IDNCT06659718
Org study ID2018P002966-DUP-SOUL

Timeline

Milestones

Study start2024-10-24actual
Study first posted2024-10-26actual
Primary completion2025-02-13actual
Study completion2025-02-13actual
Last update posted2025-05-25actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseChronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Sampling methodNon probability sample

Study population text

The study population included patients aged 50 years or older with type 2 diabetes (T2DM) and established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).

Inclusion criteria

Eligible cohort entry dates:

Market availability of oral semaglutide in the US began on 19th September 2019.

Optum: Study period between 20th Sept 2019 - 29th February 2024 Marketscan: Study period between 20th Sept 2019 - 31st Dec 2022 Medicare: Study period between 20th Sept 2019 - 31st Dec 2020

Inclusion Criteria:

•Type 2 diabetes mellitus
•Male or female, age equal to or above 50 years

At least one of the following conditions:

•Coronary heart disease defined by at least one of the following criteria:

i.Prior myocardial infarction
ii.Prior coronary revascularization procedure
ii.50% or above stenosis in coronary artery documented by cardiac catheterization, computerized tomography coronary angiography
iv.Coronary heart disease with ischemia documented by stress test with any imaging modality
•Cerebrovascular disease defined by at least one of the following criteria:

i.Prior stroke
ii.Prior carotid artery revascularization procedure
iii.50% or above stenosis in carotid artery documented by x-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound
•Symptomatic peripheral artery disease (PAD) defined by at least one of the following criteria:

i.Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest
ii.Intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by x-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound
iii.Prior peripheral artery(excluding carotid) revascularization procedure
iv.Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding trauma or osteomyelitis)
•Chronic kidney disease defined as: i. eGFR below 60mL/min/1.73 m^2 (based on medical records using latest available and no more than 6 months old assessment)

Exclusion criteria

•Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within the past 60 days prior to the day of screening
•Heart failure presently classified as being in New York Heart Association Class IV
•Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening
•Semaglutide
•History of MEN-2 or family history of medullary thyroid cancer
•History of pancreatitis
•History of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass
•Plans for pregnancy during the course of the study for women of child-bearing potential
•History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization
•Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR <30 ml/min/1.73 m2)
•Proliferative retinopathy or maculopathy requiring acute treatment
•History of diabetic ketoacidosis
•Missing age or gender
•Nursing home admission

Endpoints (2)

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.

Coverage by outcome category

Cardiovascular outcomes
1
Other clinical outcomes
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint

Major adverse cardiac event (MACE), including myocardial infarction, stroke and all cause death

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any), All-cause death

Other clinical outcomes

1 endpoint
Other/protocol endpoint

Cataract surgery (negative control)

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

time to event, event

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.