DelfaGLP-1 Atlas

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Completed

Emulating the PIONEER6 Diabetes Trial Using Healthcare Claims

Emulation of the Effects of Oral Semaglutide on Cardiovascular Outcomes in Individuals With Type 2 Diabetes: PIONEER6 Trial

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

26,126

actual

Study population

Cardiovascular 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 IDNCT06659679
Org study ID2018P002966-DUP-PIONEER

Timeline

Milestones

Study start2024-10-24actual
Study first posted2024-10-26actual
Primary completion2025-03-06actual
Study completion2025-03-06actual
Last update posted2025-05-25actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

The study population includes patients with Type 2 Diabetes (Type2DM), \>=50 years with established cardiovascular disease OR \>=60 years with subclinical cardiovascular disease.

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
•Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease: prior myocardial infarction, prior stroke or prior transient ischemic attack, prior coronary, carotid or peripheral arterial revascularization, more than 50% stenosis on angiography or imaging of coronary, carotid or lower extremities arteries, chronic heart failure - New York Heart Association (NYHA) class II-III, chronic renal impairment documents by estimated eGFR <60ml/min/1.73 m2 per MDRD
•Age 60 years or older with subclinical evidence of cardiovascular disease. Subclinical cardiovascular risk factors as one of the following: persistent microalbuminuria (30-299mg/g) or proteinuria, ankle/brachial index less than 0.9

Exclusion criteria

•Type 1 diabetes mellitus, secondary or gestational diabetes
•Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening
•Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening
•History of diabetic ketoacidosis, chronic pancreatitis or idiopathic acute pancreatitis
•Any of the following: myocardial infarction, stroke, or hospitalization for unstable angina or transient ischemic attack within the past 60 days prior to screening
•Chronic heart failure New York Heart Association (NYHA) class IV
•Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
•Chronic hemodialysis or peritoneal dialysis
•End stage liver disease
•A prior solid organ transplant or awaiting solid organ transplant
•Diagnosis of malignant neoplasm in the previous 5 years
•Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using an adequate contraceptive method
•Proliferative retinopathy or maculopathy requiring treatment
•History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
•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.