DelfaGLP-1 Atlas

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Completed

Emulation of the SUSTAIN6 Diabetes Trial Using Healthcare Claims

Emulation of Effects of Injectable Semaglutide on Cardiovascular Outcomes in Individuals With Type 2 Diabetes: SUSTAIN6 Trial

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

158,310

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 IDNCT06659744
Org study ID2018P002966-DUP-SUSTAIN

Timeline

Milestones

Study start2024-10-24actual
Study first posted2024-10-26actual
Primary completion2025-03-06actual
Study completion2025-03-06actual
Last update posted2025-10-15actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Sampling methodNon probability sample

Study population text

The study population included patients with Type 2 Diabetes (Type2DM) who had not been treated with antihyperglycemic agents or had been treated with no more than two oral antihyperglycemic agents, with or without NPH or long-acting insulin, \>=50 years with established cardiovascular disease OR \>=60 years with subclinical cardiovascular disease.

Inclusion criteria

Eligible cohort entry dates:

Market availability of injectable semaglutide in the US began on 5th December 2017.

Optum: Study period between 5th Dec 2017 - 29th February 2024 Marketscan: Study period between 5th Dec 2017 - 31st Dec 2022 Medicare: Study period between 5th Dec 2017 - 31st Dec 2020

Inclusion Criteria:

•Type 2 diabetes mellitus
•Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs
•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
•Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness
•Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening
•History of chronic pancreatitis or idiopathic acute pancreatitis
•Acute coronary or cerebro-vascular event within 90 days prior to randomization
•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
•Personal history of non-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
•Known use of non-prescribed narcotics or illicit drugs
•Proliferative retinopathy or maculopathy requiring treatment
•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

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.