DelfaGLP-1 Atlas

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STENO INTEN-CT

RecruitingPhase 4

Screening and Intervention for Subclinical Coronary Artery Disease in Patients With Type 2 Diabetes

Screening and Intervention for Subclinical Coronary Artery Disease in Patients With Type 2 Diabetes: THE STENO INTEN-CT STUDY

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

7,300

estimated

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•4-point MACE (Cardiovascular death, Non-fatal MI, Heart-failure hospitalization, Non-fatal stroke)

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 IDNCT05700877
Org study ID2022-500143-21-01

Timeline

Milestones

Study start2023-01-12actual
Study first posted2023-01-26actual
Last update posted2025-02-06actual
Primary completion2029-01-01estimated
Study completion2029-03-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age55 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•New or former diagnosis of Type 2 diabetes according to WHO.
•Age between 55-69 years (men) and 60-74 years (women).
•Signed declaration of consent

Exclusion criteria

•Previous history of CVD (previous myocardial infarction or coronary intervention (percutaneous coronary intervention or by-pass), heart failure, stroke or peripheral artery disease as documented by the patient or the patient medical record).
•Contraindications or allergies to both SGLT2 inhibitors and GLP-1 analogues.
•Signs of critical cardiac disease: >50% stenosis of left main coronary artery (CT angiography) or left ventricular ejection fraction below 30% (echocardiography). If a CT angiography is not available, a CAC>1000 on the non-contrast cardiac CT will be considered equal to critical cardiac disease.
•Expected life duration < 1 year for any reason.

Endpoints (11)

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

Patient-reported / QoL
3
Cardiovascular outcomes
2
Cardiometabolic biomarkers
2
Other (unclassified)
2
Weight & body composition
1
Other clinical outcomes
1

Cardiovascular outcomes

2 endpoints
Primary/protocol endpoint

Rates of a composite cardiovascular endpoint

Time frame:Event-driven, expected mean follow-up of 5 years

4-point MACE

composite event, event

componentsCardiovascular death, Non-fatal MI, Heart-failure hospitalization, Non-fatal stroke

Secondary/protocol endpoint

Rates of all-cause mortality and individual components of the primary outcome

Time frame:Event-driven, expected mean follow-up of 5 years

All-cause death

event count, event

SNOMED 419620001

Weight & body composition

1 endpoint
Other/protocol endpoint

Cardiovascular risk markers 3

Time frame:Event-driven, expected mean follow-up of 5 years

BMI, change

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Other/protocol endpoint

Cardiovascular risk markers 1

Time frame:Event-driven, expected mean follow-up of 5 years

change from baseline, improvement

Other/protocol endpoint

Cardiovascular risk markers 2

Time frame:Event-driven, expected mean follow-up of 5 years

descriptive, improvement

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Patient reported outcomes 1

Time frame:Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years)

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Patient reported outcomes 2

Time frame:Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years)

change from baseline, improvement

Secondary/protocol endpoint

Patient reported outcomes 3

Time frame:Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years)

change from baseline, improvement

Other clinical outcomes

1 endpoint
Other/protocol endpoint

Cardiovascular risk markers 4

Time frame:Event-driven, expected mean follow-up of 5 years

threshold achievement, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Cost-effectiveness

Time frame:Event-driven, expected mean follow-up of 5 years

descriptive

Other/protocol endpoint/low confidence

Treatment with prespecified drugs

Time frame:Event-driven, expected mean follow-up of 5 years

descriptive

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.