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Steno1

RecruitingPhase 3

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Asset

Semaglutide

GLP-1 agonist

Listed sites

2

Recruiting sites

2

Enrollment

2,000

estimated

Study population

Type 1 diabetes

Key I/E criteria

BMI ≥35eGFR ≤60UACR ≥30

Primary endpoint

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

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 IDNCT06082063
Org study IDNNF 22OC0077730

Timeline

Milestones

Study first posted2023-10-13actual
Study start2024-07-01actual
Last update posted2025-01-10actual
Primary completion2029-07-01estimated
Study completion2029-07-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age40 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Given written informed consent

2. Male or female patients ≥40 years old with type 1 diabetes (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies ( in accordance with local guidelines)) during >10 years.

3. Presence of chronic kidney disease (UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI>35 kg/m2) OR 10-year CVD risk >10% according to Steno Type 1 Risk Engine.

4. Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. Fertile participants will be pregnancy tested every six months with urine HCG.

5. Ability to communicate with the investigator and understand informed consent.

Exclusion criteria

1. Type 2 diabetes, MODY, secondary diabetes.

2. History of pancreatitis.

3. Body mass index < 18.5 kg/m2

4. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.

5. Known or suspected abuse of alcohol or recreational drugs.

6. Participant in another intervention study.

7. CKD stage 5.

Endpoints (22)

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
6
Renal / kidney
5
Safety / tolerability / PK
3
Cardiometabolic biomarkers
2
Other clinical outcomes
2
Weight & body composition
1
Glycemic / diabetes
1
Patient-reported / QoL
1
Other (unclassified)
1

Cardiovascular outcomes

6 endpoints
Primary/protocol endpoint

MACE + HHF

Time frame:5 years

4-point MACE

time to event, event

componentsNon-fatal MI, Non-fatal stroke, Cardiovascular death, Heart-failure hospitalization

Secondary/protocol endpoint

All-cause mortality

Time frame:5 years

All-cause death

time to event, event

SNOMED 419620001

Other/protocol endpoint

Lower extremity amputations

Time frame:5 years

Major amputation

event count, event

Other/protocol endpoint

Long term risk of CVD events

Time frame:10 years

Expanded / custom MACE composite

composite event, event

components3-point MACE, Heart-failure hospitalization

Other/protocol endpoint

Survival

Time frame:10 years

All-cause death

time to event, event

SNOMED 419620001

Other/protocol endpoint

Long term risk of lower extremity amputations

Time frame:10 years

Major amputation

event count, event

Weight & body composition

1 endpoint
Other/protocol endpoint

BMI

Time frame:5 years

BMI, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Other/protocol endpoint

HbA1c

Time frame:5 years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

5 endpoints
Secondary/protocol endpoint

Renal function

Time frame:5 years

Custom renal composite

composite event, event

componentsEnd-stage renal disease, Renal death, Kidney-replacement therapy, eGFR, change

Other/protocol endpoint

Reduction in kidney function

Time frame:5 years

threshold achievement, event

LOINC 98979-8

Other/protocol endpoint

Urinary albumin to creatinine ratio (UACR)

Time frame:5 years

uACR, change

ratio, improvement

LOINC 9318-7

Other/protocol endpoint

Decline in eGFR

Time frame:5 years

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other/protocol endpoint

Long term risk of ESKD

Time frame:10 years

End-stage renal disease

time to event, event

SNOMED 46177005

Cardiometabolic biomarkers

2 endpoints
Other/protocol endpoint

5- and 10-year cardiovascular risk as assessed using the Steno T1 Risk Engine

Time frame:5 years

descriptive, improvement

Other/protocol endpoint

LDL cholesteerol

Time frame:5 years

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Patient-reported / QoL

1 endpoint
Other/protocol endpoint

EQ5D questionnaire

Time frame:5 years

EQ-5D index

descriptive, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Diabetic ketoacidosis, safety

Time frame:5 years

event count, event

Other/protocol endpoint

Diabetic ketoacidosis (DKA)

Time frame:5 years

event count, event

Other/protocol endpoint

Long term risk of DKA

Time frame:10 years

time to event, event

Other clinical outcomes

2 endpoints
Other/protocol endpoint

Progression of retinopathy

Time frame:5 years

time to event, event

Other/protocol endpoint/low confidence

Biothesiometry

Time frame:5 years

change from baseline, improvement

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Indivudual components of the primary endpoint

Time frame: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.