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Steno1
RecruitingPhase 3Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Lead sponsor
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 ≥35•eGFR ≤60•UACR ≥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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsMACE + HHF
Time frame:5 years
4-point MACE
time to event, event
componentsNon-fatal MI, Non-fatal stroke, Cardiovascular death, Heart-failure hospitalization
All-cause mortality
Time frame:5 years
All-cause death
time to event, event
SNOMED 419620001
Lower extremity amputations
Time frame:5 years
Major amputation
event count, event
Long term risk of CVD events
Time frame:10 years
Expanded / custom MACE composite
composite event, event
components3-point MACE, Heart-failure hospitalization
Survival
Time frame:10 years
All-cause death
time to event, event
SNOMED 419620001
Long term risk of lower extremity amputations
Time frame:10 years
Major amputation
event count, event
Weight & body composition
1 endpointBMI
Time frame:5 years
BMI, change
change from baseline, improvement
Glycemic / diabetes
1 endpointHbA1c
Time frame:5 years
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Renal / kidney
5 endpointsRenal function
Time frame:5 years
Custom renal composite
composite event, event
componentsEnd-stage renal disease, Renal death, Kidney-replacement therapy, eGFR, change
Reduction in kidney function
Time frame:5 years
threshold achievement, event
LOINC 98979-8
Urinary albumin to creatinine ratio (UACR)
Time frame:5 years
uACR, change
ratio, improvement
LOINC 9318-7
Decline in eGFR
Time frame:5 years
eGFR, change
change from baseline, improvement
LOINC 98979-8
Long term risk of ESKD
Time frame:10 years
End-stage renal disease
time to event, event
SNOMED 46177005
Cardiometabolic biomarkers
2 endpoints5- and 10-year cardiovascular risk as assessed using the Steno T1 Risk Engine
Time frame:5 years
descriptive, improvement
LDL cholesteerol
Time frame:5 years
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Patient-reported / QoL
1 endpointEQ5D questionnaire
Time frame:5 years
EQ-5D index
descriptive, improvement
Safety / tolerability / PK
3 endpointsDiabetic ketoacidosis, safety
Time frame:5 years
event count, event
Diabetic ketoacidosis (DKA)
Time frame:5 years
event count, event
Long term risk of DKA
Time frame:10 years
time to event, event
Other clinical outcomes
2 endpointsProgression of retinopathy
Time frame:5 years
time to event, event
Biothesiometry
Time frame:5 years
change from baseline, improvement
Other (unclassified)
1 endpointIndivudual 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
- Journal of the American Society of Nephrology : JASN2024 Oct 1PMID39078403doi:10.1681/ASN.0000000000000449via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.