Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Steno1
1 other identifier
interventional
2,000
1 country
2
Brief Summary
A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 cardiovascular-diseases
Started Jul 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
January 10, 2025
January 1, 2025
5 years
May 16, 2023
January 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
MACE + HHF
Calculate the incidence of cardiovascular events (MACE+HF) to determine whether a multifactorial intervention is superior to standard care with respect to MACE+HHF (composite of time to first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure).
5 years
Secondary Outcomes (3)
All-cause mortality
5 years
Renal function
5 years
Diabetic ketoacidosis, safety
5 years
Other Outcomes (18)
Indivudual components of the primary endpoint
5 years
Lower extremity amputations
5 years
Progression of retinopathy
5 years
- +15 more other outcomes
Study Arms (2)
Multifactorial intervention group
ACTIVE COMPARATORThe multifactorial intervention will be determined by the risk profile and risk markers of each individual and the participants will be allocated to Semaglutide, sotagliflozin or finerenone. The intervention will also comprise more ambitious treatment targets for blood pressure and lipid levels. In addition, all participants will take aspirin 75 mg OD.
Standard intervention group
NO INTERVENTIONDuring the whole study period the standard intervention shall be done according to current Danish and international (ADA/EASD) guidelines. This will address similar risk factors as in the intensive group, but to a less ambitious treatment target for blood pressure and lipid lowering and will not include the use of SGTL2i, finerenone or GLP-1RA, unless these drug classes become recommended in future versions of guidelines.
Interventions
Antiplatelet treatment: with aspirin 75mg OD is mandatory except for concomitant anticoagulant therapy or allergy. In case of allergy clopidogrel will be used.
GLP-1RA treatment: With semaglutide once weekly individually stepped highest tolerable dose according to standard guidelines aiming at 1 mg/week for persons with HbA1c \>53 mmol/mol or BMI\>25 kg/m2 and/or ischemic heart disease and/or stroke. For safety see below under benefits and risks. Investigators should pay attention to the need for adjustment in insulin dose after initiation of GLP-1RA treatment.
SGLT2i treatment with sotagliflozin 200 mg once daily for persons with UACR \>30 mg/g and eGFR \< 45 ml/min/1.73 m2 and for persons with a diagnosis of HF. For safety see below under benefits and risks. The limit of eGFR (\<45ml/min) for initiation of SGLT2i treatment is set to reduce risk of ketoacidosis. SGLT2i treatment should not be offered to participants on insulin pump therapy, to reduce risk of ketoacidosis. Investigators should pay attention to the need for adjustment in insulin dose after initiation of SGLT2i treatment.
Finerenone: 10 mg once daily titrated to 20 mg as add-on in persons with persistent albuminuria (\>30 mg/g) despite RAS blockade.
Eligibility Criteria
You may qualify if:
- Given written informed consent
- 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.
- 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.
- 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.
- Ability to communicate with the investigator and understand informed consent.
You may not qualify if:
- Type 2 diabetes, MODY, secondary diabetes.
- History of pancreatitis.
- Body mass index \< 18.5 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.
- Known or suspected abuse of alcohol or recreational drugs.
- Participant in another intervention study.
- CKD stage 5.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steno Diabetes Center Copenhagenlead
- Aarhus University Hospitalcollaborator
- Steno Diabetes Center Nordjyllandcollaborator
- Steno Diabetes Center Odensecollaborator
- Slagelse Hospitalcollaborator
- Nykøbing Falster County Hospitalcollaborator
- Zealand University Hospitalcollaborator
- Hillerod Hospital, Denmarkcollaborator
- Rigshospitalet, Denmarkcollaborator
- Hvidovre University Hospitalcollaborator
- Regionshospitalet Viborg, Skivecollaborator
- Randers Regional Hospitalcollaborator
- Herning Hospitalcollaborator
- Esbjerg Hospital - University Hospital of Southern Denmarkcollaborator
- Regionshospitalet Silkeborgcollaborator
- Bispebjerg Hospitalcollaborator
- Regionshospitalet Horsenscollaborator
Study Sites (2)
Rigshospitalet
Copenhagen, Denmark
Steno Diabetes Center Copenhagen
Herlev, 2730, Denmark
Related Publications (1)
Rossing P. Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases. J Am Soc Nephrol. 2024 Oct 1;35(10):1438-1441. doi: 10.1681/ASN.0000000000000449. Epub 2024 Jul 5. No abstract available.
PMID: 39078403DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Rossing, MD, DMSc, Proffessor
Steno Diabetes Center Copenhagen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2023
First Posted
October 13, 2023
Study Start
July 1, 2024
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
January 10, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share