Status:
RECRUITING
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Aarhus University Hospital
Steno Diabetes Center Nordjylland
Conditions:
Cardiovascular Diseases
Heart Failure
Eligibility:
All Genders
40-90 years
Phase:
PHASE3
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...
Detailed Description
Background: Individuals with type 1 diabetes (T1D) are at high risk for cardiovascular disease (CVD). Even with optimal glycemic control, the risk is doubled compared to healthy individuals. Treatment...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06082063
Start Date
July 1 2024
End Date
July 1 2029
Last Update
January 10 2025
Active Locations (2)
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1
Rigshospitalet
Copenhagen, Denmark
2
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730