Tests a multi-drug plan to lower heart disease risk in type 1 diabetes
Tests combined treatments to lower heart disease risk in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Key facts
- Where
- Copenhagen and Herlev, DenmarkSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 90 years old?
Source: NCT06082063, who can take part
Where in Denmark
- RigshospitaletCopenhagen, DenmarkTaking people
- Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Steno Diabetes Center Copenhagen
- Trial code
- NCT06082063
- Record updated
- 10 January 2025
- Original description
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.Read full original descriptionShow less
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
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.
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: Known or suspected abuse of alcohol or recreational drugs; 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; Participant in another intervention study; CKD stage 5.