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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes for more than 10 years who are at high risk of heart and blood vessel disease.
- Age
- 40 to 90 years
- Sex
- Men and women can join.
- Disease stage
- Type 1 diabetes for more than 10 years, plus at least one of these: chronic kidney disease, past ischemic heart disease (heart attack, stroke or angina), heart failure, BMI above 35 kg/m2, or 10-year CVD risk above 10% on the Steno Type 1 Risk Engine.
- Earlier treatment
- Insulin from the start of the diabetes.
- Biomarker or test result
- Kidney disease means UACR above 30 mg/g or eGFR below 60 ml/min/1.73 m2. If type 1 diabetes was diagnosed after age 30, DKA or positive autoantibodies are needed.
Main reasons for not taking part
- Type 2 diabetes, MODY or secondary diabetes
- History of pancreatitis
- BMI below 18.5 kg/m2
- Pregnant, breast-feeding, planning pregnancy, or not using adequate contraception
- Alcohol or recreational drug abuse, or CKD stage 5
Read by machine on 9 November 2026.
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.