Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Recruiting now · Phase 3
Conditions studied: Cardiovascular Diseases, Heart Failure, Type 1 Diabetes, Kidney Failure
In brief
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.
Key facts
- Study ID
- NCT06082063
- Run by
- Steno Diabetes Center Copenhagen
- People needed
- 2000
- Starts
- 2024-07-01
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2025-01-10
Who can join
Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Steno Diabetes Center Copenhagen — Herlev, Denmark (enrolling)
Full record on ClinicalTrials.gov
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