Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

• Status: Not yet recruiting
• Trial end date: 2030-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center Copenhagen
• Collaborators: Aarhus University Hospital; Bispebjerg Hospital; Herning Hospital; Hillerod Hospital, Denmark; Hospital of South West Jutland; Hvidovre University Hospital; Nykøbing Falster County Hospital; Randers Regional Hospital; Regionshospitalet Horsens; Regionshospitalet Silkeborg; Regionshospitalet Viborg, Skive; Rigshospitalet, Denmark; Slagelse Hospital; Steno Diabetes Center Nordjylland; Steno Diabetes Center Odense; Zealand University Hospital
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Aspirin; Semaglutide

Criteria

Inclusion Criteria:

1. Given written informed consent

2. 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.

3. 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.

4. 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.

5. Ability to communicate with the investigator and understand informed consent.

Exclusion Criteria:

1. Type 2 diabetes, MODY, secondary diabetes.

2. History of pancreatitis.

3. Body mass index < 18.5 kg/m2

4. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.

5. Known or suspected abuse of alcohol or recreational drugs.

6. Participant in another intervention study.

7. CKD stage 5.