Multifactorial intervention to lower cardiovascular disease risk in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a multifactorial intervention in individuals with type 1 diabetes who are at high risk for cardiovascular disease. It will involve 2000 participants over a 5-year follow-up period, utilizing a cluster-randomized design to assess the impact of various treatments including aspirin, semaglutide, sotagliflozin, and finerenone. The study focuses on ambitious treatment targets to reduce major adverse cardiovascular events, hospitalizations for heart failure, kidney failure, and mortality. Participants will be monitored for their response to the intervention and overall health outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Herlev, Denmark Recruiting

Study contacts

• Principal investigator: Peter Rossing, MD, DMSc, Proffessor — Steno Diabetes Center Copenhagen
• Study coordinator: Frederik Persson, MD, DMSc
• Email: frederik.persson@regionh.dk
• Phone: +4521623779

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.