Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Launched by STENO DIABETES CENTER COPENHAGEN · Oct 8, 2023

Keywords

ClinConnect Summary

The Steno 1 study is a clinical trial designed to test a new approach to reduce the risk of heart and kidney problems in people with type 1 diabetes. This study is specifically aimed at individuals who are at high risk for cardiovascular disease (CVD) and will involve 2,000 participants over a five-year period. The goal is to see if a combined treatment plan can help improve health outcomes for those living with type 1 diabetes.

To be eligible for this study, participants need to be at least 40 years old, have been diagnosed with type 1 diabetes for more than 10 years, and show signs of chronic kidney disease or have a history of heart problems, among other criteria. Participants will receive regular check-ups and support throughout the trial, and women who can become pregnant will need to use effective birth control during the study. This is an important opportunity for people with type 1 diabetes to possibly benefit from new treatments aimed at preventing serious health issues.

Gender

ALL

Eligibility 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.