Multifactorial intervention to lower cardiovascular disease risk in type 1 diabetes
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
This study is testing whether a combination of treatments can help people with type 1 diabetes who are at high risk for heart problems stay healthier and avoid serious issues like heart attacks and kidney failure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT06082063 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with type 1 diabetes for more than 10 years, who also have chronic kidney disease, cardiovascular disease, heart failure, obesity, or a high 10-year cardiovascular disease risk.
Not a fit: Patients with type 1 diabetes who do not meet the high-risk criteria or are younger than 40 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce cardiovascular disease risk and improve overall health outcomes for patients with type 1 diabetes.
How similar studies have performed: Previous studies have shown success with multifactorial interventions in type 2 diabetes, suggesting potential for similar benefits in type 1 diabetes, although this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Copenhagen and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.