NCT06082063 Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
| NCT ID | NCT06082063 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Steno Diabetes Center Copenhagen |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,000 participants in total. It began in 2024-07-01 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Peter Rossing, MD, DMSc, Proffessor
PRINCIPAL INVESTIGATOR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT06082063 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06082063 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,000 participants.
Is NCT06082063 currently recruiting?
Yes, NCT06082063 is actively recruiting participants. Contact the research team at frederik.persson@regionh.dk for enrollment information.
Where is the NCT06082063 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Herlev, Denmark.
Who is sponsoring the NCT06082063 clinical trial?
NCT06082063 is sponsored by Steno Diabetes Center Copenhagen. The principal investigator is Peter Rossing, MD, DMSc, Proffessor at Steno Diabetes Center Copenhagen. The trial plans to enroll 2,000 participants.