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NCT06082063RecruitingPhase 3

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2000 (estimated)
First submitted
16 May 2023
Start date
1 Jul 2024
Primary completion date
1 Jul 2029
Lead sponsor
Steno Diabetes Center Copenhagen
NCT number
NCT06082063

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 2000
  • From 1 Jul 2024 to the primary completion date, 1 Jul 2029
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known or suspected abuse of alcohol or recreational drugs.

Other illness

  • Type 2 diabetes, MODY, secondary diabetes.
  • History of pancreatitis.

Other

  • Body mass index \< 18.5 kg/m2
  • Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.
  • Participant in another intervention study.
  • CKD stage 5.

Who the study is looking for

  • Given written informed consent
  • 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.
  • 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.
  • 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.
  • Ability to communicate with the investigator and understand informed consent.

Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkRecruiting
Steno Diabetes Center Copenhagen
Coordinator of this site? Confirm its status
HerlevDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.