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2023-505794-32-04RecruitingPhase 3

New treatments to reduce cardiovascular disease in type 1 diabetes

Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes

Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Oct 2026

Next steps

Brief summary (registry, in English)

The aim of the Steno 1 study is to test a strategy of intensified care based on MFI in individuals with T1D at high risk of CVD with ambitious treatment targets compared to standard of care, while simultaneously investigating the safety and efficacy of 40 mg finerenone in individuals with T1D in risk of CV death and hospitalization for heart failure (HHF )

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2000 (estimated)
First submitted
6 Feb 2024
Start date
5 Jul 2024
Lead sponsor
Steno Diabetes Center Copenhagen
EU CT number
2023-505794-32-04

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 2000
  • 19 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 or older who have had type 1 diabetes for more than 10 years and have a high risk of heart and blood vessel disease.

Age
40 years or older.
Sex
Men and women can join.
Disease stage
Type 1 diabetes for more than 10 years, plus at least one of these: chronic kidney disease (UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2), past ischemic heart disease (heart attack, stroke or angina), past heart failure, obesity grade 2 or 3 (BMI >35 kg/m2), or a 10-year CVD risk above 10% by the Steno Type 1 Risk Engine.
Earlier treatment
Insulin from the start of the diabetes. For the CGM sub-study, people must already use CGM as part of their usual diabetes care.
Biomarker or test result
If diabetes began after age 30, DKA or positive autoantibodies are needed. Kidney markers: UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2.

Main reasons for not taking part

  • Type 2 diabetes, MODY or secondary diabetes
  • History of pancreatitis
  • BMI below 18.5 kg/m2
  • Pregnant, breast-feeding, planning pregnancy, or not using adequate contraception
  • CKD stage 5

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known or suspected abuse of alcohol or recreational drugs.
  • Participant in another drug-intervention study

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
  • CKD stage 5
  • For the sub-study on CGM if for some reason the participant chooses no longer to use CGM

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)), or confirmed, at the investigator discretion by the available medical records) 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
    • For the CGM sub-study: Using CGM at inclusion, as part of their usual diabetes treatment.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (19)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Steno Diabetes Center NordjyllandAalborgDenmarkRecruiting
Steno Diabetes Center AarhusArhusDenmarkRecruiting
Bispebjerg HospitalCopenhagen NvDenmarkRecruiting
RigshospitaletCopenhagen OeDenmarkRecruiting
Sydvestjysk SygehusEsbjergDenmarkRecruiting
Steno Diabetes Center CopenhagenHerlevDenmarkRecruiting
Region MidtjyllandHerningDenmarkRecruiting
Nordsjællands HospitalHillerødDenmarkRecruiting
Holbæk SygehusHolbækDenmarkRecruiting
Region MidtjyllandHorsensDenmarkRecruiting
Hvidovre HospitalHvidovreDenmarkRecruiting
Sjællands UniversitetshospitalKøgeDenmarkRecruiting
Lillebaelt HospitalKoldingDenmarkRecruiting
Nykøbing Falster SygehuseNykøbing FalsterDenmarkRecruiting
Steno Diabetes Center OdenseOdenseDenmarkRecruiting
Region MidtjyllandRanders NoeDenmarkRecruiting
Region MidtjyllandSilkeborgDenmarkRecruiting
Slagelse SygheusSlagelseDenmarkRecruiting
Region MidtjyllandViborgDenmarkRecruiting

Are you the coordinator? Confirm the details

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