New treatments to reduce cardiovascular disease in type 1 diabetes
Key facts
- Where
- Aalborg, Arhus, Copenhagen Nv, Copenhagen Oe, Esbjerg, Herlev, Herning, Hillerød, Holbæk, Horsens, Hvidovre, Køge, Kolding, Nykøbing Falster, Odense, Randers Noe, Silkeborg, Slagelse és Viborg, DániaSee the 19 sites
- Phase
- 3. fázis
Where in Dánia
- Steno Diabetes Center NordjyllandAalborg, DániaTaking people
- Steno Diabetes Center AarhusArhus, DániaTaking people
- Bispebjerg HospitalCopenhagen Nv, DániaTaking people
- RigshospitaletCopenhagen Oe, DániaTaking people
- Sydvestjysk SygehusEsbjerg, DániaTaking people
- Steno Diabetes Center CopenhagenHerlev, DániaTaking people
- Region MidtjyllandHerning, DániaTaking people
- Nordsjællands HospitalHillerød, DániaTaking people
- Holbæk SygehusHolbæk, DániaTaking people
- Region MidtjyllandHorsens, DániaTaking people
- Hvidovre HospitalHvidovre, DániaTaking people
- Sjællands UniversitetshospitalKøge, DániaTaking people
- Lillebaelt HospitalKolding, DániaTaking people
- Nykøbing Falster SygehuseNykøbing Falster, DániaTaking people
- Steno Diabetes Center OdenseOdense, DániaTaking people
- Region MidtjyllandRanders Noe, DániaTaking people
- Region MidtjyllandSilkeborg, DániaTaking people
- Slagelse SygheusSlagelse, DániaTaking people
- Region MidtjyllandViborg, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Steno Diabetes Center Copenhagen
- Trial code
- EU 2023-505794-32-04
- Record updated
- 2026. október 5.
- Original description
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 )Read full original descriptionShow less
Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes
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 )
Inclusion: 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.
Exclusion: Known or suspected abuse of alcohol or recreational drugs; Participant in another drug-intervention study; Type 2 diabetes, MODY, secondary diabetes; History of pancreatitis; 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.