FINERENONE for Type 1 diabetes

Inclusion criteria

• {"criterion_text":"- 1. Given written informed consent"}
• {"criterion_text":"- 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)), or confirmed, at the investigator discretion by the available medical records) during >10 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 5. Ability to communicate with the investigator and understand informed consent"}
• {"criterion_text":"- 6. For the CGM sub-study: Using CGM at inclusion, as part of their usual diabetes treatment."}

Exclusion criteria

• {"criterion_text":"- Type 2 diabetes, MODY, secondary diabetes."}
• {"criterion_text":"- History of pancreatitis"}
• {"criterion_text":"- Body mass index < 18.5 kg/m2"}
• {"criterion_text":"- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods"}
• {"criterion_text":"- Known or suspected abuse of alcohol or recreational drugs."}
• {"criterion_text":"- CKD stage 5"}
• {"criterion_text":"- Participant in another drug-intervention study"}
• {"criterion_text":"- For the sub-study on CGM if for some reason the participant chooses no longer to use CGM"}

Primary endpoints

• {"endpoint_text":"- •\tFirst major adverse cardiovascular events (MACE), and first hospitalization for heart failure (HHF). The primary efficacy analysis will analyse if a multifactorial intervention strategy is superior to standard care with respect to time to first event of the composite endpoint of first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure five years after inclusion of the first patient.","definition_or_measurement_approach":"Time to first event of the composite endpoint (first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure); primary efficacy analysis at five years after inclusion of first patient."}

Secondary endpoints

• {"endpoint_text":"- Will determine whether a multifactorial intervention is superior to standard care with respect time to a composite endpoint of renal function (end-stage kidney disease (ESKD) (dialysis, renal death, transplantation) a sustained eGFR <15 ml/min/1.73 m2 or >50% sustained decline in eGFR from baseline) compared to standard of care (sustained means change in eGFR sustained for at least 30 days).","definition_or_measurement_approach":"Time to composite renal endpoint: ESKD (dialysis, renal death, transplantation), sustained eGFR <15 ml/min/1.73 m2 or >50% sustained decline in eGFR from baseline; sustained defined as ≥30 days."}
• {"endpoint_text":"- To determine the effect of multifactorial intervention is superior to standard of care with respect to the individual components of the composite endpoints.","definition_or_measurement_approach":"Analysis of individual components of the composite cardiovascular and renal endpoints (as specified in primary and other secondary endpoints)."}
• {"endpoint_text":"- To determine whether a multifactorial intervention is superior to standard care with respect to all-cause mortality.","definition_or_measurement_approach":"All-cause mortality compared between multifactorial intervention and standard care."}

Denmark

Earliest CTIS Part Ii Submission Date

27-04-2024

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

489

Number Of Sites

19

Number Of Participants

2000

Primary sponsor

Full Name

Steno Diabetes Center Copenhagen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}