Clinical Research Directory

Steno 1 inclusion criteria: * Male or female persons ≥40 years old with T1D (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's 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 5-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. * Ability to communicate with the investigator and understand informed consent. * Given written informed consent. Steno 1 exclusion criteria: * Type 2 Diabetes, Maturity-onset diabetes of the young (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. * Known or suspected abuse of alcohol or recreational drugs. * Participant in another drug-intervention study. * Chronic Kidney Disease stage 5. Additional exclusion criteria in the MICRON study: * Active malignant disease * Use of study drugs (SGLT inhibitors, GLP-1 RA, or finererone) at inclusion.