Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes

Steno Diabetes Center Copenhagen0 sites2,000 target enrollmentFebruary 6, 2024

Overview

No summary available.

Registry

who.int

Start Date

February 6, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.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, For the CGM sub\-study: Using CGM at inclusion, as part of their usual diabetes treatment.

•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, Known or suspected abuse of alcohol or recreational drugs., CKD stage 5, Participant in another drug\-intervention study, For the sub\-study on CGM if for some reason the participant chooses no longer to use CGM