ew treatments to reduce cardiovascular disease in type 1 diabetes

Phase 1

• Conditions: Type 1 diabetes; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: CTIS2023-505794-32-04
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-06
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified