IRB Study Number 25-635
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Endocrinology and Metabolism Institute
Description
The aim of the study is to investigate the effect on glycemic control and safety of treatment with once-weekly insulin icodec compared to once-daily insulin glargine U100, both in combination with insulin aspart, in participants with T1D.
Inclusion Criteria
- Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
- HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
- Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement
Exclusion Criteria
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
- Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
- Known hypoglycemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
- Recurrent severe hypoglycemic episodes within the last year as judged by the investigator.
