Clinical Trials

Inclsuion Criteria:

• Diagnosed with type 1 diabetes mellitus ≥ 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% (53.0–85.8 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, as defined in Appendix 4 (Section 10.4).
• 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 jeopardise 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 hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question.
• Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.  

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/15/2025. Questions regarding updates should be directed to the study team contact.