Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07305805
Eligibility Criteria:
Inclusion Criteria:
* Male or female participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 month without an alternative medical cause) prior to the day of screening.
* Age 18-64 years (both inclusive) at the time of signing informed consent.
* Body mass index between 18.5-29.9 Kilogram Per Square Meter (kg/m\^2) (both inclusive) at the day of screening.
* Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year prior to the day of screening.
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion ≥ 90 days prior to the day of screening.
* Glycated haemoglobin (HbA1c) less than or equal to (≤ ) 9.0 percentage (%) at the day of screening.
Exclusion Criteria:
* Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
* Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT07305805
Study Brief:
Protocol Section:
NCT07305805