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:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT05262595
Eligibility Criteria:
Inclusion Criteria:
* Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with T1DM for more than1 year prior to the day of screening.
* Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
* Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.
Exclusion Criteria:
* Known or suspected hypersensitivity to study interventions or related products.
* Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
24 Years
Study:
NCT05262595
Study Brief:
Protocol Section:
NCT05262595