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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT06588504
Eligibility Criteria:
Inclusion Criteria:
* For Adults: Asian male or female; For Adolescents: Japanese male or female.
* Age at the time of signing the informed consent:
For Adults: Age 18-75 years (both inclusive):
For Adolescents: Age 12-15 years (both inclusive).
* Diagnosed with T1D greater than (\>)1 year before screening.
* Glycated haemoglobin (HbA1c) less than (\<)10.0 percentage (%) (86 millimoles per mole \[mmol/mol\]) as assessed by subcontracted laboratory by the site on the day of screening.
* For adults: BMI between 18.5 and 29.9 kilogram per meter square (kg/m2) (both inclusive).
For adolescents: Body weight greater than or equal to (≥) 33.4 kilograms (kg).
* Treated with stable insulin treatment (based on the investigator's discretion preferably no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening.
* For Japanese participants: Japanese passport or equivalent For non-Japanese participants: Asian (non- Japanese passport or equivalent).
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products (glucagon or its derivatives).
* Exposure to an investigational medicinal product (IMP) within 30 days or 5 times the half-life of the IMP (if known), whichever is longest before screening.
* Severe hypoglycaemia in the last month prior to screening.
* Hospitalisation for diabetic ketoacidosis (DKA) in the last month prior to screening.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus).
* History of epilepsy or seizure disorder.
* Known presence or history of pheochromocytoma (i.e., adrenal gland tumour) or insulinoma (i.e., insulin-secreting pancreas tumour).
* Clinically significant abnormal electrocardiogram (ECG) at screening as evaluated by investigator.
* Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
As declared by the participant or in the medical records.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
75 Years
Study:
NCT06588504
Study Brief:
Protocol Section:
NCT06588504