Status:
COMPLETED
Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
12-75 years
Phase:
PHASE1
Brief Summary
This study will be looking to confirm the effect of dasiglucagon when compared with glucagon for treating very low sugar levels in Asian adults with T1D and the effect of dasiglucagon in Japanese adol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06588504
Start Date
September 10 2024
End Date
July 20 2025
Last Update
December 5 2025
Active Locations (1)
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1
Hakata Clinic
Fukuoka, Japan, 812-0025