Clinical trial NCT06588504: 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
Official title: A Phase 3, Randomised, Open-label, Cross-over Study to Confirm the Clinical Efficacy and Safety of Dasiglucagon Versus Glucagon for the Treatment of Severe Hypoglycaemia in Asian Adults With Type 1 Diabetes (T1D) Including an Investigation of Dasiglucagon in a Japanese Adolescent Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 adolescents with T1D. This study wants to demonstrate that dasiglucagon can raise low blood sugar levels just as well as glucagon. Participants will get dasiglucagon and glucagon. In which treatment order participants get study medicines (dasiglucagon and glucagon) is decided by chance. Dasiglucagon is a new medicine, but doctors can prescribe it in the US as it is approved there. Doctors can prescribe glucagon in multiple countries including Japan as an approved medicine. The study will last for about 17 weeks. Participant cannot be in the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding, plan to get pregnant, during the study period, or not using adequate contraceptive methods. For man: if participant have sex, participant and his partner must use an adequate birth control method during the study.


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.

Primary outcomes:
measure: Adults cohort: Time to plasma glucose (PG) recovery, where PG recovery is defined as the first increase in PG of greater than or equal to (>=) 20 milligrams per decilitre (mg/dL) (1.1 millimoles per litre [mmol/L]) from baseline
timeFrame: From 0 to 90 minutes after investigational medicinal product (IMP) injection
Secondary outcomes:
measure: Adolescent cohort: Time to PG recovery, where PG recovery is defined as the first increase in PG of ≥20 mg/dL (1.1 mmol/L) from baseline
timeFrame: From 0 to 90 minutes after IMP injection
measure: PG recovery within 30 minutes after IMP injection (yes/no)
timeFrame: From 0 to 30 minutes after IMP injection
measure: PG recovery within 20 minutes after IMP injection (yes/no)
timeFrame: From 0 to 20 minutes after IMP injection
measure: PG recovery within 15 minutes after IMP injection (yes/no)
timeFrame: From 0 to 15 minutes after IMP injection
measure: PG change from baseline at 15 minutes after IMP injection
timeFrame: From 0 to 15 minutes after IMP injection
measure: PG change from baseline at 20 minutes after IMP injection
timeFrame: From 0 to 20 minutes after IMP injection
measure: Area under the plasma dasiglucagon concentration time curve after IMP injection
timeFrame: On Day 1 after injection
measure: Maximum observed plasma (Cmax) dasiglucagon concentration
timeFrame: From 0 to 5 hours after IMP injection
measure: Number of adverse events (AEs)
timeFrame: From IMP injection (visit 2 day 1 and visit 3 day 1) until 28 days after IMP injection
measure: Number of hypoglycaemic episodes
timeFrame: From IMP injection (visit 2 day 1 and visit 3 day 1) until 12 hours after IMP injection
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Hakata Clinic
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: