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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Participants will receive s.c. injection of dasiglucagon.
Participants will receive i.m. injection of glucagon.
Hakata Clinic
Fukuoka, Japan
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
Measured in minutes.
Time frame: From 0 to 90 minutes after investigational medicinal product (IMP) injection
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
Measured in minutes.
Time frame: From 0 to 90 minutes after IMP injection
PG recovery within 30 minutes after IMP injection (yes/no)
Measured in count of participant.
Time frame: From 0 to 30 minutes after IMP injection
PG recovery within 20 minutes after IMP injection (yes/no)
Measured in count of participant.
Time frame: From 0 to 20 minutes after IMP injection
PG recovery within 15 minutes after IMP injection (yes/no)
Measured in count of participant.
Time frame: From 0 to 15 minutes after IMP injection
PG change from baseline at 15 minutes after IMP injection
Measured in milligrams per deciliter (mg/dL).
Time frame: From 0 to 15 minutes after IMP injection
PG change from baseline at 20 minutes after IMP injection
Measured in mg/dL.
Time frame: From 0 to 20 minutes after IMP injection
Area under the plasma dasiglucagon concentration time curve after IMP injection
Measured in hour\*picomoles per liter (h\*pmol/L).
Time frame: On Day 1 after injection
Maximum observed plasma (Cmax) dasiglucagon concentration
Measured in pmol/L.
Time frame: From 0 to 5 hours after IMP injection
Number of adverse events (AEs)
Measured in number of events.
Time frame: From IMP injection (visit 2 day 1 and visit 3 day 1) until 28 days after IMP injection
Number of hypoglycaemic episodes
Measured in number of episodes.
Time frame: From IMP injection (visit 2 day 1 and visit 3 day 1) until 12 hours after IMP injection
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