Hakata Clinic
Fukuoka, 812-0025, Japan
NCT Number: NCT06588504
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.
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Notify Me12 year–75 year
All sexes
Interventional
Phase 1
Fukuoka, 812-0025, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Adults: Age 18-75 years (both inclusive):
For Adolescents: Age 12-15 years (both inclusive).
For adolescents: Body weight greater than or equal to (≥) 33.4 kilograms (kg).
Exclusion criteria
As declared by the participant or in the medical records.
Participants will receive s.c. injection of dasiglucagon.
Participants will receive i.m. injection of glucagon.
Time frame: From 0 to 90 minutes after investigational medicinal product (IMP) injection
Measured in minutes.
Time frame: From 0 to 90 minutes after IMP injection
Measured in minutes.
Time frame: From 0 to 30 minutes after IMP injection
Measured in count of participant.
Time frame: From 0 to 20 minutes after IMP injection
Measured in count of participant.
Time frame: From 0 to 15 minutes after IMP injection
Measured in count of participant.
Time frame: From 0 to 15 minutes after IMP injection
Measured in milligrams per deciliter (mg/dL).
Time frame: From 0 to 20 minutes after IMP injection
Measured in mg/dL.
Time frame: On Day 1 after injection
Measured in hour*picomoles per liter (h*pmol/L).
Time frame: From 0 to 5 hours after IMP injection
Measured in pmol/L.
Time frame: From IMP injection (visit 2 day 1 and visit 3 day 1) until 28 days after IMP injection
Measured in number of events.
Time frame: From IMP injection (visit 2 day 1 and visit 3 day 1) until 12 hours after IMP injection
Measured in number of episodes.
Novo Nordisk A/S
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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