A Phase 1 interventional study of Dasiglucagon and Glucagon in Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 38 is close to the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 a single subcutaneous (s.c.) injection of dasiglucagon in first dosing visit then a single intra-mascular (i.m.) injection of glucagon in next dosing visit.
Drug: Dasiglucagon
Participants will receive a single i.m. injection of glucagon in first dosing visit then a single s.c. injection of dasiglucagon in next dosing visit.
Drug: Dasiglucagon · Drug: Glucagon
Participants will receive a single s.c. injection of dasiglucagon.
Drug: Dasiglucagon
Participants will receive s.c. injection of dasiglucagon.
Participants will receive i.m. injection of glucagon.
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
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S