Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dasiglucagon · 2 trials · 3 indications
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
Measured in minutes.
| Arm | Type | Description |
|---|---|---|
| Dasiglucagon 0.6 mg | EXPERIMENTAL | Participants will receive a single dose of 0.6 mg dasiglucagon. |
| Dasiglucagon 0.3 mg | EXPERIMENTAL | Participants will receive a single dose of 0.3 mg dasiglucagon. |
| Adult Cohort: Dasiglucagon then Glucagon | EXPERIMENTAL | 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. |
| Adult Cohort: Glucagon then Dasiglucagon | EXPERIMENTAL | 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. |
| Adolescent Cohort: Dasiglucagon | EXPERIMENTAL | Participants will receive a single s.c. injection of dasiglucagon. |
| Name | Type | Description |
|---|---|---|
| Dasiglucagon | DRUG | Dasiglucagon, 0.6 mg/0.6 mL or 0.3 mg/0.3 mL will be administered as an under the skin (subcutaneous, s.c.) injection by a prefilled syringe, into the buttocks. |
| Glucagon | DRUG | Participants will receive i.m. injection of glucagon. |
Inclusion Criteria: * Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump or MDI * Body weight greater than 8 kg * Child must be \<6 years of age at the time of screening * Further inclusion criteria apply Exclusion Criteri...
Dasiglucagon is being developed as a rescue therapy for severe hypoglycemia, which is very low blood sugar, in people with type 1 diabetes. It is studied in adults, adolescents, and children, including children under 6 years old. It is an investigational treatment and is not yet approved.
Dasiglucagon targets the glucagon receptor, also known as GCGR. It acts as a GCGR agonist, meaning it activates this receptor. Glucagon receptor activation stimulates the liver to release glucose into the bloodstream, which is the basis for its use as a hypoglycemia rescue therapy in type 1 diabetes.
Dasiglucagon is being developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical studies evaluating dasiglucagon in type 1 diabetes and hypoglycemia.
Dasiglucagon is in clinical development. A Phase 1 study has been completed, and a Phase 3 study in children under 6 years with type 1 diabetes has also been completed. It is an investigational drug and has not been approved by the FDA.
Dasiglucagon has been studied in two completed trials. NCT06588504 was a Phase 1 study in Japan comparing dasiglucagon with glucagon in Asian adults with type 1 diabetes and testing it in Japanese adolescents. NCT05378672 was a Phase 3 study of dasiglucagon as hypoglycemia rescue therapy in children under 6 years with type 1 diabetes in the United States.