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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1300-1855 | Other Identifier | World Health Organization (WHO) | |
| jRCT2071240050 | Registry Identifier | Japan Registry for Clinical Trials (jRCT) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Adolescent Cohort: Dasiglucagon | Experimental | Participants will receive a single s.c. injection of dasiglucagon. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasiglucagon | Drug | Participants will receive s.c. injection of dasiglucagon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 0 to 90 minutes after investigational medicinal product (IMP) injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 0 to 90 minutes after IMP injection |
| PG recovery within 30 minutes after IMP injection (yes/no) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hakata Clinic | Fukuoka | 812-0025 | Japan |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Glucagon | Drug | Participants will receive i.m. injection of glucagon. |
|
Measured in count of participant. |
| From 0 to 30 minutes after IMP injection |
| PG recovery within 20 minutes after IMP injection (yes/no) | Measured in count of participant. | From 0 to 20 minutes after IMP injection |
| PG recovery within 15 minutes after IMP injection (yes/no) | Measured in count of participant. | 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). | From 0 to 15 minutes after IMP injection |
| PG change from baseline at 20 minutes after IMP injection | Measured in mg/dL. | 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). | On Day 1 after injection |
| Maximum observed plasma (Cmax) dasiglucagon concentration | Measured in pmol/L. | From 0 to 5 hours after IMP injection |
| Number of adverse events (AEs) | Measured in number of events. | 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. | From IMP injection (visit 2 day 1 and visit 3 day 1) until 12 hours after IMP injection |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000710373 | dasiglucagon |
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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