severe hypoglycaemia
Conditions
Interventions
The study duration for adult participants is approximately 17 weeks and consists of 5 visits:
-an information visit (visit 0) to obtain the informed consent,
-a screening visit (visit 1) to determine
randomisation on the first dosing visit (visit 2 day 1), and
-a follow-up visit (end of study, visit 3a)
The study duration for adolescent participants is approximately 11 weeks and consists of 4 vis
Sponsors
Morii Issei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Known or suspected hypersensitivity to study intervention(s) or related products (glucagon or its derivatives). -Exposure to an investigational medicinal product (IMP) within 30 days or 5 times the half-life of the IMP (if known), whichever is longest before screening. -Severe hypoglycaemia in the last month prior to screening. -Hospitalisation for diabetic ketoacidosis (DKA) in the last month prior to screening. -Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus). -History of epilepsy or seizure disorder. -Known presence or history of pheochromocytoma (i.e., adrenal gland tumour) or insulinoma (i.e., insulin-secreting pancreas tumour). -Clinically significant abnormal ECG at screening as evaluated by investigator. -Any disorder, unwillingness or inability which in the investigators opinion, might jeopardise the participants safety or compliance with the protocol.
Exclusion criteria
Exclusion criteria: -Severe hypoglycaemia in the last month prior to screening. -Hospitalisation for diabetic ketoacidosis (DKA) in the last month prior to screening. -Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus). -History of epilepsy or seizure disorder. -Known presence or history of pheochromocytoma (i.e., adrenal gland tumour) or insulinoma (i.e., insulin-secreting pancreas tumour). -Clinically significant abnormal ECG at screening as evaluated by investigator. -Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To confirm the effect on glycaemicresponse of a single 0.6 mg s.c. injection of dasiglucagon for the treatment of insulin-induced hypoglycaemia in Asian adults with T1D. This includes comparing the difference in time to plasma glucose (PG) recovery between dasiglucagon s.c. and glucagon i.m. to a noninferiority margin of 3 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the clinical efficacy of dasiglucagon assessed by the glycaemic response of a single 0.6 mg s.c. injection of dasiglucagon for the treatment of insulin-induced hypoglycaemia in Asian participants with T1D. To investigate the pharmacokinetic properties of a single 0.6 mg s.c. injection of dasiglucagon for the treatment of insulin-induced hypoglycaemia in Asian participants with T1D. To investigate the safety of a single 0.6 mg s.c. injection of dasiglucagon for the treatment of insulin-induced hypoglycaemia in Asian participants with T1D. | — |
Contacts
Public ContactRegistrar Clinical trail information
Novo Nordisk Pharma Ltd.
Outcome results
None listed