Research study in Japan to compare dasiglucagon with glucagon in treating very low levels of blood sugar in Asian adults with type 1 diabetes and testing of dasiglucagon for the same condition in Japanese adolescents

JRCT ID: jRCT2071240050

Registered date:20/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: severe hypoglycaemia
• Date of first enrollment: 10/09/2024
• Target sample size: 38
• Study type: Interventional

Intervention(s)

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 the eligibility of the participants,
-two dosing visits (visits 2 and 3); 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 visits:
-an information visit (visit 0) to obtain the informed consent,
-a screening visit (visit 1) to determine the eligibility of the participants,
-a dosing visit (visit 2), and
-a follow-up visit (end of study, visit 3a).

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Morii Issei