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

NCTNCT06588504Other idNN9515-7675Other idU1111-1300-1855Other idjRCT2071240050

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 38 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
Japan
Start: 10 Sept 2024
Primary completion: 20 Jul 2025
Completion: 20 Jul 2025
First posted: 19 Sept 2024
Last update posted: 5 Dec 2025
Conditions: Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 1
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
NCT06588504
10 Sept 2024 to 20 Jul 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

DasiglucagonDrug
GlucagonDrug

Arms3

Experimental
Adult Cohort: Dasiglucagon then Glucagon
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.
Experimental
Adult Cohort: Glucagon then 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.
Experimental
Adolescent Cohort: Dasiglucagon
Participants will receive a single s.c. injection of dasiglucagon.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Time frame · From 0 to 90 minutes after investigational medicinal product (IMP) injection
Registry description
Measured in minutes.

Secondary outcomes(10)

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
Time frame · From 0 to 90 minutes after IMP injection
Registry description
Measured in minutes.
PG recovery within 30 minutes after IMP injection (yes/no)
Time frame · From 0 to 30 minutes after IMP injection
Registry description
Measured in count of participant.
PG recovery within 20 minutes after IMP injection (yes/no)
Time frame · From 0 to 20 minutes after IMP injection
Registry description
Measured in count of participant.
PG recovery within 15 minutes after IMP injection (yes/no)
Time frame · From 0 to 15 minutes after IMP injection
Registry description
Measured in count of participant.
PG change from baseline at 15 minutes after IMP injection
Time frame · From 0 to 15 minutes after IMP injection
Registry description
Measured in milligrams per deciliter (mg/dL).
PG change from baseline at 20 minutes after IMP injection
Time frame · From 0 to 20 minutes after IMP injection
Registry description
Measured in mg/dL.
Area under the plasma dasiglucagon concentration time curve after IMP injection
Time frame · On Day 1 after injection
Registry description
Measured in hour\*picomoles per liter (h\*pmol/L).
Maximum observed plasma (Cmax) dasiglucagon concentration
Time frame · From 0 to 5 hours after IMP injection
Registry description
Measured in pmol/L.
Number of adverse events (AEs)
Time frame · From IMP injection (visit 2 day 1 and visit 3 day 1) until 28 days after IMP injection
Registry description
Measured in number of events.
Number of hypoglycaemic episodes
Time frame · From IMP injection (visit 2 day 1 and visit 3 day 1) until 12 hours after IMP injection
Registry description
Measured in number of episodes.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * For Adults: Asian male or female; For Adolescents: Japanese male or female. * Age at the time of signing the informed consent: For Adults: Age 18-75 years (both inclusive): For Adolescents: Age 12-15 years (both inclusive). * Diagnosed with T1D greater than (\>)1 year before screening. * Glycated haemoglobin (HbA1c) less than (\<)10.0 percentage (%) (86 millimoles per mole \[mmol/mol\]) as assessed by subcontracted laboratory by the site on the day of screening. * For adults: BMI between 18.5 and 29.9 kilogram per meter square (kg/m2) (both inclusive). For adolescents: Body weight greater than or equal to (≥) 33.4 kilograms (kg). * Treated with stable insulin treatment (based on the investigator's discretion preferably no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening. * For Japanese participants: Japanese passport or equivalent For non-Japanese participants: Asian (non- Japanese passport or equivalent). Exclusion 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 electrocardiogram (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. As declared by the participant or in the medical records.

PepBank is a research reference. Talk to a doctor before you use any peptide.