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

A Phase 3, Randomised, Open-label, Cross-over Study to Confirm the Clinical Efficacy and Safety of Dasiglucagon Versus Glucagon for the Treatment of Severe Hypoglycaemia in Asian Adults With Type 1 Diabetes (T1D) Including an Investigation of Dasiglucagon in a Japanese Adolescent Cohort

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Dasiglucagon; Drug: Glucagon

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Hakata Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Dasiglucagon; Participants will receive s.c. injection of dasiglucagon.
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.	Drug: Dasiglucagon; Participants will receive s.c. injection of dasiglucagon.; Drug: Glucagon; Participants will receive i.m. injection of glucagon.
Experimental: Adolescent Cohort: Dasiglucagon; Participants will receive a single s.c. injection of dasiglucagon.	Drug: Dasiglucagon; Participants will receive s.c. injection of dasiglucagon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PG recovery within 30 minutes after IMP injection (yes/no)	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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Actual): July 20, 2025
• Study Completion (Actual): July 20, 2025

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pancreatic Hormones; Proglucagon; Glucagon; dasiglucagon
• Other Study ID Numbers: NN9515-7675; U1111-1300-1855 (Other Identifier: World Health Organization (WHO)); jRCT2071240050 (Registry Identifier: Japan Registry for Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes