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 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN9515-7675U1111-1300-1855jRCT2071240050
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 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

  From 0 to 90 minutes after IMP injection

• PG recovery within 30 minutes after IMP injection (yes/no)

  From 0 to 30 minutes after IMP injection

• PG recovery within 20 minutes after IMP injection (yes/no)

  From 0 to 20 minutes after IMP injection

• PG recovery within 15 minutes after IMP injection (yes/no)

  From 0 to 15 minutes after IMP injection

• PG change from baseline at 15 minutes after IMP injection

  From 0 to 15 minutes after IMP injection

Study Arms (3)

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.

Drug: Dasiglucagon

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.

Drug: Dasiglucagon; Drug: Glucagon

Adolescent Cohort: Dasiglucagon

EXPERIMENTAL

Participants will receive a single s.c. injection of dasiglucagon.

Drug: Dasiglucagon

Interventions

Dasiglucagon DRUG

Participants will receive s.c. injection of dasiglucagon.

Adolescent Cohort: Dasiglucagon; Adult Cohort: Dasiglucagon then Glucagon; Adult Cohort: Glucagon then Dasiglucagon

Glucagon DRUG

Participants will receive i.m. injection of glucagon.

Adult Cohort: Glucagon then Dasiglucagon

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Hakata Clinic

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

dasiglucagon; Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)