Comparing dasiglucagon and glucagon for treating low blood sugar in Asian adults and Japanese adolescents with Type 1 diabetes

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 tests whether dasiglucagon works better than glucagon for treating low blood sugar in Asian adults and Japanese teens with Type 1 diabetes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Fukuoka)
• Trial ID: NCT06588504 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of dasiglucagon compared to glucagon in treating very low blood sugar levels in Asian adults with Type 1 diabetes, as well as to assess dasiglucagon's effects in Japanese adolescents with the same condition. Participants will receive both dasiglucagon and glucagon in a randomized order to determine which treatment is more effective. The study will last approximately 17 weeks and includes specific eligibility criteria related to age, diabetes duration, and health status. The goal is to demonstrate that dasiglucagon can effectively raise low blood sugar levels similarly to glucagon.

Who should consider this trial

Good fit: Ideal candidates include Asian adults aged 18-75 and Japanese adolescents aged 12-15 diagnosed with Type 1 diabetes for more than one year.

Not a fit: Patients who are pregnant, breastfeeding, or have health risks as determined by the study doctor will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for managing severe hypoglycemia in individuals with Type 1 diabetes.

How similar studies have performed: While dasiglucagon is a newer medication, similar studies have shown promising results with glucagon, indicating potential for success with dasiglucagon.

Eligibility criteria

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.

Where this trial is running

Fukuoka

• Hakata Clinic — Fukuoka, Japan (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Diabetes Mellitus, Type 1