CompletedPhase 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

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

Lead sponsor

Novo Nordisk A/S

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

•BMI 18.5-29.9

Primary endpoint

•Adults cohort

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06588504

Org study IDNN9515-7675

Secondary IDjRCT2071240050Japan Registry for Clinical Trials (jRCT)

Secondary IDU1111-1300-1855World Health Organization (WHO)

Timeline

Milestones

Study start2024-09-10actual

Study first posted2024-09-19actual

Primary completion2025-07-20actual

Study completion2025-07-20actual

Last update posted2025-12-05actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age12 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

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

threshold achievement, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Maximum observed plasma (Cmax) dasiglucagon concentration

Time frame:From 0 to 5 hours after IMP injection

concentration, descriptive

Secondary/protocol endpoint

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

event count, event

Secondary/protocol endpoint

Number of hypoglycaemic episodes

Time frame:From IMP injection (visit 2 day 1 and visit 3 day 1) until 12 hours after IMP injection

event count, event