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Diabetes Mellitus, Type 1Phase 1NCT06588504

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 1 study testing Dasiglucagon and Glucagon in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Dasiglucagon and Glucagon
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteJapan
Study dates
10 Sep 2024to 20 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Hakata Clinic

    Fukuoka, 812-0025

Other trials in Japan

About this study

Official title: 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.

Being tested
Dasiglucagon, Glucagon
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasiglucagonDrug

    Participants will receive s.c. injection of dasiglucagon.

  • GlucagonDrug

    Participants will receive i.m. injection of glucagon.

Study groups in NCT06588504
Study groupRoleWhat they receive
Adult Cohort: Dasiglucagon then GlucagonExperimentalParticipants 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.
Receives: Drug: Dasiglucagon
Adult Cohort: Glucagon then DasiglucagonExperimentalParticipants 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.
Receives: Drug: Dasiglucagon; Drug: Glucagon
Adolescent Cohort: DasiglucagonExperimentalParticipants will receive a single s.c. injection of dasiglucagon.
Receives: Drug: Dasiglucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From 0 to 90 minutes after investigational medicinal product (IMP) injection

Secondary outcomes (10)

  1. 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.

    Measured: From 0 to 90 minutes after IMP injection

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

    Measured in count of participant.

    Measured: From 0 to 30 minutes after IMP injection

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

    Measured in count of participant.

    Measured: From 0 to 20 minutes after IMP injection

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

    Measured in count of participant.

    Measured: From 0 to 15 minutes after IMP injection

  5. PG change from baseline at 15 minutes after IMP injection

    Measured in milligrams per deciliter (mg/dL).

    Measured: From 0 to 15 minutes after IMP injection

  6. PG change from baseline at 20 minutes after IMP injection

    Measured in mg/dL.

    Measured: From 0 to 20 minutes after IMP injection

  7. Area under the plasma dasiglucagon concentration time curve after IMP injection

    Measured in hour*picomoles per liter (h*pmol/L).

    Measured: On Day 1 after injection

  8. Maximum observed plasma (Cmax) dasiglucagon concentration

    Measured in pmol/L.

    Measured: From 0 to 5 hours after IMP injection

  9. Number of adverse events (AEs)

    Measured in number of events.

    Measured: From IMP injection (visit 2 day 1 and visit 3 day 1) until 28 days after IMP injection

  10. Number of hypoglycaemic episodes

    Measured in number of episodes.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start10 Sep 2024
  3. Primary completion20 Jul 2025
  4. Study completion20 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588504
Sponsor's protocol ID
NN9515-7675
Other IDs
U1111-1300-1855, jRCT2071240050
Status last verified
Nov 2025
First submitted
6 Sep 2024
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dasiglucagon and Glucagon in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06588504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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