HypoglycemiaPhase 3NCT05378672
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
A Phase 3 study testing Dasiglucagon in people with Hypoglycemia and Type 1 Diabetes, run by Zealand Pharma at 2 sites in United States.
Trial summary
This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics). Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Hypoglycemia, Type 1 Diabetes
- What is being tested?
- Dasiglucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 May 2023to 3 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump or MDI
- Body weight greater than 8 kg
- Child must be <6 years of age at the time of screening
- Further inclusion criteria apply
Who cannot join
- Known or suspected allergy to the IMP or related products
- Any condition that in the investigators opinion may result in diminished hepatic glycogen stores (e.g., prolonged fasting (more than 24 hours) at Visit 2
- History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
- History of hypoglycemic events associated with seizures
- Further exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Cook Childrens Health Care System
Fort Worth, Texas, 76104
About this study
Official title: Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes (T1D)
This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.) into the buttocks.
Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.
Read the detailed description
This trial will use a single-administration, open-label trial design to assess the ability of a single SC injection of dasiglucagon to increase plasma glucose in pediatric children with T1D with hypoglycemia. A total of 8 children will be included; 4 children receiving a dose of 0.3 mg and 4 children receiving a dose of 0.6 mg. Of the 4 children receiving 0.3 mg, 2 children should preferably be below 2 years at screening. The 2 additional children receiving 0.3 mg should weigh below 15 kg at screening and should preferably be below 4 years at screening. For children receiving the 0.6 mg dose, all must be above 2 years at screening. Before an eligible child is dosed, the dose level (0.6 mg or 0.3 mg) must be confirmed by the sponsor. Each child will be dosed after the safety assessment of the preceding child has been completed and assessed by the Trial Safety Group.
The trial will include the following visits:
- A screening visit (Visit 1) in the period from Day - 50 to Day - 29 (pre-treatment visit)
- A dosing visit (Visit 2), Day 1 (day of single dosing with investigational medicinal product [IMP])
- A Safety follow-up visit (Visit 3) at Day 29 +5 days (the end-of-trial visit).
The primary endpoint of the trial is plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous glucose. Pharmacodynamics (PD) i.e., plasma glucose will be assessed at baseline and 15 and 30 minutes after dosing, while the glucose levels will be monitored by continuous glucose monitoring and by a plasma glucose analyzer during the dosing visit (Visit 2). Pharmacokinetics (PK) will be assessed throughout a 300-minute period at the dosing visit (Visit 2). Safety will be assessed prior to dosing and throughout a 300-minute period after dosing and again at the follow-up visit.
- Conditions
- Hypoglycemia, Type 1 Diabetes
- Being tested
- Dasiglucagon
- Keywords
- Hypoglycemia, Low Blood Sugar, Type 1 Diabetes, Diabetes, T1D
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasiglucagonDrug
Also called Zegalogue, ZP4207
Dasiglucagon, 0.6 mg/0.6 mL or 0.3 mg/0.3 mL will be administered as an under the skin (subcutaneous, s.c.) injection by a prefilled syringe, into the buttocks.
| Study group | Role | What they receive |
|---|---|---|
| Dasiglucagon 0.6 mg | Experimental | Participants will receive a single dose of 0.6 mg dasiglucagon. Receives: Drug: Dasiglucagon |
| Dasiglucagon 0.3 mg | Experimental | Participants will receive a single dose of 0.3 mg dasiglucagon. Receives: Drug: Dasiglucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
Measured: Baseline, 30 minutes after dosing on Day 1
Secondary outcomes (4)
Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
Measured: Baseline, 15 minutes after dosing on Day 1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-emergence was defined as those adverse events (AEs) that occurred after dosing and those existing AEs that worsened during the study. An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the trial intervention.
Measured: From first dose of study drug up to end of follow up (up to Day 29)
Number of Participants Who Received Rescue Intravenous (IV) Glucose Infusion Administration
Measured: Within 30 minutes of infusion on Day 1
Time to First IV Glucose Infusion Following Treatment With Dasiglucagon
Time to first IV glucose infusion (minutes) was defined as Time of start of first glucose administration - Time of administration of study medication.
Measured: Start of first glucose administration up to 30 minutes post-infusion on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start9 May 2023
- Primary completion29 Oct 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, Study director, Zealand Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378672
- Sponsor's protocol ID
- ZP4207-21052
- Status last verified
- Jul 2025
- First submitted
- 12 May 2022
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes (T1D)
- ClinicalTrials.gov ID
- NCT05378672
- Acronym / sponsor ID
- ZP4207-21052
- Conditions
- Hypoglycemia, Type 1 Diabetes
- Keywords
- Hypoglycemia, Low Blood Sugar, Type 1 Diabetes, Diabetes, T1D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S
- Study start
- 9 May 2023 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Posted 20 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.) into the buttocks.
Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.
Detailed description
This trial will use a single-administration, open-label trial design to assess the ability of a single SC injection of dasiglucagon to increase plasma glucose in pediatric children with T1D with hypoglycemia. A total of 8 children will be included; 4 children receiving a dose of 0.3 mg and 4 children receiving a dose of 0.6 mg. Of the 4 children receiving 0.3 mg, 2 children should preferably be below 2 years at screening. The 2 additional children receiving 0.3 mg should weigh below 15 kg at screening and should preferably be below 4 years at screening. For children receiving the 0.6 mg dose, all must be above 2 years at screening. Before an eligible child is dosed, the dose level (0.6 mg or 0.3 mg) must be confirmed by the sponsor. Each child will be dosed after the safety assessment of the preceding child has been completed and assessed by the Trial Safety Group.
The trial will include the following visits:
- A screening visit (Visit 1) in the period from Day - 50 to Day - 29 (pre-treatment visit)
- A dosing visit (Visit 2), Day 1 (day of single dosing with investigational medicinal product [IMP])
- A Safety follow-up visit (Visit 3) at Day 29 +5 days (the end-of-trial visit).
The primary endpoint of the trial is plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous glucose. Pharmacodynamics (PD) i.e., plasma glucose will be assessed at baseline and 15 and 30 minutes after dosing, while the glucose levels will be monitored by continuous glucose monitoring and by a plasma glucose analyzer during the dosing visit (Visit 2). Pharmacokinetics (PK) will be assessed throughout a 300-minute period at the dosing visit (Visit 2). Safety will be assessed prior to dosing and throughout a 300-minute period after dosing and again at the follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasiglucagon 0.6 mg | Experimental | Drug: DasiglucagonParticipants will receive a single dose of 0.6 mg dasiglucagon. |
| Dasiglucagon 0.3 mg | Experimental | Drug: DasiglucagonParticipants will receive a single dose of 0.3 mg dasiglucagon. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump or MDI
- Body weight greater than 8 kg
- Child must be <6 years of age at the time of screening
- Further inclusion criteria apply
Key exclusion criteria (5 listed)
- Known or suspected allergy to the IMP or related products
- Any condition that in the investigators opinion may result in diminished hepatic glycogen stores (e.g., prolonged fasting (more than 24 hours) at Visit 2
- History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
- History of hypoglycemic events associated with seizures
- Further exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasiglucagonAlso: Zegalogue, ZP4207Dasiglucagon, 0.6 mg/0.6 mL or 0.3 mg/0.3 mL will be administered as an under the skin (subcutaneous, s.c.) injection by a prefilled syringe, into the buttocks. | Drug | Dasiglucagon 0.3 mg, Dasiglucagon 0.6 mg |
Primary outcome
Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection
Time frame: Baseline, 30 minutes after dosing on Day 1
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
4 secondary outcomes
Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection
Time frame: Baseline, 15 minutes after dosing on Day 1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to end of follow up (up to Day 29)
Number of Participants Who Received Rescue Intravenous (IV) Glucose Infusion Administration
Time frame: Within 30 minutes of infusion on Day 1
Time to First IV Glucose Infusion Following Treatment With Dasiglucagon
Time frame: Start of first glucose administration up to 30 minutes post-infusion on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Operations study director
Zealand Pharma A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dasiglucagon in people with Hypoglycemia and Type 1 Diabetes, run by Zealand Pharma at 2 sites in United States.
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 4 inclusion and 5 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection (time frame: Baseline, 30 minutes after dosing on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2025.