NCT05378672CompletedPhase 3
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
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)
Source: ClinicalTrials.gov · Last updated 20 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 12 May 2022
- Start date
- May 2023
- Primary completion date
- Oct 2024
- Lead sponsor
- Zealand Pharma
- Diseases
- Type 1 diabetes
- NCT number
- NCT05378672
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 8
- From May 2023 to the primary completion date, Oct 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Further exclusion criteria apply
Who the study is looking for
- 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
Age in the registry: - to 5 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Cook Childrens Health Care System Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.