A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
Public ClinicalTrials.gov record NCT05378672. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05378672
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 8 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 5 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 8, 2023
- Primary completion
- Oct 28, 2024
- Completion
- Dec 2, 2024
- Last update posted
- Jul 19, 2025
2023 – 2024
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | — |
| Cook Childrens Health Care System | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05378672, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 19, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05378672 live on ClinicalTrials.gov.