Phase 3
N=8
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
Hypoglycemia · Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05378672 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection — 102.3; 104.3 milligrams per deciliter (mg/dL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dasiglucagon (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Zealand Pharma
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection |
102.3; 104.3 | — |
| SECONDARY Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection |
57.3; 53.3 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
3; 4 | — |
| SECONDARY Number of Participants Who Received Rescue Intravenous (IV) Glucose Infusion Administration |
0; 0 | — |
| SECONDARY Time to First IV Glucose Infusion Following Treatment With Dasiglucagon |
— | — |
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).
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05378672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.