Status:
COMPLETED
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
Lead Sponsor:
Zealand Pharma
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Hypoglycemia
Type 1 Diabetes
Eligibility:
All Genders
Up to 5 years
Phase:
PHASE3
Brief 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 w...
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 hypog...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05378672
Start Date
May 9 2023
End Date
December 3 2024
Last Update
July 20 2025
Active Locations (2)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
2
Cook Childrens Health Care System
Fort Worth, Texas, United States, 76104