A Study to Inv. Safety,Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children<6 Years With T1D
About the study
This research study will investigate whether dasiglucagon as a rescue therapy for participants between 1 and 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.).
Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump
- Body weight greater than 8 kg
Further inclusion criteria apply
EXCLUSION CRITERIA
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 (eg prolonged fasting (more than 24 hours) at Visit 2
- History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
- History of hypoglycemia unawareness
- History of hypoglycemic events associated with seizures
Further exclusion criteria apply
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hypoglycemia
Age (in years)
1 - 5
Phase
Phase 3
Participants needed
8
Est. Completion Date
Sep 25, 2024
Treatment type
Interventional
Sponsor
Zealand Pharma
ClinicalTrials.gov identifier
NCT05378672
Study number
ZP4207-21052
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