NCT05378672

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 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.

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 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

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