A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D

Launched by ZEALAND PHARMA · May 12, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called dasiglucagon to see if it is safe and effective for treating low blood sugar (hypoglycemia) in young children under 6 years old who have Type 1 Diabetes (T1D). The study will involve giving participants a single injection of dasiglucagon into their buttocks and monitoring how well it works in their bodies over a period of about 84 days.

To participate, children must be diagnosed with T1D, weigh more than 8 kg, and be receiving insulin therapy, either through a pump or multiple daily injections. The study is open to all children under 6 years old, but there are some health conditions that would exclude them from participating, such as severe allergies or a history of certain serious reactions to low blood sugar. Families can expect to attend three visits with the study team during the trial, where they will receive support and guidance throughout the process.

Gender

ALL

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