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

Completed · Phase 3

Conditions studied: Hypoglycemia, Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT05378672

Run by

Zealand Pharma

People needed

8

Starts

2023-05-09

Expected to finish

2024-12-03

Last updated by the study team

2025-07-20

Who can join

Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Cook Childrens Health Care System — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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