A Research Study to Investigate the Safety and Effect of Dasiglucagon as a Hypoglycemia Rescue Therapy and How it Works in the Body of Children Under 6 Years of Age With Type 1 Diabetes

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma

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:

• 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