CompletedPhase 3

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

United States8 participantsStarted 2023-05-09

Plain-language summary

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 participate

Age range5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection

Timeframe: Baseline, 30 minutes after dosing on Day 1

Trial details

NCT IDNCT05378672

SponsorZealand Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-29

Results submitted2025-07-01

View on ClinicalTrials.gov More Hypoglycemia trials