At a glance
ClinicalIndex Comparison Record- ✓Confirmed type 1 diabetes based on medical history and receiving daily insulin therapy (pump or MDI)
- ✓Body weight greater than 8 kg
- ✓Child must be less than 6 years of age at screening
- ✕Known or suspected allergy to dasiglucagon or related products
- ✕Any condition that may result in diminished hepatic glycogen stores, such as prolonged fasting (>24 hours) at Visit 2
- ✕History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
- ✕History of hypoglycemic events associated with seizures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes (T1D)
In Brief
A Phase 3 clinical trial evaluating Dasiglucagon for Hypoglycemia and Type 1 Diabetes. Completed, enrolled 8 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Dasiglucagon, 0.6 mg/0.6 mL or 0.3 mg/0.3 mL will be administered as an under the skin (subcutaneous, s.c.) injection by a prefilled syringe, into the buttocks.