drugset / Trial / NCT05378672
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-05-09
- Primary completion
- 2024-10-29
- Completion
- 2024-12-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dasiglucagon | Peptide | 0.3 mg | Subcutaneous |
| Subject | Dasiglucagon | Peptide | 0.6 mg | Subcutaneous |