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

NCT05378672 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-07-20

Study results available
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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.

Conditions

Interventions

DRUG

Dasiglucagon

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Operations · Zealand Pharma A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2024-10-29
Completion
2024-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378672 on ClinicalTrials.gov