COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-05-09
Study Completion:2024-12-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05378672

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump or MDI
  2. * Body weight greater than 8 kg
  3. * Child must be \<6 years of age at the time of screening
  4. * Further inclusion criteria apply
  1. * Known or suspected allergy to the IMP or related products
  2. * 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
  3. * History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
  4. * History of hypoglycemic events associated with seizures
  5. * Further exclusion criteria apply

Contacts and Locations

Principal Investigator

Clinical Operations
STUDY_DIRECTOR
Zealand Pharma A/S

Study Locations (Sites)

Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
United States
Cook Childrens Health Care System
Fort Worth, Texas, 76104
United States

Collaborators and Investigators

Sponsor: Zealand Pharma

  • Clinical Operations, STUDY_DIRECTOR, Zealand Pharma A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-09
Study Completion Date2024-12-03

Study Record Updates

Study Start Date2023-05-09
Study Completion Date2024-12-03

Terms related to this study

Keywords Provided by Researchers

  • Hypoglycemia
  • Low Blood Sugar
  • Type 1 Diabetes
  • Diabetes
  • T1D

Additional Relevant MeSH Terms

  • Hypoglycemia
  • Type 1 Diabetes