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

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.

Conditions

Hypoglycemia, Type 1 Diabetes

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Hypoglycemia
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06511

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30329

Indianapolis

Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202

Fort Worth

Cook Childrens Health Care System, Fort Worth, Texas, United States, 76104

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

to 5 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zealand Pharma,

Clinical Operations, STUDY_DIRECTOR, Zealand Pharma A/S

Study Record Dates

2024-09-25