Investigating dasiglucagon for treating low blood sugar in young children with Type 1 Diabetes
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)
This study is testing if a new treatment called dasiglucagon can safely help young children with Type 1 Diabetes who have low blood sugar.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | N/A to 5 Years |
| Sex | All |
| Sponsor | Zealand Pharma Industry-sponsored |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Trial ID | NCT05378672 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of dasiglucagon as a rescue therapy for hypoglycemia in children under 6 years of age with Type 1 Diabetes. Participants will receive a single subcutaneous injection of dasiglucagon, and their plasma glucose levels will be monitored to assess the drug's effectiveness. The study will include three visits over a period of up to 84 days, with a focus on pharmacokinetics and pharmacodynamics. A total of 8 children will be enrolled, receiving either a low or high dose of the medication based on specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are children under 6 years of age diagnosed with Type 1 Diabetes who are receiving daily insulin therapy.
Not a fit: Patients with known allergies to dasiglucagon or those with severe systemic allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safe and effective option for managing hypoglycemia in young children with Type 1 Diabetes.
How similar studies have performed: Other studies have shown promise in using similar rescue therapies for hypoglycemia, but this specific approach with dasiglucagon in young children is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
New Haven, Connecticut and 3 other locations
- Yale University — New Haven, Connecticut, United States (Withdrawn)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
- Cook Childrens Health Care System — Fort Worth, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Operations
- Email: clinicaltrials@zealandpharma.com
- Phone: +45 88 77 36 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.