Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

Trial end date:
Target enrollment:
Participant gender:
The objective of the trial is to evaluate the efficacy of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
Phase 3
Accepts Healthy Volunteers?
Lead Sponsor:
Zealand Pharma
Inclusion Criteria:

- Established and documented diagnosis of CHI based on standard of care

- Experiencing ≥3 events of hypoglycemia per week (PG <70 mg/dL [<3.9 mmol/L]) according
to the investigator's evaluation

- Previously undergone near-total pancreatectomy or being treated with a non-surgical
approach, having been evaluated as not eligible for pancreatic surgery

- If somatostatin analogues or sirolimus are used, the therapy should be well
established as judged by the investigator, especially when considering their
biological half-life

Exclusion Criteria:

- Previous administration of dasiglucagon

- Known or suspected allergy to the trial drug or related products

- Previous participation (randomization) in this trial

- Circulatory instability requiring supportive medication

- Requires exogenous insulin

- Body weight of <4 kg (8.8 lbs.)

- Documented HbA1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior
to screening

- Known or suspected presence of significant central nervous system disease/injury such
that in the investigator's opinion will affect trial participation

- Use of systemic corticosteroids, e.g., hydrocortisone >20 mg/m2 body surface area or
equivalent in the 5 days before screening

- Use of anti-inflammatory biological agents, or other immune modulating agents in the 3
months prior to screening

- Any clinically significant abnormality identified on echocardiogram that in the
opinion of the investigator would affect the patient's ability to participate in the

- Any recognized clotting or bleeding disorders

- Has participated in an interventional clinical trial (investigational or marketed
product) within 3 months of screening or 5 half-lives of the drug under investigation
(whichever comes first), or plans to participate in another clinical trial.