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

• Status: Completed
• Trial end date: 2020-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma

Criteria

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 trial

• 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.