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

• Status: Recruiting
• Trial end date: 2021-10-13
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma

Criteria

Inclusion Criteria:

• CHI diagnosis established based on the following:

1. Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or

2. Hypofattyacidemia: plasma free fatty acid <1.7 mmol/L, and/or

3. Hypoketonemia: Beta-hydroxybutyrate <1.8 mmol/L, and/or

4. Glycemic response: an increase in PG of >30 mg/dL (1.7 mmol/L) after 1 mg IV or intramuscular (IM) glucagon administration

• Male or female, age ≥7 days and <12 months at screening

• Body weight of ≥2.0 kg (4.4 lbs.)

• Continuous IV glucose requirement to prevent hypoglycemia

Exclusion Criteria:

• Is suspected of having a transient form of CHI (e.g., transient hyperinsulinism due to maternal diabetes or perinatal stress)

• Was born preterm below 34 weeks of gestational age

• Presence of hypertension or hypotension, including circulatory instability requiring supportive medication or presence of pheochromocytoma

• Known or suspected presence of severe brain damage

• Evidence of metabolic, endocrine, or syndromic causes of hypoglycemia not due to hyperinsulinism

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

• Prior use of lanreotide, sirolimus (mechanistic target of rapamycin [mTOR] inhibitors), anti inflammatory biological agents, or other immune modulating agents. Prior use of octreotide is allowed after a minimum of 48 hour washout before randomization.

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

• Any recognized clotting or bleeding disorder

• The use of prescription or non-prescription medications known to cause QT prolongation