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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Congenital Hyperinsulinism

In brief

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.

Key facts

Study ID

NCT04172441

Run by

Zealand Pharma

People needed

12

Starts

2020-06-19

Expected to finish

2022-03-07

Last updated by the study team

2025-03-14

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CHI diagnosis established based on the following:
• Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or
• Hypofattyacidemia: plasma free fatty acid <1.7 mmol/L, and/or
• Hypoketonemia: Beta-hydroxybutyrate <1.8 mmol/L, and/or
• Glycemic response: an increase in plasma glucose (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

You may not qualify if…

• 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/m\^2 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

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• University Children's Hospital — Düsseldorf, Germany
• University Hospital, Magdeburg — Magdeburg, Germany
• Hadassah Medical Center — Jerusalem, Israel
• Manchester University NHS Foundation Trust — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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