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

Age Range:Any - 12
Start Date:March 4, 2019
End Date:February 2020
Contact:Benedikte Bandak

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A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism

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.

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.
We found this trial at
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South 34th Street
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3020 Childrens way
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(858) 576-1700
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13123 E 16th Ave
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(720) 777-1234
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Aurora, CO
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