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

Completed · Phase 3

Conditions studied: Congenital Hyperinsulinism

In brief

The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.

Key facts

Study ID

NCT03777176

Run by

Zealand Pharma

People needed

32

Starts

2019-02-07

Expected to finish

2020-10-05

Last updated by the study team

2023-12-13

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established and documented diagnosis of CHI based on standard of care
• Experiencing ≥3 events of hypoglycemia per week (plasma glucose [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

You may not qualify if…

• 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 or presence of pheochromocytoma
• 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.

Where it is running

• Children's Hospital of Colorado — Aurora, Colorado, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• University Hospital Düsseldorf, Department of Pediatrics — Düsseldorf, Germany
• Otto von Guericke University Magdeburg, Department of Pediatrics — Magdeburg, Germany
• Hadassah Medical Center — Jerusalem, Israel
• NHS Greater Glasgow and Clyde — Glasgow, United Kingdom
• Alder Hey Children'sHospital NHS Foundation Trust — Liverpool, United Kingdom
• Great Osmond Street Hospital for Children NHS Foundation Trust — London, United Kingdom
• Central Manchester University Hospital NHS Foundation Trust — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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