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

NCT04172441 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-14

Study results available
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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.

Conditions

  • Congenital Hyperinsulinism

Interventions

DRUG

dasiglucagon

Glucagon analogue

DRUG

Placebo

Placebo for dasiglucagon

Sponsors & Collaborators

Principal Investigators

  • Jelena Ivkovic, MD · Zealand Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
7 Days
Max Age
364 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2022-02-17
Completion
2022-03-07
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Israel
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04172441 on ClinicalTrials.gov