At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 12 enrolled
Drug / intervention
dasiglucagon +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial in 2 Parts: Double-Blind, Placebo-Controlled, Crossover Part 1 and Open-label Part 2, Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism
In Brief
A Phase 3 clinical trial evaluating dasiglucagon and Placebo for Congenital Hyperinsulinism. Completed, enrolled 12 participants across 6 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Hyperinsulinism
CountriesGermany, Israel, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartJun 2020
Primary CompletionFeb 2022
Study CompletionMar 2022
TodayJul 2026
First PostedNov 21, 2019
Enrollment StartJun 19, 2020
Primary CompletionFeb 17, 2022
Study CompletionMar 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.6 years ago
Interventions
dasiglucagondrug
Glucagon analogue
Placebodrug
Placebo for dasiglucagon