At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 32 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 Two-Period, Open-label Trial 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 Standard of Care for Congenital Hyperinsulinism. Completed, enrolled 32 participants across 10 sites in 4 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Hyperinsulinism
CountriesGermany, Israel, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartFeb 2019
Primary CompletionAug 2020
Study CompletionOct 2020
TodayJul 2026
First PostedDec 17, 2018
Enrollment StartFeb 7, 2019
Primary CompletionAug 31, 2020
Study CompletionOct 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.5 years ago
Interventions
Dasiglucagondrug
Glucagon analog
Standard of Careother
Standard of care according to site and/or country