Trials / Completed
CompletedNCT04172441
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Zealand Pharma · Industry
- Sex
- All
- Age
- 7 Days – 364 Days
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dasiglucagon | Glucagon analogue |
| DRUG | Placebo | Placebo for dasiglucagon |
Timeline
- Start date
- 2020-06-19
- Primary completion
- 2022-02-17
- Completion
- 2022-03-07
- First posted
- 2019-11-21
- Last updated
- 2025-03-14
- Results posted
- 2025-03-14
Locations
6 sites across 4 countries: United States, Germany, Israel, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04172441. Inclusion in this directory is not an endorsement.