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NCT03777176 · ClinicalTrials.gov registry record · Phase 3
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
A Phase 3 study, sponsored by Zealand Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT03777176: Completed Phase 3 study, sponsored by Zealand Pharma.
NCT03777176 is a Phase 3 study that has completed, run by Zealand Pharma. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03777176, a Phase 3 study, has completed, sponsored by Zealand Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG \<70 mg/dL \[3.9 mmol/L\]) during Weeks 2-4 as detected by self-monitored plasma glucose (SMPG). The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period.
Interventions
- OTHER Standard of Care
- DRUG Dasiglucagon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-02-07 |
| Est. Completion | 2020-10-05 |
| Phase | Phase 3 |
What the finished NCT03777176 record still lists
NCT03777176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03777176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03777176 about?
NCT03777176 is a clinical study titled "A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism". 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.
What is the current status of trial NCT03777176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2019-02-07. Estimated completion is 2020-10-05.
What interventions are being tested in trial NCT03777176?
The interventions under investigation include: Standard of Care (OTHER), Dasiglucagon (DRUG).
Who is sponsoring clinical trial NCT03777176?
This trial is sponsored by Zealand Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03777176's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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