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NCT03667053 · ClinicalTrials.gov registry record · Phase 3
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
A Phase 3 study of Hypoglycemia, sponsored by Zealand Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
- 5
- Study locations
NCT03667053 is a Phase 3 study of Hypoglycemia that has completed, run by Zealand Pharma. The registered enrollment target is 42 participants, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT03667053, a Phase 3 study of Hypoglycemia, has completed, sponsored by Zealand Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
- 5
- Study locations
Study Summary
A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin
Conditions Studied
Interventions
- DRUG placebo
- DRUG dasiglucagon
- DRUG GlucaGen HypoKit
Study Locations (5)
Other
- Auf der Bult - Diabetes Center for Children - Hanover
- University Medical Center Ljubljana, Children's Hospital, Department for Endocrinology, Diabetes and Metabolism - Ljubljana
California
- AMCR Institute, Inc - Escondido
Connecticut
- Yale University School of Medicine - New Haven
Indiana
- Indiana University, Department of Pediatrics - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-09-28 |
| Est. Completion | 2019-06-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03667053
The ClinicalTrials.gov registry entry for NCT03667053 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (92% lower). The listed sponsor is Zealand Pharma, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypoglycemia appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT03667053 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03667053 about?
NCT03667053 is a clinical study titled "Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children". A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM...
What is the current status of trial NCT03667053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2018-09-28. Estimated completion is 2019-06-28.
What conditions does trial NCT03667053 study?
This clinical trial studies the following conditions: Hypoglycemia.
What interventions are being tested in trial NCT03667053?
The interventions under investigation include: placebo (DRUG), dasiglucagon (DRUG), GlucaGen HypoKit (DRUG).
Who is sponsoring clinical trial NCT03667053?
This trial is sponsored by Zealand Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03667053 being conducted?
This trial has 5 study locations across California, Connecticut, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.