Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Hypoglycemia, sponsored by Zealand Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Plasma glucose recovery was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes. Time to plasma glucose recovery was summarized for each treatment group using Kaplan Meier (KM) estimates together with the 95% confidence inte
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 |
What the finished NCT03667053 record still lists
NCT03667053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (92% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Hypoglycemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03667053's enrollment target sits among peer trials
42 18th of 40 higher than 23 of 40 other Hypoglycemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoglycemia 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
-
Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents
COMPLETED · Phase 3
-
External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia
RECRUITING
-
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
RECRUITING · Phase 1
-
Diabetes Clinical Decision Support
RECRUITING · NA
-
Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
RECRUITING · NA
-
Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02852213 · 42 participants · Phase 1
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
- NCT03136146 · 42 participants · Phase 2
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
- NCT03178149 · 42 participants · Phase 1
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- NCT03663530 · 42 participants · NA
Circadian Misalignment and Energy Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI