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NCT03378635 · ClinicalTrials.gov registry record · Phase 3
A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
A Phase 3 study, sponsored by Zealand Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 170
- Enrollment target
NCT03378635: Completed Phase 3 study, sponsored by Zealand Pharma.
NCT03378635 is a Phase 3 study that has completed, run by Zealand Pharma. The registered enrollment target is 170 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03378635, a Phase 3 study, has completed, sponsored by Zealand Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 170 participants
- Enrollment target
Study Summary
The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus (T1DM) with insulin-induced hypoglycemia. Additionally to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.
Primary Outcome
Plasma glucose recovery is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. The outcome measure used a Kaplan-Meier estimate with 95% confidence interval. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.
Interventions
- DRUG Placebo
- DRUG GlucaGen
- DRUG Dasiglucagon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2018-05-25 |
| Phase | Phase 3 |
What the finished NCT03378635 record still lists
NCT03378635 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03378635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03378635 about?
NCT03378635 is a clinical study titled "A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects". The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus (T1DM) with insulin-induced hypoglycemia. Additionally to compare the glycemic response observed after administrati...
What is the current status of trial NCT03378635?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 170 participants. The study started on 2017-12-07. Estimated completion is 2018-05-25.
What interventions are being tested in trial NCT03378635?
The interventions under investigation include: Placebo (DRUG), GlucaGen (DRUG), Dasiglucagon (DRUG).
Who is sponsoring clinical trial NCT03378635?
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 NCT03378635's enrollment target sits among peer trials
170 1453rd of 2000 higher than 542 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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