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NCT03738865 · ClinicalTrials.gov registry record · Phase 3
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
A Phase 3 study, sponsored by Xeris Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
NCT03738865: Completed Phase 3 study, sponsored by Xeris Pharmaceuticals.
NCT03738865 is a Phase 3 study that has completed, run by Xeris Pharmaceuticals. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03738865, a Phase 3 study, has completed, sponsored by Xeris Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose \< 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of \>70.0 mg/dL (3.89 mmol/L) or an increase of \> 20 mg/dL (\>1.11 mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.
Primary Outcome
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon
Interventions
- DRUG G-Pen
- DRUG Novo Glucagon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2019-04-02 |
| Phase | Phase 3 |
What the finished NCT03738865 record still lists
NCT03738865 is an interventional study that assigns participants to a tested intervention. The registered 132 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 (83% lower).
The record links to 0 conditions, and to 2 interventions - of which G-Pen is the first listed.
NCT03738865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03738865 about?
NCT03738865 is a clinical study titled "G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes". This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo G...
What is the current status of trial NCT03738865?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2018-09-27. Estimated completion is 2019-04-02.
What interventions are being tested in trial NCT03738865?
The interventions under investigation include: G-Pen (DRUG), Novo Glucagon (DRUG).
Who is sponsoring clinical trial NCT03738865?
This trial is sponsored by Xeris Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03738865's enrollment target sits among peer trials
132 1588th of 2000 higher than 408 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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