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NCT03439072 · ClinicalTrials.gov registry record · Phase 3
G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
A Phase 3 study, sponsored by Xeris Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 81
- Enrollment target
NCT03439072: Completed Phase 3 study, sponsored by Xeris Pharmaceuticals.
NCT03439072 is a Phase 3 study that has completed, run by Xeris Pharmaceuticals. The registered enrollment target is 81 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03439072, a Phase 3 study, has completed, sponsored by Xeris Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 81 participants
- Enrollment target
Study Summary
This is a non-inferiority, 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 Lilly 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 hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose \< 50 mg/dL is verified, the subject is administered a dose of G-Pen or Lilly Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of \>70.0 mg/dL 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 procedure 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
Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon
Interventions
- DRUG G-Pen
- DRUG Lilly Glucagon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2018-01-23 |
| Est. Completion | 2018-05-03 |
| Phase | Phase 3 |
What the finished NCT03439072 record still lists
NCT03439072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which G-Pen is the first listed.
NCT03439072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03439072 about?
NCT03439072 is a clinical study titled "G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes". This is a non-inferiority, 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...
What is the current status of trial NCT03439072?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 81 participants. The study started on 2018-01-23. Estimated completion is 2018-05-03.
What interventions are being tested in trial NCT03439072?
The interventions under investigation include: G-Pen (DRUG), Lilly Glucagon (DRUG).
Who is sponsoring clinical trial NCT03439072?
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 NCT03439072's enrollment target sits among peer trials
81 1752nd of 2000 higher than 246 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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