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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 is a Phase 3 study that has completed, run by Xeris Pharmaceuticals. The registered enrollment target is 81 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03439072
The ClinicalTrials.gov registry entry for NCT03439072 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xeris Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which G-Pen is the first listed.
NCT03439072 reports 0 study locations.
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.
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