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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 is a Phase 3 study that has completed, run by Xeris Pharmaceuticals. The registered enrollment target is 132 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03738865
The ClinicalTrials.gov registry entry for NCT03738865 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 132 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.
NCT03738865 reports 0 study locations.
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.
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