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NCT03490942 · ClinicalTrials.gov registry record · Phase 2
Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
A Phase 2 study, sponsored by Xeris Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT03490942 is a Phase 2 study that was terminated before completion, run by Xeris Pharmaceuticals. The registered enrollment target is 49 participants.
The verdict
NCT03490942, a Phase 2 study, was terminated before completion, sponsored by Xeris Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their baseline hypoglycemia counter-regulatory response hormones quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects will receive blinded study drug for 4 weeks, and they will be followed for an additional 26 weeks post-treatment. Subjects' counter-regulatory hormone response will be measured at baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.
Interventions
- DRUG Placebo
- DRUG Glucagon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2020-02-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03490942
The ClinicalTrials.gov registry entry for NCT03490942 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 49 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 Placebo is the first listed.
NCT03490942 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03490942 about?
NCT03490942 is a clinical study titled "Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses". This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their bas...
What is the current status of trial NCT03490942?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2018-03-15. Estimated completion is 2020-02-10.
What interventions are being tested in trial NCT03490942?
The interventions under investigation include: Placebo (DRUG), Glucagon (DRUG).
Who is sponsoring clinical trial NCT03490942?
This trial is sponsored by Xeris Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
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