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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: Clinical Trial Phase 2 study, sponsored by Xeris Pharmaceuticals.
NCT03490942 is a Phase 2 study that was terminated before completion, run by Xeris Pharmaceuticals. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Plasma epinephrine concentration after 30 minutes of induced hypoglycemia. Change from baseline to the end of treatment will be assessed.
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 |
Why NCT03490942 stopped before completion
NCT03490942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03490942 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03490942's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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