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NCT00835328 · ClinicalTrials.gov registry record · Phase 1
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
A Phase 1 study, sponsored by Diva De Leon.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00835328: Clinical Trial Phase 1 study, sponsored by Diva De Leon.
NCT00835328 is a Phase 1 study that was terminated before completion, run by Diva De Leon. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835328, a Phase 1 study, was terminated before completion, sponsored by Diva De Leon.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed medical therapy. The secondary aims are to determine the therapeutic plasma levels, plasma half-life and pharmacokinetics of Exendin (9-39) during a 9-hour intravenous infusion.
Primary Outcome
To assess the effect of Exendin (9-39) on glucose infusion rate, glucose infusion rate (GIR) over the last 2 hours of the treatment period was calculated by adding the total amount of intravenous glucose (mg) received over 2 hours divided by the weight (kg) and by time (120 min) during infusion of Exendin (9-39) and normal saline vehicle.
Interventions
- DRUG Vehicle
- DRUG Exendin (9-39)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-08-26 |
| Est. Completion | 2017-01-28 |
| Phase | Phase 1 |
Why NCT00835328 stopped before completion
NCT00835328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT00835328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835328 about?
NCT00835328 is a clinical study titled "Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia". The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed medical therapy. The secondary aims are to determine the therapeutic plasma levels, plasma half-life an...
What is the current status of trial NCT00835328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2009-08-26. Estimated completion is 2017-01-28.
What interventions are being tested in trial NCT00835328?
The interventions under investigation include: Vehicle (DRUG), Exendin (9-39) (DRUG).
Who is sponsoring clinical trial NCT00835328?
This trial is sponsored by Diva De Leon, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835328's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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