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NCT00571324 · ClinicalTrials.gov registry record · Phase 1

Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism

A Phase 1 study, sponsored by Diva De Leon.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target

NCT00571324: Completed Phase 1 study, sponsored by Diva De Leon.

NCT00571324 is a Phase 1 study that has completed, run by Diva De Leon. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00571324, a Phase 1 study, has completed, sponsored by Diva De Leon.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target

Study Summary

The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.

Primary Outcome

To examine the effect of Exendin-(9-39) on fasting blood glucose levels, samples were collected at various time points before and during the infusion \[Exendin-(9-39) or vehicle\] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean blood glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes)

Interventions

  • OTHER Vehicle
  • DRUG Exendin-(9-39)

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2007-08
Est. Completion 2014-12
Phase Phase 1
Diva De Leon

4 total trials

What the finished NCT00571324 record still lists

NCT00571324 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.

NCT00571324 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00571324 about?

NCT00571324 is a clinical study titled "Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism". The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.

What is the current status of trial NCT00571324?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2007-08. Estimated completion is 2014-12.

What interventions are being tested in trial NCT00571324?

The interventions under investigation include: Vehicle (OTHER), Exendin-(9-39) (DRUG).

Who is sponsoring clinical trial NCT00571324?

This trial is sponsored by Diva De Leon, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00571324's enrollment target sits among peer trials

9 1955th of 2000 higher than 42 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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Source: ClinicalTrials.gov NCT00571324, the US trial registry maintained by the National Library of Medicine. NCT00571324 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.