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NCT00897676 · ClinicalTrials.gov registry record · Phase 1
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
A Phase 1 study of Congenital Hyperinsulinism, sponsored by Diva De Leon.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT00897676: Completed Phase 1 study of Congenital Hyperinsulinism, sponsored by Diva De Leon.
NCT00897676 is a Phase 1 study of Congenital Hyperinsulinism that has completed, run by Diva De Leon. The registered enrollment target is 17 participants, below the 76-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00897676, a Phase 1 study of Congenital Hyperinsulinism, has completed, sponsored by Diva De Leon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding Source - FDA Office of Orphan Products Development (OODP).
Primary Outcome
Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion
Conditions Studied
Interventions
- DRUG placebo
- DRUG Exendin-(9-39)
Study Locations (1)
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2009-05 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
What the finished NCT00897676 record still lists
NCT00897676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 76-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00897676 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00897676 about?
NCT00897676 is a clinical study titled "Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity". The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding Source - FDA Office of Orphan Products Development (OODP).
What is the current status of trial NCT00897676?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2009-05. Estimated completion is 2017-01.
What conditions does trial NCT00897676 study?
This clinical trial studies the following conditions: Congenital Hyperinsulinism.
What interventions are being tested in trial NCT00897676?
The interventions under investigation include: placebo (DRUG), Exendin-(9-39) (DRUG).
Who is sponsoring clinical trial NCT00897676?
This trial is sponsored by Diva De Leon, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00897676 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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