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COMPLETED Phase 1

Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

NCT00897676 · View on ClinicalTrials.gov ↗

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).

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG Exendin-(9-39)

Study Locations (1)

Pennsylvania

  • The Children's Hospital of Philadelphia — Philadelphia

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2009-05
Est. Completion 2017-01
Phase Phase 1

Sponsor

Diva De Leon

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00897676

The ClinicalTrials.gov registry entry for NCT00897676 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diva De Leon, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00897676 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00897676?

The interventions under investigation include: placebo (DRUG), Exendin-(9-39) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00897676?

This trial is sponsored by Diva De Leon, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial