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NCT00882050 · ClinicalTrials.gov registry record · Phase 1

Intravenous Exenatide (Byetta) During Surgery

A Phase 1 study, sponsored by Thomas Jefferson University.

Completed
Registry status
Phase 1
Development phase
104
Enrollment target

NCT00882050: Completed Phase 1 study, sponsored by Thomas Jefferson University.

NCT00882050 is a Phase 1 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00882050, a Phase 1 study, has completed, sponsored by Thomas Jefferson University.

COMPLETED
Registry status
Phase 1
Development phase
104 participants
Enrollment target

Study Summary

The purpose of this project is to study if intravenous Exenatide is effective at maintaining normal blood glucose levels and preventing low blood glucose levels during surgery.

Primary Outcome

Logistic regression analysis will be utizlized to determine maintenance of euglycemia (yes v no) for our primary analysis. A standard area under the curve (AUC) analysis will be performed for each time point to map out drug deposition. Assuming a standard 2 compartment model, 10 subjects per group is sufficient to accurately predict mean AUC. Our primary analysis should provide ample statistical power.

Interventions

  • DRUG Placebo
  • DRUG Exenatide 0.27 ng/kg/min
  • DRUG Exenatide 0.41 ng/kg/min

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2009-03
Est. Completion 2016-04
Phase Phase 1
Thomas Jefferson University

292 total trials

What the finished NCT00882050 record still lists

NCT00882050 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00882050 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00882050 about?

NCT00882050 is a clinical study titled "Intravenous Exenatide (Byetta) During Surgery". The purpose of this project is to study if intravenous Exenatide is effective at maintaining normal blood glucose levels and preventing low blood glucose levels during surgery.

What is the current status of trial NCT00882050?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2009-03. Estimated completion is 2016-04.

What interventions are being tested in trial NCT00882050?

The interventions under investigation include: Placebo (DRUG), Exenatide 0.27 ng/kg/min (DRUG), Exenatide 0.41 ng/kg/min (DRUG).

Who is sponsoring clinical trial NCT00882050?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00882050's enrollment target sits among peer trials

104 536th of 2000 higher than 1,460 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 NCT00882050, the US trial registry maintained by the National Library of Medicine. NCT00882050 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.