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NCT00539409 · ClinicalTrials.gov registry record · Phase 2

Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus

A Phase 2 study, sponsored by Florida Atlantic University.

Terminated
Registry status
Phase 2
Development phase
152
Enrollment target

NCT00539409: Clinical Trial Phase 2 study, sponsored by Florida Atlantic University.

NCT00539409 is a Phase 2 study that was terminated before completion, run by Florida Atlantic University. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00539409, a Phase 2 study, was terminated before completion, sponsored by Florida Atlantic University.

TERMINATED
Registry status
Phase 2
Development phase
152 participants
Enrollment target

Study Summary

The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic quality of life questionnaire is completed prior to the start of the treatment and quarterly thereafter with detailed analysis performed to measure progress and outcomes

Interventions

  • PROCEDURE Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2006-11
Est. Completion 2009-08
Phase Phase 2
Florida Atlantic University

27 total trials

Why NCT00539409 stopped before completion

NCT00539409 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).

The record links to 0 conditions, and to 1 intervention - of which Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog) is the first listed.

NCT00539409 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00539409 about?

NCT00539409 is a clinical study titled "Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus". The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatil...

What is the current status of trial NCT00539409?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2006-11. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00539409?

The interventions under investigation include: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog) (PROCEDURE).

Who is sponsoring clinical trial NCT00539409?

This trial is sponsored by Florida Atlantic University, which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00539409's enrollment target sits among peer trials

152 452nd of 2000 higher than 1,547 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00539409, the US trial registry maintained by the National Library of Medicine. NCT00539409 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.