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NCT00014911 · ClinicalTrials.gov registry record · Phase 2

Islet Transplantation for Type 1 Diabetes

A Phase 2 study of Diabetes Mellitus, Insulin-Dependent, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
36
Enrollment target
9
Study locations

NCT00014911 is a Phase 2 study of Diabetes Mellitus, Insulin-Dependent that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 119-participant average among 3 other Diabetes Mellitus, Insulin-Dependent trials with a reported enrollment target (70% lower). The trial reports 9 study locations across 7 states.

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The verdict

NCT00014911, a Phase 2 study of Diabetes Mellitus, Insulin-Dependent, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target
9
Study locations

Study Summary

The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton, Canada, can be repeated. The study also is designed to learn more about diabetes control using islet cell transplantation. This is a Phase I/II study (a study that examines effectiveness and looks for side effects). The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression.

Interventions

  • DRUG Sirolimus
  • DRUG Tacrolimus
  • DRUG Daclizumab
  • PROCEDURE Islet Transplantation
  • DRUG Sulfamethoxazole

Study Locations (9)

Other

  • Justus-Leibig University - Giessen
  • University of Milan - Milan
  • University of Geneva - Geneva

Florida

  • University of Miami - Miami

Massachusetts

  • Massachusetts General Hospital - Boston

Minnesota

  • University of Minnesota - Minneapolis

Missouri

  • Washington University - St Louis

Washington

  • Benaroya Research Institute at Virginia Mason Research Center - Seattle

Alberta

  • University of Alberta - Edmonton

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2001-04
Est. Completion 2010-08
Phase Phase 2

What the Registry Record Tells You About NCT00014911

The ClinicalTrials.gov registry entry for NCT00014911 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 3 other Diabetes Mellitus, Insulin-Dependent trials with a reported enrollment target (70% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Insulin-Dependent appearing as the primary indexed condition, and to 5 interventions - of which Sirolimus is the first listed.

NCT00014911 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Other, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00014911 about?

NCT00014911 is a clinical study titled "Islet Transplantation for Type 1 Diabetes". The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton, Canada, can be repeated. The study also is designed to learn more about diabetes control using islet cell transplantation. This is a Phase I/II study (a study that e...

What is the current status of trial NCT00014911?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2001-04. Estimated completion is 2010-08.

What conditions does trial NCT00014911 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Insulin-Dependent.

What interventions are being tested in trial NCT00014911?

The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), Daclizumab (DRUG), Islet Transplantation (PROCEDURE), Sulfamethoxazole (DRUG).

Who is sponsoring clinical trial NCT00014911?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00014911 being conducted?

This trial has 9 study locations across Florida, Massachusetts, Minnesota, Missouri, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.