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NCT00434811 · ClinicalTrials.gov registry record · Phase 3

Islet Transplantation in Type 1 Diabetes

A Phase 3 study of Type 1 Diabetes Mellitus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
48
Enrollment target
8
Study locations

NCT00434811 is a Phase 3 study of Type 1 Diabetes Mellitus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (66% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT00434811, a Phase 3 study of Type 1 Diabetes Mellitus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
48 participants
Enrollment target
8
Study locations

Study Summary

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Conditions Studied

Type 1 Diabetes Mellitus

Interventions

  • DRUG Sirolimus
  • BIOLOGICAL Etanercept
  • DRUG Tacrolimus
  • BIOLOGICAL Antithymocyte Globulin
  • BIOLOGICAL Allogeneic Pancreatic Islet Cells

Study Locations (8)

Illinois

  • Northwestern University - Chicago
  • University of Illinois, Chicago - Chicago

California

  • University of Callifornia, San Francisco - San Francisco

Florida

  • University of Miami - Miami

Georgia

  • Emory University - Atlanta

Minnesota

  • University of Minnesota - Minneapolis

Pennsylvania

  • University of Pennsylvania - Philadelphia

Alberta

  • University of Alberta - Edmonton

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2006-10
Est. Completion 2014-05
Phase Phase 3

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00434811

The ClinicalTrials.gov registry entry for NCT00434811 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (66% 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 Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions - of which Sirolimus is the first listed.

NCT00434811 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Illinois, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00434811 about?

NCT00434811 is a clinical study titled "Islet Transplantation in Type 1 Diabetes". Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, for treati...

What is the current status of trial NCT00434811?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2006-10. Estimated completion is 2014-05.

What conditions does trial NCT00434811 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.

What interventions are being tested in trial NCT00434811?

The interventions under investigation include: Sirolimus (DRUG), Etanercept (BIOLOGICAL), Tacrolimus (DRUG), Antithymocyte Globulin (BIOLOGICAL), Allogeneic Pancreatic Islet Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT00434811?

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 NCT00434811 being conducted?

This trial has 8 study locations across California, Florida, Georgia, Illinois, Minnesota. 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.