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NCT00133809 · ClinicalTrials.gov registry record · Phase 2

Islet Transplantation in Type 1 Diabetics Using the Edmonton Protocol of Steroid Free Immunosuppression

A Phase 2 study, sponsored by Emory University.

Completed
Registry status
Phase 2
Development phase
8
Enrollment target

NCT00133809: Completed Phase 2 study, sponsored by Emory University.

NCT00133809 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00133809, a Phase 2 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 2
Development phase
8 participants
Enrollment target

Study Summary

This trial will study the ability of islet transplantation to restore glycemic control and achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia and unawareness, or recurrent hyperglycemia with ketoacidosis.

Primary Outcome

Independence from insulin injections is measured by the actual use of insulin by the study participants.

Interventions

  • DRUG Transplantation of Human Islets

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2002-07
Est. Completion 2014-12
Phase Phase 2
Emory University

1,208 total trials

What the finished NCT00133809 record still lists

NCT00133809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Transplantation of Human Islets is the first listed.

NCT00133809 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00133809 about?

NCT00133809 is a clinical study titled "Islet Transplantation in Type 1 Diabetics Using the Edmonton Protocol of Steroid Free Immunosuppression". This trial will study the ability of islet transplantation to restore glycemic control and achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia and unawareness, or recurrent hyperglycemia with ketoacidosis.

What is the current status of trial NCT00133809?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2002-07. Estimated completion is 2014-12.

What interventions are being tested in trial NCT00133809?

The interventions under investigation include: Transplantation of Human Islets (DRUG).

Who is sponsoring clinical trial NCT00133809?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00133809's enrollment target sits among peer trials

8 1990th of 2000 higher than 5 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 NCT00133809, the US trial registry maintained by the National Library of Medicine. NCT00133809 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.