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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: Completed Phase 2 study of Diabetes Mellitus, Insulin-Dependent, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1.) a blood glycosylated hemoglobin (HbA1c) level \< 6.5% (Normal:\<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2001-04 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00014911 record still lists
NCT00014911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 119-participant average among 3 other Diabetes Mellitus, Insulin-Dependent trials with a reported enrollment target (70% lower).
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 lists 9 locations in 7 states (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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