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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: Completed Phase 3 study of Type 1 Diabetes Mellitus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (72% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of participants with HbA1c ≤7.0% AND free of severe hypoglycemic events from Day 28 to Day 365 inclusive, following the first islet transplant, with the day of transplant designated Day 0.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2006-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT00434811 record still lists
NCT00434811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (72% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00434811's enrollment target sits among peer trials
48 57th of 112 higher than 56 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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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