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NCT00306098 · ClinicalTrials.gov registry record · Phase 2
Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression
A Phase 2 study, sponsored by Rodolfo Alejandro.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT00306098: Completed Phase 2 study, sponsored by Rodolfo Alejandro.
NCT00306098 is a Phase 2 study that has completed, run by Rodolfo Alejandro. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00306098, a Phase 2 study, has completed, sponsored by Rodolfo Alejandro.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
SPECIFIC AIMS: 1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 2. To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 3. To assess long-term safety and function of successful islet cell transplants in patients with Type 1 Diabetes Mellitus; 4. To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells; and 5. To assess the effect of infliximab in preventing early islet destruction, and thereby eliminating the need for a second donor's islet cells. 6. To assess the effect of etanercept in preventing early islet destruction. 7. To assess the effect of exenatide to improve islet graft function and survival in subjects that have returned to using exogenous insulin. 8. To assess the ability of exenatide to improve islet survival at time of transplantation.
Primary Outcome
number of subjects with a1c less than 6.5 without severe hypoglycemia
Interventions
- DRUG islets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2000-12 |
| Est. Completion | 2004-07-04 |
| Phase | Phase 2 |
What the finished NCT00306098 record still lists
NCT00306098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which islets is the first listed.
NCT00306098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00306098 about?
NCT00306098 is a clinical study titled "Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression". SPECIFIC AIMS: 1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 2. To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 3. To assess long-te...
What is the current status of trial NCT00306098?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2000-12. Estimated completion is 2004-07-04.
What interventions are being tested in trial NCT00306098?
The interventions under investigation include: islets (DRUG).
Who is sponsoring clinical trial NCT00306098?
This trial is sponsored by Rodolfo Alejandro, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00306098's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 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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