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NCT00100178 · ClinicalTrials.gov registry record · Phase 2
New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT00100178 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 126 participants.
The verdict
NCT00100178, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
The objective of this study is to identify immune intervention strategies that will preserve residual beta cell function at the onset of type 1 diabetes. Scientific evidence developed over the last 10 - 20 years suggests that type 1 diabetes is a chronic, slowly progressive autoimmune disease and that clinical symptoms do not develop until at least 80% - 90% of beta cell mass has been destroyed as a result of the autoimmune process. It is now recognized that preservation of remaining beta cells is clinically important as the ability to secrete, even small amounts of insulin, can make the disease easier to control and help minimize complications associated with having years of inadequate glycemic control. This clinical trial is the first in a series of studies to be launched by the TrialNet Study Group to test various interventions for preserving residual beta cell function in new onset type 1 diabetes. Specifically, this study is designed to determine the ability of Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab (DZB/Zenapax) to see if it is possible to stop the immune system from destroying beta cells in new onset type 1 diabetes patients (within 3 months of diagnosis.) Researchers have made great strides in understanding how the immune system works and in changing the activity of immune cells with medicines called immunotherapies. Some immunotherapies work by making the immune system less active. Scientists have discovered that key immune cells, called T cells, help to cause type 1 diabetes. These T cells are largely responsible for attacking the beta cells that produce insulin. Doctors have found medicines that slow or suppress the activity of T cells. It is hoped that these immunosuppressive medicines can help treat type 1 diabetes by stopping T cells before they destroy all of the beta cells. Medicines that make the immune system less active have been developed and studied for other diseases. Mycophenolate mofetil (MMF) an
Interventions
- DRUG Mycophenolate mofeteil (MMF)
- DRUG Daclizumab (DZB)
- DRUG Placebo control for Mycophenolate mofeteil (MMF)
- DRUG Placebo control for Daclizumab (DZB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2004-05 |
| Est. Completion | 2008-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00100178
The ClinicalTrials.gov registry entry for NCT00100178 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Mycophenolate mofeteil (MMF) is the first listed.
NCT00100178 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00100178 about?
NCT00100178 is a clinical study titled "New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial". The objective of this study is to identify immune intervention strategies that will preserve residual beta cell function at the onset of type 1 diabetes. Scientific evidence developed over the last 10 - 20 years suggests that type 1 diabetes is a chronic, slowly progressive autoimmune disease and th...
What is the current status of trial NCT00100178?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2004-05. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00100178?
The interventions under investigation include: Mycophenolate mofeteil (MMF) (DRUG), Daclizumab (DZB) (DRUG), Placebo control for Mycophenolate mofeteil (MMF) (DRUG), Placebo control for Daclizumab (DZB) (DRUG).
Who is sponsoring clinical trial NCT00100178?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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