Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100178
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2004-12-23
Brief Title:
New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial Preservation of Pancreatic Production of Insulin Through Immunosuppression-POPPII 1
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TN02
Brief 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 MMFCellCept used alone or in combination with Daclizumab DZBZenapax 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 and Daclizumab DZB are two of these medicines Their effects on the immune system are well understood Researchers believe these medicines may lessen the immune systems destruction of beta cells that leads to type 1 diabetes In addition researchers hope the effect of these medicines will last longer than other therapies
The goal of this study is to find out if two medicines are able to stop the ongoing destruction of beta cells which are still functioning at the time type 1 diabetes is diagnosed The two immunosuppressive medications being tested are Mycophenolate mofetil MMFCellCept and Daclizumab DZBZenapax They work by making the immune system less active TrialNet researchers hope that these medications will help maintain insulin secretion from remaining beta cells and thus help to maintain better glycemic control Even if the medications work study participants will still need to take insulin injections but it may make it easier to control normal blood sugar levels which can help reduce long-term complications of diabetes such as blindness kidney failure nerve damage heart attack and stroke
The aim is to arrest beta cell destruction in newly diabetic subjects because immune modulation may not work well alone once the autoimmune process has progressed to complete or near complete destruction of beta cells The studys rationale is to demonstrate a meaningful preservation of islet function with minimal immune system side effects over the 4-year course of this study
The data from this clinical trial could serve as the basis for a larger trial if the results are sufficiently positive or they could suggest other combined intervention trials that might achieve either better efficacy or potentially preserve C-peptide without the need for continued immunosuppression
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 MMFCellCept used alone or in combination with Daclizumab DZBZenapax 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 and Daclizumab DZB are two of these medicines Their effects on the immune system are well understood Researchers believe these medicines may lessen the immune systems destruction of beta cells that leads to type 1 diabetes In addition researchers hope the effect of these medicines will last longer than other therapies
The goal of this study is to find out if two medicines are able to stop the ongoing destruction of beta cells which are still functioning at the time type 1 diabetes is diagnosed The two immunosuppressive medications being tested are Mycophenolate mofetil MMFCellCept and Daclizumab DZBZenapax They work by making the immune system less active TrialNet researchers hope that these medications will help maintain insulin secretion from remaining beta cells and thus help to maintain better glycemic control Even if the medications work study participants will still need to take insulin injections but it may make it easier to control normal blood sugar levels which can help reduce long-term complications of diabetes such as blindness kidney failure nerve damage heart attack and stroke
The aim is to arrest beta cell destruction in newly diabetic subjects because immune modulation may not work well alone once the autoimmune process has progressed to complete or near complete destruction of beta cells The studys rationale is to demonstrate a meaningful preservation of islet function with minimal immune system side effects over the 4-year course of this study
The data from this clinical trial could serve as the basis for a larger trial if the results are sufficiently positive or they could suggest other combined intervention trials that might achieve either better efficacy or potentially preserve C-peptide without the need for continued immunosuppression
Detailed Description:
Design of Study
The study is a multi-center three-arm randomized double-masked placebo-controlled clinical trial Comparisons will be made among the three groups which are
Mycophenolate mofetil active drug with Daclizumab DZB placebo IV
Mycophenolate mofetil active drug with active Daclizumab IV
Mycophenolate mofetil placebo with Daclizumab placebo IV
Participants that agree to enroll in the study will be asked to take study medications for two years MMF is given by mouth twice a day DZB is given by an intravenous infusion twice once at the time of enrollment and again two weeks later Both these medications are approved by the US Food and Drug Administration and are used by people who have received an organ transplant This study is testing a new use of these medications to preserve insulin secretion by delaying or stopping further destruction of insulin-secreting cells in people with newly diagnosed type 1 diabetes Both MMF and DZB make the immune system less active Participants will be monitored closely for any possible side effects that can occur from taking either DZB andor MMF due to decreased activity of the immune system
Participants will need to go to the Clinical Center for visits and tests For the first month participants will come in every week then participants will come in at month 2 and month 3 After the month 3 visit visits will occur about every three months At most visits blood will be drawn and participants will meet with a study physician to review their overall diabetes management and be monitored for any possible side-effects from the study medication
Participants will be asked to do a longer test called a Mixed Meal Tolerance Test MMTT at the initial visit and at five additional visits while taking the assigned study medication The MMTT involves drinking a special drink which has a controlled amount of carbohydrates protein and fat to measure residual insulin secretion The test requires having an IV inserted into the arm and having blood samples taken from the IV over a period of 2 to 4 hours After completing the two year period of taking the study medication participants will be asked to return every 3-6 months for an additional 1-2 years to evaluate their ability to secrete insulin after discontinuing the study medication
The study is a multi-center three-arm randomized double-masked placebo-controlled clinical trial Comparisons will be made among the three groups which are
Mycophenolate mofetil active drug with Daclizumab DZB placebo IV
Mycophenolate mofetil active drug with active Daclizumab IV
Mycophenolate mofetil placebo with Daclizumab placebo IV
Participants that agree to enroll in the study will be asked to take study medications for two years MMF is given by mouth twice a day DZB is given by an intravenous infusion twice once at the time of enrollment and again two weeks later Both these medications are approved by the US Food and Drug Administration and are used by people who have received an organ transplant This study is testing a new use of these medications to preserve insulin secretion by delaying or stopping further destruction of insulin-secreting cells in people with newly diagnosed type 1 diabetes Both MMF and DZB make the immune system less active Participants will be monitored closely for any possible side effects that can occur from taking either DZB andor MMF due to decreased activity of the immune system
Participants will need to go to the Clinical Center for visits and tests For the first month participants will come in every week then participants will come in at month 2 and month 3 After the month 3 visit visits will occur about every three months At most visits blood will be drawn and participants will meet with a study physician to review their overall diabetes management and be monitored for any possible side-effects from the study medication
Participants will be asked to do a longer test called a Mixed Meal Tolerance Test MMTT at the initial visit and at five additional visits while taking the assigned study medication The MMTT involves drinking a special drink which has a controlled amount of carbohydrates protein and fat to measure residual insulin secretion The test requires having an IV inserted into the arm and having blood samples taken from the IV over a period of 2 to 4 hours After completing the two year period of taking the study medication participants will be asked to return every 3-6 months for an additional 1-2 years to evaluate their ability to secrete insulin after discontinuing the study medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UC4DK097835 | NIH | None | httpsreporternihgovquickSearchUC4DK097835 |
| U01DK061055 | NIH | None | None |