New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial (TN02)
Diabetes Mellitus, Type 1
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring immunosuppressive therapy, Type 1 Diabetes TrialNet, TrialNet, POPPII, POPPII-1
Eligibility Criteria
Inclusion Criteria: Potential participants must meet the following inclusion criteria: Be within 3-months of diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria Be between the ages of 8 and 45 years old Must have stimulated C-peptide levels > 0.2 pmol/ml (measured during an MMTT administered no more than one month prior to the date of randomization) Must have either detectable anti-GAD, anti-ICA512/IA-2, insulin autoantibodies (unless received insulin therapy for 7 days or more), or islet cell autoantibodies. [The reason for inclusion of these enrollment criteria is to avoid inclusion of patients with "Type 1B diabetes mellitus", which may not involve the immunologic criteria measured by the assays that will be utilized.] If participant has reproductive potential, he or she must be agreeable to an effective form of birth control (unless abstinence is the chosen method). If participant is female with reproductive potential, she must be willing to undergo pregnancy testing and to report possible or confirmed pregnancies promptly during the course of the MMF/DZB study. Must be willing to comply with intensive diabetes management. The goal of management will be an HbA1c of 7.0% for all participants, regardless of age. Participants will be expected to take a sufficient number of daily insulin shots to meet this goal. Alternatively, participants can use insulin pump therapy. Participants will also be expected to test their blood sugar at least 3-4 times per day. There will be a Certified Diabetes Educator working with study participants to achieve these goals. Exclusion Criteria: Potential participants must not meet any of the following exclusion criteria: Have any complicating medical issues that would interfere with blood drawing or monitoring. Have a Body Mass Index (BMI) that is greater than the 95th percentile for age and gender. Have serologic evidence of HIV infection. Have serologic evidence of Hepatitis B infection. Have serologic evidence of Hepatitis C infection. Have abnormal liver function tests. Have a history of leukopenia and/or neutropenia. Have a history of chronic peptic ulcer disease, erosive esophagitis, chronic inflammatory bowel disease and/or chronic colonic disease. Have a positive PPD test result. Have had any live vaccinations in the preceding 6 weeks (e.g. MMR-second dose, live flu vaccine, varicella vaccine, live polio vaccine, yellow fever vaccine). Resides outside reasonable geographical proximity to the clinic (i.e., residence outside the state in which the Investigator and study reside, residence outside an immediately neighboring state, or residence outside an area that the Investigator considers reasonable). It is left to the Investigator's discretion to decide if a patient's geographical residence is prohibitive to complete study participation. Require chronic use of steroids or other immunosuppressive agents for other conditions. Be currently pregnant or 3 months postpartum. Be currently nursing or within 6 weeks of having completed nursing. Anticipate getting pregnant, or fathering a child, during the study.
Sites / Locations
- Childrens Hospital Los Angeles
- University of California-San Francisco
- Stanford University
- Barbara Davis Center for Childhood Diabetes, University of Colorado
- University of Florida
- Indiana University
- Joslin Diabetes Center
- University of Minnesota
- Columbia University
- Benaroya Research Institute
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
MMF and DBZ
MMF Alone
Placebo
DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and MMF given orally at dose of 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
MMF given orally at dose of 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.