Status:
COMPLETED
New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
8-45 years
Phase:
PHASE2
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...
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 mof...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00100178
Start Date
May 1 2004
End Date
April 1 2008
Last Update
May 5 2020
Active Locations (11)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of California-San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305-5208
4
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, United States, 80262