Clinical trial NCT00100178 (phase 2, status: completed)
Conditions: diabetes mellitus, type 1
ICD codes: E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44
Drugs: mycophenolate mofeteil (mmf), daclizumab (dzb), placebo control for mycophenolate mofeteil (mmf), placebo control for daclizumab (dzb)
SMILES: COC1=C(C\C=C(/C)CCC(=O)OCCN2CCOCC2)C(O)=C2C(=O)OCC2=C1C, COC1=C(C\C=C(/C)CCC(=O)OCCN2CCOCC2)C(O)=C2C(=O)OCC2=C1C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.