Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: GAD-Alum; GAD-Alum and Aluminum hydroxide; Aluminum hydroxide
Intervention description: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.; Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.; Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
Intervention MeSH terms: Aluminum Hydroxide; Aluminum sulfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 145.0
Sex: All
Minimum age: 3 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: immune tolerance; immunotherapy; antigen-specific tolerance; vaccine induced tolerance; Beta-cell function; T-cells; DPT-1; treatment of type 1 diabetes; new onset type 1 diabetes; juvenile diabetes; T1D; diabetes mellitus; Type 1 diabetes TrialNet; TrialNet

Summary:

      The purpose of this study is to determine whether treatment with multiple injections of
      GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have
      been recently diagnosed with type 1 diabetes mellitus (T1DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3 to 45 years - Insulin dependent type 1-diabetes mellitus diagnosed within the
             previous 3 months

          -  Stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during a
             mixed meal tolerance test (MMTT) conducted 3 weeks from diagnosis of diabetes

          -  Presence of GAD65 antibodies

          -  At least one month from last immunization

          -  Willing to comply with intensive diabetes management

          -  If participant is a woman with reproductive potential, she must be willing to avoid
             pregnancy and have a negative pregnancy test

          -  Willing to forgo routine clinical immunizations during the first 100 days after
             initial study drug administration

        Exclusion Criteria:

          -  Immunodeficiency or clinically significant chronic lymphopenia

          -  Active infection

          -  Positive PPD test result

          -  Pregnant or lactating or anticipating becoming pregnant for 24 months following first
             injection

          -  Ongoing use of medications known to influence glucose tolerance

          -  Require use of systemic immunosuppressant(s)

          -  Serologic evidence of current or past HIV, Hep B, or Hep C infection

          -  History of malignancies

          -  Ongoing use of non-insulin pharmaceuticals to affect glycemic control

          -  Participation in another clinical trial with a new chemical entity within the past 3
             months

          -  Complicating medical issues or abnormal clinical laboratory results that interfere
             with study conduct or cause increased risk including neurological, or clinically
             significant blood count abnormalities (such as lymphopenia, leukopenia, or
             thrombocytopenia)

          -  History of epilepsy, head trauma or cerebrovascular accident or clinical

          -  History of alcohol or drug abuse