Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in
      individuals with new onset T1DM will improve insulin secretion (C-peptide production)
      compared to placebo.
    

Detailed description: 
      Type 1 diabetes mellitus (T1DM) is a T-cell mediated autoimmune disease in which
      insulin-producing beta cells are completely or near completely destroyed resulting in
      life-long dependence on exogenous insulin.

      CTLA4-Ig (Abatacept) inhibits a crucial stimulatory pathway in the activation of T cells. By
      this mechanism, the drug is thought to arrest or slow the T cell mediated autoimmune
      destruction of beta-cells and preserve their function. At the time of clinical onset of T1DM,
      a significant amount of insulin producing beta cells are destroyed, but as many as 10-20% are
      still capable of insulin production. By using CTLA4-Ig close to the onset of T1DM, we hope to
      arrest or slow down the autoimmune destruction of these beta-cells and extend the endogenous
      insulin production. CTLA4-Ig regulates T cell function but does not deplete T cells.
      Therefore, its safety profile appears to be better than other immunosuppressive agents.

      Eligible participants will be randomized to the experimental or control groups. The
      experimental group will receive intravenous infusions of CTLA-4 Ig. The first infusion will
      occur at the time of randomization, followed by another infusion 2 and 4 weeks later.
      Subsequent infusions will be given monthly for two years during the treatment phase of the
      study. There is a total of 27 infusions during the treatment phase of the study.

      Participants in the control group will receive intravenous infusions of placebo according to
      the same schedule outlined above.

      Both groups will receive standard intensive diabetes treatment with insulin and dietary
      management.

      All participants randomized into the study will be seen at study site monthly for 24 months
      and then every 6 months for up to an additional 2 years. Participants will undergo
      assessments of their insulin production, immunologic status, overall health and well being
      and diabetes care.
    

Intervention name(s): CTLA-4 Ig; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses; Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
Other intervention name(s): Abatacept
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CTLA4-Ig; Abatacept; Beta-cell function; T-cells; DPT-1; treatment; treatment of type 1 diabetes; new onset type 1 diabetes; juvenile diabetes; T1D; diabetes mellitus; Type 1 diabetes TrialNet; TrialNet