Diabetes Islet Preservation Immune Treatment

What this study is testing ClinicalTrials.gov NCT02586831 ↗

Description as written by the study sponsor.

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Treatments tested

• Anti-Thymocyte Globulin (ATG) also known as Thymoglobulin Drug

  2.5 mg/kg administered as two divided infusions of 0.5 mg/kg and 2 mg/kg on Days 1 and 2.

• Interleukin 2 also known as Aldesleukin; IL-2 or Proleukin® Drug

  1 million IU per dose administered subcutaneously for 5 consecutive days on Days 10-14, and then every two weeks.

• Exenatide also known as Bydureon® Drug

  2 mg administered subcutaneously weekly for up to 52 weeks.

• Adalimumab also known as HUMIRA® Drug

  50 mg administered subcutaneously once a month for 1 year.

• ATG Placebo Other

  ATG placebo mimicking Thymoglobulin administered intravenously.

• IL-2 Placebo Other

  IL-2 placebo mimicking Aldesleukin administered subcutaneously.

• Adalimumab Placebo Other

  Placebo mimicking Adalimumab administered subcutaneously.

• Exenatide Placebo Other

  Placebo mimicking Exenatide administered subcutaneously.