Diabetes Islet Preservation Immune Treatment

Sponsor
Camillo Ricordi and Jay Skyler
Study ID
NCT02586831
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Anti-Thymocyte Globulin (ATG) — 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 — DRUG
    1 million IU per dose administered subcutaneously for 5 consecutive days on Days 10-14, and then every two weeks.
  • Exenatide — DRUG
    2 mg administered subcutaneously weekly for up to 52 weeks.
  • Adalimumab — 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Jan 2026
Primary completion
Jun 1, 2024
Completion
Jun 1, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Participants in this group will receive Thymoglobulin, Aldesleukin, Adalimumab, and Exenatide over a period of 52 weeks. * Anti-Thymocyte Globulin (ATG or Thymoglobulin®) will be administered at a dose of 2.5mg/kg (2 infusions, 0.5 and 2mg/kg) Days 1 and 2 * Adalimumab (Humira®) will be administered at a dose of 50 mg every month, for 1 year * Low-dose Interleukin 2 (Aldesleukin; IL-2 or Proleukin®) will be administered 1 million IU/dose; 5 consecutive days (days 10-14), \& then every 2 weeks, for 52 weeks * Exenatide (Bydureon®): 2 mg SC weekly up to 52 weeks.
  • Placebo Comparator: Arm B
    Participants in this group will receive the placebos for Thymoglobulin, Aldesleukin, Adalimumab, Exenatide, and Neulasta over a period of 52 weeks.

Primary Outcome Measure

Simulated C-peptide AUC [ Time Frame: 1 Year Visit ]

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