Study of Antithymocyte Globulin for Treatment of New-onset T1DM
Condition: New-onset Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Antithymocyte globulin; Placebo
Intervention description: Daily 4-day escalating dose; Daily 4-day saline solution
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 58.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: New-onset Type 1 Diabetes Mellitus; New-onset T1DM; New-onset Type 1 Diabetes; New-onset T1D; Newly Diagnosed Type 1 Diabetes Mellitus; Autoimmune diabetes; Thymoglobulin; ATG; Rabbit antithymocyte globulin

Summary:

      Antithymocyte globulin (e.g., Thymoglobulin®) is an antibody preparation that is commonly
      used to treat and prevent organ transplant rejection. The START trial aims to determine
      whether antithymocyte globulin (ATG) treatment can halt the progression of newly diagnosed
      type 1 diabetes when given within 12 weeks of disease diagnosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 1 diabetes (according to American Diabetes Association [ADA]
             criteria) within100 days of enrollment

          -  Positive for one or more autoantibodies (anti-glutamic acid decarboxylase [GAD],
             anti-insulin, or IA-2 autoantibodies)

          -  Peak stimulated C-peptide level >0.4 pmol/mL or >1.2ng/mL following an MMTT

          -  Serologic evidence of prior Epstein-Barr virus (EBV) infection (EBV seropositive)

          -  Willing to use acceptable forms of contraception

        Exclusion Criteria:

          -  Any sign of active infection (e.g., hepatitis, tuberculosis, EBV, cytomegalovirus
             (CMV), or toxoplasmosis) at screening

          -  Positive for human immunodeficiency virus (HIV), tuberculosis, or hepatitis B surface
             antigen (HBsAg) at screening

          -  Prior history of any significant cardiac disease, such as congestive heart failure,
             arrhythmia, or structural defects, or suspicion thereof

          -  Use of glucocorticoids in the 28 days prior to study entry; or topical use of
             glucocorticoids

          -  Use of diabetes medications (other than insulin) that may affect glucose homeostasis,
             such as metformin, sulfonylureas, thiazolidinediones, or amylin

          -  Evidence of liver dysfunction

          -  Evidence of kidney disease

          -  Pregnancy or plan to become pregnant

          -  Leukopenia (<3,000 leukocytes/µL), neutropenia (<1,500neutrophils/µL), lymphopenia
             (<800 lymphocytes/µL), or thrombocytopenia (<125,000 platelets/µL).

          -  Prior treatment with rabbit ATG or known hypersensitivity or exposure to rabbit
             sera-derived products

          -  Vaccination with a live virus within the last 6 weeks before enrollment

          -  Prior or current therapy that is known to cause a significant, ongoing change in the
             course of T1DM or immunologic status

          -  Any condition that may compromise study participation or may confound the
             interpretation of the study results