Study of Antithymocyte Globulin for Treatment of New-onset T1DM (START)
New-onset Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for New-onset Type 1 Diabetes Mellitus focused on measuring 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
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
Sites / Locations
- Children's Hospital/USC School of Medicine
- Children's Hospital and Research Center
- UCSD/San Diego Children's Hospital
- Diabetes Center at UCSF
- Barbara Davis Center for Childhood Diabetes, University of Colorado
- Emory Children's Center
- University of Minnesota
- Children's Mercy Hospital
- University of Pennsylvania/Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Antithymocyte globulin
Placebo
This group received a total of 6.5 mg/kg of antithymocyte globulin (e.g., Thymoglobulin®) divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
This group received a saline solution to match the Thymoglobulin doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.