Study of Antithymocyte Globulin for Treatment of New-onset T1DM

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Antilymphocyte Serum; Thymoglobulin

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