Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes
Status:
Unknown status
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is:
- To compare the effect of ATG treatment together with intensified insulin therapy (Group
1) on fasting and glucagon-stimulated C-peptide production with that of intensified
insulin therapy only (Group 2) in type 1 diabetes mellitus of recent onset
Secondary objectives are:
- To compare the insulin doses between the two groups at 6, 12, 18, and 24 months after
diabetes onset
- To compare the course of the specific humoral markers of autoimmunity between the groups
- To evaluate the significance of in vitro testing of specific T-cell activation by an
autoantigen in the long-term follow-up in type 1 diabetes
- To assess the safety of ATG treatment in type 1 diabetes