Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes

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

Timeline

Start

2000-11

Primary completion

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Completion

2007-12

Publications

• Results Saudek F, Havrdova T, Boucek P, Karasova L, Novota P, Skibova J. Polyclonal anti-T-cell therapy for type 1 diabetes mellitus of recent onset. Rev Diabet Stud. 2004 Summer;1(2):80-8. doi: 10.1900/RDS.2004.1.80. Epub 2004 Aug 10.

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Indications