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

• Status: Unknown status
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Collaborator: Ministry of Health, Czech Republic
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• Type 1 diabetes

• Body mass index up to 32 kg/m2

• Exclusion of gravidity in women

• Known diagnosis of diabetes of less than 6 weeks

• Insulin dose of up to 40 IU per day for no longer than 1 month

• Positive for at least one autoantibody (GAD, IA2, ICA)

• C-peptide level ≥ 0.3 pmol/ml 4 min. following intravenous (IV) administration of 1 ml glucagon

• No concurrent severe infection

• Granulocyte count ≥ 2 x 10^9/l

• Platelet count ≥ 120 x 10^9/l

Exclusion Criteria:

• Other non-diabetes related autoimmune disease

• Previous immunosuppressive therapy

• Any clinical impairment precluding immunosuppressive therapy

• Leucopenia or thrombocytopenia