Etanercept in New Onset Type 1 Diabetes

"ENBREL® (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety Study" ("Study")

The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.

This is a double-blind randomized 24-week placebo-controlled feasibility and safety study. Subjects received study drug for a 24- week period, followed by 4 and 12-week wash out periods.

Inclusion Criteria:

• Males and females subjects with T1DM aged 3-18 years
• Positive GAD 65 and/or islet cell antibody
• HbA1c at diagnosis above 6%
• Insulin regimen with 3 injection of insulin daily (as described below)
• White blood count between 3,000-10,000 and platelets > 100,000
• Normal ALT and AST, creatinine < 1.8 mg/dl
• T1DM duration equal or less than 4 weeks

Exclusion Criteria:

• Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry
• BMI over 85th percentile for age and gender
• Unstable household
• Unable to provide compliance with study drug, insulin and study visits,
• Evidence of psychiatric disease in the potential study subject and/or primary care taker
• And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis