Etanercept in New Onset Type 1 Diabetes

University at Buffalo (UB)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Type 1 Diabetes

Treatments

Drug: Placebo

Drug: Etanercept

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00730392

20020197

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

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