Status:
COMPLETED
Etanercept in New Onset Type 1 Diabetes
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
Amgen
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
PHASE2
Brief Summary
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 fe...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00730392
Start Date
October 1 2002
End Date
January 1 2008
Last Update
April 28 2023
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