Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, Etanercept, honeymoon period
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 feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.
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.
Interventions
DRUGEtanercept
The study drug was provided in lyophilized 10 mg vials to be reconstituted with 1 ml of diluent/vial and was administered at a dose of 0.4 mg/Kg up to maximum dose of 25 mg/dose SC twice weekly
DRUGPlacebo
administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly
Sponsors
Amgen
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC). | At baseline and at the end of the 24-week blind treatment |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points are insulin dose and number of insulin injection discontinued, if any | At baseline and at end of the 24-week treatment period |
Outcome results
None listed