Etanercept in New Onset Type 1 Diabetes

Study Overview
=================
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.

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

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Drug: Etanercept
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 drug, 2 placebo<br>Etanercept Placebo | Drug: Etanercept<br>* 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<br>Drug: Placebo<br>* administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 diabetes, Etanercept, honeymoon period