Etanercept in New Onset Type 1 Diabetes

State University of New York at Buffalo18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

EtanerceptDRUG

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

PlaceboDRUG

administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC).

Time frame: At baseline and at the end of the 24-week blind treatment

Secondary Outcomes

Secondary end points are insulin dose and number of insulin injection discontinued, if any

Time frame: At baseline and at end of the 24-week treatment period

Data from ClinicalTrials.gov

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