Skip to main content
OpenTrials
Completed

NCT Number: NCT00730392

Etanercept in New Onset Type 1 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Amgen

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2008
First posted
Aug 8, 2008
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.