Etanercept in New Onset Type 1 Diabetes

April 26, 2023 updated by: Teresa Quattrin, State University of New York at Buffalo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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).
Time Frame: At baseline and at the end of the 24-week blind treatment
At baseline and at the end of the 24-week blind treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At baseline and at end of the 24-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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