Etanercept in New Onset Type 1 Diabetes

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Etanercept; Drug: Placebo

• Registration Number: NCT00730392
• Lead Sponsor: State University of New York at Buffalo

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.

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2007-10
• Study Completion: 2008-01
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 drug, 2 placebo	Etanercept	1. Etanercept 2. Placebo
1 drug, 2 placebo	Placebo	1. Etanercept 2. Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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