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临床试验/NCT00730392
NCT00730392已完成1 期

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

State University of New York at Buffalo0 个研究点目标入组 18 人开始时间: 2002年10月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
18
主要终点
The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC).
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
3 Years 至 18 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

1 drug, 2 placebo

Experimental
  1. Etanercept
  2. Placebo

干预措施: Etanercept (Drug)

1 drug, 2 placebo

Experimental
  1. Etanercept
  2. Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

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

时间窗: At baseline and at the end of the 24-week blind treatment

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Quattrin

Principal Investigator

State University of New York at Buffalo

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