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Trial record 28 of 2363 for:    "Diabetes Mellitus, Insulin-Dependent"

Etanercept in New Onset Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730392
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : August 8, 2008
Information provided by:
University 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Etanercept Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: "ENBREL® (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety Study" ("Study")
Study Start Date : October 2002
Actual Primary Completion Date : October 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Etanercept

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730392

Sponsors and Collaborators
University at Buffalo
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Principal Investigator: Teresa Quattrin, MD School of Medicine and Biochemical Sciences-SUNYAB

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Teresa Quattrin, University at Buffalo Identifier: NCT00730392     History of Changes
Other Study ID Numbers: 20020197
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: August 2008

Keywords provided by University at Buffalo:
Type 1 diabetes, Etanercept, honeymoon period

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors