Etanercept in New Onset Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
University at Buffalo
ClinicalTrials.gov Identifier:
NCT00730392
First received: August 5, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention Phase
Type 1 Diabetes
Drug: Etanercept
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: "ENBREL® (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety Study" ("Study")

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2002
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730392

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

No publications provided by University at Buffalo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teresa Quattrin, University at Buffalo
ClinicalTrials.gov Identifier: NCT00730392     History of Changes
Other Study ID Numbers: 20020197
Study First Received: August 5, 2008
Last Updated: August 5, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 30, 2014