Back to resultsEtanercept in New Onset Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Etanercept
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Etanercept, honeymoon period
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 drug, 2 placebo
Arm Description
Etanercept Placebo
Outcomes
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).
Secondary Outcome Measures
Secondary end points are insulin dose and number of insulin injection discontinued, if any
Full Information
NCT ID
NCT00730392
First Posted
August 5, 2008
Last Updated
April 26, 2023
Sponsor
State University of New York at Buffalo
Collaborators
Amgen
1. Study Identification
Unique Protocol Identification Number
NCT00730392
Brief Title
Etanercept in New Onset Type 1 Diabetes
Official Title
"ENBREL® (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety Study" ("Study")
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Etanercept, honeymoon period
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 drug, 2 placebo
Arm Type
Experimental
Arm Description
Etanercept
Placebo
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Quattrin, MD
Organizational Affiliation
School of Medicine and Biochemical Sciences-SUNYAB
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19366957
Citation
Mastrandrea L, Yu J, Behrens T, Buchlis J, Albini C, Fourtner S, Quattrin T. Etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind study. Diabetes Care. 2009 Jul;32(7):1244-9. doi: 10.2337/dc09-0054. Epub 2009 Apr 14.
Results Reference
derived
Learn more about this trial
Etanercept in New Onset Type 1 Diabetes
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