Etanercept in New Onset Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730392
• Other study ID #: 20020197
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2002
• Est. completion date: January 2008

Study information

• Verified date: April 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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
• Placebo
administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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