Etanercept in New Onset Type 1 Diabetes

NCT ID: NCT00730392

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2008-01-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1 drug, 2 placebo

1. Etanercept

2. Placebo

Group Type: EXPERIMENTAL

Etanercept

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Teresa Quattrin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Quattrin, MD

Role: PRINCIPAL_INVESTIGATOR

School of Medicine and Biochemical Sciences-SUNYAB

References

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.

Reference Type: DERIVED

PMID: 19366957 (View on PubMed)

Other Identifiers

20020197

Identifier Type: -

Identifier Source: org_study_id