NCT00730392

Etanercept in New Onset Type 1 Diabetes

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-10-01
• Primary completion: 2007-10-01
• Completion: 2008-01-01
• First posted: 2008-08-08
• Last updated: 2023-04-28