Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Juvenile Diabetes Research Foundation; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

Inclusion Criteria:

• age 8 - 30,

• duration of diabetes 4 - 12 months,

• weight greater than 27.5 kg,

• stimulated C-peptide >= 0.2 pmol/ml

Exclusion Criteria:

• asthma,

• history of hepatitis C, hepatitis B, HIV