TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: Juvenile Diabetes Research Foundation

Criteria

Inclusion Criteria:

• Adults 12 to 45 years old who are in good general health

• Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control

• Measurable C-peptide levels

Exclusion Criteria:

• Females must not be pregnant or lactating and willing to practice contraception

• No prior malignancy, other than non-melanoma skin cancer

• Body Mass Index (BMI) > 32 at screening