TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

Stopped early · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT00451321

Run by

GlaxoSmithKline

People needed

88

Starts

2006-07-31

Expected to finish

2011-12-01

Last updated by the study team

2017-11-13

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Aurora, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Pinellas Park, Florida, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Worcester, Massachusetts, United States
• GSK Investigational Site — Kalamazoo, Michigan, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — Gulfport, Mississippi, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Mentor, Ohio, United States
• GSK Investigational Site — Rapid City, South Dakota, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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