TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:12 - 45
Updated:10/14/2017
Start Date:July 2006
End Date:December 2011

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Trial Summary
Trial Overview
Inclusion Criteria

TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)

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.


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
We found this trial at
17
sites
GSK Investigational Site
Minneapolis, Minnesota 55404
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Minneapolis, MN
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GSK Investigational Site
Aurora, Colorado 80010
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Aurora, CO
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GSK Investigational Site
Baltimore, Maryland 21201
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Baltimore, MD
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GSK Investigational Site
Birmingham, Alabama 35249
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Birmingham, AL
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GSK Investigational Site
Chicago, Illinois 60611
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Chicago, IL
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GSK Investigational Site
Gulfport, Mississippi 39501
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Gulfport, MS
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GSK Investigational Site
Jacksonville, Florida 32207
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Jacksonville, FL
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GSK Investigational Site
Kalamazoo, Michigan 49007
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Kalamazoo, MI
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GSK Investigational Site
Mentor, Ohio 44060
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Mentor, OH
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GSK Investigational Site
Omaha, Nebraska 68131
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Omaha, NE
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GSK Investigational Site
Pinellas Park, Florida 33781
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Pinellas Park, FL
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GSK Investigational Site
Rapid City, South Dakota 57702
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Rapid City, SD
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GSK Investigational Site
San Antonio, Texas 78258
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San Antonio, TX
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GSK Investigational Site
Toronto, Ontario
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Toronto,
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GSK Investigational Site
Walnut Creek, California 94596
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Walnut Creek, CA
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GSK Investigational Site
Washington, District of Columbia 20007
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from
Washington,
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GSK Investigational Site
Worcester, Massachusetts 01655
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from
Worcester, MA
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