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DEFEND-I: Phase 3 Trial of Otelixizumnab

Young Adults With Newly Diagnosed Type I Diabetes Mellitus


 

What is the purpose of this research trial?

DEFEND is a Phase 3 clinical research study evaluating an investigational agent. In type 1 diabetes, beta cells - the cells that make insulin - are destroyed by the body's immune system. If this destruction could be slowed or stopped, the person could continue to make some of their own insulin. The purpose of this study is to find out if a single 8-day course of the investigational agent infusions leads to greater improvement in insulin secretion. DEFEND is a "placebo controlled study," meaning some participants will receive the investigational agent and some will receive an inactive substance (placebo). Two-thirds of the participants will receive the investigational agent and one-third will receive placebo. These study agents will be administered as an addition to insulin, diet, and other standard of care treatments.

Who can participate?

  • Ages Eligible: 12-35 years
    Genders Eligible: both

Who can sign up for this study?

  • 18-35 years of age and in generally good health
  • Have type 1 diabetes
  • Have been diagnosed with type 1 diabetes within 90 days of the time you receive the study drug or placebo
  • Have required insulin treatment since being diagnosed
  • Have evidence of residual beta-cell function (a test will be done to determine this)
  • Have a positive test result for one or more of the autoantibodies typically associated with autoimmune diabetes (a test will be done to determine this)

Exclusion Criteria:

  • Other, significant medical conditions based on the study doctor's evaluation

Who should I call with questions or to schedule an appointment?

Jenna Lungaro: 303.724.6758 or Jenna.Lungaro@ucdenver.edu

For more information please see:
http://www.defendagainstdiabetes.com/

http://clinicaltrials.gov/ct2/show/NCT00678886?term=defend&rank=1