Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 \[Ala-Ala\],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes.

Key facts

Study ID

NCT00129259

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

83

Starts

2005-09-01

Expected to finish

2011-03-01

Last updated by the study team

2017-05-22

Who can join

Age: 8 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 1 diabetes (according to American Diabetes Association [ADA] criteria) within the 8 weeks prior to study entry
• Weigh at least 25 kg (55 lbs)
• Insulin autoantibodies assessed within 10 days of any insulin use OR anti-glutamic acid decarboxylase (GAD) autoantibodies OR anti-ICA512/IA-2 autoantibodies
• Subjects or guardian(s) willing to provide informed consent

You may not qualify if…

• Prior participation in a clinical trial that could potentially affect diabetes condition or immunologic status
• Participation in another investigational clinical trial within the 6 weeks prior to study entry
• Pregnancy or breastfeeding

Where it is running

• The Diabetes Center at UCSF — San Francisco, California, United States
• Barbara Davis Center for Childhood Diabetes — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Dept. of Medicine, Division of Endocrinology and the Naomi Berrie Diabetes Center/Columbia University — New York, New York, United States
• Benaroya Research Institute — Seattle, Washington, United States
• Pacific Northwest Research Institute/University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.