CompletedPhase 2

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

United States83 participantsStarted 2005-09

Plain-language summary

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.

Who can participate

Age range8 Years – 30 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT)

Timeframe: Baseline (Pre-treatment), Month 24

Trial details

NCT IDNCT00129259

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-03

Results submitted2013-06-21

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials