Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2013

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

mAb hOKT3gamma1(Ala-Ala), Teplizumab

This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.

DRUG

Placebo Arm

Trial Locations (4)

10194

Children's Hospital of Philadelphia (CHOP), Philadelphia

80045

Barbara Davis Diabetes Center, Aurora

94143

University of California at San Francisco, San Francisco

06520

Yale University, New Haven

Sponsors
All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

Yale University

OTHER