Treatment With hOKT3gamma1(Ala-Ala) in T1DM
This is a phase II study to examine the clinical and immunological effects of humanized FcR non-binding anti-CD3 mAb in participants with Type 1 diabetes mellitus (T1DM), and to develop this therapy to prevent the immune destruction leading to β cell loss.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Multiple Dose Treatment of Type 1 Diabetes Mellitus With hOKT3gamma1(Ala-Ala)|
- 4-hour C-peptide AUC [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Insulin usage [ Time Frame: throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||August 2007|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
3 cycles, six months apart, each consisting of 12 daily infusions with 455-1818ug/m2 hOKT3g1(Ala-Ala)
Other Name: teplizumab
|No Intervention: Control|
This is a 2-arm, open-label phase II trial involving 0 or 3 cycles of treatment 6 months apart with hOKT3γ1 (Ala-Ala), over the first year of disease in participants with new onset T1DM. Each cycle consists of 12 daily doses of hOKT3γ1 (Ala-Ala).
Participants will be randomized in a ratio of 2:1 to either the experimental arm or the control arm and will be stratified by study site.
To be eligible, participants must be: male or female between 7-30 years of age, diagnosed with T1DM within the past 6 weeks, have a body weight ≥26 kg at the time of enrollment and have detectable anti-GAD, anti-ICA512/IA-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days).
Participants randomized to the experimental group will start the first cycle of hOKT3γ1 (Ala-Ala) within 4-8 weeks of T1DM diagnosis. Each participant randomized to the experimental group will receive 3 cycles of drug treatment, separated by 6 months each. Each cycle consists of 12 days of drug treatment.
Both groups will undergo the Mixed Meal Stimulated C-Peptide Test and receive blood draws for mechanistic studies on the same schedule.
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|United States, New York|
|Naomie Berrie Diabetes Center, Columbia University|
|New York, New York, United States, 10032|
|United States, Washington|
|Benaroya Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Kevan C Herold, MD||Yale University|