Conditions: Type 1 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

Detailed description:

Arms:
arm 1: 14-day cycle of teplizumab consisting of daily IV doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, and 413 µg/m2 on Study Days 1-4, respectively, and one dose of 826 µg/m2 on each of Study Days 5-14. Repeat at Week 26 arm 2: Subjects received a 14-day cycle of teplizumab consisting of daily IV doses of 17 µg/m2, 34 µg/m2, 68 µg/m2, and 136 µg/m2 on Study Days 1-4, respectively, and one dose of 273 µg/m2 on each of Study Days 5-14. Repeat at Week 26 arm 3: Subjects received a 6 day cycle of teplizumab consisting of daily IV doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, and 413 µg/m2 on Study Days 1-4, respectively, and one dose of 826 µg/m2 on each of Study Days 5-6, followed by 8 days of IV placebo (Study Days 7-14). Repeat at Week 26 arm 4: 14-day cycle of placebo consisting of daily IV doses. Repeat at Week 26

Interventions: intervention 1: Teplizumab Herold Regimen intervention 2: Placebo intervention 3: Teplizumab 33.3% Herold Regimen intervention 4: Teplizumab Curtailed Herold Regimen
Intervention descriptions: intervention 1: Full dose of teplizumab IV for 14 days, repeated at Week 26 intervention 2: IV dosing daily for 14 days repeated at Week 26 intervention 3: One third full dose of teplizumab IV for 14 days, repeated at Week 26 intervention 4: Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26

Protocol document: