Conditions: Type 1 Diabetes Mellitus
Keywords: Randomized Double Blind Parallel Group Controlled Clinical Trial
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 554
Healthy volunteers: no

Brief summary:
The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels.

Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.

Detailed description:
The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Arms:
arm 1: Full dose of teplizumab IV for 14 days, repeated at Week 26 arm 2: One third full dose of teplizumab IV for 14 days, repeated at Week 26 arm 3: Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 arm 4: Placebo IV dosing daily for 14 days repeated at Week 26 arm 5: Full dose of teplizumab IV for 14 days, repeated at Week 26

Interventions: intervention 1: Teplizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Daily IV dosing for 14 days, repeated at Week 26 intervention 2: Daily IV dosing for 14 days, repeated at Week 26

Protocol document: