A Multicenter, Multinational Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non -Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent -Onset Type 1 Diabetes Mellitus.

The primary objective of the extension study is to assess long-term safety (3 years), with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subjects with recent-onset T1DM who complete CP-MGA031-01. The secondary objectives of the extension study are to: 1) assess long-term efficacy; 2) evaluate immunological effects(North America only); 3) measure anti-teplizumab antibody levels;4) assess Health Related Quality of Life Questionnaires.Groups/Cohorts in the Protégé study (CP-MGA031-01)Protege had 4 study arms, 3 were dosed with different doses of teplizumab, and 1 was a control group given placebo. This Extension study will assess the subjects from these 4 arms.1 ActiveIn Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses2 Active In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses 3 Active In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses 1 controlled In Protege: Placebo Comparator: IV dosing daily for 14 days times 2 courses This is an Extension study. The patients from Core Study will be rolled over in this study for safety follow - up. No new patients would be recruited in this trial. Hence, status In this trial Globally 538 patients will be included. From India 150 subjects are to be included. Globally, the trail has started on 14-Feb-09. In India, the first patient would be enrolled on 25-Sep-09.Study Type: This is a non-interventional extension study. Update as on 10-Feb-2011: The status of the trial is "Closed to recruitment and Follow-up."