Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
Type 1 Diabetes Mellitus
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Teplizumab, Protege, MGA031, Monoclonal antibody, Type 1 Diabetes Mellitus, T1DM, MacroGenics
Eligibility Criteria
Inclusion Criteria:
- Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
- Provide written informed consent.
Exclusion Criteria:
None
Sites / Locations
- Atlanta Diabetes Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Double-blind Herold Regimen
Double-blind 33.3% Herold Regimen
Double-blind Curtailed Herold Regimen
Double-blind Placebo
Open-label Herold Regimen
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.