A clinical trial to study the long term effects of Teplizumab in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus
Phase 2
Completed
- Registration Number
- CTRI/2009/091/000729
- Lead Sponsor
- MacroGenics Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 538
Inclusion Criteria
1.Subjects must meet all of the following criteria to participate in the extension study: Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
2.Provide written informed consent. Written assent will be obtained for subjects under 18 years of age, according to applicable regulations. If possible, written informed consent and/or assent should be obtained for Protocol CP-MGA031-02 at the last visit in CP¬MGA031-01 . The investigator is to give the subject ample time to decide about participation
Exclusion Criteria
There are no exclusion criteria for this extension study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the extension study is to assess long-term safety, 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.Timepoint: Not Applicable
- Secondary Outcome Measures
Name Time Method The secondary objectives of the extension study are: <br>1) A secondary endpoint will be determining the efficacy of teplizumab by measuring the subject's total daily insulin usage and HbA1c levels.<br>2) C-peptide secretory response will be analyzed in terms of basal levels of C-peptide produced before a mixed meal and stimulated levels after a mixed meal, measured as AUC and peak post-meal production.<br>3) Immunophenotyping of blood mononuclear cells will be summarized by visit and graphed over time, as appropriate.<br>4) Assessing Heath Related Quality of Life Questionnaires filled out by subjects at different timepoints in the study.<br>Timepoint: Not Applicable