A clinical trial to study the long term effects of Teplizumab in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

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.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2009/091/000729

Enrollment

538

Registered

2009-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Teplizumab (MGA031): None Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

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 CPÂ¬MGA031-01 . The investigator is to give the subject ample time to decide about participation

Exclusion criteria

Exclusion criteria: There are no exclusion criteria for this extension study.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The secondary objectives of the extension study are: 1) A secondary endpoint will be determining the efficacy of teplizumab by measuring the subject's total daily insulin usage and HbA1c levels. 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. 3) Immunophenotyping of blood mononuclear cells will be summarized by visit and graphed over time, as appropriate. 4) Assessing Heath Related Quality of Life Questionnaires filled out by subjects at different timepoints in the study. Timepoint: Not Applicable	—

Measure

Time frame

The secondary objectives of the extension study are: 1) A secondary endpoint will be determining the efficacy of teplizumab by measuring the subject's total daily insulin usage and HbA1c levels. 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. 3) Immunophenotyping of blood mononuclear cells will be summarized by visit and graphed over time, as appropriate. 4) Assessing Heath Related Quality of Life Questionnaires filled out by subjects at different timepoints in the study. Timepoint: Not Applicable

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Countries

India

Contacts

Public ContactDarshana Dholakia

Project Manager, DiagnoSearch Life Sciences Pvt. Ltd.

darshana.dholakia@diagnosearch.com022-67776300

Outcome results