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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2009/091/000729
• Date of registration: 18-09-2009
• Prospective Registration: Yes
• Primary sponsor: MacroGenics Incorporated
• Public title: A clinical trial to study the long term effects of Teplizumab in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus
• Scientific title: 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.
• Date of first enrolment: 29-09-2009
• Target sample size: 538
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=912
• Study type: Observational
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 2/ Phase 3

Countries of recruitment

India

Contacts

• Name: Darshana Dholakia
• Affiliation: Project Manager, DiagnoSearch Life Sciences Pvt. Ltd.

• Name: Darshana Dholakia
• Affiliation: Project Manager, DiagnoSearch Life Sciences Pvt. Ltd.

Key inclusion & exclusion 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 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.

Age minimum:
Age maximum:
Gender:

Intervention(s)

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

Primary Outcome(s)

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(s)

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

Secondary ID(s)

CP-MGA031-02

Source(s) of Monetary Support

MacroGenics, Incorporated 1500 East Gude Drive Rockville, Maryland 20850 USA

Ethics review

Status: Approved
Approval date: 20/02/2009
Contact:

Ethical Committee of B.P.Poddar Hospital & Medical Research Ltd.

Status: Approved
Approval date: 29/06/2009
Contact:

Institutional Ethics Committee, Medwin Hospitals.

Status: Approved
Approval date: 31/07/2009
Contact:

Institutional Ethical Committee, Poona Medical Research foundation

Status: Approved
Approval date: 07/08/2009
Contact:

2. Institutional Review Board, PSRI

Status: Approved
Approval date: 10/08/2009
Contact:

Central India Medical Research Ethics Committee.

Status: Approved
Approval date: 22/08/2009
Contact:

Institutional Ethics Committee, Fortis Escorts Hospital.

Status: Approved
Approval date: 28/08/2009
Contact:

Astha Independent Ethics Comittee

Status: Approved
Approval date: 28/08/2009
Contact:

Medisys Clinisearch Ethical Review Board, Bangalore.

Status: Approved
Approval date: 23/09/2009
Contact:

Gujarat Kidney Foundational Ethical Committee.

Status: Approved
Approval date: 16/02/2010
Contact:

Institutional Ethics Committee for B.R.I.D.E (Bharati Research Institute of Diabetes and Endocrinology)

Status: Approved
Approval date: 18/02/2010
Contact:

Institutional Ethics Committee, Shatabdi Super specialty Hospital

Status: Approved
Approval date: 21/02/2010
Contact:

Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt. Ltd., Indore.

Status: Approved
Approval date: 30/03/2010
Contact:

CLINICOM, Bangalore

Status: Approved
Approval date: 27/04/2010
Contact:

Institutional Ethics Committee, King George Hospital