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

Phase 2/3

Completed

• Conditions: Recent Onset of Type 1 Diabetes Mellitus

• Registration Number: CTRI/2009/091/000729
• Lead Sponsor: MacroGenics Incorporated

Brief Summary

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."

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-29
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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.	Not Applicable

Secondary Outcome Measures

Name	Time	Method
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.	Not Applicable

Trial Locations

Locations (14)

A unit of Diabetes Thyroid Hormone Research Institute Pvt Ltd; 🇮🇳 Indore, MADHYA PRADESH, India

B. P. Poddar Hospital & Medical Research Limited; 🇮🇳 Kolkata, WEST BENGAL, India

Banglore Diabetes Centre; 🇮🇳 Bangalore, KARNATAKA, India

Bharti Hospital; 🇮🇳 Karnal, HARYANA, India

DHL Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

DiabetOmics India Pvt. Ltd; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Endocrine Clinic; 🇮🇳 Pur, India

Fortis Escorts Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Gandhi Endocrinology and Diabetes Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Gujarat Endocrine Centre; 🇮🇳 Ahmadabad, GUJARAT, India

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A unit of Diabetes Thyroid Hormone Research Institute Pvt Ltd

🇮🇳Indore, MADHYA PRADESH, India

Dr. Sunil Jain

Principal investigator

sunilmjain@gmail.com