Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)

Type 1 Diabetes Mellitus Clinical Trial

Official title:

An 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 Patients With Recent-Onset Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00870818
• Other study ID #: CP-MGA031-02
• Status: Terminated
• Phase: N/A
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2023
• Source: MacroGenics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).

Description:

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 219
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 37 Years

Eligibility

Inclusion Criteria:

1. 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.

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Diagnostic Test:
• Blood samples for safety
serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies

Behavioral:
• Patient reported outcome questionnaires
EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.

Diagnostic Test:
• Analysis of T-cell subsets
CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
MacroGenics	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.		Duration of study participation up to 15 months
Secondary	Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.		Month 6
Secondary	Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.		Month 12
Secondary	Proportion of Subjects With HbA1c <6.5%		Month 6
Secondary	Mean HbA1c at 6 Months		6 months
Secondary	Mean HbA1c at 12 Months		Month 12
Secondary	C-peptide Area Under the Curve (AUC) at 6 Months	This outcome measure summarizes the mean and standard deviation of the observed value.	Month 6
Secondary	C-peptide AUC at 12 Months	This outcome measure summarizes the mean and standard deviation of the observed value.	Month 12
Secondary	Total Daily Insulin Usage at 6 Months		Month 6
Secondary	Total Daily Insulin Usage at 12 Months		Month 12
Secondary	Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D)	The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life.	Month 6
Secondary	Mean Values for Participant-reported Outcomes on the EQ-5D	The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life.	Month 12
Secondary	Pediatric Quality of Life Questionnaire Total Score	The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed.	Month 6
Secondary	Pediatric Quality of Life Questionnaire Total Score	The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed.	Month 12
Secondary	Percentage of Cells by Immunophenotype		Month 6
Secondary	Human Anti-human Antibody (HAHA) Levels	Patients with HAHA levels > 0.	Month 6 and 12