NCT00870818

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
12.3 years until next milestone

Results Posted

Study results publicly available

August 9, 2023

Completed
Last Updated

August 9, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

March 26, 2009

Results QC Date

March 8, 2023

Last Update Submit

July 19, 2023

Conditions

Type 1 Diabetes Mellitus

Keywords

TeplizumabProtegeMGA031Monoclonal antibodyType 1 Diabetes MellitusT1DMMacroGenics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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

  • 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

  • Proportion of Subjects With HbA1c <6.5%

    Month 6

  • Mean HbA1c at 6 Months

    6 months

  • Mean HbA1c at 12 Months

    Month 12

  • +10 more secondary outcomes

Study Arms (5)

Double-blind Herold Regimen

EXPERIMENTAL

Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Diagnostic Test: Blood samples for safetyBehavioral: Patient reported outcome questionnairesDiagnostic Test: Analysis of T-cell subsets

Double-blind 33.3% Herold Regimen

EXPERIMENTAL

Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Diagnostic Test: Blood samples for safetyBehavioral: Patient reported outcome questionnairesDiagnostic Test: Analysis of T-cell subsets

Double-blind Curtailed Herold Regimen

EXPERIMENTAL

Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Diagnostic Test: Blood samples for safetyBehavioral: Patient reported outcome questionnairesDiagnostic Test: Analysis of T-cell subsets

Double-blind Placebo

PLACEBO COMPARATOR

Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Diagnostic Test: Blood samples for safetyBehavioral: Patient reported outcome questionnairesDiagnostic Test: Analysis of T-cell subsets

Open-label Herold Regimen

EXPERIMENTAL

Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Diagnostic Test: Blood samples for safetyBehavioral: Patient reported outcome questionnairesDiagnostic Test: Analysis of T-cell subsets

Interventions

Blood samples for safetyDIAGNOSTIC_TEST

serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies

Double-blind 33.3% Herold RegimenDouble-blind Curtailed Herold RegimenDouble-blind Herold RegimenDouble-blind PlaceboOpen-label Herold Regimen
Patient reported outcome questionnairesBEHAVIORAL

EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.

Double-blind 33.3% Herold RegimenDouble-blind Curtailed Herold RegimenDouble-blind Herold RegimenDouble-blind PlaceboOpen-label Herold Regimen
Analysis of T-cell subsetsDIAGNOSTIC_TEST

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

Double-blind 33.3% Herold RegimenDouble-blind Curtailed Herold RegimenDouble-blind Herold RegimenDouble-blind PlaceboOpen-label Herold Regimen

Eligibility Criteria

Age10 Years - 37 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
  • Provide written informed consent.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

No formal inferential analyses were conducted due to limited number of participants. Data are summarized as mean change from baseline, both from Protégé and Extension baselines, for C-peptide AUC, HbA1c, insulin, and fasting C-peptide. Only existing data are summarized, no last observation carried forward imputation was performed. Patient reported outcomes were collected and summarized as mean change from baseline. However, only change from baseline from Extension could be summarized.

Results Point of Contact

Title
Sharon Rowland
Organization
Provention Bio, Inc
SRowland@proventionbio.com
443-987-0797

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

May 1, 2011

Last Updated

August 9, 2023

Results First Posted

August 9, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)