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Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

NCT00920582 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2023-12-20

Study results available
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Summary

The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

Teplizumab Herold Regimen

Full dose of teplizumab IV for 14 days, repeated at Week 26

DRUG

Placebo

IV dosing daily for 14 days repeated at Week 26

BIOLOGICAL

Teplizumab 33.3% Herold Regimen

One third full dose of teplizumab IV for 14 days, repeated at Week 26

BIOLOGICAL

Teplizumab Curtailed Herold Regimen

Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-04-30
Completion
2012-07-31

Countries

  • United States
  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00920582 on ClinicalTrials.gov