Trials / Terminated
TerminatedNCT00920582
Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate 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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 254 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 8 Years – 35 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2012-04-01
- Completion
- 2012-07-01
- First posted
- 2009-06-15
- Last updated
- 2023-12-20
- Results posted
- 2023-12-20
Locations
118 sites across 16 countries: United States, Belgium, Czechia, Finland, France, Germany, India, Israel, Italy, Mexico, Netherlands, Poland, Romania, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00920582. Inclusion in this directory is not an endorsement.