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Sponsors and Collaborators: |
MacroGenics Juvenile Diabetes Research Foundation (JDRF) |
Information provided by: | MacroGenics |
ClinicalTrials.gov Identifier: | NCT00385697 |
The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels.
Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.
Condition | Intervention | Phase |
Type 1 Diabetes Mellitus |
Drug: Teplizumab Other: Placebo |
Phase II Phase III |
MedlinePlus related topics: | Diabetes Diabetes Type 1 |
Drug Information available for: | Visilizumab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus |
Estimated Enrollment: | 530 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Teplizumab
IV dosing daily for 14 days times 2 courses
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2: Experimental |
Drug: Teplizumab
IV dosing daily for 14 days times 2 courses
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3: Experimental |
Drug: Teplizumab
IV dosing daily for 14 days times 2 courses
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4: Placebo Comparator |
Other: Placebo
IV dosing daily for 14 days times 2 courses
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The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Ages Eligible for Study: | 8 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all of the following criteria:
One positive result on testing for any of the following antibodies:
Subject must be in one of the following age groups:
Exclusion Criteria:
Subjects must have none of the following:
Contact: Amy Knesel | 240-747-1731 | aknesel@mmgct.com |
Show 98 Study Locations |
MacroGenics |
Juvenile Diabetes Research Foundation (JDRF) |
Responsible Party: | MacroGenics, Inc. ( Ronald L. Wilder, M.D., Ph.D., Vice President, Clinical Research ) |
Study ID Numbers: | CP-MGA031-01 |
First Received: | October 7, 2006 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00385697 |
Health Authority: | United States: Food and Drug Administration |
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