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| Sponsored by: |
MacroGenics |
|---|---|
| Information provided by: | MacroGenics |
| ClinicalTrials.gov Identifier: | NCT00385697 |
Purpose
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 |
| 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 |
| Enrollment: | 556 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 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
|
| 2: Experimental |
Drug: Teplizumab
IV dosing daily for 14 days times 2 courses
|
| 3: Experimental |
Drug: Teplizumab
IV dosing daily for 14 days times 2 courses
|
| 4: Placebo Comparator |
Other: Placebo
IV dosing daily for 14 days times 2 courses
|
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
Eligibility| 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:
Contacts and Locations
Show 116 Study Locations
More Information
| Responsible Party: | MacroGenics, Inc. ( Stanley R. Pillimer, MD/ Vice President Clinical Research and Product Safety ) |
| Study ID Numbers: | CP-MGA031-01 |
| Study First Received: | October 7, 2006 |
| Last Updated: | June 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00385697 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Randomized Double Blind Parallel Group Controlled Clinical Trial |
|
Antibodies, Monoclonal Antibodies Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Immunoglobulins |
|
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |