Protege Encore Study: Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
This study is currently recruiting patients.
Verified by MacroGenics, May 2010
First Received: June 12, 2009 Last Updated: May 27, 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Type 1 Diabetes Mellitis | Drug: Tepizumab (MGA031) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Mode: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
Official Title: 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
For additional information, please visit www.protegediabetes.com/vertical_BEW
Further study details as provided by MacroGenics:
Primary Outcome Measures:
- Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subject's total daily insulin usage and his/her HbA1c levels. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subject's total daily insulin usage and his/her HbA1c levels [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- C-peptide secretory responses, as defined by the total area under the curve of the C-peptide response to a mixed meal [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 400
Study Start Date: September 2009
Estimated Starty Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
| Arms | Assigned Interventions |
| 1. Experimental | Drug: Teplizumab (MGA031) IV dosing daily for 14 days times 2 courses |
| 2. Experimental |
Drug: Teplizumab (MGA031) |
| 3. Experimental | Drug: Teplizumab (MGA031) IV doing daily for 14 days times 2 courses |
| 4. Placebo Comparator | Drug: Placebo IV doing daily for 14 days times 2 courses |
Eligibility
Ages Eligible for Study: 8 Years to 35 Years18 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
1. Subjects 8-35 years old
2. Body weight > 36 Kg
3. Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria
4. Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes
5. Requires insulin for T1DM or has required insulin at some time between diagnosis and administration of study drug
6. Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable range of the assay) at screening
7. Diagnosis of T1DM as evidenced by one positive result on testing for any of the following antibodies at screening:
- Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
- Glutamic acid decarboxylase (GAD) autoantibodies, or
- Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive).
Exclusion Criteria:
1. Prior administration of a monoclonal antibody—within the 1 year before randomization
2. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
4. Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
5. Current therapy with GLP-1 receptor agonists (eg, exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
6. Current treatment with oral antidiabetic agents
7. Evidence of active or latent tuberculosis
8. Vaccination with a live virus or organism within the 8 weeks before randomization continuing through Week 52 of the study.
- Influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle.
- Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle
9. Any infectious mononucleosis-like illness within the 6 months before randomization
Contacts and Locations
Please refer to this study by ClinicalTrials.gov identifier NCT00920582
For additional information, please visit www.protegediabetes.com/vertical_BEW
Sponsors and Collaborators
MacroGenics
Eli Lilly and Company
Investigators
Study Director: Robert Brodows, MD MacroGenics
More Information
No publications provided
Responsible Party: MacroGenics Inc. ( Robert Brodows, MD/ Study Director )
ClinicalTrials.gov Identifier: NCT00920582
Other Study ID Numbers: CP-MGA031-03
Study First Received: June 12, 2009
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration
Keywords provided by MacroGenics:
| Protege Encore | Type 1 Diabetes Mellitus |
| Encore | T1DM |
| Tepizumab | MacroGenics |
| Protege | Recent Onset Diabetes |
| MGA031 | hOKT3ya (Ala-Ala) |
| Monoclonal antibody |
Additional relevant MeSH terms:
| Antibodies, Monoclonal | Physiological Effects of Drugs |
| Autoimmune Diseases | Diabetes Mellitus |
| Metabolic Diseases | Endocrine System Diseases |
| Immunologic Factors | Glucose Metabolism Disorders |
| Immune System Diseases | Pharmacologic Actions |
| Diabetes Mellitus, Type 1 |
ClinicalTrials.gov process this record on June 08, 2010
For additional information, please visit www.protegediabetes.com/vertical_BEW
