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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Segment 1: 3 Arms | Experimental |
| |
| Segment 2: 4 Arms | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teplizumab or placebo | Drug | infusion or injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose regimen | Define and evaluate dose regimen based on AEs, PD response and drug levels. | 91 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C502540 | teplizumab |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |