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This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of REGN1193 in patients with Type 2 Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Participants in Part A will consist of 4 sequential ascending dose cohorts. Each cohort will receive 1 of 4 ascending dose levels of study drug (REGN1193) or placebo. |
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| Part B | Experimental | Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1193 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent adverse events (TEAEs) | Day 1 through Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time | Day 1 through Day 57 | |
| Concentration of REGN1193 in serum over time | Day 1 through Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States | ||||
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000601829 | crotedumab |
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|
| Atlanta |
| Georgia |
| United States |
| Knoxville | Tennessee | United States |
| D004700 | Endocrine System Diseases |