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Sopnsor decision
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This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single dose subcutaneous administration (Dose A) |
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| Cohort 2 | Experimental | Single dose subcutaneous administration (Dose B) |
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| Cohort 3 | Experimental | Single dose subcutaneous administration (Dose C) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM12460A | Biological | HM12460A is a long-acting insulin |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of HM12460A | - Maximum concentration of HM12460A over the entire dosing period | 1 month |
| AUC of HM12460A | - Area Under the Curve of HM12460A over the entire dosing period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Investigative Site | Chula Vista | California | 91911 | 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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| 1 month |
| D004700 | Endocrine System Diseases |