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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-7011 | Other Identifier | WHO |
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This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp B | Experimental |
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| IDegAsp F | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin degludec concentration-time curve | from 0 to 120 hours after single-dose | |
| Maximum observed serum insulin degludec concentration | from 0 to 120 hours after single-dose | |
| Area under the serum insulin aspart concentration-time curve | from 0 to 12 hours after single-dose | |
| Maximum observed serum insulin aspart concentration | from 0 to 12 hours after single-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed serum insulin degludec concentration | from 0 to 120 hours after single-dose | |
| Time to maximum observed serum insulin aspart concentration | from 0 to 12 hours after single-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Clinical Trial Call Center | Chula Vista | California | 91911 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
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