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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1122-2992 | Other Identifier | WHO | |
| 2011-002949-35 | EudraCT Number | ||
| P/44/2010 | Other Identifier | EMA (PDCO) | |
| P/96/2011 | Other Identifier | EMA (PDCO) |
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This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg E | Experimental |
| |
| IDeg M | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose | From 0 to 120 hours after dosing | |
| Maximum observed Insulin Degludec concentration after single dose | From 0 to 120 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed Insulin Degludec concentration after single dose | From 0 to 120 hours after dosing | |
| Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose | From 0-24 hours after dosing |
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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 | 91911-1350 | 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 |
|---|---|
| C571886 | insulin degludec |
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| insulin degludec | Drug | Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin) |
|
| Terminal half-life for Insulin Degludec | From 0 to 120 hours after dosing |