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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009465-34 | EudraCT Number |
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This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Healthy volunteers | Experimental |
| |
| B: Subjects with mild liver impairment | Experimental |
| |
| C: Subjects with moderate liver impairment | Experimental |
| |
| D: Subjects with severe liver impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the NN1250 concentration-time curve after single-dose | from 0 to 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed NN1250 concentration after single-dose | from 0 to 120 hours | |
| Renal clearance of NN1250 | from 0 to 24 hours | |
| Number of adverse events |
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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 Investigational Site | Bratislava | 833 05 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24277680 | Result | Kupcova V, Arold G, Roepstorff C, Hojbjerre M, Klim S, Haahr H. Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment. Clin Drug Investig. 2014 Feb;34(2):127-33. doi: 10.1007/s40261-013-0154-1. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| from Visit 2, Day -1 until Follow-up Visit |
| 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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