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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009466-14 | EudraCT Number | ||
| U1111-1111-0810 | Other Identifier | WHO |
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This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESRD | Experimental |
| |
| Mild | Experimental |
| |
| Moderate | Experimental |
| |
| Normal | Experimental |
| |
| Severe | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin degludec concentration-time curve | from 0 to 120 hours after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed insulin degludec concentration | from 0 to 120 hours after trial product administration | |
| Renal clearance of insulin degludec after single-dose | from 0 to 24 hours after trial product administration |
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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 | Budapest | 1115 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24163264 | Result | Kiss I, Arold G, Roepstorff C, Bottcher SG, Klim S, Haahr H. Insulin degludec: pharmacokinetics in patients with renal impairment. Clin Pharmacokinet. 2014 Feb;53(2):175-83. doi: 10.1007/s40262-013-0113-2. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin degludec | Drug | Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment |
|
| insulin degludec | Drug | Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment |
|
| insulin degludec | Drug | Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers |
|
| insulin degludec | Drug | Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment |
|
| 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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