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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1149-3924 | Other Identifier | WHO | |
| 2009-011673-33 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild, moderate or severe hepatic impairment compared to subjects with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal hepatic function | Experimental |
| |
| Mild hepatic impairment | Experimental |
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| Moderate hepatic impairment | Experimental |
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| Severe hepatic impairment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide plasma concentration-time curve | Day 1 - day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed semaglutide plasma concentration | Day 1 - day 36 | |
| Number of treatment emergent adverse events (TEAEs) | Day 1 - day 36 |
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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 | Warsaw | 02-507 | Poland | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29205786 | Result | Jensen L, Kupcova V, Arold G, Pettersson J, Hjerpsted JB. Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment. Diabetes Obes Metab. 2018 Apr;20(4):998-1005. doi: 10.1111/dom.13186. Epub 2018 Jan 17. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| WoĊomin |
| 05-200 |
| Poland |
| Novo Nordisk Investigational Site | Bratislava | 83101 | Slovakia |
| Novo Nordisk Investigational Site | Bratislava | 833 05 | Slovakia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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