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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000682-36 | EudraCT Number | ||
| U1111-1139-4281 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide in subjects with various degrees of impaired renal function compared to subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with renal impairment | Experimental |
| |
| Subjects with normal renal function | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide plasma concentration time curve | From time 0 to 24 hours after the 10th dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed semaglutide plasma concentration | 0 to 24 hours after the 10th dosing | |
| Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve | From time 0 to 24 hours after the 10th 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 Investigational Site | Hradec Králové | 50005 | Czechia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29623579 | Result | Granhall C, Sondergaard FL, Thomsen M, Anderson TW. Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment. Clin Pharmacokinet. 2018 Dec;57(12):1571-1580. doi: 10.1007/s40262-018-0649-2. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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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| Maximum observed SNAC plasma concentration | 0 to 24 hours after the 10th dosing |
| Prague |
| 17000 |
| Czechia |
| Novo Nordisk Investigational Site | Budapest | 1076 | Hungary |
| Novo Nordisk Investigational Site | Budapest | 1115 | Hungary |