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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005171-84 | EudraCT Number | ||
| U1111-1164-2741 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| semaglutide OD + placebo semaglutide OW | Experimental |
| |
| placebo semaglutide OW + placebo semaglutide OD | Placebo Comparator |
| |
| semaglutide OW + placebo semaglutide OD | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Administered subcutaneously (s.c., under the skin)once daily or once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide concentration-time curves | At steady-state from 0 to168 hours after dosing on day 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed semaglutide plasma concentration | At steady-state derived from the concentration-time curves, within 168 hours from day 78 | |
| Number of treatment emergent adverse events (TEAEs) | From baseline (day 1, post-dose) to last follow-up visit (day 120) |
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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 | Berlin | 10117 | Germany |
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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 |
|---|---|
| C000591245 | semaglutide |
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| placebo | Drug | Administered subcutaneously (s.c., under the skin)once daily or once weekly. |
|
| Area under the the single dose concentration-time curve | From 0 to 300 min after administration of paracetamol (1.5 g) at day 51 |
| Area under the the single dose concentration-time curve | From 0 to 300 min after administration of paracetamol (1.5 g) at day 79 |