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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1118-0257 | Other Identifier | Who | |
| 2010-019951-23 | EudraCT Number |
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This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral 1 | Experimental |
| |
| Oral 2 | Experimental |
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| Oral 3 | Experimental |
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| S.c. | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level. |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) | from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycaemic episodes | from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose | |
| Laboratory safety variables (haematology, biochemistry, and urinalysis) | from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose |
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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 |
|---|---|---|---|---|---|---|
| Berlin | 14050 | Germany |
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| 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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| placebo | Drug | Placebo (oral) administered once daily for 10 weeks. |
|
| semaglutide | Drug | Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level. |
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| Maximum plasma concentration of NN9924 | after dosing on the 68th, 69th and 70th Day |
| Area under the plasma concentration curve over the dosing interval (0-24 hours) | after dosing on the 68th, 69th and 70th day |
| Terminal phase elimination half-life | from last dose (day 70) to follow-up visit 91-105 days after first dose |