Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006325-13 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
| |
| E | Experimental |
| |
| F1 | Placebo Comparator |
| |
| F2 | Placebo Comparator |
| |
| F3 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | 0.1 mg once weekly, s.c. injection |
| |
| semaglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | at all scheduled visits (2 - 14) following screening |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hypoglycaemic episodes | at all scheduled visits (2 - 14) following screening | |
| Vital signs (blood pressure and pulse) | at all scheduled visits (2 - 14) including screening (visit 1) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Southwest | 17 0RE | United Kingdom |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| F4 | Placebo Comparator |
|
| F5 | Placebo Comparator |
|
| Drug |
0.2 mg once weekly, s.c. injection |
|
| semaglutide | Drug | 0.4 mg once weekly, s.c. injection |
|
| semaglutide | Drug | 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection |
|
| semaglutide | Drug | 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection |
|
|
| placebo | Drug | 0.1 mg once weekly, s.c. injection |
|
| placebo | Drug | 0.2 mg once weekly, s.c. injection |
|
| placebo | Drug | 0.4 mg once weekly, s.c. injection |
|
| placebo | Drug | 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection |
|
| placebo | Drug | 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection |
|
| 12-lead ECG (electrocardiogram) |
| at all scheduled visits (2 - 14) including screening (visit 1) |
| Haematology | at all scheduled visits (2 - 14) including screening (visit 1) |
| Biochemistry | at all scheduled visits (2 - 14) including screening (visit 1) |
| Urinalysis | at all scheduled visits (2 - 14) including screening (visit 1) |
| Calcitonin | at screening (visit 1) and at visits 2, 9 and 14 |
| Antibody development against N9535 | at visits 2 and 14 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided