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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1283-0710 | Other Identifier | World Health Organization (WHO) |
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NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0519-0130 | Experimental | Escalating multiple doses of NNC0519-0130 administered subcutaneously. |
|
| Placebo | Placebo Comparator | Escalating multiple doses of NNC0519-0130 matching placebo administered subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | Administered subcutaneously. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period | Measured in h*nmol/L. | From pre-dose until 24 hours post-dose relative to last dose in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period | Measured in nmol/L. | From pre-dose until 24 hours post-dose relative to last dose in each treatment period |
| Number of Treatment Emergent Adverse Events (TEAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI Sumida Hospital | Tokyo | 130-0004 | Japan |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Drug |
Administered subcutaneously. |
|
Measured as number of events. |
| From time of dosing (day 1) until completion of the follow-up visit (day 105) |
| D004700 | Endocrine System Diseases |