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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1235-3506 | Other Identifier | World Health Organization (WHO) | |
| 2019-002588-92 | Registry Identifier | European Medicines Agency (EudraCT) |
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The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide. Which version participants get is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DV3396 | Experimental | Semaglutide administered with the DV3396 pen-injector (semaglutide D, test formulation) |
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| PDS290 | Experimental | Semaglutide administered with the PDS290 pen-injector (semaglutide reference formulation) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period | hours*nmol/L | 0-840 hours after one dose of s.c. semaglutide 1 mg |
| Cmax,sema,1mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period | nmol/L | 0-840 hours after one dose of s.c. semaglutide 1 mg |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168h,sema,0.25mg,SS: Area under the semaglutide concentration time curve from time 0 until 168 hours at steady state after the last dose of s.c. semaglutide 0.25 mg administration | hours*nmol/L | 0-168 hours after the last dose of s.c. semaglutide 0.25 mg |
| Cmax,sema,0.25mg,SS: Maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mainz | 55116 | Germany |
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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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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nmol/L |
| 0-168 hours after the last dose of s.c. semaglutide 0.25 mg |
| AUC0-∞,sema,1mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period | hours*nmol/L | 0-840 hours after one dose of s.c. semaglutide 1 mg |
| tmax,sema,1mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period | hours | 0-840 hours after one dose of s.c. semaglutide 1 mg |
| tmax,sema,0.25mg,SS: Time of maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration | hours | 0-168 hours after the last dose of s.c. semaglutide 0.25 mg |
| t½,sema,1mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period | hours | 0-840 hours after one dose of s.c. semaglutide 1 mg |
| D004700 | Endocrine System Diseases |