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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1200-8075 | Other Identifier | World Health Organization (WHO) | |
| 2017-003437-29 | Registry Identifier | European Medicines Agency (EudraCT) |
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This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Semaglutide 0.25 mg | Experimental | Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. |
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| Cohort 2: Semaglutide 0.5 mg | Experimental | Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. |
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| Cohort 3: Semaglutide 0.5 mg | Experimental | Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide, 0.5 mg/mL | Drug | A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration | Measured in nmol·h/L. | 0-840 hours (5 weeks) |
| Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration | Measured in nmol/L. | 0-840 hours (5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration | Measured in nmol·h/L. | 0-840 hours (5 weeks) |
| tmax,sema,SD, time to Cmax,sema,SD of semaglutide |
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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 | |||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Semaglutide, 1.0 mg/mL | Drug | A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours. |
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| Semaglutide, 1.34 mg/mL | Drug | A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours. |
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| Semaglutide, 2.0 mg/mL | Drug | A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours. |
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| DV3372, 0.5 mg/mL | Device | DV3372 device will be used for administration of semaglutide 0.5 mg/mL. |
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| DV3372, 1.0 mg/mL | Device | DV3372 device will be used for administration of semaglutide 1.0 mg/mL. |
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| PDS290 | Device | PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL. |
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| NovoPen®4 | Device | NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL. |
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Measured in hours. |
| 0-840 hours (5 weeks) |
| t½,sema,SD, terminal elimination half-life of semaglutide | Measured in hours. | 0-840 hours (5 weeks) |
| Cl/F,sema,SD, total apparent clearance of semaglutide | Measured in L/h. | 0-840 hours (5 weeks) |
| Vz/F,sema,SD, apparent volume of distribution of semaglutide | Measured in L. | 0-840 hours (5 weeks) |
| Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 0.5 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL | Count of technical complaints. | Week 0-5 in both treatment period 1 and 2 |
| Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 1.0 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL | Count of technical complaints. | Week 0-5 in both treatment period 1 and 2 |
| Neuss |
| 41460 |
| Germany |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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