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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1233-0878 | Other Identifier | World Health Organization (WHO) | |
| 2019-002010-40 | Registry Identifier | European Medicines Agency (EudraCT) |
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In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. Besides semaglutide, the current version of the tablet contains 300 mg SNAC and 3 helping agents, while the new version of the tablet contains 300 mg SNAC and only one helping agent. Both are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. Semaglutide cannot yet be prescribed as a tablet. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. Participants will get semaglutide in the current tablet formulation and in a new formulation - in which order they receive the two different formulations is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment for a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, they must take their breakfast 30-45 minutes after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Current form 3 mg in treatment period 1, followed by current form 7 mg in treatment period 2, followed by new form 11.2 mg in treatment period 3 |
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| Sequence 2 | Experimental | Current form 3 mg in treatment period 1, followed by new form 5.6 mg in treatment period 2, followed by current form 14 mg in treatment period 3 |
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| Sequence 3 | Experimental | New form 2.4 mg in treatment period 1, followed by current form 7 mg in treatment period 2, followed by current form 14 mg in treatment period 3 |
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| Sequence 4 | Experimental | New form 2.4 mg in treatment period 1, followed by new form 5.6 mg in treatment period 2, followed by current form 14 mg in treatment period 3 |
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| Sequence 5 | Experimental | New form 2.4 mg in treatment period 1, followed by current form 7 mg in treatment period 2, followed by new form 11.2 mg in treatment period 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral semaglutide | Drug | Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,sema,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state | nmol*h/L | From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,sema,SS; maximum semaglutide plasma concentration at steady state | nmol/L | From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively |
| tmax,sema,SS; time to maximum semaglutide plasma contraction at steady state |
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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 | Berlin | 14050 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Sequence 6 | Experimental | Current form 3 mg in treatment period 1, followed by new form 5.6 mg in treatment period 2, followed by new form 11.2 mg in treatment period 3 |
|
h |
| From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively |
| t½,sema,SS; terminal half-life of semaglutide at steady state | h | Determined by concentrations measured between day 84 and follow-up at day 119 |
| 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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