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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005072-33 | EudraCT Number | ||
| U1111-1136-6442 | Other Identifier | WHO |
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This trial is conducted in Europe and Asia. The aim of the trial is to investigate the influence of semaglutide on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin and pharmacokinetics of metformin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide administrations | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Subjects will initiate treatment with 0.25 mg for the first four weeks followed by dose doubling every four weeks up to a dose of 1.0 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the metformin plasma concentration-time curve | During a dosing interval (0-12 hours) after the last of 7 repeated doses of metformin without semaglutide exposure (Day 4) and at semaglutide steady state (Day 104) | |
| Area under the S-warfarin plasma concentration-time curve | From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111) | |
| Area under the R-warfarin plasma concentration-time curve | From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed metformin plasma concentration at steady state | From dosing until 30 hours after the last of 7 repeated doses without semaglutide exposure and at semaglutide steady state (metformin administration on Days 4 and 104) | |
| Maximum observed S-warfarin plasma concentration after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28349387 | Result | Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Semaglutide placebo will be administered s.c. |
|
| metformin | Drug | For oral administration twice daily, in two periods, each of 3.5 days duration. The first period is initiated before semaglutide treatment and the second period is initiated at the end of semaglutide treatment. |
|
| warfarin | Drug | For oral administration, given as a single dose. The first dose is given before semaglutide treatment and the second dose is given at the end of semaglutide treatment. |
|
| (0-168 hours) after a single dose of warfarin without semaglutide exposure and at semaglutide steady state (warfarin administrations on Days 11 and 111) |
| Maximum observed R-warfarin plasma concentration after single dose | (0-168 hours) after a single dose of warfarin without semaglutide exposure and at semaglutide steady state (warfarin administrations on Days 11 and 110) |
| Incremental area under the INR (international normalised ratio) -curve | From 0 to 168 hours |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D008687 | Metformin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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