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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004820-12 | EudraCT Number | ||
| U1111-1150-0801 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Oral administration of 5 mg daily for one week, then escalated to 10 mg daily for one week, followed by escalation to 20 mg daily for 41 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the metformin plasma concentration-time curve | During a dosing interval (0 to12 hours) at steady state | |
| Area under the digoxin plasma concentration-time curve | From time 0 to infinity after single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed metformin plasma concentration | During a dosing interval (0 to 12 hours) at steady state | |
| Maximum observed digoxin plasma concentration | 0 to 120 hours 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 | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30945118 | Background | Baekdal TA, Borregaard J, Hansen CW, Thomsen M, Anderson TW. Effect of Oral Semaglutide on the Pharmacokinetics of Lisinopril, Warfarin, Digoxin, and Metformin in Healthy Subjects. Clin Pharmacokinet. 2019 Sep;58(9):1193-1203. doi: 10.1007/s40262-019-00756-2. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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 |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004071 |
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| metformin | Drug | Oral administration of 850 mg twice daily for 3 days followed by 850 mg on day 4, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) and 3) co-administration with oral semaglutide. |
|
| digoxin | Drug | Oral administration of 0.5 mg single dose, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) and 3) co-administration with oral semaglutide. |
|
| placebo | Drug | Oral administration of SNAC 300 mg. Will be administered with the morning dose of metformin (1st, 3rd, 5th and 7th dose). On Day 24, a single SNAC dose will be administered with digoxin. |
|
| Maximum observed semaglutide plasma concentration |
| During a dosing interval (0 to 24 hours) at steady state |
| Area under the SNAC plasma concentration-time curve | During a dosing interval (0 to 24 hours) at steady state |
| Number of hypoglycaemic episodes | From the first dosing (Day 1) and until completion of the post treatment follow up visit (Day 118-122) |
| Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |