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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000361-20 | EudraCT Number | ||
| U1111-1127-4408 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy - 20 mg | Experimental |
| |
| Healthy - 40 mg | Experimental |
| |
| Healthy - 60 mg | Experimental |
| |
| T2D - 20/40/60 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) recorded | From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration curve over the dosing interval (0-24 hours) | After the last 3 daily doses for semaglutide and carrier | |
| Change from baseline in fasting plasma glucose (FPG) | Week 0, week 10 (Day 69) |
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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 |
|---|---|---|---|
| 30566096 | Result | Seco A, Aparicio S, Gonzalez-Camejo J, Jimenez-Benitez A, Mateo O, Mora JF, Noriega-Hevia G, Sanchis-Perucho P, Serna-Garcia R, Zamorano-Lopez N, Gimenez JB, Ruiz-Martinez A, Aguado D, Barat R, Borras L, Bouzas A, Marti N, Paches M, Ribes J, Robles A, Ruano MV, Serralta J, Ferrer J. Resource recovery from sulphate-rich sewage through an innovative anaerobic-based water resource recovery facility (WRRF). Water Sci Technol. 2018 Dec;78(9):1925-1936. doi: 10.2166/wst.2018.492. | |
| 30565096 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| semaglutide | Drug | Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration. |
|
| semaglutide | Drug | Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration. |
|
| placebo | Drug | Placebo semaglutide. For oral administration. |
|
| placebo | Drug | Placebo semaglutide with carrier. For oral administration. |
|
| Change from baseline in C-peptide | Week 0, week 10 (Day 69) |
| Change from baseline in insulin | Week 0, week 10 (Day 69) |
| Change from baseline in glucagon | Week 0, week 10 (Day 69) |
| Change from baseline in glycosylated haemoglobin type A1c (HbA1c) | Week 0, week 10 (Day 69) |
| Derived |
| Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4. |
| 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 |
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