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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1321-8272 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to find out if the new tablet formulation oral semaglutide D is equally safe and effective as the approved oral semaglutide for treating Japanese people with type 2 diabetes. Participants will receive either oral semaglutide D (the treatment being tested) or oral semaglutide (the comparator); which treatment a participant gets is decided by chance. Oral semaglutide is an approved tablet (a treatment used as a comparator), while oral semaglutide D is described as the new tablet formulation being tested in this study. The study will last approximately 27 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral semaglutide D | Experimental | Participants will receive oral semaglutide D once daily. |
|
| Oral semaglutide | Experimental | Participants will receive oral semaglutide once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral semaglutide | Drug | Semaglutide will be administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c). | Measured in percentage (%)-point. | From baseline (week 0) to end of treatment (week 20) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Measured in Kilogram (Kg). | From baseline (week 0) to end of treatment (week 20) |
| Number of treatment emergent adverse events (TEAEs) | Measured as count of events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seino Internal Medicine Clinic_Internal medicine | Koriyama-shi, Fukushima | Fukushima, Japan | 963-8851 | Japan | ||
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| From baseline (week 0) to end of study (week 25) |
| Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine |
| Chigasaki-shi |
| Kanagawa, Japan |
| 253-0044 |
| Japan |
| Jinnouchi Hospital_Internal Medicine | Kumamoto | Kumamoto, Japan | 862-0976 | Japan |
| Heiwadai Hospital_Internal Medicine | Miyazaki | Miyazaki | 880-0034 | Japan |
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology | Aichi | 468-0009 | Japan |
| Tokuyama clinic_Diabetic internal medicine | Chiba | 261-0004 | Japan |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine | Fukuoka-shi, Fukuoka | 819-0006 | Japan |
| Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine | Hokkaido | 060-0001 | Japan |
| Naka Kinen Clinic_Internal medicine | Ibaraki | 311-0113 | Japan |
| Yokohama Minoru Clinic_Internal medicine | Kanagawa | 232-0064 | Japan |
| Shonan Takai Clinic_Internal Medicine | Kanagawa | 247-0055 | Japan |
| Soka Sugiura Internal Medicine Clinic | Soka-shi, Saitama | 340-0015 | Japan |
| Oyama East Clinic_Internal Medicine | Tochigi | 323-0022 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo | 103-0027 | Japan |
| Kato Clinic of Internal Medicine_Internal Medicine | Tokyo | 125-0054 | Japan |
| 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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