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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1253-2577 | Other Identifier | World Health Organization (WHO) |
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This study is comparing the medicine RYBELSUS® to other medicines in people with type 2 diabetes who need extra treatment. All medicines used in this study are tablets which lower blood sugar in people with type 2 diabetes. The purpose of the study is to see how well RYBELSUS® is at lowering blood sugar compared to other tablets when used in addition to metformin. Participants doctor will give participants either RYBELSUS® or any other blood sugar lowering tablets - which treatment participants get is decided by chance. The doctor treating participants diabetes will give participants a prescription for the medicine and tell how to take it. The study will last for about 1 year. Participants will have 2 planned visits with their doctor which are part of the usual routine diabetes management: the first visit is when participants are included in the study, the second visit is a 1-year follow-up visit. In addition, the study personnel will contact participants up to 3 times during this period and to follow-up on information from participant doctors visits. Participant will be asked to respond 3 times to 4 questionnaires via their personal smartphone or tablet or paper if participant do not have access to one during the study. All clinic visits are part of the usual routine diabetes management and are covered by participants health insurance plan. The study team will collect information from these visits recorded in the medical chart. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral semaglutide | Experimental | All participants are given tablets used in addition to metformin. |
|
| other oral glucose lowering medication | Active Comparator | All participants are given tablets used in addition to metformin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Oral administration The doctor will give a prescription for the medicine and tell how to take it. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated hemoglobin A1c (HbA1c) | percentage-points | From randomization to year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient achieving HbA1c below 7.0% (Yes /No) | Count of patient(s) | Year 1 |
| Patient achieving HbA1c below or equal to 6.5% (Yes/No) | Count of patient(s) |
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Key inclusion criteria
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stewart Medical Group | Alhambra | California | 91801 | United States | ||
| FDRC |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| oral glucose-lowering medications (commercially available) | Drug | Oral administration The doctor will give a prescription for the medicine and tell how to take it. |
|
| Year 1 |
| Patient achieving HbA1c below 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) | Count of patient(s) | From randomization to year 1 |
| Patient achieving greater than or equal to 5% reduction in body weight (Yes/No) | Count of patient(s) | From randomization to year 1 |
| Patient achieving individualized HbA1c target per Healthcare Effectiveness Data and Information Set (HEDIS) criteria (below 8.0% if age greater than or equal to 65 years or with defined comorbidities or otherwise below 7.0%) (Yes/No) | Count of patient(s) | Year 1 |
| Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No) | Count of patient(s) | Year 1 |
| Relative change in body weight (%) | Percentage | From randomization to year 1 |
| Change in body weight (lbs) | Lbs | From randomization to year 1 |
| Time to treatment intensification (add-on) or change (switch) | Days | From randomization to year 1 |
| Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Relative treatment satisfaction total score | Score on a scale (The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) will be used to measure the change in patient satisfaction with their diabetes treatment. It consists of a six-item scale assessing treatment satisfaction and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQc items are on a scale from 3 to -3. If they experience no change, then 0 is chosen. Higher score indicate higher satisfaction with their current treatment) | Year 1 |
| Costa Mesa |
| California |
| 92627 |
| United States |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | United States |
| Raincross Medical Group | Riverside | California | 92506 | United States |
| Reyes Clinical Research, Inc | Miami | Florida | 33175 | United States |
| DC Research Works | Marietta | Georgia | 30060 | United States |
| Urban Family Practice Assoc | Marietta | Georgia | 30067 | United States |
| Macoupin Research Group | Gillespie | Illinois | 62033 | United States |
| UnityPoint Health-Diabetes Care Center | Peoria | Illinois | 61603 | United States |
| Endeavor Health | Skokie | Illinois | 60077 | United States |
| Kernodle Clin Dpt-Pvt Diagnost | Burlington | North Carolina | 27215 | United States |
| OnSite Clinical Solutions, LLC_Charlotte | Charlotte | North Carolina | 28277 | United States |
| WakeMed Garner Hlthplx | Garner | North Carolina | 27529 | United States |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | United States |
| Valley Weight Loss Clinic | Fargo | North Dakota | 58104 | United States |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | United States |
| Central Ohio Clinical Research LLC | Columbus | Ohio | 43213 | United States |
| Jefferson Endocrinology Assocs | Philadelphia | Pennsylvania | 19107-6810 | United States |
| Tristar Clin Investigations, PC | Philadelphia | Pennsylvania | 19114 | United States |
| Preferred Primary Care Physicians_Pittsburgh | Pittsburgh | Pennsylvania | 15236 | United States |
| AnMed Health IMA | Anderson | South Carolina | 29621 | United States |
| Baylor Scott & White Res Inst | Dallas | Texas | 75246 | United States |
| Hill Country Medical Associates | New Braunfels | Texas | 78130 | United States |
| DCT-Stone Oak | San Antonio | Texas | 78258 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| 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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