A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
Public ClinicalTrials.gov record NCT05035082. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
REALYSE - Comparative Effectiveness of Once-daily Oral Semaglutide Versus Any Other Oral Glucose-lowering Medication in a Real-world Adult Population With Type 2 Diabetes on Metformin Monotherapy in US Based Health Care Systems - a Pragmatic Randomized Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05035082
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,018 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 1, 2021 (Actual)
- Primary completion
- Jun 18, 2025 (Actual)
- Completion
- Jun 18, 2025 (Actual)
- Last update posted
- Aug 10, 2026
2021 – 2025
United States locations
- U.S. sites
- 25
- U.S. states
- 11
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stewart Medical Group | Alhambra | California | 91801 | — |
| FDRC | Costa Mesa | California | 92627 | — |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | — |
| Raincross Medical Group | Riverside | California | 92506 | — |
| Reyes Clinical Research, Inc | Miami | Florida | 33175 | — |
| DC Research Works | Marietta | Georgia | 30060 | — |
| Urban Family Practice Assoc | Marietta | Georgia | 30067 | — |
| Macoupin Research Group | Gillespie | Illinois | 62033 | — |
| UnityPoint Health-Diabetes Care Center | Peoria | Illinois | 61603 | — |
| Endeavor Health | Skokie | Illinois | 60077 | — |
| Kernodle Clin Dpt-Pvt Diagnost | Burlington | North Carolina | 27215 | — |
| OnSite Clinical Solutions, LLC_Charlotte | Charlotte | North Carolina | 28277 | — |
| WakeMed Garner Hlthplx | Garner | North Carolina | 27529 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| Valley Weight Loss Clinic | Fargo | North Dakota | 58104 | — |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | — |
| Central Ohio Clinical Research LLC | Columbus | Ohio | 43213 | — |
| Jefferson Endocrinology Assocs | Philadelphia | Pennsylvania | 19107-6810 | — |
| Tristar Clin Investigations, PC | Philadelphia | Pennsylvania | 19114 | — |
| Preferred Primary Care Physicians_Pittsburgh | Pittsburgh | Pennsylvania | 15236 | — |
| AnMed Health IMA | Anderson | South Carolina | 29621 | — |
| Baylor Scott & White Res Inst | Dallas | Texas | 75246 | — |
| Hill Country Medical Associates | New Braunfels | Texas | 78130 | — |
| DCT-Stone Oak | San Antonio | Texas | 78258 | — |
| Chrysalis Clinical Research | St. George | Utah | 84790 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05035082, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05035082 live on ClinicalTrials.gov.