NCT05035082CompletedPhase 4
A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
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
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1018 (actual)
- First submitted
- 30 Aug 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 18 Jun 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT05035082
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1018
- From 1 Sept 2021 to the primary completion date, 18 Jun 2025
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any disorder which in the investigator's or treatment provider's opinion might jeopardize patient's safety.
Other
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using contraception.
Who the study is looking for
- Treatment with metformin as monotherapy prior to eligibility assessment that has failed to result in adequate glycemic control at the discretion of the investigator or treatment provider. However, prior short-term treatment with an oral glucose lowering agent or insulin for up to 14 consecutive days in addition to metformin is allowed if discontinued prior to screening.
- Current member of a health plan which includes pharmacy benefits.
- HbA1c greater than or equal to 7% within last 90 days prior to the day of screening or to be taken before randomization.
- Further intensification with an additional glucose-lowering oral agent including oral semaglutide is indicated according to approved prescribing information to achieve glycemic target at the discretion of the treatment provider.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stewart Medical Group Coordinator of this site? Confirm its status | Alhambra | United States | Unknown status |
| AnMed Health IMA Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Kernodle Clin Dpt-Pvt Diagnost Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Diab & Endo Assoc of Stark Co Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| OnSite Clinical Solutions, LLC - Charlotte Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Central Ohio Clinical Research LLC Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| FDRC Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
| Baylor Scott & White Res Inst Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Valley Weight Loss Clinic Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| WakeMed Garner Hlthplx Coordinator of this site? Confirm its status | Garner | United States | Unknown status |
| Clinical Research of Gastonia Coordinator of this site? Confirm its status | Gastonia | United States | Unknown status |
| Macoupin Research Group Coordinator of this site? Confirm its status | Gillespie | United States | Unknown status |
| Scripps Whittier Diabetes Inst Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Urban Family Practice Assoc Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| DC Research Works Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Reyes Clinical Research, Inc Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Hill Country Medical Associates Coordinator of this site? Confirm its status | New Braunfels | United States | Unknown status |
| UnityPoint Health-Diabetes Care Center Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Jefferson Endocrinology Assocs Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Tristar Clin Investigations, PC Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Preferred Primary Care Physicians - Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Raincross Medical Group Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
| DCT-Stone Oak Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Endeavor Health Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Chrysalis Clinical Research Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.