A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
Completed · Phase 4
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT05035082
- Run by
- Novo Nordisk A/S
- People needed
- 1020
- Starts
- 2021-09-01
- Expected to finish
- 2025-06-18
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stewart Medical Group — Alhambra, California, United States
- FDRC — Costa Mesa, California, United States
- Scripps Whittier Diabetes Inst — La Jolla, California, United States
- Raincross Medical Group — Riverside, California, United States
- Reyes Clinical Research, Inc — Miami, Florida, United States
- DC Research Works — Marietta, Georgia, United States
- Urban Family Practice Assoc — Marietta, Georgia, United States
- Macoupin Research Group — Gillespie, Illinois, United States
- UnityPoint Health-Diabetes Care Center — Peoria, Illinois, United States
- Endeavor Health — Skokie, Illinois, United States
- Kernodle Clin Dpt-Pvt Diagnost — Burlington, North Carolina, United States
- OnSite Clinical Solutions, LLC_Charlotte — Charlotte, North Carolina, United States
- WakeMed Garner Hlthplx — Garner, North Carolina, United States
- Clinical Research of Gastonia — Gastonia, North Carolina, United States
- Valley Weight Loss Clinic — Fargo, North Dakota, United States
- Diab & Endo Assoc of Stark Co — Canton, Ohio, United States
- Central Ohio Clinical Research LLC — Columbus, Ohio, United States
- Jefferson Endocrinology Assocs — Philadelphia, Pennsylvania, United States
- Tristar Clin Investigations, PC — Philadelphia, Pennsylvania, United States
- Preferred Primary Care Physicians_Pittsburgh — Pittsburgh, Pennsylvania, United States
- AnMed Health IMA — Anderson, South Carolina, United States
- Baylor Scott & White Res Inst — Dallas, Texas, United States
- Hill Country Medical Associates — New Braunfels, Texas, United States
- DCT-Stone Oak — San Antonio, Texas, United States
- Chrysalis Clinical Research — St. George, Utah, United States
Full record on ClinicalTrials.gov
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