A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE) (REALYSE)
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- STATUS
- Recruiting
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- End date
- Mar 21, 2025
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- participants needed
- 1900
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- sponsor
- Novo Nordisk A/S
Summary
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 2 years. Participants will have 3 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, and the last visit is a 2-year follow-up visit. In addition, the study personnel will contact participants up to 3 times per year 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.
Details
| Condition | Diabetes Mellitus, Type 2 |
|---|---|
| Treatment | semaglutide, oral glucose-lowering medications (commercially available) |
| Clinical Study Identifier | NCT05035082 |
| Sponsor | Novo Nordisk A/S |
| Last Modified on | 21 July 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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