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NCT05035082 · ClinicalTrials.gov registry record · Phase 4
A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
A Phase 4 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,020
- Enrollment target
NCT05035082 is a Phase 4 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,020 participants.
The verdict
NCT05035082, a Phase 4 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,020 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG semaglutide
- DRUG oral glucose-lowering medications (commercially available)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,020 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2025-06-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05035082
The ClinicalTrials.gov registry entry for NCT05035082 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,020 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which semaglutide is the first listed.
NCT05035082 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05035082 about?
NCT05035082 is a clinical study titled "A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)". 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 s...
What is the current status of trial NCT05035082?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,020 participants. The study started on 2021-09-01. Estimated completion is 2025-06-18.
What interventions are being tested in trial NCT05035082?
The interventions under investigation include: semaglutide (DRUG), oral glucose-lowering medications (commercially available) (DRUG).
Who is sponsoring clinical trial NCT05035082?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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