New study pits rybelsus against other diabetes pills in Real-World setting
NCT ID NCT05035082
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 4 times
Summary
This completed study compared the effectiveness of once-daily oral semaglutide (Rybelsus) to other oral diabetes medications in 1020 adults with type 2 diabetes who were already taking metformin. Participants were randomly assigned to receive either Rybelsus or another diabetes pill, and their blood sugar control was tracked over about one year. The goal was to see which approach worked better in real-world healthcare settings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- semaglutide (Rybelsus)
- What this could lead to
- If successful, this study could show that oral semaglutide is more effective than other oral diabetes medications at lowering blood sugar when added to metformin.
- What could go wrong
- This is a completed Phase 4 trial, so results are already in. However, real-world effectiveness may vary, and the study does not test long-term outcomes like heart health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
1,018 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key inclusion criteria * 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. Key exclusion criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using contraception. * Any disorder which in the investigator's or treatment provider's opinion might jeopardize patient's safety.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AnMed Health IMA
Anderson, South Carolina, 29621, United States
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Baylor Scott & White Res Inst
Dallas, Texas, 75246, United States
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Central Ohio Clinical Research LLC
Columbus, Ohio, 43213, United States
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Chrysalis Clinical Research
St. George, Utah, 84790, United States
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Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
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DC Research Works
Marietta, Georgia, 30060, United States
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DCT-Stone Oak
San Antonio, Texas, 78258, United States
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Diab & Endo Assoc of Stark Co
Canton, Ohio, 44718, United States
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Endeavor Health
Skokie, Illinois, 60077, United States
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FDRC
Costa Mesa, California, 92627, United States
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Hill Country Medical Associates
New Braunfels, Texas, 78130, United States
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Jefferson Endocrinology Assocs
Philadelphia, Pennsylvania, 19107-6810, United States
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Kernodle Clin Dpt-Pvt Diagnost
Burlington, North Carolina, 27215, United States
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Macoupin Research Group
Gillespie, Illinois, 62033, United States
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OnSite Clinical Solutions, LLC_Charlotte
Charlotte, North Carolina, 28277, United States
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Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, 15236, United States
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Raincross Medical Group
Riverside, California, 92506, United States
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Reyes Clinical Research, Inc
Miami, Florida, 33175, United States
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Scripps Whittier Diabetes Inst
La Jolla, California, 92037, United States
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Stewart Medical Group
Alhambra, California, 91801, United States
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Tristar Clin Investigations, PC
Philadelphia, Pennsylvania, 19114, United States
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UnityPoint Health-Diabetes Care Center
Peoria, Illinois, 61603, United States
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Urban Family Practice Assoc
Marietta, Georgia, 30067, United States
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Valley Weight Loss Clinic
Fargo, North Dakota, 58104, United States
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WakeMed Garner Hlthplx
Garner, North Carolina, 27529, United States
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