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New study pits rybelsus against other diabetes pills in Real-World setting

NCT ID NCT05035082

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

  • AnMed Health IMA

    Anderson, South Carolina, 29621, United States

  • Baylor Scott & White Res Inst

    Dallas, Texas, 75246, United States

  • Central Ohio Clinical Research LLC

    Columbus, Ohio, 43213, United States

  • Chrysalis Clinical Research

    St. George, Utah, 84790, United States

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054, United States

  • DC Research Works

    Marietta, Georgia, 30060, United States

  • DCT-Stone Oak

    San Antonio, Texas, 78258, United States

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718, United States

  • Endeavor Health

    Skokie, Illinois, 60077, United States

  • FDRC

    Costa Mesa, California, 92627, United States

  • Hill Country Medical Associates

    New Braunfels, Texas, 78130, United States

  • Jefferson Endocrinology Assocs

    Philadelphia, Pennsylvania, 19107-6810, United States

  • Kernodle Clin Dpt-Pvt Diagnost

    Burlington, North Carolina, 27215, United States

  • Macoupin Research Group

    Gillespie, Illinois, 62033, United States

  • OnSite Clinical Solutions, LLC_Charlotte

    Charlotte, North Carolina, 28277, United States

  • Preferred Primary Care Physicians_Pittsburgh

    Pittsburgh, Pennsylvania, 15236, United States

  • Raincross Medical Group

    Riverside, California, 92506, United States

  • Reyes Clinical Research, Inc

    Miami, Florida, 33175, United States

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037, United States

  • Stewart Medical Group

    Alhambra, California, 91801, United States

  • Tristar Clin Investigations, PC

    Philadelphia, Pennsylvania, 19114, United States

  • UnityPoint Health-Diabetes Care Center

    Peoria, Illinois, 61603, United States

  • Urban Family Practice Assoc

    Marietta, Georgia, 30067, United States

  • Valley Weight Loss Clinic

    Fargo, North Dakota, 58104, United States

  • WakeMed Garner Hlthplx

    Garner, North Carolina, 27529, United States

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