AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 4REALYSENCT05035082

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 testing semaglutide and oral glucose-lowering medications (commercially available) in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
semaglutide and oral glucose-lowering medications (commercially available)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,018 participants
Where
25 sitesUnited States
Study dates
1 Sep 2021to 18 Jun 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Stewart Medical Group

    Alhambra, California, 91801

  • AnMed Health IMA

    Anderson, South Carolina, 29621

  • Kernodle Clin Dpt-Pvt Diagnost

    Burlington, North Carolina, 27215

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718

  • OnSite Clinical Solutions, LLC_Charlotte

    Charlotte, North Carolina, 28277

  • Central Ohio Clinical Research LLC

    Columbus, Ohio, 43213

  • FDRC

    Costa Mesa, California, 92627

  • Baylor Scott & White Res Inst

    Dallas, Texas, 75246

  • Valley Weight Loss Clinic

    Fargo, North Dakota, 58104

  • WakeMed Garner Hlthplx

    Garner, North Carolina, 27529

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Macoupin Research Group

    Gillespie, Illinois, 62033

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • DC Research Works

    Marietta, Georgia, 30060

  • Urban Family Practice Assoc

    Marietta, Georgia, 30067

  • Reyes Clinical Research, Inc

    Miami, Florida, 33175

  • Hill Country Medical Associates

    New Braunfels, Texas, 78130

  • UnityPoint Health-Diabetes Care Center

    Peoria, Illinois, 61603

  • Jefferson Endocrinology Assocs

    Philadelphia, Pennsylvania, 19107-6810

  • Tristar Clin Investigations, PC

    Philadelphia, Pennsylvania, 19114

  • Preferred Primary Care Physicians_Pittsburgh

    Pittsburgh, Pennsylvania, 15236

  • Raincross Medical Group

    Riverside, California, 92506

  • DCT-Stone Oak

    San Antonio, Texas, 78258

  • Endeavor Health

    Skokie, Illinois, 60077

  • Chrysalis Clinical Research

    St. George, Utah, 84790

Other trials in United States

About this study

Official title: REALYSE - Comparative Effectiveness of Once-daily Oral Semaglutide Versus Any Other Oral Glucose-lowering Medication in a Real-world Adult Population With Type 2 Diabetes on Metformin Monotherapy in US Based Health Care Systems - a Pragmatic Randomized Trial

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.

Being tested
semaglutide, oral glucose-lowering medications (commercially available)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaglutideDrug

    Oral administration The doctor will give a prescription for the medicine and tell how to take it.

  • oral glucose-lowering medications (commercially available)Drug

    Oral administration The doctor will give a prescription for the medicine and tell how to take it.

Study groups in NCT05035082
Study groupRoleWhat they receive
oral semaglutideExperimentalAll participants are given tablets used in addition to metformin.
Receives: Drug: semaglutide
other oral glucose lowering medicationActive comparatorAll participants are given tablets used in addition to metformin.
Receives: Drug: oral glucose-lowering medications (commercially available)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycated Haemoglobin (HbA1c)

    Change in HbA1c in percentage from week 0 to year 1 is presented

    Measured: Week 0, year 1

Secondary outcomes (10)

  1. Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No)

    Participants achieving HbA1c < 7.0% (Yes /No) at year 1 is presented. 'Yes' defines participants who achieved HbA1c < 7.0% and 'No' defines participants who did not achieve HbA1c < 7.0 %.

    Measured: At year 1

  2. Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No)

    Participants achieving HbA1c ≤ 6.5% (Yes/No) at year 1 is presented. 'Yes' defines participants who achieved HbA1c ≤ 6.5% and 'No' defines participants who did not achieve HbA1c ≤ 6.5%.

    Measured: At year 1

  3. Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No)

    Participants achieving HbA1c < 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) from week 0 to year 1 is presented. 'Yes' defines participants who achieved HbA1c < 7.0% or reduction of at least 1.0%-point in HbA1c and 'No' defines participants who did not achieve HbA1c < 7.0% or reduction of at least 1.0%-point in HbA1c.

    Measured: From Week 0 to year 1

  4. Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No)

    Participants achieving ≥ 5% reduction in body weight (Yes/No) from week 0 to year 1 is presented. 'Yes' defines participants who achieved ≥ 5% reduction in body weight and 'No' defines participants who did not achieve ≥ 5% reduction in body weight.

    Measured: From week 0 to year 1

  5. Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No)

    Participants achieving individualized HbA1c target per HEDIS criteria (< 8.0% if age ≥ 65 years or with defined comorbidities or otherwise < 7.0%) (Yes/No) at year 1 is presented. 'Yes' defines participants who achieved individualized HbA1c target per HEDIS criteria and 'No' defines participants who did not achieve individualized HbA1c target per HEDIS criteria.

    Measured: At year 1

  6. Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No)

    Participant achieving HbA1c ≤ treatment provider defined individualized target (Yes/No) at year 1 is presented. 'Yes' defines participant who achieved HbA1c ≤ treatment provider defined individualized target and 'No' defines participant who did not achieve HbA1c ≤ treatment provider defined individualized target.

    Measured: At year 1

  7. Relative Change in Body Weight (%)

    Relative change in body weight from week 0 to year 1 is presented.

    Measured: Week 0, year 1

  8. Change in Body Weight (Lbs)

    Change in body weight in pounds (lbs) from week 0 to year 1 is presented.

    Measured: Week 0, year 1

  9. Time to Treatment Intensification (add-on) or Change (Switch) in Terms of Events

    Time to treatment intensification (add-on) or change (switch) in terms of events from week 0 to year 1 is presented.

    Measured: From week 0 to year 1

  10. Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Relative Treatment Satisfaction Total Score

    DTSQc relative treatment satisfaction total score measured at year 1 is presented. DTSQc are used to evaluate patient satisfaction with treatment. The measure consists of 8 items, 6 of which assess treatment satisfaction. Scores from the 6 treatment satisfaction items are summed to a total treatment satisfaction score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).

    Measured: At year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start1 Sep 2021
  3. Primary completion18 Jun 2025
  4. Study completion18 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,018 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05035082
Sponsor's protocol ID
NN9924-4558
Other IDs
U1111-1253-2577
Acronym
REALYSE
Status last verified
Jul 2026
First submitted
30 Aug 2021
Last updated
10 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing semaglutide and oral glucose-lowering medications (commercially available) in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin (HbA1c) (time frame: Week 0, year 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05035082.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in