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NCT05035082CompletedPhase 4

A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)

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

Source: ClinicalTrials.gov · Last updated 10 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1018 (actual)
First submitted
30 Aug 2021
Start date
1 Sept 2021
Primary completion date
18 Jun 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05035082

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 1018
  • From 1 Sept 2021 to the primary completion date, 18 Jun 2025
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any disorder which in the investigator's or treatment provider's opinion might jeopardize patient's safety.

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using contraception.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Stewart Medical Group
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AlhambraUnited StatesUnknown status
AnMed Health IMA
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AndersonUnited StatesUnknown status
Kernodle Clin Dpt-Pvt Diagnost
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BurlingtonUnited StatesUnknown status
Diab & Endo Assoc of Stark Co
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CantonUnited StatesUnknown status
OnSite Clinical Solutions, LLC - Charlotte
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CharlotteUnited StatesUnknown status
Central Ohio Clinical Research LLC
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ColumbusUnited StatesUnknown status
FDRC
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Costa MesaUnited StatesUnknown status
Baylor Scott & White Res Inst
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DallasUnited StatesUnknown status
Valley Weight Loss Clinic
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FargoUnited StatesUnknown status
WakeMed Garner Hlthplx
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GarnerUnited StatesUnknown status
Clinical Research of Gastonia
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GastoniaUnited StatesUnknown status
Macoupin Research Group
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GillespieUnited StatesUnknown status
Scripps Whittier Diabetes Inst
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La JollaUnited StatesUnknown status
Urban Family Practice Assoc
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MariettaUnited StatesUnknown status
DC Research Works
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MariettaUnited StatesUnknown status
Reyes Clinical Research, Inc
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MiamiUnited StatesUnknown status
Hill Country Medical Associates
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New BraunfelsUnited StatesUnknown status
UnityPoint Health-Diabetes Care Center
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PeoriaUnited StatesUnknown status
Jefferson Endocrinology Assocs
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PhiladelphiaUnited StatesUnknown status
Tristar Clin Investigations, PC
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PhiladelphiaUnited StatesUnknown status
Preferred Primary Care Physicians - Pittsburgh
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PittsburghUnited StatesUnknown status
Raincross Medical Group
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RiversideUnited StatesUnknown status
DCT-Stone Oak
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San AntonioUnited StatesUnknown status
Endeavor Health
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SkokieUnited StatesUnknown status
Chrysalis Clinical Research
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St. GeorgeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.