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

NCT ID: NCT05035082

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-06-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral semaglutide

All participants are given tablets used in addition to metformin.

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

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

other oral glucose lowering medication

All participants are given tablets used in addition to metformin.

Group Type ACTIVE_COMPARATOR

oral glucose-lowering medications (commercially available)

Intervention Type DRUG

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

Interventions

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semaglutide

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

Intervention Type DRUG

oral glucose-lowering medications (commercially available)

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

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Stewart Medical Group

Alhambra, California, United States

Site Status

FDRC

Costa Mesa, California, United States

Site Status

Scripps Whittier Diabetes Inst

La Jolla, California, United States

Site Status

Raincross Medical Group

Riverside, California, United States

Site Status

Reyes Clinical Research, Inc

Miami, Florida, United States

Site Status

DC Research Works

Marietta, Georgia, United States

Site Status

Urban Family Practice Assoc

Marietta, Georgia, United States

Site Status

Macoupin Research Group

Gillespie, Illinois, United States

Site Status

UnityPoint Health-Diabetes Care Center

Peoria, Illinois, United States

Site Status

Endeavor Health

Skokie, Illinois, United States

Site Status

Kernodle Clin Dpt-Pvt Diagnost

Burlington, North Carolina, United States

Site Status

OnSite Clinical Solutions, LLC_Charlotte

Charlotte, North Carolina, United States

Site Status

WakeMed Garner Hlthplx

Garner, North Carolina, United States

Site Status

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Site Status

Valley Weight Loss Clinic

Fargo, North Dakota, United States

Site Status

Diab & Endo Assoc of Stark Co

Canton, Ohio, United States

Site Status

Central Ohio Clinical Research LLC

Columbus, Ohio, United States

Site Status

Jefferson Endocrinology Assocs

Philadelphia, Pennsylvania, United States

Site Status

Tristar Clin Investigations, PC

Philadelphia, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians_Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

AnMed Health IMA

Anderson, South Carolina, United States

Site Status

Baylor Scott & White Res Inst

Dallas, Texas, United States

Site Status

Hill Country Medical Associates

New Braunfels, Texas, United States

Site Status

DCT-Stone Oak

San Antonio, Texas, United States

Site Status

Chrysalis Clinical Research

St. George, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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U1111-1253-2577

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4558

Identifier Type: -

Identifier Source: org_study_id

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