GLPwatch

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

NCT05035082 · Completed

Last updated 2026-05-28

This study is testing the medication RYBELSUS® against other blood sugar-lowering tablets in adults with type 2 diabetes living in America to see how it affects their HbA1c levels.

Status Completed The study has finished.
Phase Phase 4 Monitors a drug already on the market.
Type Interventional (clinical trial)
Design Randomized, open-label (no blinding) treatment study
Participants 1,020 people
Who can join Ages 18+ · all sexes
Timeline Started 2021-09 · est. completion 2025-06
Where 25 sites · United States

What this study is testing ClinicalTrials.gov NCT05035082 ↗

Description as written by the study sponsor.

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.

Treatments tested

Main thing measuredChange in Glycosylated hemoglobin A1c (HbA1c)
SponsorNovo Nordisk A/S
Conditions studiedDiabetes Mellitus, Type 2
GLP-1 drugs semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05035082 ↗