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

What Was Tested

The trial (phase 4) is built around Semaglutide.

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.

It had two arms (groups): oral semaglutide (experimental) and other oral glucose lowering medication (active comparator).

All participants are given tablets used in addition to metformin.

All participants are given tablets used in addition to metformin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1018 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-09-01 with completion listed for 2025-06-18.

It ran at 25 sites in United States (25).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycated Haemoglobin (HbA1c) (time frame: Week 0, year 1).

It also tracked 10 secondary outcomes, for example Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No), Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No), Relative Change in Body Weight (%), Change in Body Weight (Lbs), Time to Treatment Intensification (add-on) or Change (Switch) in Terms of Events and Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Relative Treatment Satisfaction Total Score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 1018 people.

With 1018 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.