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

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• semaglutide — DRUG
  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 Details

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.

Key Dates

Start date

Sep 1, 2021

Status verified

Nov 2025

Primary completion

Jun 18, 2025

Completion

Jun 18, 2025

Study Design

Enrollment

1,020 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: oral semaglutide
  All participants are given tablets used in addition to metformin.
• Active Comparator: other oral glucose lowering medication
  All participants are given tablets used in addition to metformin.

Primary Outcome Measure

Change in Glycosylated hemoglobin A1c (HbA1c) [ Time Frame: From randomization to year 1 ]

Locations (25)

Find similar trials in Alhambra, CA

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