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Completed

NCT Number: NCT05035082

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stewart Medical Group, Alhambra, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Glycated Haemoglobin (HbA1c)

    Time frame: Week 0, year 1

    Change in HbA1c in percentage from week 0 to year 1 is presented

Secondary outcomes

  1. Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No)

    Time frame: At year 1

    Participants achieving HbA1c < 7.0% (Yes /No) at year 1 is presented. 'Yes' defines participants who achieved HbA1c < 7.0% and 'No' defines participants who did not achieve HbA1c < 7.0 %.

  2. Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No)

    Time frame: At year 1

    Participants achieving HbA1c ≤ 6.5% (Yes/No) at year 1 is presented. 'Yes' defines participants who achieved HbA1c ≤ 6.5% and 'No' defines participants who did not achieve HbA1c ≤ 6.5%.

  3. Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No)

    Time frame: From Week 0 to year 1

    Participants achieving HbA1c < 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) from week 0 to year 1 is presented. 'Yes' defines participants who achieved HbA1c < 7.0% or reduction of at least 1.0%-point in HbA1c and 'No' defines participants who did not achieve HbA1c < 7.0% or reduction of at least 1.0%-point in HbA1c.

  4. Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No)

    Time frame: From week 0 to year 1

    Participants achieving ≥ 5% reduction in body weight (Yes/No) from week 0 to year 1 is presented. 'Yes' defines participants who achieved ≥ 5% reduction in body weight and 'No' defines participants who did not achieve ≥ 5% reduction in body weight.

  5. Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No)

    Time frame: At year 1

    Participants achieving individualized HbA1c target per HEDIS criteria (< 8.0% if age ≥ 65 years or with defined comorbidities or otherwise < 7.0%) (Yes/No) at year 1 is presented. 'Yes' defines participants who achieved individualized HbA1c target per HEDIS criteria and 'No' defines participants who did not achieve individualized HbA1c target per HEDIS criteria.

  6. Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No)

    Time frame: At year 1

    Participant achieving HbA1c ≤ treatment provider defined individualized target (Yes/No) at year 1 is presented. 'Yes' defines participant who achieved HbA1c ≤ treatment provider defined individualized target and 'No' defines participant who did not achieve HbA1c ≤ treatment provider defined individualized target.

  7. Relative Change in Body Weight (%)

    Time frame: Week 0, year 1

    Relative change in body weight from week 0 to year 1 is presented.

  8. Change in Body Weight (Lbs)

    Time frame: Week 0, year 1

    Change in body weight in pounds (lbs) from week 0 to year 1 is presented.

  9. Time to Treatment Intensification (add-on) or Change (Switch) in Terms of Events

    Time frame: From week 0 to year 1

    Time to treatment intensification (add-on) or change (switch) in terms of events from week 0 to year 1 is presented.

  10. Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Relative Treatment Satisfaction Total Score

    Time frame: At year 1

    DTSQc relative treatment satisfaction total score measured at year 1 is presented. DTSQc are used to evaluate patient satisfaction with treatment. The measure consists of 8 items, 6 of which assess treatment satisfaction. Scores from the 6 treatment satisfaction items are summed to a total treatment satisfaction score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: REALYSE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2021
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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