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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name REALYSE

NCTNCT05035082 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4558Other idU1111-1253-2577
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
1,018 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
1 Sept 2021
Primary completion
18 Jun 2025
Completion
18 Jun 2025
First posted
5 Sept 2021
Last update posted
10 Aug 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023202420252026
  1. Ph 4

    REALYSE

    NCT05035082

    1 Sept 2021 to 18 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • semaglutideDrug
  • oral glucose-lowering medications (commercially available)Drug

Arms2

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycated Haemoglobin (HbA1c)

    Time frame · Week 0, year 1

    Registry description

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

Secondary outcomes(10)

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

    Time frame · At year 1

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, year 1

Change in Glycated Haemoglobin (HbA1c)

GroupValue (Percentage change in HbA1c)Spread
Oral Semaglutide-1.201.463
Other Oral Glucose-lowering Medication-0.991.516
Secondary and other outcome results(7)
Secondary outcomeCount of participants· At year 1

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

GroupValue (Participants)
Oral Semaglutide190
Other Oral Glucose-lowering Medication133
Secondary outcomeCount of participants· At year 1

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

GroupValue (Participants)
Oral Semaglutide127
Other Oral Glucose-lowering Medication68
Secondary outcomeCount of participants· From Week 0 to year 1

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

GroupValue (Participants)
Oral Semaglutide239
Other Oral Glucose-lowering Medication180
Secondary outcomeCount of participants· From week 0 to year 1

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

GroupValue (Participants)
Oral Semaglutide110
Other Oral Glucose-lowering Medication83
Secondary outcomeCount of participants· At year 1

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

GroupValue (Participants)
Oral Semaglutide222
Other Oral Glucose-lowering Medication171
Secondary outcomeCount of participants· At year 1

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

GroupValue (Participants)
Oral Semaglutide179
Other Oral Glucose-lowering Medication118
Secondary outcomeMean· Week 0, year 1

Relative Change in Body Weight (%)

GroupValue (Percentage change in body weight)Spread
Oral Semaglutide-4.006.26
Other Oral Glucose-lowering Medication-3.536.49

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oral SemaglutideParticipants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.3 / 50051 / 50081 / 500
Other Oral Glucose-lowering MedicationParticipants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.2 / 49255 / 49246 / 492

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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