{"protocolSection":{"identificationModule":{"nctId":"NCT05035082","orgStudyIdInfo":{"id":"NN9924-4558"},"secondaryIdInfos":[{"id":"U1111-1253-2577","type":"OTHER","domain":"World Health Organization (WHO)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)","officialTitle":"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"},"statusModule":{"statusVerifiedDate":"2026-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-09-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-06-18","type":"ACTUAL"},"completionDateStruct":{"date":"2025-06-18","type":"ACTUAL"},"studyFirstSubmitDate":"2021-08-30","studyFirstSubmitQcDate":"2021-08-30","studyFirstPostDateStruct":{"date":"2021-09-05","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-06-17","resultsFirstSubmitQcDate":"2026-08-06","resultsFirstPostDateStruct":{"date":"2026-08-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-08-06","lastUpdatePostDateStruct":{"date":"2026-08-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"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."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1018,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"oral semaglutide","type":"EXPERIMENTAL","description":"All participants are given tablets used in addition to metformin.","interventionNames":["Drug: semaglutide"]},{"label":"other oral glucose lowering medication","type":"ACTIVE_COMPARATOR","description":"All participants are given tablets used in addition to metformin.","interventionNames":["Drug: oral glucose-lowering medications (commercially available)"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"Oral administration The doctor will give a prescription for the medicine and tell how to take it.","armGroupLabels":["oral semaglutide"]},{"type":"DRUG","name":"oral glucose-lowering medications (commercially available)","description":"Oral administration The doctor will give a prescription for the medicine and tell how to take it.","armGroupLabels":["other oral glucose lowering medication"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycated Haemoglobin (HbA1c)","description":"Change in HbA1c in percentage from week 0 to year 1 is presented","timeFrame":"Week 0, year 1"}],"secondaryOutcomes":[{"measure":"Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No)","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 %.","timeFrame":"At year 1"},{"measure":"Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No)","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%.","timeFrame":"At year 1"},{"measure":"Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No)","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.","timeFrame":"From Week 0 to year 1"},{"measure":"Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No)","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.","timeFrame":"From week 0 to year 1"},{"measure":"Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No)","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.","timeFrame":"At year 1"},{"measure":"Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No)","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.","timeFrame":"At year 1"},{"measure":"Relative Change in Body Weight (%)","description":"Relative change in body weight from week 0 to year 1 is presented.","timeFrame":"Week 0, year 1"},{"measure":"Change in Body Weight (Lbs)","description":"Change in body weight in pounds (lbs) from week 0 to year 1 is presented.","timeFrame":"Week 0, year 1"},{"measure":"Time to Treatment Intensification (add-on) or Change (Switch) in Terms of Events","description":"Time to treatment intensification (add-on) or change (switch) in terms of events from week 0 to year 1 is presented.","timeFrame":"From week 0 to year 1"},{"measure":"Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Relative Treatment Satisfaction Total Score","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).","timeFrame":"At year 1"}]},"eligibilityModule":{"eligibilityCriteria":"Key inclusion criteria\n\n* 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.\n* Current member of a health plan which includes pharmacy benefits.\n* HbA1c greater than or equal to 7% within last 90 days prior to the day of screening or to be taken before randomization.\n* 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.\n\nKey exclusion criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using contraception.\n* Any disorder which in the investigator's or treatment provider's opinion might jeopardize patient's safety.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Stewart Medical Group","city":"Alhambra","state":"California","zip":"91801","country":"United States","geoPoint":{"lat":34.09529,"lon":-118.12701}},{"facility":"FDRC","city":"Costa Mesa","state":"California","zip":"92627","country":"United States","geoPoint":{"lat":33.64113,"lon":-117.91867}},{"facility":"Scripps Whittier Diabetes Inst","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"Raincross Medical Group","city":"Riverside","state":"California","zip":"92506","country":"United States","geoPoint":{"lat":33.95335,"lon":-117.39616}},{"facility":"Reyes Clinical Research, Inc","city":"Miami","state":"Florida","zip":"33175","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"DC Research Works","city":"Marietta","state":"Georgia","zip":"30060","country":"United States","geoPoint":{"lat":33.9526,"lon":-84.54993}},{"facility":"Urban Family Practice Assoc","city":"Marietta","state":"Georgia","zip":"30067","country":"United States","geoPoint":{"lat":33.9526,"lon":-84.54993}},{"facility":"Macoupin Research Group","city":"Gillespie","state":"Illinois","zip":"62033","country":"United States","geoPoint":{"lat":39.12977,"lon":-89.81954}},{"facility":"UnityPoint Health-Diabetes Care Center","city":"Peoria","state":"Illinois","zip":"61603","country":"United States","geoPoint":{"lat":40.69365,"lon":-89.58899}},{"facility":"Endeavor Health","city":"Skokie","state":"Illinois","zip":"60077","country":"United States","geoPoint":{"lat":42.03336,"lon":-87.73339}},{"facility":"Kernodle Clin Dpt-Pvt Diagnost","city":"Burlington","state":"North Carolina","zip":"27215","country":"United States","geoPoint":{"lat":36.09569,"lon":-79.4378}},{"facility":"OnSite Clinical Solutions, LLC_Charlotte","city":"Charlotte","state":"North Carolina","zip":"28277","country":"United States","geoPoint":{"lat":35.22709,"lon":-80.84313}},{"facility":"WakeMed Garner Hlthplx","city":"Garner","state":"North Carolina","zip":"27529","country":"United States","geoPoint":{"lat":35.71126,"lon":-78.61417}},{"facility":"Clinical Research of Gastonia","city":"Gastonia","state":"North Carolina","zip":"28054","country":"United States","geoPoint":{"lat":35.26208,"lon":-81.1873}},{"facility":"Valley Weight Loss Clinic","city":"Fargo","state":"North Dakota","zip":"58104","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"Diab & Endo Assoc of Stark Co","city":"Canton","state":"Ohio","zip":"44718","country":"United States","geoPoint":{"lat":40.79895,"lon":-81.37845}},{"facility":"Central Ohio Clinical Research LLC","city":"Columbus","state":"Ohio","zip":"43213","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"Jefferson Endocrinology Assocs","city":"Philadelphia","state":"Pennsylvania","zip":"19107-6810","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Tristar Clin Investigations, PC","city":"Philadelphia","state":"Pennsylvania","zip":"19114","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Preferred Primary Care Physicians_Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","zip":"15236","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"AnMed Health IMA","city":"Anderson","state":"South Carolina","zip":"29621","country":"United States","geoPoint":{"lat":34.50344,"lon":-82.65013}},{"facility":"Baylor Scott & White Res Inst","city":"Dallas","state":"Texas","zip":"75246","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Hill Country Medical Associates","city":"New Braunfels","state":"Texas","zip":"78130","country":"United States","geoPoint":{"lat":29.703,"lon":-98.12445}},{"facility":"DCT-Stone Oak","city":"San Antonio","state":"Texas","zip":"78258","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Chrysalis Clinical Research","city":"St. George","state":"Utah","zip":"84790","country":"United States","geoPoint":{"lat":37.10415,"lon":-113.58412}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomized in a 1:1 ratio to receive either oral semaglutide or one other oral glucose-lowering medication, respectively.","recruitmentDetails":"The trial was conducted at 25 sites in the United States. One participant is counted in 'Completed' and not in 'Death in Reason for Not Completed' in Participant Flow as they died after completing the study and hence, not counted as non-completer.","groups":[{"id":"FG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"FG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"509"},{"groupId":"FG001","numSubjects":"509"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"509"},{"groupId":"FG001","numSubjects":"509"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"500"},{"groupId":"FG001","numSubjects":"492"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"449"},{"groupId":"FG001","numSubjects":"448"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"61"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"26"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"site closure","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Protocol specified withdrawal criterion met","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set included all randomised participants.","groups":[{"id":"BG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"BG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"509"},{"groupId":"BG001","value":"509"},{"groupId":"BG002","value":"1018"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59.6","spread":"11.9"},{"groupId":"BG001","value":"59.8","spread":"12.0"},{"groupId":"BG002","value":"59.7","spread":"12.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"231"},{"groupId":"BG001","value":"237"},{"groupId":"BG002","value":"468"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"278"},{"groupId":"BG001","value":"272"},{"groupId":"BG002","value":"550"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"373"},{"groupId":"BG001","value":"366"},{"groupId":"BG002","value":"739"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"133"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"80"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"60"}]},{"title":"Missing Race","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"102"},{"groupId":"BG002","value":"193"}]},{"title":"Non-Hispanic or Non-Latino","measurements":[{"groupId":"BG000","value":"408"},{"groupId":"BG001","value":"404"},{"groupId":"BG002","value":"812"}]},{"title":"Missing Ethnicity","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"13"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Glycated Haemoglobin (HbA1c)","description":"Change in HbA1c in percentage from week 0 to year 1 is presented","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change in HbA1c","timeFrame":"Week 0, year 1","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"OG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"293"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.20","spread":"1.463"},{"groupId":"OG001","value":"-0.99","spread":"1.516"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Primary estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"The endpoint is analyzed using an ANCOVA model with treatment as a categorical effect and baseline HbA1c as a covariate","pValue":"0.0180","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.44","ciUpperLimit":"-0.04"}]},{"type":"SECONDARY","title":"Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No)","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 %.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At year 1","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"OG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"293"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"190"},{"groupId":"OG001","value":"133"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"160"}]}]}]},{"type":"SECONDARY","title":"Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No)","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%.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At year 1","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"OG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"293"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"68"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"225"}]}]}]},{"type":"SECONDARY","title":"Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No)","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.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 to year 1","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"OG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"293"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"180"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"113"}]}]}]},{"type":"SECONDARY","title":"Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No)","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.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From week 0 to year 1","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"OG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"298"},{"groupId":"OG001","value":"260"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"83"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"188"},{"groupId":"OG001","value":"177"}]}]}]},{"type":"SECONDARY","title":"Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No)","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.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At year 1","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"OG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"293"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"171"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"122"}]}]}]},{"type":"SECONDARY","title":"Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No)","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.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At year 1","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"OG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"293"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"179"},{"groupId":"OG001","value":"118"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"175"}]}]}]},{"type":"SECONDARY","title":"Relative Change in Body Weight (%)","description":"Relative change in body weight from week 0 to year 1 is presented.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change in body weight","timeFrame":"Week 0, year 1","groups":[{"id":"OG000","title":"Oral Semaglutide","description":"Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks."},{"id":"OG001","title":"Other Oral Glucose-lowering Medication","description":"Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"258"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.00","spread":"6.26"},{"groupId":"OG001","value":"-3.53","spread":"6.49"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (Lbs)","description":"Change in body weight in pounds (lbs) from week 0 to year 1 is presented.","populationDescription":"Full analysis set included all randomized participants. 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