{"protocolSection":{"identificationModule":{"nctId":"NCT02863419","orgStudyIdInfo":{"id":"NN9924-4224"},"secondaryIdInfos":[{"id":"2015-005210-30","type":"EUDRACT_NUMBER"},{"id":"U1111-1176-6029","type":"OTHER","domain":"WHO"},{"id":"2015","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2015"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus","officialTitle":"Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus","acronym":"PIONEER 4"},"statusModule":{"statusVerifiedDate":"2022-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-08-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-08-19","type":"ACTUAL"},"completionDateStruct":{"date":"2018-03-30","type":"ACTUAL"},"studyFirstSubmitDate":"2016-08-08","studyFirstSubmitQcDate":"2016-08-08","studyFirstPostDateStruct":{"date":"2016-08-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-10-15","resultsFirstSubmitQcDate":"2019-10-15","resultsFirstPostDateStruct":{"date":"2019-11-07","type":"ACTUAL"},"dispFirstSubmitDate":"2018-07-31","dispFirstSubmitQcDate":"2018-07-31","dispFirstPostDateStruct":{"date":"2018-08-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-07-11","lastUpdatePostDateStruct":{"date":"2022-07-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes Mellitus."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":711,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Oral Semaglutide","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Liraglutide","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: liraglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"Oral semaglutide once-daily.","armGroupLabels":["Oral Semaglutide"]},{"type":"DRUG","name":"liraglutide","description":"Subcutaneous (s.c.) injection once-daily.","armGroupLabels":["Liraglutide"]},{"type":"DRUG","name":"placebo","description":"Placebo once-daily.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c (Week 26)","description":"Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","timeFrame":"Week 0, week 26"}],"secondaryOutcomes":[{"measure":"Change in Body Weight (Week 26)","description":"Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","timeFrame":"Week 0, week 26"},{"measure":"Change in HbA1c (Week 52)","description":"Change from baseline (week 0) in HbA1c was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 52"},{"measure":"Change in Body Weight (Week 52)","description":"Change from baseline (week 0) in body weight was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 52"},{"measure":"Change in Body Weight (%)","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Fasting Plasma Glucose","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Body Mass Index","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Total Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in VLDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Triglycerides - Ratio to Baseline","description":"Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Free Fatty Acids - Ratio to Baseline","description":"Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in SMPG - Mean 7-point Profile","description":"Change from baseline (week 0) to week 26 and week 52 in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in SMPG - Mean Postprandial Increment Over All Meals","description":"Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26, week 52"},{"measure":"Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no)","description":"Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26, week 52"},{"measure":"Participants Who Achieve Weight Loss ≥5% (Yes/no)","description":"Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26, week 52"},{"measure":"Participants Who Achieve Weight Loss ≥ 10% (Yes/no)","description":"Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26, week 52"},{"measure":"Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)","description":"Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26, week 52"},{"measure":"Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)","description":"Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26, week 52"},{"measure":"Time to Additional Anti-diabetic Medication","description":"Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-52"},{"measure":"Time to Rescue Medication","description":"Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","timeFrame":"Weeks 0-52"},{"measure":"Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Weeks 0-57"},{"measure":"Change in Amylase - Ratio to Baseline","description":"Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Lipase - Ratio to Baseline","description":"Change from baseline (week 0) in lipase (U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in SBP and DBP","description":"Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in ECG Evaluation","description":"Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and week 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26, week 52"},{"measure":"Change in Physical Examination","description":"Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.","timeFrame":"Week -2, week 52"},{"measure":"Change in Eye Examination Category","description":"Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week -2, Week 52"},{"measure":"Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-57"},{"measure":"Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-57"},{"measure":"Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0-57"},{"measure":"Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-57"},{"measure":"Anti-semaglutide Binding Antibody Levels","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-57"},{"measure":"Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.","timeFrame":"Weeks 0-57"},{"measure":"Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.","timeFrame":"Weeks 0-57"},{"measure":"Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)","description":"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 (wk 26) and week 52 (wk 52). The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.","timeFrame":"Week 0, week 26, week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age at least 20 years at the time of signing informed consent\n* Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening.\n* HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive)\n* Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with a stable daily dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days prior to day of screening (fixed-dose combinations are allowed)\n\nExclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply\n* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol\n* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)\n* History of pancreatitis (acute or chronic)\n* History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)\n* Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening\n* Subjects presently classified as being in New York Heart Association (NYHA) Class IV\n* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\n* Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL)\n* Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days\n* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation\n* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)\n* History of diabetic ketoacidosis","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35222","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Los Alamitos","state":"California","zip":"90720","country":"United States","geoPoint":{"lat":33.80307,"lon":-118.07256}},{"facility":"Novo Nordisk Investigational Site","city":"San Diego","state":"California","zip":"92111","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Novo Nordisk Investigational Site","city":"Denver","state":"Colorado","zip":"80246","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"Novo Nordisk Investigational Site","city":"Hallandale","state":"Florida","zip":"33009","country":"United States","geoPoint":{"lat":25.9812,"lon":-80.14838}},{"facility":"Novo Nordisk Investigational Site","city":"Jacksonville","state":"Florida","zip":"32256","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Novo Nordisk Investigational Site","city":"Miami","state":"Florida","zip":"33155","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Novo Nordisk Investigational Site","city":"Ocala","state":"Florida","zip":"34470","country":"United States","geoPoint":{"lat":29.1872,"lon":-82.14009}},{"facility":"Novo Nordisk Investigational 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Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Lancet. 2019 Jul 6;394(10192):39-50. doi: 10.1016/S0140-6736(19)31271-1. Epub 2019 Jun 8."},{"pmid":"34472698","type":"RESULT","citation":"Araki E, Terauchi Y, Watada H, Deenadayalan S, Christiansen E, Horio H, Kadowaki T. Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials. Diabetes Obes Metab. 2021 Dec;23(12):2785-2794. doi: 10.1111/dom.14536. Epub 2021 Sep 27."},{"pmid":"35373893","type":"RESULT","citation":"Aroda VR, Bauer R, Christiansen E, Haluzik M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9."},{"pmid":"37775297","type":"DERIVED","citation":"Ren H, Berry S, Malkin SJP, Hunt B, Bain S. Early use of oral semaglutide in the UK: A cost-effectiveness analysis versus continuing metformin and SGLT-2 inhibitor therapy. BMJ Open. 2023 Sep 29;13(9):e070473. doi: 10.1136/bmjopen-2022-070473."},{"pmid":"33660198","type":"DERIVED","citation":"Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4."},{"pmid":"32267058","type":"DERIVED","citation":"Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13."},{"pmid":"31903692","type":"DERIVED","citation":"Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Data presented in \"participant flow\" is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","recruitmentDetails":"The trial was conducted at 101 sites in 12 countries as follows:Croatia (5), Czech Republic (3), Germany (8), Hungary (9), Japan (9), Latvia (4), Poland (9), Slovakia (5), South Africa (5), Ukraine (3), United Arab Emirates (2), United States (39).","groups":[{"id":"FG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. 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Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"FG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"285"},{"groupId":"FG001","numSubjects":"284"},{"groupId":"FG002","numSubjects":"142"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"285"},{"groupId":"FG001","numSubjects":"284"},{"groupId":"FG002","numSubjects":"142"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"285"},{"groupId":"FG001","numSubjects":"284"},{"groupId":"FG002","numSubjects":"142"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"277"},{"groupId":"FG001","numSubjects":"274"},{"groupId":"FG002","numSubjects":"134"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"8"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Died","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised participants.","groups":[{"id":"BG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"BG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"BG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"285"},{"groupId":"BG001","value":"284"},{"groupId":"BG002","value":"142"},{"groupId":"BG003","value":"711"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56","spread":"10"},{"groupId":"BG001","value":"56","spread":"10"},{"groupId":"BG002","value":"57","spread":"10"},{"groupId":"BG003","value":"56","spread":"10"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"138"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"68"},{"groupId":"BG003","value":"341"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"147"},{"groupId":"BG001","value":"149"},{"groupId":"BG002","value":"74"},{"groupId":"BG003","value":"370"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"40"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"268"},{"groupId":"BG001","value":"266"},{"groupId":"BG002","value":"137"},{"groupId":"BG003","value":"671"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"Race was recorded as 'Not Applicable' for South Africa.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"208"},{"groupId":"BG001","value":"212"},{"groupId":"BG002","value":"99"},{"groupId":"BG003","value":"519"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"29"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"94"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"14"}]},{"title":"Not Applicable","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"52"}]}]}]},{"title":"Baseline HbA1c","description":"Observed mean HbA1c","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.0","spread":"0.7"},{"groupId":"BG001","value":"8.0","spread":"0.7"},{"groupId":"BG002","value":"7.9","spread":"0.7"},{"groupId":"BG003","value":"8.0","spread":"0.7"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c (Week 26)","description":"Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","populationDescription":"Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"0.9"},{"groupId":"OG001","value":"-1.1","spread":"0.9"},{"groupId":"OG002","value":"-0.1","spread":"0.7"}]}]},{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"245"},{"groupId":"OG002","value":"112"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"0.9"},{"groupId":"OG001","value":"-1.2","spread":"0.9"},{"groupId":"OG002","value":"-0.1","spread":"0.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from the non-inferiority margin. The non-inferiority margin was 0.4%","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.3","ciUpperLimit":"0.0","estimateComment":"Oral semaglutide 14 mg - Liraglutide 1.8 mg"},{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).","pValue":"0.0645","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.3","ciUpperLimit":"0.0","estimateComment":"Oral semaglutide 14 mg - Liraglutide 1.8 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"-1.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.2","ciUpperLimit":"-0.9","estimateComment":"Oral semaglutide 14 mg - Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.","statisticalMethod":"MMRM","paramType":"Mean treatment difference","paramValue":"-0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.3","ciUpperLimit":"-0.1","estimateComment":"Oral semaglutide 14 mg - Liraglutide 1.8 mg"},{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).","pValue":"0.0056","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"MMRM","paramType":"Mean treatment difference","paramValue":"-0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.3","ciUpperLimit":"-0.1","estimateComment":"Oral semaglutide 14 mg - Liraglutide 1.8 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).","pValue":"0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"MMRM","paramType":"Mean treatment difference","paramValue":"-1.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.4","ciUpperLimit":"-1.0","estimateComment":"Oral semaglutide 14 mg - Placebo"}]},{"type":"SECONDARY","title":"Change in Body Weight (Week 26)","description":"Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.4","spread":"4.4"},{"groupId":"OG001","value":"-3.2","spread":"3.7"},{"groupId":"OG002","value":"-0.6","spread":"3.1"}]}]},{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"244"},{"groupId":"OG002","value":"112"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.7","spread":"4.3"},{"groupId":"OG001","value":"-3.3","spread":"3.7"},{"groupId":"OG002","value":"-0.7","spread":"3.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).","pValue":"0.0003","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"-1.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.9","ciUpperLimit":"-0.6","estimateComment":"Oral semaglutide 14 mg - Liraglutide 1.8 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"-3.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.7","ciUpperLimit":"-3.0","estimateComment":"Oral semaglutide 14 mg - Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"MMRM","paramType":"Mean treatment difference","paramValue":"-1.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.2","ciUpperLimit":"-0.9","estimateComment":"Oral semaglutide 14 mg - Liraglutide 1.8 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"MMRM","paramType":"Mean treatment difference","paramValue":"-4.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.8","ciUpperLimit":"-3.2","estimateComment":"Oral sema 14 mg - Placebo"}]},{"type":"SECONDARY","title":"Change in HbA1c (Week 52)","description":"Change from baseline (week 0) in HbA1c was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"1.0"},{"groupId":"OG001","value":"-0.9","spread":"1.0"},{"groupId":"OG002","value":"-0.1","spread":"0.9"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (Week 52)","description":"Change from baseline (week 0) in body weight was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.4","spread":"5.5"},{"groupId":"OG001","value":"-3.1","spread":"4.4"},{"groupId":"OG002","value":"-1.0","spread":"3.8"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (%)","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.89","spread":"4.95"},{"groupId":"OG001","value":"-3.33","spread":"3.78"},{"groupId":"OG002","value":"-0.60","spread":"3.34"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.94","spread":"6.37"},{"groupId":"OG001","value":"-3.25","spread":"4.33"},{"groupId":"OG002","value":"-0.99","spread":"4.12"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.04","spread":"2.28"},{"groupId":"OG001","value":"-1.91","spread":"2.05"},{"groupId":"OG002","value":"-0.33","spread":"2.03"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"132"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.91","spread":"2.41"},{"groupId":"OG001","value":"-1.54","spread":"2.41"},{"groupId":"OG002","value":"-0.66","spread":"1.99"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/m^2","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"1.6"},{"groupId":"OG001","value":"-1.1","spread":"1.3"},{"groupId":"OG002","value":"-0.2","spread":"1.1"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"2.0"},{"groupId":"OG001","value":"-1.1","spread":"1.5"},{"groupId":"OG002","value":"-0.4","spread":"1.4"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"5.4"},{"groupId":"OG001","value":"-3.0","spread":"4.5"},{"groupId":"OG002","value":"-1.2","spread":"3.9"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"266"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.4","spread":"6.1"},{"groupId":"OG001","value":"-2.7","spread":"5.1"},{"groupId":"OG002","value":"-1.7","spread":"4.7"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"267"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"20.3"},{"groupId":"OG001","value":"0.97","spread":"21.6"},{"groupId":"OG002","value":"0.99","spread":"17.0"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"264"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"20.5"},{"groupId":"OG001","value":"0.98","spread":"19.6"},{"groupId":"OG002","value":"1.02","spread":"18.3"}]}]}]},{"type":"SECONDARY","title":"Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"267"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"29.9"},{"groupId":"OG001","value":"0.97","spread":"43.6"},{"groupId":"OG002","value":"0.99","spread":"30.8"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"264"},{"groupId":"OG002","value":"132"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"31.6"},{"groupId":"OG001","value":"1.00","spread":"38.5"},{"groupId":"OG002","value":"1.06","spread":"33.1"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in VLDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"267"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"43.5"},{"groupId":"OG001","value":"0.91","spread":"37.1"},{"groupId":"OG002","value":"1.02","spread":"29.4"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"264"},{"groupId":"OG002","value":"132"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.87","spread":"41.9"},{"groupId":"OG001","value":"0.90","spread":"37.5"},{"groupId":"OG002","value":"0.98","spread":"39.8"}]}]}]},{"type":"SECONDARY","title":"Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL-cholesterol","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"267"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"13.8"},{"groupId":"OG001","value":"1.02","spread":"15.2"},{"groupId":"OG002","value":"1.02","spread":"12.2"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"264"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"13.8"},{"groupId":"OG001","value":"1.01","spread":"14.7"},{"groupId":"OG002","value":"1.00","spread":"12.7"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides - Ratio to Baseline","description":"Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"267"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"48.4"},{"groupId":"OG001","value":"0.91","spread":"38.3"},{"groupId":"OG002","value":"1.01","spread":"34.7"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"264"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.87","spread":"47.0"},{"groupId":"OG001","value":"0.89","spread":"41.1"},{"groupId":"OG002","value":"0.97","spread":"43.4"}]}]}]},{"type":"SECONDARY","title":"Change in Free Fatty Acids - Ratio to Baseline","description":"Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of FFA","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"262"},{"groupId":"OG002","value":"132"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"48.0"},{"groupId":"OG001","value":"0.95","spread":"50.7"},{"groupId":"OG002","value":"1.06","spread":"49.1"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"261"},{"groupId":"OG002","value":"130"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.83","spread":"49.3"},{"groupId":"OG001","value":"0.87","spread":"51.2"},{"groupId":"OG002","value":"0.89","spread":"46.8"}]}]}]},{"type":"SECONDARY","title":"Change in SMPG - Mean 7-point Profile","description":"Change from baseline (week 0) to week 26 and week 52 in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"129"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"2.3"},{"groupId":"OG001","value":"-2.0","spread":"2.0"},{"groupId":"OG002","value":"-0.7","spread":"1.8"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"251"},{"groupId":"OG002","value":"126"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"2.3"},{"groupId":"OG001","value":"-1.8","spread":"2.2"},{"groupId":"OG002","value":"-0.9","spread":"1.7"}]}]}]},{"type":"SECONDARY","title":"Change in SMPG - Mean Postprandial Increment Over All Meals","description":"Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"129"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"1.9"},{"groupId":"OG001","value":"-0.4","spread":"2.0"},{"groupId":"OG002","value":"-0.2","spread":"1.9"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"253"},{"groupId":"OG002","value":"126"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"1.9"},{"groupId":"OG001","value":"-0.5","spread":"2.1"},{"groupId":"OG002","value":"-0.4","spread":"1.9"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"134"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"188"},{"groupId":"OG001","value":"168"},{"groupId":"OG002","value":"19"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"104"},{"groupId":"OG002","value":"115"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"167"},{"groupId":"OG001","value":"148"},{"groupId":"OG002","value":"20"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"113"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no)","description":"Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"134"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"116"},{"groupId":"OG002","value":"7"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"156"},{"groupId":"OG002","value":"127"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"88"},{"groupId":"OG002","value":"5"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"181"},{"groupId":"OG002","value":"128"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve Weight Loss ≥5% (Yes/no)","description":"Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"134"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"10"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"196"},{"groupId":"OG002","value":"124"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"16"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"203"},{"groupId":"OG002","value":"117"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve Weight Loss ≥ 10% (Yes/no)","description":"Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"134"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"0"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"255"},{"groupId":"OG002","value":"134"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"4"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"129"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)","description":"Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"134"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"145"},{"groupId":"OG002","value":"15"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"126"},{"groupId":"OG002","value":"119"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"15"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"118"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)","description":"Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"134"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"93"},{"groupId":"OG002","value":"5"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"178"},{"groupId":"OG002","value":"129"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"9"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"192"},{"groupId":"OG002","value":"124"}]}]}]},{"type":"SECONDARY","title":"Time to Additional Anti-diabetic Medication","description":"Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 0 to week 26","categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"12"}]}]},{"title":"Week 0 to week 52","categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"46"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"0.4915","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.75","ciUpperLimit":"1.80","estimateComment":"Oral semaglutide 14 mg / Liraglutide 1.8 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.21","ciUpperLimit":"0.48","estimateComment":"Oral semaglutide 14 mg / Placebo"}]},{"type":"SECONDARY","title":"Time to Rescue Medication","description":"Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 0 - week 26","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"11"}]}]},{"title":"Week 0 - week 52","categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"43"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity","pValue":"0.6252","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.62","ciUpperLimit":"2.22","estimateComment":"Oral semaglutide 14 mg / Liraglutide 1.8 mg"},{"groupIds":["OG000","OG002"],"groupDescription":"Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.09","ciUpperLimit":"0.26","estimateComment":"Oral semaglutide 14 mg / Placebo"}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"973"},{"groupId":"OG001","value":"927"},{"groupId":"OG002","value":"300"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase - Ratio to Baseline","description":"Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"252"},{"groupId":"OG002","value":"128"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.13","spread":"24.9"},{"groupId":"OG001","value":"1.11","spread":"26.1"},{"groupId":"OG002","value":"0.99","spread":"23.1"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"240"},{"groupId":"OG001","value":"241"},{"groupId":"OG002","value":"123"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.14","spread":"27.4"},{"groupId":"OG001","value":"1.10","spread":"26.1"},{"groupId":"OG002","value":"0.98","spread":"21.9"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase - Ratio to Baseline","description":"Change from baseline (week 0) in lipase (U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"252"},{"groupId":"OG002","value":"128"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"53.3"},{"groupId":"OG001","value":"1.40","spread":"58.8"},{"groupId":"OG002","value":"0.99","spread":"45.7"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"240"},{"groupId":"OG001","value":"241"},{"groupId":"OG002","value":"123"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.28","spread":"59.3"},{"groupId":"OG001","value":"1.32","spread":"51.5"},{"groupId":"OG002","value":"0.96","spread":"44.2"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats/min","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"255"},{"groupId":"OG002","value":"128"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"9"},{"groupId":"OG001","value":"3","spread":"11"},{"groupId":"OG002","value":"0","spread":"9"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"247"},{"groupId":"OG002","value":"123"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"9"},{"groupId":"OG001","value":"3","spread":"9"},{"groupId":"OG002","value":"0","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in SBP and DBP","description":"Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"SBP: 26 weeks","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"255"},{"groupId":"OG002","value":"128"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"13"},{"groupId":"OG001","value":"-4","spread":"13"},{"groupId":"OG002","value":"-2","spread":"13"}]}]},{"title":"SBP: 52 weeks","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"247"},{"groupId":"OG002","value":"123"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"14"},{"groupId":"OG001","value":"-3","spread":"13"},{"groupId":"OG002","value":"-0","spread":"13"}]}]},{"title":"DBP: 26 weeks","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"9"},{"groupId":"OG001","value":"-0","spread":"9"},{"groupId":"OG002","value":"-1","spread":"9"}]}]},{"title":"DBP: 52 weeks","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"247"},{"groupId":"OG002","value":"123"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"8"},{"groupId":"OG001","value":"-1","spread":"9"},{"groupId":"OG002","value":"0","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in ECG Evaluation","description":"Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and week 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Normal (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"143"},{"groupId":"OG002","value":"73"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"123"},{"groupId":"OG002","value":"67"}]}]},{"title":"Normal (week 0) to abnormal NCS (week 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(week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"51"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"37"}]}]},{"title":"Abnormal NCS (week 0) to Abnormal CS (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"51"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Abnormal CS (week 0) to Normal (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}]},{"title":"Abnormal CS (week 0) to Abnormal NCS (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Abnormal CS (week 0) to Abnormal CS (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in Physical Examination","description":"Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -2, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"1) Cardiovascular system (Week -2)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"260"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"128"}]},{"title":"Abnormal NCS","measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"12"}]},{"title":"Abnormal 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-2)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"282"},{"groupId":"OG001","value":"278"},{"groupId":"OG002","value":"140"}]},{"title":"Abnormal NCS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}]},{"title":"8) Respiratory system (Week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"262"},{"groupId":"OG002","value":"131"}]},{"title":"Abnormal NCS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}]},{"title":"9) Skin (Week -2)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"243"},{"groupId":"OG001","value":"243"},{"groupId":"OG002","value":"122"}]},{"title":"Abnormal NCS","measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"17"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"}]}]},{"title":"9) Skin (Week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"243"},{"groupId":"OG001","value":"235"},{"groupId":"OG002","value":"114"}]},{"title":"Abnormal NCS","measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"17"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"}]}]},{"title":"10) Thyroid gland (Week -2)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"277"},{"groupId":"OG002","value":"132"}]},{"title":"Abnormal NCS","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"8"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}]}]},{"title":"10) Thyroid gland (Week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"133"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"262"},{"groupId":"OG002","value":"127"}]},{"title":"Abnormal NCS","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}]}]},{"type":"SECONDARY","title":"Change in Eye Examination Category","description":"Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -2, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Left eye - Normal to Normal","categories":[{"measurements":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"144"},{"groupId":"OG002","value":"57"}]}]},{"title":"Left eye - Normal to Abnormal NCS","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"5"}]}]},{"title":"Left eye - Normal to Abnormal CS","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"}]}]},{"title":"Left eye - Abnormal NCS to normal","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"5"}]}]},{"title":"Left eye - Abnormal NCS to abnormal NCS","categories":[{"measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"38"}]}]},{"title":"Left eye - Abnormal NCS to abnormal CS","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Left eye - Abnormal CS to normal","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}]},{"title":"Left eye - Abnormal CS to abnormal NCS","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}]},{"title":"Left eye - Abnormal CS to abnormal CS","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"8"}]}]},{"title":"Right eye - Normal to Normal","categories":[{"measurements":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"150"},{"groupId":"OG002","value":"57"}]}]},{"title":"Right eye - Normal to Abnormal NCS","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"7"}]}]},{"title":"Right eye - Normal to Abnormal CS","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"}]}]},{"title":"Right eye - Abnormal NCS to Normal","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"6"}]}]},{"title":"Right eye - Abnormal NCS to Abnormal NCS","categories":[{"measurements":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"37"}]}]},{"title":"Right eye - Abnormal NCS to Abnormal CS","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Right eye - Abnormal CS to Normal","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"}]}]},{"title":"Right eye - Abnormal CS to Abnormal NCS","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]}]},{"title":"Right eye - Abnormal CS to Abnormal CS","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"6"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Anti-semaglutide Binding Antibody Levels","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.","reportingStatus":"POSTED","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"}]}]}]},{"type":"SECONDARY","title":"Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"3"}]}]}]},{"type":"SECONDARY","title":"Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)","description":"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 (wk 26) and week 52 (wk 52). The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Week 0, week 26, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG001","title":"Liraglutide 1.8 mg","description":"Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."},{"id":"OG002","title":"Placebo","description":"Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \\[SGLT-2\\] inhibitor) throughout the entire trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"284"},{"groupId":"OG002","value":"142"}]}],"classes":[{"title":"Satisfaction with treatment: wk 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"1.49"},{"groupId":"OG001","value":"0.73","spread":"1.54"},{"groupId":"OG002","value":"0.28","spread":"1.69"}]}]},{"title":"Satisfaction with treatment: wk 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"268"},{"groupId":"OG002","value":"133"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.67","spread":"1.67"},{"groupId":"OG001","value":"0.70","spread":"1.46"},{"groupId":"OG002","value":"0.48","spread":"1.45"}]}]},{"title":"Feeling of unacceptably high blood sugars: wk 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"134"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.94","spread":"2.03"},{"groupId":"OG001","value":"-1.72","spread":"2.10"},{"groupId":"OG002","value":"-0.87","spread":"2.11"}]}]},{"title":"Feeling of unacceptably high blood sugars: wk 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