{"protocolSection":{"identificationModule":{"nctId":"NCT02607865","orgStudyIdInfo":{"id":"NN9924-4222"},"secondaryIdInfos":[{"id":"2015-001351-71","type":"EUDRACT_NUMBER"},{"id":"U1111-1168-4339","type":"OTHER","domain":"WHO"},{"id":"JAPIC","type":"OTHER","domain":"JapicCTI-163174"},{"id":"2015","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2015"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes","officialTitle":"Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes","acronym":"PIONEER 3"},"statusModule":{"statusVerifiedDate":"2022-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-02-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-02-14","type":"ACTUAL"},"completionDateStruct":{"date":"2018-03-28","type":"ACTUAL"},"studyFirstSubmitDate":"2015-11-10","studyFirstSubmitQcDate":"2015-11-16","studyFirstPostDateStruct":{"date":"2015-11-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-10-15","resultsFirstSubmitQcDate":"2020-02-14","resultsFirstPostDateStruct":{"date":"2020-02-27","type":"ACTUAL"},"dispFirstSubmitDate":"2018-02-01","dispFirstSubmitQcDate":"2018-02-01","dispFirstPostDateStruct":{"date":"2018-02-05","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 the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes."},"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":1864,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 3 mg","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide","Drug: placebo"]},{"label":"Semaglutide 7 mg","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide","Drug: placebo"]},{"label":"Semaglutide 14 mg","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide","Drug: placebo"]},{"label":"Sitagliptin 100 mg","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: sitagliptin","Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"Oral administration once-daily","armGroupLabels":["Semaglutide 14 mg","Semaglutide 3 mg","Semaglutide 7 mg"]},{"type":"DRUG","name":"sitagliptin","description":"Oral administration once-daily","armGroupLabels":["Sitagliptin 100 mg"]},{"type":"DRUG","name":"placebo","description":"Oral administration once-daily","armGroupLabels":["Semaglutide 14 mg","Semaglutide 3 mg","Semaglutide 7 mg","Sitagliptin 100 mg"]}]},"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: Weeks 52 and 78","description":"Change from baseline (week 0) in HbA1c was evaluated at weeks 52 and 78. 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, week 78"},{"measure":"Change in Body Weight (kg): Weeks 52 and 78","description":"Change from baseline (week 0) in body weight was evaluated at weeks 52 and 78. 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, week 78"},{"measure":"Change in Body Weight (%)","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. 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, week 78"},{"measure":"Change in FPG","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. 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, week 78"},{"measure":"Change in BMI","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26, 52 and 78. 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, week 78"},{"measure":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated at weeks 26, 52 and 78. 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, week 78"},{"measure":"Change in Total Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26, 52 and 78 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, week 78"},{"measure":"Change in LDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26, 52 and 78 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, week 78"},{"measure":"Change in VLDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) at weeks 26, 52 and 78 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, week 78"},{"measure":"Change in HDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 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, week 78"},{"measure":"Change in Triglycerides (Ratio to Baseline)","description":"Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26, 52 and 78 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, week 78"},{"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, 52 and 78 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. Because of an issue with the handling of the blood samples for FFA, all FFA data were considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the data presented here.","timeFrame":"Week 0, week 26, week 52, week 78"},{"measure":"Change in SMPG - Mean 7-point Profile","description":"Change from baseline (week 0) 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, week 78"},{"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, 52 and 78. 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, week 78"},{"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, 52 and 78. 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, week 78"},{"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, 52 and 78 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, week 78"},{"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, 52 and 78 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, week 78"},{"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, 52 and 78 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, week 78"},{"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, 52 and 78 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, week 78"},{"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, 52 and 78 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, week 78"},{"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, week 0 to week 52 and week 0 to week 78. 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 78), 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 0-78"},{"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, week 0 to week 52 and week 0 to week 78. 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 0-78"},{"measure":"Number of TEAEs During Exposure to Trial Product","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 83 (78-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 0-83"},{"measure":"Change in Amylase (Ratio to Baseline)","description":"Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26, 52 and 78 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, week 78"},{"measure":"Change in Lipase (Ratio to Baseline)","description":"Change from baseline (week 0) in lipase (U/L) at weeks 26, 52 and 78 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, week 78"},{"measure":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate was evaluated at weeks 26, 52 and 78. 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, week 78"},{"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, 52 and 78. 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, week 78"},{"measure":"Change in ECG Evaluation","description":"Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26, 52 and 78. 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, 52 and 78. 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, week 78"},{"measure":"Change in Physical Examination","description":"Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), weeks 52 and 78 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, week 78"},{"measure":"Change in Eye Examination Category","description":"Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), week 52 and week 78 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, week 78"},{"measure":"Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-83) 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 0-83"},{"measure":"Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-83) 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 0-83"},{"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 treatment arms (3 mg, 7 mg and 14 mg). 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 0-83) 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 0-83"},{"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 treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-83) 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 0-83"},{"measure":"Anti-semaglutide Binding Antibody Levels","description":"This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-83). 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 0-83"},{"measure":"Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-83 (78-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 0-83"},{"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 83 (78-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 0-83"},{"measure":"Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses","description":"This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations for participants in the pharmacokinetic (PK) subpopulation are presented. The PK subpopulation consisted of participants from sites in Germany, Japan and the United States receiving oral semaglutide (3 mg, 7 mg or 14 mg). Results are based on the data from the on-treatment observation period and follow-up period. The on-treatment observation period was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Weeks 0-83"},{"measure":"Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26, 52 and 78. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.","timeFrame":"Week 0, week 26, week 52, week 78"},{"measure":"Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains","description":"The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. 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, week 78"},{"measure":"Change in CoEQ: Scores From the 4 Domains and the 19 Items","description":"Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks (wk) 26, 52 and 78. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.","timeFrame":"Week 0, week 26, week 52, week 78"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age at least 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 T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening\n* HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).\n* Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening\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 adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For certain specific countries: Additional specific requirements apply\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 potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)\n* Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/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* Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m\\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)\n* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Anniston","state":"Alabama","zip":"36207","country":"United States","geoPoint":{"lat":33.65983,"lon":-85.83163}},{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35211","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Tuscumbia","state":"Alabama","zip":"35674","country":"United States","geoPoint":{"lat":34.7312,"lon":-87.70253}},{"facility":"Novo Nordisk Investigational Site","city":"Glendale","state":"Arizona","zip":"85308","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"Novo Nordisk Investigational Site","city":"Little 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Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1466-1480. doi: 10.1001/jama.2019.2942."},{"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":"35064550","type":"RESULT","citation":"Eliasson B, Ericsson A, Fridhammar A, Nilsson A, Persson S, Chubb B. Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting. Pharmacoecon Open. 2022 May;6(3):343-354. doi: 10.1007/s41669-021-00317-z. Epub 2022 Jan 21."},{"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":"37178435","type":"DERIVED","citation":"Pulleyblank R, Larsen NB. Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study. Pharmacoecon Open. 2023 Jul;7(4):579-591. doi: 10.1007/s41669-023-00416-z. Epub 2023 May 13."},{"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":"32998732","type":"DERIVED","citation":"Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4."},{"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. 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In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"466"},{"groupId":"FG001","numSubjects":"466"},{"groupId":"FG002","numSubjects":"465"},{"groupId":"FG003","numSubjects":"467"}]},{"type":"Full Analysis Set (FAS)","comment":"One participant was excluded from the FAS as the participant was a confirmed screening failure.","achievements":[{"groupId":"FG000","numSubjects":"466"},{"groupId":"FG001","numSubjects":"465"},{"groupId":"FG002","numSubjects":"465"},{"groupId":"FG003","numSubjects":"467"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"466"},{"groupId":"FG001","numSubjects":"464"},{"groupId":"FG002","numSubjects":"465"},{"groupId":"FG003","numSubjects":"466"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"433"},{"groupId":"FG001","numSubjects":"436"},{"groupId":"FG002","numSubjects":"438"},{"groupId":"FG003","numSubjects":"451"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"27"},{"groupId":"FG003","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"17"},{"groupId":"FG003","numSubjects":"8"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The FAS comprised all randomised participants.","groups":[{"id":"BG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"BG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"BG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"BG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"466"},{"groupId":"BG001","value":"465"},{"groupId":"BG002","value":"465"},{"groupId":"BG003","value":"467"},{"groupId":"BG004","value":"1863"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58","spread":"10"},{"groupId":"BG001","value":"58","spread":"10"},{"groupId":"BG002","value":"57","spread":"10"},{"groupId":"BG003","value":"58","spread":"10"},{"groupId":"BG004","value":"58","spread":"10"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"220"},{"groupId":"BG002","value":"218"},{"groupId":"BG003","value":"229"},{"groupId":"BG004","value":"879"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"254"},{"groupId":"BG001","value":"245"},{"groupId":"BG002","value":"247"},{"groupId":"BG003","value":"238"},{"groupId":"BG004","value":"984"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"Race was recorded as 'Not Applicable' for Brazil and France.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"344"},{"groupId":"BG001","value":"330"},{"groupId":"BG002","value":"317"},{"groupId":"BG003","value":"333"},{"groupId":"BG004","value":"1324"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"45"},{"groupId":"BG003","value":"39"},{"groupId":"BG004","value":"160"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"69"},{"groupId":"BG002","value":"61"},{"groupId":"BG003","value":"59"},{"groupId":"BG004","value":"245"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"18"}]},{"title":"Native Hawaiian or other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"56"}]},{"title":"Not applicable","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"18"},{"groupId":"BG004","value":"59"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"Ethnicity was recorded as 'Not Applicable' for France.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"76"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"75"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"321"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"385"},{"groupId":"BG001","value":"378"},{"groupId":"BG002","value":"377"},{"groupId":"BG003","value":"366"},{"groupId":"BG004","value":"1506"}]},{"title":"Not applicable","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"36"}]}]}]},{"title":"Glycosylated haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.3","spread":"1.0"},{"groupId":"BG001","value":"8.4","spread":"1.0"},{"groupId":"BG002","value":"8.3","spread":"0.9"},{"groupId":"BG003","value":"8.3","spread":"0.9"},{"groupId":"BG004","value":"8.3","spread":"0.9"}]}]}]}]},"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 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"435"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"436"},{"groupId":"OG003","value":"446"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"1.0"},{"groupId":"OG001","value":"-1.1","spread":"1.1"},{"groupId":"OG002","value":"-1.3","spread":"1.0"},{"groupId":"OG003","value":"-0.8","spread":"0.9"}]}]},{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"391"},{"groupId":"OG001","value":"409"},{"groupId":"OG002","value":"398"},{"groupId":"OG003","value":"419"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"1.0"},{"groupId":"OG001","value":"-1.2","spread":"1.1"},{"groupId":"OG002","value":"-1.4","spread":"1.0"},{"groupId":"OG003","value":"-0.8","spread":"0.9"}]}]}],"analyses":[{"groupIds":["OG002","OG003"],"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 0.3% (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 (non-inferiority). The non-inferiority margin was 0.3%.","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"-0.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.6","ciUpperLimit":"-0.4","estimateComment":"Oral semaglutide 14 mg - Sitagliptin 100 mg"},{"groupIds":["OG002","OG003"],"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":"-0.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.6","ciUpperLimit":"-0.4","estimateComment":"Oral semaglutide 14 mg - Sitagliptin 100 mg"},{"groupIds":["OG001","OG003"],"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":"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 0.3% (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 (non-inferiority). The non-inferiority margin was 0.3%.","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"-0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.4","ciUpperLimit":"-0.1","estimateComment":"Oral semaglutide 7 mg - Sitagliptin 100 mg"},{"groupIds":["OG001","OG003"],"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":"-0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.4","ciUpperLimit":"-0.1","estimateComment":"Oral semaglutide 7 mg - Sitagliptin 100 mg"},{"groupIds":["OG000","OG003"],"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":"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 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.","pValue":"= 0.0856","pValueComment":"Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.1","ciUpperLimit":"0.3","estimateComment":"Oral semaglutide 3 mg - Sitagliptin 100 mg"},{"groupIds":["OG000","OG003"],"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 not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. 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":"= 0.0080","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.0","ciUpperLimit":"0.3","estimateComment":"Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value."},{"groupIds":["OG002","OG003"],"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 0.3%.","statisticalMethod":"MMRM","paramType":"Mean treatment difference","paramValue":"-0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.7","ciUpperLimit":"-0.5","estimateComment":"Oral semaglutide 14 mg - Sitagliptin 100 mg"},{"groupIds":["OG002","OG003"],"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 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":"-0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.7","ciUpperLimit":"-0.5","estimateComment":"Oral semaglutide 14 mg - Sitagliptin 100 mg"},{"groupIds":["OG001","OG003"],"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 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 0.3%.","statisticalMethod":"MMRM","paramType":"Mean treatment difference","paramValue":"-0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.4","ciUpperLimit":"-0.2","estimateComment":"Oral semaglutide 7 mg - Sitagliptin 100 mg"},{"groupIds":["OG001","OG003"],"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 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":"-0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.4","ciUpperLimit":"-0.2","estimateComment":"Oral semaglutide 7 mg - Sitagliptin 100 mg"},{"groupIds":["OG000","OG003"],"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 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":"=0.3851","pValueComment":"Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.","statisticalMethod":"MMRM","paramType":"Mean treatment difference","paramValue":"0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.1","ciUpperLimit":"0.4","estimateComment":"Oral semaglutide 3 mg - Sitagliptin 100 mg"},{"groupIds":["OG000","OG003"],"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 HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.","nonInferiorityType":"OTHER","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":"0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.1","ciUpperLimit":"0.4","estimateComment":"Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value."}]},{"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 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"440"},{"groupId":"OG002","value":"439"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"3.2"},{"groupId":"OG001","value":"-2.2","spread":"3.9"},{"groupId":"OG002","value":"-3.1","spread":"3.8"},{"groupId":"OG003","value":"-0.6","spread":"3.2"}]}]},{"title":"on-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"411"},{"groupId":"OG002","value":"401"},{"groupId":"OG003","value":"420"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"3.3"},{"groupId":"OG001","value":"-2.2","spread":"4.0"},{"groupId":"OG002","value":"-3.2","spread":"3.8"},{"groupId":"OG003","value":"-0.6","spread":"3.2"}]}]}],"analyses":[{"groupIds":["OG002","OG003"],"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":"-2.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.0","ciUpperLimit":"-2.0","estimateComment":"Oral semaglutide 14 mg - Sitagliptin 100 mg"},{"groupIds":["OG001","OG003"],"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":"-1.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.0","ciUpperLimit":"-1.1","estimateComment":"Oral semaglutide 7 mg - Sitagliptin 100 mg"},{"groupIds":["OG000","OG003"],"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 not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. 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":"= 0.0185","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"Pattern mixture model","paramType":"Mean treatment difference","paramValue":"-0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.1","ciUpperLimit":"-0.1","estimateComment":"Oral semaglutide 3 mg - Sitagliptin 100 mg"},{"groupIds":["OG002","OG003"],"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":"-2.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.1","ciUpperLimit":"-2.1","estimateComment":"Oral semaglutide 14 mg - Sitagliptin 100 mg"},{"groupIds":["OG001","OG003"],"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":"-2.0","ciUpperLimit":"-1.1","estimateComment":"Oral semaglutide 7 mg - Sitagliptin 100 mg"},{"groupIds":["OG000","OG003"],"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":"=0.0257","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0 (superiority).","statisticalMethod":"MMRM","paramType":"type Mean treatment difference","paramValue":"-0.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.0","ciUpperLimit":"-0.1","estimateComment":"Oral semaglutide 3 mg - Sitagliptin 100 mg"}]},{"type":"SECONDARY","title":"Change in HbA1c: Weeks 52 and 78","description":"Change from baseline (week 0) in HbA1c was evaluated at weeks 52 and 78. 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 of HbA1c","timeFrame":"Week 0, week 52, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"427"},{"groupId":"OG001","value":"431"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"436"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"1.1"},{"groupId":"OG001","value":"-1.0","spread":"1.2"},{"groupId":"OG002","value":"-1.2","spread":"1.1"},{"groupId":"OG003","value":"-0.7","spread":"1.1"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"425"},{"groupId":"OG003","value":"439"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"1.1"},{"groupId":"OG001","value":"-0.9","spread":"1.3"},{"groupId":"OG002","value":"-1.1","spread":"1.1"},{"groupId":"OG003","value":"-0.7","spread":"1.1"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (kg): Weeks 52 and 78","description":"Change from baseline (week 0) in body weight was evaluated at weeks 52 and 78. 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","timeFrame":"Week 0, week 52, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"435"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"4.1"},{"groupId":"OG001","value":"-2.5","spread":"4.9"},{"groupId":"OG002","value":"-3.5","spread":"4.7"},{"groupId":"OG003","value":"-0.7","spread":"3.7"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"425"},{"groupId":"OG002","value":"428"},{"groupId":"OG003","value":"443"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"4.9"},{"groupId":"OG001","value":"-2.8","spread":"5.4"},{"groupId":"OG002","value":"-3.2","spread":"4.9"},{"groupId":"OG003","value":"-1.0","spread":"4.1"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (%)","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"440"},{"groupId":"OG002","value":"439"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.23","spread":"3.57"},{"groupId":"OG001","value":"-2.36","spread":"4.09"},{"groupId":"OG002","value":"-3.44","spread":"4.21"},{"groupId":"OG003","value":"-0.64","spread":"3.38"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"435"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.65","spread":"4.28"},{"groupId":"OG001","value":"-2.63","spread":"5.09"},{"groupId":"OG002","value":"-3.83","spread":"5.14"},{"groupId":"OG003","value":"-0.76","spread":"3.91"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"425"},{"groupId":"OG002","value":"428"},{"groupId":"OG003","value":"443"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.87","spread":"4.87"},{"groupId":"OG001","value":"-2.92","spread":"5.67"},{"groupId":"OG002","value":"-3.47","spread":"5.34"},{"groupId":"OG003","value":"-0.99","spread":"4.39"}]}]}]},{"type":"SECONDARY","title":"Change in FPG","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"436"},{"groupId":"OG002","value":"433"},{"groupId":"OG003","value":"443"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.83","spread":"2.69"},{"groupId":"OG001","value":"-1.17","spread":"2.54"},{"groupId":"OG002","value":"-1.67","spread":"2.60"},{"groupId":"OG003","value":"-0.90","spread":"2.32"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"429"},{"groupId":"OG002","value":"432"},{"groupId":"OG003","value":"433"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.98","spread":"2.78"},{"groupId":"OG001","value":"-1.28","spread":"2.62"},{"groupId":"OG002","value":"-1.75","spread":"2.57"},{"groupId":"OG003","value":"-1.03","spread":"2.60"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"418"},{"groupId":"OG001","value":"419"},{"groupId":"OG002","value":"419"},{"groupId":"OG003","value":"434"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.07","spread":"3.21"},{"groupId":"OG001","value":"-1.11","spread":"2.92"},{"groupId":"OG002","value":"-1.65","spread":"2.71"},{"groupId":"OG003","value":"-0.91","spread":"2.59"}]}]}]},{"type":"SECONDARY","title":"Change in BMI","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26, 52 and 78. 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"440"},{"groupId":"OG002","value":"439"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"1.2"},{"groupId":"OG001","value":"-0.8","spread":"1.4"},{"groupId":"OG002","value":"-1.1","spread":"1.4"},{"groupId":"OG003","value":"-0.2","spread":"1.1"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"435"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"1.5"},{"groupId":"OG001","value":"-0.9","spread":"1.7"},{"groupId":"OG002","value":"-1.2","spread":"1.7"},{"groupId":"OG003","value":"-0.3","spread":"1.3"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"425"},{"groupId":"OG002","value":"428"},{"groupId":"OG003","value":"443"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"1.8"},{"groupId":"OG001","value":"-1.0","spread":"1.9"},{"groupId":"OG002","value":"-1.1","spread":"1.7"},{"groupId":"OG003","value":"-0.4","spread":"1.5"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated at weeks 26, 52 and 78. 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"439"},{"groupId":"OG002","value":"438"},{"groupId":"OG003","value":"445"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"5.0"},{"groupId":"OG001","value":"-1.8","spread":"5.2"},{"groupId":"OG002","value":"-2.3","spread":"5.2"},{"groupId":"OG003","value":"-0.6","spread":"4.4"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"426"},{"groupId":"OG001","value":"432"},{"groupId":"OG002","value":"435"},{"groupId":"OG003","value":"436"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"5.7"},{"groupId":"OG001","value":"-2.3","spread":"6.8"},{"groupId":"OG002","value":"-2.6","spread":"6.2"},{"groupId":"OG003","value":"-0.5","spread":"5.1"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"424"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"428"},{"groupId":"OG003","value":"440"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"6.0"},{"groupId":"OG001","value":"-2.4","spread":"7.2"},{"groupId":"OG002","value":"-2.4","spread":"6.1"},{"groupId":"OG003","value":"-0.7","spread":"5.6"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"432"},{"groupId":"OG003","value":"444"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"16.8"},{"groupId":"OG001","value":"0.98","spread":"17.5"},{"groupId":"OG002","value":"0.97","spread":"17.1"},{"groupId":"OG003","value":"1.00","spread":"16.4"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"427"},{"groupId":"OG002","value":"432"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"17.5"},{"groupId":"OG001","value":"0.99","spread":"18.5"},{"groupId":"OG002","value":"0.98","spread":"17.0"},{"groupId":"OG003","value":"1.01","spread":"16.9"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"419"},{"groupId":"OG002","value":"421"},{"groupId":"OG003","value":"438"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"18.3"},{"groupId":"OG001","value":"0.99","spread":"19.3"},{"groupId":"OG002","value":"0.99","spread":"18.7"},{"groupId":"OG003","value":"1.00","spread":"19.4"}]}]}]},{"type":"SECONDARY","title":"Change in LDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"431"},{"groupId":"OG003","value":"444"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"28.2"},{"groupId":"OG001","value":"0.98","spread":"28.0"},{"groupId":"OG002","value":"0.98","spread":"28.6"},{"groupId":"OG003","value":"1.02","spread":"26.4"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"427"},{"groupId":"OG002","value":"431"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"28.1"},{"groupId":"OG001","value":"0.99","spread":"29.7"},{"groupId":"OG002","value":"0.99","spread":"27.4"},{"groupId":"OG003","value":"1.03","spread":"27.7"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"419"},{"groupId":"OG002","value":"420"},{"groupId":"OG003","value":"438"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"30.8"},{"groupId":"OG001","value":"1.00","spread":"30.2"},{"groupId":"OG002","value":"1.00","spread":"30.2"},{"groupId":"OG003","value":"1.03","spread":"32.6"}]}]}]},{"type":"SECONDARY","title":"Change in VLDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) at weeks 26, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"431"},{"groupId":"OG003","value":"444"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"36.4"},{"groupId":"OG001","value":"0.96","spread":"36.1"},{"groupId":"OG002","value":"0.91","spread":"36.3"},{"groupId":"OG003","value":"0.97","spread":"34.1"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"427"},{"groupId":"OG002","value":"431"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"35.0"},{"groupId":"OG001","value":"0.98","spread":"39.1"},{"groupId":"OG002","value":"0.93","spread":"39.6"},{"groupId":"OG003","value":"0.98","spread":"34.4"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"419"},{"groupId":"OG002","value":"420"},{"groupId":"OG003","value":"438"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"41.7"},{"groupId":"OG001","value":"0.94","spread":"41.5"},{"groupId":"OG002","value":"0.91","spread":"40.4"},{"groupId":"OG003","value":"0.94","spread":"39.6"}]}]}]},{"type":"SECONDARY","title":"Change in HDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"431"},{"groupId":"OG003","value":"444"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"13.6"},{"groupId":"OG001","value":"0.99","spread":"14.8"},{"groupId":"OG002","value":"0.98","spread":"14.9"},{"groupId":"OG003","value":"0.99","spread":"12.6"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"427"},{"groupId":"OG002","value":"431"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"13.9"},{"groupId":"OG001","value":"1.01","spread":"14.3"},{"groupId":"OG002","value":"1.01","spread":"15.2"},{"groupId":"OG003","value":"0.99","spread":"15.9"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"419"},{"groupId":"OG002","value":"420"},{"groupId":"OG003","value":"438"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"15.3"},{"groupId":"OG001","value":"0.99","spread":"15.6"},{"groupId":"OG002","value":"1.00","spread":"15.5"},{"groupId":"OG003","value":"0.99","spread":"14.2"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (Ratio to Baseline)","description":"Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"431"},{"groupId":"OG003","value":"444"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"38.1"},{"groupId":"OG001","value":"0.96","spread":"39.2"},{"groupId":"OG002","value":"0.92","spread":"39.8"},{"groupId":"OG003","value":"0.97","spread":"36.2"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"427"},{"groupId":"OG002","value":"431"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"35.7"},{"groupId":"OG001","value":"0.97","spread":"41.3"},{"groupId":"OG002","value":"0.93","spread":"42.3"},{"groupId":"OG003","value":"0.98","spread":"37.8"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"419"},{"groupId":"OG002","value":"420"},{"groupId":"OG003","value":"438"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"43.9"},{"groupId":"OG001","value":"0.94","spread":"43.7"},{"groupId":"OG002","value":"0.92","spread":"43.1"},{"groupId":"OG003","value":"0.93","spread":"41.6"}]}]}]},{"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, 52 and 78 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. Because of an issue with the handling of the blood samples for FFA, all FFA data were considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the data presented here.","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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"426"},{"groupId":"OG001","value":"428"},{"groupId":"OG002","value":"426"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"48.7"},{"groupId":"OG001","value":"0.91","spread":"50.4"},{"groupId":"OG002","value":"0.88","spread":"55.8"},{"groupId":"OG003","value":"0.90","spread":"49.8"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"420"},{"groupId":"OG002","value":"426"},{"groupId":"OG003","value":"432"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"46.7"},{"groupId":"OG001","value":"1.00","spread":"47.9"},{"groupId":"OG002","value":"0.96","spread":"56.0"},{"groupId":"OG003","value":"0.98","spread":"47.5"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"415"},{"groupId":"OG001","value":"413"},{"groupId":"OG002","value":"414"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"54.2"},{"groupId":"OG001","value":"0.87","spread":"56.5"},{"groupId":"OG002","value":"0.88","spread":"56.3"},{"groupId":"OG003","value":"0.87","spread":"57.8"}]}]}]},{"type":"SECONDARY","title":"Change in SMPG - Mean 7-point Profile","description":"Change from baseline (week 0) 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"398"},{"groupId":"OG001","value":"410"},{"groupId":"OG002","value":"400"},{"groupId":"OG003","value":"409"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"2.3"},{"groupId":"OG001","value":"-1.5","spread":"2.3"},{"groupId":"OG002","value":"-1.7","spread":"2.4"},{"groupId":"OG003","value":"-1.2","spread":"2.3"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"399"},{"groupId":"OG001","value":"405"},{"groupId":"OG002","value":"401"},{"groupId":"OG003","value":"414"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"2.4"},{"groupId":"OG001","value":"-1.5","spread":"2.5"},{"groupId":"OG002","value":"-1.8","spread":"2.4"},{"groupId":"OG003","value":"-1.4","spread":"2.4"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"385"},{"groupId":"OG002","value":"392"},{"groupId":"OG003","value":"409"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"2.7"},{"groupId":"OG001","value":"-1.5","spread":"2.7"},{"groupId":"OG002","value":"-1.7","spread":"2.2"},{"groupId":"OG003","value":"-1.3","spread":"2.5"}]}]}]},{"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, 52 and 78. 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"400"},{"groupId":"OG001","value":"411"},{"groupId":"OG002","value":"402"},{"groupId":"OG003","value":"408"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"2.1"},{"groupId":"OG001","value":"-0.4","spread":"2.1"},{"groupId":"OG002","value":"-0.6","spread":"2.1"},{"groupId":"OG003","value":"-0.6","spread":"2.1"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"400"},{"groupId":"OG001","value":"406"},{"groupId":"OG002","value":"402"},{"groupId":"OG003","value":"413"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"2.0"},{"groupId":"OG001","value":"-0.4","spread":"2.1"},{"groupId":"OG002","value":"-0.7","spread":"2.0"},{"groupId":"OG003","value":"-0.4","spread":"2.1"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"398"},{"groupId":"OG001","value":"387"},{"groupId":"OG002","value":"392"},{"groupId":"OG003","value":"409"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"2.1"},{"groupId":"OG001","value":"-0.4","spread":"2.1"},{"groupId":"OG002","value":"-0.6","spread":"2.0"},{"groupId":"OG003","value":"-0.6","spread":"2.2"}]}]}]},{"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, 52 and 78. 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"435"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"436"},{"groupId":"OG003","value":"446"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"192"},{"groupId":"OG002","value":"246"},{"groupId":"OG003","value":"144"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"246"},{"groupId":"OG002","value":"190"},{"groupId":"OG003","value":"302"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"427"},{"groupId":"OG001","value":"431"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"436"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"168"},{"groupId":"OG002","value":"238"},{"groupId":"OG003","value":"138"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"314"},{"groupId":"OG001","value":"263"},{"groupId":"OG002","value":"196"},{"groupId":"OG003","value":"298"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"425"},{"groupId":"OG003","value":"439"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"191"},{"groupId":"OG003","value":"129"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"308"},{"groupId":"OG001","value":"259"},{"groupId":"OG002","value":"234"},{"groupId":"OG003","value":"310"}]}]}]},{"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, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"435"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"436"},{"groupId":"OG003","value":"446"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"116"},{"groupId":"OG002","value":"161"},{"groupId":"OG003","value":"61"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"322"},{"groupId":"OG002","value":"275"},{"groupId":"OG003","value":"385"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"427"},{"groupId":"OG001","value":"431"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"436"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"146"},{"groupId":"OG003","value":"59"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"332"},{"groupId":"OG002","value":"288"},{"groupId":"OG003","value":"377"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"425"},{"groupId":"OG003","value":"439"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"129"},{"groupId":"OG003","value":"60"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"324"},{"groupId":"OG002","value":"296"},{"groupId":"OG003","value":"379"}]}]}]},{"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, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"440"},{"groupId":"OG002","value":"439"},{"groupId":"OG003","value":"447"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"81"},{"groupId":"OG002","value":"131"},{"groupId":"OG003","value":"45"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"385"},{"groupId":"OG001","value":"359"},{"groupId":"OG002","value":"308"},{"groupId":"OG003","value":"402"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"435"},{"groupId":"OG003","value":"437"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"147"},{"groupId":"OG003","value":"50"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"362"},{"groupId":"OG001","value":"315"},{"groupId":"OG002","value":"288"},{"groupId":"OG003","value":"387"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"425"},{"groupId":"OG002","value":"428"},{"groupId":"OG003","value":"443"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"115"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"59"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"342"},{"groupId":"OG001","value":"310"},{"groupId":"OG002","value":"289"},{"groupId":"OG003","value":"384"}]}]}]},{"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, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"440"},{"groupId":"OG002","value":"439"},{"groupId":"OG003","value":"447"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"29"},{"groupId":"OG003","value":"8"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"417"},{"groupId":"OG002","value":"410"},{"groupId":"OG003","value":"439"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"435"},{"groupId":"OG003","value":"437"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"11"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"415"},{"groupId":"OG001","value":"402"},{"groupId":"OG002","value":"387"},{"groupId":"OG003","value":"426"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"425"},{"groupId":"OG002","value":"428"},{"groupId":"OG003","value":"443"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"17"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"413"},{"groupId":"OG001","value":"382"},{"groupId":"OG002","value":"382"},{"groupId":"OG003","value":"426"}]}]}]},{"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, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"435"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"436"},{"groupId":"OG003","value":"446"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"155"},{"groupId":"OG002","value":"208"},{"groupId":"OG003","value":"90"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"348"},{"groupId":"OG001","value":"283"},{"groupId":"OG002","value":"228"},{"groupId":"OG003","value":"356"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"427"},{"groupId":"OG001","value":"431"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"436"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"134"},{"groupId":"OG002","value":"195"},{"groupId":"OG003","value":"87"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"297"},{"groupId":"OG002","value":"239"},{"groupId":"OG003","value":"349"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"425"},{"groupId":"OG003","value":"439"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"136"},{"groupId":"OG002","value":"151"},{"groupId":"OG003","value":"84"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"336"},{"groupId":"OG001","value":"288"},{"groupId":"OG002","value":"274"},{"groupId":"OG003","value":"355"}]}]}]},{"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, 52 and 78 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"435"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"436"},{"groupId":"OG003","value":"446"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"166"},{"groupId":"OG003","value":"43"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"321"},{"groupId":"OG002","value":"270"},{"groupId":"OG003","value":"403"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"427"},{"groupId":"OG001","value":"431"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"436"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"106"},{"groupId":"OG002","value":"164"},{"groupId":"OG003","value":"51"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"354"},{"groupId":"OG001","value":"325"},{"groupId":"OG002","value":"270"},{"groupId":"OG003","value":"385"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"425"},{"groupId":"OG003","value":"439"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"113"},{"groupId":"OG002","value":"149"},{"groupId":"OG003","value":"60"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"345"},{"groupId":"OG001","value":"311"},{"groupId":"OG002","value":"276"},{"groupId":"OG003","value":"379"}]}]}]},{"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, week 0 to week 52 and week 0 to week 78. 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 78), 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 0-78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 0 to week 26","categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"20"}]}]},{"title":"Week 0 to week 52","categories":[{"measurements":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"51"},{"groupId":"OG003","value":"111"}]}]},{"title":"Week 0 to week 78","categories":[{"measurements":[{"groupId":"OG000","value":"179"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"75"},{"groupId":"OG003","value":"148"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"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":"=0.0063","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.09","ciUpperLimit":"1.65","estimateComment":"Oral semaglutide 3 mg / Sitagliptin 100 mg"},{"groupIds":["OG001","OG003"],"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":"=0.0221","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.61","ciUpperLimit":"0.96","estimateComment":"Oral semaglutide 7 mg / Sitagliptin 100 mg"},{"groupIds":["OG002","OG003"],"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":"0.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.41","ciUpperLimit":"0.68","estimateComment":"Oral semaglutide 14 mg / Sitagliptin 100 mg"}]},{"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, week 0 to week 52 and week 0 to week 78. 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 0-78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"Week 0 to week 26","categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"13"}]}]},{"title":"Week 0 to week 52","categories":[{"measurements":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"31"},{"groupId":"OG003","value":"94"}]}]},{"title":"Week 0 to week 78","categories":[{"measurements":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"103"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"129"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"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":"=0.0160","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.05","ciUpperLimit":"1.68","estimateComment":"Oral semaglutide 3 mg / Sitagliptin 100 mg"},{"groupIds":["OG001","OG003"],"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":"=0.0022","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.51","ciUpperLimit":"0.86","estimateComment":"Oral semaglutide 7 mg / Sitagliptin 100 mg"},{"groupIds":["OG002","OG003"],"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":"0.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.22","ciUpperLimit":"0.43","estimateComment":"Oral semaglutide 14 mg / Sitagliptin 100 mg"}]},{"type":"SECONDARY","title":"Number of TEAEs During Exposure to Trial Product","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 83 (78-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 0-83","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"464"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"466"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1774"},{"groupId":"OG001","value":"1686"},{"groupId":"OG002","value":"1824"},{"groupId":"OG003","value":"1852"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase (Ratio to Baseline)","description":"Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26, 52 and 78 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","timeFrame":"Week 0, week 26, week 52, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"464"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"466"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"415"},{"groupId":"OG001","value":"421"},{"groupId":"OG002","value":"401"},{"groupId":"OG003","value":"433"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"25.6"},{"groupId":"OG001","value":"1.07","spread":"27.5"},{"groupId":"OG002","value":"1.14","spread":"30.4"},{"groupId":"OG003","value":"1.08","spread":"21.4"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"391"},{"groupId":"OG001","value":"403"},{"groupId":"OG002","value":"388"},{"groupId":"OG003","value":"414"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"25.8"},{"groupId":"OG001","value":"1.09","spread":"28.8"},{"groupId":"OG002","value":"1.11","spread":"29.0"},{"groupId":"OG003","value":"1.08","spread":"24.1"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"377"},{"groupId":"OG001","value":"392"},{"groupId":"OG002","value":"366"},{"groupId":"OG003","value":"402"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"28.4"},{"groupId":"OG001","value":"1.09","spread":"29.2"},{"groupId":"OG002","value":"1.09","spread":"25.5"},{"groupId":"OG003","value":"1.08","spread":"25.9"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase (Ratio to Baseline)","description":"Change from baseline (week 0) in lipase (U/L) at weeks 26, 52 and 78 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","timeFrame":"Week 0, week 26, week 52, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"464"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"466"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"415"},{"groupId":"OG001","value":"420"},{"groupId":"OG002","value":"401"},{"groupId":"OG003","value":"433"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.07","spread":"52.6"},{"groupId":"OG001","value":"1.13","spread":"60.1"},{"groupId":"OG002","value":"1.26","spread":"64.9"},{"groupId":"OG003","value":"1.14","spread":"50.3"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"391"},{"groupId":"OG001","value":"403"},{"groupId":"OG002","value":"388"},{"groupId":"OG003","value":"414"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"51.5"},{"groupId":"OG001","value":"1.15","spread":"59.4"},{"groupId":"OG002","value":"1.25","spread":"56.6"},{"groupId":"OG003","value":"1.15","spread":"54.2"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"377"},{"groupId":"OG001","value":"392"},{"groupId":"OG002","value":"366"},{"groupId":"OG003","value":"402"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"56.2"},{"groupId":"OG001","value":"1.14","spread":"61.9"},{"groupId":"OG002","value":"1.18","spread":"54.3"},{"groupId":"OG003","value":"1.10","spread":"50.7"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate was evaluated at weeks 26, 52 and 78. 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/minute","timeFrame":"Week 0, week 26, week 52, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"464"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"466"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"422"},{"groupId":"OG002","value":"406"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1","spread":"9"},{"groupId":"OG001","value":"2","spread":"9"},{"groupId":"OG002","value":"3","spread":"10"},{"groupId":"OG003","value":"0","spread":"10"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"406"},{"groupId":"OG002","value":"391"},{"groupId":"OG003","value":"416"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"10"},{"groupId":"OG001","value":"2","spread":"9"},{"groupId":"OG002","value":"2","spread":"10"},{"groupId":"OG003","value":"-0","spread":"10"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"382"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"368"},{"groupId":"OG003","value":"405"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1","spread":"10"},{"groupId":"OG001","value":"1","spread":"10"},{"groupId":"OG002","value":"2","spread":"10"},{"groupId":"OG003","value":"0","spread":"10"}]}]}]},{"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, 52 and 78. 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"464"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"466"}]}],"classes":[{"title":"SBP: Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"422"},{"groupId":"OG002","value":"406"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"14"},{"groupId":"OG001","value":"-2","spread":"15"},{"groupId":"OG002","value":"-3","spread":"14"},{"groupId":"OG003","value":"-2","spread":"15"}]}]},{"title":"SBP: Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"397"},{"groupId":"OG001","value":"406"},{"groupId":"OG002","value":"391"},{"groupId":"OG003","value":"416"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"15"},{"groupId":"OG001","value":"-4","spread":"14"},{"groupId":"OG002","value":"-3","spread":"15"},{"groupId":"OG003","value":"-1","spread":"14"}]}]},{"title":"SBP: Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"382"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"369"},{"groupId":"OG003","value":"405"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"15"},{"groupId":"OG001","value":"-3","spread":"15"},{"groupId":"OG002","value":"-3","spread":"14"},{"groupId":"OG003","value":"0","spread":"15"}]}]},{"title":"DBP: Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"422"},{"groupId":"OG002","value":"406"},{"groupId":"OG003","value":"435"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"9"},{"groupId":"OG001","value":"-0","spread":"9"},{"groupId":"OG002","value":"-1","spread":"9"},{"groupId":"OG003","value":"-0","spread":"9"}]}]},{"title":"DBP: Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"397"},{"groupId":"OG001","value":"406"},{"groupId":"OG002","value":"391"},{"groupId":"OG003","value":"416"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"9"},{"groupId":"OG001","value":"-1","spread":"9"},{"groupId":"OG002","value":"-1","spread":"9"},{"groupId":"OG003","value":"-1","spread":"9"}]}]},{"title":"DBP: Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"382"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"369"},{"groupId":"OG003","value":"405"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"10"},{"groupId":"OG001","value":"-1","spread":"10"},{"groupId":"OG002","value":"-1","spread":"10"},{"groupId":"OG003","value":"-1","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in ECG Evaluation","description":"Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26, 52 and 78. 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, 52 and 78. 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, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"464"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"466"}]}],"classes":[{"title":"Normal (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"261"},{"groupId":"OG002","value":"254"},{"groupId":"OG003","value":"249"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"230"},{"groupId":"OG003","value":"204"}]}]},{"title":"Normal (week 0) to abnormal NCS (week 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Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-83) 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 0-83","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. 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In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. 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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 0-83","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. 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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","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"%B/T","timeFrame":"Weeks 0-83","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG002","value":"9.82","spread":"0"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.93","spread":"0"}]}]},{"title":"Week 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"3.28","spread":"0"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"2.39","spread":"0"},{"groupId":"OG002","value":"2.05","spread":"0"}]}]},{"title":"Week 38","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG002","value":"2.24","spread":"0"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 83","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-83 (78-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 0-83","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"464"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"466"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"60"},{"groupId":"OG003","value":"76"}]}]}]},{"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 83 (78-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 0-83","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"464"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"466"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"36"},{"groupId":"OG003","value":"39"}]}]}]},{"type":"SECONDARY","title":"Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses","description":"This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations for participants in the pharmacokinetic (PK) subpopulation are presented. The PK subpopulation consisted of participants from sites in Germany, Japan and the United States receiving oral semaglutide (3 mg, 7 mg or 14 mg). Results are based on the data from the on-treatment observation period and follow-up period. The on-treatment observation period 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 analysed = number of participants in the PK subpopulation. Number Analyzed = number of participants with available data in the PK subpopulation.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nmol/L","timeFrame":"Weeks 0-83","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"215"},{"groupId":"OG002","value":"205"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"193"},{"groupId":"OG001","value":"187"},{"groupId":"OG002","value":"179"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.4","spread":"0.0"},{"groupId":"OG001","value":"0.4","spread":"0.0"},{"groupId":"OG002","value":"0.4","spread":"0.0"}]}]},{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"208"},{"groupId":"OG002","value":"197"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"109.3"},{"groupId":"OG001","value":"1.5","spread":"102.1"},{"groupId":"OG002","value":"1.6","spread":"109.1"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"208"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"103.9"},{"groupId":"OG001","value":"4.1","spread":"129.4"},{"groupId":"OG002","value":"4.2","spread":"128.0"}]}]},{"title":"Week 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"190"},{"groupId":"OG002","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"111.8"},{"groupId":"OG001","value":"4.0","spread":"146.8"},{"groupId":"OG002","value":"9.4","spread":"156.6"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"190"},{"groupId":"OG002","value":"171"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"104.5"},{"groupId":"OG001","value":"3.7","spread":"122.5"},{"groupId":"OG002","value":"8.6","spread":"162.2"}]}]},{"title":"Week 38","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"183"},{"groupId":"OG001","value":"180"},{"groupId":"OG002","value":"168"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"107.8"},{"groupId":"OG001","value":"3.5","spread":"106.4"},{"groupId":"OG002","value":"8.6","spread":"163.0"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"178"},{"groupId":"OG002","value":"165"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"105.8"},{"groupId":"OG001","value":"3.5","spread":"119.0"},{"groupId":"OG002","value":"8.2","spread":"167.0"}]}]},{"title":"Week 78","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"167"},{"groupId":"OG001","value":"173"},{"groupId":"OG002","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"115.3"},{"groupId":"OG001","value":"3.5","spread":"127.2"},{"groupId":"OG002","value":"8.9","spread":"152.7"}]}]},{"title":"Week 83","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"172"},{"groupId":"OG002","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.4","spread":"10.3"},{"groupId":"OG001","value":"0.4","spread":"16.5"},{"groupId":"OG002","value":"0.4","spread":"42.6"}]}]}]},{"type":"SECONDARY","title":"Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26, 52 and 78. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.","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":"Score on a scale","timeFrame":"Week 0, week 26, week 52, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"1) Physical functioning (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.37","spread":"7.25"},{"groupId":"OG001","value":"1.12","spread":"6.52"},{"groupId":"OG002","value":"0.63","spread":"7.13"},{"groupId":"OG003","value":"0.46","spread":"6.73"}]}]},{"title":"1) Physical functioning (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.29","spread":"7.14"},{"groupId":"OG001","value":"0.64","spread":"7.34"},{"groupId":"OG002","value":"0.36","spread":"7.30"},{"groupId":"OG003","value":"0.06","spread":"7.30"}]}]},{"title":"1) Physical functioning (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"8.09"},{"groupId":"OG001","value":"0.94","spread":"6.91"},{"groupId":"OG002","value":"0.54","spread":"7.98"},{"groupId":"OG003","value":"0.09","spread":"7.60"}]}]},{"title":"2) Role-Physical (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.42","spread":"7.85"},{"groupId":"OG001","value":"0.76","spread":"7.15"},{"groupId":"OG002","value":"-0.13","spread":"7.59"},{"groupId":"OG003","value":"0.38","spread":"8.00"}]}]},{"title":"2) Role-Physical (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"8.40"},{"groupId":"OG001","value":"-0.06","spread":"9.42"},{"groupId":"OG002","value":"-0.82","spread":"8.49"},{"groupId":"OG003","value":"-0.69","spread":"8.08"}]}]},{"title":"2) Role-Physical (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.28","spread":"8.14"},{"groupId":"OG001","value":"-0.01","spread":"8.40"},{"groupId":"OG002","value":"-0.33","spread":"7.57"},{"groupId":"OG003","value":"0.44","spread":"7.96"}]}]},{"title":"3) Bodily pain (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.56","spread":"9.20"},{"groupId":"OG001","value":"-0.11","spread":"8.60"},{"groupId":"OG002","value":"0.22","spread":"9.02"},{"groupId":"OG003","value":"0.44","spread":"9.18"}]}]},{"title":"3) Bodily pain (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"433"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.16","spread":"9.44"},{"groupId":"OG001","value":"-0.65","spread":"9.92"},{"groupId":"OG002","value":"-0.64","spread":"9.40"},{"groupId":"OG003","value":"0.67","spread":"8.93"}]}]},{"title":"3) Bodily pain (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.48","spread":"9.24"},{"groupId":"OG001","value":"0.32","spread":"8.85"},{"groupId":"OG002","value":"0.74","spread":"9.40"},{"groupId":"OG003","value":"0.54","spread":"9.44"}]}]},{"title":"4) General health (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.17","spread":"6.50"},{"groupId":"OG001","value":"1.67","spread":"6.98"},{"groupId":"OG002","value":"1.19","spread":"7.00"},{"groupId":"OG003","value":"1.42","spread":"7.02"}]}]},{"title":"4) General health (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"7.07"},{"groupId":"OG001","value":"1.20","spread":"7.08"},{"groupId":"OG002","value":"1.03","spread":"6.88"},{"groupId":"OG003","value":"0.95","spread":"7.38"}]}]},{"title":"4) General health (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"7.23"},{"groupId":"OG001","value":"1.21","spread":"7.60"},{"groupId":"OG002","value":"1.21","spread":"7.62"},{"groupId":"OG003","value":"1.32","spread":"7.99"}]}]},{"title":"5) Vitality (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.59","spread":"7.28"},{"groupId":"OG001","value":"1.11","spread":"7.30"},{"groupId":"OG002","value":"0.88","spread":"7.42"},{"groupId":"OG003","value":"1.03","spread":"7.42"}]}]},{"title":"5) Vitality (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.45","spread":"7.50"},{"groupId":"OG001","value":"0.79","spread":"8.33"},{"groupId":"OG002","value":"0.58","spread":"8.15"},{"groupId":"OG003","value":"0.19","spread":"7.73"}]}]},{"title":"5) Vitality (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"8.06"},{"groupId":"OG001","value":"0.85","spread":"7.92"},{"groupId":"OG002","value":"0.71","spread":"8.42"},{"groupId":"OG003","value":"1.07","spread":"8.27"}]}]},{"title":"6) Social functioning (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.11","spread":"7.93"},{"groupId":"OG001","value":"0.15","spread":"8.03"},{"groupId":"OG002","value":"0.31","spread":"7.33"},{"groupId":"OG003","value":"0.09","spread":"8.38"}]}]},{"title":"6) Social functioning (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.25","spread":"8.35"},{"groupId":"OG001","value":"-0.37","spread":"9.39"},{"groupId":"OG002","value":"-0.83","spread":"8.83"},{"groupId":"OG003","value":"-0.68","spread":"9.23"}]}]},{"title":"6) Social functioning (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.38","spread":"8.29"},{"groupId":"OG001","value":"0.19","spread":"8.77"},{"groupId":"OG002","value":"-0.27","spread":"8.66"},{"groupId":"OG003","value":"0.57","spread":"8.93"}]}]},{"title":"7) Role emotional (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.84","spread":"10.47"},{"groupId":"OG001","value":"0.67","spread":"9.18"},{"groupId":"OG002","value":"-0.37","spread":"9.77"},{"groupId":"OG003","value":"0.15","spread":"9.97"}]}]},{"title":"7) Role emotional (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.15","spread":"10.99"},{"groupId":"OG001","value":"-0.45","spread":"11.89"},{"groupId":"OG002","value":"-0.86","spread":"10.65"},{"groupId":"OG003","value":"-0.63","spread":"10.33"}]}]},{"title":"7) Role emotional (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"424"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.32","spread":"10.98"},{"groupId":"OG001","value":"0.23","spread":"10.95"},{"groupId":"OG002","value":"-0.30","spread":"11.00"},{"groupId":"OG003","value":"-0.24","spread":"10.58"}]}]},{"title":"8) Mental health (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"8.32"},{"groupId":"OG001","value":"0.24","spread":"8.17"},{"groupId":"OG002","value":"0.24","spread":"8.14"},{"groupId":"OG003","value":"0.61","spread":"8.03"}]}]},{"title":"8) Mental health (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.45","spread":"8.02"},{"groupId":"OG001","value":"0.42","spread":"9.11"},{"groupId":"OG002","value":"0.05","spread":"7.99"},{"groupId":"OG003","value":"0.23","spread":"8.20"}]}]},{"title":"8) Mental health (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.19","spread":"9.08"},{"groupId":"OG001","value":"0.29","spread":"9.33"},{"groupId":"OG002","value":"0.28","spread":"8.87"},{"groupId":"OG003","value":"0.30","spread":"9.33"}]}]},{"title":"Physical component summary (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"438"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.56","spread":"6.42"},{"groupId":"OG001","value":"0.98","spread":"5.72"},{"groupId":"OG002","value":"0.63","spread":"6.00"},{"groupId":"OG003","value":"0.69","spread":"6.24"}]}]},{"title":"Physical component summary (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"433"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.31","spread":"6.50"},{"groupId":"OG001","value":"0.36","spread":"6.82"},{"groupId":"OG002","value":"0.09","spread":"6.47"},{"groupId":"OG003","value":"0.31","spread":"6.54"}]}]},{"title":"Physical component summary (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"424"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"441"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.46","spread":"6.74"},{"groupId":"OG001","value":"0.71","spread":"6.24"},{"groupId":"OG002","value":"0.67","spread":"6.29"},{"groupId":"OG003","value":"0.70","spread":"6.38"}]}]},{"title":"Mental component summary (week 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The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. 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":"Score on a scale","timeFrame":"Week 0, week 26, week 52, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"1) Physical (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.25","spread":"14.81"},{"groupId":"OG001","value":"2.38","spread":"14.87"},{"groupId":"OG002","value":"2.87","spread":"17.32"},{"groupId":"OG003","value":"1.97","spread":"15.07"}]}]},{"title":"1) Physical (week 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26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.52","spread":"16.48"},{"groupId":"OG001","value":"2.78","spread":"16.13"},{"groupId":"OG002","value":"3.20","spread":"18.48"},{"groupId":"OG003","value":"1.70","spread":"16.54"}]}]},{"title":"2) Physical function (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"432"},{"groupId":"OG002","value":"433"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.28","spread":"17.00"},{"groupId":"OG001","value":"3.24","spread":"18.17"},{"groupId":"OG002","value":"3.19","spread":"19.76"},{"groupId":"OG003","value":"1.22","spread":"18.21"}]}]},{"title":"2) Physical function (week 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26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"447"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.69","spread":"13.32"},{"groupId":"OG001","value":"4.30","spread":"15.05"},{"groupId":"OG002","value":"2.98","spread":"14.86"},{"groupId":"OG003","value":"2.10","spread":"13.21"}]}]},{"title":"4) Psychosocial (week 52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"432"},{"groupId":"OG002","value":"434"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.12","spread":"14.55"},{"groupId":"OG001","value":"5.19","spread":"15.04"},{"groupId":"OG002","value":"3.97","spread":"16.46"},{"groupId":"OG003","value":"2.53","spread":"14.09"}]}]},{"title":"4) Psychosocial (week 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52)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"432"},{"groupId":"OG002","value":"433"},{"groupId":"OG003","value":"437"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.67","spread":"13.01"},{"groupId":"OG001","value":"4.43","spread":"13.59"},{"groupId":"OG002","value":"3.64","spread":"15.22"},{"groupId":"OG003","value":"2.17","spread":"12.86"}]}]},{"title":"IWQOL-Lite-CT Total (week 78)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"424"},{"groupId":"OG001","value":"425"},{"groupId":"OG002","value":"427"},{"groupId":"OG003","value":"440"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.45","spread":"13.32"},{"groupId":"OG001","value":"4.73","spread":"14.07"},{"groupId":"OG002","value":"3.77","spread":"14.97"},{"groupId":"OG003","value":"3.16","spread":"13.76"}]}]}]},{"type":"SECONDARY","title":"Change in CoEQ: Scores From the 4 Domains and the 19 Items","description":"Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks (wk) 26, 52 and 78. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.","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":"Score on a scale","timeFrame":"Week 0, week 26, week 52, week 78","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78."},{"id":"OG003","title":"Sitagliptin 100 mg","description":"Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"466"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"465"},{"groupId":"OG003","value":"467"}]}],"classes":[{"title":"1) Feeling of hunger (wk 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"435"},{"groupId":"OG002","value":"437"},{"groupId":"OG003","value":"446"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.41","spread":"2.61"},{"groupId":"OG001","value":"-0.37","spread":"2.58"},{"groupId":"OG002","value":"-0.54","spread":"2.58"},{"groupId":"OG003","value":"-0.18","spread":"2.49"}]}]},{"title":"1) Feeling of hunger (wk 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