{"protocolSection":{"identificationModule":{"nctId":"NCT02849080","orgStudyIdInfo":{"id":"NN9924-4257"},"secondaryIdInfos":[{"id":"2015-005593-38","type":"EUDRACT_NUMBER"},{"id":"U1111-1177-5103","type":"OTHER","domain":"WHO"},{"id":"2015","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2015"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.","officialTitle":"Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus","acronym":"PIONEER 7"},"statusModule":{"statusVerifiedDate":"2022-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-09-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-02-28","type":"ACTUAL"},"completionDateStruct":{"date":"2019-03-27","type":"ACTUAL"},"studyFirstSubmitDate":"2016-07-21","studyFirstSubmitQcDate":"2016-07-26","studyFirstPostDateStruct":{"date":"2016-07-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-10-15","resultsFirstSubmitQcDate":"2020-02-14","resultsFirstPostDateStruct":{"date":"2020-02-17","type":"ACTUAL"},"dispFirstSubmitDate":"2019-02-26","dispFirstSubmitQcDate":"2019-02-26","dispFirstPostDateStruct":{"date":"2019-03-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-07-11","lastUpdatePostDateStruct":{"date":"2022-07-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":504,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide flexible dosing (3, 7 or 14 mg)","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Sitagliptin 100 mg","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: sitagliptin"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"Oral administration once-daily.","armGroupLabels":["Semaglutide flexible dosing (3, 7 or 14 mg)"]},{"type":"DRUG","name":"sitagliptin","description":"Oral administration once-daily.","armGroupLabels":["Sitagliptin 100 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"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 week 52. 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 52"}],"secondaryOutcomes":[{"measure":"Change in Body Weight","description":"Change from baseline (week 0) in body weight was evaluated at week 52. 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 52"},{"measure":"Change in HbA1c","description":"Change from baseline (week 0) in HbA1c was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 52"},{"measure":"Change in FPG","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 52"},{"measure":"Change in Body Weight (%)","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 52"},{"measure":"Change in BMI","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, Week 52"},{"measure":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 52"},{"measure":"Change in Total Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, Week 52"},{"measure":"Change in LDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 52"},{"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 52"},{"measure":"Change in Triglycerides (Ratio to Baseline)","description":"Change from baseline (week 0) in triglycerides (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 52"},{"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 week 52. 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 52"},{"measure":"Change in DTSQ","description":"Change from baseline (week 0) in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.","timeFrame":"Week 0, Week 52"},{"measure":"Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)","description":"Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 52 is 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 52"},{"measure":"Participants Who Achieve Weight Loss ≥5% (Yes/no)","description":"Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 52 is 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 52"},{"measure":"Participants Who Achieve Weight Loss ≥10% (Yes/no)","description":"Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at week 52 is 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 52"},{"measure":"Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)","description":"Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 52 is 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 52"},{"measure":"Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)","description":"Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at week 52 is 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 52"},{"measure":"Time to Rescue Medication","description":"Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","timeFrame":"Weeks 0-52"},{"measure":"Time to Additional Anti-diabetic Medication","description":"Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-52"},{"measure":"Number of TEAEs During Exposure to Trial Product","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). 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":"Week 0-57"},{"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 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). 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 participant 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":"Week 0-57"},{"measure":"Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). 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 participant 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":"Week 0-57"},{"measure":"Change in Amylase (Ratio to Baseline)","description":"Change from baseline (week 0) in biochemical parameter- amylase (units per liter \\[U/L\\]) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, Week 52"},{"measure":"Change in Lipase (Ratio to Baseline)","description":"Change from baseline (week 0) in lipase (U/L) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, Week 52"},{"measure":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 52"},{"measure":"Change in HbA1c- Switch","description":"Change from week 52 in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 52, week 104"},{"measure":"Change in Body Weight- Switch","description":"Change from week 52 in body weight was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 52, week 104"},{"measure":"Change in Body Weight (%)- Switch","description":"Relative change from week 52 in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 52, week 104"},{"measure":"Change in FPG- Switch","description":"Change from week 52 in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 52, week 104"},{"measure":"Change in BMI- Switch","description":"Change from week 52 in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 52, Week 104"},{"measure":"Change in Waist Circumference- Switch","description":"Change from week 52 in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 52, week 104"},{"measure":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)"},{"measure":"Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch","description":"Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)"},{"measure":"Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch","description":"Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)"},{"measure":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch","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 week 104 is 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 re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)"},{"measure":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) and no need for rescue medication (yes/no), was evaluated at week 104. 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":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)"},{"measure":"Time to Additional Anti-diabetic Medication- Switch","description":"Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 53 to week 104. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after re-randomisation (week 52) and before (planned) end-of-treatment (week 104), 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 re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 53-104"},{"measure":"Time to Rescue Medication- Switch","description":"Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 53 to week 104. 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 re-randomisation (week 52) 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 53-104"},{"measure":"Number of TEAEs During Exposure to Trial Product- Switch","description":"Treatment emergent adverse events (TEAEs) were recorded from week 53 to week 109. 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":"Week 53-109"},{"measure":"Change in Amylase (Ratio to Baseline)- Switch","description":"Change from week 52 in biochemical parameter- amylase (U/L) to week 104 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 52, Week 104"},{"measure":"Change in Lipase (Ratio to Baseline)- Switch","description":"Change from week 52 in lipase (U/L) to week 104 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 52, Week 104"},{"measure":"Change in Pulse Rate- Switch","description":"Change from week 52 in pulse rate was evaluated at week 104. 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 52, week 104"},{"measure":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch","description":"Change from week 52 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. 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 52, week 104"},{"measure":"Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. 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 participant 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":"Week 53-109"},{"measure":"Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch","description":"Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. 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 participant 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":"Week 53-109"},{"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)- Switch","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 week 52 in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since week 52. Results are based on the data from the in-trial observation period.","timeFrame":"Week 52, week 104"},{"measure":"Change in DTSQ- Switch","description":"Change from week 52 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.","timeFrame":"Week 52, week 104"},{"measure":"Change in HbA1c- Sustainability","description":"Change from baseline (week 0) in HbA1c was evaluated at week 104. 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 104"},{"measure":"Change in Body Weight (kg)- Sustainability","description":"Change from baseline (week 0) in body weight was evaluated at week 104. 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.","timeFrame":"Week 0, week 104"},{"measure":"Change in Body Weight (%)- Sustainability","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at week 104. 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 104"},{"measure":"Change in FPG- Sustainability","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 104. 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 104"},{"measure":"Change in BMI- Sustainability","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at week 104. 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 104"},{"measure":"Change in Waist Circumference- Sustainability","description":"Change from baseline (week 0) in waist circumference was evaluated at week 104. 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 104"},{"measure":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. 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.","timeFrame":"Week 104"},{"measure":"Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability","description":"Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is 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 104"},{"measure":"Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability","description":"Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is 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 104"},{"measure":"Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability","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 week 104 is 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 104"},{"measure":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability","description":"Participants who achieved HbA1c \\<7.0% ADA target or HbA1c reduction ≥ 1%-point (10.9 mmol/mol) (yes/no), was evaluated at week 104. 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.","timeFrame":"Week 104"},{"measure":"Number of TEAEs During Exposure to Trial Product- Sustainability","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) 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":"Week 0-109"},{"measure":"Change in Amylase (Ratio to Baseline)- Sustainability","description":"Change from baseline (week 0) in biochemical parameter- amylase (units per liter \\[U/L\\]) to week 104 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 104"},{"measure":"Change in Lipase (Ratio to Baseline)- Sustainability","description":"Change from baseline (week 0) in lipase (U/L) to week 104 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 104"},{"measure":"Change in Pulse Rate- Sustainability","description":"Change from baseline (week 0) in pulse rate was evaluated at week 104. 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 104"},{"measure":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability","description":"Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. 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 104"},{"measure":"Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) 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 participant 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":"Week 0-109"},{"measure":"Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability","description":"Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) 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 participant 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":"Week 0-109"},{"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)- Sustainability","description":"Short form (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 week 104. 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 104"},{"measure":"Change in DTSQ- Sustainability","description":"Change from week 0 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.","timeFrame":"Week 0, week 104"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nMain phase (the inclusion criteria for the main phase are not reassessed for the extension phase):\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* Male or female, age above or equal to 18 years at the time of signing informed consent. For Korea only: Male or female, age above or equal to 19 years at the time of signing informed consent\n* Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening\n* HbA1c (glycosylated haemoglobin) 7.5-9.5% (58-80 mmol/mol) (both inclusive)\n* Treatment target of HbA1c below 7.0% (53 mmol/mol), as judged by the investigator\n* Stable daily dose(s) of 1-2 of the following anti-diabetic drugs within 90 days prior to the day of screening:\n* Metformin (equal or above 1500 mg or maximum tolerated dose as documented in the subject medical record)\n* Sulfonylureas (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)\n* Sodium glucose co-transporter 2 inhibitors\n* Thiazolidinediones (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)\n\nExtension phase:\n\n* Informed consent for the extension phase obtained before any trial-related activities for the extension phase.\n* On randomised treatment with or without rescue medication at week 52.\n\nExclusion Criteria:\n\nMain phase (the exclusion criteria for the main phase are not reassessed for the extension phase):\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For certain specific countries: Additional specific requirements apply\n* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol\n* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma\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 hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation\n* Subjects presently classified as being in New York Heart Association Class IV\n* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\n* Subjects with alanine aminotransferase above 2.5 x upper normal limit\n* Renal impairment defined as Estimated Glomerular Filtration rate 60 mL/min/1.73 m\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days\n* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation\n* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)\n* History of diabetic ketoacidosis\n\nExtension phase: There are no new exclusion criteria for the extension phase","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Glendale","state":"Arizona","zip":"85306-4652","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"Novo Nordisk Investigational Site","city":"Phoenix","state":"Arizona","zip":"85050","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Novo Nordisk Investigational Site","city":"Lancaster","state":"California","zip":"93534","country":"United 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Investigational Site","city":"Sankt Gallen","zip":"9007","country":"Switzerland","geoPoint":{"lat":47.42391,"lon":9.37477}},{"facility":"Novo Nordisk Investigational Site","city":"Sankt Gallen","zip":"9016","country":"Switzerland","geoPoint":{"lat":47.42391,"lon":9.37477}},{"facility":"Novo Nordisk Investigational Site","city":"Winterthur","zip":"8401","country":"Switzerland","geoPoint":{"lat":47.50564,"lon":8.72413}},{"facility":"Novo Nordisk Investigational Site","city":"Adana","zip":"01130","country":"Turkey (Türkiye)","geoPoint":{"lat":36.98615,"lon":35.32531}},{"facility":"Novo Nordisk Investigational Site","city":"Ankara","zip":"06100","country":"Turkey (Türkiye)","geoPoint":{"lat":39.91987,"lon":32.85427}},{"facility":"Novo Nordisk Investigational Site","city":"Antalya","zip":"07058","country":"Turkey (Türkiye)","geoPoint":{"lat":36.90812,"lon":30.69556}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34096","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34722","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34752","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34890","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34899","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Rize","zip":"53020","country":"Turkey (Türkiye)","geoPoint":{"lat":41.02083,"lon":40.52194}}]},"referencesModule":{"references":[{"pmid":"31189520","type":"RESULT","citation":"Pieber TR, Bode B, Mertens A, Cho YM, Christiansen E, Hertz CL, Wallenstein SOR, Buse JB; PIONEER 7 investigators. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2019 Jul;7(7):528-539. doi: 10.1016/S2213-8587(19)30194-9. Epub 2019 Jun 9."},{"pmid":"33318068","type":"RESULT","citation":"Buse JB, Bode BW, Mertens A, Cho YM, Christiansen E, Hertz CL, Nielsen MA, Pieber TR; PIONEER 7 investigators. Long-term efficacy and safety of oral semaglutide and the effect of switching from sitagliptin to oral semaglutide in patients with type 2 diabetes: a 52-week, randomized, open-label extension of the PIONEER 7 trial. BMJ Open Diabetes Res Care. 2020 Dec;8(2):e001649. doi: 10.1136/bmjdrc-2020-001649."},{"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":"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. Epub 2020 Feb 5."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to Novo Nordisk disclosure commitment on novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The trial consisted of two treatment periods: a 52-week main phase and a 52-week extension phase. In Switch, participants were allowed to re-randomise from sitagliptin to oral semaglutide. Sustainability included results for participants who received oral semaglutide during main + extension phase.","recruitmentDetails":"The main phase of the trial was conducted at 77 sites in 10 countries, and the extension phase (Switch) at 71 sites in 9 countries, as follows (main phase/extension phase): Argentina (3/3), Austria (3/3), Belgium (7/7), Brazil (2/0), Egypt (4/4), Norway (4/4), South Korea (7/7), Switzerland (8/5), Turkey (8/8), and United States (31/30).","groups":[{"id":"FG000","title":"Oral Semaglutide Flex","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants who were still on treatment at week 52 were allowed to continue on oral semaglutide in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial."},{"id":"FG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"FG002","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"FG003","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"periods":[{"title":"Main Phase: 0 - 52 Weeks","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"253"},{"groupId":"FG001","numSubjects":"251"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"253"},{"groupId":"FG001","numSubjects":"250"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"253"},{"groupId":"FG001","numSubjects":"251"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"253"},{"groupId":"FG001","numSubjects":"250"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"241"},{"groupId":"FG001","numSubjects":"244"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Extension Phase: 53 - 104 Weeks","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Participants who had provided consent to continue in the extension phase started in this period.","numSubjects":"185"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","comment":"Participants who had provided consent to continue in the extension phase started in this period.","numSubjects":"100"},{"groupId":"FG003","comment":"Participants who had provided consent to continue in the extension phase started in this period.","numSubjects":"98"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"184"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"100"},{"groupId":"FG003","numSubjects":"97"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"182"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"99"},{"groupId":"FG003","numSubjects":"98"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised participants. Baseline characteristics were presented for the participants who started in the Main phase of trial.","groups":[{"id":"BG000","title":"Oral Semaglutide Flex","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants who were still on treatment at week 52 were allowed to continue on oral semaglutide in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial."},{"id":"BG001","title":"Sitagliptin 100 mg","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants who were still on treatment at week 52 were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"253"},{"groupId":"BG001","value":"251"},{"groupId":"BG002","value":"504"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57","spread":"10"},{"groupId":"BG001","value":"58","spread":"10"},{"groupId":"BG002","value":"57","spread":"10"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"108"},{"groupId":"BG001","value":"111"},{"groupId":"BG002","value":"219"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"145"},{"groupId":"BG001","value":"140"},{"groupId":"BG002","value":"285"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"105"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"205"},{"groupId":"BG001","value":"194"},{"groupId":"BG002","value":"399"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Race","categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"195"},{"groupId":"BG001","value":"186"},{"groupId":"BG002","value":"381"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"47"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"72"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","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 week 52. 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":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"251"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"238"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"60"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"178"}]}]},{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"184"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"52"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"132"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, 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 1.","statisticalMethod":"Pattern mixture model","paramType":"Odds Ratio (OR)","paramValue":"4.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.89","ciUpperLimit":"6.70","estimateComment":"Oral Semaglutide flex / Sitagliptin 100 mg."},{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on multiple imputation, imputing sequentially using post-baseline measurements up to and including week 52. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.","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 1.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"5.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.54","ciUpperLimit":"8.68","estimateComment":"Oral Semaglutide flex / Sitagliptin 100 mg"}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change from baseline (week 0) in body weight was evaluated at week 52. 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":"Kilogram (Kg)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"251"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.7","spread":"3.9"},{"groupId":"OG001","value":"-0.7","spread":"3.5"}]}]},{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"188"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.9","spread":"4.0"},{"groupId":"OG001","value":"-0.9","spread":"3.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, 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.","statisticalMethod":"Pattern mixture model","paramType":"Treatment difference","paramValue":"-1.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.6","ciUpperLimit":"-1.2","estimateComment":"Oral semaglutide flex - Sitagliptin 100 mg"},{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a Mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 52. 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.","statisticalMethod":"Mixed model for repeated measurements","paramType":"Treatment difference","paramValue":"-2.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.9","ciUpperLimit":"-1.5","estimateComment":"Oral semaglutide flex - Sitagliptin 100 mg"}]},{"type":"SECONDARY","title":"Change in HbA1c","description":"Change from baseline (week 0) in HbA1c was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"238"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"0.9"},{"groupId":"OG001","value":"-0.8","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change in FPG","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per liter (mmol/L)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"232"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.41","spread":"2.35"},{"groupId":"OG001","value":"-1.39","spread":"3.13"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (%)","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"239"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.99","spread":"4.42"},{"groupId":"OG001","value":"-0.76","spread":"3.91"}]}]}]},{"type":"SECONDARY","title":"Change in BMI","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms per square meter (kg/m^2)","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"239"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"1.5"},{"groupId":"OG001","value":"-0.3","spread":"1.3"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeters (cm)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"237"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.6","spread":"5.3"},{"groupId":"OG001","value":"-0.7","spread":"5.1"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = 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 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"234"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"19.3"},{"groupId":"OG001","value":"1.01","spread":"16.2"}]}]}]},{"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 week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = 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 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"233"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"31.8"},{"groupId":"OG001","value":"1.03","spread":"27.2"}]}]}]},{"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 = 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 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"233"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"14.0"},{"groupId":"OG001","value":"1.02","spread":"16.5"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (Ratio to Baseline)","description":"Change from baseline (week 0) in triglycerides (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"233"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"38.2"},{"groupId":"OG001","value":"0.91","spread":"43.1"}]}]}]},{"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 week 52. 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 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"251"}]}],"classes":[{"title":"Physical functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.54","spread":"7.92"},{"groupId":"OG001","value":"-0.03","spread":"7.16"}]}]},{"title":"Role physical","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.40","spread":"7.82"},{"groupId":"OG001","value":"0.13","spread":"8.38"}]}]},{"title":"Bodily pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.09","spread":"9.01"},{"groupId":"OG001","value":"1.20","spread":"8.72"}]}]},{"title":"General health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.83","spread":"7.65"},{"groupId":"OG001","value":"1.62","spread":"6.71"}]}]},{"title":"Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.07","spread":"8.16"},{"groupId":"OG001","value":"0.51","spread":"7.28"}]}]},{"title":"Social functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.38","spread":"9.00"},{"groupId":"OG001","value":"0.41","spread":"7.86"}]}]},{"title":"Role emotional","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.91","spread":"11.71"},{"groupId":"OG001","value":"-0.54","spread":"10.58"}]}]},{"title":"Mental health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.21","spread":"8.54"},{"groupId":"OG001","value":"0.86","spread":"7.97"}]}]},{"title":"PCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.51","spread":"6.39"},{"groupId":"OG001","value":"0.74","spread":"5.81"}]}]},{"title":"MCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"8.75"},{"groupId":"OG001","value":"0.26","spread":"7.67"}]}]}]},{"type":"SECONDARY","title":"Change in DTSQ","description":"Change from baseline (week 0) in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. 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 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"251"}]}],"classes":[{"title":"1) Satisfaction with treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.09","spread":"1.61"},{"groupId":"OG001","value":"0.92","spread":"1.65"}]}]},{"title":"2) Feeling of unacceptably high blood sugars","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.58","spread":"2.13"},{"groupId":"OG001","value":"-1.14","spread":"2.13"}]}]},{"title":"3) Feeling of unacceptably low blood sugars","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"238"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.15","spread":"1.70"},{"groupId":"OG001","value":"-0.24","spread":"1.99"}]}]},{"title":"4) Convenience of treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"234"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.82","spread":"1.54"},{"groupId":"OG001","value":"0.59","spread":"1.48"}]}]},{"title":"5) Flexibility of current treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.80","spread":"1.58"},{"groupId":"OG001","value":"0.68","spread":"1.51"}]}]},{"title":"6) Satisfaction with understanding of diabetes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.77","spread":"1.51"},{"groupId":"OG001","value":"0.77","spread":"1.71"}]}]},{"title":"7) Recommending treatment to others","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"237"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.88","spread":"1.54"},{"groupId":"OG001","value":"0.79","spread":"1.46"}]}]},{"title":"8) Satisfaction to continue with present treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"238"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"1.66"},{"groupId":"OG001","value":"0.95","spread":"1.88"}]}]},{"title":"Total treatment satisfaction score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.39","spread":"6.84"},{"groupId":"OG001","value":"4.70","spread":"7.23"}]}]}]},{"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 week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"238"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"29"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"209"}]}]}]},{"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 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"239"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"29"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"170"},{"groupId":"OG001","value":"210"}]}]}]},{"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 week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"239"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"5"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"218"},{"groupId":"OG001","value":"234"}]}]}]},{"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 week 52 is 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"238"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"35"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"203"}]}]}]},{"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 week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"238"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"25"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"213"}]}]}]},{"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 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"251"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"40"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.09","ciUpperLimit":"0.39","estimateComment":"Oral semaglutide flex / Sitagliptin 100 mg"}]},{"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 period from week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"251"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"47"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"0.0175","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.37","ciUpperLimit":"0.91","estimateComment":"Oral Semaglutide flex / 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 57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). 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":"Week 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"768"},{"groupId":"OG001","value":"519"}]}]}]},{"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 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). 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 participant 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":"Week 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"22"}]}]}]},{"type":"SECONDARY","title":"Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). 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 participant 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":"Week 0-57","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"14"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase (Ratio to Baseline)","description":"Change from baseline (week 0) in biochemical parameter- amylase (units per liter \\[U/L\\]) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"225"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.14","spread":"25.5"},{"groupId":"OG001","value":"1.08","spread":"26.3"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase (Ratio to Baseline)","description":"Change from baseline (week 0) in lipase (U/L) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"225"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.24","spread":"55.2"},{"groupId":"OG001","value":"1.13","spread":"55.3"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"225"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3","spread":"9"},{"groupId":"OG001","value":"0","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."},{"id":"OG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"225"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"14"},{"groupId":"OG001","value":"-2","spread":"15"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-0","spread":"9"},{"groupId":"OG001","value":"-1","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c- Switch","description":"Change from week 52 in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"96"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"1.2"},{"groupId":"OG001","value":"0.0","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight- Switch","description":"Change from week 52 in body weight was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.6","spread":"3.8"},{"groupId":"OG001","value":"-0.9","spread":"5.4"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (%)- Switch","description":"Relative change from week 52 in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.12","spread":"4.50"},{"groupId":"OG001","value":"-0.70","spread":"5.27"}]}]}]},{"type":"SECONDARY","title":"Change in FPG- Switch","description":"Change from week 52 in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per liter (mmol/L)","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.35","spread":"1.95"},{"groupId":"OG001","value":"0.02","spread":"2.31"}]}]}]},{"type":"SECONDARY","title":"Change in BMI- Switch","description":"Change from week 52 in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/m^2","timeFrame":"Week 52, Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.4"},{"groupId":"OG001","value":"-0.3","spread":"2.2"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference- Switch","description":"Change from week 52 in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeters (cm)","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"4.3"},{"groupId":"OG001","value":"-0.9","spread":"5.8"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"96"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"26"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"70"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch","description":"Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"96"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"11"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"85"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch","description":"Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"12"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"85"}]}]}]},{"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)- Switch","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 week 104 is 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 re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"96"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"18"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"78"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) and no need for rescue medication (yes/no), was evaluated at week 104. 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104 (i.e., after 52 weeks of treatment in the extension phase)","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"96"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"23"}]}]}]},{"type":"SECONDARY","title":"Time to Additional Anti-diabetic Medication- Switch","description":"Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 53 to week 104. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after re-randomisation (week 52) and before (planned) end-of-treatment (week 104), 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 re-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 53-104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"26"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"0.4381","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":"0.39","ciUpperLimit":"1.50","estimateComment":"Oral Semaglutide flex- Switch / Sitagliptin 100 mg- Switch"}]},{"type":"SECONDARY","title":"Time to Rescue Medication- Switch","description":"Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 53 to week 104. 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 re-randomisation (week 52) 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 53-104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"23"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"0.0790","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.20","ciUpperLimit":"1.09","estimateComment":"Oral semaglutide flex- Switch / Sitagliptin 100 mg- Switch"}]},{"type":"SECONDARY","title":"Number of TEAEs During Exposure to Trial Product- Switch","description":"Treatment emergent adverse events (TEAEs) were recorded from week 53 to week 109. 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":"Week 53-109","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"225"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase (Ratio to Baseline)- Switch","description":"Change from week 52 in biochemical parameter- amylase (U/L) to week 104 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Week 52, Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.09","spread":"22.9"},{"groupId":"OG001","value":"1.00","spread":"26.6"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase (Ratio to Baseline)- Switch","description":"Change from week 52 in lipase (U/L) to week 104 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Week 52, Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.13","spread":"46.7"},{"groupId":"OG001","value":"0.92","spread":"54.9"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate- Switch","description":"Change from week 52 in pulse rate was evaluated at week 104. 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1","spread":"9"},{"groupId":"OG001","value":"-0","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch","description":"Change from week 52 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"93"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"15"},{"groupId":"OG001","value":"2","spread":"15"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"10"},{"groupId":"OG001","value":"-0","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. 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 participant 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":"Week 53-109","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"12"}]}]}]},{"type":"SECONDARY","title":"Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch","description":"Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. 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 participant 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":"Week 53-109","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}]}]},{"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)- Switch","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 week 52 in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since week 52. Results are based on the data from the in-trial observation period.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"classes":[{"title":"Physical functioning","categories":[{"measurements":[{"groupId":"OG000","value":"1.14","spread":"8.55"},{"groupId":"OG001","value":"-0.97","spread":"6.71"}]}]},{"title":"Role physical","categories":[{"measurements":[{"groupId":"OG000","value":"1.37","spread":"7.68"},{"groupId":"OG001","value":"-0.22","spread":"7.61"}]}]},{"title":"Bodily pain","categories":[{"measurements":[{"groupId":"OG000","value":"-0.18","spread":"7.22"},{"groupId":"OG001","value":"-0.30","spread":"7.06"}]}]},{"title":"General health","categories":[{"measurements":[{"groupId":"OG000","value":"0.69","spread":"6.74"},{"groupId":"OG001","value":"0.53","spread":"6.59"}]}]},{"title":"Vitality","categories":[{"measurements":[{"groupId":"OG000","value":"-0.18","spread":"6.91"},{"groupId":"OG001","value":"-0.15","spread":"7.32"}]}]},{"title":"Social functioning","categories":[{"measurements":[{"groupId":"OG000","value":"0.21","spread":"7.36"},{"groupId":"OG001","value":"0.10","spread":"6.54"}]}]},{"title":"Role emotional","categories":[{"measurements":[{"groupId":"OG000","value":"1.72","spread":"9.61"},{"groupId":"OG001","value":"-0.39","spread":"8.79"}]}]},{"title":"Mental health","categories":[{"measurements":[{"groupId":"OG000","value":"0.37","spread":"6.68"},{"groupId":"OG001","value":"0.20","spread":"6.46"}]}]},{"title":"PCS","categories":[{"measurements":[{"groupId":"OG000","value":"0.66","spread":"6.06"},{"groupId":"OG001","value":"-0.43","spread":"5.36"}]}]},{"title":"MCS","categories":[{"measurements":[{"groupId":"OG000","value":"0.52","spread":"7.21"},{"groupId":"OG001","value":"0.19","spread":"6.46"}]}]}]},{"type":"SECONDARY","title":"Change in DTSQ- Switch","description":"Change from week 52 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. 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 52, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."},{"id":"OG001","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"98"}]}],"classes":[{"title":"1) Satisfaction with treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"1.06"},{"groupId":"OG001","value":"-0.24","spread":"1.43"}]}]},{"title":"2) Feeling of unacceptably high blood sugars","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"1.95"},{"groupId":"OG001","value":"0.09","spread":"2.04"}]}]},{"title":"3) Feeling of unacceptably low blood sugars","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"1.63"},{"groupId":"OG001","value":"0.23","spread":"1.94"}]}]},{"title":"4) Convenience of treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"94"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.13","spread":"1.18"},{"groupId":"OG001","value":"0.13","spread":"1.16"}]}]},{"title":"5) Flexibility of current treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"1.19"},{"groupId":"OG001","value":"0.06","spread":"1.22"}]}]},{"title":"6) Satisfaction with understanding of diabetes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"1.38"},{"groupId":"OG001","value":"0.04","spread":"1.16"}]}]},{"title":"7) Recommending treatment to others","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"96"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.04","spread":"1.04"},{"groupId":"OG001","value":"-0.05","spread":"1.20"}]}]},{"title":"8) Satisfaction to continue with present treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"97"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"1.07"},{"groupId":"OG001","value":"0.00","spread":"1.48"}]}]},{"title":"Total treatment satisfaction score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.20","spread":"5.14"},{"groupId":"OG001","value":"-0.06","spread":"5.62"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c- Sustainability","description":"Change from baseline (week 0) in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (kg)- Sustainability","description":"Change from baseline (week 0) in body weight was evaluated at week 104. 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.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.7","spread":"5.2"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (%)- Sustainability","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.03","spread":"5.75"}]}]}]},{"type":"SECONDARY","title":"Change in FPG- Sustainability","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per liter (mmol/L)","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"178"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-39.4","spread":"51.2"}]}]}]},{"type":"SECONDARY","title":"Change in BMI- Sustainability","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/m^2","timeFrame":"Week 0, Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"1.9"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference- Sustainability","description":"Change from baseline (week 0) in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"178"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.5","spread":"6.3"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. 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.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"101"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"79"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability","description":"Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"63"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"117"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability","description":"Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"61"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"119"}]}]}]},{"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)- Sustainability","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 week 104 is 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"73"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"107"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability","description":"Participants who achieved HbA1c \\<7.0% ADA target or HbA1c reduction ≥ 1%-point (10.9 mmol/mol) (yes/no), was evaluated at week 104. 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.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"126"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"54"}]}]}]},{"type":"SECONDARY","title":"Number of TEAEs During Exposure to Trial Product- Sustainability","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) 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 = SAS which comprised all randomised participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Week 0-109","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1157"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase (Ratio to Baseline)- Sustainability","description":"Change from baseline (week 0) in biochemical parameter- amylase (units per liter \\[U/L\\]) to week 104 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"167"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.13","spread":"25.1"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase (Ratio to Baseline)- Sustainability","description":"Change from baseline (week 0) in lipase (U/L) to week 104 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Week 0, Week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"167"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.18","spread":"58.0"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate- Sustainability","description":"Change from baseline (week 0) in pulse rate was evaluated at week 104. 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability","description":"Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"14"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) 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 participant 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":"Week 0-109","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}]}]},{"type":"SECONDARY","title":"Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability","description":"Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) 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 participant 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":"Week 0-109","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}]}]},{"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)- Sustainability","description":"Short form (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 week 104. 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 = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"title":"Physical functioning","categories":[{"measurements":[{"groupId":"OG000","value":"1.44","spread":"8.48"}]}]},{"title":"Role physical","categories":[{"measurements":[{"groupId":"OG000","value":"0.22","spread":"8.31"}]}]},{"title":"Bodily pain","categories":[{"measurements":[{"groupId":"OG000","value":"1.07","spread":"9.72"}]}]},{"title":"General health","categories":[{"measurements":[{"groupId":"OG000","value":"1.98","spread":"8.01"}]}]},{"title":"Vitality","categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"8.49"}]}]},{"title":"Social functioning","categories":[{"measurements":[{"groupId":"OG000","value":"-0.11","spread":"8.14"}]}]},{"title":"Role emotional","categories":[{"measurements":[{"groupId":"OG000","value":"-0.04","spread":"10.49"}]}]},{"title":"Mental health","categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"8.25"}]}]},{"title":"PCS","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"6.96"}]}]},{"title":"MCS","categories":[{"measurements":[{"groupId":"OG000","value":"0.20","spread":"8.34"}]}]}]},{"type":"SECONDARY","title":"Change in DTSQ- Sustainability","description":"Change from week 0 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. 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 104","groups":[{"id":"OG000","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"classes":[{"title":"1) Satisfaction with treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.19","spread":"1.61"}]}]},{"title":"2) Feeling of unacceptably high blood sugars","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.46","spread":"2.44"}]}]},{"title":"3) Feeling of unacceptably low blood sugars","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.14","spread":"2.09"}]}]},{"title":"4) Convenience of treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"179"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.88","spread":"1.52"}]}]},{"title":"5) Flexibility of current treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.86","spread":"1.56"}]}]},{"title":"6) Satisfaction with understanding of diabetes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"179"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.84","spread":"1.50"}]}]},{"title":"7) Recommending treatment to others","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"1.58"}]}]},{"title":"8) Satisfaction to continue with present treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.11","spread":"1.62"}]}]},{"title":"Total treatment satisfaction score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"180"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.81","spread":"7.11"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.","description":"Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., 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.","eventGroups":[{"id":"EG000","title":"Oral Semaglutide Flex- Main Phase","description":"Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).","deathsNumAffected":0,"deathsNumAtRisk":253,"seriousNumAffected":24,"seriousNumAtRisk":253,"otherNumAffected":126,"otherNumAtRisk":253},{"id":"EG001","title":"Sitagliptin 100 mg- Main Phase","description":"Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).","deathsNumAffected":2,"deathsNumAtRisk":250,"seriousNumAffected":24,"seriousNumAtRisk":250,"otherNumAffected":70,"otherNumAtRisk":250},{"id":"EG002","title":"Oral Semaglutide Flex- Sustainability","description":"Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104).","deathsNumAffected":0,"deathsNumAtRisk":253,"seriousNumAffected":36,"seriousNumAtRisk":253,"otherNumAffected":148,"otherNumAtRisk":253},{"id":"EG003","title":"Oral Semaglutide Flex- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).","deathsNumAffected":0,"deathsNumAtRisk":100,"seriousNumAffected":9,"seriousNumAtRisk":100,"otherNumAffected":46,"otherNumAtRisk":100},{"id":"EG004","title":"Sitagliptin 100 mg- Switch","description":"Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).","deathsNumAffected":0,"deathsNumAtRisk":97,"seriousNumAffected":7,"seriousNumAtRisk":97,"otherNumAffected":27,"otherNumAtRisk":97}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":250},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Acute pulmonary oedema","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":250},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Adenocarcinoma gastric","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Adenocarcinoma of colon","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":253},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Aortic stenosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":250},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Basal cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":250},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Benign prostatic hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":250},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Bladder prolapse","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Campylobacter gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Cardiac failure chronic","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":250},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":97}]},{"term":"Catheterisation cardiac","organSystem":"Investigations","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":250},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":250},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Choroid melanoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":253},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":250},{"groupId":"EG002","numEvents":4,"numAffected":2,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Coronary artery insufficiency","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":250},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":253},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":97}]},{"term":"Depression","organSystem":"Psychiatric 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