{"protocolSection":{"identificationModule":{"nctId":"NCT02827708","orgStudyIdInfo":{"id":"NN9924-4234"},"secondaryIdInfos":[{"id":"2015-005326-19","type":"EUDRACT_NUMBER"},{"id":"U1111-1176-9230","type":"OTHER","domain":"WHO"},{"id":"2015","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2015"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment","officialTitle":"Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment","acronym":"PIONEER 5"},"statusModule":{"statusVerifiedDate":"2020-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-09-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-04-10","type":"ACTUAL"},"completionDateStruct":{"date":"2018-05-15","type":"ACTUAL"},"studyFirstSubmitDate":"2016-07-06","studyFirstSubmitQcDate":"2016-07-06","studyFirstPostDateStruct":{"date":"2016-07-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-10-15","resultsFirstSubmitQcDate":"2020-02-14","resultsFirstPostDateStruct":{"date":"2020-02-17","type":"ACTUAL"},"dispFirstSubmitDate":"2019-03-25","dispFirstSubmitQcDate":"2019-03-25","dispFirstPostDateStruct":{"date":"2019-03-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-02-14","lastUpdatePostDateStruct":{"date":"2020-02-17","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":324,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","interventionNames":["Drug: semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"semaglutide","description":"Oral administration once daily.","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"placebo","description":"Oral administration once daily.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c","description":"Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","timeFrame":"Week 0, week 26"}],"secondaryOutcomes":[{"measure":"Change in Body Weight (kg)","description":"Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","timeFrame":"Week 0, week 26"},{"measure":"Change in FPG","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"measure":"Change in Body Weight (%)","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"measure":"Change in BMI","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"measure":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"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 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26"},{"measure":"Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)","description":"Participants who achieved HbA1c ≤6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no), was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26"},{"measure":"Participants Who Achieve Weight Loss ≥5% (Yes/no)","description":"Participants who achieved weight loss ≥5% of their baseline body weight (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26"},{"measure":"Participants Who Achieve Weight Loss ≥10% (Yes/no)","description":"Participants who achieved weight loss of ≥10% of their baseline body weight (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26"},{"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 \\<7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) was evaluated at week 26. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26"},{"measure":"Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)","description":"Participants who achieved HbA1c reduction ≥1% and weight loss of ≥3% (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 26"},{"measure":"Change in Total Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"measure":"Change in LDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"measure":"Change in HDL Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"measure":"Change in Triglycerides (Ratio to Baseline)","description":"Change from baseline (week 0) in triglycerides (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"measure":"Change in CRP (Ratio to Baseline)","description":"Change from baseline (week 0) in C-reactive protein (CRP) (mg/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"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 26. 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 26), 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 0-26"},{"measure":"Time to Rescue Medication","description":"Presented results are the number of participants who had taken rescue medication anytime during the period, from week 0 to week 26. 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 0-26"},{"measure":"Number of TEAEs","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Adverse events (AEs) 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.","timeFrame":"Weeks 0-31"},{"measure":"Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG-confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the first dose of trial product until last dose of trial product were considered treatment -emergent. Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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":"Weeks 0-31"},{"measure":"Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)","description":"Number of participants with treatment emergent severe or BG-confirmed symptomatic hypoglycaemic episodes was recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the first dose of trial product until last dose of trial product were considered treatment -emergent. Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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":"Weeks 0-31"},{"measure":"Change in Amylase (Ratio to Baseline)","description":"Change from baseline (week 0) in amylase (units/litre (U/L)) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change in Lipase (Ratio to Baseline)","description":"Change from baseline (week 0) in lipase (U/L) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change in Urinary Albumin to Creatinine Ratio (Ratio to Baseline)","description":"Change from baseline (week 0) in urinary albumin to creatinine ratio (mg/mmol) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","timeFrame":"Week 0, week 26"},{"measure":"Change in ECG","description":"Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at week 26. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week 0, week 26"},{"measure":"Change in Physical Examination","description":"Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (week \\[wk\\] -2) and wk 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Nervous system (central and peripheral); 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head (ears, eyes, nose), throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.","timeFrame":"Week -2, week 26"},{"measure":"Change in Eye Examination","description":"Participants with eye examination findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Week -2, week 26"},{"measure":"Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-31"},{"measure":"Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-31"},{"measure":"Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-31"},{"measure":"Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-31"},{"measure":"Anti-semaglutide Binding Antibody Levels","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-31). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","timeFrame":"Weeks 0-31"},{"measure":"Semaglutide Plasma Concentrations for Population PK Analyses","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Semaglutide plasma concentrations were measured at weeks 4, 8, 14 and 26. 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":"Weeks 0-26"},{"measure":"SNAC Plasma Concentrations","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Sodium N-\\[8-(2-hydroxybenzoyl) amino\\]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at weeks 4, 14 and 26. 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":"Weeks 0-26"},{"measure":"Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (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 26. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.","timeFrame":"Week 0, week 26"},{"measure":"Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)","description":"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.","timeFrame":"Week 0, week 26"},{"measure":"Change in Urinalysis","description":"Participants with urinalysis, \"leukocytes and erythrocytes\" findings, negative, trace, small, moderate or large at baseline (week \\[wk\\] 0) and wk 26 are presented. Participants with urinalysis, \"nitrit\" findings, negative or positive at baseline (wk 0) and wk 26 are presented. 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 -2, week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* Male or female, age above or equal to 18 years at the time of signing informed consent\n* Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening\n* HbA1c (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive)\n* Moderate renal impairment defined as estimated glomerular filtration rate of 30-59 mL/min/1.73 m\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula\n* Stable daily dose(s) within 90 days prior to the day of screening of any of the following treatment regimens:\n* 1-2 of the following oral anti-diabetic drugs:\n* Metformin equal or above 1500 mg or maximum tolerated dose documented in the subject medical record),\n* Sulfonylurea (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)\n* Basal insulin alone (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin) or\n* Metformin (equal or above 1500 mg or maximum tolerated dose documented in the subject medical record) in combination with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin)\n\nExclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For certain specific countries: Additional specific requirements apply\n* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol\n* Family or personal history of Multiple Endocrine Neoplasia Type 2 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* Rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above 2200 mg/24 hours or above 2200 mg/g)\n* Use of systemic immunosuppressive treatment within 90 days prior to screening\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* Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator\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)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Tuscumbia","state":"Alabama","zip":"35674","country":"United States","geoPoint":{"lat":34.7312,"lon":-87.70253}},{"facility":"Novo Nordisk Investigational Site","city":"Bermuda Dunes","state":"California","zip":"92203","country":"United States","geoPoint":{"lat":33.7428,"lon":-116.28918}},{"facility":"Novo Nordisk Investigational Site","city":"Concord","state":"California","zip":"94520","country":"United States","geoPoint":{"lat":37.97798,"lon":-122.03107}},{"facility":"Novo Nordisk Investigational Site","city":"Costa Mesa","state":"California","zip":"92627","country":"United States","geoPoint":{"lat":33.64113,"lon":-117.91867}},{"facility":"Novo Nordisk Investigational Site","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Novo Nordisk Investigational Site","city":"La Jolla","state":"California","zip":"92161-0002","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"Novo Nordisk Investigational Site","city":"San Ramon","state":"California","zip":"94583","country":"United States","geoPoint":{"lat":37.77993,"lon":-121.97802}},{"facility":"Novo Nordisk Investigational Site","city":"Danbury","state":"Connecticut","zip":"06810","country":"United States","geoPoint":{"lat":41.39482,"lon":-73.45401}},{"facility":"Novo Nordisk Investigational Site","city":"Norwalk","state":"Connecticut","zip":"06851","country":"United States","geoPoint":{"lat":41.1176,"lon":-73.4079}},{"facility":"Novo 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Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2019 Jul;7(7):515-527. doi: 10.1016/S2213-8587(19)30192-5. Epub 2019 Jun 9."},{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."},{"pmid":"36056351","type":"DERIVED","citation":"Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, Weimers P, Rosenstock J. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Cardiovasc Diabetol. 2022 Sep 2;21(1):172. doi: 10.1186/s12933-022-01585-7."},{"pmid":"33660198","type":"DERIVED","citation":"Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4."},{"pmid":"32998732","type":"DERIVED","citation":"Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4."},{"pmid":"32267058","type":"DERIVED","citation":"Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13."},{"pmid":"31903692","type":"DERIVED","citation":"Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. 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Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"1.0"},{"groupId":"OG001","value":"-0.2","spread":"0.9"}]}]},{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"127"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"0.9"},{"groupId":"OG001","value":"-0.1","spread":"0.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.","nonInferiorityType":"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":"-0.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.0","ciUpperLimit":"-0.6","estimateComment":"Oral semaglutide 14 mg - Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as 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":"MMRM","paramType":"Treatment difference","paramValue":"-1.0","ciPctValue":"95","ciLowerLimit":"-1.2","ciUpperLimit":"-0.8","estimateComment":"Oral semaglutide 14 mg - Placebo"}]},{"type":"SECONDARY","title":"Change in Body Weight (kg)","description":"Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.","populationDescription":"Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.5","spread":"3.8"},{"groupId":"OG001","value":"-0.9","spread":"2.9"}]}]},{"title":"On-treatment without rescue medication","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"127"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.9","spread":"3.6"},{"groupId":"OG001","value":"-0.9","spread":"2.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0.","statisticalMethod":"Pattern Mixture model","paramType":"Treatment difference","paramValue":"-2.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.2","ciUpperLimit":"-1.8","estimateComment":"Oral semaglutide 14 mg - Placebo"},{"groupIds":["OG000","OG001"],"groupDescription":"The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as 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":"MMRM","paramType":"Treatment difference","paramValue":"-2.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.5","ciUpperLimit":"-1.9","estimateComment":"Oral semaglutide 14 mg - Placebo"}]},{"type":"SECONDARY","title":"Change in FPG","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 26. 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":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.58","spread":"2.96"},{"groupId":"OG001","value":"-0.34","spread":"3.03"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (%)","description":"Relative change from baseline (week 0) in body weight (kg) was evaluated at week 26. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.75","spread":"4.10"},{"groupId":"OG001","value":"-0.92","spread":"3.13"}]}]}]},{"type":"SECONDARY","title":"Change in BMI","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"1.3"},{"groupId":"OG001","value":"-0.3","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated at week 26. 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":"Centimetre (cm)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"154"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.8","spread":"4.9"},{"groupId":"OG001","value":"-0.7","spread":"3.8"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c <7.0% (53 mmol/Mol), ADA Target (Yes/no)","description":"Participants who achieved HbA1c \\<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 26. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"35"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"120"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)","description":"Participants who achieved HbA1c ≤6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no), was evaluated at week 26. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"12"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"143"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve Weight Loss ≥5% (Yes/no)","description":"Participants who achieved weight loss ≥5% of their baseline body weight (yes/no) was evaluated at week 26. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"15"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"140"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve Weight Loss ≥10% (Yes/no)","description":"Participants who achieved weight loss of ≥10% of their baseline body weight (yes/no) was evaluated at week 26. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"155"}]}]}]},{"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 \\<7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) was evaluated at week 26. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"27"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"128"}]}]}]},{"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 ≥1% and weight loss of ≥3% (yes/no) was evaluated at week 26. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"155"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"12"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"143"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at week 26 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"153"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"20.1"},{"groupId":"OG001","value":"1.00","spread":"23.0"}]}]}]},{"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 26 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"152"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"32.7"},{"groupId":"OG001","value":"1.00","spread":"38.2"}]}]}]},{"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 week 26 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"153"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"17.5"},{"groupId":"OG001","value":"1.02","spread":"15.4"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (Ratio to Baseline)","description":"Change from baseline (week 0) in triglycerides (mmol/L) at week 26 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"153"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.87","spread":"37.7"},{"groupId":"OG001","value":"0.95","spread":"37.1"}]}]}]},{"type":"SECONDARY","title":"Change in CRP (Ratio to Baseline)","description":"Change from baseline (week 0) in C-reactive protein (CRP) (mg/L) at week 26 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 CRP","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"154"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.86","spread":"135.1"},{"groupId":"OG001","value":"1.00","spread":"136.0"}]}]}]},{"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 26. 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 26), 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 0-26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"21"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"This hypothesis was not controlled for multiplicity.","pValue":"=0.1834","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.34","ciUpperLimit":"1.23"}]},{"type":"SECONDARY","title":"Time to Rescue Medication","description":"Presented results are the number of participants who had taken rescue medication anytime during the period, from week 0 to week 26. 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 0-26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"16"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction 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":"=0.0610","pValueComment":"Unadjusted two-sided p-value for test of no difference from 1.","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.17","ciUpperLimit":"1.04"}]},{"type":"SECONDARY","title":"Number of TEAEs","description":"Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Adverse events (AEs) 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.","populationDescription":"Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Weeks 0-31","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"463"},{"groupId":"OG001","value":"331"}]}]}]},{"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 from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the first dose of trial product until last dose of trial product were considered treatment -emergent. Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-31","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","title":"Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)","description":"Number of participants with treatment emergent severe or BG-confirmed symptomatic hypoglycaemic episodes was recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the first dose of trial product until last dose of trial product were considered treatment -emergent. Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-31","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase (Ratio to Baseline)","description":"Change from baseline (week 0) in amylase (units/litre (U/L)) at week 26 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"140"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.09","spread":"22.9"},{"groupId":"OG001","value":"0.99","spread":"25.6"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase (Ratio to Baseline)","description":"Change from baseline (week 0) in lipase (U/L) at week 26 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"140"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.16","spread":"57.6"},{"groupId":"OG001","value":"0.94","spread":"52.5"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate","description":"Change from baseline (week 0) in pulse rate was evaluated at week 26. 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/minute","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1","spread":"9"},{"groupId":"OG001","value":"-1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated at week 26. 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":"mmHg","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"141"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-8","spread":"14"},{"groupId":"OG001","value":"0","spread":"13"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"9"},{"groupId":"OG001","value":"0","spread":"8"}]}]}]},{"type":"SECONDARY","title":"Change in Urinary Albumin to Creatinine Ratio (Ratio to Baseline)","description":"Change from baseline (week 0) in urinary albumin to creatinine ratio (mg/mmol) at week 26 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","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.86","spread":"119.7"},{"groupId":"OG001","value":"1.19","spread":"145.4"}]}]}]},{"type":"SECONDARY","title":"Change in ECG","description":"Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at week 26. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"title":"Normal (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"39"}]}]},{"title":"Normal (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"9"}]}]},{"title":"Normal (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Abnormal (week 0) NCS to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"103"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"13"}]}]},{"title":"Abnormal (week 0) NCS to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"103"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"88"}]}]},{"title":"Abnormal (week 0) NCS to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"103"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]},{"title":"Abnormal (week 0) CS to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Abnormal (week 0) CS to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Abnormal (week 0) CS to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"Change in Physical Examination","description":"Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (week \\[wk\\] -2) and wk 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Nervous system (central and peripheral); 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head (ears, eyes, nose), throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -2, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"title":"1) Cardiovascular system (wk -2): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"103"}]}]},{"title":"1) Cardiovascular system (wk -2): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"55"}]}]},{"title":"1) Cardiovascular system (wk -2): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}]}]},{"title":"1) Cardiovascular system (wk 26): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"104"}]}]},{"title":"1) Cardiovascular system (wk 26): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"47"}]}]},{"title":"1) Cardiovascular system (wk 26): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}]}]},{"title":"2) Nervous system (wk -2): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"116"}]}]},{"title":"2) Nervous system (wk -2): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"45"}]}]},{"title":"2) Nervous system (wk -2): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}]}]},{"title":"2) Nervous system (wk 26): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"115"}]}]},{"title":"2) Nervous system (wk 26): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"39"}]}]},{"title":"2) Nervous system (wk 26): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"0"}]}]},{"title":"3) Gastrointestinal system (wk -2): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"152"}]}]},{"title":"3) Gastrointestinal system (wk -2): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"9"}]}]},{"title":"3) Gastrointestinal system (wk -2): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"3) Gastrointestinal system (wk 26): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"153"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"145"}]}]},{"title":"3) Gastrointestinal system (wk 26): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"153"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"}]}]},{"title":"3) Gastrointestinal system (wk 26): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"153"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"4) General appearance (wk -2): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"138"}]}]},{"title":"4) General appearance (wk -2): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"20"}]}]},{"title":"4) General appearance (wk -2): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}]},{"title":"4) General appearance (wk 26): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"137"}]}]},{"title":"4) General appearance (wk 26): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"16"}]}]},{"title":"4) General appearance (wk 26): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"154"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]},{"title":"5) Head, throat, neck (wk -2): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"143"}]}]},{"title":"5) Head, throat, neck (wk -2): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"15"}]}]},{"title":"5) Head, throat, neck (wk -2): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}]},{"title":"5) Head, throat, neck (wk 26): 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Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -2, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"title":"Left eye (week -2): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"159"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"66"}]}]},{"title":"Left eye (week -2): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"159"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"93"}]}]},{"title":"Left eye (week -2): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"159"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}]}]},{"title":"Left eye (week 26): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"150"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"55"}]}]},{"title":"Left eye (week 26): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"150"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"95"}]}]},{"title":"Left eye (week 26): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"150"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"0"}]}]},{"title":"Right eye (week -2): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"159"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"66"}]}]},{"title":"Right eye (week -2): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"159"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"93"}]}]},{"title":"Right eye (week -2): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"159"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"0"}]}]},{"title":"Right eye (week 26): Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"150"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"55"}]}]},{"title":"Right eye (week 26): Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"150"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"95"}]}]},{"title":"Right eye (week 26): Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"150"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-31","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"162"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-31","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"162"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-31","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"162"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0-31","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"162"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Anti-semaglutide Binding Antibody Levels","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-31). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.","populationDescription":"Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies. As only one subject was analyzed, standard deviation could not be calculated.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"%B/T","timeFrame":"Weeks 0-31","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"3.1","spread":"NA","comment":"As only one subject was analyzed, standard deviation could not be calculated."}]}]},{"title":"Week 31","categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"NA","comment":"As only one subject was analyzed, standard deviation could not be calculated."}]}]}]},{"type":"SECONDARY","title":"Semaglutide Plasma Concentrations for Population PK Analyses","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Semaglutide plasma concentrations were measured at weeks 4, 8, 14 and 26. 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 = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanomoles per litre (nmol/L)","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.8","spread":"113.5"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.2","spread":"143.4"}]}]},{"title":"Week 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"140"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.4","spread":"206.6"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.9","spread":"251.3"}]}]}]},{"type":"SECONDARY","title":"SNAC Plasma Concentrations","description":"This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Sodium N-\\[8-(2-hydroxybenzoyl) amino\\]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at weeks 4, 14 and 26. 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 = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanograms per milliliter (ng/mL)","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"}]}],"classes":[{"title":"Week 4: 25 minutes post-dose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"578","spread":"347.4"}]}]},{"title":"Week 4: 40 minutes post-dose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"364","spread":"308.5"}]}]},{"title":"Week 14: 25 minutes post-dose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"136"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"418","spread":"389.7"}]}]},{"title":"Week 14: 40 minutes post-dose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"137"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"330","spread":"349.2"}]}]},{"title":"Week 26: 25 minutes post-dose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"435","spread":"688.0"}]}]},{"title":"Week 26: 40 minutes post-dose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"288","spread":"596.1"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (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 26. 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","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"title":"1) Physical functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"7.21"},{"groupId":"OG001","value":"-0.41","spread":"6.43"}]}]},{"title":"2) Role functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.97","spread":"8.43"},{"groupId":"OG001","value":"-0.36","spread":"7.76"}]}]},{"title":"3) Bodily pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.18","spread":"10.14"},{"groupId":"OG001","value":"-0.33","spread":"11.47"}]}]},{"title":"4) General health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.18","spread":"6.01"},{"groupId":"OG001","value":"-0.13","spread":"5.77"}]}]},{"title":"5) Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.05","spread":"7.53"},{"groupId":"OG001","value":"0.56","spread":"8.02"}]}]},{"title":"6) Social functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.87","spread":"7.81"},{"groupId":"OG001","value":"-0.06","spread":"9.64"}]}]},{"title":"7) Role emotional","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.62","spread":"10.83"},{"groupId":"OG001","value":"-1.18","spread":"12.32"}]}]},{"title":"8) Mental health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.34","spread":"8.72"},{"groupId":"OG001","value":"-0.19","spread":"9.48"}]}]},{"title":"Physical component summary (PCS)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.78","spread":"7.16"},{"groupId":"OG001","value":"-0.15","spread":"6.10"}]}]},{"title":"Mental component summary (MCS)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"155"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.26","spread":"8.74"},{"groupId":"OG001","value":"-0.32","spread":"10.15"}]}]}]},{"type":"SECONDARY","title":"Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)","description":"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being \"none of the time\" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.","populationDescription":"Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"154"}]}],"classes":[{"title":"1) Satisfaction with treatment","categories":[{"measurements":[{"groupId":"OG000","value":"0.41","spread":"1.56"},{"groupId":"OG001","value":"0.74","spread":"1.57"}]}]},{"title":"2) Feeling of unacceptably high blood sugars","categories":[{"measurements":[{"groupId":"OG000","value":"-1.26","spread":"2.17"},{"groupId":"OG001","value":"-0.30","spread":"2.08"}]}]},{"title":"3) Feeling of unacceptably low blood sugars","categories":[{"measurements":[{"groupId":"OG000","value":"0.11","spread":"1.84"},{"groupId":"OG001","value":"-0.32","spread":"1.82"}]}]},{"title":"4) Convenience of treatment","categories":[{"measurements":[{"groupId":"OG000","value":"0.43","spread":"1.41"},{"groupId":"OG001","value":"0.42","spread":"1.76"}]}]},{"title":"5) Flexibility of treatment","categories":[{"measurements":[{"groupId":"OG000","value":"0.37","spread":"1.45"},{"groupId":"OG001","value":"0.52","spread":"1.45"}]}]},{"title":"6) Satisfaction with understanding of diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"0.31","spread":"1.42"},{"groupId":"OG001","value":"0.60","spread":"1.59"}]}]},{"title":"7) Recommending treatment to others","categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"1.73"},{"groupId":"OG001","value":"0.37","spread":"1.61"}]}]},{"title":"8) Satisfaction to continue with present treatment","categories":[{"measurements":[{"groupId":"OG000","value":"0.58","spread":"1.84"},{"groupId":"OG001","value":"0.47","spread":"1.87"}]}]},{"title":"Total treatment satisfaction","categories":[{"measurements":[{"groupId":"OG000","value":"2.82","spread":"6.61"},{"groupId":"OG001","value":"3.13","spread":"7.25"}]}]}]},{"type":"SECONDARY","title":"Change in Urinalysis","description":"Participants with urinalysis, \"leukocytes and erythrocytes\" findings, negative, trace, small, moderate or large at baseline (week \\[wk\\] 0) and wk 26 are presented. Participants with urinalysis, \"nitrit\" findings, negative or positive at baseline (wk 0) and wk 26 are presented. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.","populationDescription":"Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -2, week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}]}],"classes":[{"title":"Leucocytes (wk 0): 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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 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.","deathsNumAffected":1,"deathsNumAtRisk":163,"seriousNumAffected":17,"seriousNumAtRisk":163,"otherNumAffected":75,"otherNumAtRisk":163},{"id":"EG001","title":"Placebo","description":"Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.","deathsNumAffected":2,"deathsNumAtRisk":161,"seriousNumAffected":17,"seriousNumAtRisk":161,"otherNumAffected":32,"otherNumAtRisk":161}],"seriousEvents":[{"term":"Acute kidney injury","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":163},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":161}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Animal bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 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20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Bladder transitional 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":163},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":161}]},{"term":"Confusional state","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Gastroenteritis bacterial","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Gout","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Haemorrhagic stroke","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Hypertensive crisis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":163},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":161}]},{"term":"Infected bite","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":163},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":161}]},{"term":"Injection site abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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