<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015220</url>
  </required_header>
  <id_info>
    <org_study_id>NN9924-4282</org_study_id>
    <secondary_id>U1111-1181-4133</secondary_id>
    <secondary_id>JapicCTI-173485</secondary_id>
    <nct_id>NCT03015220</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes</brief_title>
  <acronym>PIONEER 10</acronym>
  <official_title>Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy&#xD;
      of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic&#xD;
      drug) in Japanese subjects with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">July 12, 2018</completion_date>
  <primary_completion_date type="Actual">July 12, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>Weeks 0-57</time_frame>
    <description>Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight (kg)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight (%)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Total Cholesterol (Ratio to Baseline)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Triglyceride (Ratio to Baseline)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved HbA1c below 7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value &lt;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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Additional Anti-diabetic Medication</measure>
    <time_frame>Weeks 0-52</time_frame>
    <description>Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Rescue Medication</measure>
    <time_frame>Weeks 0-52</time_frame>
    <description>Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Amylase (Ratio to Baseline)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in amylase (measured as units per liter [U/L]) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lipase (Ratio to Baseline)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulse Rate</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Blood Pressure</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ECG Evaluation</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Examination</measure>
    <time_frame>Week -2, week 26, week 52</time_frame>
    <description>Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Eye Examination Category</measure>
    <time_frame>Week -2, week 52</time_frame>
    <description>Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes</measure>
    <time_frame>Weeks 0-57</time_frame>
    <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</measure>
    <time_frame>Weeks 0-57</time_frame>
    <description>Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains</measure>
    <time_frame>week 0, week 26, week 52</time_frame>
    <description>DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: &quot;Burden on social activities and daily activities&quot;, &quot;Anxiety and dissatisfaction with treatment&quot;, &quot;Hypoglycemia&quot; and &quot;Satisfaction with treatment&quot; on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">458</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Oral semaglutide 3 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral semaglutide 7 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral semaglutide 14 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dulaglutide 0.75 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Semaglutide</intervention_name>
    <description>Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).</description>
    <arm_group_label>Oral semaglutide 14 mg</arm_group_label>
    <arm_group_label>Oral semaglutide 3 mg</arm_group_label>
    <arm_group_label>Oral semaglutide 7 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dulaglutide</intervention_name>
    <description>Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).</description>
    <arm_group_label>Dulaglutide 0.75 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any trial-related activities. Trial-related&#xD;
             activities are any procedures that are carried out as part of the trial, including&#xD;
             activities to determine suitability for the trial&#xD;
&#xD;
          -  Japanese male or female, age above or equal to 20 years at the time of signing&#xD;
             informed consent&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening&#xD;
&#xD;
          -  HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive)&#xD;
&#xD;
          -  OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days&#xD;
             prior to the day of screening of one of SU (sulphonylurea) glinide , TZD&#xD;
             (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose&#xD;
             cotransporter-2) inhibitor according to Japanese labelling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of&#xD;
             child-bearing potential and not using an adequate contraceptive method. Adequate&#xD;
             contraceptive measures are abstinence (not having sex), diaphragm, condom (by the&#xD;
             partner), intrauterine device, sponge, spermicide or oral contraceptives&#xD;
&#xD;
          -  Any disorder, which in the investigator's opinion might jeopardise subject's safety or&#xD;
             compliance with the protocol&#xD;
&#xD;
          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary&#xD;
             thyroid carcinoma (MTC)&#xD;
&#xD;
          -  History of pancreatitis (acute or chronic)&#xD;
&#xD;
          -  History of major surgical procedures involving the stomach potentially affecting&#xD;
             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,&#xD;
             gastric bypass surgery)&#xD;
&#xD;
          -  Any of the following: myocardial infarction, stroke or hospitalisation for unstable&#xD;
             angina or transient ischaemic attack (TIA) within the past 180 days prior to the day&#xD;
             of screening and randomisation&#xD;
&#xD;
          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV&#xD;
&#xD;
          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of&#xD;
             screening&#xD;
&#xD;
          -  Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)&#xD;
&#xD;
          -  Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30&#xD;
             mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula&#xD;
             (CKD-EPI)&#xD;
&#xD;
          -  Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or&#xD;
             once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the&#xD;
             day of screening&#xD;
&#xD;
          -  For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a&#xD;
             period of 90 days before the day of screening&#xD;
&#xD;
          -  Treatment with any medication for the indication of diabetes or obesity in addition to&#xD;
             background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of&#xD;
             60 days before the day of screening with the exception of short-term insulin treatment&#xD;
             for acute illness for a total of at least 14 days&#xD;
&#xD;
          -  Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus&#xD;
             photography or dilated fundoscopy performed within 90 days prior to randomisation&#xD;
&#xD;
          -  History or presence of malignant neoplasms within the last 5 years (except basal and&#xD;
             squamous cell skin cancer and in situ carcinomas)&#xD;
&#xD;
          -  History of diabetic ketoacidosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Adachi-ku, Tokyo</city>
        <zip>123-0845</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Annaka-shi, Gunma</city>
        <zip>379-0116</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Arakawa-ku, Tokyo</city>
        <zip>116-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba-shi, Chiba</city>
        <zip>260-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chuo-ku, Tokyo</city>
        <zip>104-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fukushima</city>
        <zip>963-8851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>373-0036</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>311-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Iruma-shi, Saitama</city>
        <zip>358-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>232-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kashiwara-shi, Osaka</city>
        <zip>582-0005</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kawagoe-shi, Saitama</city>
        <zip>350-0851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kawaguchi-shi, Saitama</city>
        <zip>332-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>862-0976</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kurashiki-shi, Okayama</city>
        <zip>701-0192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kyoto-shi, Kyoto</city>
        <zip>601-1495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mitaka-shi, Tokyo</city>
        <zip>181-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mito-shi, Ibaraki</city>
        <zip>310-0826</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miyazaki</city>
        <zip>880-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>569-1045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ota-ku, Tokyo</city>
        <zip>144-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sapporo-shi, Hokkaido</city>
        <zip>004-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>062 0007</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sendai-shi, Miyagi</city>
        <zip>980-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimotsuke-shi, Tochigi</city>
        <zip>329-0433</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shinagawa-ku, Tokyo</city>
        <zip>141-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka-shi, Shizuoka</city>
        <zip>424-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Suita-shi, Osaka</city>
        <zip>565-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>125-0054</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>160-0008</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toshima-ku, Tokyo</city>
        <zip>171-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamato-shi, Kanagawa</city>
        <zip>242-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <results_reference>
    <citation>Ishii H, Hansen BB, Langer J, Horio H. Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial. Diabetes Ther. 2021 Feb;12(2):613-623. doi: 10.1007/s13300-020-00985-w. Epub 2021 Jan 18.</citation>
    <PMID>33460016</PMID>
  </results_reference>
  <results_reference>
    <citation>Yabe D, Nakamura J, Kaneto H, Deenadayalan S, Navarria A, Gislum M, Inagaki N; PIONEER 10 Investigators. Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2020 May;8(5):392-406. doi: 10.1016/S2213-8587(20)30074-7.</citation>
    <PMID>32333876</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>October 15, 2019</results_first_submitted>
  <results_first_submitted_qc>December 6, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 30, 2019</results_first_posted>
  <disposition_first_submitted>July 8, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 8, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 9, 2019</disposition_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dulaglutide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitent on novonordisk-trials.com</ipd_description>
    <ipd_url>http://novonordisk-trials.com/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03015220/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03015220/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 36 sites in Japan.</recruitment_details>
      <pre_assignment_details>Data presented in &quot;participant flow&quot; is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Oral Semaglutide 3 mg</title>
          <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="P2">
          <title>Oral Semaglutide 7 mg</title>
          <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="P3">
          <title>Oral Semaglutide 14 mg</title>
          <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="P4">
          <title>Dulaglutide 0.75 mg</title>
          <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="132"/>
                <participants group_id="P3" count="130"/>
                <participants group_id="P4" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="132"/>
                <participants group_id="P3" count="130"/>
                <participants group_id="P4" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SAS)</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="132"/>
                <participants group_id="P3" count="130"/>
                <participants group_id="P4" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="130"/>
                <participants group_id="P3" count="127"/>
                <participants group_id="P4" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The FAS comprised of all randomised participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Oral Semaglutide 3 mg</title>
          <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="B2">
          <title>Oral Semaglutide 7 mg</title>
          <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="B3">
          <title>Oral Semaglutide 14 mg</title>
          <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="B4">
          <title>Dulaglutide 0.75 mg</title>
          <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="131"/>
            <count group_id="B2" value="132"/>
            <count group_id="B3" value="130"/>
            <count group_id="B4" value="65"/>
            <count group_id="B5" value="458"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59" spread="10"/>
                    <measurement group_id="B2" value="58" spread="11"/>
                    <measurement group_id="B3" value="57" spread="10"/>
                    <measurement group_id="B4" value="61" spread="9"/>
                    <measurement group_id="B5" value="58" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="130"/>
                    <measurement group_id="B4" value="65"/>
                    <measurement group_id="B5" value="458"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="130"/>
                    <measurement group_id="B4" value="65"/>
                    <measurement group_id="B5" value="458"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Treatment-emergent Adverse Events (TEAEs)</title>
        <description>Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Weeks 0-57</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Adverse Events (TEAEs)</title>
          <description>Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="330"/>
                    <measurement group_id="O2" value="350"/>
                    <measurement group_id="O3" value="324"/>
                    <measurement group_id="O4" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c</title>
        <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c</title>
          <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="0.9"/>
                    <measurement group_id="O2" value="-1.7" spread="0.9"/>
                    <measurement group_id="O3" value="-2.0" spread="1.0"/>
                    <measurement group_id="O4" value="-1.6" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.0"/>
                    <measurement group_id="O2" value="-1.4" spread="1.0"/>
                    <measurement group_id="O3" value="-1.8" spread="1.0"/>
                    <measurement group_id="O4" value="-1.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose</title>
        <description>Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose</title>
          <description>Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.23" spread="1.54"/>
                    <measurement group_id="O2" value="-2.25" spread="1.93"/>
                    <measurement group_id="O3" value="-2.72" spread="1.86"/>
                    <measurement group_id="O4" value="-2.22" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.95" spread="1.72"/>
                    <measurement group_id="O2" value="-1.96" spread="1.72"/>
                    <measurement group_id="O3" value="-2.18" spread="2.50"/>
                    <measurement group_id="O4" value="-1.80" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile</title>
        <description>Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile</title>
          <description>Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="2.2"/>
                    <measurement group_id="O2" value="-2.7" spread="2.1"/>
                    <measurement group_id="O3" value="-3.5" spread="2.3"/>
                    <measurement group_id="O4" value="-2.9" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="2.1"/>
                    <measurement group_id="O2" value="-2.5" spread="2.4"/>
                    <measurement group_id="O3" value="-3.3" spread="2.6"/>
                    <measurement group_id="O4" value="-2.6" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals</title>
        <description>Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals</title>
          <description>Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="2.5"/>
                    <measurement group_id="O2" value="-1.3" spread="2.0"/>
                    <measurement group_id="O3" value="-1.2" spread="2.4"/>
                    <measurement group_id="O4" value="-0.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="2.6"/>
                    <measurement group_id="O2" value="-0.8" spread="2.0"/>
                    <measurement group_id="O3" value="-0.9" spread="2.6"/>
                    <measurement group_id="O4" value="-0.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight (kg)</title>
        <description>Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight (kg)</title>
          <description>Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="2.0"/>
                    <measurement group_id="O2" value="-1.0" spread="3.0"/>
                    <measurement group_id="O3" value="-2.2" spread="3.2"/>
                    <measurement group_id="O4" value="0.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="2.4"/>
                    <measurement group_id="O2" value="-0.9" spread="3.4"/>
                    <measurement group_id="O3" value="-1.7" spread="3.5"/>
                    <measurement group_id="O4" value="1.0" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight (%)</title>
        <description>Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight (%)</title>
          <description>Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.28" spread="2.79"/>
                    <measurement group_id="O2" value="-1.49" spread="4.25"/>
                    <measurement group_id="O3" value="-3.21" spread="4.32"/>
                    <measurement group_id="O4" value="0.25" spread="3.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="3.28"/>
                    <measurement group_id="O2" value="-1.34" spread="4.77"/>
                    <measurement group_id="O3" value="-2.33" spread="4.67"/>
                    <measurement group_id="O4" value="1.25" spread="4.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Mass Index (BMI)</title>
        <description>Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Mass Index (BMI)</title>
          <description>Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Kilogram per square meter (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.7"/>
                    <measurement group_id="O2" value="-0.4" spread="1.1"/>
                    <measurement group_id="O3" value="-0.8" spread="1.2"/>
                    <measurement group_id="O4" value="0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.9"/>
                    <measurement group_id="O2" value="-0.3" spread="1.3"/>
                    <measurement group_id="O3" value="-0.6" spread="1.3"/>
                    <measurement group_id="O4" value="0.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Waist Circumference</title>
        <description>Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Waist Circumference</title>
          <description>Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Centimeters (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="3.1"/>
                    <measurement group_id="O2" value="-0.6" spread="3.4"/>
                    <measurement group_id="O3" value="-1.2" spread="4.3"/>
                    <measurement group_id="O4" value="0.3" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="3.6"/>
                    <measurement group_id="O2" value="-0.8" spread="3.9"/>
                    <measurement group_id="O3" value="-1.7" spread="4.2"/>
                    <measurement group_id="O4" value="0.7" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Total Cholesterol (Ratio to Baseline)</title>
        <description>Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Total Cholesterol (Ratio to Baseline)</title>
          <description>Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Ratio of fasting total cholesterol</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="9.4"/>
                    <measurement group_id="O2" value="0.91" spread="12.3"/>
                    <measurement group_id="O3" value="0.91" spread="12.3"/>
                    <measurement group_id="O4" value="0.92" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="12.7"/>
                    <measurement group_id="O2" value="0.95" spread="13.3"/>
                    <measurement group_id="O3" value="0.94" spread="12.5"/>
                    <measurement group_id="O4" value="0.93" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)</title>
        <description>Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)</title>
          <description>Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Ratio of fasting LDL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="15.9"/>
                    <measurement group_id="O2" value="0.88" spread="18.4"/>
                    <measurement group_id="O3" value="0.87" spread="20.7"/>
                    <measurement group_id="O4" value="0.88" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="17.4"/>
                    <measurement group_id="O2" value="0.94" spread="19.0"/>
                    <measurement group_id="O3" value="0.92" spread="18.6"/>
                    <measurement group_id="O4" value="0.91" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)</title>
        <description>Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)</title>
          <description>Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Ratio of fasting HDL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="13.1"/>
                    <measurement group_id="O2" value="0.99" spread="12.8"/>
                    <measurement group_id="O3" value="1.00" spread="12.5"/>
                    <measurement group_id="O4" value="0.99" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="11.2"/>
                    <measurement group_id="O2" value="0.99" spread="14.5"/>
                    <measurement group_id="O3" value="1.01" spread="13.1"/>
                    <measurement group_id="O4" value="1.00" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)</title>
        <description>Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)</title>
          <description>Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Ratio of fasting VLDL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="37.9"/>
                    <measurement group_id="O2" value="0.92" spread="32.3"/>
                    <measurement group_id="O3" value="0.96" spread="33.6"/>
                    <measurement group_id="O4" value="0.93" spread="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="33.3"/>
                    <measurement group_id="O2" value="0.87" spread="39.4"/>
                    <measurement group_id="O3" value="0.86" spread="36.9"/>
                    <measurement group_id="O4" value="0.88" spread="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Triglyceride (Ratio to Baseline)</title>
        <description>Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Triglyceride (Ratio to Baseline)</title>
          <description>Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Ratio of fasting triglycerides</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="41.1"/>
                    <measurement group_id="O2" value="0.91" spread="34.1"/>
                    <measurement group_id="O3" value="0.96" spread="34.0"/>
                    <measurement group_id="O4" value="0.93" spread="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="33.9"/>
                    <measurement group_id="O2" value="0.87" spread="43.0"/>
                    <measurement group_id="O3" value="0.87" spread="38.3"/>
                    <measurement group_id="O4" value="0.88" spread="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)</title>
        <description>Participants who achieved HbA1c below 7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)</title>
          <description>Participants who achieved HbA1c below 7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="105"/>
                    <measurement group_id="O4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="77"/>
                    <measurement group_id="O3" value="90"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)</title>
        <description>Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)</title>
          <description>Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="67"/>
                    <measurement group_id="O3" value="88"/>
                    <measurement group_id="O4" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="40"/>
                    <measurement group_id="O4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="69"/>
                    <measurement group_id="O4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="58"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)</title>
        <description>Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value &lt;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.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)</title>
          <description>Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value &lt;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.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="84"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="71"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="76"/>
                    <measurement group_id="O3" value="56"/>
                    <measurement group_id="O4" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)</title>
        <description>Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)</title>
          <description>Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="62"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="94"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="97"/>
                    <measurement group_id="O3" value="85"/>
                    <measurement group_id="O4" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).</title>
        <description>Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).</title>
          <description>Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="105"/>
                    <measurement group_id="O3" value="89"/>
                    <measurement group_id="O4" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="108"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)</title>
        <description>Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)</title>
          <description>Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="122"/>
                    <measurement group_id="O3" value="120"/>
                    <measurement group_id="O4" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="120"/>
                    <measurement group_id="O3" value="120"/>
                    <measurement group_id="O4" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Additional Anti-diabetic Medication</title>
        <description>Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment, 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.</description>
        <time_frame>Weeks 0-52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Additional Anti-diabetic Medication</title>
          <description>Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment, 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.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 to week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 to week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata 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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.2963</p_value>
            <p_value_desc>Unadjusted two-sided p-value for the test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>3.20</ci_upper_limit>
            <estimate_desc>Oral Semaglutide 3 mg&#xD;
/Dulaglutide 0.75 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata 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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.5997</p_value>
            <p_value_desc>Unadjusted two-sided p-value for the test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>1.83</ci_upper_limit>
            <estimate_desc>Oral Semaglutide 7 mg&#xD;
/Dulaglutide 0.75 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata 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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.1871</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
            <estimate_desc>Oral Semaglutide 14 mg&#xD;
/Dulaglutide 0.75 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Rescue Medication</title>
        <description>Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.</description>
        <time_frame>Weeks 0-52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Rescue Medication</title>
          <description>Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 to week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 to week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.1672</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>4.72</ci_upper_limit>
            <estimate_desc>Oral Semaglutide 3 mg&#xD;
/Dulaglutide 0.75 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.3391</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.21</ci_lower_limit>
            <ci_upper_limit>1.72</ci_upper_limit>
            <estimate_desc>Oral Semaglutide 7 mg&#xD;
/Dulaglutide 0.75 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.0110</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
            <estimate_desc>Oral Semaglutide 14 mg&#xD;
/Dulaglutide 0.75 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Amylase (Ratio to Baseline)</title>
        <description>Change from baseline (week 0) in amylase (measured as units per liter [U/L]) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Amylase (Ratio to Baseline)</title>
          <description>Change from baseline (week 0) in amylase (measured as units per liter [U/L]) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>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.</population>
          <units>Ratio of amylase</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="123"/>
                    <count group_id="O3" value="121"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" spread="15.1"/>
                    <measurement group_id="O2" value="1.07" spread="18.1"/>
                    <measurement group_id="O3" value="1.10" spread="19.4"/>
                    <measurement group_id="O4" value="1.05" spread="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="122"/>
                    <count group_id="O3" value="113"/>
                    <count group_id="O4" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="18.5"/>
                    <measurement group_id="O2" value="1.10" spread="23.8"/>
                    <measurement group_id="O3" value="1.11" spread="20.0"/>
                    <measurement group_id="O4" value="1.07" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Lipase (Ratio to Baseline)</title>
        <description>Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipase (Ratio to Baseline)</title>
          <description>Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>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.</population>
          <units>Ratio of lipase</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="123"/>
                    <count group_id="O3" value="121"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread="37.4"/>
                    <measurement group_id="O2" value="1.27" spread="35.8"/>
                    <measurement group_id="O3" value="1.40" spread="42.8"/>
                    <measurement group_id="O4" value="1.14" spread="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="122"/>
                    <count group_id="O3" value="113"/>
                    <count group_id="O4" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="34.7"/>
                    <measurement group_id="O2" value="1.36" spread="50.3"/>
                    <measurement group_id="O3" value="1.40" spread="42.0"/>
                    <measurement group_id="O4" value="1.15" spread="57.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulse Rate</title>
        <description>Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulse Rate</title>
          <description>Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>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.</population>
          <units>Beats per minute (beats/min)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="124"/>
                    <count group_id="O3" value="121"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="9"/>
                    <measurement group_id="O2" value="4" spread="10"/>
                    <measurement group_id="O3" value="4" spread="9"/>
                    <measurement group_id="O4" value="4" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="123"/>
                    <count group_id="O3" value="114"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="10"/>
                    <measurement group_id="O2" value="3" spread="9"/>
                    <measurement group_id="O3" value="3" spread="9"/>
                    <measurement group_id="O4" value="2" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Blood Pressure</title>
        <description>Change from baseline (week 0) in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Blood Pressure</title>
          <description>Change from baseline (week 0) in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>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.</population>
          <units>Millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26: SBP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="124"/>
                    <count group_id="O3" value="121"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="13.0"/>
                    <measurement group_id="O2" value="-5.0" spread="13.0"/>
                    <measurement group_id="O3" value="-6.0" spread="15.0"/>
                    <measurement group_id="O4" value="-4.0" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: SBP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="123"/>
                    <count group_id="O3" value="114"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="14.0"/>
                    <measurement group_id="O2" value="-2.0" spread="13.0"/>
                    <measurement group_id="O3" value="-2.0" spread="13.0"/>
                    <measurement group_id="O4" value="-3.0" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26: DBP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="124"/>
                    <count group_id="O3" value="121"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="9.0"/>
                    <measurement group_id="O2" value="-1.0" spread="9.0"/>
                    <measurement group_id="O3" value="-2.0" spread="10.0"/>
                    <measurement group_id="O4" value="-1.0" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: DBP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="9.0"/>
                    <measurement group_id="O2" value="0.0" spread="9.0"/>
                    <measurement group_id="O3" value="-1.0" spread="10.0"/>
                    <measurement group_id="O4" value="0.0" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in ECG Evaluation</title>
        <description>Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ECG Evaluation</title>
          <description>Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>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.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal (week 0) to normal (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="110"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to abnormal NCS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to abnormal CS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS (week 0) to normal (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS (week 0) to abnormal NCS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS (week 0) to abnormal CS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS (week 0) to normal (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS (week 0) to abnormal NCS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS (week 0) to abnormal CS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to normal (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="108"/>
                    <measurement group_id="O3" value="95"/>
                    <measurement group_id="O4" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to abnormal NCS (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to abnormal CS (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal (week 0) NCS to normal (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal (week 0) NCS to abnormal NCS (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal (week 0) NCS to abnormal CS (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal (week 0) CS to normal (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal (week 0) CS to abnormal NCS (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal (week 0) CS to abnormal CS (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Physical Examination</title>
        <description>Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.</description>
        <time_frame>Week -2, week 26, week 52</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Physical Examination</title>
          <description>Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.</description>
          <population>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.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1) Cardiovascular system (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="132"/>
                    <measurement group_id="O3" value="128"/>
                    <measurement group_id="O4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1) Cardiovascular system (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="125"/>
                    <measurement group_id="O4" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1) Cardiovascular system (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                    <measurement group_id="O2" value="129"/>
                    <measurement group_id="O3" value="126"/>
                    <measurement group_id="O4" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Central and peripheral nervous system (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="131"/>
                    <measurement group_id="O3" value="130"/>
                    <measurement group_id="O4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Central and peripheral nervous system (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="128"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Central and peripheral nervous system (week 56)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="126"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Gastrointestinal system, incl. mouth (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="129"/>
                    <measurement group_id="O4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Gastrointestinal system, incl. mouth (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="123"/>
                    <measurement group_id="O3" value="125"/>
                    <measurement group_id="O4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Gastrointestinal system, incl. mouth (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="124"/>
                    <measurement group_id="O3" value="126"/>
                    <measurement group_id="O4" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4.General appearance (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="132"/>
                    <measurement group_id="O3" value="130"/>
                    <measurement group_id="O4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4.General appearance (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="127"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4.General appearance (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="127"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5.Head, ears, eyes, nose, throat, neck (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="124"/>
                    <measurement group_id="O4" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5.Head, ears, eyes, nose, throat, neck (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="122"/>
                    <measurement group_id="O3" value="125"/>
                    <measurement group_id="O4" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5.Head, ears, eyes, nose, throat, neck (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="123"/>
                    <measurement group_id="O3" value="122"/>
                    <measurement group_id="O4" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6. Lymph node palpation (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="131"/>
                    <measurement group_id="O3" value="129"/>
                    <measurement group_id="O4" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6. Lymph node palpation (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="128"/>
                    <measurement group_id="O4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6. Lymph node palpation (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="127"/>
                    <measurement group_id="O4" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7. Musculoskeletal system (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="126"/>
                    <measurement group_id="O3" value="127"/>
                    <measurement group_id="O4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7. Musculoskeletal system (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="123"/>
                    <measurement group_id="O3" value="124"/>
                    <measurement group_id="O4" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7. Musculoskeletal system (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="125"/>
                    <measurement group_id="O3" value="123"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Respiratory system (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="132"/>
                    <measurement group_id="O3" value="130"/>
                    <measurement group_id="O4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Respiratory system (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="128"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Respiratory system (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="127"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9) Skin (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="128"/>
                    <measurement group_id="O4" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9) Skin (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="126"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9) Skin (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="125"/>
                    <measurement group_id="O4" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10) Thyroid gland (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="130"/>
                    <measurement group_id="O3" value="129"/>
                    <measurement group_id="O4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10) Thyroid gland (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="128"/>
                    <measurement group_id="O4" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10) Thyroid gland (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="129"/>
                    <measurement group_id="O3" value="127"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Eye Examination Category</title>
        <description>Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week -2, week 52</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Eye Examination Category</title>
          <description>Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>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.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Left eye (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="97"/>
                    <measurement group_id="O3" value="90"/>
                    <measurement group_id="O4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left eye (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="92"/>
                    <measurement group_id="O3" value="93"/>
                    <measurement group_id="O4" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right eye (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="98"/>
                    <measurement group_id="O3" value="89"/>
                    <measurement group_id="O4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right eye (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="90"/>
                    <measurement group_id="O3" value="90"/>
                    <measurement group_id="O4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes</title>
        <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
        <time_frame>Weeks 0-57</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes</title>
          <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</title>
        <description>Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
        <time_frame>Weeks 0-57</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</title>
          <description>Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)</title>
        <description>SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)</title>
          <description>SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1) Physical functioning (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="3.34"/>
                    <measurement group_id="O2" value="0.08" spread="4.04"/>
                    <measurement group_id="O3" value="-0.06" spread="4.16"/>
                    <measurement group_id="O4" value="-0.24" spread="3.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1) Physical functioning (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.37" spread="3.34"/>
                    <measurement group_id="O2" value="0.70" spread="4.08"/>
                    <measurement group_id="O3" value="-0.02" spread="4.27"/>
                    <measurement group_id="O4" value="-0.61" spread="5.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Role Physical (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" spread="5.12"/>
                    <measurement group_id="O2" value="0.59" spread="5.49"/>
                    <measurement group_id="O3" value="-1.01" spread="6.00"/>
                    <measurement group_id="O4" value="-0.48" spread="5.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Role Physical (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.92" spread="5.66"/>
                    <measurement group_id="O2" value="0.05" spread="6.13"/>
                    <measurement group_id="O3" value="-0.92" spread="7.26"/>
                    <measurement group_id="O4" value="-0.28" spread="5.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Bodily Pain (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.88" spread="8.39"/>
                    <measurement group_id="O2" value="0.05" spread="8.26"/>
                    <measurement group_id="O3" value="-0.99" spread="9.32"/>
                    <measurement group_id="O4" value="-0.44" spread="7.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Bodily Pain (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.72" spread="9.74"/>
                    <measurement group_id="O2" value="-0.27" spread="8.88"/>
                    <measurement group_id="O3" value="0.01" spread="9.48"/>
                    <measurement group_id="O4" value="0.24" spread="5.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4)General Health (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="4.59"/>
                    <measurement group_id="O2" value="0.09" spread="5.26"/>
                    <measurement group_id="O3" value="0.71" spread="5.94"/>
                    <measurement group_id="O4" value="-1.03" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4)General Health (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.34" spread="5.27"/>
                    <measurement group_id="O2" value="0.01" spread="5.27"/>
                    <measurement group_id="O3" value="0.59" spread="6.13"/>
                    <measurement group_id="O4" value="-0.97" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) Vitality (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.62" spread="7.49"/>
                    <measurement group_id="O2" value="-0.79" spread="7.08"/>
                    <measurement group_id="O3" value="-0.83" spread="6.84"/>
                    <measurement group_id="O4" value="-1.40" spread="7.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) Vitality (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.90" spread="7.29"/>
                    <measurement group_id="O2" value="-0.11" spread="7.03"/>
                    <measurement group_id="O3" value="0.09" spread="6.83"/>
                    <measurement group_id="O4" value="-0.86" spread="7.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6) Social functioning (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.77" spread="5.87"/>
                    <measurement group_id="O2" value="-0.15" spread="5.95"/>
                    <measurement group_id="O3" value="-0.15" spread="6.08"/>
                    <measurement group_id="O4" value="0.15" spread="4.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6) Social functioning (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.98" spread="8.10"/>
                    <measurement group_id="O2" value="-0.42" spread="6.80"/>
                    <measurement group_id="O3" value="-0.12" spread="5.92"/>
                    <measurement group_id="O4" value="-0.08" spread="6.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7) Role emotional (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.54" spread="7.87"/>
                    <measurement group_id="O2" value="0.42" spread="6.96"/>
                    <measurement group_id="O3" value="-1.16" spread="6.60"/>
                    <measurement group_id="O4" value="-1.01" spread="6.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7) Role emotional (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.02" spread="7.70"/>
                    <measurement group_id="O2" value="0.59" spread="6.89"/>
                    <measurement group_id="O3" value="-1.05" spread="8.16"/>
                    <measurement group_id="O4" value="-1.21" spread="7.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Mental health (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.03" spread="6.54"/>
                    <measurement group_id="O2" value="0.16" spread="6.66"/>
                    <measurement group_id="O3" value="-0.41" spread="7.32"/>
                    <measurement group_id="O4" value="0.27" spread="7.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Mental health (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.64" spread="7.63"/>
                    <measurement group_id="O2" value="-0.35" spread="6.68"/>
                    <measurement group_id="O3" value="0.27" spread="7.58"/>
                    <measurement group_id="O4" value="-0.31" spread="10.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical component summary (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="4.19"/>
                    <measurement group_id="O2" value="0.14" spread="4.27"/>
                    <measurement group_id="O3" value="-0.23" spread="5.24"/>
                    <measurement group_id="O4" value="-0.57" spread="4.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical component summary (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.88" spread="4.73"/>
                    <measurement group_id="O2" value="0.19" spread="4.91"/>
                    <measurement group_id="O3" value="-0.03" spread="5.34"/>
                    <measurement group_id="O4" value="-0.24" spread="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental component summary (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.13" spread="6.54"/>
                    <measurement group_id="O2" value="-0.07" spread="5.85"/>
                    <measurement group_id="O3" value="-0.71" spread="5.91"/>
                    <measurement group_id="O4" value="-0.42" spread="6.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental component summary (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.52" spread="7.26"/>
                    <measurement group_id="O2" value="-0.19" spread="6.31"/>
                    <measurement group_id="O3" value="-0.23" spread="6.15"/>
                    <measurement group_id="O4" value="-0.74" spread="8.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains</title>
        <description>DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: &quot;Burden on social activities and daily activities&quot;, &quot;Anxiety and dissatisfaction with treatment&quot;, &quot;Hypoglycemia&quot; and &quot;Satisfaction with treatment&quot; on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.</description>
        <time_frame>week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 0.75 mg</title>
            <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains</title>
          <description>DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: &quot;Burden on social activities and daily activities&quot;, &quot;Anxiety and dissatisfaction with treatment&quot;, &quot;Hypoglycemia&quot; and &quot;Satisfaction with treatment&quot; on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="130"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1.Burden on social and daily activities (W26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.44" spread="17.59"/>
                    <measurement group_id="O2" value="6.93" spread="18.09"/>
                    <measurement group_id="O3" value="4.88" spread="16.46"/>
                    <measurement group_id="O4" value="5.29" spread="19.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.Burden on social and daily activities (W52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.73" spread="18.69"/>
                    <measurement group_id="O2" value="6.81" spread="18.85"/>
                    <measurement group_id="O3" value="5.44" spread="16.57"/>
                    <measurement group_id="O4" value="3.99" spread="19.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.Anxiety and dissatisfaction with treatment(W26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.54" spread="18.08"/>
                    <measurement group_id="O2" value="10.94" spread="17.83"/>
                    <measurement group_id="O3" value="12.24" spread="17.41"/>
                    <measurement group_id="O4" value="9.24" spread="20.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.Anxiety and dissatisfaction with treatment(W52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="18.60"/>
                    <measurement group_id="O2" value="9.93" spread="19.61"/>
                    <measurement group_id="O3" value="11.37" spread="18.68"/>
                    <measurement group_id="O4" value="3.14" spread="19.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.Hypoglycemia (W26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.18" spread="20.62"/>
                    <measurement group_id="O2" value="1.95" spread="18.14"/>
                    <measurement group_id="O3" value="2.67" spread="21.14"/>
                    <measurement group_id="O4" value="3.26" spread="19.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.Hypoglycemia (W52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.20" spread="19.61"/>
                    <measurement group_id="O2" value="1.94" spread="19.36"/>
                    <measurement group_id="O3" value="3.87" spread="20.70"/>
                    <measurement group_id="O4" value="-0.66" spread="23.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4.Satisfaction with treatment(W26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.67" spread="19.08"/>
                    <measurement group_id="O2" value="10.81" spread="24.53"/>
                    <measurement group_id="O3" value="14.29" spread="28.11"/>
                    <measurement group_id="O4" value="13.15" spread="24.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4.Satisfaction with treatment(W52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" spread="19.66"/>
                    <measurement group_id="O2" value="7.88" spread="23.92"/>
                    <measurement group_id="O3" value="15.49" spread="27.01"/>
                    <measurement group_id="O4" value="6.35" spread="26.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score(W26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.74" spread="13.01"/>
                    <measurement group_id="O2" value="7.88" spread="14.40"/>
                    <measurement group_id="O3" value="7.90" spread="12.72"/>
                    <measurement group_id="O4" value="7.18" spread="15.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score(W52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.31" spread="13.47"/>
                    <measurement group_id="O2" value="7.15" spread="15.69"/>
                    <measurement group_id="O3" value="8.25" spread="12.81"/>
                    <measurement group_id="O4" value="3.44" spread="14.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.</time_frame>
      <desc>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.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oral Semaglutide 3 mg</title>
          <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="E2">
          <title>Oral Semaglutide 7 mg</title>
          <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="E3">
          <title>Oral Semaglutide 14 mg</title>
          <description>Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
        <group group_id="E4">
          <title>Dulaglutide 0.75 mg</title>
          <description>Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="131"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="130"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden hearing loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colorectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac ablation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Spinal operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="131"/>
                <counts group_id="E2" subjects_affected="79" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="84" subjects_at_risk="130"/>
                <counts group_id="E4" subjects_affected="36" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="131"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="132"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="130"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="131"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="132"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="130"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="131"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="132"/>
                <counts group_id="E3" events="20" subjects_affected="20" subjects_at_risk="130"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="131"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="132"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="130"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="131"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="132"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="130"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="131"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="132"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="130"/>
                <counts group_id="E4" events="9" subjects_affected="6" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="130"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="131"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="132"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="130"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="49" subjects_affected="34" subjects_at_risk="131"/>
                <counts group_id="E2" events="63" subjects_affected="39" subjects_at_risk="132"/>
                <counts group_id="E3" events="49" subjects_affected="39" subjects_at_risk="130"/>
                <counts group_id="E4" events="27" subjects_affected="19" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="132"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="130"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="131"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="132"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="130"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="131"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="132"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="130"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Reporting Anchor and Disclosure (1452)</name_or_title>
      <organization>Novo Nordisk A/S</organization>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015220
org study id: NN9924-4282
secondary id: U1111-1181-4133
secondary id: JapicCTI-173485
nct id: NCT03015220
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy
      of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic
      drug) in Japanese subjects with type 2 diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Treatment-emergent Adverse Events (TEAEs)
time frame: Weeks 0-57
description: Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in HbA1c
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Fasting Plasma Glucose
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Body Weight (kg)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Body Weight (%)
time frame: Week 0, week 26, week 52
description: Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Body Mass Index (BMI)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Waist Circumference
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Fasting Total Cholesterol (Ratio to Baseline)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Fasting Triglyceride (Ratio to Baseline)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)
time frame: Week 26, week 52
description: Participants who achieved HbA1c below 7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)
time frame: Week 26, week 52
description: Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
time frame: Week 26, week 52
description: Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)
time frame: Week 26, week 52
description: Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).
time frame: Week 26, week 52
description: Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)
time frame: Week 26, week 52
description: Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Time to Additional Anti-diabetic Medication
time frame: Weeks 0-52
description: Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment, 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.
measure: Time to Rescue Medication
time frame: Weeks 0-52
description: Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
measure: Change in Amylase (Ratio to Baseline)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in amylase (measured as units per liter [U/L]) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in Lipase (Ratio to Baseline)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in Pulse Rate
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in Blood Pressure
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in ECG Evaluation
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Physical Examination
time frame: Week -2, week 26, week 52
description: Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.
measure: Change in Eye Examination Category
time frame: Week -2, week 52
description: Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
time frame: Weeks 0-57
description: Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
measure: Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
time frame: Weeks 0-57
description: Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
measure: Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
time frame: Week 0, week 26, week 52
description: SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
measure: Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains
time frame: week 0, week 26, week 52
description: DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.
arm group label: Oral semaglutide 3 mg
arm group type: Experimental
arm group label: Oral semaglutide 7 mg
arm group type: Experimental
arm group label: Oral semaglutide 14 mg
arm group type: Experimental
arm group label: Dulaglutide 0.75 mg
arm group type: Active Comparator
intervention type: Drug
intervention name: Semaglutide
description: Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).
arm group label: Oral semaglutide 14 mg
arm group label: Oral semaglutide 3 mg
arm group label: Oral semaglutide 7 mg
intervention type: Drug
intervention name: Dulaglutide
description: Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).
arm group label: Dulaglutide 0.75 mg
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
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country: Japan
citation: Ishii H, Hansen BB, Langer J, Horio H. Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial. Diabetes Ther. 2021 Feb;12(2):613-623. doi: 10.1007/s13300-020-00985-w. Epub 2021 Jan 18.
PMID: 33460016
citation: Yabe D, Nakamura J, Kaneto H, Deenadayalan S, Navarria A, Gislum M, Inagaki N; PIONEER 10 Investigators. Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2020 May;8(5):392-406. doi: 10.1016/S2213-8587(20)30074-7.
PMID: 32333876
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dulaglutide
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitent on novonordisk-trials.com
ipd url: http://novonordisk-trials.com/
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