<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <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/NCT02254291</url>
  </required_header>
  <id_info>
    <org_study_id>NN9535-4092</org_study_id>
    <secondary_id>U1111-1140-5334</secondary_id>
    <secondary_id>JapicCTI-142663</secondary_id>
    <nct_id>NCT02254291</nct_id>
  </id_info>
  <brief_title>A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes</brief_title>
  <acronym>SUSTAIN™</acronym>
  <official_title>Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing&#xD;
      of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy&#xD;
      during 30 weeks of treatment in Japanese subjects with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2014</start_date>
  <completion_date type="Actual">November 11, 2015</completion_date>
  <primary_completion_date type="Actual">November 11, 2015</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 0-30</time_frame>
    <description>An adverse events (AEs) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes</measure>
    <time_frame>Weeks 0-30</time_frame>
    <description>Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of &lt;56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glycosylated Haemoglobin A1c (HbA1c)</measure>
    <time_frame>Week 0 and week 30</time_frame>
    <description>Mean changes in HbA1c values from baseline after 30 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the &quot;on-treatment without rescue medication&quot; observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">308</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Semaglutide 0.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide 1.0 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitagliptin 100 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>Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).</description>
    <arm_group_label>Semaglutide 0.5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).</description>
    <arm_group_label>Semaglutide 1.0 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sitagliptin</intervention_name>
    <description>Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.</description>
    <arm_group_label>Sitagliptin 100 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 20 years or older at the time of signing informed consent&#xD;
&#xD;
          -  Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive)&#xD;
             for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0%&#xD;
             and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and&#xD;
             exercise therapy at screening&#xD;
&#xD;
          -  Japanese subjects diagnosed with type 2 diabetes who are: a) on stable OAD monotherapy&#xD;
             at a half-maximum dose or below according to the approved Japanese labelling in&#xD;
             addition to diet and exercise therapy for at least 30 days prior to screening (week&#xD;
             -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for&#xD;
             METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be&#xD;
             applied.). 'Stable' is defined as unchanged medication and unchanged dose, or b) on&#xD;
             stable diet and exercise therapy for at least 30 days prior to screening (week -2)&#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 (e.g.&#xD;
             abstinence, diaphragm, condom [by the partner], intrauterine device, sponge,&#xD;
             spermicide or oral contraceptives) throughout the trial including the 5-week follow-up&#xD;
             period&#xD;
&#xD;
          -  Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90&#xD;
             days prior to screening&#xD;
&#xD;
          -  Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject&#xD;
             treated with OAD monotherapy) in a period of 60 days prior to screening. An exception&#xD;
             is short-term treatment (7 days or less in total) with insulin in connection with&#xD;
             inter-current illness&#xD;
&#xD;
          -  Any disorder which, in the opinion of the investigator, might jeopardise subject's&#xD;
             safety or compliance with the protocol&#xD;
&#xD;
          -  History of chronic or idiopathic acute pancreatitis&#xD;
&#xD;
          -  Screening calcitonin value of 50 ng/L (pg/mL) or greater&#xD;
&#xD;
          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine&#xD;
             neoplasia syndrome type 2 (MEN2)&#xD;
&#xD;
          -  Impaired renal function defined as estimated glomerular filtration rate (eGFR) less&#xD;
             than 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4&#xD;
             variable version)&#xD;
&#xD;
          -  Acute coronary or cerebrovascular event within 90 days before randomisation&#xD;
&#xD;
          -  Heart failure, New York Heart Association (NYHA) class IV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry GCR, 1452</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Asahikawa-shi, Hokkaido</city>
        <zip>070 0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chitose, Hokkaido</city>
        <zip>066-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chuo-ku Tokyo</city>
        <zip>103-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chuo-ku Tokyo</city>
        <zip>104-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chuo-ku, Tokyo</city>
        <zip>103 0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ebina-shi</city>
        <zip>243 0432</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Izumisano-shi</city>
        <zip>598 0048</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>Katsushika-ku, Tokyo</city>
        <zip>125 0054</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kumamoto-shi,Kumamoto</city>
        <zip>862 0976</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Naka-shi, Ibaraki</city>
        <zip>311 0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nishinomiya-shi, Hygo</city>
        <zip>662 0971</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oita-shi</city>
        <zip>870 0039</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osaka-shi, Osaka</city>
        <zip>553 0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ota-ku, Tokyo</city>
        <zip>144 0035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ota-ku, Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sapporo-shi, Hokkaido</city>
        <zip>060 0062</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sapporo-shi, Hokkaido</city>
        <zip>060-0001</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>Shinjuku-ku, Tokyo</city>
        <zip>160-0008</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>Takatsuki-shi, Osaka</city>
        <zip>569 1096</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>181-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yokohama, Kanagawa</city>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yokohama-shi</city>
        <zip>235 0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Seino Y, Terauchi Y, Osonoi T, Yabe D, Abe N, Nishida T, Zacho J, Kaneko S. Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes. Diabetes Obes Metab. 2018 Feb;20(2):378-388. doi: 10.1111/dom.13082. Epub 2017 Oct 5.</citation>
    <PMID>28786547</PMID>
  </results_reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>December 21, 2017</results_first_submitted>
  <results_first_submitted_qc>December 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2018</results_first_posted>
  <disposition_first_submitted>December 6, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>December 6, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 8, 2016</disposition_first_posted>
  <last_update_submitted>December 21, 2017</last_update_submitted>
  <last_update_submitted_qc>December 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2018</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>Sitagliptin Phosphate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 25 sites in Japan. These sites randomised/assigned subjects to treatment.</recruitment_details>
      <pre_assignment_details>Subjects were either on stable diet and exercise therapy only or on stable oral anti-diabetic drug (OAD) monotherapy (a maximum dose of 750 mg metformin or 2250 mg METGLUCO according to approved Japanese labelling) in addition to stable diet and exercise therapy for at least 30 days prior to screening (week -8 or week -2).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Semaglutide 0.5 mg</title>
          <description>Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
        <group group_id="P2">
          <title>Semaglutide 1.0 mg</title>
          <description>Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
        <group group_id="P3">
          <title>Sitagliptin</title>
          <description>The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="102"/>
                <participants group_id="P3" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Exposed</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="102"/>
                <participants group_id="P3" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="99"/>
                <participants group_id="P3" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" 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="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing follow-up information</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The full analysis set (FAS) included all randomised subjects who have received at least one dose of trial product.</population>
      <group_list>
        <group group_id="B1">
          <title>Semaglutide 0.5 mg</title>
          <description>Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
        <group group_id="B2">
          <title>Semaglutide 1.0 mg</title>
          <description>Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
        <group group_id="B3">
          <title>Sitagliptin</title>
          <description>The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
        <group group_id="B4">
          <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="103"/>
            <count group_id="B2" value="102"/>
            <count group_id="B3" value="103"/>
            <count group_id="B4" value="308"/>
          </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="58.8" spread="10.4"/>
                    <measurement group_id="B2" value="58.1" spread="11.6"/>
                    <measurement group_id="B3" value="57.9" spread="10.1"/>
                    <measurement group_id="B4" value="58.3" spread="10.7"/>
                  </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="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycosylated haemoglobin (HbA1c)</title>
          <units>percentage of glycosylated haemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.23" spread="1.02"/>
                    <measurement group_id="B2" value="8.01" spread="0.85"/>
                    <measurement group_id="B3" value="8.20" spread="0.89"/>
                    <measurement group_id="B4" value="8.15" spread="0.93"/>
                  </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>An adverse events (AEs) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).</description>
        <time_frame>Weeks 0-30</time_frame>
        <population>The safety analysis set (SAS) included all subjects receiving at least one dose of trial product and subjects contributed to the evaluation &quot;as treated&quot;.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
          <group group_id="O3">
            <title>Sitagliptin</title>
            <description>The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Adverse Events (TEAEs)</title>
          <description>An adverse events (AEs) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).</description>
          <population>The safety analysis set (SAS) included all subjects receiving at least one dose of trial product and subjects contributed to the evaluation &quot;as treated&quot;.</population>
          <units>Number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228"/>
                    <measurement group_id="O2" value="197"/>
                    <measurement group_id="O3" value="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes</title>
        <description>Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of &lt;56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).</description>
        <time_frame>Weeks 0-30</time_frame>
        <population>The safety analysis set (SAS) included all subjects receiving at least one dose of trial product and subjects contributed to the evaluation &quot;as treated&quot;.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
          <group group_id="O3">
            <title>Sitagliptin</title>
            <description>The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes</title>
          <description>Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of &lt;56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).</description>
          <population>The safety analysis set (SAS) included all subjects receiving at least one dose of trial product and subjects contributed to the evaluation &quot;as treated&quot;.</population>
          <units>Number of episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Glycosylated Haemoglobin A1c (HbA1c)</title>
        <description>Mean changes in HbA1c values from baseline after 30 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the &quot;on-treatment without rescue medication&quot; observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.</description>
        <time_frame>Week 0 and week 30</time_frame>
        <population>The full analysis set (FAS) included all randomised subjects who have received at least one dose of trial product. All subjects contributed to the statistical model of the data analysis, but not all subjects had a value at week 30.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
          <group group_id="O3">
            <title>Sitagliptin</title>
            <description>The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glycosylated Haemoglobin A1c (HbA1c)</title>
          <description>Mean changes in HbA1c values from baseline after 30 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the &quot;on-treatment without rescue medication&quot; observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.</description>
          <population>The full analysis set (FAS) included all randomised subjects who have received at least one dose of trial product. All subjects contributed to the statistical model of the data analysis, but not all subjects had a value at week 30.</population>
          <units>Percentage of glycosylated haemoglobin</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.87" spread="0.07"/>
                    <measurement group_id="O2" value="-2.18" spread="0.07"/>
                    <measurement group_id="O3" value="-0.74" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All AEs presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).</time_frame>
      <desc>The safety analysis set (SAS) included all subjects receiving at least one dose of the trial product and subjects contributed to the evaluation &quot;as treated&quot;.</desc>
      <group_list>
        <group group_id="E1">
          <title>Semaglutide 0.5 mg</title>
          <description>Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
        <group group_id="E2">
          <title>Semaglutide 1.0 mg</title>
          <description>Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
        <group group_id="E3">
          <title>Sitagliptin</title>
          <description>The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma stage IV</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Postrenal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Coronary arterial stent insertion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18</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="53" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="102"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="103"/>
              </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="4" subjects_at_risk="103"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="103"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="102"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="103"/>
                <counts group_id="E2" events="14" subjects_affected="9" subjects_at_risk="102"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="103"/>
                <counts group_id="E2" events="22" subjects_affected="13" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="103"/>
                <counts group_id="E2" events="22" subjects_affected="18" subjects_at_risk="102"/>
                <counts group_id="E3" events="42" subjects_affected="30" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="103"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="103"/>
              </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="10" subjects_affected="9" subjects_at_risk="103"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </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>&quot;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 less than 60 days to protect intellectual property&quot;.</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>
      <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/NCT02254291
org study id: NN9535-4092
secondary id: U1111-1140-5334
secondary id: JapicCTI-142663
nct id: NCT02254291
lead sponsor: 
has dmc: No
This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing
      of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy
      during 30 weeks of treatment 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 0-30
description: An adverse events (AEs) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
measure: Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
time frame: Weeks 0-30
description: Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
measure: Change in Glycosylated Haemoglobin A1c (HbA1c)
time frame: Week 0 and week 30
description: Mean changes in HbA1c values from baseline after 30 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the "on-treatment without rescue medication" observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.
arm group label: Semaglutide 0.5 mg
arm group type: Experimental
arm group label: Semaglutide 1.0 mg
arm group type: Experimental
arm group label: Sitagliptin 100 mg
arm group type: Active Comparator
intervention type: Drug
intervention name: semaglutide
description: Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).
arm group label: Semaglutide 0.5 mg
intervention type: Drug
intervention name: semaglutide
description: Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).
arm group label: Semaglutide 1.0 mg
intervention type: Drug
intervention name: sitagliptin
description: Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.
arm group label: Sitagliptin 100 mg
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry GCR, 1452
role: Study Director
affiliation: Novo Nordisk A/S
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country: Japan
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Seino Y, Terauchi Y, Osonoi T, Yabe D, Abe N, Nishida T, Zacho J, Kaneko S. Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes. Diabetes Obes Metab. 2018 Feb;20(2):378-388. doi: 10.1111/dom.13082. Epub 2017 Oct 5.
PMID: 28786547
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Sitagliptin Phosphate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 