<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/NCT02207374</url>
  </required_header>
  <id_info>
    <org_study_id>NN9535-4091</org_study_id>
    <secondary_id>U1111-1140-3081</secondary_id>
    <secondary_id>JapicCTI-142640</secondary_id>
    <nct_id>NCT02207374</nct_id>
  </id_info>
  <brief_title>A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes</brief_title>
  <acronym>SUSTAIN™</acronym>
  <official_title>Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy</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 Asia. The aim of the trial is to investigate safety and efficacy&#xD;
      of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic&#xD;
      drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on&#xD;
      diet/exercise therapy or OAD monotherapy.&#xD;
&#xD;
      All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD&#xD;
      monotherapy in addition to diet and exercise therapy) during the trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2014</start_date>
  <completion_date type="Actual">February 27, 2016</completion_date>
  <primary_completion_date type="Actual">February 27, 2016</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 0-56</time_frame>
    <description>An adverse event (AEs) was defined as any unfavorable 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 0-56 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 0-56</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 0-56 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, week 56</time_frame>
    <description>The observed mean change in HbA1c values from baseline after 56 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">601</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>One additional OAD + pre-trial treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.</description>
    <arm_group_label>Semaglutide 0.5 mg</arm_group_label>
    <arm_group_label>Semaglutide 1.0 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DPP-4 inhibitor</intervention_name>
    <description>Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.</description>
    <arm_group_label>One additional OAD + pre-trial treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age at least 20 years at the time of signing informed consent&#xD;
&#xD;
          -  HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both&#xD;
             inclusive)&#xD;
&#xD;
          -  Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable&#xD;
             treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and&#xD;
             exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD&#xD;
             monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or&#xD;
             TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and&#xD;
             exercise therapy for at least 60 days before Visit 1 (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 [not having sex], diaphragm, condom [by the partner], intrauterine device,&#xD;
             sponge, spermicide or oral contraceptives) throughout the trial including the 5 week&#xD;
             follow-up period&#xD;
&#xD;
          -  Treatment with glucose lowering agent(s) other than stated in the inclusion criteria&#xD;
             within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like&#xD;
             peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An&#xD;
             exception is short-term treatment (below or equal to 7 days in total) with insulin in&#xD;
             connection with 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 above or equal to 50 ng/L (pg/mL)&#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) below&#xD;
             30 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 (Visit 2&#xD;
             [week 0])&#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>Akita-shi, Akita</city>
        <zip>010 8543</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>Asahikawa-shi, Hokkaido</city>
        <zip>070 0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Asahikawa-shi, Hokkaido</city>
        <zip>078 8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bunkyo-ku, Tokyo</city>
        <zip>113 8431</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 0002</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>104-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>812 0025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Higashiosaka-shi, Osaka</city>
        <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>Kitakyushu-shi, Fukuoka</city>
        <zip>800 0252</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Koriyama-shi, Fukushima</city>
        <zip>963 8851</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>Kyoto-shi, Kyoto</city>
        <zip>615 8125</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mito-shi, Ibaraki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miyazaki-shi</city>
        <zip>880 0034</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>Nishinomiya-shi, Hyogo</city>
        <zip>663-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Okawa-shi, Fukuoka</city>
        <zip>831 0016</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Okayama-shi, Okayama</city>
        <zip>700 8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osaka-shi, Osaka</city>
        <zip>532 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>Oyama-shi, Tochigi</city>
        <zip>323 0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saga-shi,Saga</city>
        <zip>849 0937</zip>
        <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>062 0007</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sendai-shi</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>Shinjuku-ku, Tokyo</city>
        <zip>160-0008</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka-shi</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>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>103-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>123-0845</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ube-shi, Yamaguchi</city>
        <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>Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Diabetes Obes Metab. 2018 May;20(5):1202-1212. doi: 10.1111/dom.13218. Epub 2018 Feb 21.</citation>
    <PMID>29322610</PMID>
  </results_reference>
  <results_reference>
    <citation>Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.</citation>
    <PMID>29748996</PMID>
  </results_reference>
  <results_reference>
    <citation>Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.</citation>
    <PMID>29907893</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>December 21, 2017</results_first_submitted>
  <results_first_submitted_qc>June 21, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 7, 2019</results_first_posted>
  <disposition_first_submitted>December 6, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>March 30, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 31, 2017</disposition_first_posted>
  <last_update_submitted>June 21, 2018</last_update_submitted>
  <last_update_submitted_qc>June 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</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>Dipeptidyl-Peptidase IV Inhibitors</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 41 sites in Japan.</recruitment_details>
      <pre_assignment_details>Subjects were either on diet and exercise therapy only or on stable treatment on oral anti-diabetic drugs (OADs) mono-therapy [either of sulphonyl urea (SU), glinide, alpha-glucosidase inhibitor (α-GI) or thiazolidinediones (TZD)] within approved Japanese labelling in addition to diet and exercise therapy before 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.</description>
        </group>
        <group group_id="P3">
          <title>Additional OAD</title>
          <description>Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during 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="239"/>
                <participants group_id="P2" count="241"/>
                <participants group_id="P3" count="121"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Exposed</title>
              <participants_list>
                <participants group_id="P1" count="239"/>
                <participants group_id="P2" count="241"/>
                <participants group_id="P3" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="231"/>
                <participants group_id="P3" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <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="1"/>
                <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 had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD.</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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.</description>
        </group>
        <group group_id="B3">
          <title>Additional OAD</title>
          <description>Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during 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="239"/>
            <count group_id="B2" value="241"/>
            <count group_id="B3" value="120"/>
            <count group_id="B4" value="600"/>
          </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="58.0" spread="10.6"/>
                    <measurement group_id="B2" value="58.7" spread="10.2"/>
                    <measurement group_id="B3" value="59.2" spread="10.1"/>
                    <measurement group_id="B4" value="58.5" spread="10.3"/>
                  </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="73"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="171"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                    <measurement group_id="B2" value="174"/>
                    <measurement group_id="B3" value="89"/>
                    <measurement group_id="B4" value="429"/>
                  </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="8.04" spread="0.89"/>
                    <measurement group_id="B2" value="8.14" spread="0.96"/>
                    <measurement group_id="B3" value="8.10" spread="0.89"/>
                    <measurement group_id="B4" value="8.09" spread="0.92"/>
                  </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 event (AEs) was defined as any unfavorable 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 0-56 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 0-56</time_frame>
        <population>The safety analysis set (SAS) included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.</description>
          </group>
          <group group_id="O3">
            <title>Additional OAD</title>
            <description>Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AEs) was defined as any unfavorable 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 0-56 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 randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS 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="239"/>
                <count group_id="O2" value="241"/>
                <count group_id="O3" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="909"/>
                    <measurement group_id="O2" value="954"/>
                    <measurement group_id="O3" value="269"/>
                  </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 0-56 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 0-56</time_frame>
        <population>The safety analysis set (SAS) included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.</description>
          </group>
          <group group_id="O3">
            <title>Additional OAD</title>
            <description>Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during 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 0-56 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 randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS 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="239"/>
                <count group_id="O2" value="241"/>
                <count group_id="O3" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Glycosylated Haemoglobin A1c (HbA1c)</title>
        <description>The observed mean change in HbA1c values from baseline after 56 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, week 56</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 56.</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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.</description>
          </group>
          <group group_id="O3">
            <title>Additional OAD</title>
            <description>Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glycosylated Haemoglobin A1c (HbA1c)</title>
          <description>The observed mean change in HbA1c values from baseline after 56 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 56.</population>
          <units>Percentage (%) of HbA1c</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="220"/>
                <count group_id="O2" value="204"/>
                <count group_id="O3" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.74" spread="0.05"/>
                    <measurement group_id="O2" value="-2.03" spread="0.05"/>
                    <measurement group_id="O3" value="-0.67" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>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 0-56 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 included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise 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 period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 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. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.</description>
        </group>
        <group group_id="E3">
          <title>Additional OAD</title>
          <description>Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during 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="19" subjects_at_risk="239"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="241"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drowning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Beta haemolytic streptococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Limb traumatic amputation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of prostate</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Diffuse large B-cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Oesophageal carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Haemorrhoid operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Joint arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Percutaneous coronary intervention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Peripheral artery angioplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Peripheral revascularisation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Varicose vein operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </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="160" subjects_at_risk="239"/>
                <counts group_id="E2" subjects_affected="169" subjects_at_risk="241"/>
                <counts group_id="E3" subjects_affected="61" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="239"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="241"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="239"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="49" subjects_affected="44" subjects_at_risk="239"/>
                <counts group_id="E2" events="40" subjects_affected="36" subjects_at_risk="241"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="33" subjects_affected="24" subjects_at_risk="239"/>
                <counts group_id="E2" events="49" subjects_affected="38" subjects_at_risk="241"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="38" subjects_affected="29" subjects_at_risk="239"/>
                <counts group_id="E2" events="70" subjects_affected="46" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="239"/>
                <counts group_id="E2" events="21" subjects_affected="14" subjects_at_risk="241"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="239"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="241"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="132" subjects_affected="81" subjects_at_risk="239"/>
                <counts group_id="E2" events="105" subjects_affected="75" subjects_at_risk="241"/>
                <counts group_id="E3" events="60" subjects_affected="41" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="239"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="241"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="239"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="241"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="25" subjects_affected="21" subjects_at_risk="239"/>
                <counts group_id="E2" events="36" subjects_affected="33" subjects_at_risk="241"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="120"/>
              </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="22" subjects_affected="18" subjects_at_risk="239"/>
                <counts group_id="E2" events="36" subjects_affected="32" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </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="10" subjects_affected="9" subjects_at_risk="239"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="241"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="120"/>
              </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/NCT02207374
org study id: NN9535-4091
secondary id: U1111-1140-3081
secondary id: JapicCTI-142640
nct id: NCT02207374
lead sponsor: 
has dmc: No
This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy
      of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic
      drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on
      diet/exercise therapy or OAD monotherapy.

      All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD
      monotherapy in addition to diet and exercise therapy) during the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Treatment Emergent Adverse Events (TEAEs)
time frame: Weeks 0-56
description: An adverse event (AEs) was defined as any unfavorable 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 0-56 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 0-56
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 0-56 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, week 56
description: The observed mean change in HbA1c values from baseline after 56 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: One additional OAD + pre-trial treatment
arm group type: Active Comparator
description: The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen.
intervention type: Drug
intervention name: semaglutide
description: Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.
arm group label: Semaglutide 0.5 mg
arm group label: Semaglutide 1.0 mg
intervention type: Drug
intervention name: DPP-4 inhibitor
description: Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.
arm group label: One additional OAD + pre-trial treatment
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: Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Diabetes Obes Metab. 2018 May;20(5):1202-1212. doi: 10.1111/dom.13218. Epub 2018 Feb 21.
PMID: 29322610
citation: Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.
PMID: 29748996
citation: Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
PMID: 29907893
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dipeptidyl-Peptidase IV Inhibitors
participant flow: 
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reported events: 
certain agreements: 
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