<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/NCT02243202</url>
  </required_header>
  <id_info>
    <org_study_id>CR103086</org_study_id>
    <secondary_id>28431754OBE2002</secondary_id>
    <nct_id>NCT02243202</nct_id>
  </id_info>
  <brief_title>Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of canagliflozin and phentermine to those&#xD;
      of placebo to promote on a change in body weight over a 26 week period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (the study medication is assigned by chance), double-blind (neither&#xD;
      physician nor participant knows the identity of the assigned treatment), placebo-controlled&#xD;
      (an inactive substance that is compared with a medication to test whether the medication has&#xD;
      a real effect), parallel-group, multicenter study of the effects of canagliflozin and&#xD;
      phentermine co-administration in non-diabetic overweight or obese participants. The study&#xD;
      will be conducted for about 33 weeks, approximately 344 participants will be randomly&#xD;
      assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of&#xD;
      canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All&#xD;
      participants will be also provided with diet and exercise counseling for weight loss&#xD;
      (standardized non-pharmacological therapy).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Body Weight at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>The percent change from baseline in body weight at Week 26 was analysed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Weight Loss More Than Equal to (&gt;=) 5 Percent at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Percentage of participants with weight loss &gt;= 5 percent were analysed at week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline in systolic blood pressure was analysed at week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Body Weight at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Absolute change from baseline in body weight was analysed at week 26.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline in diastolic blood pressure (DBP) at week 26.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline in Pulse Rate at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline in pulse rate at week 26</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Weight Loss More Than Equal to (&gt;=) 10 Percent at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Percentage of participants with weight loss &gt;= 10 percent at week 26.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">335</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Canagliflozin + Phentermine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Canagliflozin + Placebo (Phentermine)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phentermine + Placebo (Canagliflozin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canagliflozin</intervention_name>
    <description>300 mg capsule, taken once daily, orally for 26 weeks.</description>
    <arm_group_label>Canagliflozin + Phentermine</arm_group_label>
    <arm_group_label>Canagliflozin + Placebo (Phentermine)</arm_group_label>
    <other_name>INVOKANA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phentermine</intervention_name>
    <description>15 mg capsule, taken once daily, orally for 26 weeks.</description>
    <arm_group_label>Canagliflozin + Phentermine</arm_group_label>
    <arm_group_label>Phentermine + Placebo (Canagliflozin)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo to Canagliflozin</intervention_name>
    <description>Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.</description>
    <arm_group_label>Phentermine + Placebo (Canagliflozin)</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo to Phentermine</intervention_name>
    <description>Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.</description>
    <arm_group_label>Canagliflozin + Placebo (Phentermine)</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have BMI &gt;=30 kg/m2 and &lt;50 kg/m2 at screening or BMI &gt;=27 kg/m2 and &lt;50 kg/m2 at&#xD;
             screening in the presence of a comorbidity of hypertension and/or dyslipidemia&#xD;
&#xD;
          -  Must have stable weight, ie, change of &lt; =5% in the 3 months before screening&#xD;
&#xD;
          -  Must agree to utilize a highly effective method of birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An established diagnosis of diabetes mellitus&#xD;
&#xD;
          -  Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)&#xD;
&#xD;
          -  Has a history of hereditary glucose-galactose malabsorption or primary renal&#xD;
             glycosuria&#xD;
&#xD;
          -  Myocardial infarction, unstable angina, revascularization procedure, or&#xD;
             cerebrovascular accident within 12 weeks before screening&#xD;
&#xD;
          -  Has an Glycated hemoglobin (HBA1c) greater than or equal (&gt;=) to 65 percent&#xD;
&#xD;
          -  An average of 3 seated blood pressure (BP) readings of systolic BP &gt;= 160 mm Hg and/or&#xD;
             Diastolic BP &gt;= 100 millimeters of mercury at screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milford</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manlius</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mt Pleasant</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Odessa</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>June 16, 2016</results_first_submitted>
  <results_first_submitted_qc>August 10, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 6, 2016</results_first_posted>
  <last_update_submitted>August 10, 2016</last_update_submitted>
  <last_update_submitted_qc>August 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Overweight</keyword>
  <keyword>Canagliflozin</keyword>
  <keyword>Phentermine</keyword>
  <keyword>INVOKANA®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Canagliflozin</mesh_term>
    <mesh_term>Phentermine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Between screening and randomisation, eligible subjects were included in a 4-week single-blind run-in period in which all subjects were placed on a hypocaloric diet.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo tablets orally for 26 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Phentermine 15 mg</title>
          <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Canagliflozin 300 mg</title>
          <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
          <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="85"/>
                <participants group_id="P3" count="84"/>
                <participants group_id="P4" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="85"/>
                <participants group_id="P3" count="84"/>
                <participants group_id="P4" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not received treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo tablets orally for 26 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Phentermine 15 mg</title>
          <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Canagliflozin 300 mg</title>
          <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
          <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="82"/>
            <count group_id="B2" value="85"/>
            <count group_id="B3" value="84"/>
            <count group_id="B4" value="83"/>
            <count group_id="B5" value="334"/>
          </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="44.8" spread="11.09"/>
                    <measurement group_id="B2" value="46.4" spread="11.14"/>
                    <measurement group_id="B3" value="45.2" spread="11.02"/>
                    <measurement group_id="B4" value="46.3" spread="12.45"/>
                    <measurement group_id="B5" value="45.7" spread="11.41"/>
                  </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="67"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="69"/>
                    <measurement group_id="B5" value="273"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="84"/>
                    <measurement group_id="B4" value="83"/>
                    <measurement group_id="B5" value="334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Weight</title>
          <units>Kilogram [kg]</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="104.3" spread="18.16"/>
                    <measurement group_id="B2" value="102.8" spread="17.89"/>
                    <measurement group_id="B3" value="103.3" spread="19.14"/>
                    <measurement group_id="B4" value="101.1" spread="18.07"/>
                    <measurement group_id="B5" value="102.9" spread="18.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Body Mass Index (BMI)</title>
          <units>kilogram per meter square [kg/m²]</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38" spread="5.2"/>
                    <measurement group_id="B2" value="37" spread="5.4"/>
                    <measurement group_id="B3" value="37.3" spread="4.68"/>
                    <measurement group_id="B4" value="36.8" spread="5.36"/>
                    <measurement group_id="B5" value="37.3" spread="5.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Systolic Blood Pressure</title>
          <units>millimeters of mercury [mmHg]</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="122.5" spread="13.86"/>
                    <measurement group_id="B2" value="123.0" spread="11.83"/>
                    <measurement group_id="B3" value="124.5" spread="13.01"/>
                    <measurement group_id="B4" value="124.8" spread="12.83"/>
                    <measurement group_id="B5" value="123.7" spread="12.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Diastolic Blood Pressure</title>
          <units>millimeters of mercury [mmHg]</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78.8" spread="8.43"/>
                    <measurement group_id="B2" value="78.1" spread="9.00"/>
                    <measurement group_id="B3" value="80.2" spread="7.88"/>
                    <measurement group_id="B4" value="79.4" spread="8.21"/>
                    <measurement group_id="B5" value="79.1" spread="8.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Pulse Rate</title>
          <units>(BEATS/MIN)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.5" spread="8.72"/>
                    <measurement group_id="B2" value="70.7" spread="10.09"/>
                    <measurement group_id="B3" value="71.5" spread="9.40"/>
                    <measurement group_id="B4" value="72.4" spread="9.66"/>
                    <measurement group_id="B5" value="72.0" spread="9.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Body Weight at Week 26</title>
        <description>The percent change from baseline in body weight at Week 26 was analysed.</description>
        <time_frame>Week 26</time_frame>
        <population>The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Phentermine 15 mg</title>
            <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Canagliflozin 300 mg</title>
            <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
            <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Body Weight at Week 26</title>
          <description>The percent change from baseline in body weight at Week 26 was analysed.</description>
          <population>The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
          <units>Percent Change</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="76"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.6"/>
                    <measurement group_id="O2" value="-4.1" spread="0.6"/>
                    <measurement group_id="O3" value="-1.9" spread="0.6"/>
                    <measurement group_id="O4" value="-7.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-3.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.9</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.3</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.142</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.9</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-6.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.9</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.6</ci_lower_limit>
            <ci_upper_limit>-5.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Weight Loss More Than Equal to (&gt;=) 5 Percent at Week 26</title>
        <description>Percentage of participants with weight loss &gt;= 5 percent were analysed at week 26.</description>
        <time_frame>Week 26</time_frame>
        <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Phentermine 15 mg</title>
            <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Canagliflozin 300 mg</title>
            <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
            <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Weight Loss More Than Equal to (&gt;=) 5 Percent at Week 26</title>
          <description>Percentage of participants with weight loss &gt;= 5 percent were analysed at week 26.</description>
          <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5"/>
                    <measurement group_id="O2" value="41.7"/>
                    <measurement group_id="O3" value="17.9"/>
                    <measurement group_id="O4" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Generalized linear Mixed Model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.70</ci_lower_limit>
            <ci_upper_limit>10.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.825</p_value>
            <method>Generalized linear Mixed Model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>3.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Generalized linear Mixed Model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>10.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.15</ci_lower_limit>
            <ci_upper_limit>25.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure at Week 26</title>
        <description>Change from baseline in systolic blood pressure was analysed at week 26.</description>
        <time_frame>Week 26</time_frame>
        <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Phentermine 15 mg</title>
            <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Canagliflozin 300 mg</title>
            <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
            <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure at Week 26</title>
          <description>Change from baseline in systolic blood pressure was analysed at week 26.</description>
          <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
          <units>mmHg (millimeters of mercury)</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="75"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="1.3"/>
                    <measurement group_id="O2" value="-1.4" spread="1.2"/>
                    <measurement group_id="O3" value="-3.1" spread="1.3"/>
                    <measurement group_id="O4" value="-6.9" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.456</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.8</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>4.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.827</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.8</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.9</ci_lower_limit>
            <ci_upper_limit>3.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.015</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-4.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.7</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Body Weight at Week 26</title>
        <description>Absolute change from baseline in body weight was analysed at week 26.</description>
        <time_frame>Week 26</time_frame>
        <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Phentermine 15 mg</title>
            <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Canagliflozin 300 mg</title>
            <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
            <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Body Weight at Week 26</title>
          <description>Absolute change from baseline in body weight was analysed at week 26.</description>
          <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
          <units>Kilogram (Kg)</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="76"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.6"/>
                    <measurement group_id="O2" value="-4.1" spread="0.6"/>
                    <measurement group_id="O3" value="-1.9" spread="0.7"/>
                    <measurement group_id="O4" value="-7.3" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-3.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.9</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.3</ci_lower_limit>
            <ci_upper_limit>-1.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.153</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.9</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-6.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.9</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-8.5</ci_lower_limit>
            <ci_upper_limit>-4.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26</title>
        <description>Change from baseline in diastolic blood pressure (DBP) at week 26.</description>
        <time_frame>Week 26</time_frame>
        <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Phentermine 15 mg</title>
            <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Canagliflozin 300 mg</title>
            <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
            <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26</title>
          <description>Change from baseline in diastolic blood pressure (DBP) at week 26.</description>
          <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
          <units>mmHg (millimeters of mercury)</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="75"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.9"/>
                    <measurement group_id="O2" value="0.1" spread="0.8"/>
                    <measurement group_id="O3" value="-1.5" spread="0.9"/>
                    <measurement group_id="O4" value="-2.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Pulse Rate at Week 26</title>
        <description>Change from baseline in pulse rate at week 26</description>
        <time_frame>Week 26</time_frame>
        <population>The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Phentermine 15 mg</title>
            <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Canagliflozin 300 mg</title>
            <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
            <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Rate at Week 26</title>
          <description>Change from baseline in pulse rate at week 26</description>
          <population>The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.</population>
          <units>Beats Per Minute (Beats/Min)</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="75"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.0"/>
                    <measurement group_id="O2" value="4.1" spread="1.0"/>
                    <measurement group_id="O3" value="0.7" spread="1.0"/>
                    <measurement group_id="O4" value="3.5" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Weight Loss More Than Equal to (&gt;=) 10 Percent at Week 26</title>
        <description>Percentage of participants with weight loss &gt;= 10 percent at week 26.</description>
        <time_frame>Week 26</time_frame>
        <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Phentermine 15 mg</title>
            <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Canagliflozin 300 mg</title>
            <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
            <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Weight Loss More Than Equal to (&gt;=) 10 Percent at Week 26</title>
          <description>Percentage of participants with weight loss &gt;= 10 percent at week 26.</description>
          <population>The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8"/>
                    <measurement group_id="O2" value="8.3"/>
                    <measurement group_id="O3" value="5.4"/>
                    <measurement group_id="O4" value="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 33 weeks</time_frame>
      <desc>Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo tablets orally for 26 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Phentermine 15 mg</title>
          <description>Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Canagliflozin 300 mg</title>
          <description>Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Canagliflozin 300 mg/Phentermine 15 mg</title>
          <description>Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 18.0</default_vocab>
        <default_assessment>Non-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="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA Version 18.0</default_vocab>
        <default_assessment>Non-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="41" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="42" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="42" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Pharyngitis Streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Tooth Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Mycotic Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Muscle Strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Creatine Phosphokinase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Tension Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Sleep Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Sinus Congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </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>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Leader</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <email>ClinicalTrialDisclosure@its.jnj.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/NCT02243202
org study id: CR103086
secondary id: 28431754OBE2002
nct id: NCT02243202
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the effects of canagliflozin and phentermine to those
      of placebo to promote on a change in body weight over a 26 week period.
This is a randomized (the study medication is assigned by chance), double-blind (neither
      physician nor participant knows the identity of the assigned treatment), placebo-controlled
      (an inactive substance that is compared with a medication to test whether the medication has
      a real effect), parallel-group, multicenter study of the effects of canagliflozin and
      phentermine co-administration in non-diabetic overweight or obese participants. The study
      will be conducted for about 33 weeks, approximately 344 participants will be randomly
      assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of
      canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All
      participants will be also provided with diet and exercise counseling for weight loss
      (standardized non-pharmacological therapy).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percent Change From Baseline in Body Weight at Week 26
time frame: Week 26
description: The percent change from baseline in body weight at Week 26 was analysed.
measure: Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
time frame: Week 26
description: Percentage of participants with weight loss >= 5 percent were analysed at week 26.
measure: Change From Baseline in Systolic Blood Pressure at Week 26
time frame: Week 26
description: Change from baseline in systolic blood pressure was analysed at week 26.
measure: Absolute Change From Baseline in Body Weight at Week 26
time frame: Week 26
description: Absolute change from baseline in body weight was analysed at week 26.
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
time frame: Week 26
description: Change from baseline in diastolic blood pressure (DBP) at week 26.
measure: Change From Baseline in Pulse Rate at Week 26
time frame: Week 26
description: Change from baseline in pulse rate at week 26
measure: Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
time frame: Week 26
description: Percentage of participants with weight loss >= 10 percent at week 26.
arm group label: Canagliflozin + Phentermine
arm group type: Experimental
description: 300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
arm group label: Canagliflozin + Placebo (Phentermine)
arm group type: Experimental
description: 300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
arm group label: Phentermine + Placebo (Canagliflozin)
arm group type: Experimental
description: 15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
intervention type: Drug
intervention name: Canagliflozin
description: 300 mg capsule, taken once daily, orally for 26 weeks.
arm group label: Canagliflozin + Phentermine
arm group label: Canagliflozin + Placebo (Phentermine)
other name: INVOKANA
intervention type: Drug
intervention name: Phentermine
description: 15 mg capsule, taken once daily, orally for 26 weeks.
arm group label: Canagliflozin + Phentermine
arm group label: Phentermine + Placebo (Canagliflozin)
intervention type: Drug
intervention name: Matching Placebo to Canagliflozin
description: Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
arm group label: Phentermine + Placebo (Canagliflozin)
arm group label: Placebo
intervention type: Drug
intervention name: Matching Placebo to Phentermine
description: Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
arm group label: Canagliflozin + Placebo (Phentermine)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Canagliflozin
mesh term: Phentermine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 