<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/NCT03267576</url>
  </required_header>
  <id_info>
    <org_study_id>CR108346</org_study_id>
    <secondary_id>28431754DIA4026</secondary_id>
    <nct_id>NCT03267576</nct_id>
  </id_info>
  <brief_title>An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin</brief_title>
  <acronym>COMETA</acronym>
  <official_title>Canagliflozin Continuous Glucose Monitoring (CANA CGM) Trial: A Pilot Randomized, Double-Blind, Controlled, Crossover Study on the Effects of the SGLT-2 Inhibitor Canagliflozin (vs. the DPP-4 Inhibitor Sitagliptin) on Glucose Variability in Mexican Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin</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>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to assess the effects of 4 weeks each of daily treatment&#xD;
      with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to&#xD;
      metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV),&#xD;
      expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27)</time_frame>
    <description>Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2</measure>
    <time_frame>Baseline up to End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean 24-hour Glucose Profile</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose Levels</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (&gt;) 140 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Percent change from baseline in time during 24 hours within the glucose levels &gt;140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Time During 24 Hours With Glucose Level &gt; 180 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Percent change from baseline in time during 24 hours within the glucose levels &gt;180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (&lt;) 70 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Percent change from baseline in time during 24 hours within the glucose levels &lt; 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Time Spent With Glucose Level &gt; 140 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Time spent with the glucose level &gt; 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Time Spent With Glucose Level &gt; 180 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Time spent with the glucose level &gt; 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Time Spent With Glucose Level &lt; 70 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>Time spent with the glucose level &lt; 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Percentage of 2 Consecutive Glucose Readings With &lt; 70 mg/dL</measure>
    <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
    <description>The percentage of 2 consecutive glucose readings with &lt; 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canagliflozin 300 mg</intervention_name>
    <description>Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.</description>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
    <other_name>JNJ-28431754</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin 100 mg</intervention_name>
    <description>Participants will receive sitagliptin 100 mg oral tablet once-daily for 28 days.</description>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Participants will receive metformin at a stable dose of &gt;= 1500 mg/day throughout the study including the washout period between each intervention.</description>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus&#xD;
&#xD;
          -  Inadequate glucose control while using metformin monotherapy (MET) for at least 8&#xD;
             weeks at stable daily doses of at least 1500 milligram (mg) before screening visit&#xD;
             (Visit 1)&#xD;
&#xD;
             a. Hemoglobin A1c (HbA1c) equal to (=) 7.5 percent (%) to 10.5% at Visit 1&#xD;
&#xD;
          -  Adequate qualifying continuous glucose monitoring (CGM) reading during the&#xD;
             pre-randomization (selection) phase&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) of at least 60 milliliter/minute&#xD;
             (mL/min)/1.73 meter square (m^2) at Visit 1&#xD;
&#xD;
          -  Body mass index of 22 through 45 kilogram per meter square (kg/m^2) at Visit 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any of the following (at Visit 1):&#xD;
&#xD;
               1. Diabetic ketoacidosis (DKA)&#xD;
&#xD;
               2. Type 1 diabetes mellitus (T1DM)&#xD;
&#xD;
               3. Pancreatic (for example, Beta-islet cell) transplantation&#xD;
&#xD;
               4. Diabetes secondary to pancreatitis or pancreatectomy&#xD;
&#xD;
               5. Personal history of, or ongoing, pancreatitis&#xD;
&#xD;
               6. One or more episodes of severe hypoglycemia (requiring assistance from others),&#xD;
                  as documented in the history obtained at Visit 1&#xD;
&#xD;
               7. Hereditary glucose-galactose malabsorption or primary renal glucosuria&#xD;
&#xD;
          -  Repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose (SMBG)&#xD;
             greater than (&gt;) 270 milligram per deciliter (mg/dL) during the pre-treatment phase&#xD;
&#xD;
          -  Treatment with any other oral or parenteral antidiabetic medications different from&#xD;
             metformin monotherapy, including but not limited to Dipeptidyl peptidase-4 (DPP-4)&#xD;
             inhibitors, Sulphonylureas, thiazolidinediones, insulins and Glucagon-like peptide-1&#xD;
             receptor agonist (GLP-1RAs); Sodium-glucose co-transporter 2 (SGLT-2) inhibitors and&#xD;
             investigational agents&#xD;
&#xD;
          -  Received an investigational drug or vaccine or used an invasive investigational&#xD;
             medical device within 30 days before the planned first dose of study drug&#xD;
&#xD;
          -  Current use of &quot;natural medicines&quot; or natural medicinal products for diabetes (for&#xD;
             example, cactus-derived nutrients, celery)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>54 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>
      <name>Consultorio Privado</name>
      <address>
        <city>Guadalajara</city>
        <zip>44150</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigación Clínica Especializada</name>
      <address>
        <city>Guadalajara</city>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultorio Privado en Unidad de Patología Clínica</name>
      <address>
        <city>Guadalajara</city>
        <zip>44650</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán</name>
      <address>
        <city>Mexico City</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <results_first_submitted>September 27, 2019</results_first_submitted>
  <results_first_submitted_qc>November 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 29, 2019</results_first_posted>
  <last_update_submitted>November 11, 2019</last_update_submitted>
  <last_update_submitted_qc>November 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 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>Metformin</mesh_term>
    <mesh_term>Sitagliptin Phosphate</mesh_term>
    <mesh_term>Canagliflozin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03267576/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03267576/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 64 participants were enrolled in this study but 1 participant has withdrawn consent before assigning to any study treatment hence, 63 participants were randomized to study treatment arms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment Sequence AB</title>
          <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of at least 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Sequence BA</title>
          <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1: Day 0 to 27</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period: 16 Days</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2: Day 44 to 71</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (greater than [&gt;] 70 percent (%) of tracings available).</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Sequence AB</title>
          <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of at 16 days (from Days 28 to 43) along with continued metformin monotherapy.</description>
        </group>
        <group group_id="B2">
          <title>Treatment Sequence BA</title>
          <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
        </group>
        <group group_id="B3">
          <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="31"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="63"/>
          </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="46.03" spread="6.237"/>
                    <measurement group_id="B2" value="44.84" spread="9.088"/>
                    <measurement group_id="B3" value="45.3" spread="7.8"/>
                  </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="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic Mexican mestizo</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Afro-American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>Meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.63" spread="0.10"/>
                    <measurement group_id="B2" value="1.64" spread="0.10"/>
                    <measurement group_id="B3" value="1.63" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>Kilogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.01" spread="15.86"/>
                    <measurement group_id="B2" value="88.96" spread="14.17"/>
                    <measurement group_id="B3" value="86.52" spread="15.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1</title>
        <description>Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27)</time_frame>
        <population>Intent-to-treat (ITT) analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (greater than [&gt;] 70% of tracings available).</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1</title>
          <description>Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>Intent-to-treat (ITT) analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (greater than [&gt;] 70% of tracings available).</population>
          <units>Percentage of CV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="5.17"/>
                    <measurement group_id="O2" value="0.24" spread="10.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2</title>
        <description>Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>ITT analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (&gt;70% of tracings available).</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2</title>
          <description>Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>ITT analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (&gt;70% of tracings available).</population>
          <units>Percentage of CV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="7.41"/>
                    <measurement group_id="O2" value="0.77" spread="6.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile</title>
        <description>Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>Per-protocol (PP) analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile</title>
          <description>Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure.</description>
          <population>Per-protocol (PP) analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.64" spread="6.56"/>
                    <measurement group_id="O2" value="-8.40" spread="11.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.53" spread="10.35"/>
                    <measurement group_id="O2" value="-7.13" spread="12.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean 24-hour Glucose Profile</title>
        <description>Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean 24-hour Glucose Profile</title>
          <description>Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.81" spread="34.87"/>
                    <measurement group_id="O2" value="-39.56" spread="39.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.27" spread="33.27"/>
                    <measurement group_id="O2" value="-41.74" spread="34.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose Levels</title>
        <description>Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose Levels</title>
          <description>Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.04" spread="33.95"/>
                    <measurement group_id="O2" value="-34.48" spread="32.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.69" spread="32.19"/>
                    <measurement group_id="O2" value="-45.51" spread="35.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels</title>
        <description>2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels</title>
          <description>2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-47.03" spread="45.85"/>
                    <measurement group_id="O2" value="-43.36" spread="48.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.12" spread="44.77"/>
                    <measurement group_id="O2" value="-44.03" spread="43.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL</title>
        <description>Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all intent-to-treat participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL</title>
          <description>Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all intent-to-treat participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.157" spread="0.134"/>
                    <measurement group_id="O2" value="0.191" spread="0.224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.192" spread="0.214"/>
                    <measurement group_id="O2" value="0.182" spread="0.209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (&gt;) 140 mg/dL</title>
        <description>Percent change from baseline in time during 24 hours within the glucose levels &gt;140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (&gt;) 140 mg/dL</title>
          <description>Percent change from baseline in time during 24 hours within the glucose levels &gt;140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.161" spread="0.145"/>
                    <measurement group_id="O2" value="-0.216" spread="0.257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-214" spread="0.237"/>
                    <measurement group_id="O2" value="-0.221" spread="0.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Time During 24 Hours With Glucose Level &gt; 180 mg/dL</title>
        <description>Percent change from baseline in time during 24 hours within the glucose levels &gt;180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Time During 24 Hours With Glucose Level &gt; 180 mg/dL</title>
          <description>Percent change from baseline in time during 24 hours within the glucose levels &gt;180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.235" spread="0.204"/>
                    <measurement group_id="O2" value="-0.212" spread="0.286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.246" spread="0.232"/>
                    <measurement group_id="O2" value="-0.251" spread="0.249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (&lt;) 70 mg/dL</title>
        <description>Percent change from baseline in time during 24 hours within the glucose levels &lt; 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (&lt;) 70 mg/dL</title>
          <description>Percent change from baseline in time during 24 hours within the glucose levels &lt; 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL</title>
        <description>Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL</title>
          <description>Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.64" spread="193.01"/>
                    <measurement group_id="O2" value="275.64" spread="323.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="277.00" spread="309.46"/>
                    <measurement group_id="O2" value="261.57" spread="301.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Time Spent With Glucose Level &gt; 140 mg/dL</title>
        <description>Time spent with the glucose level &gt; 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Time Spent With Glucose Level &gt; 140 mg/dL</title>
          <description>Time spent with the glucose level &gt; 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-231.98" spread="208.27"/>
                    <measurement group_id="O2" value="-310.41" spread="370.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-308.68" spread="341.00"/>
                    <measurement group_id="O2" value="318.23" spread="303.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Time Spent With Glucose Level &gt; 180 mg/dL</title>
        <description>Time spent with the glucose level &gt; 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Time Spent With Glucose Level &gt; 180 mg/dL</title>
          <description>Time spent with the glucose level &gt; 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-338.36" spread="293.40"/>
                    <measurement group_id="O2" value="-305.69" spread="412.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-354.63" spread="333.52"/>
                    <measurement group_id="O2" value="-361.65" spread="358.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Time Spent With Glucose Level &lt; 70 mg/dL</title>
        <description>Time spent with the glucose level &lt; 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Time Spent With Glucose Level &lt; 70 mg/dL</title>
          <description>Time spent with the glucose level &lt; 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Percentage of 2 Consecutive Glucose Readings With &lt; 70 mg/dL</title>
        <description>The percentage of 2 consecutive glucose readings with &lt; 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
        <time_frame>Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)</time_frame>
        <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence AB</title>
            <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin &gt;=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Sequence BA</title>
            <description>Participants received metformin monotherapy at stable doses &gt;=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin &gt;= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Percentage of 2 Consecutive Glucose Readings With &lt; 70 mg/dL</title>
          <description>The percentage of 2 consecutive glucose readings with &lt; 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.</description>
          <population>PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.</population>
          <units>Percentage of readings</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Period 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Period 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Here, NA signifies that data could not be calculated since there were &lt;5 cases with valid observations of glycemic readings &lt;70 mg/dL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 96 Days</time_frame>
      <desc>Adverse events (AEs) reported are when they occurred under the actual treatment group they were receiving at the AE and not by the randomized sequence. Safety population included all randomized participants who received at least 1 dose of study agent.</desc>
      <group_list>
        <group group_id="E1">
          <title>Canagliflozin 300 mg</title>
          <description>Participants received metformin monotherapy at stable doses (greater than or equal to [&gt;=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) under fasted condition.</description>
        </group>
        <group group_id="E2">
          <title>Sitagliptin 100 mg</title>
          <description>Participants received metformin monotherapy at stable doses &gt;= 1500 milligram mg/day orally once daily with sitagliptin 100 mg tablet orally once daily (Treatment B) under fasted condition.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.1</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="7" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
              </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>
    <limitations_and_caveats>The main limitation of the study was the sample size limited to demonstrate any significant difference.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Director</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <phone>844-434-4210</phone>
      <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/NCT03267576
org study id: CR108346
secondary id: 28431754DIA4026
nct id: NCT03267576
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The main purpose of this study is to assess the effects of 4 weeks each of daily treatment
      with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to
      metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV),
      expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27)
description: Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.
measure: Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2
time frame: Baseline up to End of Treatment Period 2 (Days 66 to 71)
description: Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.
measure: Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure.
measure: Change From Baseline in Mean 24-hour Glucose Profile
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Change From Baseline in Fasting Plasma Glucose Levels
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: 2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Percent change from baseline in time during 24 hours within the glucose levels >140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Percent change from baseline in time during 24 hours within the glucose levels >180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.
measure: Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Percent change from baseline in time during 24 hours within the glucose levels < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Change From Baseline in Time Spent With Glucose Level > 140 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Time spent with the glucose level > 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Change From Baseline in Time Spent With Glucose Level > 180 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Time spent with the glucose level > 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.
measure: Change From Baseline in Time Spent With Glucose Level < 70 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: Time spent with the glucose level < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
measure: Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL
time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
description: The percentage of 2 consecutive glucose readings with < 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
arm group label: Treatment Sequence AB
arm group type: Experimental
description: Participants will receive metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
arm group label: Treatment Sequence BA
arm group type: Experimental
description: Participants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
intervention type: Drug
intervention name: Canagliflozin 300 mg
description: Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
other name: JNJ-28431754
intervention type: Drug
intervention name: Sitagliptin 100 mg
description: Participants will receive sitagliptin 100 mg oral tablet once-daily for 28 days.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
intervention type: Drug
intervention name: Metformin
description: Participants will receive metformin at a stable dose of >= 1500 mg/day throughout the study including the washout period between each intervention.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
criteria: 
gender: All
minimum age: 19 Years
maximum age: 54 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Sitagliptin Phosphate
mesh term: Canagliflozin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The main limitation of the study was the sample size limited to demonstrate any significant difference.
point of contact: 