<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/NCT02206607</url>
  </required_header>
  <id_info>
    <org_study_id>B1621015</org_study_id>
    <nct_id>NCT02206607</nct_id>
  </id_info>
  <brief_title>Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.</brief_title>
  <official_title>A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three&#xD;
      modified release formulations of PF-04937319 compared with the immediate release&#xD;
      material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
    <description>AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose</time_frame>
    <description>MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed PF-04937319 Plasma Concentration (Cmax)</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
    <description>Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Half-Life (t1/2)</measure>
    <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
    <description>t1/2 is the time measured for the plasma concentration to decrease by one half.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 28 days after last study drug administration in Period 4</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>PF-04937319 IR MST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reference formulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-04937319 MR 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test MR #1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-04937319 MR 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test MR #2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-04937319 MR 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test MR #3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04937319 IR MST</intervention_name>
    <description>Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch</description>
    <arm_group_label>PF-04937319 IR MST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04937319 MR 1</intervention_name>
    <description>Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST</description>
    <arm_group_label>PF-04937319 MR 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04937319 MR 2</intervention_name>
    <description>Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST</description>
    <arm_group_label>PF-04937319 MR 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04937319 MR 3</intervention_name>
    <description>Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST</description>
    <arm_group_label>PF-04937319 MR 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with type 2 diabetes, on stable background metformin therapy either alone or in&#xD;
             combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones&#xD;
             (TZDs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiovascular event within 6 months of screening&#xD;
&#xD;
          -  Patients with diabetic complications&#xD;
&#xD;
          -  Female subjects who are pregnant or planning to become pregnant&#xD;
&#xD;
          -  Subjects with unstable medical conditions (eg, hypertension)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>High Point Clinical Trials Center</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1621015</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <results_first_submitted>December 14, 2015</results_first_submitted>
  <results_first_submitted_qc>February 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 4, 2016</results_first_posted>
  <last_update_submitted>February 4, 2016</last_update_submitted>
  <last_update_submitted_qc>February 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 1</keyword>
  <keyword>bioavailability</keyword>
  <keyword>type 2 diabetes mellitus</keyword>
  <keyword>PF-04937319</keyword>
  <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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Prior to being enrolled in the 4 period crossover, participants were required to complete an open-label, sponsor-provided metformin period. 42 participants started the metformin period and of those 42 participants, 39 were enrolled in the 4 period crossover and received at least 1 dose PF-04937319.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Metformin Run-In</title>
          <description>Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment sequences.</description>
        </group>
        <group group_id="P2">
          <title>Sequence ADBC: PF-04937319 150+100 mg IR First</title>
          <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch, followed by PF-04937319 modified-release formulation #3 (MR3) 330 mg, followed by PF-04937319 modified-release formulation #1 (MR1) 250 mg, followed by PF-04937319 modified-release formulation #2 (MR2) 300 mg. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
        </group>
        <group group_id="P3">
          <title>Sequence BACD: PF-04937319 250 mg MR1 First</title>
          <description>Participants received PF-04937319 MR1 250 mg, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 300 mg MR2, followed by PF-04937319 330 mg MR3. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
        </group>
        <group group_id="P4">
          <title>Sequence CBDA: PF-04937319 300 mg MR2 First</title>
          <description>Participants received PF-04937319 300 mg MR2, followed by PF-04937319 250 mg MR1, followed by PF-04937319 330 mg MR3, followed by PF-04937319 150+100 mg IR. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
        </group>
        <group group_id="P5">
          <title>Sequence DCAB: PF-04937319 330 mg MR3 First</title>
          <description>Participants received PF-04937319 330 mg MR3, followed by PF-04937319 300 mg MR2, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 250 mg MR1. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Open-Label Run-In</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>First Intervention Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>First Washout Period 5 to 10 Days</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Insufficient Clinical Response</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Washout Period 5 to 10 Days</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Third Intervention Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Third Washout Period 5 to 10 Days</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Fourth Intervention Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population included all participants who received at least 1 dose of study treatment (PF-04937319).</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>Participants received at least 1 dose of PF-04937319.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </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="57.7" spread="7.1"/>
                  </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="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]</title>
        <description>AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.</description>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]</title>
          <description>AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.</description>
          <population>The pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.</population>
          <units>nanogram*hour/milliliter (ng*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10690" spread="26"/>
                    <measurement group_id="O2" value="3187" spread="59"/>
                    <measurement group_id="O3" value="2725" spread="35"/>
                    <measurement group_id="O4" value="3430" spread="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR1/IR</param_type>
            <param_value>31.27</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.09</ci_lower_limit>
            <ci_upper_limit>34.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR2/IR</param_type>
            <param_value>25.56</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.11</ci_lower_limit>
            <ci_upper_limit>28.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR3/IR</param_type>
            <param_value>32.04</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.93</ci_lower_limit>
            <ci_upper_limit>35.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1</title>
        <description>MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.</description>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose</time_frame>
        <population>The pharmacodynamic analysis included participants who had taken at least 1 dose of PF-04937319 and who had WMDG assessment for at least 1 modified-release formulation and the Reference (IR MST) formulation; n=number of participants evaluated in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1</title>
          <description>MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.</description>
          <population>The pharmacodynamic analysis included participants who had taken at least 1 dose of PF-04937319 and who had WMDG assessment for at least 1 modified-release formulation and the Reference (IR MST) formulation; n=number of participants evaluated in respective arms for category.</population>
          <units>milligrams per deciliter (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="36"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="36"/>
                <count group_id="O4" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed (n=36,33,32,35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.47" spread="42.949"/>
                    <measurement group_id="O2" value="176.24" spread="42.648"/>
                    <measurement group_id="O3" value="170.85" spread="38.928"/>
                    <measurement group_id="O4" value="180.47" spread="50.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Reference (36,33,32,35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No measure type or method of dispersion was calculated, as the 'PF-04937319 150+100 mg IR' arm is the Reference.</measurement>
                    <measurement group_id="O2" value="15.55" spread="19.358"/>
                    <measurement group_id="O3" value="15.96" spread="17.122"/>
                    <measurement group_id="O4" value="20.15" spread="20.005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0000</p_value>
            <p_value_desc>1-sided p-value</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.</method_desc>
            <param_type>Least Square Mean</param_type>
            <param_value>15.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.357</dispersion_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.39</ci_lower_limit>
            <ci_upper_limit>20.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.000</p_value>
            <p_value_desc>1-sided p-value</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.</method_desc>
            <param_type>Least Square Mean</param_type>
            <param_value>16.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.399</dispersion_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.93</ci_lower_limit>
            <ci_upper_limit>20.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0000</p_value>
            <p_value_desc>1-sided p-value</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean</param_type>
            <param_value>20.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.291</dispersion_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.13</ci_lower_limit>
            <ci_upper_limit>24.62</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed PF-04937319 Plasma Concentration (Cmax)</title>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed PF-04937319 Plasma Concentration (Cmax)</title>
          <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="641.2" spread="22"/>
                    <measurement group_id="O2" value="161.8" spread="37"/>
                    <measurement group_id="O3" value="171.3" spread="24"/>
                    <measurement group_id="O4" value="236.2" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR1/IR</param_type>
            <param_value>25.21</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.28</ci_lower_limit>
            <ci_upper_limit>27.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR2/IR</param_type>
            <param_value>26.38</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.36</ci_lower_limit>
            <ci_upper_limit>28.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR3/IR</param_type>
            <param_value>36.94</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34.09</ci_lower_limit>
            <ci_upper_limit>40.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)</title>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)</title>
          <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="413.2" spread="26"/>
                    <measurement group_id="O2" value="124.3" spread="43"/>
                    <measurement group_id="O3" value="154.3" spread="29"/>
                    <measurement group_id="O4" value="202.1" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)</title>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)</title>
          <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="324.7" spread="34"/>
                    <measurement group_id="O2" value="74.49" spread="57"/>
                    <measurement group_id="O3" value="58.88" spread="37"/>
                    <measurement group_id="O4" value="77.92" spread="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)</title>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)</title>
          <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
          <units>ng/dL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171.1" spread="37"/>
                    <measurement group_id="O2" value="56.04" spread="64"/>
                    <measurement group_id="O3" value="39.38" spread="52"/>
                    <measurement group_id="O4" value="48.17" spread="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)</title>
        <description>Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.</description>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)</title>
          <description>Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.</description>
          <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.748" spread="33"/>
                    <measurement group_id="O2" value="2.887" spread="49"/>
                    <measurement group_id="O3" value="4.350" spread="48"/>
                    <measurement group_id="O4" value="4.903" spread="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)</title>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)</title>
          <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" lower_limit="3.00" upper_limit="15.2"/>
                    <measurement group_id="O2" value="6.00" lower_limit="4.00" upper_limit="48.0"/>
                    <measurement group_id="O3" value="5.00" lower_limit="1.00" upper_limit="7.07"/>
                    <measurement group_id="O4" value="5.00" lower_limit="3.00" upper_limit="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)</title>
        <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)</title>
          <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
          <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10560" spread="26"/>
                    <measurement group_id="O2" value="3287" spread="55"/>
                    <measurement group_id="O3" value="2644" spread="34"/>
                    <measurement group_id="O4" value="3369" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR1/IR</param_type>
            <param_value>31.06</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.28</ci_lower_limit>
            <ci_upper_limit>34.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR2/IR</param_type>
            <param_value>24.96</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.73</ci_lower_limit>
            <ci_upper_limit>27.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Adjusted Geometric Mean Ratio MR3/IR</param_type>
            <param_value>31.69</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.86</ci_lower_limit>
            <ci_upper_limit>34.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Half-Life (t1/2)</title>
        <description>t1/2 is the time measured for the plasma concentration to decrease by one half.</description>
        <time_frame>0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose</time_frame>
        <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-Life (t1/2)</title>
          <description>t1/2 is the time measured for the plasma concentration to decrease by one half.</description>
          <population>The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.648" spread="2.7801"/>
                    <measurement group_id="O2" value="12.10" spread="5.5922"/>
                    <measurement group_id="O3" value="13.52" spread="6.9657"/>
                    <measurement group_id="O4" value="12.62" spread="6.1783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.</description>
        <time_frame>Baseline up to 28 days after last study drug administration in Period 4</time_frame>
        <population>The safety analysis population included all participants who received at least 1 dose of open-label, sponsor-provided metformin.</population>
        <group_list>
          <group group_id="O1">
            <title>Metformin Run-In</title>
            <description>Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.</description>
          </group>
          <group group_id="O2">
            <title>PF-04937319 150+100 mg IR</title>
            <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O3">
            <title>PF-04937319 250 mg MR1</title>
            <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O4">
            <title>PF-04937319 300 mg MR2</title>
            <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
          <group group_id="O5">
            <title>PF-04937319 330 mg MR3</title>
            <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.</description>
          <population>The safety analysis population included all participants who received at least 1 dose of open-label, sponsor-provided metformin.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 28 days after last study drug administration in Period 4</time_frame>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Metformin Run-In</title>
          <description>Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.</description>
        </group>
        <group group_id="E2">
          <title>PF-04937319 150+100 mg IR</title>
          <description>Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
        </group>
        <group group_id="E3">
          <title>PF-04937319 250 mg MR1</title>
          <description>Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
        </group>
        <group group_id="E4">
          <title>PF-04937319 300 mg MR2</title>
          <description>Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
        </group>
        <group group_id="E5">
          <title>PF-04937319 330 mg MR3</title>
          <description>Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</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="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="38"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT02206607
org study id: B1621015
nct id: NCT02206607
lead sponsor: 
has dmc: No
Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three
      modified release formulations of PF-04937319 compared with the immediate release
      material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
description: AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
measure: Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose
description: MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.
measure: Maximum Observed PF-04937319 Plasma Concentration (Cmax)
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
measure: PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
measure: PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
measure: PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
measure: Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
description: Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.
measure: Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
measure: Terminal Elimination Half-Life (t1/2)
time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
description: t1/2 is the time measured for the plasma concentration to decrease by one half.
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
time frame: Baseline up to 28 days after last study drug administration in Period 4
description: An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
arm group label: PF-04937319 IR MST
arm group type: Experimental
description: Reference formulation
arm group label: PF-04937319 MR 1
arm group type: Experimental
description: Test MR #1
arm group label: PF-04937319 MR 2
arm group type: Experimental
description: Test MR #2
arm group label: PF-04937319 MR 3
arm group type: Experimental
description: Test MR #3
intervention type: Drug
intervention name: PF-04937319 IR MST
description: Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
arm group label: PF-04937319 IR MST
intervention type: Drug
intervention name: PF-04937319 MR 1
description: Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
arm group label: PF-04937319 MR 1
intervention type: Drug
intervention name: PF-04937319 MR 2
description: Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
arm group label: PF-04937319 MR 2
intervention type: Drug
intervention name: PF-04937319 MR 3
description: Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
arm group label: PF-04937319 MR 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1621015
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 