<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/NCT04465877</url>
  </required_header>
  <id_info>
    <org_study_id>AT662-U-20-003</org_study_id>
    <nct_id>NCT04465877</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety, Tolerability, Pharmacokinetics &amp; Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes</brief_title>
  <official_title>Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akros Pharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akros Pharma Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of&#xD;
      JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM)&#xD;
      who are receiving metformin monotherapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">February 17, 2021</completion_date>
  <primary_completion_date type="Actual">February 17, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Treatment-emergent Adverse Events</measure>
    <time_frame>6 Weeks (from Day -1 to the follow-up visit on Day 42)</time_frame>
    <description>Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Stools and Type of Stools Based on Bristol Stool Chart</measure>
    <time_frame>7 Weeks (from Day -6 to the follow-up visit on Day 42)</time_frame>
    <description>Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28</measure>
    <time_frame>28 Days</time_frame>
    <description>Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28</measure>
    <time_frame>Days 1, 14 and 28</time_frame>
    <description>Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>JTT-662 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTT-662 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTT-662 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo orally once daily from Day -1 to Day 28</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JTT-662</intervention_name>
    <description>Active drug tablets containing JTT-662</description>
    <arm_group_label>JTT-662 10 mg</arm_group_label>
    <arm_group_label>JTT-662 20 mg</arm_group_label>
    <arm_group_label>JTT-662 5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablets matching in appearance to the active drug tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit&#xD;
&#xD;
          -  Currently treated with a stable oral dose of metformin monotherapy for at least 12&#xD;
             weeks prior to the Screening Visit and until Day -3&#xD;
&#xD;
          -  Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the&#xD;
             Screening Visit&#xD;
&#xD;
          -  Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening&#xD;
             Visit and on Day -3&#xD;
&#xD;
          -  Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes&#xD;
             of the Young or secondary forms of diabetes&#xD;
&#xD;
          -  Known medical history or presence of diabetic complications&#xD;
&#xD;
          -  Have taken anti-diabetic medications (other than metformin) or medications that act&#xD;
             mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior&#xD;
             to the Screening Visit or from the Screening Visit to Day -3&#xD;
&#xD;
          -  Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or&#xD;
             diastolic blood pressure of at least 95 mmHg) at the Screening Visit&#xD;
&#xD;
          -  Have impaired renal function (estimated glomerular filtration rate (eGFR) &lt;60&#xD;
             mL/min/1.73 m2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Qps-Mra, Llc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <results_first_submitted>February 8, 2022</results_first_submitted>
  <results_first_submitted_qc>April 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 27, 2023</results_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JTT-662</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Safety</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 29, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT04465877/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT04465877/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Written informed consent was obtained prior to performing any study-related procedures. A copy of the informed consent was provided to each subject enrolled in this study. To qualify for the study, subjects were required to satisfy defined criteria.</recruitment_details>
      <pre_assignment_details>Following informed consent signing, screening procedures to confirm eligibility were performed.&#xD;
All subjects received a single dose of placebo on Day -1 (Placebo Run-in Period) followed by JTT-662 or placebo once-daily (QD) for 28 consecutive days (Day 1 through Day 28).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>JTT-662 5 mg</title>
          <description>JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="P2">
          <title>JTT-662 10 mg</title>
          <description>JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="P3">
          <title>JTT-662 20 mg</title>
          <description>JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Placebo orally once daily from Day -1 to Day 28</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized Population</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PK (Pharmacokinetic) Population</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PD (Pharmacodynamic) Population</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
              </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="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Noncompliant with study requirements</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>JTT-662 5 mg</title>
          <description>JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="B2">
          <title>JTT-662 10 mg</title>
          <description>JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="B3">
          <title>JTT-662 20 mg</title>
          <description>JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Placebo orally once daily from Day -1 to Day 28</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </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="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Treatment-emergent Adverse Events</title>
        <description>Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.</description>
        <time_frame>6 Weeks (from Day -1 to the follow-up visit on Day 42)</time_frame>
        <population>Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>JTT-662 5 mg</title>
            <description>JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O2">
            <title>JTT-662 10 mg</title>
            <description>JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O3">
            <title>JTT-662 20 mg</title>
            <description>JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo orally once daily from Day -1 to Day 28</description>
          </group>
          <group group_id="O5">
            <title>Placebo Run-in</title>
            <description>Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Treatment-emergent Adverse Events</title>
          <description>Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.</description>
          <population>Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Number of subjects with TEAEs</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of subjects with no TEAEs</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Stools and Type of Stools Based on Bristol Stool Chart</title>
        <description>Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.</description>
        <time_frame>7 Weeks (from Day -6 to the follow-up visit on Day 42)</time_frame>
        <population>Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>JTT-662 5 mg</title>
            <description>JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O2">
            <title>JTT-662 10 mg</title>
            <description>JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O3">
            <title>JTT-662 20 mg</title>
            <description>JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo orally once daily from Day -1 to Day 28</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Stools and Type of Stools Based on Bristol Stool Chart</title>
          <description>Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.</description>
          <population>Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.</population>
          <units>Number of stools</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Number of Stools</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491"/>
                    <measurement group_id="O2" value="550"/>
                    <measurement group_id="O3" value="815"/>
                    <measurement group_id="O4" value="599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226"/>
                    <measurement group_id="O2" value="173"/>
                    <measurement group_id="O3" value="119"/>
                    <measurement group_id="O4" value="329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="117"/>
                    <measurement group_id="O3" value="106"/>
                    <measurement group_id="O4" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="94"/>
                    <measurement group_id="O3" value="242"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="130"/>
                    <measurement group_id="O3" value="310"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28</title>
        <description>Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.</description>
        <time_frame>28 Days</time_frame>
        <population>PK Population consists of subjects randomized to JTT-662 treatment groups who received at least one dose of JTT-662 and had available PK data. The number of subjects on Days 21 and 28 is only 27 since 1 subject in the JTT-662 20 mg group discontinued the study on Day 19.</population>
        <group_list>
          <group group_id="O1">
            <title>JTT-662 5 mg</title>
            <description>JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O2">
            <title>JTT-662 10 mg</title>
            <description>JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O3">
            <title>JTT-662 20 mg</title>
            <description>JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28</title>
          <description>Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.</description>
          <population>PK Population consists of subjects randomized to JTT-662 treatment groups who received at least one dose of JTT-662 and had available PK data. The number of subjects on Days 21 and 28 is only 27 since 1 subject in the JTT-662 20 mg group discontinued the study on Day 19.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.2" spread="14.4"/>
                    <measurement group_id="O2" value="124" spread="36.0"/>
                    <measurement group_id="O3" value="231" spread="61.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="209" spread="61.5"/>
                    <measurement group_id="O2" value="518" spread="155"/>
                    <measurement group_id="O3" value="845" spread="359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235" spread="64.3"/>
                    <measurement group_id="O2" value="629" spread="181"/>
                    <measurement group_id="O3" value="959" spread="449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="257" spread="97.3"/>
                    <measurement group_id="O2" value="703" spread="224"/>
                    <measurement group_id="O3" value="1130" spread="502"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="266" spread="83.7"/>
                    <measurement group_id="O2" value="689" spread="209"/>
                    <measurement group_id="O3" value="1140" spread="475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="281" spread="100"/>
                    <measurement group_id="O2" value="787" spread="237"/>
                    <measurement group_id="O3" value="1180" spread="665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292" spread="103"/>
                    <measurement group_id="O2" value="786" spread="326"/>
                    <measurement group_id="O3" value="1190" spread="583"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28</title>
        <description>Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.</description>
        <time_frame>Days 1, 14 and 28</time_frame>
        <population>PD Population consists of subjects who were randomly assigned to treatment, received at least one dose of JTT-662 or placebo starting on Day 1 and had evaluable PD data. For the JTT-662 20 mg group, number of participants analyzed on Day 28 is 9 since 1 subject did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>JTT-662 5 mg</title>
            <description>JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O2">
            <title>JTT-662 10 mg</title>
            <description>JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O3">
            <title>JTT-662 20 mg</title>
            <description>JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo orally once daily from Day -1 to Day 28</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28</title>
          <description>Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.</description>
          <population>PD Population consists of subjects who were randomly assigned to treatment, received at least one dose of JTT-662 or placebo starting on Day 1 and had evaluable PD data. For the JTT-662 20 mg group, number of participants analyzed on Day 28 is 9 since 1 subject did not complete the study.</population>
          <units>mg*hr/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.34" lower_limit="-55.64" upper_limit="54.96"/>
                    <measurement group_id="O2" value="-98.24" lower_limit="-153.78" upper_limit="-42.69"/>
                    <measurement group_id="O3" value="-88.19" lower_limit="-140.71" upper_limit="-35.67"/>
                    <measurement group_id="O4" value="1.78" lower_limit="-54.00" upper_limit="57.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.22" lower_limit="-106.31" upper_limit="43.88"/>
                    <measurement group_id="O2" value="-169.40" lower_limit="-244.67" upper_limit="-94.13"/>
                    <measurement group_id="O3" value="-253.57" lower_limit="-324.85" upper_limit="-182.29"/>
                    <measurement group_id="O4" value="-31.55" lower_limit="-106.99" upper_limit="43.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-61.17" lower_limit="-154.63" upper_limit="32.28"/>
                    <measurement group_id="O2" value="-230.87" lower_limit="-324.46" upper_limit="-137.28"/>
                    <measurement group_id="O3" value="-250.64" lower_limit="-340.71" upper_limit="-160.58"/>
                    <measurement group_id="O4" value="-1.83" lower_limit="-95.55" upper_limit="91.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.956</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-79.67</ci_lower_limit>
            <ci_upper_limit>75.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.995</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-105.41</ci_lower_limit>
            <ci_upper_limit>106.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.366</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-59.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-191.15</ci_lower_limit>
            <ci_upper_limit>72.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.016</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-100.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-179.96</ci_lower_limit>
            <ci_upper_limit>-20.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-137.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-245.28</ci_lower_limit>
            <ci_upper_limit>-30.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-229.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-362.17</ci_lower_limit>
            <ci_upper_limit>-95.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.025</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-89.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-167.62</ci_lower_limit>
            <ci_upper_limit>-12.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-222.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-326.54</ci_lower_limit>
            <ci_upper_limit>-117.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-248.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-379.35</ci_lower_limit>
            <ci_upper_limit>-118.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)</time_frame>
      <desc>Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>JTT-662 5 mg</title>
          <description>JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="E2">
          <title>JTT-662 10 mg</title>
          <description>JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="E3">
          <title>JTT-662 20 mg</title>
          <description>JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Placebo orally once daily from Day -1 to Day 28</description>
        </group>
        <group group_id="E5">
          <title>Placebo Run-in</title>
          <description>Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </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>The sponsor can review results communications at least 60 days prior to public release. The sponsor will have a review period of 60 days and can embargo communications regarding trial results for an additional period of 60 days from the end of sponsor review period. The sponsor may require removal of any and all confidential information (other than study results) in the communication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kazuhiro Okamiya</name_or_title>
      <organization>Akros Pharma Inc.</organization>
      <phone>609-919-6123</phone>
      <email>okamiya@akrospharma.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/NCT04465877
org study id: AT662-U-20-003
nct id: NCT04465877
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM)
      who are receiving metformin monotherapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of Subjects With Treatment-emergent Adverse Events
time frame: 6 Weeks (from Day -1 to the follow-up visit on Day 42)
description: Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.
measure: Number of Stools and Type of Stools Based on Bristol Stool Chart
time frame: 7 Weeks (from Day -6 to the follow-up visit on Day 42)
description: Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.
measure: Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
time frame: 28 Days
description: Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.
measure: Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
time frame: Days 1, 14 and 28
description: Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.
arm group label: JTT-662 5 mg
arm group type: Experimental
description: JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
arm group label: JTT-662 10 mg
arm group type: Experimental
description: JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
arm group label: JTT-662 20 mg
arm group type: Experimental
description: JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo orally once daily from Day -1 to Day 28
intervention type: Drug
intervention name: JTT-662
description: Active drug tablets containing JTT-662
arm group label: JTT-662 10 mg
arm group label: JTT-662 20 mg
arm group label: JTT-662 5 mg
intervention type: Drug
intervention name: Placebo
description: Placebo tablets matching in appearance to the active drug tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 