<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/NCT01699737</url>
  </required_header>
  <id_info>
    <org_study_id>AT851-U-12-002</org_study_id>
    <nct_id>NCT01699737</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to&#xD;
      assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients&#xD;
      either treated with metformin or treatment-naïve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, double-dummy, placebo and active-controlled&#xD;
      (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on&#xD;
      HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and&#xD;
      pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated&#xD;
      type 2 diabetic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851</measure>
    <time_frame>12 weeks</time_frame>
    <description>To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the safety and tolerability of JTT-851 when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on ancillary efficacy measures</measure>
    <time_frame>12 weeks</time_frame>
    <description>To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of JTT-851 and its metabolites</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Relationship between dose and response of JTT-851</measure>
    <time_frame>12 weeks</time_frame>
    <description>To explore the relationship between the JTT-851 dose (exposure) and response</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">325</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>JTT-851 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTT-851 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTT-851 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glimepiride Dose 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo active &amp; Placebo comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JTT-851</intervention_name>
    <arm_group_label>JTT-851 Dose 1</arm_group_label>
    <arm_group_label>JTT-851 Dose 2</arm_group_label>
    <arm_group_label>JTT-851 Dose 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glimepiride</intervention_name>
    <description>Encapsulated Glimepiride tablets</description>
    <arm_group_label>Glimepiride Dose 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Active</intervention_name>
    <arm_group_label>Glimepiride Dose 1</arm_group_label>
    <arm_group_label>Placebo active &amp; Placebo comparator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for comparator</intervention_name>
    <arm_group_label>JTT-851 Dose 1</arm_group_label>
    <arm_group_label>JTT-851 Dose 2</arm_group_label>
    <arm_group_label>JTT-851 Dose 3</arm_group_label>
    <arm_group_label>Placebo active &amp; Placebo comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females with type 2 diabetes, 18-70 years of age at Visit 1&#xD;
&#xD;
          -  Managing diabetes with diet and exercise only or currently being treated with a stable&#xD;
             dose of metformin (at least 1500 mg/day)&#xD;
&#xD;
          -  Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between&#xD;
             7.5% and 10.9%, if without treatment&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females who are pregnant or breast-feeding&#xD;
&#xD;
          -  Known medical history or presence of type 1 diabetes or acute metabolic diabetic&#xD;
             complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy&#xD;
&#xD;
          -  Acute coronary syndrome or uncontrolled hypertension&#xD;
&#xD;
          -  Does not meet all diet or previous/concomitant medication restriction criteria&#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>Hisashi Kodama, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Akros Pharma Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Muscle Shoals</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Artesia</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chino</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paramount</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spring Valley</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ft. Lauderdale</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kissimee</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oxon Hill</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olive Branch</city>
        <state>Mississippi</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mine Hill</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glen Falls</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marion</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Munroe Falls</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wadsworth</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lansdale</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Carrollton</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sugarland</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suffolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <disposition_first_submitted>July 25, 2013</disposition_first_submitted>
  <disposition_first_submitted_qc>July 25, 2013</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">August 1, 2013</disposition_first_posted>
  <last_update_submitted>July 25, 2013</last_update_submitted>
  <last_update_submitted_qc>July 25, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glimepiride</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01699737
org study id: AT851-U-12-002
nct id: NCT01699737
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to
      assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients
      either treated with metformin or treatment-naïve.
This is a randomized, double-blind, double-dummy, placebo and active-controlled
      (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on
      HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and
      pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated
      type 2 diabetic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851
time frame: 12 weeks
description: To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks
measure: Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo
time frame: 12 weeks
description: To evaluate the safety and tolerability of JTT-851 when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo.
measure: Effect on ancillary efficacy measures
time frame: 12 weeks
description: To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.
measure: Pharmacokinetics of JTT-851 and its metabolites
time frame: 12 weeks
description: To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes
measure: Relationship between dose and response of JTT-851
time frame: 12 weeks
description: To explore the relationship between the JTT-851 dose (exposure) and response
arm group label: JTT-851 Dose 1
arm group type: Experimental
description: JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
arm group label: JTT-851 Dose 2
arm group type: Experimental
description: JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
arm group label: JTT-851 Dose 3
arm group type: Experimental
description: JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
arm group label: Glimepiride Dose 1
arm group type: Active Comparator
description: Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
arm group label: Placebo active & Placebo comparator
arm group type: Placebo Comparator
description: Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks
intervention type: Drug
intervention name: JTT-851
arm group label: JTT-851 Dose 1
arm group label: JTT-851 Dose 2
arm group label: JTT-851 Dose 3
intervention type: Drug
intervention name: Glimepiride
description: Encapsulated Glimepiride tablets
arm group label: Glimepiride Dose 1
intervention type: Drug
intervention name: Placebo for Active
arm group label: Glimepiride Dose 1
arm group label: Placebo active & Placebo comparator
intervention type: Drug
intervention name: Placebo for comparator
arm group label: JTT-851 Dose 1
arm group label: JTT-851 Dose 2
arm group label: JTT-851 Dose 3
arm group label: Placebo active & Placebo comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hisashi Kodama, Ph.D.
role: Study Chair
affiliation: Akros Pharma Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Glimepiride