<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/NCT02222350</url>
  </required_header>
  <id_info>
    <org_study_id>DS8500-A-J201</org_study_id>
    <nct_id>NCT02222350</nct_id>
  </id_info>
  <brief_title>Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes</brief_title>
  <official_title>A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with&#xD;
      placebo in Japanese patients with Type 2 Diabetes Mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75&#xD;
      mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients&#xD;
      with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design.&#xD;
      The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline.&#xD;
      The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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 24-hour weighted mean blood glucose</measure>
    <time_frame>Day -1 (baseline) to Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in 24 hour weighted mean blood glucose</measure>
    <time_frame>Day -1 (baseline) to Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood fasting plasma glucose level</measure>
    <time_frame>Day -1 (baseline) to Days 7, 14, 21, 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood plasma glucose level</measure>
    <time_frame>Day -1 (baseline) to Days 14 and 28</time_frame>
    <description>Change in the parameter at Day 14 or 28 from Day -1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood insulin level</measure>
    <time_frame>Day -1 (baseline) to Days 14 and 28</time_frame>
    <description>Change in the parameter at Day 14 or 28 from Day -1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood C-peptide level</measure>
    <time_frame>Day -1 (baseline) to Days 14 and 28</time_frame>
    <description>Change in the parameter at Day 14 or 28 from Day -1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood active GLP-1 level</measure>
    <time_frame>Day -1 (baseline) to Days 14 and 28</time_frame>
    <description>Change in the parameter at Day 14 or 28 from Day -1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood PYY level</measure>
    <time_frame>Day -1 (baseline) to Days 14 and 28</time_frame>
    <description>Change in the parameter at Day 14 or 28 from Day -1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood HbA1c level</measure>
    <time_frame>Day -1 (baseline) to Days 14 and 28</time_frame>
    <description>Change in the parameter at Day 14 or 28 from Day -1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood glycoalbumin level</measure>
    <time_frame>Day -1 (baseline) to Days 14 and 28</time_frame>
    <description>Change in the parameter at Day 14 or 28 from Day -1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects experiencing adverse events as a measure of safety</measure>
    <time_frame>Day -1 (baseline) to Day 28</time_frame>
    <description>Number of subjects experiencing adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pharmacokinetic profile of DS-8500a</measure>
    <time_frame>Day -1 (baseline) to Day 28</time_frame>
    <description>Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in postprandial plasma glucose level</measure>
    <time_frame>Day -1 (baseline) to Days 14 and 28</time_frame>
    <description>Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>DS-8500a 10mg once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10mg DS-8500a tablet given orally once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DS8500a 75 mg once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>75mg DS-8500a tablet given orally once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo to match DS-8500a tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo matching DS-8500a tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10mg DS-8500a tablet</intervention_name>
    <arm_group_label>DS-8500a 10mg once daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>75mg DS-8500a tablet</intervention_name>
    <arm_group_label>DS8500a 75 mg once daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>placebo to match DS-8500a tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥ 20 years at the time of informed consent&#xD;
&#xD;
          -  Japanese patients with type 2 diabetes&#xD;
&#xD;
          -  Patients who have HbA1c ≥ 7.0% and &lt; 10.0% if untreated with antidiabetic agent.&#xD;
&#xD;
          -  Patients who have HbA1c ≥ 6.5% and &lt; 9.5% if treated with antidiabetic agent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥ 70 years at the time of informed consent&#xD;
&#xD;
          -  Patients with a history of type 1 diabetes or diabetic ketoacidosis&#xD;
&#xD;
          -  Patients receiving or requiring treatment with insulin&#xD;
&#xD;
          -  Patients with a body mass index (BMI) of &lt; 18.5 kg/m2 or ≥ 35.0 kg/m2&#xD;
&#xD;
          -  Patients with an estimated glomerular filtration rate (eGFR), &lt; 45 mL/min per 1.73 m2&#xD;
&#xD;
          -  Patients with fasting plasma glucose ≥ 240 mg/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Heishinkai Medical Group Incorporated OCROM Clinic</name>
      <address>
        <city>Kasuga</city>
        <state>Osaka</state>
        <zip>565-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 2 diabetes mellitus</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>Firuglipel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/daiichi-sankyo/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02222350
org study id: DS8500-A-J201
nct id: NCT02222350
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with
      placebo in Japanese patients with Type 2 Diabetes Mellitus.
The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75
      mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients
      with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design.
      The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline.
      The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: change in 24-hour weighted mean blood glucose
time frame: Day -1 (baseline) to Day 28
measure: change in 24 hour weighted mean blood glucose
time frame: Day -1 (baseline) to Day 14
measure: change in blood fasting plasma glucose level
time frame: Day -1 (baseline) to Days 7, 14, 21, 28
measure: change in blood plasma glucose level
time frame: Day -1 (baseline) to Days 14 and 28
description: Change in the parameter at Day 14 or 28 from Day -1
measure: change in blood insulin level
time frame: Day -1 (baseline) to Days 14 and 28
description: Change in the parameter at Day 14 or 28 from Day -1
measure: change in blood C-peptide level
time frame: Day -1 (baseline) to Days 14 and 28
description: Change in the parameter at Day 14 or 28 from Day -1
measure: change in blood active GLP-1 level
time frame: Day -1 (baseline) to Days 14 and 28
description: Change in the parameter at Day 14 or 28 from Day -1
measure: change in blood PYY level
time frame: Day -1 (baseline) to Days 14 and 28
description: Change in the parameter at Day 14 or 28 from Day -1
measure: change in blood HbA1c level
time frame: Day -1 (baseline) to Days 14 and 28
description: Change in the parameter at Day 14 or 28 from Day -1
measure: change in blood glycoalbumin level
time frame: Day -1 (baseline) to Days 14 and 28
description: Change in the parameter at Day 14 or 28 from Day -1
measure: Number of subjects experiencing adverse events as a measure of safety
time frame: Day -1 (baseline) to Day 28
description: Number of subjects experiencing adverse events
measure: pharmacokinetic profile of DS-8500a
time frame: Day -1 (baseline) to Day 28
description: Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2
measure: change in postprandial plasma glucose level
time frame: Day -1 (baseline) to Days 14 and 28
description: Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1
arm group label: DS-8500a 10mg once daily
arm group type: Experimental
description: 10mg DS-8500a tablet given orally once daily
arm group label: DS8500a 75 mg once daily
arm group type: Experimental
description: 75mg DS-8500a tablet given orally once daily
arm group label: placebo to match DS-8500a tablet
arm group type: Placebo Comparator
description: placebo matching DS-8500a tablet
intervention type: Drug
intervention name: 10mg DS-8500a tablet
arm group label: DS-8500a 10mg once daily
intervention type: Drug
intervention name: 75mg DS-8500a tablet
arm group label: DS8500a 75 mg once daily
intervention type: Drug
intervention name: placebo
arm group label: placebo to match DS-8500a tablet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 69 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Firuglipel
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
ipd access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
ipd url: https://vivli.org/ourmember/daiichi-sankyo/