<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/NCT01672762</url>
  </required_header>
  <id_info>
    <org_study_id>1941-CL-0122</org_study_id>
    <nct_id>NCT01672762</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients</brief_title>
  <official_title>Phase III Study of ASP1941 -A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to&#xD;
      diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will undergo the 6-week screening period before entering the 24-week treatment&#xD;
      period and will receive ASP1941 before breakfast during the treatment period. All subjects&#xD;
      will be followed for 4 weeks after study treatment is discontinued.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2012</start_date>
  <completion_date type="Actual">April 13, 2013</completion_date>
  <primary_completion_date type="Actual">April 13, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>Before and at 4-, 8-, 12-, 16-, 20- and 24-week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose</measure>
    <time_frame>Before and at 4-, 8-, 12-, 16-, 20- and 24-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting serum insulin</measure>
    <time_frame>Before and at 4-, 8-, 12-, 16-, 20- and 24-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>Before and at 4-, 8-, 12-, 16-, 20- and 24-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Before and at 4-, 8-, 12-, 16-, 20- and 24-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urine glucose</measure>
    <time_frame>Before and at 4-, 8-, 12-, 16-, 20- and 24-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>ASP1941 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ipragliflozin</intervention_name>
    <description>oral</description>
    <arm_group_label>ASP1941 group</arm_group_label>
    <other_name>ASP1941</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus patients&#xD;
&#xD;
          -  Subject is only on a diet and exercise program or has received a single&#xD;
             antihyperglycemic agent or two antihyperglycemic agents (excluding insulin) with low&#xD;
             dose (≤50% of the maximum dose of each recommended dosage)&#xD;
&#xD;
          -  Subject has a HbA1c value (JDS value) between 6.5% and 9.5% and the difference of&#xD;
             HbA1c values (JDS value) within ± 1.0%&#xD;
&#xD;
          -  BMI 20.0 - 45.0 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 Diabetes Mellitus&#xD;
&#xD;
          -  Subject has received insulin within 12 weeks (84 days) before the study&#xD;
&#xD;
          -  Subject has proliferative diabetic retinopathy&#xD;
&#xD;
          -  Subject has a history of clinically significant renal disease such as renovascular&#xD;
             occlusive disease, nephrectomy and/or renal transplant&#xD;
&#xD;
          -  Subject with obvious dysuria caused by a neurogenic bladder or a benign prostatic&#xD;
             hypertrophy&#xD;
&#xD;
          -  Subject has a history of cerebral vascular attack, unstable angina, myocardial&#xD;
             infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 12&#xD;
             weeks (84 days). Subject has heart disease, cerebral vascular disease which, in the&#xD;
             opinion of the principal investigator or the sub-investigator, may interfere with&#xD;
             treatment or evaluation of safety of this study.&#xD;
&#xD;
          -  Female subject who is currently pregnant or lactating, or who is possibly pregnant&#xD;
&#xD;
          -  Male and pre-menopausal Female subject who cannot use an appropriate contraception&#xD;
             during the study&#xD;
&#xD;
          -  Subject has a history of treatment with ASP1941&#xD;
&#xD;
          -  Subject has participated in another clinical study, post marketing study, or medical&#xD;
             equipment study within 12 weeks (84 days) before providing written informed consent,&#xD;
             or who is currently participating in any of those studies&#xD;
&#xD;
          -  Subject has a serum creatinine value higher than upper limit of normal range&#xD;
&#xD;
          -  Subject has a urinary microalbumin/ urinary creatinine ratio &gt; 300 mg/g in urinalysis&#xD;
&#xD;
          -  Subject has uncontrolled severe hypertension (subject whose systolic blood pressure is&#xD;
             &gt; 170 mmHg or diastolic blood pressure of &gt; 95 mmHg measured in a sitting position&#xD;
             after 5 minutes of rest&#xD;
&#xD;
          -  Subject who is judged inappropriate for enrollment into the study by the principal&#xD;
             investigator or the sub-investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Chubu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kantou</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyushu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shikoku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Touhoku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://astellasclinicalstudyresults.com/study.aspx?ID=107</url>
    <description>Link to results on Astellas Clinical Study Results website</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glucose excretion</keyword>
  <keyword>ipragliflozin</keyword>
  <keyword>hypoglycemic agents</keyword>
  <keyword>serum Insulin</keyword>
  <keyword>diabetes mellitus</keyword>
  <keyword>blood glucose</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>Ipragliflozin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </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/NCT01672762
org study id: 1941-CL-0122
nct id: NCT01672762
lead sponsor: 
has dmc: No
This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to
      diabetic patients.
Subjects will undergo the 6-week screening period before entering the 24-week treatment
      period and will receive ASP1941 before breakfast during the treatment period. All subjects
      will be followed for 4 weeks after study treatment is discontinued.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c
time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in fasting plasma glucose
time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in fasting serum insulin
time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in waist circumference
time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in body weight
time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in urine glucose
time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs
time frame: 24 weeks
arm group label: ASP1941 group
arm group type: Experimental
description: oral
intervention type: Drug
intervention name: ipragliflozin
description: oral
arm group label: ASP1941 group
other name: ASP1941
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
url: https://astellasclinicalstudyresults.com/study.aspx?ID=107
description: Link to results on Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Ipragliflozin
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."