<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/NCT02226822</url>
  </required_header>
  <id_info>
    <org_study_id>D1692R00001</org_study_id>
    <nct_id>NCT02226822</nct_id>
  </id_info>
  <brief_title>DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan</brief_title>
  <acronym>J-DISCOVER</acronym>
  <official_title>J-DISCOVER: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to prospectively research the treatment reality and long-term disease&#xD;
      control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes&#xD;
      treatment in sites across Japan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a single country, multicenter, observational, prospective, longitudinal cohort&#xD;
      study which will include adult patients with documented history of T2DM who are initiating a&#xD;
      second line oral or parenteral anti-diabetes mediation after their first line anti-diabetic&#xD;
      therapy in real world setting. The follow-up period is 3 years. Patients will undergo&#xD;
      clinical assessments and receive standard medical care as determined by the treating&#xD;
      physician. Patients will not receive experimental intervention or experimental treatment as a&#xD;
      consequence of their participation in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2014</start_date>
  <completion_date type="Actual">February 12, 2019</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Classes of diabetic medications at baseline and changes up to 3 years</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Classes of anti-diabetic medications at baseline and any changes of anti-diabetic medications during 3 years follow-up period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, treatment response in terms of changes in HbA1c from baseline, achievement rate of HbA1c and blood glucose target goals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose level change from baseline</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood glucose level (FPG or CPG or PPG) from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight change from baseline</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, treatment response in terms of changes in body weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure change from baseline</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood pressure from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile changes from baseline</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, treatment response in terms of changes in lipid profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of microvascular complications</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, disease progression in terms of microvascular complications: incidence of chronic nephropathy, dialysis, diabetic retinopathy, retinal photocoagulation, amputation of lower extremity, diabetic foot, peripheral nerve disorders, autonomic nervous system disorders and erectile dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia events</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, hypoglycemic events and hyperglycermia hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported Quality of Life, diet, and physical activity level</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, patient reported Quality of Life, diet, and physical activity level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initiation of insulin therapy, Proportion of patients using insulin</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Initiation of insulin therapy (e.g., reporting the average number of anti-diabetic therapies prescribed as insulin therapy is initiated and dose of insulin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Switching of anti-diabetic medications or dose change</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Switching of anti-diabetic medications or dose change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initiation of third line or above add-on anti-diabetic medications</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Initiation of third line or above add-on anti-diabetic medication (e.g., reporting proportion of patients receiving 2nd, 3rd, 4th or greater anti-diabetic therapies at each follow-up visit)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of macrovascular complications</measure>
    <time_frame>At 6, 12, 24, 36 month from enrollment</time_frame>
    <description>Overall and by second line anti-diabetic medication class, disease progression in terms of macrovascular complications (heart failure, myocardial infarction and stroke).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors</measure>
    <time_frame>At 6, 12, 24, 36 month after enrollment</time_frame>
    <description>Risk factors (patient characteristics at baseline: e.g. age, gender, duration of diabetes, presence of co-morbidities) associated with poorer clinical outcomes during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment choice</measure>
    <time_frame>At baseline</time_frame>
    <description>Determinants of treatment choice</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1869</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Adult patients with documented T2DM</arm_group_label>
    <description>Adult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with documented history of type 2 diabetes mellitus who are initiating their&#xD;
        second line oral or parenteral anti-diabetics medication after first line oral diabetic&#xD;
        therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written consent obtained&#xD;
&#xD;
          2. Aged &gt; = 20 years&#xD;
&#xD;
          3. Diagnosed with type 2 diabetes mellitus&#xD;
&#xD;
          4. Initiating a second oral or parenteral anti-diabetic therapy added to oral&#xD;
             anti-diabetic monotherapy or switching from the monotherapy to another monotherapy&#xD;
             with different drug class&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Type 1 Diabetes Mellitus&#xD;
&#xD;
          2. Current pregnancy&#xD;
&#xD;
          3. Current treatment for any cancer&#xD;
&#xD;
          4. Current dialysis treatment or renal transplantation&#xD;
&#xD;
          5. Current treatment with any oral steroids&#xD;
&#xD;
          6. Participation in any randomized control trials&#xD;
&#xD;
          7. Presence of any condition/circumstance which in the opinion of the investigator could&#xD;
             significantly limit the complete follow up of the patient (e.g. tourist, non-native&#xD;
             speaker who does not understand the local language where interpreter are not&#xD;
             available, psychiatric disturbances, alcohol or drug abuse).&#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>Kiyoshi Hashigami, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca K.K.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Iichiro Shimomura, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Metabolic Medicine (Internal Medicine), Graduate School of Medicine, Osaka University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hirotaka Watada, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Metabolism &amp; Endocrinology, Graduate School of Medicine, Juntendo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anjo</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anzai</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Komatsu</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hirosaki</city>
        <state>Aomori</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Funabashi</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kisarazu</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tateyama</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ono</city>
        <state>Fukui</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Itoshima</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kurate-gun</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oguri</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Onojo</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iwaki</city>
        <state>Fukushima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shirakawa</city>
        <state>Fukushima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Isesaki</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kanra-gun</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shibukawa</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Takasaki</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukuyama</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Asahikawa</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hakodate</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kamikawa</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Muroran</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nakagawa</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Otaru</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amagasaki</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kobe</city>
        <state>Hyougo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tamba</city>
        <state>Hyougo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hitachi</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Koga</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ushiku</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Komatsu</city>
        <state>Ishikawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Takamatsu</city>
        <state>Kagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kanoya</city>
        <state>Kagoshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chigasaki</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hiratsuka</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Isehara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kamakura</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hitoyoshi</city>
        <state>Kumamoto</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tamana</city>
        <state>Kumamoto</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ise</city>
        <state>Mie</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tsu</city>
        <state>Mie</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yokkaichi</city>
        <state>Mie</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nichinan</city>
        <state>Miyazaki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iida</city>
        <state>Nagano</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ueda</city>
        <state>Nagano</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kitakatsuragi-gun</city>
        <state>Nara</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Joetsu</city>
        <state>Nigata</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tomigusuku</city>
        <state>Okinawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Urazoe</city>
        <state>Okinawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ikuno-ku</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kashiwara</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sennan-gun</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toyonaka</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Imari</city>
        <state>Saga</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Karatsu</city>
        <state>Saga</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nishimatuura</city>
        <state>Saga</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kasukabe</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sakado</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Koka</city>
        <state>Shiga</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kouka</city>
        <state>Shiga</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Maibara</city>
        <state>Shiga</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Otsu</city>
        <state>Shiga</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yaizu</city>
        <state>Shizuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nasushiobara</city>
        <state>Tochigi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oyama</city>
        <state>Tochigi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shimotsuga-gun</city>
        <state>Tochigi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edogawa-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hachioji</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kita-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Koganei</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kokubunji</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mitaka</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nerima-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shinjuku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iwade</city>
        <state>Wakayama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mogami</city>
        <state>Yamagata</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Koufu</city>
        <state>Yamanashi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukui</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kochi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miyazaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tochigi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D1692R00001&amp;amp;attachmentIdentifier=c4198b29-3cc2-4610-9434-d1ed7ba52643&amp;amp;fileName=D1692R00001_CSR_synopsis_redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>redacted CSR synopsis</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</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>
  <!-- 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/NCT02226822
org study id: D1692R00001
nct id: NCT02226822
lead sponsor: 
collaborator: 
has dmc: No
This study is intended to prospectively research the treatment reality and long-term disease
      control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes
      treatment in sites across Japan.
This study is a single country, multicenter, observational, prospective, longitudinal cohort
      study which will include adult patients with documented history of T2DM who are initiating a
      second line oral or parenteral anti-diabetes mediation after their first line anti-diabetic
      therapy in real world setting. The follow-up period is 3 years. Patients will undergo
      clinical assessments and receive standard medical care as determined by the treating
      physician. Patients will not receive experimental intervention or experimental treatment as a
      consequence of their participation in the study.
observational model: Cohort
time perspective: Prospective
measure: Classes of diabetic medications at baseline and changes up to 3 years
time frame: At 6, 12, 24, 36 month from enrollment
description: Classes of anti-diabetic medications at baseline and any changes of anti-diabetic medications during 3 years follow-up period.
measure: Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, treatment response in terms of changes in HbA1c from baseline, achievement rate of HbA1c and blood glucose target goals
measure: Blood glucose level change from baseline
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood glucose level (FPG or CPG or PPG) from baseline.
measure: Body weight change from baseline
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, treatment response in terms of changes in body weight.
measure: Blood pressure change from baseline
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood pressure from baseline.
measure: Lipid profile changes from baseline
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, treatment response in terms of changes in lipid profile
measure: Incidence of microvascular complications
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, disease progression in terms of microvascular complications: incidence of chronic nephropathy, dialysis, diabetic retinopathy, retinal photocoagulation, amputation of lower extremity, diabetic foot, peripheral nerve disorders, autonomic nervous system disorders and erectile dysfunction.
measure: Hypoglycemia events
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, hypoglycemic events and hyperglycermia hospitalizations
measure: Patient reported Quality of Life, diet, and physical activity level
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, patient reported Quality of Life, diet, and physical activity level
measure: Initiation of insulin therapy, Proportion of patients using insulin
time frame: At 6, 12, 24, 36 month from enrollment
description: Initiation of insulin therapy (e.g., reporting the average number of anti-diabetic therapies prescribed as insulin therapy is initiated and dose of insulin)
measure: Switching of anti-diabetic medications or dose change
time frame: At 6, 12, 24, 36 month from enrollment
description: Switching of anti-diabetic medications or dose change
measure: Initiation of third line or above add-on anti-diabetic medications
time frame: At 6, 12, 24, 36 month from enrollment
description: Initiation of third line or above add-on anti-diabetic medication (e.g., reporting proportion of patients receiving 2nd, 3rd, 4th or greater anti-diabetic therapies at each follow-up visit)
measure: Incidence of macrovascular complications
time frame: At 6, 12, 24, 36 month from enrollment
description: Overall and by second line anti-diabetic medication class, disease progression in terms of macrovascular complications (heart failure, myocardial infarction and stroke).
measure: Risk factors
time frame: At 6, 12, 24, 36 month after enrollment
description: Risk factors (patient characteristics at baseline: e.g. age, gender, duration of diabetes, presence of co-morbidities) associated with poorer clinical outcomes during follow-up
measure: Treatment choice
time frame: At baseline
description: Determinants of treatment choice
arm group label: Adult patients with documented T2DM
description: Adult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Kiyoshi Hashigami, M.D.
role: Study Director
affiliation: AstraZeneca K.K.
last name: Iichiro Shimomura, M.D., Ph.D.
role: Principal Investigator
affiliation: Department of Metabolic Medicine (Internal Medicine), Graduate School of Medicine, Osaka University
last name: Hirotaka Watada, M.D., Ph.D.
role: Principal Investigator
affiliation: Department of Metabolism & Endocrinology, Graduate School of Medicine, Juntendo University
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: 
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: Japan
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D1692R00001&amp;attachmentIdentifier=c4198b29-3cc2-4610-9434-d1ed7ba52643&amp;fileName=D1692R00001_CSR_synopsis_redacted.pdf&amp;versionIdentifier=
description: redacted CSR synopsis
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2