<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/NCT01685502</url>
  </required_header>
  <id_info>
    <org_study_id>16517</org_study_id>
    <secondary_id>Glucobay OD</secondary_id>
    <nct_id>NCT01685502</nct_id>
  </id_info>
  <brief_title>Special Drug Use Investigation of Glucobay OD</brief_title>
  <official_title>Special Drug Use Investigation of Glucobay OD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the efficacy and safety under practical use of&#xD;
      Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1&#xD;
      year observation period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Decrease rate of HbA1c</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>up to1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2289</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Patients treated with Glucobay OD under practical manner</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucobay ODT (Acarbose, BAYG5421)</intervention_name>
    <description>Patients treated with Glucobay OD under practical manner</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Glucobay OD naive diabetics. Patients with at least one of the following conditions:&#xD;
        Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Glucobay OD naive diabetics. patients with at least one of the following conditions:&#xD;
             Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin&#xD;
             therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are contraindicated based on the product label&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>October 17, 2014</last_update_submitted>
  <last_update_submitted_qc>October 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glucobay OD</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acarbose</mesh_term>
  </intervention_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/NCT01685502
org study id: 16517
secondary id: Glucobay OD
nct id: NCT01685502
lead sponsor: 
has dmc: No
The objective of this study is to assess the efficacy and safety under practical use of
      Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1
      year observation period.
observational model: Case-Only
time perspective: Prospective
measure: Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)
time frame: Up to 1 year
measure: Decrease rate of HbA1c
time frame: Up to 1 year
measure: Body weight
time frame: up to1 year
arm group label: Group 1
description: Patients treated with Glucobay OD under practical manner
intervention type: Drug
intervention name: Glucobay ODT (Acarbose, BAYG5421)
description: Patients treated with Glucobay OD under practical manner
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Acarbose