<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/NCT03817463</url>
  </required_header>
  <id_info>
    <org_study_id>1245-0195</org_study_id>
    <nct_id>NCT03817463</nct_id>
  </id_info>
  <brief_title>A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes</brief_title>
  <official_title>Multi-country Non-interventional Study on the Effectiveness of Empagliflozin in Adult Patients With Type 2 Diabetes in Europe and Asia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-interventional, multi-country cohort study using existing data and including adults (≥18&#xD;
      years) with a diagnosis of Type 2 diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">December 10, 2021</completion_date>
  <primary_completion_date type="Actual">December 10, 2021</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>Number of participants hospitalized for heart failure</measure>
    <time_frame>up to 4.5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with all-cause mortality</measure>
    <time_frame>up to 4.5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with both hospitalization for heart failure and all cause mortality</measure>
    <time_frame>up to 4.5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with myocardial infraction (MI), stroke, all cause mortality</measure>
    <time_frame>up to 4.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Cardiovascular mortality</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a composite outcome including hospitalization for heart failure and cardiovascular (CV) mortality</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with 3-point major adverse cardiovascular (CV) events (MACE), defined as a composite outcome including myocardial infarction (MI),stroke, and cardiovascular (CV) mortality</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with coronary revascularization procedure</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with end-stage renal disease (ESRD)</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with estimated glomerular filtration rate (eGFR) decline</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with progression from normoalbuminuria to micro- or macroalbuminuria</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a composite outcome including eGFR decline and progression to micro- or macroalbuminuria</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with bone fracture</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with diabetic ketoacidosis</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with severe hypoglycemia</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with lower-limb amputation</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with acute kidney injury requiring dialysis</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resource utilization</measure>
    <time_frame>up to 4.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of care</measure>
    <time_frame>up to 4.5 years</time_frame>
    <description>Costs of HCRU</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">171808</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Patients with T2DM</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor</intervention_name>
    <description>Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor</description>
    <arm_group_label>Patients with T2DM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor</intervention_name>
    <description>Dipeptidyl peptidase-4 (DPP-4) inhibitor</description>
    <arm_group_label>Patients with T2DM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This will be a non-interventional, multi-country cohort study using existing data and&#xD;
        including adults (≥18 years) with a diagnosis of T2DM. All data will be obtained from&#xD;
        electronically recorded longitudinal secondary data sources, separately in each included&#xD;
        country. In each country, patients initiating treatment with empagliflozin or any other&#xD;
        SGLT-2 inhibitor will be compared with PS-matched patients initiating treatment with any&#xD;
        DPP-4inhibitor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dispensation or any other record of empagliflozin, any SGLT-2 inhibitor, or any DPP-4&#xD;
             inhibitor use during the study period&#xD;
&#xD;
          -  No dispensation or any other record of any other SGLT-2 inhibitor or DPP-4 inhibitor&#xD;
             use during the preceding 12 months including at index date&#xD;
&#xD;
          -  Having a diagnosis of T2DM before the index date, based on ICD-10 codes or other&#xD;
             available data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged &lt;18 years on the first dispensation date or date of the first record of&#xD;
             empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor use&#xD;
&#xD;
          -  Type 1 diabetes mellitus&#xD;
&#xD;
          -  Secondary diabetes&#xD;
&#xD;
          -  Gestational diabetes&#xD;
&#xD;
          -  Having a diagnosis of ESRD during the 12 months before the index date&#xD;
&#xD;
          -  &lt;12 months of available data before the index date, and/or no complete history of drug&#xD;
             dispensations/other records of the drug use during this period&#xD;
&#xD;
          -  Missing or ambiguous data on age or sex&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly G Brodovicz, (203) 448-1937</last_name>
    <role>Study Chair</role>
    <affiliation>kimberly.brodovicz@boehringer-ingelheim.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology</name>
      <address>
        <city>Gentofte</city>
        <zip>2820</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ulm, Institute for Epidemiology and medical biometry</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maccabi Healthcare Services</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6812509</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu University</name>
      <address>
        <city>Gifu</city>
        <zip>501-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital, Department of Clinical Lipidology</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital, Department of Cardiology</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigación Sanitaria INCLIVA</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TFS Trial Form Support International AB</name>
      <address>
        <city>Lund</city>
        <zip>223 63</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quantify Research AB</name>
      <address>
        <city>Stockholm</city>
        <zip>112 21</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR)</name>
      <address>
        <city>Taipei City</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Real World Evidence Unit, Leicester general Hospital</name>
      <address>
        <city>Leicester</city>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 18, 2022</last_update_submitted>
  <last_update_submitted_qc>January 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Empagliflozin</mesh_term>
    <mesh_term>Dipeptidyl-Peptidase IV Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
For more details refer to: https://www.mystudywindow.com/msw/datatransparency</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>December 8, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03817463
org study id: 1245-0195
nct id: NCT03817463
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Non-interventional, multi-country cohort study using existing data and including adults (≥18
      years) with a diagnosis of Type 2 diabetes mellitus.
observational model: Cohort
time perspective: Prospective
measure: Number of participants hospitalized for heart failure
time frame: up to 4.5 years
measure: Number of participants with all-cause mortality
time frame: up to 4.5 years
measure: Number of participants with both hospitalization for heart failure and all cause mortality
time frame: up to 4.5 years
measure: Number of participants with myocardial infraction (MI), stroke, all cause mortality
time frame: up to 4.5 years
measure: Number of participants with Cardiovascular mortality
time frame: up to 4.5 years
measure: Number of participants with a composite outcome including hospitalization for heart failure and cardiovascular (CV) mortality
time frame: up to 4.5 years
measure: Number of participants with 3-point major adverse cardiovascular (CV) events (MACE), defined as a composite outcome including myocardial infarction (MI),stroke, and cardiovascular (CV) mortality
time frame: up to 4.5 years
measure: Number of participants with coronary revascularization procedure
time frame: up to 4.5 years
measure: Number of participants with end-stage renal disease (ESRD)
time frame: up to 4.5 years
measure: Number of participants with estimated glomerular filtration rate (eGFR) decline
time frame: up to 4.5 years
measure: Number of participants with progression from normoalbuminuria to micro- or macroalbuminuria
time frame: up to 4.5 years
measure: Number of participants with a composite outcome including eGFR decline and progression to micro- or macroalbuminuria
time frame: up to 4.5 years
measure: Number of participants with bone fracture
time frame: up to 4.5 years
measure: Number of participants with diabetic ketoacidosis
time frame: up to 4.5 years
measure: Number of participants with severe hypoglycemia
time frame: up to 4.5 years
measure: Number of participants with lower-limb amputation
time frame: up to 4.5 years
measure: Number of participants with acute kidney injury requiring dialysis
time frame: up to 4.5 years
measure: Healthcare resource utilization
time frame: up to 4.5 years
measure: Cost of care
time frame: up to 4.5 years
description: Costs of HCRU
arm group label: Patients with T2DM
intervention type: Drug
intervention name: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
description: Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
arm group label: Patients with T2DM
intervention type: Drug
intervention name: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor
description: Dipeptidyl peptidase-4 (DPP-4) inhibitor
arm group label: Patients with T2DM
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kimberly G Brodovicz, (203) 448-1937
role: Study Chair
affiliation: kimberly.brodovicz@boehringer-ingelheim.com
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Finland
country: Germany
country: Israel
country: Japan
country: Korea, Republic of
country: Norway
country: Spain
country: Sweden
country: Taiwan
country: United Kingdom
url: https://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Empagliflozin
mesh term: Dipeptidyl-Peptidase IV Inhibitors
sharing ipd: No
ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
submitted: December 8, 2022