<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/NCT03748810</url>
  </required_header>
  <id_info>
    <org_study_id>SGLT2 inhibitor 2018</org_study_id>
    <nct_id>NCT03748810</nct_id>
  </id_info>
  <brief_title>Head-to-head Comparison of Empagliflozin and Dapagliflozin</brief_title>
  <official_title>Head-to-head Comparison of Quadruple Combination Therapy With Empagliflozin and Dapagliflozin in Patients With Poorly Controlled Type 2 Diabetes (T2D) Despite Three Existing Oral Antidiabetic Drugs (OAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chungbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chungbuk National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-labeled, prospective, observational, 3-year, clinical study was conducted to&#xD;
      compare the effectiveness and safety between empagliflozin (25 mg once daily) and&#xD;
      dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes&#xD;
      despite preexisting triple OAD combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants included in this study were initially requested to initiate therapy with&#xD;
      insulin, but they insisted on another form of OAD. When participants declined insulin&#xD;
      injection and requested another OAD, they were not randomly assigned to each groups. It is&#xD;
      fairly common among participants with T2D to decline insulin therapy, despite being aware of&#xD;
      its importance and the benefits in controlling blood glucose. Their lack of willingness to&#xD;
      use insulin is explained by their avoidance of painful injections, the potential for body&#xD;
      weight gain and their fear of hypoglycemia. The investigators conducted a regimen consisting&#xD;
      of four OADs, including empagliflozin or dapagliflozin, to confirm which regimen would be&#xD;
      effective and safe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Changes in HbA1c from baseline to week 156 (3-year)</measure>
    <time_frame>Baseline, week 156 (3-year)</time_frame>
    <description>Changes in HbA1c from baseline to week 156 (3-year)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in fasting plasma glucose from baseline to week 156 (3-year)</measure>
    <time_frame>Baseline, week 156 (3-year)</time_frame>
    <description>Changes in fasting plasma glucose from baseline to week 156 (3-year)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in HbA1c from baseline to week 104 (2-year)</measure>
    <time_frame>Baseline, week 104 (2-year)</time_frame>
    <description>Changes in HbA1c from baseline to week 104 (2-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HbA1c from baseline to week 52 (1-year)</measure>
    <time_frame>Baseline, week 52 (1-year)</time_frame>
    <description>Changes in HbA1c from baseline to week 52 (1-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HbA1c from baseline to week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Changes in HbA1c from baseline to week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting plasma glucose from baseline to week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Changes in fasting plasma glucose from baseline to week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting plasma glucose from baseline to week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Changes in fasting plasma glucose from baseline to week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting plasma glucose from baseline to week 56 (1-year)</measure>
    <time_frame>Baseline, Week 56 (1-year)</time_frame>
    <description>Changes in fasting plasma glucose from baseline to week 56 (1-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>Changes in weight between baseline and week 156 (3-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight between baseline and week 104 (2-year)</measure>
    <time_frame>Baseline, Week 104 (2-year)</time_frame>
    <description>Changes in weight between baseline and week 104 (2-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight between baseline and week 52</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Changes in weight between baseline and week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight between baseline and week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Changes in weight between baseline and week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight between baseline and week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Changes in weight between baseline and week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic blood pressure between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>Changes in systolic blood pressure between baseline and week 156 (3-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic blood pressure between baseline and week 104 (2-year)</measure>
    <time_frame>Baseline, Week 104 (2-year)</time_frame>
    <description>Changes in systolic blood pressure between baseline and week 104 (2-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic blood pressure between baseline and week 52</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Changes in systolic blood pressure between baseline and week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic blood pressure between baseline and week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Changes in systolic blood pressure between baseline and week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic blood pressure between baseline and week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Changes in systolic blood pressure between baseline and week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diastolic blood pressure between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>Changes in diastolic blood pressure between baseline and week 156 (3-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diastolic blood pressure between baseline and week 104 (2-year)</measure>
    <time_frame>Baseline, Week 104 (2-year)</time_frame>
    <description>Changes in diastolic blood pressure between baseline and week 104 (2-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diastolic blood pressure between baseline and week 52</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Changes in diastolic blood pressure between baseline and week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diastolic blood pressure between baseline and week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Changes in diastolic blood pressure between baseline and week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diastolic blood pressure between baseline and week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Changes in diastolic blood pressure between baseline and week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total cholesterol between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>Changes in total cholesterol between baseline and week 156 (3-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in triglyceride between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>Changes in triglyceride between baseline and week 156 (3-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in LDL-cholesterol between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>Changes in LDL-cholesterol between baseline and week 156 (3-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HDL-cholesterol between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>Changes in HDL-cholesterol between baseline and week 156 (3-year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with hypoglycemic episodes between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>All episodes consistent with hypoglycemic episodes with or without a confirmatory blood glucose reading were collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with at least 1 episode of genitourinary tract infections between baseline and week 156 (3-year)</measure>
    <time_frame>Baseline, Week 156 (3-year)</time_frame>
    <description>Percentage of patients with at least 1 episode of genitourinary tract infections</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Triple OADs failure</arm_group_label>
    <description>Empagliflozin or dapagliflozin as an add-on drug for inadequately controlled T2D patients who are already receiving a regimen of three distinct OADs, including metformin, glimepiride and dipeptidyl peptidase 4 (DPP4) inhibitors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin</intervention_name>
    <description>Empagliflozin 25 mg once daily add on the background OADs for 3 years</description>
    <arm_group_label>Triple OADs failure</arm_group_label>
    <other_name>Metformin</other_name>
    <other_name>Glimepiride</other_name>
    <other_name>DPP4 inhibitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin</intervention_name>
    <description>Dapagliflozin 25 mg once daily add on the background OADs for 3 years</description>
    <arm_group_label>Triple OADs failure</arm_group_label>
    <other_name>Metformin</other_name>
    <other_name>Glimepiride</other_name>
    <other_name>DPP4 inhibitor</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The targeted population consists of adult patients with type 2 diabetes mellitus treated in&#xD;
        outpatient setting by specialists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inadequately controlled under triple OADs (metformin, glimepiride, dipeptidyl&#xD;
             peptidase inhibitor) as evidenced by HbA1c 7.5-12%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Gestational diabetes&#xD;
&#xD;
          -  Diabetes due to secondary causes&#xD;
&#xD;
          -  Receiving anticancer treatment&#xD;
&#xD;
          -  Receiving glucocorticoids or immune-suppressants&#xD;
&#xD;
          -  have been treated with sodium-glucose co-transporter 2 inhibitors for more than 7&#xD;
             consecutive days within 3 months before entering this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae Hyun Ahn</last_name>
    <role>Study Chair</role>
    <affiliation>Chungbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Cheonju</city>
        <state>Chungcheongbuk-do</state>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chungbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Eu Jeong Ku</investigator_full_name>
    <investigator_title>Clinical assistant professor</investigator_title>
  </responsible_party>
  <keyword>Empagliflozin</keyword>
  <keyword>Dapagliflozin</keyword>
  <keyword>Sodium-glucose cotransporter 2 inhibitors</keyword>
  <keyword>Quadruple combination antidiabetic drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Metformin</mesh_term>
    <mesh_term>Dapagliflozin</mesh_term>
    <mesh_term>Empagliflozin</mesh_term>
    <mesh_term>Glimepiride</mesh_term>
    <mesh_term>Dipeptidyl-Peptidase IV Inhibitors</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/NCT03748810
org study id: SGLT2 inhibitor 2018
nct id: NCT03748810
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This open-labeled, prospective, observational, 3-year, clinical study was conducted to
      compare the effectiveness and safety between empagliflozin (25 mg once daily) and
      dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes
      despite preexisting triple OAD combination.
All participants included in this study were initially requested to initiate therapy with
      insulin, but they insisted on another form of OAD. When participants declined insulin
      injection and requested another OAD, they were not randomly assigned to each groups. It is
      fairly common among participants with T2D to decline insulin therapy, despite being aware of
      its importance and the benefits in controlling blood glucose. Their lack of willingness to
      use insulin is explained by their avoidance of painful injections, the potential for body
      weight gain and their fear of hypoglycemia. The investigators conducted a regimen consisting
      of four OADs, including empagliflozin or dapagliflozin, to confirm which regimen would be
      effective and safe.
observational model: Case-Control
time perspective: Prospective
measure: Changes in HbA1c from baseline to week 156 (3-year)
time frame: Baseline, week 156 (3-year)
description: Changes in HbA1c from baseline to week 156 (3-year)
measure: Changes in fasting plasma glucose from baseline to week 156 (3-year)
time frame: Baseline, week 156 (3-year)
description: Changes in fasting plasma glucose from baseline to week 156 (3-year)
measure: Changes in HbA1c from baseline to week 104 (2-year)
time frame: Baseline, week 104 (2-year)
description: Changes in HbA1c from baseline to week 104 (2-year)
measure: Changes in HbA1c from baseline to week 52 (1-year)
time frame: Baseline, week 52 (1-year)
description: Changes in HbA1c from baseline to week 52 (1-year)
measure: Changes in HbA1c from baseline to week 24
time frame: Baseline, Week 24
description: Changes in HbA1c from baseline to week 24
measure: Changes in fasting plasma glucose from baseline to week 12
time frame: Baseline, Week 12
description: Changes in fasting plasma glucose from baseline to week 12
measure: Changes in fasting plasma glucose from baseline to week 24
time frame: Baseline, Week 24
description: Changes in fasting plasma glucose from baseline to week 24
measure: Changes in fasting plasma glucose from baseline to week 56 (1-year)
time frame: Baseline, Week 56 (1-year)
description: Changes in fasting plasma glucose from baseline to week 56 (1-year)
measure: Changes in weight between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: Changes in weight between baseline and week 156 (3-year)
measure: Changes in weight between baseline and week 104 (2-year)
time frame: Baseline, Week 104 (2-year)
description: Changes in weight between baseline and week 104 (2-year)
measure: Changes in weight between baseline and week 52
time frame: Baseline, Week 52
description: Changes in weight between baseline and week 52
measure: Changes in weight between baseline and week 24
time frame: Baseline, Week 24
description: Changes in weight between baseline and week 24
measure: Changes in weight between baseline and week 12
time frame: Baseline, Week 12
description: Changes in weight between baseline and week 12
measure: Changes in systolic blood pressure between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: Changes in systolic blood pressure between baseline and week 156 (3-year)
measure: Changes in systolic blood pressure between baseline and week 104 (2-year)
time frame: Baseline, Week 104 (2-year)
description: Changes in systolic blood pressure between baseline and week 104 (2-year)
measure: Changes in systolic blood pressure between baseline and week 52
time frame: Baseline, Week 52
description: Changes in systolic blood pressure between baseline and week 52
measure: Changes in systolic blood pressure between baseline and week 24
time frame: Baseline, Week 24
description: Changes in systolic blood pressure between baseline and week 24
measure: Changes in systolic blood pressure between baseline and week 12
time frame: Baseline, Week 12
description: Changes in systolic blood pressure between baseline and week 12
measure: Changes in diastolic blood pressure between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: Changes in diastolic blood pressure between baseline and week 156 (3-year)
measure: Changes in diastolic blood pressure between baseline and week 104 (2-year)
time frame: Baseline, Week 104 (2-year)
description: Changes in diastolic blood pressure between baseline and week 104 (2-year)
measure: Changes in diastolic blood pressure between baseline and week 52
time frame: Baseline, Week 52
description: Changes in diastolic blood pressure between baseline and week 52
measure: Changes in diastolic blood pressure between baseline and week 24
time frame: Baseline, Week 24
description: Changes in diastolic blood pressure between baseline and week 24
measure: Changes in diastolic blood pressure between baseline and week 12
time frame: Baseline, Week 12
description: Changes in diastolic blood pressure between baseline and week 12
measure: Changes in total cholesterol between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: Changes in total cholesterol between baseline and week 156 (3-year)
measure: Changes in triglyceride between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: Changes in triglyceride between baseline and week 156 (3-year)
measure: Changes in LDL-cholesterol between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: Changes in LDL-cholesterol between baseline and week 156 (3-year)
measure: Changes in HDL-cholesterol between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: Changes in HDL-cholesterol between baseline and week 156 (3-year)
measure: Percentage of patients with hypoglycemic episodes between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: All episodes consistent with hypoglycemic episodes with or without a confirmatory blood glucose reading were collected
measure: Percentage of patients with at least 1 episode of genitourinary tract infections between baseline and week 156 (3-year)
time frame: Baseline, Week 156 (3-year)
description: Percentage of patients with at least 1 episode of genitourinary tract infections
arm group label: Triple OADs failure
description: Empagliflozin or dapagliflozin as an add-on drug for inadequately controlled T2D patients who are already receiving a regimen of three distinct OADs, including metformin, glimepiride and dipeptidyl peptidase 4 (DPP4) inhibitors.
intervention type: Drug
intervention name: Empagliflozin
description: Empagliflozin 25 mg once daily add on the background OADs for 3 years
arm group label: Triple OADs failure
other name: Metformin
other name: Glimepiride
other name: DPP4 inhibitor
intervention type: Drug
intervention name: Dapagliflozin
description: Dapagliflozin 25 mg once daily add on the background OADs for 3 years
arm group label: Triple OADs failure
other name: Metformin
other name: Glimepiride
other name: DPP4 inhibitor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jae Hyun Ahn
role: Study Chair
affiliation: Chungbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chungbuk National University Hospital
investigator full name: Eu Jeong Ku
investigator title: Clinical assistant professor
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Dapagliflozin
mesh term: Empagliflozin
mesh term: Glimepiride
mesh term: Dipeptidyl-Peptidase IV Inhibitors