<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/NCT03038789</url>
  </required_header>
  <id_info>
    <org_study_id>D1691R00001</org_study_id>
    <nct_id>NCT03038789</nct_id>
  </id_info>
  <brief_title>XIGDUO Extended Release (XR) Post Marketing Surveillance</brief_title>
  <acronym>XigduoPMS</acronym>
  <official_title>XIGDUO Extended Release (XR) (DAPAGLIFLOZIN/METFORMIN XR FDC) Regulatory Postmarketing Surveillance To Observe Safety and Effectiveness Of XigduoXR (Registered) In Korean Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</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 is a local, prospective, non-interventional, regulatory postmarketing surveillance&#xD;
      study. Adult patients with type 2 diabetes mellitus who are initiating Xigduo XR as indicated&#xD;
      by the Ministry of Food and Drug Safety (MFDS) will be included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Primary objective: Descriptive analysis of the proportion (%) of adverse events (AEs),&#xD;
           serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs&#xD;
           of special interest (AESI) in patients who are treated with Xigduo XR for type 2&#xD;
           diabetes mellitus by physicians in the normal clinical practice setting over a period of&#xD;
           12 or 24 weeks.&#xD;
&#xD;
        -  Secondary objective: To follow the changes of values of hemoglobin A1c (HbA1c), fasting&#xD;
           plasma glucose (FPG), 2-hr post-prandial glucose (PPG-2hr), blood pressure, abdominal&#xD;
           circumference and body weight and self-reported data in this cohort of patients from&#xD;
           baseline to completion of the study.&#xD;
&#xD;
      To evaluate the safety and tolerability of Xigduo XR in patients with type 2 diabetes&#xD;
      mellitus based on conducted laboratory test (Laboratory tests are not mandatory because of&#xD;
      the non-interventional nature of this study)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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>Descriptive analysis of the percentage (%) of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs of special interest (AESI)</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Percentage (%) of AEs, SAEs and AESI in patients who are treated with Xigduo XR&#xD;
Nature, incidence and severity of AE in patients who are treated with Xigduo XR&#xD;
Nature, incidence and severity of unexpected adverse drug reactions in patients who are treated with Xigduo XR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c (HbA1c)</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Change in HbA1c in % during the observation period to evaluate effectivenss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma glucose (FPG)</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Change in FPG in mg/dL during the observation period to evaluate effectivenss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-hr post-prandial glucose (PPG-2hr)</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Change of PPG-2hr in mg/dL during the observation period to evaluate effectivenss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Change in blood pressure in mmHg during the observation period to evaluate effectivenss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal circumference</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Change in abdominal circumference in cm during the observation period to evaluate effectiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Change in body weight in Kg during the observation period to evaluate effectiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall investigator's assessment on the outcome of the treatment</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Overall investigator's assessment on the outcome of the treatment: &quot;Improved&quot;, &quot;Unchanged&quot;, &quot;Worsened&quot;, &quot;Assessment impossible&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Laboratory Values</measure>
    <time_frame>12 or 24 weeks</time_frame>
    <description>Laboratory measures (chemistry/hematology/ urinalysis) during the observation period to evaluate the safety and tolerability of Xigduo XR based on conducted laboratory test (Laboratory tests are not mandatory because of the non-interventional nature of this study).&#xD;
Chemistry: AST, ALT, BUN, Cr, Na+, K+, Total cholesterol, TG&#xD;
Hematology: Hb, Hct&#xD;
Urinalylsis: Proteinurea</description>
  </secondary_outcome>
  <enrollment type="Actual">623</enrollment>
  <condition>Adult Patients With Type 2 Diabetes Mellitus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who are diagnosed with type 2 diabetes mellitus (T2DM) eligible for the&#xD;
        treatment with Xigduo XR according to prescription information approved by MFDS and as&#xD;
        decided by the investigator&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patients will be enrolled by a continuous registration method. Investigators should enroll&#xD;
        adult patients who are diagnosed with T2DM and who initiate treatment with Xigduo XR for&#xD;
        the first time. Patients (or a legally acceptable representative) who has been informed of&#xD;
        all pertinent aspects of the study will sign the Informed Consent Form for use of data.&#xD;
        Discontinuation of treatment will be determined by a patient's willingness to continue&#xD;
        treatment and the investigator's discretion. The reason for discontinued treatment will be&#xD;
        documented.&#xD;
&#xD;
          1. Patients aged 18 years and older&#xD;
&#xD;
          2. Patients with T2DM eligible for treatment with Xigduo XR at first according to the&#xD;
             indication as indicated in the locally approved prescribing information&#xD;
&#xD;
          3. Patients with evidence of a personally signed and dated informed consent document&#xD;
             indicating that the patient (or a legally acceptable representative) has been informed&#xD;
             of all pertinent aspects of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to the active substances or to any of the excipients&#xD;
&#xD;
          2. Patients with renal impairment (e.g., serum creatinine levels ≥ 1.5 mg/dL for men, ≥&#xD;
             1.4 mg/dL for women, or creatinine clearance &lt; 60 milliliter(mL)/min or estimated&#xD;
             glomerular filtration rate (eGFR)&lt; 60mL/min/1.73 m2) which may also result from&#xD;
             conditions such as cardiovascular collapse (shock), acute myocardial infarction, and&#xD;
             septicemia.&#xD;
&#xD;
          3. Patients with type 1 diabetes mellitus, lactic acidosis, or acute or chronic metabolic&#xD;
             acidosis including diabetic ketoacidosis with or without a coma&#xD;
&#xD;
          4. Diabetic precoma&#xD;
&#xD;
          5. Congestive heart failure that medicinal treatment is required&#xD;
&#xD;
          6. Patients with radiologic studies involving the use of intravascular iodinated contrast&#xD;
             materials (for example, intravenous urogram, intravenous cholangiography, angiography,&#xD;
             and computed tomography (CT) scans with intravascular contrast materials)&#xD;
&#xD;
          7. Patients with severe infection or severe traumatism&#xD;
&#xD;
          8. In terms of Surgical procedures (except minor procedures not associated with&#xD;
             restricted intake of food and fluids)&#xD;
&#xD;
          9. Patients with nutrition poor condition, starvation condition, pituitary insufficiency,&#xD;
             capsular insufficiency&#xD;
&#xD;
         10. Patients with impaired hepatic function (Since impaired hepatic function has been&#xD;
             associated with some cases of lactic acidosis, this drug should generally be avoided&#xD;
             in patients with clinical or laboratory evidence of hepatic disease.), respiratory&#xD;
             failure, acute myocardial infarction, acute or chronic disease causing histotoxic&#xD;
             hypoxia like shock, an alcoholic, gastroenteric trouble (anhydremia, diarrhea,&#xD;
             vomiting and etc.)&#xD;
&#xD;
         11. Pregnant women, women with potential of pregnancy, lactating women&#xD;
&#xD;
         12. Patients with hereditary problems such as galactose intolerance, Lapp lactase&#xD;
             deficiency or glucose-galactose malabsorption.&#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>JiSeong Yoon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>YoungNam University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>ChungCheong</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>DaeGu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>DaeJeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>GyeongGi</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>SunCheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>WonJu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D1691R00001&amp;amp;attachmentIdentifier=2678caf3-b8c2-455f-905c-e38a498d516d&amp;amp;fileName=D1691R00001_CSR_synopsis.pdf&amp;amp;versionIdentifier=</url>
    <description>D1691R00001 CSR synopsis</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</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, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03038789
org study id: D1691R00001
nct id: NCT03038789
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a local, prospective, non-interventional, regulatory postmarketing surveillance
      study. Adult patients with type 2 diabetes mellitus who are initiating Xigduo XR as indicated
      by the Ministry of Food and Drug Safety (MFDS) will be included.
-  Primary objective: Descriptive analysis of the proportion (%) of adverse events (AEs),
           serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs
           of special interest (AESI) in patients who are treated with Xigduo XR for type 2
           diabetes mellitus by physicians in the normal clinical practice setting over a period of
           12 or 24 weeks.

        -  Secondary objective: To follow the changes of values of hemoglobin A1c (HbA1c), fasting
           plasma glucose (FPG), 2-hr post-prandial glucose (PPG-2hr), blood pressure, abdominal
           circumference and body weight and self-reported data in this cohort of patients from
           baseline to completion of the study.

      To evaluate the safety and tolerability of Xigduo XR in patients with type 2 diabetes
      mellitus based on conducted laboratory test (Laboratory tests are not mandatory because of
      the non-interventional nature of this study)
observational model: Case-Only
time perspective: Prospective
measure: Descriptive analysis of the percentage (%) of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs of special interest (AESI)
time frame: 12 or 24 weeks
description: Percentage (%) of AEs, SAEs and AESI in patients who are treated with Xigduo XR
Nature, incidence and severity of AE in patients who are treated with Xigduo XR
Nature, incidence and severity of unexpected adverse drug reactions in patients who are treated with Xigduo XR
measure: Hemoglobin A1c (HbA1c)
time frame: 12 or 24 weeks
description: Change in HbA1c in % during the observation period to evaluate effectivenss
measure: Fasting plasma glucose (FPG)
time frame: 12 or 24 weeks
description: Change in FPG in mg/dL during the observation period to evaluate effectivenss
measure: 2-hr post-prandial glucose (PPG-2hr)
time frame: 12 or 24 weeks
description: Change of PPG-2hr in mg/dL during the observation period to evaluate effectivenss
measure: Blood pressure
time frame: 12 or 24 weeks
description: Change in blood pressure in mmHg during the observation period to evaluate effectivenss
measure: Abdominal circumference
time frame: 12 or 24 weeks
description: Change in abdominal circumference in cm during the observation period to evaluate effectiveness
measure: Body weight
time frame: 12 or 24 weeks
description: Change in body weight in Kg during the observation period to evaluate effectiveness
measure: Overall investigator's assessment on the outcome of the treatment
time frame: 12 or 24 weeks
description: Overall investigator's assessment on the outcome of the treatment: "Improved", "Unchanged", "Worsened", "Assessment impossible"
measure: Number of Participants With Abnormal Laboratory Values
time frame: 12 or 24 weeks
description: Laboratory measures (chemistry/hematology/ urinalysis) during the observation period to evaluate the safety and tolerability of Xigduo XR based on conducted laboratory test (Laboratory tests are not mandatory because of the non-interventional nature of this study).
Chemistry: AST, ALT, BUN, Cr, Na+, K+, Total cholesterol, TG
Hematology: Hb, Hct
Urinalylsis: Proteinurea
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: JiSeong Yoon, PhD
role: Principal Investigator
affiliation: YoungNam University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D1691R00001&amp;attachmentIdentifier=2678caf3-b8c2-455f-905c-e38a498d516d&amp;fileName=D1691R00001_CSR_synopsis.pdf&amp;versionIdentifier=
description: D1691R00001 CSR synopsis
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No