<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/NCT02966626</url>
  </required_header>
  <id_info>
    <org_study_id>20163-2261</org_study_id>
    <nct_id>NCT02966626</nct_id>
  </id_info>
  <brief_title>A Real World Experience of Dapagliflozin in Type 2 Diabetes</brief_title>
  <official_title>Dapaglifozin in Type 2 Diabetes Mellitus Patients: A Single-centre Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 2 diabetes mellitus (T2DM) is creating a health pandemic globally. Management of type 2&#xD;
      diabetes involves combination of lifestyle intervention and drug intervention, which includes&#xD;
      sodium-glucose transporter 2 (SGLT-2) inhibitors, such as dapagliflozin. Dapagliflozin&#xD;
      (Forxiga®) was approved by the Malaysian Drug Authority for the treatment of type 2 diabetes&#xD;
      in 2014. This study will describe the characteristics of patients who are prescribed&#xD;
      dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe&#xD;
      their glycaemic control, weight, and renal function at baseline and during use of&#xD;
      dapagliflozin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of type 2 diabetes among adults &gt;18 years old is 17.5% in Malaysia, where half&#xD;
      of them are undiagnosed. Diabetes also accounts for 14.5% of all-cause mortality worldwide,&#xD;
      with close to half of the deaths are in subjects &lt;60 years old. These highlight the&#xD;
      importance of early diagnosis of disease, timely intervention with appropriate therapy, and&#xD;
      treating type 2 diabetes patients to goal to prevent the development of complications.&#xD;
&#xD;
      Asian type 2 diabetes phenotypes are different than Caucasians, i.e. significant pancreatic&#xD;
      beta-cell dysfunction, higher visceral adiposity, more vulnerable to cardio-renal&#xD;
      complications. Although clinical trials of SGLT-2 inhibitors have been published, real-world&#xD;
      data on the use of this new class of antidiabetic medication is still lacking, in&#xD;
      particularly among Asians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the change in HbA1c from baseline to 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the change in body weight from baseline to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in estimated glomerular filtration rate</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the change in estimates glomerular filtration rate from baseline to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in albuminuria</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the change in albuminuria from baseline to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the change in body mass index from baseline to 6 months</description>
  </secondary_outcome>
  <enrollment type="Actual">223</enrollment>
  <condition>Type2 Diabetes</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All adult T2DM patients who received at least one prescription for dapagliflozin for the&#xD;
        first time between March 2014 and December 2015 at the University of Malaya Medical Center&#xD;
        (UMMC) will be recruited. UMMC is an academic medical institution with 1,300 beds, serving&#xD;
        a population of 1.8 million in Kuala Lumpur, Malaysia.&#xD;
&#xD;
        The date of the first prescription for dapagliflozin in the Hospital Pharmacy Database is&#xD;
        defined as the index date. Dapaglifozin is only available at the study site from March 2014&#xD;
        onwards.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of T2DM prior to the first prescription of dapagliflozin&#xD;
&#xD;
          -  Patients with T2DM who are initiated with dapagliflozin from March 2014 till December&#xD;
             2015&#xD;
&#xD;
          -  Patients need to be on dapagliflozin therapy for at least six consecutive months from&#xD;
             the index date&#xD;
&#xD;
          -  Patients need to have diabetologists/endocrinologists' follow up for at least six&#xD;
             months after the initiation of dapagliflozin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with T2DM who are initiated with dapagliflozin after December 2015&#xD;
&#xD;
          -  Patients with incomplete electronic medical records&#xD;
&#xD;
          -  Patients with Type 1 diabetes&#xD;
&#xD;
          -  Patients with latent autoimmune diabetes of adults (LADA)&#xD;
&#xD;
          -  Female Patients with T2DM who are found to be pregnant during the treatment period of&#xD;
             dapagliflozin&#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>Lee Ling LIM, MRCP (UK)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaya, Malaysia</affiliation>
  </overall_official>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pragmatic, Sodium-Glucose Transporter 2 inhibitor, Malaysia</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>
  <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/NCT02966626
org study id: 20163-2261
nct id: NCT02966626
lead sponsor: 
has dmc: No
Type 2 diabetes mellitus (T2DM) is creating a health pandemic globally. Management of type 2
      diabetes involves combination of lifestyle intervention and drug intervention, which includes
      sodium-glucose transporter 2 (SGLT-2) inhibitors, such as dapagliflozin. Dapagliflozin
      (Forxiga®) was approved by the Malaysian Drug Authority for the treatment of type 2 diabetes
      in 2014. This study will describe the characteristics of patients who are prescribed
      dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe
      their glycaemic control, weight, and renal function at baseline and during use of
      dapagliflozin.
The prevalence of type 2 diabetes among adults >18 years old is 17.5% in Malaysia, where half
      of them are undiagnosed. Diabetes also accounts for 14.5% of all-cause mortality worldwide,
      with close to half of the deaths are in subjects <60 years old. These highlight the
      importance of early diagnosis of disease, timely intervention with appropriate therapy, and
      treating type 2 diabetes patients to goal to prevent the development of complications.

      Asian type 2 diabetes phenotypes are different than Caucasians, i.e. significant pancreatic
      beta-cell dysfunction, higher visceral adiposity, more vulnerable to cardio-renal
      complications. Although clinical trials of SGLT-2 inhibitors have been published, real-world
      data on the use of this new class of antidiabetic medication is still lacking, in
      particularly among Asians.
observational model: Case-Only
time perspective: Retrospective
measure: Change in HbA1c
time frame: 6 months
description: To assess the change in HbA1c from baseline to 6 months
measure: Change in body weight
time frame: 6 months
description: To assess the change in body weight from baseline to 6 months
measure: Change in estimated glomerular filtration rate
time frame: 6 months
description: To assess the change in estimates glomerular filtration rate from baseline to 6 months
measure: Change in albuminuria
time frame: 6 months
description: To assess the change in albuminuria from baseline to 6 months
measure: Change in body mass index
time frame: 6 months
description: To assess the change in body mass index from baseline to 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lee Ling LIM, MRCP (UK)
role: Principal Investigator
affiliation: University of Malaya, Malaysia
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No