<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/NCT02971618</url>
  </required_header>
  <id_info>
    <org_study_id>D1690R00030</org_study_id>
    <nct_id>NCT02971618</nct_id>
  </id_info>
  <brief_title>Study With Dapagliflozin</brief_title>
  <acronym>GLORIA</acronym>
  <official_title>Observational Retrospective Multicenter Study to Evaluate Clinical Outcome Variables Change With dapaGLiflozin Treatment Introduced in Patients With T2D uncOntrolled by the Current Therapy in Real Clinical Practice in RussIA</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will retrospectively collect clinical variables and socio-demographic data from&#xD;
      medical records of patients with T2DM initiating treatment with dapagliflozin after the&#xD;
      previous failure/inefficiency of other treatment options (defined as non-achievement of&#xD;
      target Hb1Ac) and according to the officially approved indication as per instruction for the&#xD;
      use of medicinal product.&#xD;
&#xD;
      It is expected that the best available data regarding clinical variables and patient&#xD;
      socio-demographic profiled will be collected from the patient medical records at up to 40&#xD;
      major Russian outpatient clinics/centers specialized in the treatment and management of T2DM&#xD;
      patients.&#xD;
&#xD;
      There are 2 time points:&#xD;
&#xD;
        -  Baseline data: baseline data are defined as data available within 3 months prior to the&#xD;
           first dose of dapagliflozin. In case of presence of multiple data values within baseline&#xD;
           period the most recent pre-dose value will be selected&#xD;
&#xD;
        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary&#xD;
           analysis will be focused on data available at 6 plus/minus 3 months after the initiation&#xD;
           of dapagliflozin. In case of discontinuation dapagliflozin, data will be collected at&#xD;
           routine visit within 3-month time frame after the last dose&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives and Hypotheses:&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      To describe HbA1c (glycosylated haemoglobin) change from baseline to follow-up&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      Clinical data:&#xD;
&#xD;
        -  To estimate percentage (%) of patients with reduction of HbA1c by 0.5% or more from&#xD;
           baseline to follow-up&#xD;
&#xD;
        -  To estimate percentage (%) of patients reaching the therapeutic glycemic response (HbA1c&#xD;
           &lt;7.0%) from baseline to follow-up&#xD;
&#xD;
        -  To describe change of fasting blood glucose from baseline to follow-up&#xD;
&#xD;
        -  To estimate change of body weight from baseline to follow-up&#xD;
&#xD;
        -  To estimate percentage (%) of patients with body weight reduction by at least 5% from&#xD;
           baseline to follow-up&#xD;
&#xD;
        -  To estimate percentage (%) of patients with reduction of HbA1c by 0.5% or more and body&#xD;
           weight reduction by at least 5% from baseline to follow-up&#xD;
&#xD;
        -  To describe change of systolic and diastolic blood pressure from baseline to follow-up&#xD;
           (systolic and diastolic, in mmHg)&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      The study will retrospectively collect clinical variables and socio-demographic data from&#xD;
      medical records of patients with T2DM initiating treatment with dapagliflozin after the&#xD;
      previous failure/inefficiency of other treatment options (defined as non-achievement of&#xD;
      target Hb1Ac) and according to the officially approved indication as per instruction for the&#xD;
      use of medicinal product.&#xD;
&#xD;
      It is expected that the best available data regarding clinical variables and patient&#xD;
      socio-demographic profiled will be collected from the patient medical records at up to 40&#xD;
      major Russian outpatient clinics/centers specialized in the treatment and management of T2DM&#xD;
      patients.&#xD;
&#xD;
      There are 2 time points:&#xD;
&#xD;
        -  Baseline data: baseline data are defined as data available within 3 months prior to the&#xD;
           first dose of dapagliflozin. In case of presence of multiple data values within baseline&#xD;
           period the most recent pre-dose value will be selected&#xD;
&#xD;
        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary&#xD;
           analysis will be focused on data available at 6 plus/minus 3 months after the initiation&#xD;
           of dapagliflozin. In case of discontinuation dapagliflozin, data will be collected at&#xD;
           routine visit within 3-month time frame after the last dose.&#xD;
&#xD;
      Data Source(s):&#xD;
&#xD;
      Participating investigators should be physicians-endocrinologists working in approximately 12&#xD;
      outpatient clinics specialized in management of patients with T2DM in Moscow. There is no&#xD;
      current legislation on EMR in Russia, so, paper medical records will be utilized, and data&#xD;
      collection using electronic CRFs will be done.&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      T2DM patients previously uncontrolled on standard therapy (mono-, double therapy with OADs:&#xD;
      metformin, SU or DPP-4 inhibitors or on insulin) initiating treatment with dapagliflozin as&#xD;
      monotherapy, combination with OADs or as add-on to insulin with available data on Hb1c within&#xD;
      3 months prior to the first dose of dapagliflozin. All consecutive patients at the clinic in&#xD;
      inclusion period who meet inclusion and exclusion criteria will be included.&#xD;
&#xD;
      Exposure(s):&#xD;
&#xD;
      Only patients initiating treatment with dapagliflozin as monotherapy, combination with OADs&#xD;
      or as add-on to insulin will be included in the study.&#xD;
&#xD;
      Outcome(s):&#xD;
&#xD;
      Population parameters&#xD;
&#xD;
        -  Date of birth&#xD;
&#xD;
        -  Gender&#xD;
&#xD;
        -  Level of education&#xD;
&#xD;
        -  Level of income&#xD;
&#xD;
        -  Ethnicity/race&#xD;
&#xD;
        -  Living conditions&#xD;
&#xD;
        -  Working conditions All documented macro- and microvascular T2DM complications and&#xD;
           concomitant medications (antidiabetic drugs, statins, ACE inhibitors, sartans,&#xD;
           beta-blockers, calcium channel antagonists) will be collected for whole course of&#xD;
           dapagliflozin administration.&#xD;
&#xD;
      Clinical parameters&#xD;
&#xD;
        -  Hb1Ac&#xD;
&#xD;
        -  Fasting glucose&#xD;
&#xD;
        -  Body weight&#xD;
&#xD;
        -  Blood pressure (systolic and diastolic)&#xD;
&#xD;
      Sample Size Estimations:&#xD;
&#xD;
      Approximate sample size is 850 patients.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      Epidemiological methods mainly will be used to represent the study data. A descriptive&#xD;
      analysis approach will be used to analyse study objectives. Descriptive statistics will be&#xD;
      used to analyse the study population, baseline data and clinical outcomes. The descriptive&#xD;
      statistics will include mean, standard deviation, median, minimum and maximum, range, number&#xD;
      of valid cases for continuous variables, number, percentage, and distribution for categorical&#xD;
      variables. The percentage will be given with the relevant two-sided 95% confidence intervals.&#xD;
&#xD;
      Only available data will be analyzed; no missing values imputation will be applied. Only&#xD;
      patients with available data on HbA1c both within 3 months prior to the first dose of&#xD;
      dapagliflozin and at 6±3 months after the initiation of dapagliflozin will be included in the&#xD;
      main analysis.&#xD;
&#xD;
      All other baseline, effectiveness parameters will be tabulated, assessed in subgroups where&#xD;
      available..&#xD;
&#xD;
      In order to evaluate the association between achievement of the HbA1C goals and patient&#xD;
      characteristics, the multivariate logistic regression model was developed. A binary&#xD;
      categorical attribute-HbA1C within/outside &lt; 7% at 6±3 months after the initiation of&#xD;
      dapagliflozin -serves as a dependable variable in this model&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">August 3, 2018</completion_date>
  <primary_completion_date type="Actual">August 3, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c (glycosylated haemoglobin)</measure>
    <time_frame>3 months</time_frame>
    <description>To describe HbA1c (glycosylated haemoglobin) change from baseline to follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>reduction of HbA1c by 0.5% or more</measure>
    <time_frame>3 months</time_frame>
    <description>To estimate percentage (%) of patients with reduction of HbA1c by 0.5% or more from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(%) of patients reaching the therapeutic glycemic response (HbA1c &lt;7.0%)</measure>
    <time_frame>3 months</time_frame>
    <description>To estimate percentage (%) of patients reaching the therapeutic glycemic response (HbA1c &lt;7.0%) from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of fasting blood glucose</measure>
    <time_frame>3 months</time_frame>
    <description>To describe change of fasting blood glucose from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of body weight</measure>
    <time_frame>3 months</time_frame>
    <description>To estimate change of body weight from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage (%) of patients with body weight reduction by at least 5%</measure>
    <time_frame>3 months</time_frame>
    <description>To estimate percentage (%) of patients with body weight reduction by at least 5% from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage (%) of patients with reduction of HbA1c by 0.5% or more and body weight reduction by at least 5%</measure>
    <time_frame>3 months</time_frame>
    <description>To estimate percentage (%) of patients with reduction of HbA1c by 0.5% or more and body weight reduction by at least 5% from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of systolic and diastolic blood pressure</measure>
    <time_frame>3 months</time_frame>
    <description>To describe change of systolic and diastolic blood pressure from baseline to follow-up (systolic and diastolic, in mmHg)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">929</enrollment>
  <condition>Diabetes Mellitus Type 2</condition>
  <arm_group>
    <arm_group_label>Total group</arm_group_label>
    <description>Patients T2D with dapagliflozin treatment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        T2DM patients previously uncontrolled on standard therapy (mono-, double therapy with OADs:&#xD;
        metformin, SU or DPP-4 inhibitors or on insulin) initiating treatment with dapagliflozin as&#xD;
        monotherapy, combination with OADs or as add-on to insulin with available data on Hb1c&#xD;
        within 3 months prior to the first dose of dapagliflozin. All consecutive patients at the&#xD;
        clinic in inclusion period who meet inclusion and exclusion criteria will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with Type 2 Diabetes Mellitus Male and female, age 18-65 years (both inclusive)&#xD;
        Patients with T2DM given a first prescription for dapagliflozin after Dec 2014 till 1&#xD;
        October 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Type 1 diabetes Contraindications for SGLT 2 inhibitors (high individual sensitivity to&#xD;
        SGLT 2 inhibitors, T1DM, diabetic ketoacidosis, moderate and severe renal failure (eGFR &lt;&#xD;
        60 ml/min/1.73 m3), end-stage renal disease, lactose intolerance, intolerance of glucose&#xD;
        and galactose, pregnancy and breast feeding, age younger than 18 years old, use of loop&#xD;
        diuretics, decrease of circulating blood volume due to acute disease, age of 77 years old&#xD;
        and older Prior use of SGLT 2 inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vladimir Bulatov</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mikhail Antsiferov, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moscow endocrinology dispensary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D1690R00030&amp;amp;attachmentIdentifier=74eb5465-b987-433b-a09b-ee6ea1f2791c&amp;amp;fileName=GLORIA-CSR-SYNOPSIS_ENG.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>August 2, 2019</last_update_submitted>
  <last_update_submitted_qc>August 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dapagliflozin,</keyword>
  <keyword>Russia,</keyword>
  <keyword>retrospective study,</keyword>
  <keyword>diabetes mellitus type 2</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>
  <!-- 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/NCT02971618
org study id: D1690R00030
nct id: NCT02971618
lead sponsor: 
has dmc: No
The study will retrospectively collect clinical variables and socio-demographic data from
      medical records of patients with T2DM initiating treatment with dapagliflozin after the
      previous failure/inefficiency of other treatment options (defined as non-achievement of
      target Hb1Ac) and according to the officially approved indication as per instruction for the
      use of medicinal product.

      It is expected that the best available data regarding clinical variables and patient
      socio-demographic profiled will be collected from the patient medical records at up to 40
      major Russian outpatient clinics/centers specialized in the treatment and management of T2DM
      patients.

      There are 2 time points:

        -  Baseline data: baseline data are defined as data available within 3 months prior to the
           first dose of dapagliflozin. In case of presence of multiple data values within baseline
           period the most recent pre-dose value will be selected

        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary
           analysis will be focused on data available at 6 plus/minus 3 months after the initiation
           of dapagliflozin. In case of discontinuation dapagliflozin, data will be collected at
           routine visit within 3-month time frame after the last dose
Objectives and Hypotheses:

      Primary objective:

      To describe HbA1c (glycosylated haemoglobin) change from baseline to follow-up

      Secondary objectives:

      Clinical data:

        -  To estimate percentage (%) of patients with reduction of HbA1c by 0.5% or more from
           baseline to follow-up

        -  To estimate percentage (%) of patients reaching the therapeutic glycemic response (HbA1c
           <7.0%) from baseline to follow-up

        -  To describe change of fasting blood glucose from baseline to follow-up

        -  To estimate change of body weight from baseline to follow-up

        -  To estimate percentage (%) of patients with body weight reduction by at least 5% from
           baseline to follow-up

        -  To estimate percentage (%) of patients with reduction of HbA1c by 0.5% or more and body
           weight reduction by at least 5% from baseline to follow-up

        -  To describe change of systolic and diastolic blood pressure from baseline to follow-up
           (systolic and diastolic, in mmHg)

      Methods:

      Study design:

      The study will retrospectively collect clinical variables and socio-demographic data from
      medical records of patients with T2DM initiating treatment with dapagliflozin after the
      previous failure/inefficiency of other treatment options (defined as non-achievement of
      target Hb1Ac) and according to the officially approved indication as per instruction for the
      use of medicinal product.

      It is expected that the best available data regarding clinical variables and patient
      socio-demographic profiled will be collected from the patient medical records at up to 40
      major Russian outpatient clinics/centers specialized in the treatment and management of T2DM
      patients.

      There are 2 time points:

        -  Baseline data: baseline data are defined as data available within 3 months prior to the
           first dose of dapagliflozin. In case of presence of multiple data values within baseline
           period the most recent pre-dose value will be selected

        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary
           analysis will be focused on data available at 6 plus/minus 3 months after the initiation
           of dapagliflozin. In case of discontinuation dapagliflozin, data will be collected at
           routine visit within 3-month time frame after the last dose.

      Data Source(s):

      Participating investigators should be physicians-endocrinologists working in approximately 12
      outpatient clinics specialized in management of patients with T2DM in Moscow. There is no
      current legislation on EMR in Russia, so, paper medical records will be utilized, and data
      collection using electronic CRFs will be done.

      Study Population:

      T2DM patients previously uncontrolled on standard therapy (mono-, double therapy with OADs:
      metformin, SU or DPP-4 inhibitors or on insulin) initiating treatment with dapagliflozin as
      monotherapy, combination with OADs or as add-on to insulin with available data on Hb1c within
      3 months prior to the first dose of dapagliflozin. All consecutive patients at the clinic in
      inclusion period who meet inclusion and exclusion criteria will be included.

      Exposure(s):

      Only patients initiating treatment with dapagliflozin as monotherapy, combination with OADs
      or as add-on to insulin will be included in the study.

      Outcome(s):

      Population parameters

        -  Date of birth

        -  Gender

        -  Level of education

        -  Level of income

        -  Ethnicity/race

        -  Living conditions

        -  Working conditions All documented macro- and microvascular T2DM complications and
           concomitant medications (antidiabetic drugs, statins, ACE inhibitors, sartans,
           beta-blockers, calcium channel antagonists) will be collected for whole course of
           dapagliflozin administration.

      Clinical parameters

        -  Hb1Ac

        -  Fasting glucose

        -  Body weight

        -  Blood pressure (systolic and diastolic)

      Sample Size Estimations:

      Approximate sample size is 850 patients.

      Statistical Analysis:

      Epidemiological methods mainly will be used to represent the study data. A descriptive
      analysis approach will be used to analyse study objectives. Descriptive statistics will be
      used to analyse the study population, baseline data and clinical outcomes. The descriptive
      statistics will include mean, standard deviation, median, minimum and maximum, range, number
      of valid cases for continuous variables, number, percentage, and distribution for categorical
      variables. The percentage will be given with the relevant two-sided 95% confidence intervals.

      Only available data will be analyzed; no missing values imputation will be applied. Only
      patients with available data on HbA1c both within 3 months prior to the first dose of
      dapagliflozin and at 6±3 months after the initiation of dapagliflozin will be included in the
      main analysis.

      All other baseline, effectiveness parameters will be tabulated, assessed in subgroups where
      available..

      In order to evaluate the association between achievement of the HbA1C goals and patient
      characteristics, the multivariate logistic regression model was developed. A binary
      categorical attribute-HbA1C within/outside < 7% at 6±3 months after the initiation of
      dapagliflozin -serves as a dependable variable in this model
observational model: Case-Control
time perspective: Retrospective
measure: HbA1c (glycosylated haemoglobin)
time frame: 3 months
description: To describe HbA1c (glycosylated haemoglobin) change from baseline to follow-up
measure: reduction of HbA1c by 0.5% or more
time frame: 3 months
description: To estimate percentage (%) of patients with reduction of HbA1c by 0.5% or more from baseline to follow-up
measure: (%) of patients reaching the therapeutic glycemic response (HbA1c <7.0%)
time frame: 3 months
description: To estimate percentage (%) of patients reaching the therapeutic glycemic response (HbA1c <7.0%) from baseline to follow-up
measure: change of fasting blood glucose
time frame: 3 months
description: To describe change of fasting blood glucose from baseline to follow-up
measure: change of body weight
time frame: 3 months
description: To estimate change of body weight from baseline to follow-up
measure: percentage (%) of patients with body weight reduction by at least 5%
time frame: 3 months
description: To estimate percentage (%) of patients with body weight reduction by at least 5% from baseline to follow-up
measure: percentage (%) of patients with reduction of HbA1c by 0.5% or more and body weight reduction by at least 5%
time frame: 3 months
description: To estimate percentage (%) of patients with reduction of HbA1c by 0.5% or more and body weight reduction by at least 5% from baseline to follow-up
measure: change of systolic and diastolic blood pressure
time frame: 3 months
description: To describe change of systolic and diastolic blood pressure from baseline to follow-up (systolic and diastolic, in mmHg)
arm group label: Total group
description: Patients T2D with dapagliflozin treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Vladimir Bulatov
role: Study Director
affiliation: AstraZeneca
last name: Mikhail Antsiferov, Prof.
role: Principal Investigator
affiliation: Moscow endocrinology dispensary
facility: 
facility: 
country: Russian Federation
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D1690R00030&amp;attachmentIdentifier=74eb5465-b987-433b-a09b-ee6ea1f2791c&amp;fileName=GLORIA-CSR-SYNOPSIS_ENG.pdf&amp;versionIdentifier=
description: Related Info
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2