<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/NCT04445714</url>
  </required_header>
  <id_info>
    <org_study_id>D1683C00013</org_study_id>
    <nct_id>NCT04445714</nct_id>
  </id_info>
  <brief_title>To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients</brief_title>
  <official_title>A Prospective, Multicenter, Phase -IV Study to Assess the Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</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>
      A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of&#xD;
      dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the study, an AstraZeneca representative/delegate will have regular contacts with the&#xD;
      study site, including visits to site for the site monitoring and source data verification&#xD;
      activities. Electronic Case Report Forms (eCRF) will be used for data collection and query&#xD;
      handling. The investigator will sign the completed electronic Case Report Forms. A copy of&#xD;
      the completed electronic Case Report Forms will be archived at the study site. Authorized&#xD;
      representatives of AstraZeneca or delegate, a regulatory authority, or an Ethics Committee&#xD;
      may perform audits or inspections at the center's. Number and percentages of Incidence of&#xD;
      adverse events will be presented, stratified by age/gender/baseline medications. Annualised&#xD;
      event rate shall also be presented in addition to the incidence rate during the study. Mean&#xD;
      change in HbA1C from baseline to 6 months for patients will be analysed using paired t test /&#xD;
      Wilcoxon signed-rank test at 5% level of significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2021</start_date>
  <completion_date type="Actual">March 14, 2023</completion_date>
  <primary_completion_date type="Actual">March 14, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the safety of fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients</measure>
    <time_frame>6 Months</time_frame>
    <description>Number, frequency and percentages of incidence of adverse events (AEs) and serious adverse events (SAEs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the efficacy of fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients</measure>
    <time_frame>6 Months</time_frame>
    <description>Mean change in Glycated haemoglobin (HbA1c) from baseline to 6 months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>dapagliflozin and saxagliptin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dapagliflozin and saxagliptin</intervention_name>
    <description>Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally</description>
    <arm_group_label>dapagliflozin and saxagliptin</arm_group_label>
    <other_name>QTERN Tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        For inclusion in the study subjects should fulfil the following criteria:&#xD;
&#xD;
          1. Provision of signed and dated, written informed consent prior to any study specific&#xD;
             procedures according to local Indian procedure.&#xD;
&#xD;
          2. Male and female patients aged &gt; 18 and above&#xD;
&#xD;
          3. Documented history of type 2 diabetes mellitus with HbA1c level &gt;7.0% and ≤ 10% at&#xD;
             screening visit&#xD;
&#xD;
          4. Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose&#xD;
             between 1000-2000mg) in the past 3 months&#xD;
&#xD;
          5. Female subjects must be 1 year post-menopausal, surgically sterile, or using an&#xD;
             acceptable method of contraception (an acceptable method of contraception is defined&#xD;
             as a barrier method in conjunction with a spermicide) for the duration of the study&#xD;
             (from the time they sign consent) to prevent pregnancy. In addition, oral&#xD;
             contraceptives, approved contraceptive implant, long-term injectable contraception,&#xD;
             intrauterine device, or tubal ligation are allowed. Oral contraception alone is not&#xD;
             acceptable; additional barrier methods in conjunction with spermicide must be used.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Known allergies or contraindication to the contents of the IP, dapagliflozin or&#xD;
             saxagliptin tablets.&#xD;
&#xD;
          2. Active participation in another clinical study with IP and/or investigational device&#xD;
&#xD;
          3. For women only - currently pregnant (confirmed with positive pregnancy test) or&#xD;
             breast-feeding.&#xD;
&#xD;
          4. Type 1 diabetes mellitus.&#xD;
&#xD;
          5. Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2&#xD;
&#xD;
          6. Patients with moderate to severe renal impairment (eGFR persistently &lt;45 mL/min/1.73&#xD;
             m2 by CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula or end-stage&#xD;
             renal disease (ESRD) or 'Unstable or rapidly progressing renal disease&#xD;
&#xD;
          7. Patients with severe hepatic impairment (Child-Pugh class C)&#xD;
&#xD;
          8. History of pancreatitis or pancreatic surgery&#xD;
&#xD;
          9. Patients with a history of any malignancy&#xD;
&#xD;
         10. Patients with any of the following CV/Vascular Diseases within 3 months prior to&#xD;
             signing the consent at enrolment, as assessed by the investigator:&#xD;
&#xD;
               -  Myocardial infarction.&#xD;
&#xD;
               -  Cardiac surgery or revascularization (CABG/PTCA).&#xD;
&#xD;
               -  Unstable angina.&#xD;
&#xD;
               -  Transient ischemic attack (TIA) or significant cerebrovascular disease.&#xD;
&#xD;
               -  Unstable or previously undiagnosed arrhythmia.&#xD;
&#xD;
         11. History of heart failure&#xD;
&#xD;
         12. Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or&#xD;
             diastolic blood pressure ≥110 mm Hg at any visit up to randomisation&#xD;
&#xD;
         13. History of diabetic ketoacidosis&#xD;
&#xD;
         14. Any acute/chronic systemic infections&#xD;
&#xD;
         15. Recurrent urogenital infections&#xD;
&#xD;
         16. Patients at risk for volume depletion as judged by the investigator&#xD;
&#xD;
         17. Any condition which, in the judgment of the Investigator, may render the patient&#xD;
             unable to complete the study or which may pose a significant risk to the patient or&#xD;
             patient suspected or with confirmed poor protocol or medication compliance&#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>Dr Anil Bhansali</last_name>
    <role>Principal Investigator</role>
    <affiliation>Post Graduate Institute of Medical Education &amp; Research, Chandigarh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr K P Singh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fortis Hospital Mohali</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr Indira Pattnaik</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sparsh Hospitals &amp; Critical Care (P) Ltd, Bhubaneswar</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr Sandeep Kumar Gupta</last_name>
    <role>Principal Investigator</role>
    <affiliation>M V Hospital &amp;Research centre Lucknow</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr Faraz Farishta</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thumbay Hospital New Life Hyderabad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr Girithara Jayaram Naidu</last_name>
    <role>Principal Investigator</role>
    <affiliation>KG Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bangalore</city>
        <zip>560017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bhubaneswar</city>
        <zip>751007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coimbatore</city>
        <zip>641018</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hyderabad</city>
        <zip>500024</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kolkata</city>
        <zip>700020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lucknow</city>
        <zip>226003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mohali</city>
        <zip>160062</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Delhi</city>
        <zip>110076</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</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>Dapagliflozin</mesh_term>
    <mesh_term>Saxagliptin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.&#xD;
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </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/NCT04445714
org study id: D1683C00013
nct id: NCT04445714
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of
      dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients.
During the study, an AstraZeneca representative/delegate will have regular contacts with the
      study site, including visits to site for the site monitoring and source data verification
      activities. Electronic Case Report Forms (eCRF) will be used for data collection and query
      handling. The investigator will sign the completed electronic Case Report Forms. A copy of
      the completed electronic Case Report Forms will be archived at the study site. Authorized
      representatives of AstraZeneca or delegate, a regulatory authority, or an Ethics Committee
      may perform audits or inspections at the center's. Number and percentages of Incidence of
      adverse events will be presented, stratified by age/gender/baseline medications. Annualised
      event rate shall also be presented in addition to the incidence rate during the study. Mean
      change in HbA1C from baseline to 6 months for patients will be analysed using paired t test /
      Wilcoxon signed-rank test at 5% level of significance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To assess the safety of fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients
time frame: 6 Months
description: Number, frequency and percentages of incidence of adverse events (AEs) and serious adverse events (SAEs)
measure: To assess the efficacy of fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients
time frame: 6 Months
description: Mean change in Glycated haemoglobin (HbA1c) from baseline to 6 months
arm group label: dapagliflozin and saxagliptin
arm group type: Other
description: Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally
intervention type: Drug
intervention name: dapagliflozin and saxagliptin
description: Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally
arm group label: dapagliflozin and saxagliptin
other name: QTERN Tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Anil Bhansali
role: Principal Investigator
affiliation: Post Graduate Institute of Medical Education & Research, Chandigarh
last name: Dr K P Singh
role: Principal Investigator
affiliation: Fortis Hospital Mohali
last name: Dr Indira Pattnaik
role: Principal Investigator
affiliation: Sparsh Hospitals & Critical Care (P) Ltd, Bhubaneswar
last name: Dr Sandeep Kumar Gupta
role: Principal Investigator
affiliation: M V Hospital &Research centre Lucknow
last name: Dr Faraz Farishta
role: Principal Investigator
affiliation: Thumbay Hospital New Life Hyderabad
last name: Dr Girithara Jayaram Naidu
role: Principal Investigator
affiliation: KG Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dapagliflozin
mesh term: Saxagliptin
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home