xml: <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/NCT05977465</url>
    </required_header>
    <id_info>
      <org_study_id>35200/1/22</org_study_id>
      <nct_id>NCT05977465</nct_id>
    </id_info>
    <brief_title>Empagliflozin in Treatment of Peripheral Diabetic Neuropathy</brief_title>
    <official_title>Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        The aim of the study is to investigate the possible protective effect of empagliflozin in&#xD;
        patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2&#xD;
        inhibitors treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 20, 2022</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.</measure>
      <time_frame>change from baseline at three month</time_frame>
      <description>The electrophysiological studies will be performed using Nihon Kohden Neuropack, six-channel apparatus (Nihon Kohden, Japan) using surface electrodes, for the two studied groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in HbA1c %</measure>
      <time_frame>change from baseline at three months</time_frame>
      <description>HbA1c % will be assayed in whole blood using an automated System (H.P.L.C model: G89051, Tosoh, USA), for the two studied groups.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Diabetic Neuropathy Peripheral</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Empagliflozin group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Empagliflozin 25 MG</intervention_name>
      <description>treatment</description>
      <arm_group_label>Empagliflozin group</arm_group_label>
      <other_name>empagliflozin tablets</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with type 2 diabetes mellitus (Hba1c 7 %- 9%). Patients receiving dipeptidyl&#xD;
          peptidase-4 inhibitors, metformin ± basal insulin.&#xD;
  &#xD;
          Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged&#xD;
          between 18 years old to 65 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Breastfeeding female.&#xD;
  &#xD;
            -  Pregnant female.&#xD;
  &#xD;
            -  Estimated Glomerular Filtration Rate less than 45 mL/minute/1.73 m2.&#xD;
  &#xD;
            -  Patients with type 1 diabetes mellitus.&#xD;
  &#xD;
            -  Patients with diabetic ketoacidosis.&#xD;
  &#xD;
            -  Patients with urinary tract infections.&#xD;
  &#xD;
            -  Dehydrated patients till normalized.&#xD;
  &#xD;
            -  Lower limb amputation patients.&#xD;
  &#xD;
            -  SGLT2 inhibitors hypersensitivity.&#xD;
  &#xD;
            -  Severe hepatic patients.&#xD;
  &#xD;
            -  Patients on neuroprotective drugs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maha Khalifa, Pharm D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Pharmacy, Tanta University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of pharmacy</name>
        <address>
          <city>Tanta</city>
          <zip>31111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Maha Khalifa</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
      <mesh_term>Diabetic Neuropathies</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Empagliflozin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977465
  org study id: 35200/1/22
  nct id: NCT05977465
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to investigate the possible protective effect of empagliflozin in
        patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2
        inhibitors treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
  time frame: change from baseline at three month
  description: The electrophysiological studies will be performed using Nihon Kohden Neuropack, six-channel apparatus (Nihon Kohden, Japan) using surface electrodes, for the two studied groups.
  measure: Change in HbA1c %
  time frame: change from baseline at three months
  description: HbA1c % will be assayed in whole blood using an automated System (H.P.L.C model: G89051, Tosoh, USA), for the two studied groups.
  arm group label: Control group
  arm group type: No Intervention
  description: include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
  arm group label: Empagliflozin group
  arm group type: Experimental
  description: include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
  intervention type: Drug
  intervention name: Empagliflozin 25 MG
  description: treatment
  arm group label: Empagliflozin group
  other name: empagliflozin tablets
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maha Khalifa, Pharm D
  role: Principal Investigator
  affiliation: Faculty of Pharmacy, Tanta University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Maha Khalifa
  investigator title: Principal Investigator
  mesh term: Peripheral Nervous System Diseases
  mesh term: Diabetic Neuropathies
  mesh term: Empagliflozin
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)