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/NCT05998837</url>
    </required_header>
    <id_info>
      <org_study_id>D169AL00005</org_study_id>
      <nct_id>NCT05998837</nct_id>
    </id_info>
    <brief_title>GLUcose Transport and REnalPROtection in Chronic Kidney Disease</brief_title>
    <acronym>GLUTREPRO</acronym>
    <official_title>Single-center, Randomized, Controlled Study to Evaluate the Effects of a Six-month Treatment With Renal Glucose Transport Inhibitor (SGLT2i) Drugs on Markers of Senescence, Inflammation and Tubulointerstitial Damage in the Kidney of Patients With Chronic Kidney Disease With or Without Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy</source>
    <oversight_info>
      <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 single-center, double blind, randomized, parallel-arms study designed to&#xD;
        investigate the effects of a six-month treatment with the SGLT2i dapagliflozin on markers of&#xD;
        kidney senescence, inflammation and tubulointerstitial damage compared to placebo. These&#xD;
        mechanisms of renal damage will be investigated in proximal tubular epithelial cells (PTECs)&#xD;
        isolated from urine from patients with CKD with or without T2DM and in renal biopsy specimens&#xD;
        in a subgroup of patients with diabetic kidney disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the run-in phase, clinical parameters will be optimized by the use of&#xD;
        metformin/repaglinide and or RAAS-I on the basis of the presence/absence of a diagnosis of&#xD;
        diabetes. Subsequently, patients will be randomly assigned to start with standard therapy and&#xD;
        placebo or dapagliflozin at the dose of 10 mg and will continue the assigned treatment for 24&#xD;
        weeks in double-blind and with dapagliflozin at the dose of 10 mg for an additional 48 weeks&#xD;
        in open-label/Extended treatment.&#xD;
  &#xD;
        Urine samples will be collected at T0, T1, T2, T3 and T4 and used as a source of PTECs in&#xD;
        order to study the expression of mediators of senescence, fibrosis and inflammation in the&#xD;
        kidney. 24-hour ambulatory blood pressure monitoring, Bio-impedancemetry will be evaluated at&#xD;
        T0, and T2 and the assessment of tubular oxygen consumption by MRI with BOLD method will be&#xD;
        performed at baseline (T0) and after 12 weeks of treatment (T1). This timeline seems to be&#xD;
        more appropriate for investigating chances in functional parameters such as blood pressure&#xD;
        behaviour, distribution of body water and tubular oxigen consumption.&#xD;
  &#xD;
        Based on health claims data published in scientific journals, the treatment extension with&#xD;
        Dapaglifozin will be proposed to patients of both arms of the Study at the end of 24 Weeks of&#xD;
        treatment (T2) for additional 48 Weeks (T3, T4).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 13, 2021</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</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>
      <intervention_model_description>Allocation to treatment group will be done by stratified randomization for diabetics and non-diabetics.&#xD;
  The randomization list will be generated with a designed computer program.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Once eligibility is verified, the Investigator will randomize the subject contacting by e-mail the Secretarial Office of the Nephrologic Clinic of the Ospedale Policlinico San Martino The assigned randomization number will communicated via e-mail and recorded by the Investigator in the CRF. Therefore both investigators and participants will be blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Urinary proximal tubule cells changes in protein expression of inflammatory genes such as p16ink4a, TLR-4, phospho-p65, DKK3, Myostatin, TGFβ, SMAD 2,3 and MAPK pathways.</measure>
      <time_frame>baseline and every 3 months up to 18 month</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Urinary proximal tubule cells changes in genes such as type IV collagen fibronectin, TGF-β, TNF receptor 1, EMF cadherin production, NF-kB, MCP-1 , DKK3, myostatin and Activin A</measure>
      <time_frame>baseline and every 3 months up to 18 month</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Biopsy changes in the expression and location of senescence markers by immunohistochemistry</measure>
      <time_frame>Baseline and after 6 month</time_frame>
      <description>In the first six patients with T2DM, proteinuria &gt; 1 g/day and biopsy proven diabetic kidney disese allocated to the treatment with dapagliflozin, we will investigate the following changes in expression and location of p16inkA, SA-beta-galactosidase, TNF receptor 1, EMF cadherin NF-kB.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in BOLD MRI</measure>
      <time_frame>Baseline and after 3 month</time_frame>
      <description>Changes in global and segmental renal oxygenation estimated by BOLD MRI (changes in R2* value defined as 1/T2*) at 12 and 24 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urinary markers of interstitial fibrosis</measure>
      <time_frame>Baseline and every 3 months up to 18 month</time_frame>
      <description>Changes in urinary markers of a proxy of interstitial fibrosis in patients with CKD (Mir 20)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in urinary albumin excretion</measure>
      <time_frame>Baseline and every 3 months up to 18 month</time_frame>
      <description>Changes in urinary albumin excretion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in eGFR</measure>
      <time_frame>Baseline and every 3 months up to 18 month</time_frame>
      <description>decrease of eGFR ml/min &gt; 30%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Outcomes of blood presssure control</measure>
      <time_frame>Baseline and every 6 months up to 18 month</time_frame>
      <description>changes in blood pressure values and in the need of antihypertensive drugs</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Chronic Kidney Disease</condition>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Type 2 Diabetes Dapagliflozin 10 mg</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with Type 2 Diabetes allocated to Dapagliflozin 10 mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type 2 Diabetes Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients with Type 2 Diabetes allocated to Placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Without Diabetes Dapagliflozin 10 mg</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients without Type 2 Diabetes allocated to Dapagliflozin 10 mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Without Diabetes Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients without Type 2 Diabetes allocated to Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dapagliflozin 10mg Tab</intervention_name>
      <description>Dapagliflozin will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject.&#xD;
  Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide</description>
      <arm_group_label>Type 2 Diabetes Dapagliflozin 10 mg</arm_group_label>
      <arm_group_label>Without Diabetes Dapagliflozin 10 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject.&#xD;
  Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide</description>
      <arm_group_label>Type 2 Diabetes Placebo</arm_group_label>
      <arm_group_label>Without Diabetes Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Albuminuria defined as urinary albumin:creatinine ratio ≥ 25 mg/g (or&#xD;
               protein:creatinine ratio ≥ 30 mg/g) or albuminuria &gt; 30 mg/24h&#xD;
  &#xD;
            -  eGFR &gt; 25 and &lt; 75 ml/minute 1.73m2&#xD;
  &#xD;
            -  BMI between 19 kg/m2 and 30 kg/m2&#xD;
  &#xD;
            -  Treatment with an ACE inhibitor and/or ARB at the maximum tolerated (for the&#xD;
               individual subject) dose. The maximum tolerated dose for an individual subject may be&#xD;
               less than the maximum labeled dose or may be zero if the medical reason is documented.&#xD;
  &#xD;
            -  Mean systolic and diastolic blood pressure (determined as the average of three&#xD;
               replicates) must be &lt; 180/90mmHg&#xD;
  &#xD;
            -  Pre-menopausal women of child-bearing potential 1 must have a negative pregnancy test&#xD;
               performed before the inclusion in the study V e r s i o n 6 . 0 - P a g . 10 | 32&#xD;
  &#xD;
            -  Willingness to participate in the study (signed informed consent)&#xD;
  &#xD;
          IN PARTICIPANTS WITH Type 2 Diabetes&#xD;
  &#xD;
            -  Clinical diagnosis of T2DM for at least 1 year&#xD;
  &#xD;
            -  Hemoglobin A1c (HbA1c) value of &lt; 9.5%&#xD;
  &#xD;
            -  Patients treated only with metformin and/or repaglinide&#xD;
  &#xD;
            -  A diagnosis of Diabetic Nephropathy at renal biopsy made not more than 6 months before&#xD;
               the screening visit (only for the subgroup of patients candidated to the second kidney&#xD;
               biopsy)&#xD;
  &#xD;
            -  Proteinuria &gt; 1g/24h (only for the subgroup of patients candidated to the second&#xD;
               kidney biopsy)&#xD;
  &#xD;
            -  Hemoglobin A1c (HbA1c) value of &gt; 6.5% (only for patients candidated to the second&#xD;
               kidney biopsy) In PARTICIPANTS Without Type 2 Diabetes&#xD;
  &#xD;
            -  diagnosis of hypertension for at least 5 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Type 1 Diabetes&#xD;
  &#xD;
            -  Hemoglobin A1c (HbA1c) value of &gt; 9.5% during the Screening period (based on central&#xD;
               laboratory measurement).&#xD;
  &#xD;
            -  The need for an adjunctive drugs on top on metformin and repaglinide&#xD;
  &#xD;
            -  Hemoglobin A1c (HbA1c) value of &lt; 6.5% only for patients candidated to the second&#xD;
               kidney biopsy&#xD;
  &#xD;
            -  Estimated glomerular filtration rate &lt; 25 or &gt; 75 ml/min/1.73m2 (according to the&#xD;
               CKD-EPI) at screening&#xD;
  &#xD;
            -  Untreated urinary or genital infection at screening and follow-up&#xD;
  &#xD;
            -  Clear signs of volume depletion&#xD;
  &#xD;
            -  Symptomatic hypotension, or systolic blood pressure &lt; 90 or non-controlled&#xD;
               hypertension&#xD;
  &#xD;
            -  History of alcohol or drug abuse, anuria, dialysis, or acute kidney injury/acute renal&#xD;
               failure in the 3 months prior to Screening Period&#xD;
  &#xD;
            -  Heart, liver or kidney transplant V e r s i o n 6 . 0 - P a g . 11 | 32&#xD;
  &#xD;
            -  Acute coronary syndrome, stroke, or transient ischemic attack within 3 months prior to&#xD;
               informed consent&#xD;
  &#xD;
            -  Liver disease, defined by serum levels of alanine aminotransferase, aspartate&#xD;
               aminotransferase, or alkaline phosphatase above 3 x upper limit of normal (ULN) during&#xD;
               screening&#xD;
  &#xD;
            -  Planned cardiac surgery or angioplasty within 3 months&#xD;
  &#xD;
            -  Cancer or medical history of cancer (except for basal cell carcinoma) within the last&#xD;
               5 years&#xD;
  &#xD;
            -  Treatment with anti-obesity drugs 3 months prior to informed consent or any other&#xD;
               treatment at time of screening leading to unstable body weight (e.g. surgery,&#xD;
               aggressive diet regimen, etc.)&#xD;
  &#xD;
            -  SGLT2i treatment in the 10 weeks before the Screening Period&#xD;
  &#xD;
            -  Treatment with systemic steroids at time of informed consent or change in dosage of&#xD;
               thyroid hormones within 6 weeks prior to informed consent&#xD;
  &#xD;
            -  Any uncontrolled endocrine disorder except T2DM&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding&#xD;
  &#xD;
            -  Pre-menopausal women of child bearing potential who are not willing to employ&#xD;
               effective contraception according to 2007 CTFG Recommendations related to&#xD;
               contraception and pregnancy testing in clinical trials from screening for all the&#xD;
               duration of the study&#xD;
  &#xD;
            -  Patients with a known hypersensitivity to Dapagliflozin or other SGLT2- inhibitors,&#xD;
               including hypersensitivity to excipients (e.g. lactose)&#xD;
  &#xD;
            -  History of pancreatitis, or pancreatic surgery, diabetic ketoacidosis&#xD;
  &#xD;
            -  Prior lower extremity amputation or current threat of amputation (eg, lower extremity&#xD;
               ulcer and peripheral artery disease)&#xD;
  &#xD;
            -  History of severe hypoglycaemia and hypoglycaemia unawareness.&#xD;
  &#xD;
            -  Contraindication to MRI&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Francesca Viazzi</last_name>
      <phone>+3903470731273</phone>
      <email>francesca.viazzi@unige.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>IRCCS Ospedale Policlinico San Martino</name>
        <address>
          <city>Genova</city>
          <state>GE</state>
          <zip>16132</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Francesca Viazzi</last_name>
        <phone>03470731273</phone>
        <email>francesca.viazzi@unige.it</email>
      </contact>
      <investigator>
        <last_name>Elisa Russo, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pasquale Esposito, Professor</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy</investigator_affiliation>
      <investigator_full_name>Francesca Viazzi</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>gliflozine</keyword>
    <keyword>senescence</keyword>
    <keyword>BOLD MRI</keyword>
    <keyword>Blood pressure variability</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</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>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05998837
  org study id: D169AL00005
  nct id: NCT05998837
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, double blind, randomized, parallel-arms study designed to
        investigate the effects of a six-month treatment with the SGLT2i dapagliflozin on markers of
        kidney senescence, inflammation and tubulointerstitial damage compared to placebo. These
        mechanisms of renal damage will be investigated in proximal tubular epithelial cells (PTECs)
        isolated from urine from patients with CKD with or without T2DM and in renal biopsy specimens
        in a subgroup of patients with diabetic kidney disease.
  In the run-in phase, clinical parameters will be optimized by the use of
        metformin/repaglinide and or RAAS-I on the basis of the presence/absence of a diagnosis of
        diabetes. Subsequently, patients will be randomly assigned to start with standard therapy and
        placebo or dapagliflozin at the dose of 10 mg and will continue the assigned treatment for 24
        weeks in double-blind and with dapagliflozin at the dose of 10 mg for an additional 48 weeks
        in open-label/Extended treatment.
  
        Urine samples will be collected at T0, T1, T2, T3 and T4 and used as a source of PTECs in
        order to study the expression of mediators of senescence, fibrosis and inflammation in the
        kidney. 24-hour ambulatory blood pressure monitoring, Bio-impedancemetry will be evaluated at
        T0, and T2 and the assessment of tubular oxygen consumption by MRI with BOLD method will be
        performed at baseline (T0) and after 12 weeks of treatment (T1). This timeline seems to be
        more appropriate for investigating chances in functional parameters such as blood pressure
        behaviour, distribution of body water and tubular oxigen consumption.
  
        Based on health claims data published in scientific journals, the treatment extension with
        Dapaglifozin will be proposed to patients of both arms of the Study at the end of 24 Weeks of
        treatment (T2) for additional 48 Weeks (T3, T4).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Allocation to treatment group will be done by stratified randomization for diabetics and non-diabetics.
  The randomization list will be generated with a designed computer program.
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  masking description: Once eligibility is verified, the Investigator will randomize the subject contacting by e-mail the Secretarial Office of the Nephrologic Clinic of the Ospedale Policlinico San Martino The assigned randomization number will communicated via e-mail and recorded by the Investigator in the CRF. Therefore both investigators and participants will be blind
  measure: Urinary proximal tubule cells changes in protein expression of inflammatory genes such as p16ink4a, TLR-4, phospho-p65, DKK3, Myostatin, TGFβ, SMAD 2,3 and MAPK pathways.
  time frame: baseline and every 3 months up to 18 month
  measure: Urinary proximal tubule cells changes in genes such as type IV collagen fibronectin, TGF-β, TNF receptor 1, EMF cadherin production, NF-kB, MCP-1 , DKK3, myostatin and Activin A
  time frame: baseline and every 3 months up to 18 month
  measure: Biopsy changes in the expression and location of senescence markers by immunohistochemistry
  time frame: Baseline and after 6 month
  description: In the first six patients with T2DM, proteinuria > 1 g/day and biopsy proven diabetic kidney disese allocated to the treatment with dapagliflozin, we will investigate the following changes in expression and location of p16inkA, SA-beta-galactosidase, TNF receptor 1, EMF cadherin NF-kB.
  measure: Changes in BOLD MRI
  time frame: Baseline and after 3 month
  description: Changes in global and segmental renal oxygenation estimated by BOLD MRI (changes in R2* value defined as 1/T2*) at 12 and 24 weeks
  measure: Urinary markers of interstitial fibrosis
  time frame: Baseline and every 3 months up to 18 month
  description: Changes in urinary markers of a proxy of interstitial fibrosis in patients with CKD (Mir 20)
  measure: Changes in urinary albumin excretion
  time frame: Baseline and every 3 months up to 18 month
  description: Changes in urinary albumin excretion
  measure: Changes in eGFR
  time frame: Baseline and every 3 months up to 18 month
  description: decrease of eGFR ml/min > 30%
  measure: Outcomes of blood presssure control
  time frame: Baseline and every 6 months up to 18 month
  description: changes in blood pressure values and in the need of antihypertensive drugs
  arm group label: Type 2 Diabetes Dapagliflozin 10 mg
  arm group type: Active Comparator
  description: Patients with Type 2 Diabetes allocated to Dapagliflozin 10 mg
  arm group label: Type 2 Diabetes Placebo
  arm group type: Placebo Comparator
  description: Patients with Type 2 Diabetes allocated to Placebo
  arm group label: Without Diabetes Dapagliflozin 10 mg
  arm group type: Active Comparator
  description: Patients without Type 2 Diabetes allocated to Dapagliflozin 10 mg
  arm group label: Without Diabetes Placebo
  arm group type: Placebo Comparator
  description: Patients without Type 2 Diabetes allocated to Placebo
  intervention type: Drug
  intervention name: Dapagliflozin 10mg Tab
  description: Dapagliflozin will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject.
  Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide
  arm group label: Type 2 Diabetes Dapagliflozin 10 mg
  arm group label: Without Diabetes Dapagliflozin 10 mg
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject.
  Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide
  arm group label: Type 2 Diabetes Placebo
  arm group label: Without Diabetes Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Francesca Viazzi
  phone: +3903470731273
  email: francesca.viazzi@unige.it
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  investigator full name: Francesca Viazzi
  investigator title: Professor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Dapagliflozin
  sharing ipd: No