<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/NCT03253562</url>
  </required_header>
  <id_info>
    <org_study_id>IDE00217</org_study_id>
    <nct_id>NCT03253562</nct_id>
  </id_info>
  <brief_title>Metformin Versus Vildagliptin for Diabetic Hypertensive Patients</brief_title>
  <official_title>Comparative Efficacy and Safety of Vildagliptin Versus Metformin in Reduction of Cardiovascular Complications in Type 2 Diabetic Patients With Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MTI University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MTI University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a controlled study to measure the efficacy of using metformin or vildagliptin for&#xD;
      type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk&#xD;
      resulting from both diabetes and hypertension using different parameters measuring&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies indicated that type 2 diabetes mellitus and hypertension are associated with&#xD;
      increased cardiovascular complications. Recently, studies suggest that metformin and&#xD;
      vildagliptin can reduce cardiovascular complications in diabetic patients with unclear&#xD;
      mechanisms. This work aimed to determine the effect of metformin and vildagliptin on&#xD;
      diabetic-hypertensive patients. Patients were allocated into four groups: groupI: healthy&#xD;
      volunteers, groupII: patients recently diagnosed with their hypertension and diabetes,&#xD;
      groupIII: patients treated with captopril (25mg once daily) for their hypertension in&#xD;
      addition to metformin (1000mg bid) groupIV: patients treated with captopril (25mg bid) for&#xD;
      hypertension in addition to vildagliptin (50mg bid). At the end of the therapeutic period,&#xD;
      then total cholesterol, LDL,serum Creatinine level, blood pressure and vascular endothelial&#xD;
      growth factor (VEGF) levels in serum will be measured for different groups to estimate the&#xD;
      benefits of one drug over the other one in protecting against cardiovascular risks for&#xD;
      diabetic hypertensive patients..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>benefit of reducing hypertension in diabetic hypertensive patients</measure>
    <time_frame>6 months</time_frame>
    <description>blood pressure will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>benefit of lowering cardiovascular risks for diabetic hypertensive patients</measure>
    <time_frame>6 months</time_frame>
    <description>total lipid profile will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>benefit of improving the condition of elevated blood pressure in patients through neovascularization</measure>
    <time_frame>6 months</time_frame>
    <description>vascular endothelial growth factor level in serum will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>reducing obesity for diabetic patients</measure>
    <time_frame>6months</time_frame>
    <description>difference in body weight at the beginning and the end of the study will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients</measure>
    <time_frame>6 months</time_frame>
    <description>glycated hemoglobin will be measured</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients</condition>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>healthy volunteers not suffering from diabetes or hypertension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diabetic hypertensive recently diagnosed patients</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>recently diagnosed patients suffers from diabetes type 2 and hypertension but didnot receive their proper treatment yet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin treated group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>diabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vildagliptin treated group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin Pill</intervention_name>
    <description>a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus</description>
    <arm_group_label>Metformin treated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vildagliptin 50 mg</intervention_name>
    <description>Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus</description>
    <arm_group_label>Vildagliptin treated group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from moderate HTN and DM, their HbA1c ≥ 7 and age range between&#xD;
             40-60 years, treatment with diet alone, any combination of oral antidiabetic agents&#xD;
             and/or insulin before admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical evidence of ischemic heart disease, chronic obstructive pulmonary disease,&#xD;
             presence of diabetic ketoacidosis (DKA), patients admitted to intensive care unit&#xD;
             (ICU), subjects expected to undergo surgery during the study period, patients with&#xD;
             clinically relevant hepatic disease, impaired renal function (serum creatinine ≥3.0&#xD;
             mg/dL), systemic infections or pregnancy. Also, patients on medications known to&#xD;
             interfere with the blood glucose level (either increasing or decreasing) were excluded&#xD;
             from the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hekma A Abdel-Latif, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>cairo university faculty of pharmacy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abdel Rahman M El-Naggar, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammed F Elyamany, assistant professor</last_name>
    <role>Study Director</role>
    <affiliation>cairo university faculty of pharmacy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Soha O Hassanin, lecturer</last_name>
    <role>Study Director</role>
    <affiliation>MTI unuversity faculty of pharmacy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Atef Bassyouni, Professor</last_name>
    <role>Study Director</role>
    <affiliation>National institute of diabetes and endocrinology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dalia K Zaafar, assistant lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>MTI unuversity faculty of pharmacy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National institute of diabetes and endocrinology</name>
      <address>
        <city>Cairo</city>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MTI University</investigator_affiliation>
    <investigator_full_name>Dalia Kamal Zaafar Ali</investigator_full_name>
    <investigator_title>assistant lecturer of pharmacology and toxicology</investigator_title>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>Metformin</keyword>
  <keyword>vildagliptin</keyword>
  <keyword>hypertension</keyword>
  <keyword>cardiovascular risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Vildagliptin</mesh_term>
  </intervention_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/NCT03253562
org study id: IDE00217
nct id: NCT03253562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a controlled study to measure the efficacy of using metformin or vildagliptin for
      type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk
      resulting from both diabetes and hypertension using different parameters measuring
Several studies indicated that type 2 diabetes mellitus and hypertension are associated with
      increased cardiovascular complications. Recently, studies suggest that metformin and
      vildagliptin can reduce cardiovascular complications in diabetic patients with unclear
      mechanisms. This work aimed to determine the effect of metformin and vildagliptin on
      diabetic-hypertensive patients. Patients were allocated into four groups: groupI: healthy
      volunteers, groupII: patients recently diagnosed with their hypertension and diabetes,
      groupIII: patients treated with captopril (25mg once daily) for their hypertension in
      addition to metformin (1000mg bid) groupIV: patients treated with captopril (25mg bid) for
      hypertension in addition to vildagliptin (50mg bid). At the end of the therapeutic period,
      then total cholesterol, LDL,serum Creatinine level, blood pressure and vascular endothelial
      growth factor (VEGF) levels in serum will be measured for different groups to estimate the
      benefits of one drug over the other one in protecting against cardiovascular risks for
      diabetic hypertensive patients..
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: benefit of reducing hypertension in diabetic hypertensive patients
time frame: 6 months
description: blood pressure will be measured
measure: benefit of lowering cardiovascular risks for diabetic hypertensive patients
time frame: 6 months
description: total lipid profile will be measured
measure: benefit of improving the condition of elevated blood pressure in patients through neovascularization
time frame: 6 months
description: vascular endothelial growth factor level in serum will be measured
measure: reducing obesity for diabetic patients
time frame: 6months
description: difference in body weight at the beginning and the end of the study will be measured
measure: comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients
time frame: 6 months
description: glycated hemoglobin will be measured
arm group label: Healthy control
arm group type: No Intervention
description: healthy volunteers not suffering from diabetes or hypertension
arm group label: diabetic hypertensive recently diagnosed patients
arm group type: No Intervention
description: recently diagnosed patients suffers from diabetes type 2 and hypertension but didnot receive their proper treatment yet
arm group label: Metformin treated group
arm group type: Other
description: diabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes
arm group label: Vildagliptin treated group
arm group type: Other
description: diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes
intervention type: Drug
intervention name: Metformin Pill
description: a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus
arm group label: Metformin treated group
intervention type: Drug
intervention name: Vildagliptin 50 mg
description: Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus
arm group label: Vildagliptin treated group
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hekma A Abdel-Latif, Professor
role: Study Chair
affiliation: cairo university faculty of pharmacy
last name: Abdel Rahman M El-Naggar, Professor
role: Study Director
affiliation: Cairo University
last name: Mohammed F Elyamany, assistant professor
role: Study Director
affiliation: cairo university faculty of pharmacy
last name: Soha O Hassanin, lecturer
role: Study Director
affiliation: MTI unuversity faculty of pharmacy
last name: Atef Bassyouni, Professor
role: Study Director
affiliation: National institute of diabetes and endocrinology
last name: Dalia K Zaafar, assistant lecturer
role: Principal Investigator
affiliation: MTI unuversity faculty of pharmacy
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: MTI University
investigator full name: Dalia Kamal Zaafar Ali
investigator title: assistant lecturer of pharmacology and toxicology
mesh term: Hypertension
mesh term: Metformin
mesh term: Vildagliptin
sharing ipd: No