<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/NCT04507438</url>
  </required_header>
  <id_info>
    <org_study_id>SH201804</org_study_id>
    <nct_id>NCT04507438</nct_id>
  </id_info>
  <brief_title>The Effect of Donepezil on Glycemic Control in Type II Diabetics</brief_title>
  <official_title>The Effect of Donepezil on Glycemic Control in Type II Diabetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to establish the effectiveness of the drug Donepezil in treating&#xD;
      Type 2 Diabetes Mellitus compared to a control treatment. Donepezil is not approved by the&#xD;
      FDA to treat Type 2 Diabetes Mellitus and its use in this research is experimental. 50&#xD;
      patients with Type 2 Diabetes Mellitus (Adult Onset Diabetes Mellitus) will be randomized to&#xD;
      either the donepezil treatment group or the control group after screening. (25 patients in&#xD;
      each arm; a total of 50 patients). Both men and women shall be enrolled.Donepezil shall be&#xD;
      orally administered to the study group. Control group will get an orally administered placebo&#xD;
      which is an inert compound, lactose. Wk0 will be the randomization visit. The patients will&#xD;
      take the drug for 8 weeks and the last follow up visit will be the last day of week 8.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized, double blinded, treatment-controlled, parallel design to&#xD;
      investigate the effect of donepezil (administration of 5-10 mg of donepezil daily, orally,&#xD;
      over 8 week period) on clinical outcomes reflecting diabetic control. The research assistant&#xD;
      will not be blinded. The investigator and patient shall be blinded. A computer program will&#xD;
      be used to randomize the patients.&#xD;
&#xD;
      50 patients with Type 2 Diabetes Mellitus (Adult Onset Diabetes Mellitus) will be randomized&#xD;
      to either the donepezil treatment group or the control group after screening. (25 patients in&#xD;
      each arm; a total of 50 patients). Both men and women shall be enrolled.&#xD;
&#xD;
      As many patients as required to meet the enrollment numbers shall be screened. Patients will&#xD;
      be monitored daily for blood pressure, glucose levels and heart rate, during the period of&#xD;
      hospitalization. Adjustments in insulin or oral hypoglycemic, blood pressure and heart rate&#xD;
      control medications will occur during this time. Follow up visits will be made as required&#xD;
      and at the end of week 8.&#xD;
&#xD;
      Donepezil shall be orally administered to the study group. Control group will get an orally&#xD;
      administered placebo which is an inert compound, lactose.&#xD;
&#xD;
      Wk0 will be the randomization visit. The patients will take the drug for 8 weeks and the last&#xD;
      follow up visit will be the last day of week 8.&#xD;
&#xD;
      Any anticholinergic drugs will be eliminated from the patients' medical regimen with the&#xD;
      exception for inhaled anticholinergic. There is no known major contraindication of&#xD;
      acetylcholinesterase inhibitors (like for eg: galantamine, rivastigmine and donepezil)&#xD;
      Patients shall be monitored closely for vagotonic effect. Acetylcholine is known to have a&#xD;
      vagotonic effect lowering heart rate and blood pressure. Therefore, during the course of&#xD;
      administration of the drug close attention to heart rate and blood pressure will be a&#xD;
      significant part off the clinical management of patients. If the patients are on beta&#xD;
      blockers, their beta blocker dose will be closely monitored and adjusted as required.&#xD;
&#xD;
      Proton pump inhibitors will be used to guard against any possible GI bleed. 40 mg of&#xD;
      pantoprazole once daily.&#xD;
&#xD;
      Patient will be observed for seizures. The patients will be examined for pulmonary&#xD;
      exacerbation during treatment in the hospital. If the pulmonary status deteriorates they will&#xD;
      be eliminated from the study. The medication administration will not start sooner than 24 hrs&#xD;
      after surgery. Patients shall be observed for exaggerated response from anesthesia.&#xD;
&#xD;
      Only lipid profile and fasting blood sugar has to be done fasting. As many tests as possible&#xD;
      shall be combined and done at the same time to avoid multiple needle pricks to the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2023</primary_completion_date>
  <phase>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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Hemoglobin A1C</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in blood urea nitrogen</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Change will be assessed by reviewing blood urea nitrogen/creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in creatinine</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change will be assessed by reviewing blood urea nitrogen/creatinine</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>8 Weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in albumin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Weight and albumin will be monitored to asses change in nutritional status</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Donepezil treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of 5mg or 10 mg of donepezil daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil 5-10 Mg Oral Tablet</intervention_name>
    <description>Donepezil 5mg or 10mg oral tablet administered daily for an 8 week period</description>
    <arm_group_label>Donepezil treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo oral tablet administered daily for an 8 week period</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 50 with Type 2 Diabetes Mellitus, regardless of&#xD;
             co-morbidities including renal and vascular insufficiency, Cardiovascular Autonomic&#xD;
             Neuropathy, Hypertension, Chronic Obstructive Pulmonary Disease or Coronary Disease&#xD;
             will be selected.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 50&#xD;
&#xD;
          -  Patients who are pregnant or lactating&#xD;
&#xD;
          -  Patients who are lactose intolerance&#xD;
&#xD;
          -  Patients with an allergy to Donepezil&#xD;
&#xD;
          -  Prothrombin Time and International Normalized Ratio value greater than 1.25&#xD;
&#xD;
          -  Pre-menopausal women and patients allergic to Donepezil are excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>51 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Stephen Wills, MD</last_name>
    <phone>410-822-1000</phone>
    <phone_ext>5226</phone_ext>
    <email>swills@umm.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Maryland Shore Regional Health</name>
      <address>
        <city>Easton</city>
        <state>Maryland</state>
        <zip>21601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen Wills, MD</last_name>
      <phone>410-822-1000</phone>
      <phone_ext>5226</phone_ext>
      <email>swills@umm.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>March 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Stephen Wills</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Donepezil</mesh_term>
  </intervention_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/NCT04507438
org study id: SH201804
nct id: NCT04507438
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of the study is to establish the effectiveness of the drug Donepezil in treating
      Type 2 Diabetes Mellitus compared to a control treatment. Donepezil is not approved by the
      FDA to treat Type 2 Diabetes Mellitus and its use in this research is experimental. 50
      patients with Type 2 Diabetes Mellitus (Adult Onset Diabetes Mellitus) will be randomized to
      either the donepezil treatment group or the control group after screening. (25 patients in
      each arm; a total of 50 patients). Both men and women shall be enrolled.Donepezil shall be
      orally administered to the study group. Control group will get an orally administered placebo
      which is an inert compound, lactose. Wk0 will be the randomization visit. The patients will
      take the drug for 8 weeks and the last follow up visit will be the last day of week 8.
The study is a randomized, double blinded, treatment-controlled, parallel design to
      investigate the effect of donepezil (administration of 5-10 mg of donepezil daily, orally,
      over 8 week period) on clinical outcomes reflecting diabetic control. The research assistant
      will not be blinded. The investigator and patient shall be blinded. A computer program will
      be used to randomize the patients.

      50 patients with Type 2 Diabetes Mellitus (Adult Onset Diabetes Mellitus) will be randomized
      to either the donepezil treatment group or the control group after screening. (25 patients in
      each arm; a total of 50 patients). Both men and women shall be enrolled.

      As many patients as required to meet the enrollment numbers shall be screened. Patients will
      be monitored daily for blood pressure, glucose levels and heart rate, during the period of
      hospitalization. Adjustments in insulin or oral hypoglycemic, blood pressure and heart rate
      control medications will occur during this time. Follow up visits will be made as required
      and at the end of week 8.

      Donepezil shall be orally administered to the study group. Control group will get an orally
      administered placebo which is an inert compound, lactose.

      Wk0 will be the randomization visit. The patients will take the drug for 8 weeks and the last
      follow up visit will be the last day of week 8.

      Any anticholinergic drugs will be eliminated from the patients' medical regimen with the
      exception for inhaled anticholinergic. There is no known major contraindication of
      acetylcholinesterase inhibitors (like for eg: galantamine, rivastigmine and donepezil)
      Patients shall be monitored closely for vagotonic effect. Acetylcholine is known to have a
      vagotonic effect lowering heart rate and blood pressure. Therefore, during the course of
      administration of the drug close attention to heart rate and blood pressure will be a
      significant part off the clinical management of patients. If the patients are on beta
      blockers, their beta blocker dose will be closely monitored and adjusted as required.

      Proton pump inhibitors will be used to guard against any possible GI bleed. 40 mg of
      pantoprazole once daily.

      Patient will be observed for seizures. The patients will be examined for pulmonary
      exacerbation during treatment in the hospital. If the pulmonary status deteriorates they will
      be eliminated from the study. The medication administration will not start sooner than 24 hrs
      after surgery. Patients shall be observed for exaggerated response from anesthesia.

      Only lipid profile and fasting blood sugar has to be done fasting. As many tests as possible
      shall be combined and done at the same time to avoid multiple needle pricks to the patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Hemoglobin A1C
time frame: 8 weeks
measure: Change in blood urea nitrogen
time frame: 8 Weeks
description: Change will be assessed by reviewing blood urea nitrogen/creatinine
measure: Change in creatinine
time frame: 8 weeks
description: Change will be assessed by reviewing blood urea nitrogen/creatinine
measure: Change in lipid profile
time frame: 8 Weeks
measure: Change in albumin
time frame: 8 weeks
description: Weight and albumin will be monitored to asses change in nutritional status
arm group label: Donepezil treatment group
arm group type: Experimental
description: Administration of 5mg or 10 mg of donepezil daily
arm group label: Control group
arm group type: Placebo Comparator
description: Administration of placebo
intervention type: Drug
intervention name: Donepezil 5-10 Mg Oral Tablet
description: Donepezil 5mg or 10mg oral tablet administered daily for an 8 week period
arm group label: Donepezil treatment group
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo oral tablet administered daily for an 8 week period
arm group label: Control group
criteria: 
gender: All
minimum age: 51 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen Wills, MD
phone: 410-822-1000
phone ext: 5226
email: swills@umm.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Stephen Wills
investigator title: Principal Investigator
mesh term: Diabetes Mellitus, Type 2
mesh term: Donepezil