<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/NCT02216799</url>
  </required_header>
  <id_info>
    <org_study_id>2121166</org_study_id>
    <nct_id>NCT02216799</nct_id>
  </id_info>
  <brief_title>Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)</brief_title>
  <acronym>GLUCOSE-in-PN</acronym>
  <official_title>Glargine Insulin Versus Continous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Faisal Specialist Hospital &amp; Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Faisal Specialist Hospital &amp; Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperglycemia increases the risk of complications in surgical patients. Focus on poor&#xD;
      glycemic control as a contributor to adverse outcomes in settings outside the intensive care&#xD;
      unit (ICU) is often dismissed. Total parenteral Nutrition (TPN) has been used in providing&#xD;
      surgical patients with nutrition to prevent deterioration of nutritional status. However,&#xD;
      many diabetic patients receiving TPN develop exaggerated hyperglycemia that requires frequent&#xD;
      insulin administration via sliding scale. Providing diabetic patient's receiving TPN basal&#xD;
      insulin is a known strategy to aid in blood sugar control and prevention of high blood sugar&#xD;
      spikes. Many strategies for basal insulin provision have been utilized clinically during the&#xD;
      administration of TPN; this includes the incorporation of insulin with TPN solution or&#xD;
      administration of long acting insulin such as glargine. However, no study has compared any of&#xD;
      these strategies aiming for selecting the optimum modality for controlling blood glucose in&#xD;
      diabetic surgical patient's receiving TPN. We will conduct a study to compare the efficacy of&#xD;
      once daily insulin glargine versus continuous regular insulin incorporated TPN in controlling&#xD;
      blood glucose in non-critically ill diabetic surgical patients receiving TPN.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Achievement of target blood glucose (140 mg/dL to 200 mg/dL)</measure>
    <time_frame>2-years</time_frame>
    <description>Assessemnt of:&#xD;
Whole blood glucose every morning&#xD;
The amount of subcutenous insulin adminstraed via sliding scale every 6 hours.&#xD;
A target number of 60 patients to complete the study ( 30 patients in each arm) The achievement of target blood glucose based on whole blood glucose levels will be compared in two arms of the study for 5 days while on TPN. Also, the amount of insulin adminstred via sliding scale every day will be comapred as well</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Developement of hypoglycemia ( blood glucose &lt; 70 mg/dL)</measure>
    <time_frame>2-years</time_frame>
    <description>To assess the development of hypoglycemia in both arms of the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition</condition>
  <arm_group>
    <arm_group_label>Regular Insulin incorporated in parenteral nutrition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk, will be added to parenteral nutrition to run over 24 hours as 80% of the total insulin requirement of the preceding day administered via subcutaneous sliding scale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin glargine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insulin glargine adminstred at daily night, calculated as 80% of the total insulin requirement of the preceding day from the insulin administered via subcutaneous sliding scale</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glargine Insulin</intervention_name>
    <description>80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine</description>
    <arm_group_label>Insulin glargine</arm_group_label>
    <arm_group_label>Regular Insulin incorporated in parenteral nutrition</arm_group_label>
    <other_name>LANTUS (insulin glargine [rDNA origin] injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Regular insulin</intervention_name>
    <description>80% of the Regular insulin administrated via sliding scale will be will be added to TPN bag to run over 24 hours</description>
    <arm_group_label>Insulin glargine</arm_group_label>
    <arm_group_label>Regular Insulin incorporated in parenteral nutrition</arm_group_label>
    <other_name>Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult diabetic patients undergoing abdominal surgery operated by the surgical&#xD;
             oncology team at KFSH &amp; RC and required TPN therapy are possible subjects of the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving octreotide or immunosuppressive agents including corticosteroids.&#xD;
&#xD;
          -  Recipient of &lt; 3 units of regular insulin per day via subcutaneous insulin sliding&#xD;
             scale after the third day of TPN recipient.&#xD;
&#xD;
          -  Patients with clinically relevant hepatic disease (&gt; three times normal AST and ALT on&#xD;
             admission to the hospital) or impaired renal function (GFR &lt; 60 ml/min), history of&#xD;
             diabetic ketoacidosis.&#xD;
&#xD;
        Patients who get infected while on TPN as reflected with elevation of white blood cells and&#xD;
        elevated temperature &gt; 37.5 C will be excluded as well.&#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>Hakeam A Hakeam, MS., BCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Faisal Specialist Hospital &amp; Research Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital &amp; Research Centre</name>
      <address>
        <city>Riyadh</city>
        <zip>11211</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <link>
    <url>http://www.kfshrc.edu.sa</url>
    <description>Study Site</description>
  </link>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 24, 2016</last_update_submitted>
  <last_update_submitted_qc>February 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parenteral nutrition</keyword>
  <keyword>Hyperglycemia</keyword>
  <keyword>Glargine insulin</keyword>
  <keyword>Regular insulin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</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/NCT02216799
org study id: 2121166
nct id: NCT02216799
lead sponsor: 
has dmc: No
Hyperglycemia increases the risk of complications in surgical patients. Focus on poor
      glycemic control as a contributor to adverse outcomes in settings outside the intensive care
      unit (ICU) is often dismissed. Total parenteral Nutrition (TPN) has been used in providing
      surgical patients with nutrition to prevent deterioration of nutritional status. However,
      many diabetic patients receiving TPN develop exaggerated hyperglycemia that requires frequent
      insulin administration via sliding scale. Providing diabetic patient's receiving TPN basal
      insulin is a known strategy to aid in blood sugar control and prevention of high blood sugar
      spikes. Many strategies for basal insulin provision have been utilized clinically during the
      administration of TPN; this includes the incorporation of insulin with TPN solution or
      administration of long acting insulin such as glargine. However, no study has compared any of
      these strategies aiming for selecting the optimum modality for controlling blood glucose in
      diabetic surgical patient's receiving TPN. We will conduct a study to compare the efficacy of
      once daily insulin glargine versus continuous regular insulin incorporated TPN in controlling
      blood glucose in non-critically ill diabetic surgical patients receiving TPN.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Achievement of target blood glucose (140 mg/dL to 200 mg/dL)
time frame: 2-years
description: Assessemnt of:
Whole blood glucose every morning
The amount of subcutenous insulin adminstraed via sliding scale every 6 hours.
A target number of 60 patients to complete the study ( 30 patients in each arm) The achievement of target blood glucose based on whole blood glucose levels will be compared in two arms of the study for 5 days while on TPN. Also, the amount of insulin adminstred via sliding scale every day will be comapred as well
measure: Developement of hypoglycemia ( blood glucose < 70 mg/dL)
time frame: 2-years
description: To assess the development of hypoglycemia in both arms of the study
arm group label: Regular Insulin incorporated in parenteral nutrition
arm group type: Active Comparator
description: Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk, will be added to parenteral nutrition to run over 24 hours as 80% of the total insulin requirement of the preceding day administered via subcutaneous sliding scale
arm group label: Insulin glargine
arm group type: Active Comparator
description: Insulin glargine adminstred at daily night, calculated as 80% of the total insulin requirement of the preceding day from the insulin administered via subcutaneous sliding scale
intervention type: Drug
intervention name: Glargine Insulin
description: 80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine
arm group label: Insulin glargine
arm group label: Regular Insulin incorporated in parenteral nutrition
other name: LANTUS (insulin glargine [rDNA origin] injection
intervention type: Drug
intervention name: Regular insulin
description: 80% of the Regular insulin administrated via sliding scale will be will be added to TPN bag to run over 24 hours
arm group label: Insulin glargine
arm group label: Regular Insulin incorporated in parenteral nutrition
other name: Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hakeam A Hakeam, MS., BCPS
role: Principal Investigator
affiliation: King Faisal Specialist Hospital & Research Centre
facility: 
country: Saudi Arabia
url: http://www.kfshrc.edu.sa
description: Study Site
responsible party type: Sponsor
mesh term: Gastrointestinal Neoplasms
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine