<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/NCT02189395</url>
  </required_header>
  <id_info>
    <org_study_id>437860</org_study_id>
    <nct_id>NCT02189395</nct_id>
  </id_info>
  <brief_title>Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting</brief_title>
  <official_title>Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riverside University Health System Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riverside University Health System Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the current study is to determine difference in glycemic control between&#xD;
      traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs&#xD;
      basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly&#xD;
      encountered in the investigators county hospital setting which include newly diagnosed type 2&#xD;
      patients and patients on relatively high dose of insulin (dose &gt;0.4 units/kg body weight.&#xD;
      Primary outcome of the study is to determine differences in glycemic control between&#xD;
      treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure&#xD;
      number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effect of insulin depends not only on the pharmacokinetics and pharmacodynamics of a&#xD;
      particular preparation, but also on patient specific factors which includes state of&#xD;
      inflammation, obesity etc. Although effect on glucose disposal is the central to insulin&#xD;
      action, there could be differences of insulin action on other metabolic parameters. It is not&#xD;
      known if there is a difference in suppression of inflammation with improved glycemic control&#xD;
      which could vary with analog insulin. It is unknown if natural insulin (NPH, recombinant&#xD;
      human insulin with protamine) differs from insulin analogs (glargine and detemir, made by&#xD;
      substituting amino acid in the native sequence) in terms of metabolic outcome other than&#xD;
      glucose disposal.&#xD;
&#xD;
      At this point it is uncertain if there is any clear benefit of use of lantus over NPH in&#xD;
      inpatient glycemic management. Currently, both lantus and NPH based regimen is practiced in&#xD;
      inpatient hospital setting. Current practice of inpatient insulin regimen is based more on&#xD;
      familiarity of physicians with a particular insulin type and personal preference rather than&#xD;
      evidenced based knowledge. Lantus is an expensive insulin preparation compared to NPH with&#xD;
      uncertain benefit in inpatient setting. Current research proposal will compare this two&#xD;
      insulin based regimen in the management of diabetes of hospitalized patients. Information&#xD;
      obtained through this research will guide the investigators practice in this institution as&#xD;
      well as in other institutions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    difficulty in subject recruitment&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>difference in glycemic control between treatment groups as measured by the mean daily blood glucose</measure>
    <time_frame>Duration of hospital stay, up to 24 weeks</time_frame>
    <description>Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of hypoglycemic events</measure>
    <time_frame>duration of hospital stay, up to 24 weeks</time_frame>
    <description>number of hypoglycemic events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>NPH and regular insuline group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the group receiving NPH and regular 2/3 and 1/3 formula will be followed. If Nil per os (NPO), patient will receive NPH twice daily but AM dose will equal to PM dose. Regular insulin given along with NPH will be held while patient is NPO. A correctional dose of regular insulin will be given for any blood glucose &gt;180 mg/dL. If subjects were not eating, they could also receive correctional doses of regular insulin. Correctional insulin could be given four times daily with meals or at bedtime.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glargine and humalog group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Half of the total insulin dose will be given as glargine once daily, either in the AM or in the PM, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as humalog; doses were divided equally between breakfast, lunch, and dinner. An additional correctional dose of humalog will be given for any blood glucose &gt;180 mg/dL. If subjects were not eating, they received glargine once daily and could also receive correctional doses of humalog. Correctional humalog could be given four times daily with meals or at bedtime.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPH and regular insulin</intervention_name>
    <arm_group_label>NPH and regular insuline group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glargine and humalog</intervention_name>
    <arm_group_label>glargine and humalog group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with type II diabetes regardless of duration of diagnosis with an admission&#xD;
             blood glucose level between 140 mg/dL to 400 mg/dL will be included in the study.&#xD;
&#xD;
          -  Other inclusion criteria are as follows:&#xD;
&#xD;
               -  age 18-80 years old&#xD;
&#xD;
               -  treated with diet alone&#xD;
&#xD;
               -  any combination of oral anti-diabetic agents or insulin treatment with any dosage&#xD;
                  before admission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hyperglycemia without a known history of diabetes&#xD;
&#xD;
          -  H/o recent cardiac surgery (within 6 months)&#xD;
&#xD;
          -  Impaired renal function (glomerular filtration rate less than 45)&#xD;
&#xD;
          -  History of diabetic ketoacidosis&#xD;
&#xD;
          -  Diabetes mellitus type 1&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients on steroid treatment&#xD;
&#xD;
          -  Known hypopituitarism or adrenal insufficiency&#xD;
&#xD;
          -  Known hypoglycemia of unawareness&#xD;
&#xD;
          -  Length of stay &lt;48 h&#xD;
&#xD;
          -  And severe liver disease and patent admitted in intensive care unit.&#xD;
&#xD;
          -  Patients already received an insulin dose greater than 0.5 units/kg body weight after&#xD;
             admission prior to initiation of study protocol will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Riverside County Regional Medical Center</name>
      <address>
        <city>Moreno Valley</city>
        <state>California</state>
        <zip>92555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Riverside University Health System Medical Center</investigator_affiliation>
    <investigator_full_name>Iqbal Munir, MD, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Uncontrolled blood glucose</keyword>
  <keyword>insulin</keyword>
  <keyword>glargine</keyword>
  <keyword>NPH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Hypoglycemia</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 Lispro</mesh_term>
    <mesh_term>Insulin, Globin Zinc</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/NCT02189395
org study id: 437860
nct id: NCT02189395
lead sponsor: 
has dmc: Yes
The goal of the current study is to determine difference in glycemic control between
      traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs
      basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly
      encountered in the investigators county hospital setting which include newly diagnosed type 2
      patients and patients on relatively high dose of insulin (dose >0.4 units/kg body weight.
      Primary outcome of the study is to determine differences in glycemic control between
      treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure
      number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.
The effect of insulin depends not only on the pharmacokinetics and pharmacodynamics of a
      particular preparation, but also on patient specific factors which includes state of
      inflammation, obesity etc. Although effect on glucose disposal is the central to insulin
      action, there could be differences of insulin action on other metabolic parameters. It is not
      known if there is a difference in suppression of inflammation with improved glycemic control
      which could vary with analog insulin. It is unknown if natural insulin (NPH, recombinant
      human insulin with protamine) differs from insulin analogs (glargine and detemir, made by
      substituting amino acid in the native sequence) in terms of metabolic outcome other than
      glucose disposal.

      At this point it is uncertain if there is any clear benefit of use of lantus over NPH in
      inpatient glycemic management. Currently, both lantus and NPH based regimen is practiced in
      inpatient hospital setting. Current practice of inpatient insulin regimen is based more on
      familiarity of physicians with a particular insulin type and personal preference rather than
      evidenced based knowledge. Lantus is an expensive insulin preparation compared to NPH with
      uncertain benefit in inpatient setting. Current research proposal will compare this two
      insulin based regimen in the management of diabetes of hospitalized patients. Information
      obtained through this research will guide the investigators practice in this institution as
      well as in other institutions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: difference in glycemic control between treatment groups as measured by the mean daily blood glucose
time frame: Duration of hospital stay, up to 24 weeks
description: Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose
measure: number of hypoglycemic events
time frame: duration of hospital stay, up to 24 weeks
description: number of hypoglycemic events
arm group label: NPH and regular insuline group
arm group type: Experimental
description: For the group receiving NPH and regular 2/3 and 1/3 formula will be followed. If Nil per os (NPO), patient will receive NPH twice daily but AM dose will equal to PM dose. Regular insulin given along with NPH will be held while patient is NPO. A correctional dose of regular insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they could also receive correctional doses of regular insulin. Correctional insulin could be given four times daily with meals or at bedtime.
arm group label: glargine and humalog group
arm group type: Active Comparator
description: Half of the total insulin dose will be given as glargine once daily, either in the AM or in the PM, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as humalog; doses were divided equally between breakfast, lunch, and dinner. An additional correctional dose of humalog will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and could also receive correctional doses of humalog. Correctional humalog could be given four times daily with meals or at bedtime.
intervention type: Drug
intervention name: NPH and regular insulin
arm group label: NPH and regular insuline group
intervention type: Drug
intervention name: glargine and humalog
arm group label: glargine and humalog group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Riverside University Health System Medical Center
investigator full name: Iqbal Munir, MD, PhD
investigator title: Principal Investigator
mesh term: Diabetes Mellitus, Type 2
mesh term: Hypoglycemia
mesh term: Insulin
mesh term: Insulin Lispro
mesh term: Insulin, Globin Zinc