<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/NCT02222623</url>
  </required_header>
  <id_info>
    <org_study_id>14-1623</org_study_id>
    <nct_id>NCT02222623</nct_id>
  </id_info>
  <brief_title>The Inova Type 2 Diabetes Mellitus Study</brief_title>
  <acronym>InovaDM2</acronym>
  <official_title>Insulin Glargine vs NPH as Basal Insulin on Glycemic Values in Hospitalized Patients: The Inova Diabetes Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inova Health Care Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the safety and effectiveness of the two different&#xD;
      basal insulins commonly used for basal blood sugar control in the treatment of type 2&#xD;
      diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral&#xD;
      protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown&#xD;
      that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of&#xD;
      blood sugar in a type 2 diabetic patient. This research is being done because the costs of&#xD;
      medications for diabetic patients are very expensive. Our goal with this research is to show&#xD;
      that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin&#xD;
      [glargine (Lantus®)] in patients with type 2 diabetes mellitus who are in the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, open label trial comparing effectiveness of insulin glargine and&#xD;
      insulin NPH in a basal plus correctional regimen. Patients will be randomized to either an&#xD;
      intervention (NPH) or a control group (glargine) upon admission. The following data will be&#xD;
      collected: age, sex, weight, preadmission diabetes medications, admission diagnosis, HbA1C,&#xD;
      blood glucose (BG), chemistry, hematology, urine analysis, pregnancy test, duration of&#xD;
      hospitalization, insulin dose, and discharge status. Data will be recorded and maintained&#xD;
      confidentially.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled&#xD;
  </why_stopped>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</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>Mean daily blood glucose</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of total BG readings within target BG 70-180 mg/dL before meals.</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number (Percent) of episodes and total BG readings of hypoglycemic events (BG &lt; 70 mg/dL)</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number (Percent) of total BG readings of severe hyperglycemia (BG &gt; 300 mg/dL) after the first day of treatment.</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean total daily dose of insulin</measure>
    <time_frame>5 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>within first 30 days of admission</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes, Type 2</condition>
  <arm_group>
    <arm_group_label>glargine insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Basal glargine given once daily in the morning before breakfast plus standard hospital corrective doses of insulin aspart before meals and at bedtime.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NPH insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Basal NPH given twice daily before breakfast and at bedtime plus standard hospital corrective doses of insulin aspart before meals and at bedtime.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glargine</intervention_name>
    <description>Glargine given as 100% total daily dose with breakfast. The initial dose will be calculated using the patient's weight or using their basal insulin doses prior to hospitalization.</description>
    <arm_group_label>glargine insulin</arm_group_label>
    <other_name>Lantus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPH</intervention_name>
    <description>NPH 2/3 of the total daily dose given with breakfast, 1/3 of the total daily dose given at bedtime. The initial dose is calculated using the patient's weight or using the basal insulin dose prior to hospitalization.</description>
    <arm_group_label>NPH insulin</arm_group_label>
    <other_name>Novolin N</other_name>
    <other_name>Humulin N</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients ages18-75 admitted to a general medicine or surgical Department of&#xD;
             Medicine hospitalist services.&#xD;
&#xD;
          2. A known history of T2DM, receiving either diet alone, low dose insulin (≤0.4&#xD;
             units/kg/day), OADs, GLP1 analogs, or in any combination of OADs, GLP1 analogs and low&#xD;
             dose insulin (≤0.4 units/kg/day).&#xD;
&#xD;
          3. Subjects must have a BG &gt;140 mg/dL and ≤240 mg/dL before randomization without&#xD;
             laboratory evidence of diabetic ketoacidosis or hyperglycemic hyperosmolar nonketotic&#xD;
             syndrome (bicarbonate &lt;18 mEq/L, pH &lt;7.30, or positive serum or urinary ketones, BG&#xD;
             &gt;240 mg/dL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a diagnosis of type 1 diabetes mellitus.&#xD;
&#xD;
          2. Patients using nutritional bolus insulin at home.&#xD;
&#xD;
          3. Patients with increased blood glucose concentration, but without a known history of&#xD;
             diabetes.&#xD;
&#xD;
          4. Patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar&#xD;
             nonketotic syndrome, or ketonuria.&#xD;
&#xD;
          5. Patients admitted to or expected to require admission to any intensive care unit (ICU)&#xD;
             or intermediate care unit (IMC).&#xD;
&#xD;
          6. Patients who are receiving or are anticipated to receive enteral or parenteral&#xD;
             nutrition.&#xD;
&#xD;
          7. Patients admitted for cardiac surgery.&#xD;
&#xD;
          8. Patients receiving continuous insulin infusion.&#xD;
&#xD;
          9. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and&#xD;
             portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥&#xD;
             3.5 mg/dL).&#xD;
&#xD;
         10. Persons with decisional incapacity (mental condition rendering the subject unable to&#xD;
             understand the nature, scope, and possible consequences of the study).&#xD;
&#xD;
         11. Female subjects who are pregnant or immediately (same hospitalization) post partum at&#xD;
             time of enrollment into the study.&#xD;
&#xD;
         12. Patients with recognized or suspected endocrine disorders associated with increased&#xD;
             insulin resistance, acromegaly, or hyperthyroidism.&#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_official>
    <last_name>Stephen C Clement, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inova Fairfax Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 3, 2016</last_update_submitted>
  <last_update_submitted_qc>August 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>insulin</keyword>
  <keyword>basal</keyword>
  <keyword>diabetes</keyword>
  <keyword>hospital</keyword>
  <keyword>glucose</keyword>
  <keyword>hypoglycemia</keyword>
  <keyword>glargine</keyword>
  <keyword>NPH</keyword>
  <keyword>neutral protamine hagedorn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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>Isophane Insulin, Human</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/NCT02222623
org study id: 14-1623
nct id: NCT02222623
lead sponsor: 
has dmc: No
The purpose of this study is to compare the safety and effectiveness of the two different
      basal insulins commonly used for basal blood sugar control in the treatment of type 2
      diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral
      protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown
      that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of
      blood sugar in a type 2 diabetic patient. This research is being done because the costs of
      medications for diabetic patients are very expensive. Our goal with this research is to show
      that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin
      [glargine (Lantus®)] in patients with type 2 diabetes mellitus who are in the hospital.
This is a randomized, open label trial comparing effectiveness of insulin glargine and
      insulin NPH in a basal plus correctional regimen. Patients will be randomized to either an
      intervention (NPH) or a control group (glargine) upon admission. The following data will be
      collected: age, sex, weight, preadmission diabetes medications, admission diagnosis, HbA1C,
      blood glucose (BG), chemistry, hematology, urine analysis, pregnancy test, duration of
      hospitalization, insulin dose, and discharge status. Data will be recorded and maintained
      confidentially.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean daily blood glucose
time frame: 5 days
measure: Percent of total BG readings within target BG 70-180 mg/dL before meals.
time frame: 5 days
measure: Number (Percent) of episodes and total BG readings of hypoglycemic events (BG < 70 mg/dL)
time frame: 5 days
measure: Number (Percent) of total BG readings of severe hyperglycemia (BG > 300 mg/dL) after the first day of treatment.
time frame: 5 days
measure: Hospital mortality
time frame: 5 days
measure: Mean total daily dose of insulin
time frame: 5 days
measure: Length of hospital stay
time frame: within first 30 days of admission
arm group label: glargine insulin
arm group type: Active Comparator
description: Basal glargine given once daily in the morning before breakfast plus standard hospital corrective doses of insulin aspart before meals and at bedtime.
arm group label: NPH insulin
arm group type: Active Comparator
description: Basal NPH given twice daily before breakfast and at bedtime plus standard hospital corrective doses of insulin aspart before meals and at bedtime.
intervention type: Drug
intervention name: Glargine
description: Glargine given as 100% total daily dose with breakfast. The initial dose will be calculated using the patient's weight or using their basal insulin doses prior to hospitalization.
arm group label: glargine insulin
other name: Lantus
intervention type: Drug
intervention name: NPH
description: NPH 2/3 of the total daily dose given with breakfast, 1/3 of the total daily dose given at bedtime. The initial dose is calculated using the patient's weight or using the basal insulin dose prior to hospitalization.
arm group label: NPH insulin
other name: Novolin N
other name: Humulin N
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Stephen C Clement, MD
role: Principal Investigator
affiliation: Inova Fairfax Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Isophane Insulin, Human