<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/NCT04460326</url>
  </required_header>
  <id_info>
    <org_study_id>H-39600</org_study_id>
    <nct_id>NCT04460326</nct_id>
  </id_info>
  <brief_title>Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus</brief_title>
  <acronym>In-FI</acronym>
  <official_title>Comparison of Postprandial Glycemic Control in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus Using Novolog vs. Fiasp Insulin: a Randomized Controlled Open Label Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</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>
      Hyperglycemia affects 30-40% of hospitalized patients. Despite the fact that basal/bolus&#xD;
      insulin therapy has been demonstrated to improve glycemic control and clinical outcomes in&#xD;
      patients, achieving good glucose control remains a challenge.&#xD;
&#xD;
      This study examines the effects of Fiasp (a faster acting insulin) on blood sugars after&#xD;
      meals compared to another type of insulin known as Novolog. The study will be performed in&#xD;
      patients with type 2 diabetes admitted to the hospital, who are not in the intensive care&#xD;
      unit, and who are being seen by the inpatient diabetes consult team. Eligible participants&#xD;
      will be treated with Fiasp or Novolog injected multiple times a day before meals and at&#xD;
      bedtime, in addition to a once daily injection of insulin glargine as basal insulin. Which&#xD;
      type of meal time insulin (Fiasp vs Novolog) the subject gets is decided by chance, like the&#xD;
      flip of a coin. Insulin doses will be started and titrated based on a protocol. All the&#xD;
      subjects will wear a blinded continuous glucose monitoring (CGM)) sensor placed in their arm&#xD;
      which they will wear for 72 hours during the study. The glucose values from the CGM,&#xD;
      collected during the time it is worn, will be downloaded and compared to assess the response&#xD;
      to the two different types of insulins - Fiasp and Novolog. The goal is to determine if Fiasp&#xD;
      works as well as or better than Novolog in controlling blood sugars, particularly after&#xD;
      meals, in the subjects of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 3</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>Postprandial glucose control</measure>
    <time_frame>4 hour postprandial</time_frame>
    <description>The amount of time in minutes spent in sensor glucose control target range of 100-180 mg/dL in the 4 hour postprandial period will be assessed using a continuous glucose monitoring (CGM) system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic control while hospitalized</measure>
    <time_frame>From date of admission to date of discharge, up to 30 days</time_frame>
    <description>Percent of time spent in the glycemic target range of 100-180 mg/dL during the duration of the study will be assessed using a continuous glucose monitoring (CGM) system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of postprandial time in glycemic range of 70-140 mg/dL</measure>
    <time_frame>4 hour postprandial</time_frame>
    <description>Percent of time spent in the glycemic target range of 70-140 mg/dL during the duration of the study assessed using a continuous glucose monitoring (CGM) system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of nocturnal time in glycemic target range 100-180 mg/dL</measure>
    <time_frame>From date of admission to date of discharge, up to 30 days</time_frame>
    <description>The percent of nocturnal time (from 00.01 AM to 5:59 AM) in the glycemic target range of 100-180 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of postprandial time spent with hypoglycemia</measure>
    <time_frame>4 hours postprandial</time_frame>
    <description>The percent of postprandial time in three categories of hypoglycemia will be assessed: &lt;70 mg/dL, &lt;54 mg/dL, and &lt;40 mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of nocturnal time spent with hypoglycemia</measure>
    <time_frame>From date of admission to date of discharge, up to 30 days</time_frame>
    <description>The percent of nocturnal time (from 00.01 AM to 5:59 AM) in three categories of hypoglycemia: &lt;70 mg/dL, &lt;54 mg/dL, and &lt;40 mg/dL will be assessed using CGM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time spent with hypoglycemia during hospitalization</measure>
    <time_frame>From date of admission to date of discharge, up to 30 days</time_frame>
    <description>The percent of time in three categories of hypoglycemia : &lt;70 mg/dL, &lt;54 mg/dL, and &lt;40 mg/dL will be assessed using a CGM during hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of postprandial time spent with level 1 hyperglycemia</measure>
    <time_frame>4 hours postprandial</time_frame>
    <description>The percent of time spent in level 1 hyperglycemia (181-239 mg/dL) will be assessed using CGM in the 4 hour postprandial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of postprandial time spent with level 2 hyperglycemia</measure>
    <time_frame>4 hours postprandial</time_frame>
    <description>The percent of time spent in level 2 hyperglycemia (&gt;240 mg/dL) will be assessed using CGM in the 4 hour postprandial period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Type 2 Diabetes Treated With Insulin</condition>
  <arm_group>
    <arm_group_label>Group 1 insulin glargine and Novolog</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal BG is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 insulin glargine and Fiasp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine</intervention_name>
    <description>Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in &gt;10%</description>
    <arm_group_label>Group 1 insulin glargine and Novolog</arm_group_label>
    <arm_group_label>Group 2 insulin glargine and Fiasp</arm_group_label>
    <other_name>Lantus®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NovoLog</intervention_name>
    <description>Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.</description>
    <arm_group_label>Group 1 insulin glargine and Novolog</arm_group_label>
    <other_name>NovoLog®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Fiasp</intervention_name>
    <description>Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.</description>
    <arm_group_label>Group 2 insulin glargine and Fiasp</arm_group_label>
    <other_name>Fiasp®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard carbohydrate diet</intervention_name>
    <description>Standard carbohydrate diet as per usual hospital care (75g with each meal)</description>
    <arm_group_label>Group 1 insulin glargine and Novolog</arm_group_label>
    <arm_group_label>Group 2 insulin glargine and Fiasp</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. English-speaking&#xD;
&#xD;
          2. Males and female adult subjects admitted to Boston Medical Center to a medical or&#xD;
             surgical floor.&#xD;
&#xD;
          3. Consultation by the Inpatient Diabetes Service at Boston Medical Center is required&#xD;
             prior to consent.&#xD;
&#xD;
          4. Age ≥ 21 and &lt;= 80 years.&#xD;
&#xD;
          5. Diagnosed with type 2 diabetes at least 180 days prior to screening.&#xD;
&#xD;
          6. Hyperglycemia during admission, as defined by a point of care and/or venous blood&#xD;
             glucose ≥ 140 mg/dL.&#xD;
&#xD;
          7. Prior to admission subjects must be using one of the following for outpatient diabetes&#xD;
             management:&#xD;
&#xD;
               1. Insulin&#xD;
&#xD;
               2. ≥ 2 oral/injectable agents&#xD;
&#xD;
               3. One oral/injectable agent with a hemoglobin A1c of ≥ 8% within 3 months of&#xD;
                  enrollment.&#xD;
&#xD;
          8. Patients who are expected to remain hospitalized for a minimum of 48 hours following&#xD;
             CGM sensor placement.&#xD;
&#xD;
          9. BMI &lt;45 kg/m^2.&#xD;
&#xD;
         10. Subjects must have insulin glargine dosing planned at bedtime for the duration of the&#xD;
             study period. Morning and afternoon dosing of insulin glargine are exclusionary.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients with a history of type 1 diabetes or late-onset autoimmune diabetes (LADA).&#xD;
&#xD;
          2. Treatment or plan for treatment with glucocorticoids during the index hospitalization.&#xD;
&#xD;
          3. Female patients who are pregnant (tested during hospitalization or screening) or&#xD;
             breast-feeding during the hospitalization.&#xD;
&#xD;
          4. Patients admitted with the following conditions: diabetic ketoacidosis, hyperosmolar&#xD;
             hyperglycemic state, solid organ transplantation, or coronary artery bypass surgery.&#xD;
&#xD;
          5. Prior diagnosis of gastroparesis or cirrhosis.&#xD;
&#xD;
          6. Acute or chronic kidney disease with a serum creatinine of ≥ 2 mg/dL at the time of&#xD;
             screening.&#xD;
&#xD;
          7. Clinically significant nausea and/or vomiting or unable to consume more than 30 grams&#xD;
             of carbohydrate at each meal.&#xD;
&#xD;
          8. Patients expected to receive nothing by mouth (NPO) for &gt;24 hours.&#xD;
&#xD;
          9. Use of continuous or intermittent enteral feeding or parenteral nutrition.&#xD;
&#xD;
         10. Patient receiving aspirin and/or vitamin C during the hospitalization.&#xD;
&#xD;
         11. Any mental condition rendering the subject unable to provide informed consent.&#xD;
&#xD;
         12. Patients currently incarcerated.&#xD;
&#xD;
         13. Patients using &gt;1 unit/kg/day of insulin prior to admission.&#xD;
&#xD;
         14. Insulin pump usage within the 2 weeks prior to or during admission.&#xD;
&#xD;
         15. Patients currently using real-time continuous glucose monitoring (CGM) or personal&#xD;
             flash glucose monitoring system (FGM).&#xD;
&#xD;
         16. Patients with a history of an allergy to any of the types of insulin or one of the&#xD;
             excipients in the insulin used in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara M Alexanian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sara M Alexanian, MD</last_name>
    <phone>617-638-8545</phone>
    <email>sara.alexanian@bmc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhihui Ju, MPH</last_name>
    <phone>617-638-5921</phone>
    <email>zhihui.ju@bmc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Alexanian, MD</last_name>
      <phone>617-638-8545</phone>
      <email>sara.alexanian@bmc.org</email>
    </contact>
    <investigator>
      <last_name>Sara Aleanian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 23, 2023</last_update_submitted>
  <last_update_submitted_qc>April 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fiasp</keyword>
  <keyword>Novolog</keyword>
  <keyword>Continuous glucose monitor (CGM)</keyword>
  <keyword>Hypoglycemia</keyword>
  <keyword>Hyperglycemia</keyword>
  <keyword>Hemoglobin A1c</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>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
    <mesh_term>Insulin Aspart</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/NCT04460326
org study id: H-39600
nct id: NCT04460326
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Hyperglycemia affects 30-40% of hospitalized patients. Despite the fact that basal/bolus
      insulin therapy has been demonstrated to improve glycemic control and clinical outcomes in
      patients, achieving good glucose control remains a challenge.

      This study examines the effects of Fiasp (a faster acting insulin) on blood sugars after
      meals compared to another type of insulin known as Novolog. The study will be performed in
      patients with type 2 diabetes admitted to the hospital, who are not in the intensive care
      unit, and who are being seen by the inpatient diabetes consult team. Eligible participants
      will be treated with Fiasp or Novolog injected multiple times a day before meals and at
      bedtime, in addition to a once daily injection of insulin glargine as basal insulin. Which
      type of meal time insulin (Fiasp vs Novolog) the subject gets is decided by chance, like the
      flip of a coin. Insulin doses will be started and titrated based on a protocol. All the
      subjects will wear a blinded continuous glucose monitoring (CGM)) sensor placed in their arm
      which they will wear for 72 hours during the study. The glucose values from the CGM,
      collected during the time it is worn, will be downloaded and compared to assess the response
      to the two different types of insulins - Fiasp and Novolog. The goal is to determine if Fiasp
      works as well as or better than Novolog in controlling blood sugars, particularly after
      meals, in the subjects of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postprandial glucose control
time frame: 4 hour postprandial
description: The amount of time in minutes spent in sensor glucose control target range of 100-180 mg/dL in the 4 hour postprandial period will be assessed using a continuous glucose monitoring (CGM) system.
measure: Glycemic control while hospitalized
time frame: From date of admission to date of discharge, up to 30 days
description: Percent of time spent in the glycemic target range of 100-180 mg/dL during the duration of the study will be assessed using a continuous glucose monitoring (CGM) system.
measure: Percent of postprandial time in glycemic range of 70-140 mg/dL
time frame: 4 hour postprandial
description: Percent of time spent in the glycemic target range of 70-140 mg/dL during the duration of the study assessed using a continuous glucose monitoring (CGM) system.
measure: Percent of nocturnal time in glycemic target range 100-180 mg/dL
time frame: From date of admission to date of discharge, up to 30 days
description: The percent of nocturnal time (from 00.01 AM to 5:59 AM) in the glycemic target range of 100-180 mg/dL
measure: Percent of postprandial time spent with hypoglycemia
time frame: 4 hours postprandial
description: The percent of postprandial time in three categories of hypoglycemia will be assessed: <70 mg/dL, <54 mg/dL, and <40 mg/dL.
measure: Percent of nocturnal time spent with hypoglycemia
time frame: From date of admission to date of discharge, up to 30 days
description: The percent of nocturnal time (from 00.01 AM to 5:59 AM) in three categories of hypoglycemia: <70 mg/dL, <54 mg/dL, and <40 mg/dL will be assessed using CGM.
measure: Percent of time spent with hypoglycemia during hospitalization
time frame: From date of admission to date of discharge, up to 30 days
description: The percent of time in three categories of hypoglycemia : <70 mg/dL, <54 mg/dL, and <40 mg/dL will be assessed using a CGM during hospitalization.
measure: Percent of postprandial time spent with level 1 hyperglycemia
time frame: 4 hours postprandial
description: The percent of time spent in level 1 hyperglycemia (181-239 mg/dL) will be assessed using CGM in the 4 hour postprandial period.
measure: Percent of postprandial time spent with level 2 hyperglycemia
time frame: 4 hours postprandial
description: The percent of time spent in level 2 hyperglycemia (>240 mg/dL) will be assessed using CGM in the 4 hour postprandial period.
arm group label: Group 1 insulin glargine and Novolog
arm group type: Active Comparator
description: Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal BG is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.
arm group label: Group 2 insulin glargine and Fiasp
arm group type: Experimental
description: Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.
intervention type: Drug
intervention name: Insulin glargine
description: Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in >10%
arm group label: Group 1 insulin glargine and Novolog
arm group label: Group 2 insulin glargine and Fiasp
other name: Lantus®
intervention type: Drug
intervention name: NovoLog
description: Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
arm group label: Group 1 insulin glargine and Novolog
other name: NovoLog®
intervention type: Drug
intervention name: Insulin Fiasp
description: Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
arm group label: Group 2 insulin glargine and Fiasp
other name: Fiasp®
intervention type: Other
intervention name: Standard carbohydrate diet
description: Standard carbohydrate diet as per usual hospital care (75g with each meal)
arm group label: Group 1 insulin glargine and Novolog
arm group label: Group 2 insulin glargine and Fiasp
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sara M Alexanian, MD
role: Principal Investigator
affiliation: Boston Medical Center
last name: Sara M Alexanian, MD
phone: 617-638-8545
email: sara.alexanian@bmc.org
last name: Zhihui Ju, MPH
phone: 617-638-5921
email: zhihui.ju@bmc.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine
mesh term: Insulin Aspart
sharing ipd: No