<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/NCT01678235</url>
  </required_header>
  <id_info>
    <org_study_id>Glulisine_Aspart</org_study_id>
    <nct_id>NCT01678235</nct_id>
  </id_info>
  <brief_title>Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus</brief_title>
  <official_title>The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine whether insulin glulisine is more effective in&#xD;
      postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1&#xD;
      diabetes (T1DM) treated with insulin pump (CSII).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of&#xD;
      action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct&#xD;
      effect on postprandial glycaemia (PPG).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial glycemia</measure>
    <time_frame>baseline, 30, 60, 90, 120 and 180 minutes after the breakfast</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia episodes</measure>
    <time_frame>3-h study period</time_frame>
    <description>Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Area Under the Curve (AUC)</measure>
    <time_frame>3-h study period</time_frame>
    <description>based on continuous glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean amplitude of glycemic excursion (MAGE)</measure>
    <time_frame>3-h study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between the maximum and baseline glycemia</measure>
    <time_frame>3-h study period</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Questionnaire: Glycemic Index Knowledge</measure>
    <time_frame>each subject was asked to fullfill the questionnaire before entering the study (day one)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>GLU_ASP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.&#xD;
First day: insulin glulisine&#xD;
Second day: insulin aspart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASP_GLU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.&#xD;
First day: insulin aspart&#xD;
Second day: insulin glulisine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glulisine</intervention_name>
    <arm_group_label>ASP_GLU</arm_group_label>
    <arm_group_label>GLU_ASP</arm_group_label>
    <other_name>Apidra®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin aspart</intervention_name>
    <arm_group_label>ASP_GLU</arm_group_label>
    <arm_group_label>GLU_ASP</arm_group_label>
    <other_name>NovoRapid®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes mellitus&#xD;
&#xD;
          -  CSII for at least 3 months&#xD;
&#xD;
          -  Duration of diabetes &gt; 1 years&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant dietary restrictions (e.g. celiac disease or food allergy)&#xD;
&#xD;
          -  Diabetes related complications&#xD;
&#xD;
          -  Baseline hyperglycemia &gt;150 mg/dl&#xD;
&#xD;
          -  Any disease judged by the investigator to affect the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katarzyna Dżygało, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pediatrics, Medical University of Warsaw, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatrics, Medical University of Warsaw, Poland</name>
      <address>
        <city>Warsaw</city>
        <zip>01-184</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <results_reference>
    <citation>Dzygalo K, Szypowska A. Impact of insulins glulisine and aspart on postprandial glycemia after a high-glycemic index meal in children with type 1 diabetes. Eur J Endocrinol. 2014 Mar 8;170(4):539-45. doi: 10.1530/EJE-13-0696. Print 2014 Apr.</citation>
    <PMID>24412929</PMID>
  </results_reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>insulin pump</keyword>
  <keyword>glulisine</keyword>
  <keyword>aspart</keyword>
  <keyword>glycemic index</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 1</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 Aspart</mesh_term>
    <mesh_term>Insulin glulisine</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/NCT01678235
org study id: Glulisine_Aspart
nct id: NCT01678235
lead sponsor: 
has dmc: No
The aim of this study is to determine whether insulin glulisine is more effective in
      postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1
      diabetes (T1DM) treated with insulin pump (CSII).
Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of
      action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct
      effect on postprandial glycaemia (PPG).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Postprandial glycemia
time frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast
measure: Hypoglycemia episodes
time frame: 3-h study period
description: Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms
measure: Glucose Area Under the Curve (AUC)
time frame: 3-h study period
description: based on continuous glucose monitoring system
measure: Mean amplitude of glycemic excursion (MAGE)
time frame: 3-h study period
measure: Difference between the maximum and baseline glycemia
time frame: 3-h study period
measure: Questionnaire: Glycemic Index Knowledge
time frame: each subject was asked to fullfill the questionnaire before entering the study (day one)
arm group label: GLU_ASP
arm group type: Experimental
description: Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.
First day: insulin glulisine
Second day: insulin aspart
arm group label: ASP_GLU
arm group type: Experimental
description: Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.
First day: insulin aspart
Second day: insulin glulisine
intervention type: Drug
intervention name: Insulin glulisine
arm group label: ASP_GLU
arm group label: GLU_ASP
other name: Apidra®
intervention type: Drug
intervention name: Insulin aspart
arm group label: ASP_GLU
arm group label: GLU_ASP
other name: NovoRapid®
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Katarzyna Dżygało, MD
role: Principal Investigator
affiliation: Department of Pediatrics, Medical University of Warsaw, Poland
facility: 
country: Poland
citation: Dzygalo K, Szypowska A. Impact of insulins glulisine and aspart on postprandial glycemia after a high-glycemic index meal in children with type 1 diabetes. Eur J Endocrinol. 2014 Mar 8;170(4):539-45. doi: 10.1530/EJE-13-0696. Print 2014 Apr.
PMID: 24412929
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Aspart
mesh term: Insulin glulisine