xml: <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/NCT06021119</url>
    </required_header>
    <id_info>
      <org_study_id>Ain Shams University 232212</org_study_id>
      <nct_id>NCT06021119</nct_id>
    </id_info>
    <brief_title>Feasibility of DPP-4 Inhibitor Therapy on Advanced Hybrid Closed Loop System</brief_title>
    <official_title>Feasibility of DPP-4 Inhibitor for the Treatment of Iftar-Related Glycemic Excursions in Patients With Type 1 Diabetes on MiniMed™ 780G Advanced Hybrid Closed Loop System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4&#xD;
        inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood&#xD;
        glucose levels with low risk of hypoglycemia.&#xD;
  &#xD;
        Aim: To investigate the efficacy and safety of vildagliptin as an add-on therapy among&#xD;
        adolescents and young adults with type 1 diabetes mellitus (T1DM) on glucose excursions of&#xD;
        Iftar Ramadan meals and glycemic metrics during advanced hybrid closed-loop (AHCL) treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin&#xD;
        therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia;&#xD;
        hence, worldwide guidelines recommend carbohydrates counting for determining pre-prandial&#xD;
        insulin doses. Currently, the insulin to carbohydrate ratio (ICR) is frequently used to&#xD;
        calculate the meal insulin dose. However, ICRs are considered difficult, ineffective and&#xD;
        inaccurate for some patient, with an estimation error of around 20% in adults demonstrating&#xD;
        only modest improvements in glycated hemoglobin (HbA1c). This lack of effectiveness and the&#xD;
        wide variability using ICRs suggests it should be improved upon.&#xD;
  &#xD;
        However, there have been only a few randomized control studies that investigated the efficacy&#xD;
        and safety of DPP-4 inhibitors as an add-on drug in patients treated with basal insulin.&#xD;
        Therefore, we conducted a one-month randomized control trial to investigate the efficacy and&#xD;
        safety of DPP-4 inhibitors as an add-on therapy among adolescents and young adults with T1DM&#xD;
        on glucose excursions of Iftar Ramadan meals and glucometrics during AHCL treatment .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 23, 2023</start_date>
    <completion_date type="Actual">April 21, 2023</completion_date>
    <primary_completion_date type="Actual">April 21, 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>peak postprandial plasma glucose (PPG) level in mg/dl</measure>
      <time_frame>4 weeks</time_frame>
      <description>peak postprandial plasma glucose (PPG) level in mg/dl</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time in range %</measure>
      <time_frame>4 weeks</time_frame>
      <description>Time in range %</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Time in Range</condition>
    <arm_group>
      <arm_group_label>Dipeptidyl peptidase-4 inhibitors</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Dipeptidyl peptidase-4 inhibitors with Iftar meal</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No Dipeptidyl peptidase-4 inhibitors intake with Iftar meal</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dipeptidyl peptidase-4 inhibitors</intervention_name>
      <description>Dipeptidyl peptidase-4 inhibitors with Iftar meal</description>
      <arm_group_label>Dipeptidyl peptidase-4 inhibitors</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with type 1 diabetes (T1DM )for at least one year&#xD;
  &#xD;
            -  patients aged 12-27 years&#xD;
  &#xD;
            -  patients using MiniMed 780G AHCL system (Medtronic, Northridge, CA, USA) at least 6&#xD;
               months before the study&#xD;
  &#xD;
            -  patients with minimum daily insulin requirement of more than 8 units&#xD;
  &#xD;
            -  patients willingness and ability to adhere to the study protocol, access to the&#xD;
               internet and a computer system that met requirements for uploading the study pump&#xD;
               data.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with any microvascular or macrovascular complications&#xD;
  &#xD;
            -  pregnancy, lactation&#xD;
  &#xD;
            -  patients who had a point-of-care screening HbA1c &gt;10.0% (86 mmol/mol)&#xD;
  &#xD;
            -  patients with hypoglycemic unawareness or recurrent severe hypoglycemic episode in the&#xD;
               last 6 months prior to recruitment&#xD;
  &#xD;
            -  patients with recurrent DKA (more than 2 episodes in the previous 6 months).&#xD;
  &#xD;
            -  patients with any chronic medical condition, current use of medications (other than&#xD;
               insulin) that are known to affect blood glucose level.&#xD;
  &#xD;
            -  patients who had prior adverse reactions to the adjunctive agent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>27 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Nancy Elbarbary</name>
        <address>
          <city>Cairo</city>
          <zip>11361</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Dyson PA, Twenefour D, Breen C, Duncan A, Elvin E, Goff L, Hill A, Kalsi P, Marsland N, McArdle P, Mellor D, Oliver L, Watson K. Diabetes UK evidence-based nutrition guidelines for the prevention and management of diabetes. Diabet Med. 2018 May;35(5):541-547. doi: 10.1111/dme.13603.</citation>
      <PMID>29443421</PMID>
    </reference>
    <reference>
      <citation>Brazeau AS, Mircescu H, Desjardins K, Leroux C, Strychar I, Ekoe JM, Rabasa-Lhoret R. Carbohydrate counting accuracy and blood glucose variability in adults with type 1 diabetes. Diabetes Res Clin Pract. 2013 Jan;99(1):19-23. doi: 10.1016/j.diabres.2012.10.024. Epub 2012 Nov 10.</citation>
      <PMID>23146371</PMID>
    </reference>
    <reference>
      <citation>Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.</citation>
      <PMID>31618560</PMID>
    </reference>
    <reference>
      <citation>Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834.</citation>
      <PMID>36920756</PMID>
    </reference>
    <reference>
      <citation>Lakshman R, Boughton C, Hovorka R. The changing landscape of automated insulin delivery in the management of type 1 diabetes. Endocr Connect. 2023 Jul 31;12(8):e230132. doi: 10.1530/EC-23-0132.</citation>
      <PMID>37289734</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Nancy Samir Elbarbary</investigator_full_name>
      <investigator_title>Prof. of Pediatrics</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dipeptidyl-Peptidase IV Inhibitors</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021119
  org study id: Ain Shams University 232212
  nct id: NCT06021119
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4
        inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood
        glucose levels with low risk of hypoglycemia.
  
        Aim: To investigate the efficacy and safety of vildagliptin as an add-on therapy among
        adolescents and young adults with type 1 diabetes mellitus (T1DM) on glucose excursions of
        Iftar Ramadan meals and glycemic metrics during advanced hybrid closed-loop (AHCL) treatment.
  Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin
        therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia;
        hence, worldwide guidelines recommend carbohydrates counting for determining pre-prandial
        insulin doses. Currently, the insulin to carbohydrate ratio (ICR) is frequently used to
        calculate the meal insulin dose. However, ICRs are considered difficult, ineffective and
        inaccurate for some patient, with an estimation error of around 20% in adults demonstrating
        only modest improvements in glycated hemoglobin (HbA1c). This lack of effectiveness and the
        wide variability using ICRs suggests it should be improved upon.
  
        However, there have been only a few randomized control studies that investigated the efficacy
        and safety of DPP-4 inhibitors as an add-on drug in patients treated with basal insulin.
        Therefore, we conducted a one-month randomized control trial to investigate the efficacy and
        safety of DPP-4 inhibitors as an add-on therapy among adolescents and young adults with T1DM
        on glucose excursions of Iftar Ramadan meals and glucometrics during AHCL treatment .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: peak postprandial plasma glucose (PPG) level in mg/dl
  time frame: 4 weeks
  description: peak postprandial plasma glucose (PPG) level in mg/dl
  measure: Time in range %
  time frame: 4 weeks
  description: Time in range %
  arm group label: Dipeptidyl peptidase-4 inhibitors
  arm group type: Active Comparator
  description: Dipeptidyl peptidase-4 inhibitors with Iftar meal
  arm group label: Control group
  arm group type: No Intervention
  description: No Dipeptidyl peptidase-4 inhibitors intake with Iftar meal
  intervention type: Drug
  intervention name: Dipeptidyl peptidase-4 inhibitors
  description: Dipeptidyl peptidase-4 inhibitors with Iftar meal
  arm group label: Dipeptidyl peptidase-4 inhibitors
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 27 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  citation: Dyson PA, Twenefour D, Breen C, Duncan A, Elvin E, Goff L, Hill A, Kalsi P, Marsland N, McArdle P, Mellor D, Oliver L, Watson K. Diabetes UK evidence-based nutrition guidelines for the prevention and management of diabetes. Diabet Med. 2018 May;35(5):541-547. doi: 10.1111/dme.13603.
  PMID: 29443421
  citation: Brazeau AS, Mircescu H, Desjardins K, Leroux C, Strychar I, Ekoe JM, Rabasa-Lhoret R. Carbohydrate counting accuracy and blood glucose variability in adults with type 1 diabetes. Diabetes Res Clin Pract. 2013 Jan;99(1):19-23. doi: 10.1016/j.diabres.2012.10.024. Epub 2012 Nov 10.
  PMID: 23146371
  citation: Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.
  PMID: 31618560
  citation: Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834.
  PMID: 36920756
  citation: Lakshman R, Boughton C, Hovorka R. The changing landscape of automated insulin delivery in the management of type 1 diabetes. Endocr Connect. 2023 Jul 31;12(8):e230132. doi: 10.1530/EC-23-0132.
  PMID: 37289734
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Nancy Samir Elbarbary
  investigator title: Prof. of Pediatrics
  mesh term: Dipeptidyl-Peptidase IV Inhibitors
  sharing ipd: No