<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/NCT03243903</url>
  </required_header>
  <id_info>
    <org_study_id>KSE01</org_study_id>
    <nct_id>NCT03243903</nct_id>
  </id_info>
  <brief_title>Comparison of Safety and Efficacy of QS-M Needle- Free Injector and Insulin Pen in Controlling T2DM Patient's Glucose</brief_title>
  <official_title>The Safety and Efficacy of QS-M Needle -Free Injector Versus Needle-insulin Pen as a Drug Carrier for Controlling the Blood Glucose in T2DM：a Randomized, Parallel Controlled, Open-label, Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing QS Medical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing QS Medical Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, QS-M needle-free injector and needle-insulin pen were used as a drug carrier&#xD;
      to control blood glucose in type 2 diabetic patients（T2DM）.The efficacy and safety of QS-M&#xD;
      needle-free injector and needle-insulin pen were evaluated and compared.This is a&#xD;
      needle-insulin pen as control group, using a prospective, multicenter, randomized, open,&#xD;
      parallel grouping study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research purpose is to evaluate the efficacy and safety of QS-M needle-free injector as a&#xD;
      drug carrier in the control of blood glucose in patients with type 2 diabetes mellitus by&#xD;
      non-inferiority study，using needle-insulin pen as the comparison. This is a prospective,&#xD;
      multicenter, randomized, open and parallel grouping study. QS-M needle-free injector produced&#xD;
      by Beijing QS medical technology co., Ltd.is used as the insulin carrier in the experimental&#xD;
      group. While needle-insulin pen is used as the insulin carrier in the control group. In this&#xD;
      study, the investigators investigated whether the changes of glycosylated hemoglobin (HbA1c)&#xD;
      at the 16th week in the experimental group respected to the baseline is non-inferiority&#xD;
      compared with that in control group. A total of 427 patients with T2DM were enrolled in a&#xD;
      prospective, multicenter,randomized, open-label study, and were randomly assigned 1:1 to&#xD;
      receive 16 weeks' treatment with basal insulin or premixed insulin administered either by a&#xD;
      needle-free insulin injector (NFII)or insulin treatment via a conventional insulin pen (CIP)&#xD;
&#xD;
      Patients in both groups entered a 2-week screening period after providing their written&#xD;
      informed consent. A run-in period from week 1 to the end of week 4 was implemented to allow&#xD;
      treatment adjustment. Assessment visits occurred at screening (week -2), baseline, and week&#xD;
      1, 2, 4, 6, 8, 12 and 16.After the 4-week run-in phase, the patients entered a 12-week&#xD;
      treatment observation period. All patients were unable to change the type of insulin and the&#xD;
      number of injections during the study period. In this study, the treatment regimen was&#xD;
      adjusted according to the results of the determination of prescription blood glucose.&#xD;
      According to clinical experience, the adjustment of blood glucose fluctuations in the&#xD;
      possibility of a larger, so the study of the adjustment phase follow-up frequency is greater&#xD;
      than the treatment period.&#xD;
&#xD;
      Explanation of Visits and Timing of Assessments:&#xD;
&#xD;
      Baseline assessment was performed for all subjects during the screening period. On the first&#xD;
      day of treatment, the first week after treatment (± 2 days), the second week (± 2 days), the&#xD;
      4th week (± 5 days), the 6th week (± 5 days), the 8th week (± 5 days),the 12th week (± 5&#xD;
      days), the 16th week (± 5 days) for visit.The 3th week (± 2 days), the 5th week (± 5 days),&#xD;
      the 7th week (± 5 days), the 10th week (± 5 days), the 14th week (± 5 days), for telephone&#xD;
      interviews.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">November 8, 2018</completion_date>
  <primary_completion_date type="Actual">November 8, 2018</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>glycosylated hemoglobin (HbA1c)</measure>
    <time_frame>16weeks</time_frame>
    <description>The changes in glycosylated hemoglobin (HbA1c) value between the 16th week of treatment and the start of the adjustment period (using NGSP approved detection method to detect the glycosylated hemoglobin values) .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-monitoring of blood glucose(SMBG)</measure>
    <time_frame>16 weeks</time_frame>
    <description>SMBG blood glucose value (on the first day and two days before the 1st, 2nd, 4th, 6th, 8th, 12th, 16th weeks interview, test the values before and 2 hours after the three meals and before sleeping).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The rate of glycosylated hemoglobin</measure>
    <time_frame>16 weeks</time_frame>
    <description>The rate of glycosylated hemoglobin (according to the percentage of HbA1c &lt;7.0% of the total number of subjetcs at 16th weeks).</description>
  </other_outcome>
  <other_outcome>
    <measure>SF-36</measure>
    <time_frame>16 weeks</time_frame>
    <description>Quality of Life Questionnaire (SF-36) (the changes comparison about SF-36 quality of life score between 16th weeks of subjects and baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin dose</measure>
    <time_frame>16 weeks</time_frame>
    <description>Insulin dose (the actual total dose of injected insulin of the first day and the day before the 1st,2nd,4th,6th,8th,12th,16th weeks' interview).</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin treatment compliance</measure>
    <time_frame>16 weeks</time_frame>
    <description>Insulin treatment compliance (recording whether the subjects obey the program to inject insulin at the specified time point in the 1st, 2nd, 4th, 6th, 8th, 12th, 16th weeks).</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>16weeks</time_frame>
    <description>Subject Satisfaction ( the 16th Week overall satisfaction for the use of injectable equipment). At the end of the trial (16th week),recording and comparing the experimental group / control subjects the overall satisfaction of the injector used in the trial. According to the subjective satisfaction to scoring, the satisfaction score form 0 to 10. With the minimum score 0 for the least satisfied and the maximum score 10 for the most satisfied.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">427</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>needle-free insulin injector</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional insulin pen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>QS-M insulin-free injector</intervention_name>
    <description>Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.</description>
    <arm_group_label>needle-free insulin injector</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>conventional insulin pen</intervention_name>
    <description>Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.</description>
    <arm_group_label>conventional insulin pen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. have been diagnosed with type 2 diabetes; (A) have been treated with insulin (premixed&#xD;
             or basal) subcutaneous injection therapy (without limitation or combined oral&#xD;
             hypoglycemic agents); (B) the subjects with poor blood sugar control is taking oral&#xD;
             hypoglycemic agents or living interventions need Initiating insulin therapy (see&#xD;
             Appendix 1 for initiating treatment regimens);&#xD;
&#xD;
          2. adults aged 18-75 years, women of childbearing age need to take adequate contraceptive&#xD;
             measures to reduce the pregnancy risk to the minimum;&#xD;
&#xD;
          3. injection of insulin and / or oral hypoglycemic agents ≥ 3 months before enroll the&#xD;
             study, the insulin dose adjustment ≤ 10% within 1 month before enrolling (adjustment =&#xD;
             (the maximum dose within a month - the minimum dose) / Final dose (dose of the day&#xD;
             before the visit) × 100%);&#xD;
&#xD;
          4. have a HbAlc value (detected by NGSP approved method) between 7.5-11% ;&#xD;
&#xD;
          5. BMI ≤ 32kg / m2, the body weight remained relatively stable, body weight change of no&#xD;
             more than 10% at least 3 months before screening,&#xD;
&#xD;
          6. Male subjects hemoglobin≥12g/dl (≥ 120g / L), female subjects hemoglobin ≥ 11g / dl (≥&#xD;
             110g / L);&#xD;
&#xD;
          7. serum creatinine &lt;1.5 mg / dL for male subjects, serum creatinine &lt;1.4 mg / dL for&#xD;
             female subjects;&#xD;
&#xD;
          8. have not participated in other clinical studies related diabetes treatment within 3&#xD;
             months ;&#xD;
&#xD;
          9. be volunteered to participate in this clinical study and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the persons who attend or perform this study;&#xD;
&#xD;
          2. women in pregnancy or lactation;&#xD;
&#xD;
          3. have frequent severe hypoglycaemia in one month; have blood glucose control adverse&#xD;
             events like diabetic ketoacidosis or hyperosmotic diabetic coma within half a year;&#xD;
&#xD;
          4. have severe cardiovascular events in the past 6 months, such as myocardial infarction,&#xD;
             acute coronary syndrome, cerebral infarction, cardiovascular and cerebrovascular&#xD;
             surgery;&#xD;
&#xD;
          5. have used hormones or immunosuppressive agents, or have immunologic deficiency&#xD;
             disease;&#xD;
&#xD;
          6. have end-stage renal disease, and are receiving dialysis treatment;&#xD;
&#xD;
          7. have of history of cancer within 5 years;&#xD;
&#xD;
          8. have history of severe mental instability;&#xD;
&#xD;
          9. have long-term alcohol abuse or drug abuse history;&#xD;
&#xD;
         10. have Skin lesions in the insulin injection site;&#xD;
&#xD;
         11. have history of anemia caused by hemoglobinopathy (such as sickle cell red blood cell&#xD;
             anemia, thalassemia, sideroblastic anemia) or any other course;&#xD;
&#xD;
         12. have critically ill, or life expectancy is less than one year;&#xD;
&#xD;
         13. difficult to evaluate the effectiveness and safety of the device intervention;&#xD;
&#xD;
         14. have a clear infection history within a month, such as pneumonia;&#xD;
&#xD;
         15. have active liver disease (AST&gt; 3 times of normal upper limit or ALT&gt; 3 times of&#xD;
             normal upper limit);&#xD;
&#xD;
         16. have history of acute pancreatitis within a month;&#xD;
&#xD;
         17. have history of insulin allergy;&#xD;
&#xD;
         18. have been expected to have poor compliance and can not be treated according to the&#xD;
             research protocol;&#xD;
&#xD;
         19. other cases that investigators believe that the subject may fail to complete the study&#xD;
             or may have a significant impact.&#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>Ji Li Nong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People 's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University People 's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>10000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T2DM</keyword>
  <keyword>QS-M needle free injector</keyword>
  <keyword>insulin pen</keyword>
  <keyword>effective</keyword>
  <keyword>safety</keyword>
  <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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 19, 2021</submitted>
    <returned>August 11, 2021</returned>
  </pending_results>
  <!-- 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/NCT03243903
org study id: KSE01
nct id: NCT03243903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, QS-M needle-free injector and needle-insulin pen were used as a drug carrier
      to control blood glucose in type 2 diabetic patients（T2DM）.The efficacy and safety of QS-M
      needle-free injector and needle-insulin pen were evaluated and compared.This is a
      needle-insulin pen as control group, using a prospective, multicenter, randomized, open,
      parallel grouping study.
The research purpose is to evaluate the efficacy and safety of QS-M needle-free injector as a
      drug carrier in the control of blood glucose in patients with type 2 diabetes mellitus by
      non-inferiority study，using needle-insulin pen as the comparison. This is a prospective,
      multicenter, randomized, open and parallel grouping study. QS-M needle-free injector produced
      by Beijing QS medical technology co., Ltd.is used as the insulin carrier in the experimental
      group. While needle-insulin pen is used as the insulin carrier in the control group. In this
      study, the investigators investigated whether the changes of glycosylated hemoglobin (HbA1c)
      at the 16th week in the experimental group respected to the baseline is non-inferiority
      compared with that in control group. A total of 427 patients with T2DM were enrolled in a
      prospective, multicenter,randomized, open-label study, and were randomly assigned 1:1 to
      receive 16 weeks' treatment with basal insulin or premixed insulin administered either by a
      needle-free insulin injector (NFII)or insulin treatment via a conventional insulin pen (CIP)

      Patients in both groups entered a 2-week screening period after providing their written
      informed consent. A run-in period from week 1 to the end of week 4 was implemented to allow
      treatment adjustment. Assessment visits occurred at screening (week -2), baseline, and week
      1, 2, 4, 6, 8, 12 and 16.After the 4-week run-in phase, the patients entered a 12-week
      treatment observation period. All patients were unable to change the type of insulin and the
      number of injections during the study period. In this study, the treatment regimen was
      adjusted according to the results of the determination of prescription blood glucose.
      According to clinical experience, the adjustment of blood glucose fluctuations in the
      possibility of a larger, so the study of the adjustment phase follow-up frequency is greater
      than the treatment period.

      Explanation of Visits and Timing of Assessments:

      Baseline assessment was performed for all subjects during the screening period. On the first
      day of treatment, the first week after treatment (± 2 days), the second week (± 2 days), the
      4th week (± 5 days), the 6th week (± 5 days), the 8th week (± 5 days),the 12th week (± 5
      days), the 16th week (± 5 days) for visit.The 3th week (± 2 days), the 5th week (± 5 days),
      the 7th week (± 5 days), the 10th week (± 5 days), the 14th week (± 5 days), for telephone
      interviews.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: glycosylated hemoglobin (HbA1c)
time frame: 16weeks
description: The changes in glycosylated hemoglobin (HbA1c) value between the 16th week of treatment and the start of the adjustment period (using NGSP approved detection method to detect the glycosylated hemoglobin values) .
measure: Self-monitoring of blood glucose(SMBG)
time frame: 16 weeks
description: SMBG blood glucose value (on the first day and two days before the 1st, 2nd, 4th, 6th, 8th, 12th, 16th weeks interview, test the values before and 2 hours after the three meals and before sleeping).
measure: The rate of glycosylated hemoglobin
time frame: 16 weeks
description: The rate of glycosylated hemoglobin (according to the percentage of HbA1c <7.0% of the total number of subjetcs at 16th weeks).
measure: SF-36
time frame: 16 weeks
description: Quality of Life Questionnaire (SF-36) (the changes comparison about SF-36 quality of life score between 16th weeks of subjects and baseline.
measure: Insulin dose
time frame: 16 weeks
description: Insulin dose (the actual total dose of injected insulin of the first day and the day before the 1st,2nd,4th,6th,8th,12th,16th weeks' interview).
measure: Insulin treatment compliance
time frame: 16 weeks
description: Insulin treatment compliance (recording whether the subjects obey the program to inject insulin at the specified time point in the 1st, 2nd, 4th, 6th, 8th, 12th, 16th weeks).
measure: Subject Satisfaction
time frame: 16weeks
description: Subject Satisfaction ( the 16th Week overall satisfaction for the use of injectable equipment). At the end of the trial (16th week),recording and comparing the experimental group / control subjects the overall satisfaction of the injector used in the trial. According to the subjective satisfaction to scoring, the satisfaction score form 0 to 10. With the minimum score 0 for the least satisfied and the maximum score 10 for the most satisfied.
arm group label: needle-free insulin injector
arm group type: Experimental
description: Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
arm group label: conventional insulin pen
arm group type: Active Comparator
description: Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
intervention type: Device
intervention name: QS-M insulin-free injector
description: Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
arm group label: needle-free insulin injector
intervention type: Device
intervention name: conventional insulin pen
description: Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
arm group label: conventional insulin pen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ji Li Nong
role: Principal Investigator
affiliation: Peking University People 's Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Insulin
mesh term: Insulin, Globin Zinc
sharing ipd: No
submitted: July 19, 2021
returned: August 11, 2021