We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Safety and Efficacy of QS-M Needle- Free Injector and Insulin Pen in Controlling T2DM Patient's Glucose

This study is currently recruiting participants.
Verified August 2017 by Beijing QS Medical Technology Co., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03243903
First Posted: August 9, 2017
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Beijing QS Medical Technology Co., Ltd.
  Purpose
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.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.

Condition Intervention
Diabetes Device: QS-M insulin-free injector Device: needle-insulin pen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Beijing QS Medical Technology Co., Ltd.:

Primary Outcome Measures:
  • glycosylated hemoglobin (HbAlc) [ Time Frame: 16weeks ]
    The changes in glycosylated hemoglobin (HbAlc) 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)


Secondary Outcome Measures:
  • SMBG [ Time Frame: 16 weeks ]
    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)


Other Outcome Measures:
  • The rate of glycosylated hemoglobin [ Time Frame: 16 weeks ]
    The rate of glycosylated hemoglobin (according to the percentage of HbAlc <7.0% of the total number of subjetcs at 16th weeks)

  • SF-36 [ Time Frame: 16 weeks ]
    Quality of Life Questionnaire (SF-36) (the changes comparison about SF-36 quality of life score between 16th weeks of subjects and baseline

  • Insulin dose [ Time Frame: 16 weeks ]
    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)

  • Insulin treatment compliance [ Time Frame: 16 weeks ]
    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)

  • Subject Satisfaction [ Time Frame: 16weeks ]
    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. Each subject's satisfaction score should be an integer.


Estimated Enrollment: 420
Actual Study Start Date: May 19, 2017
Estimated Study Completion Date: December 30, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QS-M insulin-free injector
Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
Device: QS-M insulin-free injector
Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
Active Comparator: needle-insulin pen
Using needle-insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
Device: needle-insulin pen
Using needle-insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.

Detailed Description:

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, we investigated whether the changes of glycosylated hemoglobin (HbAlc) at the 16th week in the experimental group respected to the baseline is non-inferiority compared with that in control group. A total of 420 cases were included in this study. The experimental group and the control group were assigned by 1:1 ratio.

The duration of each participant was designed for the screening period: 0-2 weeks; treatment adjustment period: 4 weeks; treatment observation period: 12 weeks. Therefore, the expected duration of each participant is 18 weeks.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. have been diagnosed with type 2 diabetes; (A) have been treated with insulin (premixed or basal) subcutaneous injection therapy (without limitation or combined oral hypoglycemic agents); (B) the subjects with poor blood sugar control is taking oral hypoglycemic agents or living interventions need Initiating insulin therapy (see Appendix 1 for initiating treatment regimens);
  2. adults aged 18-75 years, women of childbearing age need to take adequate contraceptive measures to reduce the pregnancy risk to the minimum;
  3. injection of insulin and / or oral hypoglycemic agents ≥ 3 months before enroll the study, the insulin dose adjustment ≤ 10% within 1 month before enrolling (adjustment = (the maximum dose within a month - the minimum dose) / Final dose (dose of the day before the visit) × 100%);
  4. have a HbAlc value (detected by NGSP approved method) between 7.5-11% ;
  5. BMI ≤ 32kg / m2, the body weight remained relatively stable, body weight change of no more than 10% at least 3 months before screening,
  6. Male subjects hemoglobin≥12g/dl (≥ 120g / L), female subjects hemoglobin ≥ 11g / dl (≥ 110g / L);
  7. serum creatinine <1.5 mg / dL for male subjects, serum creatinine <1.4 mg / dL for female subjects;
  8. have not participated in other clinical studies related diabetes treatment within 3 months ;
  9. be volunteered to participate in this clinical study and signed informed consent.

Exclusion Criteria:

  1. the persons who attend or perform this study;
  2. women in pregnancy or lactation;
  3. have frequent severe hypoglycaemia in one month; have blood glucose control adverse events like diabetic ketoacidosis or hyperosmotic diabetic coma within half a year;
  4. have severe cardiovascular events in the past 6 months, such as myocardial infarction, acute coronary syndrome, cerebral infarction, cardiovascular and cerebrovascular surgery;
  5. have used hormones or immunosuppressive agents, or have immunologic deficiency disease;
  6. have end-stage renal disease, and are receiving dialysis treatment;
  7. have of history of cancer within 5 years;
  8. have history of severe mental instability;
  9. have long-term alcohol abuse or drug abuse history;
  10. have Skin lesions in the insulin injection site;
  11. have history of anemia caused by hemoglobinopathy (such as sickle cell red blood cell anemia, thalassemia, sideroblastic anemia) or any other course;
  12. have critically ill, or life expectancy is less than one year;
  13. difficult to evaluate the effectiveness and safety of the device intervention;
  14. have a clear infection history within a month, such as pneumonia;
  15. have active liver disease (AST> 3 times of normal upper limit or ALT> 3 times of normal upper limit);
  16. have history of acute pancreatitis within a month;
  17. have history of insulin allergy;
  18. have been expected to have poor compliance and can not be treated according to the research protocol;
  19. other cases that investigators believe that the subject may fail to complete the study or may have a significant impact.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243903


Contacts
Contact: Jing YangZi +8615010117246 jingyangzi@qsjet.com
Contact: Li Yu Meng +8613466774231 49387957@qq.com

Locations
China, Beijing
Peking University People 's Hospital Recruiting
Beijing, Beijing, China, 10000
Contact: Ji Li Nong         
Contact: Gao LeiLi         
Sponsors and Collaborators
Beijing QS Medical Technology Co., Ltd.
Investigators
Principal Investigator: Ji Li Nong Peking University People 's Hospital
  More Information

Responsible Party: Beijing QS Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03243903     History of Changes
Other Study ID Numbers: KSE01
First Submitted: August 6, 2017
First Posted: August 9, 2017
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beijing QS Medical Technology Co., Ltd.:
T2DM
QS-M needle free injector
insulin pen
effective
safety

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs