Comparison of Safety and Efficacy of QS-M Needle- Free Injector and Insulin Pen in Controlling T2DM Patient's Glucose
Condition: Diabetes
Study type: Interventional

Summary: 
      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.
    

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, 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.
    

Intervention name(s): QS-M insulin-free injector; conventional insulin pen
Intervention type(s): Device; Device
Intervention description(s): Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.; Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T2DM; QS-M needle free injector; insulin pen; effective; safety