Diabetes Clinical Trial
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
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.
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