Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-04 @ 5:12 PM
Study NCT ID:
NCT03243903
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2017-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Safety and Efficacy of QS-M Needle- Free Injector and Insulin Pen in Controlling T2DM Patient's Glucose
Sponsor:
Beijing QS Medical Technology Co., Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: