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Clinical Trial Summary

In this prospective, multi-center, randomized, open-label, parallel group trial, the safety and efficacy of needle-free injector will be compared with insulin pen after 2 weeks of treatment in patients with type 2 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in Time in Range (TIR), a newly recommended measurement of blood glucose fluctuations.


Clinical Trial Description

The objective of the current study is to investigate the efficacy, safety and tolerability of needle-free injector compared to conventional insulin pen given for 2 weeks as the insulin carrier in patients with type 2 diabetes mellitus. The primary endpoint in this study is the change from baseline in TIR (after 2 weeks of treatment) in all patients with baseline and at least one post baseline measurement. Patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 200 patients will be enrolled in the study. Patients who qualify will be randomized to needle-free injector group or conventional insulin pen group. Duration of treatment includes 1-week screening period, 2-week treatment observation period and 2-week follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04682795
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Yuezhong Ren, MD
Phone +8657189713764
Email renyuez@zju.edu.cn
Status Recruiting
Phase N/A
Start date September 1, 2021
Completion date December 31, 2022

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