NCT04682795

Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM

A Prospective, Multi-center, Randomized, Open-label, Parallel Group Study to Evaluate Safety and Efficacy of Needle-free Injector Versus Insulin Pen in Patients With Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• T2DM (Type 2 Diabetes Mellitus)
• Needle-free Injector
• Time in Range

Interventions

Type	Name	Description
DEVICE	Needle-free injector	Using needle-free injector as insulin carrier to treat T2DM
DEVICE	Insulin pen	Using insulin pen as insulin carrier to treat T2DM

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-12-24
• Last updated: 2021-09-01

Locations

21 sites across 1 country: China