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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Using needle-free injector as insulin carrier to treat T2DM
Using insulin pen as insulin carrier to treat T2DM
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
Changxing, Zhejiang, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITING2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGAffiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGThe 2nd Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGThe First People's Hospital of Xiaoshan
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGHuzhou Central Hospital
Huzhou, Zhejiang, China
NOT_YET_RECRUITINGThe First Hospital of Jiaxing
Jiaxing, Zhejiang, China
NOT_YET_RECRUITINGJinhua Municipal Central Hospital Medical Group
Jinhua, Zhejiang, China
NOT_YET_RECRUITINGLanxi People's Hospital
Lanxi, Zhejiang, China
NOT_YET_RECRUITING...and 11 more locations
Time In Range
Time In Range (TIR, 3.9-10mmol/L)
Time frame: 2 weeks
Time to occurrence of treat to target
Fasting glucose on treatment \<7mmol/L and non-fasting glucose \<10mmol/L, or TIR \>70% (SMBG or FCGM)
Time frame: 2 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
Occurrence of a treat to target response and without any hypoglycemic episodes
Time frame: 2 weeks
EQ-5D Health Questionnaire
the EQ-5D descriptive system The change from baseline after 2 weeks of treatment
Time frame: 2 weeks
EQ-VAS Health Questionnaire
the EQ-VAS. The change from baseline after 2 weeks of treatment
Time frame: 2 weeks
Short Form 36 (SF-36)
The change from baseline after 2 weeks of treatment
Time frame: 2 weeks
Insulin dose
The change from baseline after 2 weeks of treatment
Time frame: 2 weeks
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