Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM
- Conditions
- Time in RangeT2DM (Type 2 Diabetes Mellitus)Needle-free Injector
- Interventions
- Device: Needle-free injectorDevice: Insulin pen
- Registration Number
- NCT04682795
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Patients ≥ 18 and ≤75 years with type 2 diabetes;
- HbA1c ≥ 7.5 to ≤11.0%;
- Receipt of premixed insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study, and insulin dose adjustments ≤ 10% within 4 weeks before enrollment (dose adjustment = (the maximum dose within a month - the minimum dose) / Final dose (dose of the day before the visit) × 100%);
- BMI ≤ 32kg / m2.
- Patients with any of the following conditions will be excluded:
- Pregnant or lactating women
- Severe hypoglycemia within one month; diabetic ketoacidosis or hyperosmotic diabetic status within 6 months prior to informed consent
- Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent
- Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent
- Severe mental instability, or alcohol abuse, or drug abuse
- Skin lesions at the insulin injection site
- Cancer within 5 years prior to informed consent
- Pancreatitis of severe infectious diseases within 1 months prior to informed consent
- Known hypersensitivity or allergy to the insulin
- Renal impairment (CKD-EPI eGFR<60ml/min)
- Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined
- Participation in another trial within 2 months prior to informed consent
- Patients that investigators believe may fail to complete the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Needle-free injector group Needle-free injector To evaluate the efficacy and safety of the needle-free injector in T2DM Insulin pen group Insulin pen To evaluate the efficacy and safety of the insulin pen in T2DM
- Primary Outcome Measures
Name Time Method Time In Range 2 weeks Time In Range (TIR, 3.9-10mmol/L)
- Secondary Outcome Measures
Name Time Method Occurrence of a treat to target response and without any hypoglycemic episodes 2 weeks Occurrence of a treat to target response and without any hypoglycemic episodes
EQ-5D Health Questionnaire 2 weeks the EQ-5D descriptive system The change from baseline after 2 weeks of treatment
EQ-VAS Health Questionnaire 2 weeks the EQ-VAS. The change from baseline after 2 weeks of treatment
Time to occurrence of treat to target 2 weeks Fasting glucose on treatment \<7mmol/L and non-fasting glucose \<10mmol/L, or TIR \>70% (SMBG or FCGM)
Short Form 36 (SF-36) 2 weeks The change from baseline after 2 weeks of treatment
Insulin dose 2 weeks The change from baseline after 2 weeks of treatment
Trial Locations
- Locations (21)
The 2nd Affiliated Hospital of Zhejiang Chinese Medical University
🇨🇳Hangzhou, Zhejiang, China
2nd Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China
Lanxi People's Hospital
🇨🇳Lanxi, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Taizhou Hospital
🇨🇳Taizhou, Zhejiang, China
The Affiliated Hospital of Shaoxing University
🇨🇳Shaoxing, Zhejiang, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
The First People's Hospital of Xiaoshan
🇨🇳Hangzhou, Zhejiang, China
Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
🇨🇳Changxing, Zhejiang, China
Jinhua Municipal Central Hospital Medical Group
🇨🇳Jinhua, Zhejiang, China
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Hangzhou, Zhejiang, China
The Affiliated People's Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China
Tongxiang First Hospital
🇨🇳Tongxiang, Zhejiang, China
Lishui People's Hospital
🇨🇳Lishui, Zhejiang, China
Quzhou People's Hospital
🇨🇳Quzhou, Zhejiang, China
Shangyu People's Hospital of Shaoxing
🇨🇳Shaoxing, Zhejiang, China
Zhoushan Hospital
🇨🇳Zhoushan, Zhejiang, China
The First People's Hospital of Wenling
🇨🇳Wenling, Zhejiang, China