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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Needle-free injector
* Device: Insulin pen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needle-free injector group<br>To evaluate the efficacy and safety of the needle-free injector in T2DM | Device: Needle-free injector<br>* Using needle-free injector as insulin carrier to treat T2DM<br>|
| Active Comparator: Insulin pen group<br>To evaluate the efficacy and safety of the insulin pen in T2DM | Device: Insulin pen<br>* Using insulin pen as insulin carrier to treat T2DM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time In Range | Time In Range (TIR, 3.9-10mmol/L) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 2 weeks | 
| EQ-5D Health Questionnaire | the EQ-5D descriptive system The change from baseline after 2 weeks of treatment | 2 weeks | 
| EQ-VAS Health Questionnaire | the EQ-VAS. The change from baseline after 2 weeks of treatment | 2 weeks | 
| Short Form 36 (SF-36) | The change from baseline after 2 weeks of treatment | 2 weeks | 
| Insulin dose | The change from baseline after 2 weeks of treatment | 2 weeks |