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

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.

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