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

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