Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

Exclusion Criteria

• •\- Subjects who meet any of the following criteria will be excluded from this study.
• •1\. The following laboratory or ancillary abnormalities were present from screening until randomization:
• •1\) Poor blood pressure control, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
• •2\. Subject has any history or evidence meet the following diseases or conditions:
• •1. have had severe hypoglycaemia episodes within 6 months before screening as judged by the investigator.
• •2. Have hospitalization due to diabetic ketoacidosis or hyperglycaemic hyperosmolar state within 6 months prior to screening;
• •3. Proliferative retinopathy, maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
• •3\. Previous and anticipated concomitant treatments:
• •1. Not able or willing to refrain from any use of herbal products and non-routine vitamins within 14 days or within 5 half-lives (whichever is longer), and routine vitamins within 48 hours prior to trial product administration
• •2. Within 1 month or have within 5 half-lives (whichever is longer) participated in any trail (defined participate in trail as having had randomized) of using investigational drug or therapy prior to screening.
• •4\. General information:
• •1. Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent nicotine per day).
• •2. Previous participation in this study. Participation was defined as randomised.
• •5\. Any other situation judged by investigator that may endanger the safety of the subjects or influence the evaluation of the results.