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Pharmacokinetics of Fast Acting Insulin when injected with the INJEX needle-free injector versus a syringe and needle.

Investigators - Radiant Research - Marshall Block, M.D.
Diabetes and Endocrine Association - Daniel Einhorn, M.D.

In this efficacy study, two methods of insulin delivery were compared with regard to the pharmacokinetics of a fast-acting insulin. A total of twenty-five (25) subjects were given insulin on different days using the INJEX needle-free device and a syringe and needle. Blood tests were performed on each subject prior to the insulin delivery and at 20, 40, and 60 minutes after the insulin injection.

A statistical analysis of the data was conducted to determine if there was a difference in the pharmacokinetics of the insulin level absorbed from an injection using the INJEX compared to the needle/syringe delivery. The analysis was conducted with a 95% confidence level. The size of both samples was 25 subjects.

In conclusion, the statistical analysis shows that there is no difference in the pharmacokinetics of a fast-acting insulin when delivered with either INJEX or needle/syringe.

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