New Needle Free Insulin Injector Shows Same Adsorption as Needles

Results Show No Significant Differences Between Needle-Free and Syringe Delivery of Insulin Lispro A specialized pharmaceutical product development company with patented drug delivery systems and injectable device engineering capabilities, announced the successful completion of a clinical study comparing the delivery of insulin lispro by its Medi-Jector Vision(R) needle-free injector and a conventional needle injection.

The study, conducted by Dr. Sherwyn L.Schwartz at the Diabetes and Glandular Disease Clinic of San Antonio, TX,showed no significant differences in several key pharmacokinetic (PK) and pharmacodynamic (PD) measures between the two delivery methods.

Numerous previous studies have demonstrated that delivery of insulin by needle-free injection versus syringe is comparable. However, this clinical study is the first to report PK and PD results using the newer generation of rapid-acting insulin, such as lispro, when delivered by these methods.

This study was an open label, 2-period crossover study in Type I and Type II diabetic subjects. Each subject received a controlled meal and a 10U lispro insulin dose delivered by either the Medi-Jector Vision(R) needle-free injector or a traditional syringe injection. Resulting changes in insulin levels (PK) and blood glucose levels (PD) were recorded over a 4-hour period.
Insulin concentrations were analyzed to determine Cmax, Tmax, and AUC for each patient. Glucose concentrations were assessed to determine maximum glucose levels (Gmax), time to maximum glucose levels (TGmax), and area under the
curve (AUCG). There were no significant differences in AUC and AUCG between delivery methods, or in Cmax, Gmax, or TGmax, but Tmax for lispro delivery using a needle-free device was significantly earlier than for a needle.

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