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Bentley Reports Positive Results with Nasulin Intranasal Insulin,Spray at the American Diabetes Association Meeting

atment commercially available to patients around the world."

Sherwyn L. Schwartz, M.D., of dgd Research Associates, Inc., principal investigator in the type 1 diabetes and smoking/non-smoking trials, said, "The encouraging results of these clinical studies demonstrate the positive pharmacokinetic, glucodynamic and bioavailability properties of Nasulin compared with injected insulin. Onset of action with Nasulin was favorable. In the type 1 diabetes study, patients' plasma insulin levels peaked sooner with Nasulin than with the very rapid acting Humalog and Humulin R (20 vs. 53 vs. 81 min.). Compared with Humalog, Nasulin resulted in a greater decrease in plasma glucose concentration (AUC) in the first hour, with Humalog being slightly better in the second hour."

"Bioavailability is a key consideration in assessing the efficacy of non-injected formulations of insulin, and Nasulin performed well in this area," said Schwartz. "When administered to type 1 diabetes patients, the relative bioavailability of Nasulin versus Humalog was 17.0 percent over one hour and 8.7 percent over two hours. The relative bioavailability of Nasulin versus Humalin R was 26.5 percent over two hours. In addition, it was encouraging to find that absorption of Nasulin was not affected by smoking in the study of normal male smokers and non-smokers."

As administered to patients in the type 1 diabetes study, Nasulin was formulated as a stable liquid emulsion containing 1 percent human recombinant insulin, 2 percent CPE-215(R)excipient, Bentley's patented permeation enhancer, and surfactants as emulsifiers. CPE-215, which has received GRAS status from the FDA as a direct food additive, has been shown to be non-irritating, stable and effective in gels, ointments, lotions and creams as well as intranasal spray formulations.

About dgd Research Associates, Inc.

The research arm of the Diabetes & Glandular Disease Clinic, founded in 1979 by Dr. Schwartz, dgd Resear
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