EXETER, N.H.--(BUSINESS WIRE)--CPEX Pharmaceuticals Inc. (NASDAQ: CPEX) today reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the Company’s nasal insulin product, Nasulin™. The study was designed to evaluate the efficacy and safety of Nasulin versus placebo over a 6-week treatment period in subjects with Type 2 diabetes who were being treated with basal insulin and oral anti-diabetes agents. The primary objective was to demonstrate that subjects receiving Nasulin would achieve a larger increase from baseline in the mean proportion of time spent with normal glucose levels (or in euglycemia) than those receiving placebo, as assessed by continuous glucose monitoring. Although subjects in the placebo group spent less time in euglycemia at the end of the study compared to subjects in the Nasulin group, the difference between the two groups was not statistically significant (p-value = 0.2). The secondary efficacy measurements of change from baseline in average glucose as measured by continuous glucose monitoring and the change from baseline in serum fructosamine were consistent with the primary endpoint analysis.
