At the end of the trial, the Company conducted a meal challenge which demonstrated significant reductions in the maximum concentrations of serum glucose in the Nasulin group versus placebo, as well as significant reductions in the overall glucose load during 60, 90 and 240 minutes after dosing. These findings support the pharmacodynamic data demonstrated in previous Phase 1 clinical studies.
The Phase 2a, double-blind, multi-center, placebo-controlled trial was initiated in the United States in February 2009 and randomized 94 subjects. Efficacy, as measured by the proportion of time spent with normal glucose levels, was assessed using continuous glucose monitoring. Subjects were administered either Nasulin or placebo at the start of each meal and were treated for 6 weeks during the double-blind period of the study.
The Company intends to conduct additional analyses on the data from this trial and together with all other Nasulin data will determine the appropriate next steps for the Nasulin program. In the interim the Company will not commence its planned Phase 2b trial or other Nasulin development initiatives. The Company also intends to present the results of this study at the AACE 19th Annual Meeting and Clinical Congress, April 21-25, 2010.
SOURCE CPEX Pharmaceuticals, Inc.