CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today announced that the
ongoing Phase 2a clinical trial of Nasulin™, the Company’s intranasal
insulin candidate, has now completed enrollment. The study was initiated
in February of this year and randomized 94 subjects. Results are
expected at the end of the first quarter or beginning of the second
quarter of 2010.
The Phase 2a, double-blind, placebo-controlled trial is being conducted
at multiple centers across the U.S. The study is designed to evaluate
the efficacy and safety of Nasulin™ versus placebo over a 6-week
treatment period in Type 2 diabetics who are currently being treated
with basal insulin and oral anti-diabetes agents. Efficacy, as measured
by the proportion of time spent with normal glucose levels, or
euglycemia, is being assessed using continuous glucose monitoring.
Earlier clinical studies of Nasulin™ indicated that CPEX’s intranasal
insulin candidate achieved a faster time to peak plasma insulin levels
when compared to other approved rapid-acting insulin therapies, thereby
more closely mimicking the natural response of the pancreas to meals. To
date, Nasulin™ has also been well tolerated by approximately 300
clinical trial subjects with no drug-related serious adverse events
observed. Results of additional clinical studies conducted using
CPEX’s Nasulin™ insulin therapy were recently featured in an oral
presentation and four abstracts at the Annual Diabetes Technology
Meeting, held in San Francisco last month.
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