Cpex Completes Enrollment In Phase 2a Clinical Trial Of Nasulin

Cpex Pharmaceuticals (Cpex) has completed enrollment in its ongoing phase 2a clinical trial of Nasulin, the company’s intranasal insulin candidate.

Reportedly, the study was initiated in February of this year and randomised 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 US. The study is designed to evaluate the efficacy and safety of Nasulin versus placebo over a six-week treatment period in Type 2 diabetics, who are currently being treated with basal insulin and oral anti-diabetes agents.

In the study, 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 has 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.

The company said that 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.