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news.Biopharmaceutical firm Biodel has completed enrollment of its two pivotal Phase III clinical trials of VIAject, a rapid-acting injectable meal-time insulin for use by patients with type 1 and type 2 diabetes.
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The company also announced its intention to build and operate a fill and finish manufacturing facility for VIAject, on the campus of its current headquarters in Danbury, Connecticut.
Biodel has now enrolled over 400 patients with type 1 diabetes at approximately 60 clinical sites in the US, Europe and Asia, and over 400 patients with type 2 diabetes at approximately 50 clinical sites in the US, Europe and Asia.
Both studies are multi-center, open label and six months in duration, comparing the effects of VIAject to Humulin R, the leading recombinant human insulin. Biodel expects to complete these trials and, if the trials are successful, the company intends to submit a new drug application for VIAject to the FDA by the end of 2008.