Dr. Rodbard commented, "This study demonstrated the non-inferiority of the new more-rapid-acting injectable human insulin versus regular human insulin and the favorable impact of the faster-acting insulin on hypoglycemia and weight gain, two key side effects of currently marketed insulins which can be difficult to manage.  These findings are encouraging and suggest that we can achieve proper glycemic control with reduced hypoglycemia and weight gain through the use of a more-rapid-acting form of human insulin.  I believe these results represent a meaningful advance in the treatment of type 2 diabetes."  Dr. Rodbard is a practicing endocrinologist based in Rockville, Maryland, a Master of the American College of Endocrinology (MACE), a Fellow of the American College of Physicians (FACP) and past president of the American College of Endocrinology and the American Association of Clinical Endocrinologists.  

This study is one of two Phase 3 controlled clinical trials sponsored by Biodel Inc. (Nasdaq: BIOD) to evaluate the safety and efficacy of VIAject?® as a treatment for diabetes.  The results of the companion Phase 3 study of VIAject?® in patients with type 1 diabetes will be presented at the ADA meeting in a poster (#642-P) by Hollander et al. on June 26 from 12 “ 2pm EDT.  Biodel is seeking U.S. Food and Drug Administration clearance to market VIAject?® based upon results from pharmacokinetic, pharmacodynamic and standardized meal studies, the two pivotal 6-month Phase 3 clinical trials of VIAject?® in patients with type 1 and type 2 diabetes, as well as results from long-term, 18-month safety extension trials for patients who completed the two pivotal Phase 3 clinical trials.  The Prescription Drug User Fee Act action date for Biodel's new drug application is expected to be October 30, 2010.  

SOURCE Biodel Inc.