Biodel Announces Preliminary Results of Pivotal Phase III Clinical Trials for VIAject(TM)
DANBURY, Conn.--(BUSINESS WIRE)--At the 44th Annual Meeting of the European
Association for the Study of Diabetes (EASD) in Rome, Biodel Inc. (Nasdaq: BIOD - News) today reported results from
its two pivotal Phase III clinical trials designed to compare the efficacy and
safety of VIAject™ to Humulin® R, a regular human insulin (RHI), in the
treatment of patients with Type 1 and Type 2 diabetes. The primary objective of
the trials was to determine if VIAject™ is non- inferior to RHI in the
management of blood glucose levels, as measured by the mean change in patients’
glycosylated hemoglobin, or HbA1c, levels from baseline. HbA1c is a measure of
average blood glucose level and an indication of how well patients are
controlling their blood glucose. Based on the initial analyses, both clinical
trials met the primary endpoint of non-inferior mean change in HbA1c over six
months of treatment.
VIAject™ is Biodel’s proprietary injectable formulation of recombinant human insulin designed to be absorbed into the blood more rapidly than currently marketed rapid-acting insulin analogs. Two posters summarizing the preliminary Phase III clinical trials results are being presented at the EASD conference and are now available on the Biodel website, http://www.biodel.com/. The first poster is entitled “Insulin VIAject™ and Regular Human Insulin in Patients with Type 2 Diabetes; Efficacy and Safety in an Open Label Multicenter Clinical Trial.” The second poster is entitled “Insulin VIAject™ and Regular Human Insulin in Patients with Type 1 Diabetes; Efficacy and Safety in
So I guess the point of non inferior is it isn't any worse. Faster with less of an insulin on board tail sounds cool to me.
The usual full disclosure statement here. I have a few shares of Biodel.