At the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Rome, Biodel Inc 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 haemoglobin, 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, www.biodel.com. The first poster is entitled "Insulin VIAject and regular human insulin in patients 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 an open label Multicenter Clinical Trial."
In both, type-1 and type-2 clinical trials, swelling, itching and redness were reported in less than 5 per cent of patients receiving VIAject or RHI. VIAject was associated with injection site pain, the prevalence of which decreased with time.
Dr Solomon Steiner, chief executive officer and chairman of Biodel, stated, "We are pleased with the results of these clinical trials. Our findings demonstrate equivalent glycaemia control with VIAject compared to regular human insulin, consistent with the requirements for a 505(b)(2) regulatory submission. Moreover, we believe VIAject has substantially differentiated itself from other insulin products by being the first product to demonstrate in patients with type-1 diabetes a statistically significant decrease in the incidence of severe hypoglycaemic events and in patients with type-2 diabetes a statistically significant decrease in the incidence of mild and moderate hypoglycaemic events. Additionally, patients receiving VIAject showed a statistically significant improvement in weight control compared to patients receiving regular human insulin. Based upon these results, we plan to meet with the U.S. Food and Drug Administration as soon as possible to discuss our findings and next steps for submitting a new drug application to market VIAject."
Biodel is currently conducting open-label extensions of the two phase-III clinical trials to evaluate the safety of VIAject in patients who remained on or were switched to VIAject treatment after completing the initial six-month studies.
Hypoglycaemia, or low blood sugar, is common in people with diabetes who take insulin.
VIAject is an ultra-rapid-acting injectable human insulin intended for meal-time use by patients with type-1 or type-2 diabetes.
Biodel Inc is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis.