Biodel BIOD-531 demonstrates superior glucose control after meals Biodel announced positive preliminary results from Study 3-152, a Phase 2a clinical trial comparing Biodel's proprietary, concentrated insulin formulation BIOD-531 to Humalog Mix 75/25 and Humulin R U-500 in patients with type 2 diabetes with moderate insulin resistance who use between 50 and 200 units of insulin per day. BIOD-531 was associated with superior glucose control compared to Humalog Mix 75/25 throughout the day of observation. BIOD-531 was also associated with superior glucose control compared to Humulin R U-500. BIOD-531 dosed 20 minutes after the start of the standardized breakfast also resulted in superior glucose control compared to either Humalog Mix 75/25 or Humulin R U-500 dosed prior to the meal. Mean visual analog scores and absolute severity scores were low for all participants, suggesting excellent injection site tolerability.
Biodel initiates proof of concept study in Glucagon Emergency Management program Biodel has initiated enrollment of normal human subjects in a Phase 1 clinical trial of its lyophilized glucagon formulation designed for use in a proprietary auto-reconstitution device intended for the rescue of patients with severe hypoglycemia. The combination of the formulation and the auto-reconstitution device constitutes the Glucagon Emergency Management system, which is intended to be a more user-friendly glucagon presentation compared to emergency kits currently marketed. Biodel expects to report top line results of the Phase 1 proof of concept GEM study in late 1Q15.