BIOD-531: Preliminary Phase IIa data

Preliminary data from the single-blind, 4-way crossover, U.S. Phase IIa Study 3-152 in 12 Type II diabetics showed that a single subcutaneous injection of 0.6 U/kg BIOD-531 provided superior postprandial glucose control vs. single subcutaneous injections of 0.6 U/kg Humalog Mix 75/25 insulin lispro protamine/insulin lispro and 0.6 U/kg Humulin R insulin (U-500). The trial enrolled Type II diabetics with moderate insulin resistance who used 50-200 units of insulin per day to receive BIOD-531, Humalog Mix 75/25 or Humulin R immediately before a breakfast (pre-meal) or BIOD-531 20 minutes after the start of breakfast (post-meal).

Specifically, mean postprandial glucose concentration for pre-meal BIOD-531 was 167.8 mg/dL vs. 205.1 mg/dL for Humalog Mix 75/25 (p<0.001) and 193.1 mg/dL for Humulin R (p=0.006). Post-meal BIOD-531 led to a mean postprandial glucose concentration of 173.4 mg/dL vs. Humalog Mix 75/25 (p=0.001) and Humulin R (p=0.031). Over the course of the entire day of observation, pre-meal BIOD-531 led to an average glucose concentration of 177.8 mg/dL vs. 225.1 mg/dL for Humalog Mix 75/25 (p<0.001) and 197.2 mg/dL for Humulin R (p=0.042). Pre-meal BIOD-531 also increased the percentage of glucose readings within the target range of 70-180 mg/dL vs. Humalog Mix 75/25 and Humulin R (46.3% vs. 20.6% and 29.1%, respectively, p=0.002 and p=0.032). ...