- Biodel (BIOD -0.9%) commences a Phase 2b clinical trial evaluating BIOD-531, its proprietary recombinant human insulin-based ultra-rapid-acting prandial/basal combination insulin. The trial, called Study 3-250, is a randomized, open-label, parallel group study that will enroll ~130 patients with type 2 diabetes. Participants will be randomized to receive either BIOD-531 or Eli Lilly's (LLY +0.6%) Humalog Mix 75/25 dosed twice daily for 18 weeks. The primary endpoint is the change in HbA1c from baseline. Top-line results are expected in mid-2016.
- BIOD-531 is a formulation of recombinant human insulin that is designed to be more rapid-acting than currently available insulins for type 1 and type 2 diabetics.