Experimental Insulin Superior to Existing Formulations on Glucose Control

In a mid-stage clinical trial, Biodel’s concentrated insulin formulation, BIOD-531, was superior to Eli Lilly and Co’s Humalog Mix 75/25 in lowering glucose levels among patients with type 2 diabetes. Additionally, BIOD-531 appeared to control glucose levels more effectively than Humulin R U-500, the only approved, concentrated insulin available in the United States.

"Many patients with type 2 diabetes who use pre-mixed insulins such as Humalog Mix 75/25 may not achieve adequate prandial control due to the slow absorption of currently available, pre-mixed insulin formulations,” said Alan Krasner, MD, chief medical officer of Biodel, in a press release. “These data…validate the benefits of the ultra-rapid-acting onset of action of BIOD-531 seen in our previous Phase 1 study and clearly demonstrate the clinical superiority of this profile on post-prandial glucose control compared to Humalog Mix 75/25 and Humulin R U-500.”

When BIOD-531 was administered before breakfast, it achieved significantly lower mean glucose concentrations than Humalog Mix 75/25 and Humulin R U-500, Biodel noted. Patients who received BIOD-531 after eating also had more control over their glucose level than they did when using Humalog Mix 75/25 or Humulin R U-500 alone.

The company said health care professionals could benefit from the fact that patients showed excellent tolerability at the site where BIOD-531 was injected.

BIOD-531 contains 400 units/ml of recombinant human insulin formulated with EDTA, citrate, and magnesium sulfate. Because it is designed for ultra-rapid absorption, BIOD-531 is an ideal glucose management drug for patients with type 2 diabetes, Biodel said.

“BIOD-531 is a valuable asset within Biodel's expanding portfolio,” said Errol De Souza, president and chief executive officer of Biodel. “It appears from these data that BIOD-531 may have utility both in the niche but rapidly growing segment of insulin resistant patients largely treated by endocrinologists and currently served by Humulin R U-500, as well as in the much larger segment of patients currently using pre-mixed insulins and often managed by primary care physicians.”