Experimental Insulin Superior to Existing Formulations on Glucose Control

Krystle Vermes
Published Online: Wednesday, August 13, 2014
Follow Pharmacy_Times:
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.”
Related Articles
Only 1 in 3 older adults with diabetes meet the American Diabetes Association’s treatment targets for blood glucose, cholesterol, and blood pressure.
Here are new drugs for 2015 that pharmacists can expect to handle.
John Moorman, PharmD, BCPS, talks about changes in pharmacy practice to improve patient adherence to diabetes drugs as they move through transitions of care settings.
Pharmacists included in primary care teams improve antihypertensive medication management for patients with type 2 diabetes.
Latest Issues
$auto_registration$