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New Ultra-Rapid-Acting Insulin Formulation

BIOD-531 is a new ultra-rapid-acting insulin formulation that has been shown to work better than current therapies at treating diabetes in a mid-stage trial…. 

BIOD-531 is an ultra-rapid-acting formulation of recombinant human insulin (RHI) at a concentration of 400 units/ml (U-400) combined with EDTA, citrate and magnesium sulfate. In the Phase 1 Study 3-150, the results of which were released in February 2014, BIOD-531 administered to non-diabetic, obese volunteers demonstrated ultra-rapid absorption and onset of action in comparison with Humalog Mix 75/25 and Humulin R U-500, and had an extended duration of action that is expected to be suitable for basal insulin needs.

The recently completed Study 3-152 was designed to test the hypothesis that a single dose of BIOD-531 would confer better postprandial glucose control for two consecutive meals compared to Humalog Mix 75/25 when administered to type 2 diabetes patients with moderate insulin resistance.

In Study 3-152, glucose profiles were assessed after single subcutaneous injection of 0.6 U/kg doses of the study drugs administered with a standardized breakfast on separate days in a randomized four arm cross-over sequence in which subjects received pre-meal BIOD-531, pre-meal Humalog Mix 75/25, pre-meal Humulin R U-500 and post meal BIOD-531. In order to assess the duration of glucose lowering, subjects received a standardized lunch at 330 minutes (5.5 hours) after breakfast dosing with no insulin administered at that time. Glucose levels were measured every five minutes during the 720 minutes (12 hours) after test insulin dosing at breakfast.

The results of the current study demonstrate that the ultra-rapid-acting profile with an extended duration of action of BIOD-531 seen in Study 3-150 may translate into clinically meaningful benefits of superior mealtime and basal coverage for type 2 diabetes patients with moderate insulin resistance.

Practice Pearls:

  • BIOD-531 is a new ultra-rapid-acting concentrated insulin formulation containing 400 units of RHI per mL.
  • When compared to Humalog Mix 75/25, mid-stage trial results indicated that this new insulin formulation has been found to be more effective at controlling blood sugar after two meals in patients with type 2 diabetes with moderate insulin resistance who use 50-200 units of insulin daily.
  • Other preclinical studies have shown that BIOD-531 has a more rapid rate of absorption and onset of action, along with a similar duration of action in patients with diabetic swine when compared against Humulin R U-500 and that BIOD-531 has a more rapid rate of absorption and onset of action when compared against Humalog pre-mixed prandial/basal insulin formulations.

Concentrated Ultra-Rapid-Acting Insulin. Biodel Inc.; 2014.