Biodel reports positive preliminary results from Phase IIa trial of diabetes drug

Data Highlights

• BIOD-531 was associated with superior glucose control compared to Humalog Mix 75/25 throughout the day of observation.
• BIOD-531 was also associated with superior glucose control compared to Humulin R U-500.
• BIOD-531 dosed 20 minutes after the start of the standardized breakfast also resulted in superior glucose control compared to either Humalog Mix 75/25 or Humulin R U-500 dosed prior to the meal.
• Mean visual analog scores and absolute severity scores were low for all participants, suggesting excellent injection site tolerability.

Many type 2 diabetes patients in clinical practice are treated with pre-mixed insulins, such as Humalog Mix 75/25, in order to receive both basal and prandial insulin in a single injection. Pre-mixed insulin is commonly dosed before breakfast and before dinner and is usually used in patients who are not candidates for an intensive basal-bolus insulin regimen that would require four or more injections per day. Humulin® R U-500 is the only concentrated insulin available in the U.S. and is usually used to treat type 2 diabetes patients with severe insulin resistance who require very high doses of insulin — typically greater than 200 units per day.

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.