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Positive Results Reported for Concentrated Insulin (BIOD-531) in Mid-Stage Trial

Treatment more effective than Humalog Mix 75/25 and Humulin R U-500

Positive preliminary results have been reported from a phase IIa clinical trial that compared a concentrated insulin formulation (BIOD-531, Biodel Corporation) with two insulin products (Humalog Mix 75/25 and Humulin R U-500, Eli Lilly) in patients with type-2 diabetes with moderate insulin resistance who used between 50 and 200 units of insulin per day.

Key findings included the following:

  • BIOD-531 was associated with superior glucose control compared with Humalog Mix 75/25 throughout the day of observation.
  • BIOD-531 was also associated with superior glucose control compared with Humulin R U-500.
  • BIOD-531 dosed 20 minutes after the start of a standardized breakfast also resulted in superior glucose control compared with 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 favorable injection-site tolerability.

BIOD-531 is an ultra–rapid-acting formulation of recombinant human insulin at a concentration of 400 units/mL (U-400) combined with ethylenediaminetetraacetic acid(EDTA), citrate, and magnesium sulfate. In a phase I study, reported in February 2014, BIOD-531 administered to non-diabetic, obese volunteers demonstrated ultra-rapid absorption and onset of action compared 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 new phase IIa trial was designed to test the hypothesis that a single dose of BIOD-531 would confer better postprandial glucose control for two consecutive meals compared with Humalog Mix 75/25 when administered to patients with type-2 diabetes with moderate insulin resistance.

Glucose profiles were assessed after a single subcutaneous injection of 0.6 U/kg of the study drugs, administered with a standardized breakfast on separate days, in a randomized four-arm cross-over sequence in which the subjects received pre-meal BIOD-531, pre-meal Humalog Mix 75/25, pre-meal Humulin R U-500, and post-meal BIOD-531. To assess the duration of glucose lowering, the 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 5 minutes during the 720 minutes (12 hours) after test insulin dosing at breakfast.

BIOD-531 was associated with superior glucose control compared with Humalog Mix 75/25 throughout the day of observation. A single dose of BIOD-531 administered immediately before breakfast (pre-meal) achieved significantly lower mean glucose concentrations than did Humalog Mix 75/25 administered immediately before breakfast. The mean glucose concentration after breakfast was 167.8 mg/dL for BIOD-531 compared with 205.1 mg/dL for Humalog Mix 75/25 (P < 0.001). Mean glucose concentrations were also significantly improved after lunch with pre-meal BIOD-531.

BIOD-531 was also associated with superior glucose control compared with Humulin R U-500. Mean glucose concentrations after the standardized breakfast were 167.8mg/dL for BIOD-531 compared with 193.1 mg/dL for Humulin R U-500 (P = 0.006). Over the entire day of observation, mean glucose concentrations were 177.8 mg/dL for BIOD-531 compared with 197.2 mg/dl for Humulin R U-500 (P = 0.042).

Further, BIOD-531 dosed 20 minutes after the start of the standardized breakfast resulted in superior glucose control compared with either Humalog Mix 75/25 or Humulin R U-500 dosed prior to the meal. Mean glucose concentrations over the course of the day were 178.3 mg/dL for post-meal BIOD-531 compared with 225.1 mg/dL for pre-meal Humalog Mix 75/25 (P < 0.001). The percentage of readings within the 70- to 180-mg/dL target range was 46.2% for post-meal BIOD-531 compared with 20.6% for pre-meal Humalog Mix 75/25 (P = 0.003) and 29.1% for pre-meal Humulin R U-500 (P = 0.040).

Source: Biodel Corporation; August 11, 2014.

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