US-based biopharmaceutical firm Biodel has started a Phase I clinical study of its novel formulation of concentrated recombinant human insulin (RHI) candidate BIOD-531 to treat severely insulin resistant type 2 diabetes patients.

In addition, BIOD-531 is designed to address the existing population of patients currently using premixed insulins to manage both prandial and basal glucose control requirements with a single injection.

Biodel chief executive officer Errol De Souza said: "BIOD-531’s ultra-rapid-acting onset and basal duration profile, coupled with its high concentration, could offer diabetes patients and medical practitioners a novel tool to improve prandial coverage, while maintaining adequate basal coverage, in both insulin resistant patients and patients who use premixed insulins."

The trial is aimed at assessing the pharmacokinetic, pharmacodynamic and injection site toleration profiles of BIOD-531 as well as compare the drug candidate to Humulin R, U-500 and Humalog prandial/basal premixed insulin.

In the trial around 12 volunteers will be given single injections of each insulin on separate days in a randomised treatment sequence and the identity of each study drug will be blinded at the time of the injection.

The company said that after each test injection, volunteers will undergo euglycemic clamp studies to determine the pharmacodynamic profile of the test insulin formulation.

On two of the test days of the four period trial, patients with type 2 diabetes and severe insulin resistance will be given doses of 1.0 unit/kg of BIOD-531 and Humulin R, U-500, while on the remaining days they will be given BIOD-531 and Humalog 75/25 premixed insulin at a dose of 0.5 units/kg.

Top line data of the four-way cross-over Phase I clinical trial is expected to be released in the quarter of 2014.

BIOD-531 contains 400 units per millilitre (U-400) of RHI formulated with EDTA, citrate and magnesium sulfate.

The company said that in preclinical studies in diabetic swine, the drug candidate showed a more rapid rate of absorption and onset of action than RHI Humulin R, U-500 and Humalog premixed formulations and had a comparable duration of action as RHI Humulin R U-500.

For patients using premixed prandial/basal insulins, BIOD-531 is expected to allow patients to reduce injection volume as well as benefit from the ultra-rapid onset of action.

Image: Insulin hexamer. Photo: courtesy of Ras67.