US-based specialty biopharmaceutical firm Biodel has started a Phase IIb clinical trial of its concentrated, proprietary and recombinant human insulin (RHI) based ultra-rapid-acting prandial/basal combination insulin candidate, BIOD-531.
The study 3-250 is a randomised, open-label and parallel group trial in patients with insulin-treated type 2 diabetes.
Biodel president and CEO Dr Errol De Souza said: "BIOD-531 has shown in three clinical studies to be associated with a best-in-class, ultra-rapid insulin profile and a basal duration of action appropriate for twice daily dosing.
"We believe this pharmacokinetic profile of BIOD-531 to be superior to that of existing products that are marketed as combinations of prandial and basal insulin, namely Humulin R U-500 and pre-mixed insulins such as Humalog Mix 75/25.
"As a result, postprandial glucose has been shown to be better controlled with BIOD-531 after standardised meals."
Biodel plans to enrol around 130 patients in the Phase IIb clinical study at 25 investigative centres in the US.
The company will randomise the patients to receive either BIOD-531 or Humalog Mix 75/25 dosed twice daily.
In the trial, the patients will be treated for 18 weeks, of which first six weeks will focus on active dose titration.
The primary analysis of the study will assess change from baseline in HbA1c and secondary endpoints will compare postprandial glucose excursions, hypoglycemic event rates and weight changes.
Biodel intends to present the top line results of the trial in mid-2016.