Bentley initiates Ph II trial of insulin nose spray

The USA's Bentley Pharmaceuticals has initiated a Phase II trial of its human recombinant intranasal insulin spray for the treatment of postprandial hyperglycemia in diabetics. The US Phase II evaluation is designed to enroll 24 patients with type 1 diabetes in a randomized, single-dose four-way crossover study to determine the dose equivalency of intranasal insulin in comparison to subcutaneous insulin injections and to elucidate an optimal dosing sequence. Over the next 12 months, Bentley expects to complete Phase II clinical studies for both type 1 and type 2 diabetics.

Bentley noted that two earlier studies conducted in Ireland with normal subjects and type 1 diabetics demonstrated rapid absorption from the nasal spray and the expected glucose response. Peak insulin levels were generally attained in 15-20 minutes, remaining elevated for approximately one hour; the resultant impact on glucose peaked in 40 minutes and decreased 1.5 - 2 hours after dosing, the firm noted.

The initial Phase II studies have been planned and are being carried out at the Diabetes and Glandular Disease Clinic in Texas, San Antonio, led by Sherwyn Schwartz. Dr Schwartz stated that "nasal insulin has the potential of helping a lot of people, particularly those who are afraid of needles or who have lung disease."