Canadian biotech company Generex has begun a study of its flagship oral insulin spray in patients with Type-1 diabetes. The product, already available for type 2 diabetes in Ecuador, was the first non-injectable form of insulin to reach the market when it was launched late last year.
Oral-lyn is delivered by the company's proprietary RapidMist device into the mouth of the patient where it is then absorbed, with no lung deposition.
By offering an alternative to insulin injections, Oral-lyn is designed to improve patient compliance in the millions of diabetes sufferers worldwide, and thus delay the progression of diabetes and the onset of associated complications such as amputation, retinopathy, cardiovascular disease, nephropathy, neuropathy, and peripheral vascular disease.
The company hopes to soon make the product available in Ecuador for patients with Type 1 (insulin dependant) diabetes and is now conducting a six-month study of Oral-lyn in this patient population.
According to the company, a preliminary 12-day study has already proved successful in 10 adult patients; comparing short-acting subcutaneously injected pre-prandial insulin (Humulin) with Oral-lyn spray taken both before and after each meal at breakfast, lunch, and dinner.
However, this new study aims to demonstrate the application of Oral-lyn on a longer-term basis in adolescent patients with Type-1 diabetes, a very challenging group to treat successfully.
The study, conducted in Ecuador, will compare the use of Oral-lyn versus Humulin in 22 adolescents and five young adults at lunchtime over a 30-day period, followed by a six-month replacement of Humulin with Oral-lyn taken at lunchtime before and after each meal.
In addition to Oral-lyn, Generex, a pioneer in the field of buccal drug delivery, is expanding its diabetes treatment pipeline to include a new metformin chewing gum that aims to avoid the significant adverse gastrointestinal side-effects often accompanying the use of metformin tablets.