This insulin delivery method provides hope that a new noninjectable type of insulin delivery system is on the way for both Type 1 and Type 2 diabetes.

Lead author and presenter Nicola Napoli, MD, PhD, stated that, "We are experimenting with new routes for administering insulin because the most important problem in diabetic patients is injections.... This is the biggest limitation of insulin treatment. [Injections are] not accepted by patients; they're painful and they're difficult to manage."

Dr. Napoli and colleagues investigated the safety and efficacy of a buccal spray insulin developed by Generex, called Oral-lyn. "The device delivers the insulin to the oropharyngeal mucosa, so it doesn't go to the lungs ... and the absorption is very good, giving a peak 10 minutes after administration." In the puffer, regular acting human DNA insulin is dissolved in a buffer at neutral pH, identical to injection. The puffer also contains absorption enhancers, stabilizers, and a non-CFC propellant.

Thirty-one patients, all with established IGT, were randomized to take 4, 6, or 12 buccal spray insulin puffs in 2 doses. One dose was taken before a standard 75 g oral glucose tolerance test, and the other was taken 30 minutes later. One puff is equivalent to 1 unit of insulin. Glucose and insulin levels were then measured at 30, 60, 90, 120, and 180 minutes.

Although taking 4 or 6 puffs from the puffer did not change blood glucose levels, compared with patients who received no treatment, the 12-puff dose did have an impact. Two hours after ingestion of glucose, patients who had taken the 12-puff dose had blood glucose levels that were, on average, 29.6% lower than patients who did not receive any treatment (P < .05). At 3 hours, blood glucose was 26.8% lower in the 12-puff group (P <.05). Taking all time points together, there was a mean reduction in blood glucose of 15.8% with 12 puffs, compared with no treatment. The 12-puff dose was also associated with a trend toward increased insulin levels at all time points that reached statistical significance at 30 minutes. No hypoglycemia or other adverse events were noted during the study.

Larry C. Deeb, MD, a pediatric endocrinologist believes the buccal spray definitely has potential. "You are exposing yourself to less hyperglycemia over time."

Generex News Release