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Buccal Insulin Spray shows Promise

A study reported that 12 puffs per day from a buccal spray unit (Oral-Lyn, Generex) can help individuals with impaired glucose tolerance keep their blood glucose levels down, providing hope for a new, noninjectable type of insulin delivery system for both type 1 and type 2 diabetes patients.

According to Nicola Napoli, MD, PhD, the biggest limitation of insulin treatment is its route of administration, which is not widely accepted by diabetic patients. “We are experimenting with new routes for administering insulin because the most important problem in diabetic patients is injections,” Dr. Napoli said.

In their study, Dr. Napoli and colleagues investigated the safety and efficacy of Oral-Lyn— a novel device that delivers insulin to the oropharyngeal mucosa. “The absorption is very good, giving a peak 10 minutes after administration.”

Thirty-one patients with established IGT were randomized to take 4, 6, or 12 buccal spray insulin puffs in two doses. One dose was taken before a standard 75 grams 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.

Dr. Napoli and colleagues found that 2 hours after ingestion of glucose, patients who had taken the 12-puff dose had blood glucose levels that were, on average, 29.6 percent lower than patients who did not receive any treatment. At 3 hours, their blood glucosewas 26.8 percent lower. Taking all time points together, there was a mean reduction in blood glucose of 15.8 percent 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.

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