TORONTO — A formulation of insulin that is sprayed in the mouth and absorbed buccally appears to control glucose as well as injected insulin when used before a meal, Dr. Gerald Bernstein reported at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.
The product, Generex Oral-lyn, is made by Toronto-based Generex Biotechnology. When sprayed into the mouth using the company's “RapidMist” device, the insulin is absorbed into the buccal epithelium and is dispersed directly into the vascular system, thereby avoiding the problem of digestion that would occur if insulin were swallowed. The product has been approved for use in Ecuador for patients with type 1 and type 2 diabetes, according to a company statement.
Dr. Bernstein, the company's vice president for medical affairs, presented a 3-month interim analysis of a 6-month study conducted by Dr. Jaime Guevara-Aguirre and his associates at the Institute of Endocrinology IEMYR in Quito, Ecuador. A total of 24 adolescents (mean age 15 years) and 5 young adults (21 years) with type 1 diabetes were first stabilized for 6 weeks with basal twice-daily glargine and premeal injections of regular insulin. For the next 6 weeks, they took Oral-lyn immediately before and immediately after lunch instead of the injected regular insulin, while continuing to inject the glargine twice daily and the regular insulin before breakfast and dinner.
At baseline, the group had a mean hemoglobin A1c of 9.9% and mean glucose of 236.6 mg/dL. After stabilization, their mean A1c level dropped to 8.4% and mean glucose—measured by the patients six times each day—dropped to 140.4 mg/dL.
After 3 weeks of substituting Oral-lyn for regular insulin at lunch, the mean A1c was 8.5%, and mean glucose was 143.3 mg/dL. Three weeks later (study week 12), the mean A1c was down to 8.0%, Dr. Bernstein reported.
Doses of the glargine and the prelunch Oral-lyn were split in this study because previous data on each had shown that doing so improves efficacy. However, in practice, patients could take the entire dose of Oral-lyn prior to the meal, since the timing of its action is similar to that of currently available short-acting analogs: It begins working within 5 minutes, peaks at 30 minutes, and is cleared from the bloodstream by 2 hours, he explained.
A larger study is now underway comparing glargine plus either regular insulin or Oral-lyn given before each meal.
Generex Biotechnology plans to file a submission for approval in Canada and Europe concurrently within the next 12–15 months. Submission to the Food and Drug Administration is expected to follow and may fall within an 18-month time frame, according to a company spokesperson.