Efforts to make diabetes care more manageable, and easier on the patient, have led to the introduction of insulin "analogs" - medicines that act similarly to ordinary insulin, but which are supposed to provide additional benefits. Recent research from Generex Biotechnology, a company focused on advanced insulin delivery and diabetes vaccine research, shows that the advantages of insulin analogs may be illusory. Investigators from the company presented their data at the recently completed Endocrine Society 90th Annual Meeting, held in San Francisco from June 15 through 18. The presentation was co-authored by researchers from the Institute for Endocrinology IEMYR, Quito, Ecuador, and the University of Florida, Gainsville.
The year-long study examined 26 subjects with type 1 diabetes, which is normally treated with "basal" injected injection once or twice a day to provide baseline glycemic control, and additional insulin injections before meals. The control study group received insulin glargine (an insulin analog) once a day as their basal dose, and a faster-acting insulin analog before meals. The treatment group received a non-analog long-acting insulin twice a day as their basal insulin; before meals the they took Oral-lyn™, a liquid formulation of human insulin, developed by Generex, that is absorbed through the lining of the mouth. All subjects were monitored for three standard measures of glycemic control: Hemoglobin A1c and fructosamine levels were recorded every two weeks by investigators, and pre-meal glucose levels were taken by patients themselves. Together, these readings assess the effectiveness of diabetes treatment regimens better than any test alone. Higher readings generally indicate less-effective glucose control.
At the end of the study all three measures were found to be consistently and significantly lower in the group that received the human insulin regimen that included the Oral-lyn product before meals. Oral-lyn uses a formulation that allows insulin to pass through the "buccal" mucosa - the soft tissues lining the inside of the mouth - and into the bloodstream rapidly and safely, without injection. Oral-lyn is delivered to the mouth using Generex's proprietary RapidMist™ spray device. Unlike inhaled insulin products which have enjoyed limited success, the combination of Oral-lyn insulin and RapidMist delivery technology allows patients to deliver their insulin dose as needed, and do not deposit insulin into the lungs.
People with diabetes, and physicians treating them, have become excited in recent years by insulin analogs due to their rapid window of action. Several studies have also claimed that analogs improve glycemic control. Insulin analogs can cost up to three times as much as insulin, however, which can place serious financial strains on families that pay for their own insulin. Even families with comprehensive drug coverage will find that plans charge a significantly higher co-pay for insulin analogs than for "regular" human insulin.
"Our results clearly show that over the course of a year-long study the advantage of these analogues is equaled or improved upon by the use of Oral-lyn. When Oral-lyn is absorbed through the buccal mucosa its rapid entry into the blood stream mimics and improves upon the rapid acting analogues." commented Dr. Jaime Guevara, a study author and clinician that has conducted studies for Generex's Oral-lyn. "Claims that analogs provide superior convenience do have some merit when these agents are compared with insulin injected before meals. However, when compared with Oral-lyn, which is not injected, even those arguments fail to make the case for drugs that cost three times as much as standard insulin."
Oral-lyn is currently approved in two countries, and is currently undergoing clinical testing for U.S. approval.