This is the first report in which patients with type-1 diabetes, using glargine insulin (Sanofi-Aventis’ Lantus) as their baseline therapy, have been maintained with optimal control using a schedule of meal oral insulin during a period of nine days.
The open-label, single-center trial was conducted to find the optimal therapeutic regimen of Oral-lyn and to establish the protocol for the formulation’s use in a much larger upcoming multi-center, multi-jurisdictional phase IIb/III study.
A comparison of the daily nine-point glucose profile of each patient between the Oral-lyn regimen and injected regular human insulin indicated that Oral-lyn, administered as a pre-meal insulin in a divided dose schedule, produced glucodynamic profiles comparable to that produced by injected regular human insulin.
“This study demonstrates that patients with type-1 diabetes who manage their disease on a daily basis using Oral-lyn and their usual long-lasting injectable insulin overnight were able to maintain glucose levels in the same fashion as they were using daily mealtime injections,” said Dr Gerald Bernstein, Generex’s director of medical affairs.
Unlike injection or various pulmonary delivery methods, Oral-lyn is delivered as a fine spray to the buccal (oral) cavity via Generex’ proprietary Rapidmist delivery system. This results in rapid insulin absorption through the buccal mucosal lining of the mouth without pulmonary exposure or the pain and inconvenience of needles.