Oral Insulin Oral-lyn ™ Matches Fast-Acting Insulin in Study

Oral Insulin Oral-lyn ™ Matches Fast-Acting Insulin in Study

Oral-lyn(TM), administered as a pre-meal insulin in a divided dose schedule, produced glucodynamic profiles comparable to that produced by injected regular human insulin. Generex Biotechnology Corp, a leader in the area of buccal drug delivery, reported results of a recently completed Phase IIb clinical study of Oral-lyn(TM) in which Oral-lyn(TM) successfully replaced rapid-acting insulin in patients with type-1 diabetes mellitus.

This is the first report in which patients with type-1 diabetes, using glargine insulin (Lantus(R)) as their baseline therapy, have been maintained with optimal control using a schedule of meal oral insulin — Generex’s Oral- lyn(TM) — during a period of 9 days. Unlike injection or various pulmonary delivery methods (in which a powdered or liquid insulin formulation is inhaled into and absorbed by the lungs), Oral-lyn(TM) is delivered as a fine spray to the buccal (oral) cavity via the Company’s proprietary Rapidmist(TM) delivery system. The result is rapid insulin absorption through the buccal mucosal lining of the mouth without pulmonary (lung) exposure or the pain and inconvenience of needles.

"This study demonstrates that patients with type-1 diabetes who manage their disease on a daily basis using Oral-lyn(TM) 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. "Clearly, the ease and convenience of the administration of Oral-lyn(TM), combined with its ability to reproduce the effects of daily injections, can offer a profound increase in the quality of life of many patients with type-1 diabetes."

The open-label, single-center trial was conducted to find the optimal therapeutic regimen of Oral-lyn(TM) and to establish the protocol for the formulation’s use in a much larger upcoming multi-center, multi-jurisdictional phase IIb/III study.

The trial involved 10 patients who had been receiving multiple daily injections (four to six). Two of these injections were basal glargine insulin administered as a two-thirds dose in the morning and one-third dose in the evening. All 10 patients received rapid insulin as their pre-meal insulin in an average of 3 to 4 injections per day (5-6 injections/day including the baseline treatment with glargine) for three days. They then received Oral- lyn(TM) as their exclusive meal insulin for nine days. The meal Oral-lyn(TM) was given as a split dose equally divided before and after each meal. Corrections with either rapid insulin or Oral-lyn(TM) were allowed at mid- morning, mid-afternoon or before the bed-time snack.

Nine-point glucose profiles were determined each day for further comparison. A comparison of the daily nine-point glucose profile of each patient between the Oral-lyn(TM) regimen and injected regular human insulin indicated that Oral-lyn(TM), administered as a pre-meal insulin in a divided dose schedule, produced glucodynamic profiles comparable to that produced by injected regular human insulin (see chart). Fructosamine levels displayed a tendency to lower values with the Oral-lyn(TM) therapy at the end of the trial indicating the better control attained during the study period.
Diabetes Care, March 2005