WORCESTER, Mass. and TORONTO, July 8, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (OTC Bulletin Board: GNBT ) (www.generex.com ) today announced preliminary clinical results of two major trials using the Generex Oral-lyn™ formulation that will be used for registration and marketing. Unlike prior reported results from studies using older versions of the formulation, the combined data from the now completed 084 Trial in Type 1 patients and the Prevoral Trial in patients with Impaired Glucose Tolerance provide key insights into both the short-term pharmacokinetic and glucodynamic effectiveness of Generex Oral-lyn™ in reducing post-prandial increases in blood sugar as well as the long-term (one year) safety and positive effect on metabolic control using the registration formulation of Generex Oral-lyn™.
In the 084 Trial the final patient completed last visit in June providing 463 type 1 diabetes patients completing the study. The Prevoral trial had 31 patients with obesity and Impaired Glucose Tolerance (a pre-diabetes syndrome) completing the study.
Generex Oral-lyn™ was designed as a prandial (meal-time) insulin to replace the failing rapid secretion of insulin, which a healthy person's insulin secreting cells in the pancreas normally produce in response to eating a meal. While equally important in both type 1 and type 2 diabetes patients, this rapid release of insulin (first phase release) is one of the first abnormalities to occur in type 2 patients and in those individuals with pre-diabetes. The ability to reduce post meal hyperglycemia by replacing this first phase insulin release is key to providing glucose control in all patients