Generex Biotechnology announced preliminary clinical results of two major trials using the Generex Oral-lyn formulation that will be used for registration and marketing.
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.
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 with, or developing, diabetes mellitus. The reduction of postprandial hyperglycemia is even more important than the fasting blood glucose with respect to lowering the incidence of morbidity and mortality associated with the complications of diabetes.
In the Prevoral Trial, 31 subjects diagnosed with Impaired Glucose Tolerance (IGT), with a mean age of 52 years, and a body mass index of 33 (i.e. obese) received Generex Oral-lyn in equal doses before and 30 minutes after drinking 75 grams of glucose in a standard oral glucose tolerance test.
Glucose and insulin levels were measured at baseline and 30, 60, 90, 120, and 180 minutes after consuming the glucose. Treatment with an aggregate of 12 Generex Oral-lyn sprays resulted in a 29.6% decrease in plasma glucose at two hours and a 26.8% decrease at three hours. The study found a mean reduction in glucose levels of 15.8%. Plasma insulin was also significantly increased at 30 minutes but not at two hours or three hours, demonstrating the important increase in first-phase insulin availability. The lack of elevation of plasma insulin at two and three hours with Generex Oral-lyn, in contrast to the elevations seen with injected insulin, reduces the potential for hypoglycemia (low blood sugar) to occur several hours after the meal.
When compared to placebo treatment, at six months, there was a significant reduction in hemoglobin A1c of -0.34 +/- 0.1% compared to an increase in the diet and exercise only group of +0.07 +/- 0.1% (p=0.03). There was no significant difference in body weight change and no hypoglycemic or other adverse events were observed during the study period in either group. No generation of insulin antibodies was observed in the subjects treated with Generex Oral-lyn.
Generex Oral-lyn clinical trial 084, conducted in 463 patients with type 1 diabetes, has been completed. Preliminary data from the final analyses demonstrated that Generex Oral-lyn was effective in maintaining the hemoglobin A1c concentrations comparable to injected insulin during the six-month head-to-head clinical trial. Patients continuing on Generex Oral-lyn or transferred from injected insulin to Generex Oral-lyn after six months, did not lose metabolic control during the six-month extension phase of the study despite the fact that their physician visit interval changed from every four weeks to every three months (a factor usually associated with less compliant behavior and loss of control in many clinical trials).
Poorly controlled patients (with HbA1c above 8.0) using Generex Oral-lyn for the entire 12 months had an HbA1c of 8.3% at baseline and 8.2% at 12 months. Those patients originally randomized to injected insulin, who had an HbA1c of 7.7% at start of Generex Oral-lyn therapy, had an HbA1c of 7.8% at study completion. Well controlled patients (with average baseline HbA1c less than 6.5) using Generex Oral-lyn had less than a 0.2% difference in HbA1c compared to those randomized to insulin for the first six months. Those insulin treated patients placed on Generex Oral-lyn therapy at six months had no change in HbA1c from their baseline to study end. There were no serious hypoglycemic events or other adverse events attributable to Generex Oral-lyn. Patients with type 1 diabetes, Generex Oral-lyn demonstrated safety and comparability to injected insulin across a broad range of levels of metabolic control.