Generex Biotechnology Corporation, a leader in the area of buccal drug delivery, reported the details of promising data from studies presented at this week's American Diabetes Association conference in Philadelphia, PA that indicate that Oralin, Generex' proprietary oral insulin formulation, may be used safely and effectively in place of injected insulin to treat Type-1 and Type-2 diabetes. Oralin is delivered as a fine spray to the buccal (oral) cavity via Generex' Rapidmist device, where the formulation is rapidly absorbed through the buccal mucosal lining.

Dr. Pankaj Modi, Generex' chief scientific officer and a Director of the company, made four oral presentations at the ADA conference, including two long-term studies and two short-term proof of concept studies.

The study entitled "Long-Term Efficacy of Oral Insulin and Pioglitazone Combination Therapy for Treatment of Type-2 Diabetes" evaluated the long-term (12 weeks or more) efficacy of low doses of oral insulin in combination with pioglitazone against placebo plus pioglitazone.

In a double blind, randomized study, type-2 diabetic patients failing on oral agents received oral insulin or placebo puffs in the buccal cavity via Generex' Rapidmist device in combination with pioglitazone tablets. The HbA1c levels were measured every 2 to 4 weeks.

The data from the study showed that the HbA1c levels significantly improved in the group receiving oral insulin with pioglitazone when compared to the baseline group, thus indicating that oral insulin can be safely used on a long-term basis without any adverse effect to treat diabetes in place of injections.

The study entitled "Replacement of Failing Sulfonylurea Drugs with Oral Insulin, a Long-Term Efficacy Study in Treatment of Type-2 Diabetes" evaluated the efficacy of low doses of oral insulin comparison to placebo in sulfonylurea failure to improve HbA1c levels in type-2 diabetics.

In a single blind, randomized study, 33 type-2 diabetic patients failing on oral agents received metformin plus Oralin (3 times a day, before each meal) or metformin plus maximum dose of glyburide 20 mg/day (sulfonylurea) and placebo puffs. The HbA1c levels were measured every 2-4 weeks along with the daily glucose profile every week.

The data from the study showed that the HbA1c levels significantly improved in the group receiving oral insulin when compared to the control group receiving oral tablets, thus indicating that Oralin can be used safely in place of failing sulfonylurea drugs.

The study entitled "Replacement of s.c. Injections with Oralin in Treatment of Diabetes" evaluated the efficacy of oral insulin versus subcutaneous injection to control post-prandial glucose in type-2 diabetic patients after a standard meal challenge.

In a single blind, randomized, crossover study, 11 type-2 diabetic patients received oral insulin buccally via Generex' Rapidmist device or subcutaneous injections of insulin, followed by 360 calories Sustacal meal 15 minutes after dosing. Patients received both treatments in replicate dosing.

The data from the study showed no statistically significant differences between the treatments in terms of post-prandial glucose control after a standard Sustacal meal challenge, rise in plasma insulin levels and the suppression of C-peptide levels, indicating that Oralin can be used safely to replace mealtime injections to treat diabetes.

The study entitled "Combination Therapy with Oral Insulin and Metformin for Treatment of Type-2 Diabetes" evaluated the efficacy of oral insulin in combination with metformin against metformin alone with placebo puffs to control post-prandial glucose in type-2 diabetic patients after a standard meal challenge with Sustacal.

In a double blind, randomized, crossover study, 23 type-2 diabetic patients received oral insulin with metformin or metformin alone with placebo puffs followed by 360 calories Sustacal meal 15 minutes after dosing. Patients received both treatments in replicate dosing.

The data from the study showed that oral insulin was rapidly absorbed and increased serum insulin by 53 per cent accompanied by glucose (45 per cent) and C-peptide (25 per cent) lowering in type-2 diabetics, thus indicating that oral insulin can be safely used in combination with metformin to control meal-related glucose levels.