Phase III data on Oral-Lyn (Generex) show it is as effective as human insulin in Type 2 Diabetes

Results of a Phase III clinical trial of Oral-Lyn (insulin spray), from Generex Biotechnology, in patients with Type 2 Diabetes, shows this oral spray is as effective as injected insulin. Two hundred and nine subjects were randomized to receive either Oral-Lyn or injected human regular insulin before each major meal as an add-on to the patient's current oral hypoglycemic agent. Oral-Lyn significantly lowered haemoglobin A1c (HbA1c) at 6 weeks and 12 weeks compared to baseline while injected human regular insulin did not significantly lower the HbA1c until 12 weeks. Oral-Lyn resulted in a significantly lower HbA1c at 6 weeks than did injected regular insulin. At 12 weeks the HbA1c for both groups were statistically comparable.

Adverse events were rare and comparable between groups. Oral-Lyn was shown to be easily used and well-tolerated by patients, and over two thirds of patients preferred it to injection. The results have been used as part of the submission for approval in India. The product, known in India as Oral Recosulin, is expected to be approved by the end of 2013.