US firm Generex Biotechnology says that it has seen positive data from a clinical study of its insulin spray Oral-lyn in type 2 diabetes, presented at the 41st Annual Meeting of the European Association for the Study of Diabetes in Athens, Greece, this week.
The purpose of the 12-week study was to determine the long-term effect of the drug at mealtime in type 2 diabetics, against a background of glargine insulin injection therapy and metformin.
Interim analysis of the data at week eight revealed no change in fasting glucose, but a 15.4% reduction in the Oral-lyn treatment group versus 3.9% rise in the placebo arm (p<0.05) in post-prandial glucose was observed. Moreover, HbA1c levels – a measure of long-term blood glucose - were cut 6.6% versus 3.4%, respectively. Therefore, the study concluded that, in patients with type 2 diabetes receiving therapy with glargine and metformin, Oral-lyn was especially effective in the control of post-prandial glucose excursions.
Earlier this year, the group reported encouraging findings from a pilot study of the agent, which showed that patients with type1 diabetes had comparable blood glucose levels whether they were given insulin via injection or a spray into the mouth. According to the firm, Oral-lyn is an effective, safe, fast, convenient, flexible and pain-free alternative to diabetes therapy, and thereby represents a potential treatment and a consequent improvement in patient compliance.