Emisphere Technologies Inc presented the results from a multiple-dose clinical study of an oral insulin tablet using its Eligen technology as a poster at the 64th Scientific Sessions of the American Diabetes Association, according to company sources.

The study's results indicated that treatment with Emisphere oral insulin over 14 days led to improvements in post-prandial blood glucose concentrations both under oral glucose tolerance test (OGTT) and standardized meal conditions, and tended to improve fasting blood glucose concentrations and insulin resistance.

Tim Heise, CEO-Clinical Science, PROFIL Institute, and lead investigator, commented on the study results, stating, "The results from this pilot study are very promising. The study confirmed oral insulin could achieve an early indication of glycemic control in a modest sized patient population. These encouraging results were obtained in subjects with type 2 diabetes in excellent metabolic control. Future, larger studies in a more heterogeneous patient population may further demonstrate the great potential of oral insulin. If further studies support these findings, this oral insulin -which combines convenience, a desirable dosing form and an improved tolerability profile -could represent a significant advance over the current standard of care," he added.

Only two adverse events occurred in the oral insulin group (one patient reported moderate joint pain, another patient suffered from mild headaches that were of short duration). Six adverse events occurred in the control group.

Despite the tight diabetes control and the frequent blood glucose self-monitoring of the subjects, no hypoglycemic episodes were observed in this study.

"Of particular significance is that the study results demonstrated that repeated administration of Emisphere's oral insulin was not associated with hypoglycemic events, an adverse complication that is often associated with injected insulin and other anti-diabetic treatments," commented Michael M. Goldberg, chairman and CEO of Emisphere Technologies Inc.

Emisphere's oral insulin has the potential to mimic the natural physiology of insulin release, by targeting the liver prior to being distributed to the peripheral circulation, so that both the timing and location of naturally secreted (endogenous) insulin release are replicated, the company claims.

Emisphere's oral drug delivery technology platform, known as the Eligen technology, is based on the use of proprietary, synthetic chemical compounds, known as Emisphere delivery agents.

The study was conducted at PROFIL Institute, a diabetes research centre in Neuss, Germany.