EMISPHERE ANNOUNCES RESULTS OF ORAL INSULIN STUDY

Emisphere Technologies has announced results from its 90-day, Phase II study of its oral insulin product utilizing its eligen oral-delivery technology. The four-arm study evaluated the safety and efficacy of low and high fixed doses of oral insulin tablets versus placebo in patients with Type 2 diabetes mellitus on existing oral metformin monotherapy. The trial focused on the safety of oral insulin, specifically noting incidents of hypoglycemia, as well as the occurrence of insulin antibodies. The efficacy component of the trial was designed to measure changes in Hemoglobin A1c (HbA1c) over 90 days, the standard for evaluating glucose control in Type 2 diabetics. An additional objective was to confirm that insulin delivered orally could be administered as a fixed-dose product without the need to conduct glucose monitoring or titrate the insulin dose. The study met the company's objectives for both safety and efficacy.

The four arms of the study consisted of three doses of oral insulin and placebo. There were 35 patients enrolled in each oral insulin arm of the trial and 36 in placebo. Results showed that the total number of patients achieving a hemoglobin A1c (HbA1c) decrease of more than 1.1 percent among the 35 patients dosed at the 10-mg four times a day (QID) dose of oral insulin was statistically significantly higher than in the 36 placebo patients. The study also demonstrated it was possible to deliver a fixed dose of insulin without the need to frequently monitor the patients' blood glucose or to titrate the dose for any reason. Blood glucose was measured on a monthly basis.

A dose response was also observed in Hba1c for the 10 mg QID and 5 mg QID doses of oral insulin versus placebo in patients enrolled with Hba1c values above 7.5 percent and being treated with 1,500 mg per day or more of metformin; however, these values did not reach statistical significance.