Emisphere Technologies has produced results from its 90-day, Phase II study of 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 II 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.
Emisphere believes its oral insulin product has a very encouraging safety profile. During the study, there were no significant differences in number of hypoglycemic events, serious adverse events, or insulin antibody formation for the orally administered insulin compared to placebo. There were no hypoglycemic events in any of the high responder patients as measured by HbA1c. There were no insulin antibodies in any of the three oral insulin arms. The patients in all three active arms saw no change in weight and no nighttime hypoglycemic events.
"We are very pleased with these study results. The goal of this study was to demonstrate that orally dosed insulin can be effective and safe in a real world setting over a protracted period of time, 90 days, without the need to titrate the dose or frequently monitor the blood glucose levels. Such a product can improve both the quality of care and the quality of life for many diabetics" said Michael M. Goldberg, M.D., chairman and chief executive officer of Emisphere. "The oral delivery of insulin has been an important goal of the pharmaceutical industry since insulin's discovery over 80 years ago. The results from this Phase II study represent a major milestone in Emisphere's efforts toward the accomplishment of that goal. The Phase 2 clinical trial was also designed to evaluate the safety and efficacy of various dosage strengths of our product compared to placebo. In- depth analysis of the data from this study should better define the patient populations most likely to benefit from the unique characteristics of oral insulin."