Emisphere oral diabetic treatment shows promise

The 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 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,” said Michael Goldberg, CEO of Emisphere. “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”

The trial focused on the safety of oral insulin, specifically noting incidents of hypoglycemia. The efficacy component of the trial was designed to measure changes in Hemoglobin A1c, 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.

The study met the company’s objectives for both safety and efficacy.A dose response was observed for the active arms versus placebo in the diabetic patients on the highest doses of metformin enrolled in the study. Additionally, oral insulin had no statistical difference in hypoglycemic episodes or serious adverse events.

“Significant interest was expressed by the investigators and their patients in an oral insulin product, which will not require dose titration or frequent glucose monitoring” said Vasu Ginde, CEO of iGate Clinical Research International.