Emisphere Technologies reported that its oral insulin product satisfied the safety and efficacy objectives of its 90-day, Phase II study. The product utilizes 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. 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. None of the high responder patients experienced hypoglycemic events as measured by Hemoglobin A1c (HbA1c). The company also observed no insulin antibodies in any of the three oral insulin arms. Additionally, the patients in all three active arms saw no change in weight and no nighttime hypoglycemic events.
The efficacy component of the trial was designed to measure changes in HbA1c over 90 days, the standard for evaluating glucose control in type 2 diabetics.The four arms of the study consisted of three doses of oral insulin (10-mg QID, 5-mg QID, and 10-mg BID) 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 HbA1c decrease of more than 1.1% among the 35 patients dosed at the 10-mg QID dose of oral insulin was statistically significantly higher than in the 36 placebo patients (p=0.0368).
The study demonstrated that insulin delivered orally could be administered as a fixed dose product without the need to conduct glucose monitoring or titrate the insulin dose. Blood glucose was measured on a monthly basis.