Emisphere Technologies has received permission from regulatory authorities in India to commence a Phase II trial for its oral insulin product.
Emisphere intends to initiate patient enrollment later this month for a 90-day, multicenter, double-blind, randomized clinical trial. The four arm study will evaluate the safety and efficacy of low and high doses of oral insulin tablets versus placebo in 120 subjects with Type 2 diabetes mellitus who have inadequate glycemic control with their existing oral antidiabetic monotherapy. The primary efficacy endpoint of the study is related to the change in hemoglobin A1c, the standard for evaluating glucose control in Type 2 diabetics. Emisphere also will focus on the safety of oral insulin, specifically incidents of hypoglycemia as well as the occurrence of insulin antibodies.