Emisphere to begin diabetes trial in India

Emisphere intends to initiate patient enrollment before the end of November for a 90-day, multi-center, 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 II diabetics. The company says that it will also focus on the safety of oral insulin, specifically incidents of hypoglycemia as well as the occurrence of insulin antibodies.

“India has a large diabetic patient population and provides Emisphere, with the help of its locally based CRO, the opportunity to rapidly enroll patients in a cost effective manner,” commented Dr Michael Goldberg, chairman and CEO of Emisphere. “We anticipate that this study will be critical to demonstrating our belief that orally administered insulin is a safe and effective drug for type II diabetic patients.”