Emisphere Technologies has completed enrollment of the first 120 patients in its Phase II oral insulin clinical trial, and has received permission from regulatory authorities in India to expand the trial enrollment from 120 patients to 140 patients.
A significant number of patients showed a greater than one percent drop in their hemoglobin A1c (HbA1c) at 60 days. In addition, these patients are not showing weight gain, which is very commonly seen with insulin treatment. There have been no reported cases of treatment-related serious adverse events or hypoglycemia. Hypoglycemia is also very commonly observed in diabetic patients treated with insulin, and as a result, insulin therapy requires patients to frequently monitor their blood sugar and adjust their insulin therapy accordingly.