Transition Therapeutics has completed target enrolment for an exploratory Phase IIa clinical trial of its lead regenerative therapy, E1-I.N.T., in Type II diabetes patients. E1-I.N.T. is a short-course combination therapy aimed at stimulating the regeneration of the body's insulin-producing cells, called islet cells.
The exploratory clinical studies for E1-I.N.T. are randomized, double-blind, controlled trials to evaluate the safety, tolerability and efficacy of daily E1-I.N.T. treatments for 28 days with a six-month follow-up. The Type I diabetes clinical study examines 20 Type I diabetes patients (15 E1-I.N.T., 5 placebo) and the Type II diabetes clinical study examines 30 Type II diabetes patients (20 E1-I.N.T., 10 placebo).