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news.Patient enrolment has commenced for Transition Therapeutics' phase IIa clinical trial in type 2 diabetes patients. The study will evaluate the company's lead regenerative diabetes therapy, E1-INT.
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E1-INT is a short course combination therapy aimed at stimulating the regeneration of the body’s insulin-producing cells, called islet cells.
“Expansion into type 2 diabetes significantly broadens the number of patients that can benefit from an islet cell regeneration therapy,” said Dr Tony Cruz, chairman and CEO of Transition. “For these patients, an islet cell regeneration therapy could eliminate the need for daily insulin injections and the many potentially serious complications that are associated with long-term insulin usage.”
In this placebo controlled study, a total of 30 type 2 diabetes patients will be enrolled. Twenty patients will receive daily treatments of E1-INT and 10 patients will receive placebo for 28 days.
The patients will be followed for six months post-treatment and monitored for islet cell function parameters. Interim data from the trial is expected in the fourth quarter of 2005.
The INT technology platform is based on the discovery that a short course of injections of naturally occurring peptides can regenerate insulin-producing cells in the body.