GI Dynamics (ASX: GID) has begun a U.S. multicentre pivotal clinical trial of its EndoBarrier® product for the treatment of patients who have uncontrolled type-2 diabetes and are obese, as it pursues commercialisation in the U.S.
EndoBarrier® is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine.
In previous clinical studies, EndoBarrier has been shown to achieve rapid reductions in blood sugar levels and weight loss of around 20% in 12 months.
EndoBarrier® received CE Mark approval in 2010, and approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity for up to 12 months.
The ENDO Trial is a randomised, double-blind, sham controlled, multi-centre trial that is expected to enrol about 500 people living with uncontrolled diabetes and obesity at up to 25 sites in the U.S.
The trial is designed to assess improvements in diabetes over a treatment period of up to 12 months.
The primary endpoint of the trial is improvement in HbA1c, a key blood sugar measure for diabetes, while secondary measures include weight loss and improvement in select cardiovascular risk factors, such as cholesterol.
GI Dynamics currently markets EndoBarrier® in select regions in Europe, South America and Australia and is planning near-term commercial expansion into additional markets.
The U.S. represents a market of around 23 million people affected by type-2 diabetes, which accounts for about 90% of all cases of diabetes.
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