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news.MetaCure has started patient enrollment in a national diabetes clinical trial of its Tantalus System, an investigational device being tested in patients with type 2 diabetes who are overweight.
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The 300-patient trial will evaluate the Tantalus, an implantable device that delivers electrical pulses to the stomach when a person eats. The primary objective of the randomized, double-blind controlled study is to evaluate the Tantalus System in treating patients who have type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood pressure and other clinical and metabolic parameters will be studied.
To be considered for the trial, patients must meet certain inclusion criteria, including a diagnosis of type 2 diabetes with a body mass index between 28 and 45kg/m2 and ages 18 to 70. The study is being conducted in up to 30 sites in the US. Glandular Diseases Center of San Antonio, Texas is the first trial site to enroll patients.
Irit Yaniv, chief operating officer of MetaCure, said: “The Tantalus System is currently CE marked and available to patients in Europe for the indication to treat type 2 diabetes with obesity. It has been clinically evaluated in more than 100 patients worldwide.”