MetaCure Limited, announced that it began
patient enrollment in a national diabetes clinical trial of its TANTALUS(R)
System, an investigational device being tested in patients with type 2 diabetes
who are overweight. The study is being conducted in up to 30 sites in the United
States.
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 (BMI) between 28 and 45
kg/m2 and ages 18 to 70.
"Even with current medications and lifestyle changes,
controlling blood glucose levels in type 2 diabetes patients who are overweight
can be difficult," said Naji N. Abumrad, MD, MetaCure's Medical Director and
John L. Sawyers Professor of Surgery and Chairman, Department of Surgery at
Vanderbilt University Medical Center, Nashville, TN. "We are excited to have
this trial underway as a potential alternative treatment for patients where we
have been unsuccessful in managing their type 2 diabetes and weight."
Glandular Diseases Center of San Antonio, Texas, is the
first trial site to enroll patients. "We are delighted to be participating in
this trial and to be the initial center to implant the TANTALUS System in study
patients," said Mark Kipnes, MD, of the Glandular Diseases Center.
"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 world wide,"
explained Dr. Irit Yaniv, MetaCure's Chief Operating Officer. "We look forward
to potentially being able to make it accessible in the future to U.S. patients
as well."