Trial is Currently Enrolling Patients at Three Investigational Sites in the Netherlands
Heerlen, Netherlands, February 22, 2010 – Atrium Medical Center Parkstad in Heerlen, Netherlands, and GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced the initiation of a multi-center clinical trial to evaluate the safety and efficacy of the EndoBarrier™ Gastrointestinal Liner compared to a diet control group to treat obese patients with type 2 diabetes. The trial is currently enrolling patients and being conducted by the following principal investigators at their respective clinics: Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad, Heerlen; Nicole Bouvy, M.D., Ph.D., Department of General Surgery, Maastricht University Medical Center; and Ignace Janssen, M.D., Department of Surgery, Ziekenhuis Rijnstate Arnhem.
“In addition to facilitating weight loss, data from clinical trials conducted to date have shown that the EndoBarrier lowers HbA1c levels and helps control diabetic factors in obese patients with type 2 diabetes, results similar to those experienced with gastric bypass surgery,” stated Dr. Greve. “Following the recent European CE mark approval for the EndoBarrier and the initiation of this clinical trial, we look forward to further exploring the therapeutic potential of the EndoBarrier as a non-surgical and non-pharmaceutical treatment option for the millions of patients suffering from the twin epidemics of type 2 diabetes and obesity.”
The trial is an open label, randomized, controlled study which will enroll approximately 70 patients with type 2 diabetes among the three investigational sites. Trial participants will be randomized one to one with 35 patients receiving EndoBarrier treatment and 35 patients in the diet control group. The trial lasts for 12 months and evaluates reduction in HbA1c and weight loss. Patients in the diet control group may be offered to receive EndoBarrier treatment after 12 months participating in the trial.
The trial is currently recruiting male and female patients between the ages of 18 to 65 years with type 2 diabetes who have been treated for their type 2 diabetes for 1 to ≤10 years, have a body mass index (BMI) between 30 and 50, and HbA1c level >7.5 and ≤10.0%. For more information on the trial, including detailed inclusion and exclusion criteria, please visit www.clinicaltrials.gov or contact the clinical trial call center at 043 – 308 81 50 or EndoBarrier@meditech.nl.
Addressing Unmet Need for Treating Type 2 Diabetes
The EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity, received European CE mark approval in December 2009. Clinical trials to date involving more than 280 patients have demonstrated the significant weight loss and diabetes improvement with the EndoBarrier Gastrointestinal Liner.
Type 2 diabetes affects an estimated 21 million Americans and 200 million people worldwide. According to the World Health Organization, type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight. Type 2 diabetes can lead to significant health problems including cardiovascular disease, retinopathy, neuropathy and nephropathy.
GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.
About the EndoBarrier™ Gastrointestinal Liner
The patented EndoBarrier Gastrointestinal Liner is an advanced investigational, non-surgical medical device based on the EndoBarrier Technology platform for treating type 2 diabetes and obesity. The EndoBarrier Gastrointestinal Liner is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. A growing body of pre-clinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to change the treatment landscape for people living with type 2 diabetes, obese people at risk for type 2 diabetes, and people with severe weight problems.
About GI Dynamics
GI Dynamics is focused on developing effective, non-surgical approaches for treating type 2 diabetes and obesity. The company’s patented EndoBarrier™ Technology has the potential to deliver medical interventions for people combating weight problems and diabetes or diabetes risk factors. Data from clinical trials demonstrate that the EndoBarrier™ Gastrointestinal Liner, an advanced device in the EndoBarrier portfolio, may provide rapid improvement in glycemic control and significant weight loss by modifying metabolic pathways.
The company is also developing the EndoBarrier Flow Restrictor, which is designed to further enhance the effectiveness of the liner by doubling the amount of weight-loss that can be achieved using the liner alone. Each device in the EndoBarrier portfolio is designed to assist patients gain control of their blood sugar and achieve a healthier body mass index (BMI). GI Dynamics is collaborating with experts in endocrinology, gastroenterology, bariatric surgery and medical weight loss on these efforts.
Based in Lexington, Massachusetts and founded in 2003, GI Dynamics is backed by top-tier investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, and Polaris Venture Partners. For more information, visit GI Dynamics online at www.gidynamics.com.