Interim Data From A Clinical Trial Evaluating GI Dynamics' EndoBarrier™ Gastrointestinal Liner In Patients With Type 2 Diabetes

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Diabetes;  GastroIntestinal / Gastroenterology
Article Date: 24 Nov 2009 - 22:00 PDT

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GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, announced that interim data from its ongoing clinical study of the EndoBarrier™ Gastrointestinal Liner in obese patients with type 2 diabetes will be presented by Eduardo G. Moura, M.D., Ph.D., director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo, on Monday, November 23, 2009 at GASTRO 2009 organized by the United European Gastroenterology Federation (UEGF), World Gastroenterology Organisation (WGO), World Organisation of Digestive Endoscopy (OMED) and British Society of Gastroenterology (BSG), in London.

The clinical trial was designed to examine the efficacy of the EndoBarrier in obese patients with type 2 diabetes over 24 weeks. Thirty-seven patients were enrolled in this single arm, open label trial. Baseline values included HbA1c of 7.8±1.3%, fasting plasma glucose of 141.1±43.4 mg/dL and body mass index (BMI) of 47.3±7.6 kg/m2. Of the 37 patients treated with the EndoBarrier, data are currently available for the 19 patients that have already completed 24 weeks of treatment. Highlights of these results include the following:

- HbA1c decreased by 1.5±1.1%
- Mean fasting plasma glucose decreased by 16.3±58 mg/dL
- Mean weight loss of 15.0±7.8 kg
- Mean total body weight loss of 13.5±6.4%

"With over 200 million people worldwide currently affected by type 2 diabetes, these data are encouraging as they show the potential of non-surgical therapeutics in controlling diabetic factors and facilitating weight loss in patients suffering from the twin epidemics of type 2 diabetes and obesity," said Stuart A. Randle, chief executive officer of GI Dynamics. "The data at GASTRO 2009 build upon a growing body of promising clinical data demonstrating the potential of the EndoBarrier as a treatment option for patients living with type 2 diabetes. We look forward to sharing additional results from this study upon completion of the trial."

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. Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

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 dramatically 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.

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. Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

Source
GI Dynamics

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