REVISE-Diabesity to Evaluate EndoBarrier Therapy in Patients with
Uncontrolled Type 2 Diabetes and Obesity
LEXINGTON, Massachusetts & SYDNEY – 10 September 2013 – GI Dynamics, Inc. (ASX: GID) today announced that the Association of British Clinical Diabetologists (ABCD) has initiated an open label, multi-center, randomized, controlled clinical trial of EndoBarrier® Therapy in patients with type 2 diabetes and obesity. The study, called REVISE-Diabesity, is being funded by a grant from the Diabetes Care Trust (ABCD), Registered Charity Number 1139057 in the UK, and is supported by the UK’s publicly funded health system, the National Health Service (NHS), as one of the National Institute for Health Research Clinical (Diabetes) Research Network Portfolio Studies.
Stuart A. Randle, president and CEO of GI Dynamics, commented, “The ABCD is a highly prestigious clinical organization in the global diabetes community and it is extremely gratifying that the charity associated with ABCD has chosen to invest its funds in an independent clinical study of our innovative medical device in patients in the UK who are suffering from type 2 diabetes and obesity. We look forward to seeing the outcomes of this study and are hopeful it will help establish EndoBarrier Therapy as a routine part of diabetes treatment under the NHS.”
The REVISE-Diabesity study is centered at City Hospital in Birmingham with supporting centers in London (King’s College Hospital and Guy’s and St Thomas’ Hospitals) and Glasgow (Glasgow Royal Infirmary, Scotland). It will enroll 72 subjects with type 2 diabetes and obesity who have been treated with liraglutide for at least six months, but remain suboptimally-controlled. Of the total subjects enrolled in the study, 24 will be treated with EndoBarrier Therapy, 24 will receive EndoBarrier Therapy in combination with liraglutide and the remaining 24 will receive liraglutide only (control group). Liraglutide is recommended as a treatment option for people with poorly controlled type 2 diabetes and high body weight, by the National Institute of Health and Care Excellence (NICE). The trial is designed to include a treatment period of 12 months with a 12-month follow-up period for each individual involved in the study. Primary endpoints of the trial are weight and HbA1c (a key blood sugar measure for diabetes).
“New, effective therapies for type 2 diabetes and obesity are urgently needed,” said Dr Bob Ryder, consultant physician in diabetes at Sandwell and West Birmingham Hospitals and chief investigator for the ABCD study. “The REVISE-Diabesity trial presents an exciting opportunity for patients who have been unsuccessful in managing their diseases to try a new option that may help them improve both their blood sugar and weight without surgery. Depending on the results of this study, EndoBarrier Therapy may become a standard NHS treatment option for patients throughout the UK who are struggling with type 2 diabetes and obesity.” For patients interested in being involved or clinicians with referrals please visit www.diabetologists-ABCD.org.uk/research/endobarrier_study.htm or email firstname.lastname@example.org reference; REVISE-Diabesity.
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between ingested food and a portion of the wall of the intestine. Inserted endoscopically (through the mouth without any cutting or scarring of tissue), the EndoBarrier liner prevents the interaction of food with enzymes and hormones in the proximal intestine. In effect, food bypasses the duodenum, but without surgery or permanent changes to the anatomy. In clinical studies, more than 80% of patients were able to reach healthy blood glucose levels (HbA1c ≤ 7.0%) and achieve weight loss of approximately 20 percent within one year. EndoBarrier Therapy is currently available as a private-pay procedure in select hospitals in the UK and is also available in other countries throughout Europe, as well as Australia, Israel and Chile.
About EndoBarrier Therapy
EndoBarrier Therapy is a revolutionary, non-surgical, non-pharmaceutical treatment proven to help people living with uncontrolled type 2 diabetes and obesity achieve rapid and dramatic reductions in blood sugar levels, as well as substantial weight loss. EndoBarrier Therapy is a convenient and discreet treatment for people whose diabetes medications are no longer effective, who are at risk for serious health complications and who want to avoid the progression to daily insulin injections. This first-of-its-kind therapy is helping patients around the world fight their battle against type 2 diabetes and obesity while providing a pathway to a healthier lifestyle. For more information, please visit www.endobarrier.com.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is the developer and marketer of EndoBarrier®, a breakthrough device that represents an entirely new class of non-surgical, non-pharmaceutical therapy for the treatment of type 2 diabetes and/or obesity. EndoBarrier is approved and commercially available in multiple countries outside the U.S. EndoBarrier is not approved for sale in the U.S. and is limited by federal law to investigational use only in the United States. GI Dynamics is conducting a pivotal clinical trial of EndoBarrier in the U.S. for the treatment of patients who have uncontrolled type 2 diabetes and are obese. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our EndoBarrier® including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrollment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. GI Dynamics does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. GI Dynamics may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, described in “Risk Factors” in our Prospectus lodged with the Australian Securities & Investments Commission on 3 August 2011.
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 Escalona, A., et al, “Weight Loss and Metabolic Improvement in Morbidly Obese Subjects Implanted for 1 Year With an Endoscopic Duodenal-Jejunal Bypass Liner.” Department of Digestive Surgery. Faculty of Medicine Pontificia Universidad Católica de Chile. Annals of Surgery, June 2012, Vol 255, Issue 6, p 1080–1085