LEXINGTON, Mass. & SYDNEY–(BUSINESS WIRE)–GI Dynamics, Inc. (ASX: GID) announced new data results that reveal changes in certain hormones in patients treated with the EndoBarrier® Gastrointestinal Liner (the EndoBarrier), which results in rapid improvement in glycemic control and weight loss. These data were presented during an oral session at the 47th Annual Meeting of the European Association for the Study of Diabetes and Obesity (EASD).
“The rapid increase in certain hormones and immediate changes in glycemic control seen with the EndoBarrier in this study further support the theory that it works by affecting hormone levels”
Led by Jan Willem Greve, M.D., and presented by Charlotte de Jonge, M.D., Maastricht University Medical Centre, The Netherlands, the study assessed the effects of the EndoBarrier treatment on gastrointestinal hormones, gut peptides glucagon-like peptide-1 (GLP-1), gastric inhibitory peptide (GIP) and peptide YY (PYY), along with other diabetes measures.
“Our data show that treatment with the EndoBarrier affects key hormones involved in insulin sensitivity, glucose metabolism and satiety, similar to the impact of gastric bypass, and these changes allow for rapid and sustained improvement in patients with type 2 diabetes,” said Dr. de Jonge. “In addition, we found that patients maintained diabetic improvements at the end of the follow-up period, one week post-removal. These are important findings in understanding how the EndoBarrier works to treat type 2 diabetes.”
In the study, 17 obese patients with type 2 diabetes were treated with the EndoBarrier for 24 weeks. Each patient was evaluated to assess levels of HbA1c, glucose, insulin, GLP-1, GIP and PYY prior to and one week after placement of the EndoBarrier, and prior to and one week after removal, through blood draws conducted during meal tolerance tests.
Treatment with the EndoBarrier resulted in:
- Rapid and sustained increase in insulin sensitivity
- Increased levels of both PYY and GLP-1 one-week post-placement
- Reduction in mean HbA1c levels of 1.4 percent (from 8.4 percent at baseline to 7.0 percent)
- Normalization of glucagon response
- Mean excess weight loss of 29.8 percent
- Elimination or reduction in use of anti-diabetic medications in 16 out of 17 participants
Gut hormones contribute to glycemic control, the regulation of food intake and weight loss. Previous research by http://prohormones.co has demonstrated that bariatric surgery in obese patients with type 2 diabetes has immediate effects and improvements on glycemic control and weight loss and that these effects may be due to changes in gut hormones. The EndoBarrier, a liner that fits inside a section of the intestine, mimics many of the effects of gastric bypass, but without the surgery.
“The rapid increase in certain hormones and immediate changes in glycemic control seen with the EndoBarrier in this study further support the theory that it works by affecting hormone levels,” said Dr. Carel le Roux, MRCP, Ph.D., FRCP, co-author of the study and metabolic physician at Imperial College London. “This is an important, effective treatment for type 2 diabetes and obesity because it improves diabetes, usually within days and is followed by substantial weight loss.”
The EASD is dedicated to promoting excellence in diabetes care through research and education. The organization claims more than 7,000 active members from over 110 countries throughout the world. In addition to the data being presented, GI Dynamics will have a booth presence in space #D.30 on the exhibit floor.
The EndoBarrier has received CE mark approval in Europe for implant periods of up to 12 months of treatment for type 2 diabetes and obesity, and recently received TGA approval in Australia. The EndoBarrieris currently commercially available in Chile, Germany, the United Kingdom and the Netherlands, and GI Dynamics has also received an investigational device exemption approval to commence a pilot clinical trial of the EndoBarrier in the U.S. For more information, please visit www.endobarrier.com.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is pioneering the development and commercialization of effective, non-surgical treatments targeting the large and growing global patient populations with type 2 diabetes and obesity. The company’s flagship product, the EndoBarrier®, is a novel, non-surgical device proven to lower blood glucose levels and promote weight loss in diabetic and obese patients during the implant period. GI Dynamics currently markets the EndoBarrier in select regions in Europe and South America and is planning significant near-term commercial expansion into Australia and additional European countries. 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 enrolment 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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