The medical community is beginning to realize the role that gastric bypass surgery plays on diabetes, which has several companies developing devices to induce weight loss and, subsequently, send Type 2 diabetes into remission.

But one company, GI Dynamics (Lexington, Massachusetts), recently reported data that showed its gastrointestinal (GI) liner improved glycemic control in diabetics independently of weight loss.

"We're the first ones to really have a device that can treat those conditions independently of one another," Stuart Randle, CEO of GI Dynamics, told Medical Device Daily.

According to new data the company reported this week, patients with uncontrolled Type 2 diabetes treated with an EndoBarrier GI liner from GI Dynamics achieved "significant improvement" of glycemic control in a week as compared to a sham control. Most importantly, the company noted, the immediate improvement of glycemic control was independent of weight loss, suggesting a direct action on diabetes. This glycemic improvement was sustained throughout the duration of the study, the company said. The device is designed to mimic the effects of gastric bypass surgery on a patient's metabolism, resulting in weight loss and remission of Type 2 diabetes.

Randle pointed out that there are "a number of techniques and concepts out there," but GI Dynamics is running trials for both weight loss and Type 2 diabetes. And, best of all, the EndoBarrier is implanted and removed endoscopically (through the mouth), without the need for surgical intervention.

"We're the only company in the device world that has presented data for both, we feel we're very unique," Randle said.

The EndoBarrier, creates a mechanical bypass of the duodenum and proximal jejunum. It allows food to pass through the device, and allows bile and pancreatic enzymes to travel outside the liner, allowing bile and intestinal hormones to travel around the liner without touching the food until later in the gut (Medical Device Daily, June 27, 2008).

The initial concept of the EndoBarrier GI liner came about in 2002, Randle said, and the company received its 'A' round of financing in 2003 (MDD, July 23, 2003), "so we've been at it for five years now."

More than 100 patients have been treated with the EndoBarrier device for both weight loss as well as diabetes, Randle said, and the company anticipates launching larger, longer-term studies with an enhanced device design in 2009.

The new findings were presented Tuesday by Lee Kaplan, MD, PhD, associate professor of medicine at Harvard Medical School (Boston) and director of the weight center at Massachusetts General Hospital (also Boston), at the First World Congress on Interventional Therapies for Type 2 Diabetes in New York.

"Obesity and Type 2 diabetes have reached epidemic proportions, and the healthcare community is struggling to find new ways to improve the treatment of these devastating and often fatal diseases," Kaplan said. "The immediate and sustained reduction in HbA1c levels observed with EndoBarrier in this controlled clinical trial equal or exceed the glycemic control produced by leading pharmaceutical treatments. The rigorous trial designs included a sham treatment group to compare with the device group – making these results even more compelling. We look forward to further data evaluating the potential role of the EndoBarrier as an option for treating patients living with Type 2 diabetes."

According to Christopher Sorli, MD, of the Department of Endocrinology at Billings Clinic (Billings, Montana), lead clinical advisor in the EndoBarrier clinical trial and presenter at the World Congress, "It can take a patient up to two years on aggressive therapies to see the kind of drop in HbA1c that we are seeing in just 30 weeks with the EndoBarrier. The EndoBarrier provides a non-surgical, completely endoscopic technique for duodenal-jejunal bypass in patients with Type 2 diabetes, and these preliminary results suggest durability of glycemic improvement throughout device implantation."

HbA1c levels are a gold standard in the assessment of glycemic control and can provide an indication for how well diabetes is being managed. The HbA1c test measures the amount of glycosylated hemoglobin in the blood over a three-month period. Glycosylated hemoglobin is a molecule in red blood cells that attaches to glucose (blood sugar). An individual will have more glycosylated hemoglobin if he or she has frequently elevated blood sugar levels.

The clinical trial was designed to examine the EndoBarrier for the treatment of Type 2 diabetes. In a single-blind, long term study, 12 Type 2 diabetics were prospectively randomized to receive the EndoBarrier GI liner and six Type 2 diabetics received a sham endoscopy. The primary endpoint was reduction of HbA1c (average blood glucose level over three months). Secondary endpoints included absolute weight loss, reduction in fasting glucose from baseline, improvement in post-prandial glycemic response, and reduction or discontinuation of oral hypoglycemic medications. The trial is now complete, and data are available on patients with the device for up to eleven months, GI Dynamics said.

The data show that EndoBarrier patients experienced a mean reduction of 2.9% of HbA1c glucose levels from baseline (8.9%) vs. a mean 0.76% reduction from baseline (9%) for the sham arm for an average of 31 weeks. The company says these results support the initial findings reported at the American Diabetes Association (Alexandria, Virginia) annual meeting in June that the EndoBarrier rapidly improves glycemic control in Type 2 diabetics at one week, independent of weight loss. As a point of reference, Kaplan noted the promising results observed in this small study with the EndoBarrier compare favorably to previously reported findings with the latest blockbuster diabetes treatment, Byetta. According to published data, patients on Byetta reported a 0.8% reduction in HbA1c from baseline (8.6%) at 30 weeks. Additionally, EndoBarrier patients experienced an average 27.5-pound weight loss in this trial by week 30.

Another company working in this space is EnteroMedics (St. Paul, Minnesota), which has developed the VBLOC vagal blocking system and a neuromodulation system designed to trick the patient's digestive tract into feeling full after a small meal. Although the company did not plan to evaluate the system's affect on diabetes, some anticipate that it would help to reverse the disease because the vagal nerves affect the release of intestinal hormones.

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