New EndoBarrier® Data Informs on Glycemic Control and Obesity

We’ve followed the emergence of GI Dynamics’ Endobarrier® device a lot over the past few years, most recently in May (2014) when clinical results from a collaborative study with GlaxoSmithKline (GSK) pointed to an effect on bile acid levels as being the explanation for weight loss and glucose stabilization when the product was indwelling. Now new data findings further demonstrate the acute effects of EndoBarrier® Therapy on glycemic control, its ability to reduce reliance on diabetes medications, including insulin, as well as findings that help explain its potential mechanism of action.

Background

These new findings were presented in three poster presentations at the 74th Scientific Sessions of the American Diabetes Association in San Francisco.

Poster 1: “The Acute Effect of EndoBarrier Treatment on Glucose Homeostasis in Obese Uncontrolled Diabetic Subjects,” evaluated the effects of the EndoBarrier device on glucose homeostasis, HbA1c, weight loss, insulin requirements and appetite in 33 patients.

Glucose was monitored continuously for one week beginning two days before placement of the device. 

Use of the EndoBarrier device resulted in an acute drop in average daily glucose by 29% within days post implantation, despite a reduction of 50% in insulin dose during this time. As early as 12 weeks after EndoBarrier insertion, subjects demonstrated a significant reduction in both weight (-8.9 kg) and HbA1c levels (-1.4%) leading to a decrease in insulin requirements. Interestingly, weight loss was accompanied by a decrease in appetite demonstrated by the visual analog scale.

Poster 2: “Endoscopic, Duodenal-Jejunal Bypass Liner Exerts Robust Improvement in Glycemia and Body Weight in Obese Patients with Type 2 Diabetes,” evaluated 71 patients who completed 12 months of EndoBarrier Therapy. A pooled analysis of five open-label studies continues to demonstrate the effects of the EndoBarrier device to lower HbA1c, accelerate weight loss and reduce reliance on diabetes medications.

The use of the EndoBarrier device resulted in a 1.4% median decrease in HbA1c (from 8.2% at baseline to 6.8); of these 57% achieved the recommended 7% HbA1c of the American Diabetes Association. Patients experienced a robust effect on total body weight loss with EndoBarrier Therapy, resulting in a 10.4% reduction (from 106.2 at baseline to 93.4 kg). Notably, patients were able to reduce use of background diabetes medications.

Poster 3: “Duodenal-Jejunal Bypass Liner Increases Bile Acids Levels in Patients with Severe Obesity and Type 2 Diabetes Mellitus” investigated the use of the EndoBarrier device and its effects on bile acids to explore its potential mechanism of action (Research has indicated that bile acids levels may be tied to the effectiveness of gastric bypass surgery, such as Roux-en-Y gastric bypass). 

Primary and secondary bile acids levels were measured in seven patients with type 2 diabetes and obesity prior to placement of the EndoBarrier device and following removal at 52 weeks of treatment. After treatment, fasting total bile acids levels increased to 4.3±0.8 μmol/L (from 0.7±0.3 μmol/L baseline; p<0.05). Also, fasting primary (from 0.04±0.01 to 2.1±0.4 μmol/L) and secondary (from 0.07±0.02 to 1.5±0.4 μmol/L) bile acids levels increased from baseline (p<0.05 vs. baseline for both). These findings offer further insight into the mechanisms that underlie the therapeutic effect of EndoBarrier Therapy and are broadly consistent with the study referenced earlier.

Investigator comments

“The ability of the EndoBarrier to acutely affect glucose homeostasis, before significant weight loss has had a chance to occur is fascinating and resembles reports on bariatric surgery,” stated Gabriella Lieberman, M.D., Institute of Endocrinology, Sheba Medical Center, Tel Aviv, Israel (Poster 1). “The fact that the device impacts all weight, glucose and appetite makes it attractive for the treatment of diabesity and makes one curious as to the underlying mechanism by which this device exerts its effects.”

Company comments

“The data presented at ADA expand upon already established evidence presented recently at other medical meetings and further validate how the EndoBarrier device works to affect and improve glycemic control,” said David Maggs, M.D., chief medical officer, GI Dynamics, Inc. “The findings from these studies and analyses show that EndoBarrier positively impacts HbA1c and weight in patients with type 2 diabetes and obesity. Importantly, the findings also show that EndoBarrier Therapy can reduce reliance on diabetes medications, from oral agents to insulin therapy. This is an important consideration for physicians as they contemplate treatment regimens for their patients.”

Source: GI Dynamics, Inc., Business Wire

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