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EndoBarrier Therapy reduces reliance on diabetes medication

Findings show that EndoBarrier Therapy can reduce reliance on diabetes medications, from oral agents to insulin therapy

Outcomes from three studies examining EndoBarrier Therapy have conclude that the treatment further demonstrate its acute effects on glycaemic control, its ability to reduce reliance on diabetes medications (including insulin), as well as findings that help explain its potential mechanism of action. The findings were presented in three poster presentations at the 74th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco.

“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 Dr Gabriella LiebermanInstitute of Endocrinology, Sheba Medical Center, Tel Aviv, Israel. “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.”

The poster, “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 (-8.9kg) 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 analogue scale.

The poster, “Endoscopic, Duodenal-Jejunal Bypass Liner Exerts Robust Improvement in Glycemia and Body Weight in Obese Patients with Type 2 Diabetes,” was a pooled analysis of five open-label studies that showed EndoBarrier Therapy continues to lower HbA1c, accelerate weight loss and reduce reliance on diabetes medications.

This analysis evaluated 71 patients who completed 12 months of EndoBarrier Therapy.  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 ADA.

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 93.4kg). Notably, patients were able to reduce use of background diabetes medications.

The presentation, “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.

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±0.8μmol/L (from 0.7±0.3μmol/L baseline; p<0.05). Also, fasting primary (from 0.04±0.01 to 2.1±0.4μmol/L) and secondary (from 0.07±0.02 to 1.5±0.4μmol/L) bile acids levels increased from baseline (p<0.05 vs. baseline for both).

“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 glycaemic control,” said Dr David Maggs, chief medical officer, GI Dynamics. “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.”

The EndoBarrier device is currently under investigation in the US in a multicentre, pivotal clinical trial (The ENDO Trial) for the treatment of patients who have uncontrolled type 2 diabetes and are obese. EndoBarrier Therapy has been approved in select countries internationally since 2010 and is available in Chile, Australia and select countries in Europe and the Middle East.

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