Friday, September 19, 2008
EndoBarrier, an Internal Condom, Gets Positive Results in Diabetic Clinical Trial
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GI Dynamics, a company out of Lexington MA, is developing a device called EndoBarrier™, which is essentially a gastrointestinal impermeable liner designed to prevent food from coming in contact with the wall of the intestine. The company has just announced positive results from a pilot clinical trial in patients with uncontrolled type 2 diabetes, who had EndoBarrier Gastrointestinal Liner implantations, and have "achieved a statistically significant improvement of glycemic control in just one week as compared to a sham control." We are not sure what indications the company is pursuing for its device, but they probably hope to have regulatory OKs for treatment of obesity and type 2 diabetes, 'cause that's where the money is.
More about the device:
The EndoBarrier™ is a gastrointestinal liner that acts as an impermeable barrier to prevent food from coming in contact with the wall of the intestine. This may have an effect on the patient's uptake of both nutrients and calories. It may also have a metabolic effect that is similar to Roux-en-Y gastric bypass surgery, which produces significant weight loss and resolution of type 2 diabetes. However, the EndoBarrier™ is placed and removed endoscopically. As with many endoscopic procedures, the EndoBarrier™ may provide a safer alternative with more rapid recovery and lower costs.Potential Features
* May mimic the metabolic effects of Roux-en-Y gastric bypass
* Performed as a day procedure
* Delivered and removed endoscopically
* Is a reversible procedurePotential Benefits
* Metabolic weight loss and control of type 2 diabetes
* Minimizes potential for morbidity and mortality of traditional surgery
* Is less invasive than surgical alternatives
* Eliminates hospital stays
Details from the clinical trial:
The data show that EndoBarrier patients experienced a mean reduction of 2.9% (p=0.04) of HbA1c glucose levels from baseline (8.9%) versus a mean 0.76% (p=0.04) reduction from baseline (9.0%) for the sham arm for an average of 31 weeks (ranged from 16 to 44 weeks). These results support the initial findings announced at the American Diabetes Association 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, Dr. 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 (Diabetes Care 2005; 28; 1083-1091). Additionally, EndoBarrier patients experienced an average 27.5 lb. weight loss in this trial by week 30.Most device patients experienced a substantial 51.6 point reduction of fasting blood glucose levels by one week, another key indicator of diabetic status. There was a 76.6 point reduction in fasting blood glucose levels at 20 weeks. Some device patients were able to stop taking their diabetes medication as blood sugar levels normalized. Patients in the sham-treatment group who did not receive the device experienced a 17.4 point reduction in fasting blood glucose levels at week one and 38.2 point reduction at 20 weeks. There was an immediate impact on glucose levels. EndoBarrier patients exhibited an 18.6% decrease in the area under the glucose curve during a meal tolerance test at week one versus an increase of 10.1% in the sham-treatment group.
Flashback: Eat Away, Just Don't Digest...
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