Drug Combined with Intestinal Device Improves Uncontrolled Diabetes

The combination of an endobarrier intestinal device and the drug liraglutide may improve diabetes and obesity among patients, a recent study suggests.

The endobarrier is 23.6 inch open-ended, thin, flexible plastic sleeve that is inserted through the mouth. The endobarrier lines the upper small intestine to prevent food contact with that part of the digestive tract.

During the study presented at the annual meeting of the Endocrine Society, researchers enrolled 70 obese patients with uncontrolled type 2 diabetes despite previous treatment with liraglutide. At baseline, all groups had an average body mass index (BMI) of about 41 kg/m2 and were on average in their early to mid-50s.

Participants were randomized to receive an endobarrier and liraglutide (24 patients), an endobarrier solely (24 patients), and liraglutide solely (22 patients).

Patients were given the same dietary information and placed on the same diet for the first 2 weeks. Those who received an endobarrier had the device for up to 1 year and were assessed every 3 months.

The results of the study showed that at 1 year, the group who received the combinational therapy of the device and liraglutide, as well as the group who received the endobarrier alone, lost more weight than the liraglutide only group (12.8 kg, 12.5 kg and by 4.0 kg, respectively).

“This is the first study in which the combination of a GLP-1 receptor agonist drug and the endobarrier intestinal device has been used to successfully treat diabetes and obesity,” said researcher Piya Sen Gupta, MBBS, BMedSci, MRCP. “The combination seems to result in the best improvements in both. The endobarrier is less invasive than surgery, achieves a similar level of bypass, and can be inserted as a simple quick outpatient endoscopic procedure that patients are likely to find more acceptable. They have one year in which to change their eating behavior, and the endobarrier helps to do this.”

The endobarrier in combination with liraglutide group saw the quickest and most successful diabetes improvement, with a drop in glycated hemoglobin by 2.1%, 1.5%, and 1.2%, respectively.

Serious adverse events in the endobarrier group included gastrointestinal bleeding, obstruction, complicated removal, and liver abscess, which were resolved once the device was removed.

“This is an exciting area of research,” Sen Gupta said. “Surgical options such as gastric bypass of a large area of stomach and upper intestine are often successful in improving diabetes and producing weight loss, but they are fairly radical and irreversible options, and are not widely available. Less invasive options that produce similar effects would be ideal, particularly if they result in sustained eating behavior modification.”