Temporary intestinal bypass device plus liraglutide may improve obesity and diabetes

Last Updated: 2016-04-18

By Lorraine L. Janeczko

NEW YORK (Reuters Health) - A temporary intestinal bypass device plus liraglutide therapy may help patients lose weight and control their diabetes better than either the device or the drug alone, new research from the U.K. suggests.

The device (EndoBarrier from GI Dynamics, Inc.) is a 60 cm-long, removable thin, flexible, open-ended plastic sleeve that is non-surgically inserted through the mouth and attached to the duodenum by a metal anchor. It lines the upper small intestine to prevent food digestion in that section of the digestive tract.

"In a group of patients with poor diabetes control and considerable obesity who had already been treated with liraglutide, we added the EndoBarrier," explained chief investigator Dr. Bob Ryder from Sandwell and West Birmingham Hospitals National Health Service Trust in Birmingham.

"The resultant fall in HbA1c represented a very significant clinical improvement, far more than one would see in clinical trials with the usual alternative therapies," he told Reuters Health in an email. "The mean fall in weight was also considerable, compared with usual therapy with insulin, which would have led to an increase in weight in patients already overweight."

"As a clinician, it is particularly gratifying to hear patients treated with the EndoBarrier report their many individual improvements in overall health, including considerable improvements in exercise tolerance, reduction in breathlessness and general sense of wellbeing. The patients are usually especially pleased about the substantial reductions in the need for other diabetes medications, in particular insulin, which frequently is no longer required," added Dr. Ryder.

Dr. Ryder and colleagues presented the one-year results of their two-year trial on April 2 at ENDO 2016, the annual meeting of the Endocrine Society, in Boston.

For the study, they recruited 70 patients who had difficulty controlling their type 2 diabetes and were obese despite previous liraglutide treatment. Participants were in their early- to mid-fifties and had an average body mass index of about 41 kg/m2.

The researchers randomly assigned the patients to one of three groups: 24 participants were implanted with an EndoBarrier and given liraglutide; 24 received only an EndoBarrier; and 22 received only liraglutide.

For the first two weeks, all patients were given the same dietary information and maintained the same diet. Those receiving the device had it for one year and were examined every three months.

Of the 57 patients who have reached the one-year point, all have lost significant amounts of weight. The 19 treated with the EndoBarrier plus liraglutide lost 11.3 kg, compared to 11.7 kg among the 23 treated with the EndoBarrier alone and 4.5 kg among the 15 patients on liraglutide only.

Hb1Ac dropped from 9.7% to 7.6% (p<0.0001) in patients receiving both treatments; from 9.3% to 8.1% (p=0.001) in patients receiving only the device; and from 9.8% to 8.3% (p=0.004) in those on liraglutide only.

Overall, 5 (11.9%) of the 42 patients implanted with the devices had them removed early due to gastrointestinal symptoms (three from the EndoBarrier-only group).

The device was safe, and the EndoBarrier-liraglutide combination was well tolerated, the researchers report

Co-author Dr. Piya Sen Gupta of King's College London and City Hospital Birmingham added in an email to Reuters Health, "We're in the middle of a global pandemic of diabesity. New treatments must be found. We need innovation. When novel treatments such as the EndoBarrier are devised, we need to prove efficacy and safety, but we should also try to find the best ways of using such therapies so that we can extract their maximum effect. Our trial is designed to do just that."

The device is commercially available in several countries, but in the U.S. it is approved for investigational use only.

The Association of British Clinical Diabetologists funded the study, and the authors stated that they had no conflicts of interest.

SOURCE: http://bit.ly/1S60LU2

ENDO 2016.