Dr. Russell Drummond, of the National Health Service (NHS) Greater Glasgow and Clyde, Scotland, has presented findings from the Randomization to Endobarrier alone Versus with Incretin analogue in SustainEd Diabesity (REVISE Diabesity) study.
The two-year study focused on the treatment of obese type 2 diabetes patients with EndoBarrier Therapy (EBT) and a GLP-1 receptor agonist (liraglutide), compared to either liraglutide alone or EBT alone. Study results were presented in April at the Endocrine Society’s ENDO 2016 meeting in Boston, Mass.
EBT is a thin plastic sleeve worn inside the small intestine that causes food to be absorbed further in the intestine. Liraglutide is a medication that lowers blood sugar levels.
Study investigators measured both weight reduction and clinically meaningful improvements in hemoglobin A1c (HbA1c) levels – a measure of the average blood glucose levels.
Study subjects who took EBT plus liraglutide were found to have the greatest and quickest diabetes improvement. The patients who took EBT, with or without liraglutide, lost more weight than those taking liraglutide only. In addition, EBT allowed reductions in the patients’ liraglutide dose while retaining its effectiveness. Of those taking EBT, six subjects (25 %) reduced their diabetes medications. EBT was found generally safe and well-tolerated by the patients.
The study’s lead investigator Dr. Bob Ryder, of Sandwell and West Birmingham Hospitals NHS Trust, said in a press release: “As a clinician, it is particularly gratifying to meet patients treated with EndoBarrier Therapy and hear them report their many individual improvements in overall health.”
Ryder said most patients reported added tolerance to exercise, less breathlessness and an overall improved sense of well-being.
“We also see substantial reduction in the need for other diabetes medications, particularly insulin, which is often no longer required. Usually, patients are especially pleased about this.” Ryder said.
Scott Schorer, president and chief executive officer of GI Dynamics, said the data further validates EBT.
“We are delighted to see that EndoBarrier Therapy, administered alone or in combination with diabetes medication, compares favorably to treatment with pharmacotherapy,” Schorer said.
The study could mark a milestone in diabetes and obesity treatment.
Dr. Piya Sen Gupta, MD, ABCD Study research fellow at King’s College Hospital London and City Hospital Birmingham, U.K., said the study is the first in which the combination of a GLP-1 receptor agonist and the EndoBarrier intestinal device has been used to successfully treat diabetes and obesity.
“The combination seems to result in the best improvements in glucose control and weight reduction,” said Gupta. “EndoBarrier is less invasive than surgery, achieves a similar level of bypass and can be inserted as a simple and quick outpatient endoscopic procedure that patients are likely to find more acceptable. They have one year in which to change their eating behavior; EndoBarrier helps them do this.”