Obese Patients With Diabetes Benefit From Combination Device-Drug Therapy

BOSTON — Treatment with a novel endoscopic device combined with a glucagon-like petide-1 (GLP-1) receptor agonist promoted weight loss and improved glycemic control in obese patients with type 2 diabetes after 1 year, according to new data.

The new device, named endobarrier, is a 60-cm open-ended, thin, flexible plastic sleeve that is inserted nonsurgically through the mouth and lines the upper small intestine to prevent food contact with that portion of the digestive tract, thereby achieving endoscopic duodenal exclusion.

In this study, which was presented at ENDO 2016, researchers recruited patients with obesity, defined as a BMI of 35 or greater, and poorly controlled type 2 diabetes, defined as an HbA1c of 7.5% or greater, despite treatment with liraglutide 1.2 mg (Victoza, Novo Nordisk) daily.

A total of 70 patients were randomly assigned to treatment with endobarrier added to liraglutide (n=24), endobarrier only (n=24), or an escalated dose of liraglutide without endobarrier (n=22). The researchers matched groups for age (50.9, 50.4, and 53.7 years, respectively), BMI (40, 41.5, and 41.4, respectively), sex (men, 36.8%, 26.1%, and 46.7%, respectively), and ethnicity (Caucasian, 63.2%, 69.6%, and 66.7%, respectively).

For the first 2 weeks, all patients were on the same diet and given the same dietary information. Those who received the endobarrier were implanted with the device for up to 1 year and evaluated at 3-month intervals.

Results revealed greater weight loss in patients who received endobarrier plus liraglutide and endobarrier alone when compared with those who only received liraglutide (12.8 kg and 12.5 kg vs 4 kg; P=.04).

Patients receiving both treatments experienced a greater reduction in HbA1c compared with the endobarrier alone or liraglutide alone (2.1% vs 1.2% and 1.5%, respectively; P=.004).

“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. The combination seems to result in the best improvements in both,” said study author Piya Sen Gupta, MBBS, BMedSci, MRCP, research fellow at King’s College Hospital London and City Hospital Birmingham in the United Kingdom. “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 1 year in which to change their eating behavior, and the endobarrier helps to do this.”

In terms of safety, 11.9% of patients treated with the endobarrier experienced serious device-related adverse events, including gastrointestinal bleed, obstruction, complicated removal, liver abscess, and cholecystitis, with all resolving after device removal. Early device removal related to gastrointestinal symptoms occurred in 5 of 42 patients.

“This is an exciting area of research,” noted Dr Sen Gupta. “Surgical options such as gastric bypass of a large area of the 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.”

The Association of British Clinical Diabetologists funded the study. The researchers report no relevant financial disclosures.

Reference

1. Sen Gupta P, Drummond RS, Lugg ST, McGowan BMC, Amiel SA, Ryder REJ. SAT-690: One Year Efficacy, Safety and Tolerability Outcomes of Endoscopic Duodenal Exclusion Using Endobarrier as an Adjunct to Glucagon-like Peptide-1 (GLP-1) Therapy in Suboptimally Controlled Type 2 Diabetes: A Randomised Controlled Trial. Presented at: ENDO 2016; April 1-4, 2016; Boston, MA.