Data from the meta-analysis study was presented at the Digestive Disease Week meeting in Chicago.
The EndoBarrier device from the Lexington, Mass.-based company is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract.
Results from the analysis, which examined the use of the device in 431 patients, indicated an average reduction in HbA1c of 1.3% compared to control groups upon removal of the EndoBarrier after an average implant duration of 8.4 months. A subgroup analysis of 123 patients in randomized controlled trials reported an average decrease in HbA1c levels of 0.9% compared to control groups.
Secondary outcomes in the meta-analysis examined changes in weight and digestive hormones at removal, as well as HbA1c level changes 6 months post-removal. In 2 studies with 6-month post removal data, HbA1c levels remained lower than baseline by 1%.
An analysis of 10 studies, with a total patient population of 395, reported average weight loss of 14.2% and average BMI reduction of 4.2kg/m2.
The company said that in 5 studies, with a population of 84 patients, there was a significant decrease in glucose-dependent insulinotropic peptides at 7.8 months.
A separate meta-analysis reported 16 serious adverse events with the most common being abdominal pain, nausea and vomiting. Not hepatic abscesses were reported in the studies.
“This meta-analysis is very encouraging as we continue to see clinically significant reductions in HbA1c levels at 1.3% with 77% retention of the eight-month implant duration of HbA1c and month 14 (six months’ post explant). Weight loss at the time of explant is also clinically significant. This analysis further reinforces the unique method of treatment and highly differentiated clinical treatment effect of EndoBarrier,” prez & CEO Scott Schorer said in a press release.