Meta-Analysis Show EndoBarrier Improves Glycemic Control, Induces Weight Loss in Diabetics

GI Dynamics Inc., a medical device company that has commercialized EndoBarrier in Europe, the Middle East, and South America for patients with type 2 diabetes and obesity, announced data from an investigator-initiated meta-analysis of 14 studies showing EndoBarrier improves glycemic control in a clinically impactful manner in patients with type 2 diabetes and obesity. According to the studies, EndoBarrier induces significant weight loss and positively affects certain digestive hormones.
 
Pichamol Jirapinyo, M.D., of the Division of Gastroenterology, Hepatology and Endoscopy at Brigham and Women’s Hospital and Harvard Medical School in Boston, Mass., headed a study team that analyzed publicly available data from 14 studies as part of the most comprehensive meta-analysis of EndoBarrier to date.
 
Jirapinyo and the study team used a strict methodology to determine inclusion and exclusion of the different potential clinical studies. In addition, publication bias and potential bias from large studies were accounted for. Authors were also contacted for additional data.
 
“This meta-analysis is very encouraging as we continue to see clinically significant reductions in HbA1c levels at 1.3 percent with 77 percent 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,” said Scott Schorer, president and CEO of GI Dynamics “This analysis further reinforces the unique method of treatment and highly differentiated clinical treatment effect of EndoBarrier.”
 
Meta-analysis Highlights
Primary Outcomes:
In 14 studies with a total population of 431 patients, the average decrease of HbA1c was 1.3 percent at removal of EndoBarrier, following an average implant duration of 8.4 months. Of note, in the earlier studies, EndoBarrier was implanted for six months while later studies extended this duration to 12 months. A subgroup analysis of four randomized controlled trials (RCTs) with a patient population of 123, saw a decrease in their HbA1c levels by 0.9 percent compared to the control group.
 
Secondary Outcomes:
Secondary outcomes in this meta-analysis measured change in weight and digestive hormones at removal and changes in HbA1c levels six months after EndoBarrier removal. Two studies with six-month data after removal of EndoBarrier showed HbA1c remained lower than baseline by 1 percent. As for weight loss, 10 studies with a total patient population of 395 patients reported average weight loss of 14.2 percent and average BMI reduction of 4.2 kg/m2.
 
In addition, in five studies with a population of 84 patients, the meta-analysis showed a significant decrease in glucose-dependent insulinotropic peptide (GIP) at 7.8 months.
 
Secondary outcomes also examined adverse events. The meta-analysis revealed 16 serious adverse events with the most common including abdominal pain, nausea and vomiting. No hepatic abscesses were found in the published studies.
 
This meta-analysis reviewed published, randomized controlled trials and cohort studies found in MEDLINE, EMBASE and Web of Science through Nov. 1, 2016, that assessed outcomes of EndoBarrier in patients with type 2 diabetes and obesity. Data were pooled using a mixed-effect model or a random-effect model for high heterogeneity. Of 593 potential eligible studies, 18 were included and sevent studies provided additional data.
 
GI Dynamics Inc. developed the EndoBarrier, the first endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. Founded in 2003, GI Dynamics is headquartered in Boston, Mass.