GI Dynamics (ASX:GID) today released data from an investigator-initiated study examining the safety and efficacy of its EndoBarrier after reimplantation for treatment for patients with type 2 diabetes and obesity, touting no complications and reduced insulin use.
The study followed 5 patients which all completed an initial course of EndoBarrier treatment for 12 months, after which the devices were explanted and patients were monitored for 4 months, after which the device was reimplanted for another 12 months.
Data from the trial indicated no complications and showed reductions in HbA1c levels and insulin during both implantation periods. HbA1c fell from a baseline of 9.1% to 6.7% after the 1st explant, and from 7.8% upon 2nd implantation to 7.1% upon the 2nd explant, the company said.
Insulin usage fell from a baseline of 60iU to 19iU at the 1st explant, and from 33iU to 20iU on the second round of implanting and explanting of the device, according to GI Dynamics.
“Although small, this study provided important information regarding serial usage of EndoBarrier. Re-implantation and re-explantation of the EndoBarrier device were performed on all five study subjects without any complications, and the early clinical data is promising. In addition, there was a significant reduction in insulin,” study primary investigator Dr. Jurgen Stein said in a prepared statement.
“The study shows early indication of efficacy to support multiple treatments utilizing EndoBarrier. Especially encouraging is the reduction of blood sugar and weight combined with concurrent reduction in insulin. We appreciate Dr. Stein’s efforts to conduct a study that adds such interesting insights into the growing body of evidence proving EndoBarrier safety and efficacy,” CEO & prez Scott Schorer said in a press release.
Last month, GI Dynamics released data from a meta-analysis of its EndoBarrier device, touting improved glycemic control in patients with type 2 diabetes and obesity. Data from the meta-analysis study was presented at the Digestive Disease Week meeting in Chicago.