Phase III results from VBLOC DM2 Study of vBloc neurometabolic therapy in obese patients with type 2 diabetes published- EnteroMedics

EnteroMedics announced the publication of three-year data from the Company's VBLOC DM2 Study of vBloc Neurometabolic Therapy in obese patients with Type 2 diabetes. Results from the study demonstrate that after three years, the average percentage excess weight loss (%EWL) was 21% with reductions in hemoglobin A1c (HbA1c) of 0.6 percentage points from a baseline of 7.8%. This clinically meaningful reduction in HbA1c resulted in 39% of participants either reducing or stopping their diabetes medications. Additionally, 71% of study participants were at or below the American Diabetes Association target for HbA1c for people with diabetes of 7%.

Also at three years, mean estimated fasting plasma glucose was significantly decreased by 18 mg/dL from 151 mg/dL at baseline. The DM2 Study is an international, open-label, prospective, multi-center study designed to evaluate the safety and efficacy of vBloc Therapy in 28 diabetic subjects with obesity by measuring average percentage excess weight loss (EWL), HbA1c (blood sugar), fasting plasma glucose (FPG, blood sugar) and blood pressure, following device activation. No deaths, unanticipated adverse device effects, or life-threatening complications occurred through three years.

See: "Vagal Nerve Block for Improvements in Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus: Three-Year Results of the VBLOC DM2 Study" Miguel F Herrera et al. Journal of Diabetes and Obesity, January 24, 2017 DOI: 10.15436/2376-0494.17.1250