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ENABLE Study

DM2 ENABLE data shows reduction in HbA1c levels

83% of the patients reported no change, a decrease or discontinuation of their medication suggesting that the progression of their diabetes had been modified

Three year diabetes, hypertension and weight loss data from the DM2 ENABLE Study of VBLOC vagal blocking therapy delivered via the Maestro Rechargeable (RC) System, presented XIX IFSO World Congress in Montreal, Canada, has revealed that at 36 months, HbA1c levels dropped from 7.6% at baseline to 7.0% (p=0.04).  Furthermore, 83% of the patients who were being treated with one or more diabetic medications at the start of the trial reported no change, a decrease or discontinuation of their medication suggesting that the progression of their diabetes had been modified. 

Scott Shikora

"Results from the DM2 ENABLE study of reversible vagal nerve blocking with the implantable Maestro Rechargeable System continue to demonstrate both medically meaningful weight loss as well as improvement in diabetes control in obese subjects with Type II Diabetes Mellitus. Most significantly, the benefits of VBLOC Therapy are sustained through the 36 month follow-up period of the trial with continued excellent overall and cardiovascular safety profiles," said Dr Scott Shikora, Associate Professor of Surgery, Harvard Medical School, Director, Center for Metabolic and Bariatric Surgery, Brigham and Women's Hospital and EnteroMedics' Consulting Chief Medical Officer.  "These data continue to support the widely accepted role of bariatric surgery in the treatment of metabolic disorders."

The DM2 Study is an international, open-label, prospective, multi-center study designed to evaluate the safety and efficacy of VBLOC vagal blocking therapy delivered via the Maestro RC System 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. To date, no deaths or unanticipated adverse device effects have been reported during the VBLOC-DM2 ENABLE Study and the safety profile is similar to that seen in other VBLOC clinical trials.

In combination with the HbA1c results, three year fasting plasma glucose (from 155.6 mg/dl at baseline to 131.5mg/dl (p=0.015)) and excess weight loss of 24.3% (p < 0.0001) continue to demonstrate the long-term stability of VBLOC Therapy as both a weight loss and a promising metabolic disease intervention.  Of note, the improvement in blood pressure at 36 months (mean arterial pressure -7.3mm/Hg (p=0.14)) in hypertensive patients was also maintained. These metabolic effects in diabetes, hypertension and weight loss are consistent with previous findings from other time points and are considered medically meaningful improvements. 

EnteroMedics' proprietary technology, VBLOC vagal blocking therapy, delivered by a pacemaker-like device called the Maestro Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses.

EnteroMedics' Maestro Rechargeable System has received CE Mark and is listed on the Australian Register of Therapeutic Goods. In June 2014, the FDA Advisory Gastroenterology and Urology Devices Panel (GUDP) that the device is safe when used as designed and voted four to five against on the issue of a reasonable assurance of efficacy. 

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