BOSTON — April 4, 2023 — GI Dynamics® Inc., a medical device company that is developing EndoBarrier® for patients with type 2 diabetes and obesity, is pleased to announce updated positive data from the Association of British Clinical Diabetologists (ABCD) Worldwide EndoBarrier Registry showing improvements in weight, glycemic control, blood pressure, and cholesterol.
The article recently published in Diabetes Care, “Endoscopic Duodenal-Jejunal Bypass Liner Treatment for Type 2 Diabetes and Obesity: Glycemic and Cardiovascular Disease Risk Factor Improvements in 1,022 Patients Treated Worldwide,” authored by Robert Ryder, M.D. of City Hospital, Birmingham, U.K, demonstrates treatment with EndoBarrier reduced microvascular and macrovascular risk factors that could reduce the complications of type 2 diabetes (T2D).
The duodenal-jejunal bypass liner was developed to mimic the small-bowel mechanisms of Roux-en-Y gastric bypass while being less invasive. Over 3,000 patients have been treated with EndoBarrier worldwide, and in 2017 a secure, online registry was established by ABCD for the collection of safety and efficacy data for EndoBarrier treated patients worldwide.
The ABCD Worldwide EndoBarrier Registry, led by Dr. Ryder, collected data from 34 centers in ten countries. As of October 2022, data had been entered on 1,022 patients and continues to support a positive benefit: risk profile for patients with type 2 diabetes and/or obesity treated with EndoBarrier.
According to Dr. Ryder, “There is an increasing number of patients with refractory uncontrolled T2D and obesity worldwide with no readily available treatment option, and the potential demand is too great for available metabolic surgery resources. The overall clinical benefit of EndoBarrier is highlighted in the Worldwide Registry data analyses demonstrating clinically significant reductions in weight during EndoBarrier implantation and additional associated improvements in HbA1c, blood pressure and cholesterol. This reduction in microvascular and macrovascular risk factors could serve to reduce the overall complications associated with type 2 diabetes.”
As shown below, EndoBarrier treatment was associated with considerable reduction in weight, HbA1c, systolic blood pressure and cholesterol:
| Parameter | n | Baseline | EndoBarrier Explant | Difference | P-value |
|---|---|---|---|---|---|
| Weight (kg) | 811 | 120.2±25.3 | 106.9±23.8 | -13.3±9.7 | <0.001 |
| HbA1c (%) | 646 | 8.3±1.8 | 7.1±1.3 | -1.3±1.5 | <0.001 |
| Systolic BP (mmHg) | 448 | 135.7±18.0 | 129.5±17.0 | -6.3±19.2 | <0.001 |
| Cholesterol (mmol/L) | 467 | 4.8±1.2 | 4.2±1.0 | -0.6±1.03 | <0.001 |
n=patient population
Analysis of the data according to baseline HbA1c clearly shows the higher the initial HbA1c the greater the reduction with EndoBarrier treatment. Similarly, the study showed the higher the initial BMI, the greater the reduction. There were no differences in HbA1c or weight reduction by age or sex.
| HbA1C Range (%) | n | Baseline | EndoBarrier removal |
Difference | P-value |
|---|---|---|---|---|---|
| All HbA1c | 646 | 8.3±1.8 | 7.1±1.3 | -1.3±1.5 | <0.001 |
| All HbA1c ≥ 7 | 141 | 7.5±0.3 | 6.8±0.8 | -0.7±0.8 | <0.001 |
| All HbA1c ≥ 8 | 158 | 8.4±0.3 | 7.3±1.0 | -1.1±1.0 | <0.001 |
| All HbA1c ≥ 9 | 96 | 9.4±0.3 | 7.8±1.1 | -1.6±1.1 | <0.001 |
| All HbA1c ≥ 10 | 111 | 11.2±1.2 | 8.0±1.5 | -3.2±1.7 | <0.001 |
| BMI Ranges | |||||
| All | 808 | 41.2±10.0 | 36.6±8.8 | -4.6±3.6 | <0.001 |
| BMI 23.0 – 29.9 | 24 | 28.3±1.9 | 26.0±2.2 | -2.2±1.9 | <0.001 |
| BMI 30.0 – 34.9 | 144 | 32.9±1.4 | 29.8±2.6 | -3.1±2.4 | <0.001 |
| BMI 35.0 – 39.9 | 253 | 37.6±1.4 | 33.3±2.9 | -4.3±2.6 | <0.001 |
| BMI ≥40 | 387 | 47.5±10.4 | 41.9±9.7 | -5.5±4.2 | <0.001 |
n=patient population
“The Worldwide Registry continues to demonstrate the positive impact of EndoBarrier on behalf of patients suffering from T2D and obesity. The clinical benefits we have seen are compelling and reinforce our belief that EndoBarrier has the potential to offer a less invasive, reversible option compared to traditional bariatric surgeries. The resulting therapeutic benefits could dramatically enhance the lives of these high-risk patients,” commented Joe Virgilio, President and CEO of GI Dynamics.
About GI Dynamics
GI Dynamics Inc. is the developer of EndoBarrier, an endoscopically delivered device therapy which offers a non-surgical, alternative treatment 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.
Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information, please visit gidynamics.com or follow us on Twitter and LinkedIn.
GI Dynamics Media Contact:
Joseph Virgilio
jvirgilio@gidynamics.com
(781) 357-3296
