Data demonstrate favorable safety and efficacy profile for the duodenal jejunal bypass liner (DJBL) technology
BOSTON — July 13, 2022 — GI Dynamics® Inc., a medical device company that is developing EndoBarrier® for patients with type 2 diabetes and obesity, is pleased to announce positive data from the Association of British Clinical Diabetologists (ABCD) Worldwide EndoBarrier Registry and data from use within the National Health Service (NHS) in the UK evaluating the benefit:risk of EndoBarrier. The data was presented by Robert Ryder, M.D. of City Hospital, Birmingham, U.K. at the 82nd Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans on June 6, 2022. Both studies demonstrate the safety and efficacy profile that EndoBarrier provides patients diagnosed with type 2 diabetes and/or obesity.
“In these analyses, the data highlight clinically significant reductions in HbA1c showing 1.3% absolute mean reduction Worldwide and a 1.9% mean reduction in the UK, even though there were many patients without diabetes or with good glycemic control. In addition, we also saw a 13.3kg mean reduction in weight Worldwide and 17.3kg mean reduction in the UK study along with improved associated cardiovascular metrics and systolic blood pressure,” said Ryder. “When considering the overall clinical benefit of EndoBarrier treatment with the acceptable risk profile, the data combines to present a positive case for treatment of patients with type 2 diabetes and obesity.”
ABCD Worldwide EndoBarrier Registry
The ABCD¹ Worldwide EndoBarrier Registry, led by Dr. Ryder, collected data from 33 centers in nine countries. As of December 2021, data has been entered on 1001 patients with an increase of 130 patient records since 2019.
The Worldwide EndoBarrier Registry continues to support a positive benefit:risk profile for patients with type 2 diabetes and/or obesity treated with EndoBarrier. Many benefits are seen in patients including considerable improvements in weight, HbA1c, systolic blood pressure and cholesterol as shown below:
| Parameter | n | Baseline | EndoBarrier Explant | Difference | P-value |
|---|---|---|---|---|---|
| Weight (kg) | 792 | 120.2±25.4 | 106.8±24.0 | -13.3±9.7 | <0.001 |
| HbA1c (%) | 632 | 8.4±1.8 | 7.1±1.3 | -1.3±1.5 | <0.001 |
| Systolic BP (mmHg) | 429 | 136.0±18.1 | 130.0±17.1 | -6.2±19.5 | <0.001 |
| Cholesterol (mmol/L) | 448 | 4.9±1.2 | 4.3±1.0 | -0.6±1.0 | <0.001 |
n=patient population
Analysis of the data according to baseline HbA1c is summarized below, clearly showing the higher the baseline HbA1c the greater the impact of EndoBarrier treatment.
| HbA1C Range (%) | n | Baseline | EndoBarrier removal |
Difference | P-value |
|---|---|---|---|---|---|
| All HbA1c | 632 | 8.4±1.8 | 7.1±1.3 | -1.3±1.5 | <0.001 |
| All HbA1c ≥ 7 | 506 | 9.0±1.5 | 7.4±1.2 | -1.6±1.5 | <0.001 |
| All HbA1c ≥ 8 | 365 | 9.5±1.4 | 7.6±1.2 | -1.9±1.5 | <0.001 |
| All HbA1c ≥ 9 | 207 | 10.4±1.3 | 7.9±1.3 | -2.5±1.6 | <0.001 |
| All HbA1c ≥ 10 | 111 | 11.2±1.2 | 8.0±1.5 | -3.2±1.7 | <0.001 |
n=patient population
“All the data submitted from the 33 participating centers will continue to improve our efforts of evaluating the safety and efficacy of EndoBarrier,” said Ryder. “It is imperative for us, as clinicians, to push for new and innovative technologies, like EndoBarrier, to provide this patient population with alternative ways to help treat or manage their uncontrolled type 2 diabetes and obesity.”
UK 1st National Health Service (NHS) EndoBarrier Service for Uncontrolled Diabesity
In the first NHS EndoBarrier service in the U.K., EndoBarrier was provided to patients with uncontrolled diabesity despite all available standard therapies and monitored in the ABCD Worldwide Registry. Data presented at ADA was for 4-year outcomes for all 62 treated patients, of these 44 (71%) patients attended follow-up.
As seen in the Worldwide registry study, EndoBarrier led to many benefits in those patients with both baseline and explant data (n=42), and 10 of the 29 (34%) insulin treated patients discontinued insulin.
See data below:
| Parameter | Baseline | EndoBarrier Explant | Difference | P-value |
|---|---|---|---|---|
| Weight (kg) | 122.8±29.1 | 105.4±30.6 | -17.3±9.0 | <0.001 |
| HbA1c (%) | 9.1±1.8 | 7.2±1.0 | -1.9±1.8 | <0.001 |
| Systolic BP (mmHg) | 138.8±14.3 | 125.9±14.9 | -12.9±16.3 | <0.001 |
| Cholesterol (mmol/L) | 4.6±1.0 | 3.7±0.7 | -0.9±0.9 | <0.001 |
Analyses show that 75% of patients maintain most of the improvement achieved in response to EndoBarrier treatment with 25% (11/44) reverting to baseline by 3 years after EndoBarrier. Those who deteriorated to baseline reported many problems in their lives and all had depression and/or bereavement and/or major health problems/disability.
Removal of EndoBarrier prior to the full year of treatment due to adverse events or symptoms was realized in 10 of the 62 patients treated. All 10 patients fully recovered after removal and most derived significant benefit.
Commenting on the two data sets displayed at the 2022 meeting of the American Diabetes Associate, Joe Virgilio, President and CEO of GI Dynamics added, “As previously demonstrated, the Worldwide EndoBarrier Registry continues to collect important and valuable data supporting the many potential clinical benefits to patients suffering from uncontrolled type 2 diabetes and/or obesity. Combined with the data emerging from the 1st NHS service in the UK, clinicians may be able to better understand the potential lasting benefits of EndoBarrier for these high-risk patients.”
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
References:
1. Association of British Clinical Diabetologists: https://abcd.care/
