GI Dynamics Announces an Update to the Worldwide Registry Data for 1,022 Patients Recently Published in Diabetes Care, the Journal of the American Diabetes Association

Data demonstrate favorable safety and efficacy profile for the duodenal jejunal bypass liner (DJBL) technology

BOSTON–(BUSINESS WIRE)–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 Ranges (%)

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.

Contacts

GI Dynamics Media Contact:
Joseph Virgilio

[email protected]
(781) 357-3296

Subscribe on LinkedIn

Get the free newsletter

Subscribe to MedicaEx for top news, trends & analysis

We're committed to your privacy. MedicaEx uses the information you provide to us to contact you about our relevant content, products, and services. You may unsubscribe from these communications at any time. For more information, check out our Privacy Policy.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Businesswire is solely responsible for the content of the above news submissions. If there are any violations of laws, violations of the membership terms of this website, or the risk of infringing on the rights of third parties, businesswire will be solely responsible for legal and damage compensation. Responsibility has nothing to do with MedicaEx.

Are you in?

Subscribe to receive exclusive content and notifications to your inbox

We're committed to your privacy. MedicaEx uses the information you provide to us to contact you about our relevant content, products, and services. You may unsubscribe from these communications at any time. For more information, check out our Privacy Policy.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.