{"id":46181,"date":"2022-07-14T16:02:37","date_gmt":"2022-07-14T14:02:37","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/gi-dynamics-announces-the-presentation-of-updated-data-sets-at-the-2022-meeting-of-the-american-diabetes-association\/"},"modified":"2022-07-14T16:02:37","modified_gmt":"2022-07-14T14:02:37","slug":"gi-dynamics-announces-the-presentation-of-updated-data-sets-at-the-2022-meeting-of-the-american-diabetes-association","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/gi-dynamics-announces-the-presentation-of-updated-data-sets-at-the-2022-meeting-of-the-american-diabetes-association\/","title":{"rendered":"GI Dynamics Announces the Presentation of Updated Data Sets at the 2022 Meeting of the American Diabetes Association"},"content":{"rendered":"
\n

\nData demonstrate favorable safety and efficacy profile for the duodenal jejunal bypass liner (DJBL) technology<\/i>\n<\/p>\n

BOSTON–(BUSINESS WIRE)–GI Dynamics\u00ae Inc.<\/a>, a medical device company that is developing EndoBarrier\u00ae 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.\n<\/p>\n

<\/a><\/p>\n

\n\u201cIn 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,\u201d said Ryder. \u201cWhen 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.\u201d\n<\/p>\n

\nABCD Worldwide EndoBarrier Registry
\n
<\/b>The ABCD1<\/sup> 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.\n<\/p>\n

\nThe 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:\n<\/p>\n\n\n\n\n\n\n
\n

\nParameter<\/b>\n<\/p>\n<\/td>\n

\n

\nn<\/b>\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\nBaseline<\/b>\n<\/p>\n<\/td>\n

\n

\nEndoBarrier Explant<\/b>\n<\/p>\n<\/td>\n

\n

\nDifference<\/b>\n<\/p>\n<\/td>\n

\n

\nP-value<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nWeight (kg)\n<\/p>\n<\/td>\n

\n

\n792\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n120.2\u00b125.4\n<\/p>\n<\/td>\n

\n

\n106.8\u00b124.0\n<\/p>\n<\/td>\n

\n

\n-13.3\u00b19.7\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHbA1c (%)\n<\/p>\n<\/td>\n

\n

\n632\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n8.4\u00b11.8\n<\/p>\n<\/td>\n

\n

\n7.1\u00b11.3\n<\/p>\n<\/td>\n

\n

\n-1.3\u00b11.5\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nSystolic BP (mmHg)\n<\/p>\n<\/td>\n

\n

\n429\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n136.0\u00b118.1\n<\/p>\n<\/td>\n

\n

\n130.0\u00b117.1\n<\/p>\n<\/td>\n

\n

\n-6.2\u00b119.5\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nCholesterol (mmol\/L)\n<\/p>\n<\/td>\n

\n

\n448\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n4.9\u00b11.2\n<\/p>\n<\/td>\n

\n

\n4.3\u00b11.0\n<\/p>\n<\/td>\n

\n

\n-0.6\u00b11.0\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nn=patient population<\/i>\n<\/p>\n

\n<\/div>\n

\nAnalysis of the data according to baseline HbA1c is summarized below, clearly showing the higher the baseline HbA1c the greater the impact of EndoBarrier treatment.\n<\/p>\n\n\n\n\n\n\n\n
\n

\nHbA1C Range (%)<\/b>\n<\/p>\n<\/td>\n

\n

\nn<\/b>\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\nBaseline<\/b>\n<\/p>\n<\/td>\n

\n

\nEndoBarrier
\n
removal<\/b>\n<\/p>\n<\/td>\n

\n

\nDifference<\/b>\n<\/p>\n<\/td>\n

\n

\nP-value<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c\n<\/p>\n<\/td>\n

\n

\n632\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n8.4\u00b11.8\n<\/p>\n<\/td>\n

\n

\n7.1\u00b11.3\n<\/p>\n<\/td>\n

\n

\n-1.3\u00b11.5\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c \u2265 7\n<\/p>\n<\/td>\n

\n

\n506\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n9.0\u00b11.5\n<\/p>\n<\/td>\n

\n

\n7.4\u00b11.2\n<\/p>\n<\/td>\n

\n

\n-1.6\u00b11.5\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c \u2265 8\n<\/p>\n<\/td>\n

\n

\n365\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n9.5\u00b11.4\n<\/p>\n<\/td>\n

\n

\n7.6\u00b11.2\n<\/p>\n<\/td>\n

\n

\n-1.9\u00b11.5\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c \u2265 9\n<\/p>\n<\/td>\n

\n

\n207\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n10.4\u00b11.3\n<\/p>\n<\/td>\n

\n

\n7.9\u00b11.3\n<\/p>\n<\/td>\n

\n

\n-2.5\u00b11.6\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c \u2265 10\n<\/p>\n<\/td>\n

\n

\n111\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

\n11.2\u00b11.2\n<\/p>\n<\/td>\n

\n

\n8.0\u00b11.5\n<\/p>\n<\/td>\n

\n

\n-3.2\u00b11.7\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nn=patient population<\/i>\n<\/p>\n

\n\u201cAll the data submitted from the 33 participating centers will continue to improve our efforts of evaluating the safety and efficacy of EndoBarrier,\u201d said Ryder. \u201cIt 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.\u201d\n<\/p>\n

\nUK 1st National Health Service (NHS) EndoBarrier Service for Uncontrolled Diabesity
\n
<\/b>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.\n<\/p>\n

\nAs 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:\n<\/p>\n\n\n\n\n\n\n
\n

\nParameter<\/b>\n<\/p>\n<\/td>\n

\n

\nBaseline<\/b>\n<\/p>\n<\/td>\n

\n

\nEndoBarrier Explant<\/b>\n<\/p>\n<\/td>\n

\n

\nDifference<\/b>\n<\/p>\n<\/td>\n

\n

\nP-value<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nWeight (kg)\n<\/p>\n<\/td>\n

\n

\n122.8\u00b129.1\n<\/p>\n<\/td>\n

\n

\n105.4\u00b130.6\n<\/p>\n<\/td>\n

\n

\n-17.3\u00b19.0\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHbA1c (%)\n<\/p>\n<\/td>\n

\n

\n9.1\u00b11.8\n<\/p>\n<\/td>\n

\n

\n7.2\u00b11.0\n<\/p>\n<\/td>\n

\n

\n-1.9\u00b11.8\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nSystolic BP (mmHg)\n<\/p>\n<\/td>\n

\n

\n138.8\u00b114.3\n<\/p>\n<\/td>\n

\n

\n125.9\u00b114.9\n<\/p>\n<\/td>\n

\n

\n-12.9\u00b116.3\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nCholesterol (mmol\/L)\n<\/p>\n<\/td>\n

\n

\n4.6\u00b11.0\n<\/p>\n<\/td>\n

\n

\n3.7\u00b10.7\n<\/p>\n<\/td>\n

\n

\n-0.9\u00b10.9\n<\/p>\n<\/td>\n

\n

\n<0.001\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nAnalyses 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.\n<\/p>\n

\nRemoval 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.\n<\/p>\n

\nCommenting on the two data sets displayed at the 2022 meeting of the American Diabetes Associate, Joe Virgilio, President and CEO of GI Dynamics added, \u201cAs 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 1 NHS service in the UK, clinicians may be able to better understand the potential lasting benefits of EndoBarrier for these high-risk patients.\u201d\n<\/p>\n

\nAbout GI Dynamics<\/b>\n<\/p>\n

\nGI Dynamics Inc.<\/a> 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.\n<\/p>\n

\nFounded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information, please visit gidynamics.com or follow us on Twitter<\/a> and LinkedIn<\/a>.\n<\/p>\n\n\n\n
\n

\nReferences:\n<\/p>\n<\/td>\n<\/tr>\n

\n
    \n
  1. \nAssociation of British Clinical Diabetologists: https:\/\/abcd.care\/<\/a>\n<\/li>\n<\/ol>\n<\/td>\n<\/tr>\n<\/table>\n

    \n\u00a0\n<\/p>\n

    Contacts<\/b> <\/p>\n

    \nGI Dynamics Media Contact:<\/b>\n<\/p>\n

    \nJoseph Virgilio
    \n
    jvirgilio@gidynamics.com<\/a>
    (781) 357-3296\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Data demonstrate favorable safety and efficacy profile for the duodenal jejunal bypass liner (DJBL) technology BOSTON–(BUSINESS WIRE)–GI Dynamics\u00ae Inc., a medical device company that is developing EndoBarrier\u00ae 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 … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-46181","format-standard","category-industry"],"yoast_head":"\nGI Dynamics Announces the Presentation of Updated Data Sets at the 2022 Meeting of the American Diabetes Association - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/gi-dynamics-announces-the-presentation-of-updated-data-sets-at-the-2022-meeting-of-the-american-diabetes-association\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GI Dynamics Announces the Presentation of Updated Data Sets at the 2022 Meeting of the American Diabetes Association - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Data demonstrate favorable safety and efficacy profile for the duodenal jejunal bypass liner (DJBL) technology BOSTON–(BUSINESS WIRE)–GI Dynamics\u00ae Inc., a medical device company that is developing EndoBarrier\u00ae 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 ... 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