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Trial to focus on reduction of hemoglobin A1c for patients diagnosed with type 2 diabetes and obesity.
January 16, 2019
By: Business Wire
GI Dynamics Inc., a medical device company developing EndoBarrier for patients diagnosed with type 2 diabetes and obesity, has entered today into an agreement with Apollo Sugar1 to jointly study the safety and efficacy of EndoBarrier in India. Apollo Sugar is a collaboration between Apollo Health & Lifestyle Limited and Sanofi.2 Apollo Sugar is a division of Apollo Hospitals Group (Apollo) focused on the treatment of metabolic disorders and operates an integrated network of centers of excellence for diabetes, obesity and endocrinology. Apollo is the largest hospital system in India and has emerged as Asia’s foremost integrated healthcare services provider, maintaining a robust presence of hospitals, pharmacies, primary care and diagnostic clinics across the healthcare ecosystem. Since its inception, Apollo has treated over 65 million patients from 141 countries. Commenting on the collaboration, Apollo Sugar CEO Gagan Bhalla said, “Apollo Sugar is pleased to work with GI Dynamics to study EndoBarrier as a means of treating patients diagnosed with type 2 diabetes and obesity. Apollo Hospitals have always focused on providing advanced, safe and effective treatments to its patients. We believe EndoBarrier can provide a novel and powerful clinical tool for our clinicians, and we look forward to studying EndoBarrier in our hospitals for patients based in India and Southeast Asia.” The agreement between Apollo Sugar and GI Dynamics provides for the commencement of a clinical trial, pending appropriate regulatory submissions and approvals, that consists of 100 patients randomized into 75 EndoBarrier and 25 control patients with a three-to-one ratio. Subject to GI Dynamics raising additional capital, enrollment is expected to commence in the first half of 2019 and conclude by the end of the third quarter of 2019. GI Dynamics and Apollo Sugar have agreed to work toward setting the terms of a joint partnership that will focus on the marketing, distribution and clinical support of EndoBarrier to appropriate patients throughout India and Southeast Asia. Final terms of the proposed collaboration are subject to negotiation and will be disclosed upon completion. GI Dynamics CEO Scott Schorer said, “We are pleased to announce this clinical trial as a first part of a partnership with Apollo Sugar to study EndoBarrier in India. We look forward to working closely with the clinical team at Apollo Sugar to first study the safety and efficacy of EndoBarrier in the region and then supply EndoBarrier to appropriate patients within the region.” Apollo Sugar is a single-specialty diabetes and endocrine healthcare service provider formed as a collaboration between Apollo Health & Lifestyle and Sanofi. Recognizing the epidemic scale and complications of this disease in the region, the Apollo Hospitals Group created the Apollo Sugar model. This initiative aims to reach out to the larger population and address the increasing health concerns of type 1 and type 2 diabetes, gestational diabetes and prediabetes populations with specialized and comprehensive multidisciplinary integrated care models that are personalized, intensive and proven to deliver results. This proven model of success aims to provide patients with accessible care for diabetes and continues to expand its network across India. Apollo Sugar’s mission is to touch the lives of 1 million diabetic patients and make diabetes “disease free” by delivering the best outcomes via a proven, patient-centric care model that combines comprehensive clinical care with sustained lifestyle management and behavioral modification in the individual. GI Dynamics Inc. is the developer of EndoBarrier, an endoscoapically delivered device therapy for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale and is limited by federal law to investigative use only. Founded in 2003, GI Dynamics is headquartered in Boston, Mass. References 1. Apollo Sugar Clinics (apollosugar.com), a division of Apollo Hospitals Group (apollohospitals.com) 2. Sanofi (sanofi.com)
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