Medical device company GI Dynamics Inc (ASX:GID) said on Tuesday that it plans to study the safety and efficacy of EndoBarrier in India under a joint collaboration with Apollo Sugar, a collaboration between Apollo Health & Lifestyle Limited and Sanofi.
The EndoBarrier is an endoscopically delivered device therapy for the treatment of type 2 diabetes and obesity developed by GI Dynamics Inc.
Pending appropriate regulatory submissions and approvals, the partnership plans to launch a clinical trial, under which, 100 patients will be randomised into 75 EndoBarrier and 25 control patients in a three to one ratio. The trial will focus on the reduction of haemoglobin A1c for patients diagnosed with type 2 diabetes and obesity.
Subject to GI Dynamics raising additional capital, the enrolment is expected to commence in the first half of 2019 and conclude by the end of the third quarter of 2019.
This joint partnership will focus on the marketing, distribution and clinical support of EndoBarrier to appropriate patients throughout India and Southeast Asia, subject to negotiation. This initiative aims to reach out to the larger population and address the ever-increasing health concerns of type 1 and type 2 diabetes, gestational diabetes and pre-diabetes populations with specialised and comprehensive multidisciplinary integrated care models that are personalised, intensive and proven to deliver results.
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