GI Dynamics gains approval to begin I-STEP clinical study in India

GI Dynamics has received regulatory approval to begin enrolment in the I-STEP clinical trial in India. I-STEP is a multi-centre, randomised, pivotal study evaluating the safety and efficacy of EndoBarrier for glycaemic improvement in patients with inadequately controlled type 2 diabetes and obesity and will be conducted exclusively in partnership with the Apollo Hospital System and Apollo Sugar Clinics. The EndoBarrier System is an endoscopically delivered device therapy which offers a non-surgical, alternative treatment for the treatment to type 2 diabetes and obesity.

This study, which is intended to follow 100 subjects up to 24 months, will evaluate EndoBarrier in patients who fall within a predetermined haemoglobin A1c range. All enrolled patients will follow a moderate intensity lifestyle and receive dietary counselling, along with standard practice medication management.


Diabetes has become a significant health problem in India, with nearly 74 million people suffering from the condition and a proportion of the population that has been undiagnosed. The number of people with diabetes in India is expected to grow to 125 million by 2045, according to the IDF Diabetes Atlas 2021 (10th Edition).


Obesity is a leading factor for type 2 diabetes, and worryingly, the prevalence of obesity in India is increasing faster than the world average (Luhar S et al. Forecasting the prevalence of overweight and obesity in India to 2040. PLoS ONE 2020;15(2)). According to an ICMR-INDIAB study, the prevalence rate of obesity and central obesity vary from 11.8% - 31.3% and 16.9% - 36.3%, respectively (Ahirwar R et al. 2018. Prevalence of obesity in India: A systematic review. Diabetes Metab Syndr 2018;13(1):318-321).


Apollo Sugar is a collaboration between Apollo Health & Lifestyle Limited and Sanofi. Apollo Sugar is a division of Apollo Hospitals Group (Apollo), focused on the treatment of metabolic disorders, and operates an integrated network of centres of excellence for diabetes, obesity and endocrinology.


“Apollo Sugar is pleased to partner with GI Dynamics to study EndoBarrier as an innovative means of treating patients diagnosed with type 2 diabetes and obesity. We at Apollo Hospitals have always focused on providing advanced, safe, and effective treatments to our patients,” said Anand P Wasker, Chief Executive Officer of Apollo Sugar. “We believe that 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.”


In addition to partnership in the I-STEP clinical trial, 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.


“As the incidence and risks of type 2 diabetes and obesity continue to increase throughout the globe, we see the I-STEP trial as an important step towards offering patients and clinicians another safe and effective treatment option,” added Joe Virgilio, President and CEO of GI Dynamics. “Through this partnership with Apollo Sugar, access to this therapy has the potential to significantly improve the disease management of millions of patients throughout India.”


EndoBarrier is not approved for sale in the US and is limited by federal law to investigational use only.