India Regulators Approve GI Dynamic’s I-STEP Clinical Study

GI Dynamics Inc. is enrolling patients in India for its I-STEP clinical trial.
 
Having received approval from Indian regulators, I-STEP is a multi-center, randomized, pivotal study evaluating the safety and efficacy of EndoBarrier for glycemic improvement in patients with inadequately controlled type 2 diabetes and obesity. The trial will be conducted exclusively in partnership with the Apollo Hospital System and Apollo Sugar Clinics. The study will follow 100 subjects up to 24 months, and will evaluate EndoBarrier in patients who fall within a predetermined hemoglobin A1c range. All enrolled patients will follow a moderate intensity lifestyle and receive dietary counseling, along with standard practice medication management.

“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. 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,” stated Joe Virgilio, president and CEO of GI Dynamics.
 
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 2045.¹
 
Obesity is a leading factor for type 2 diabetes, and worryingly, the prevalence of obesity in India is increasing faster than the world average.² According to an ICMR-INDIAB study, the prevalence rate of obesity and central obesity vary from 11.8 percent to 31.3 percent and 16.9 percent to 36.3 percent, respectively.³

“Apollo Sugar is pleased to partner with GI Dynamics to study EndoBarrier as a 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. We believe that EndoBarrier can provide a powerful clinical tool for our clinicians, and we look forward to studying EndoBarrier in our hospitals, for patients based in India and Southeast Asia,” Apollo Sugar CEO Anand P. Wasker said.
 
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.

Apollo Sugar is a collaboration between Apollo Health & Lifestyle Limited and Sanofi Ltd.. 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 Sugar is a single-specialty diabetes and endocrine healthcare service provider, formed as a collaboration between Apollo Health & Lifestyle and Sanofi Ltd. 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 ever-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.
 
GI Dynamics Inc. developed the EndoBarrier System, an endoscopically delivered device therapy which offers a non-surgical, alternative treatment for the treatment to 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, Mass.
 
References
¹ IDF Diabetes Atlas 2021, 10th Edition.
² Luhar S et al. Forecasting the prevalence of overweight and obesity in India to 2040. PLoS ONE 2020;15(2).
³ Ahirwar R et al. 2018. Prevalence of obesity in India: A systematic review. Diabetes Metab Syndr 2018;13(1):318-321.