GI Dynamics has obtained regulatory approval to commence enrolment in the I-STEP clinical trial of its EndoBarrier System in India.
EndoBarrier is an endoscopically delivered device therapy that is designed to treat type 2 diabetes and obesity.
The randomised, multi-centre, pivotal I-STEP trial will be conducted in partnership with the Apollo Hospital System and Apollo Sugar Clinics.
In the study, EndoBarrier’s efficacy and safety will be assessed for glycemic improvement in patients with inadequately controlled type 2 diabetes and obesity.
The company stated that the I-STEP trial will follow 100 participants with a predetermined hemoglobin A1c range for 24 months.
The patients enrolled in the study will receive dietary counselling and standard practice medication management while following a moderate intensity lifestyle,
GI Dynamics president and CEO Joe Virgilio said: “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.”
Apollo Hospitals Group’s unit Apollo Sugar is a collaboration between Apollo Health & Lifestyle and Sanofi.
With a focus on metabolic disorders treatment, the healthcare provider operates a network of centres for obesity, endocrinology and diabetes.
Apollo Sugar and GI Dynamics have also agreed to form a joint partnership for distributing, selling and providing clinical support for the EndoBarrier system to patients in Southeast Asia and India.
Subject to negotiation, the final terms of the proposed partnership will be disclosed upon completion.