GI Dynamics has announced the first patient has been treated in the India as part of the company’s I-STEP clinical study, which is focusing on the reduction of haemoglobin A1c for patients diagnosed with type 2 diabetes and obesity. The patient was treated at Apollo Speciality Hospital in Chennai, India, with the company’s EndoBarrier System, an endoscopically delivered device therapy which offers a non-surgical, alternative treatment for the treatment of type 2 diabetes and obesity. This is the first of 100 patients who are expected to be enrolled into the I-STEP trial.
I-STEP is a multi-centre, randomised (3 EndoBarrier: 1 Control), controlled, pivotal trial designed to evaluate the safety and efficacy of EndoBarrier for glycaemic improvement in patients with inadequately controlled type 2 diabetes and obesity. All enrolled patients will fall within a predetermined haemoglobin A1c range, follow a moderate intensity lifestyle, and receive dietary counselling along with standard practice medication management.
The I-STEP trial’s lead investigators are Dr K S Soma Sekhar Rao, Consultant Gastroenterologist and Hepatologist in the Department of Medical Gastroenterology and Hepatology at Apollo Hospital, Jubilee Hills, Hyderabad, and Dr Usha Ayyagari, Senior Consultant Endocrinologist, Apollo Speciality Hospital, OMR, Chennai. The four clinical trial sites include Apollo Hospitals/Apollo Sugar Clinics in Chennai, Hyderabad, Mumbai, and Bangalore.
“As a pioneer in healthcare in India, we are always looking for new treatments and providing the best healthcare in the world to our patients,” said Dr Soma Sekhar Rao. “EndoBarrier is a promising new treatment for our growing type 2 diabetes and obesity population which addresses both high haemoglobin A1c levels and weight, and we look forward to gathering data in the I-STEP trial.”
“We have taken a first step forward for a newer option/medical device, EndoBarrier for high BMI type 2 diabetes patients,” said Dr Harpal Singh Malhotra, Head, Medical Services, Apollo Sugar Clinics. “We are glad that obese diabetic patients can choose an option before Bariatric Surgery and have another option in general which shall help them to reduce weight and cut down on their medication as well as maintaining HbA1c in a normal range.”
“We are very excited to be able to offer EndoBarrier treatment to patients in India via the I-STEP Clinical Trial. Apollo has proven to be a very collaborative partner and their innovative approach to treating patients should serve to accelerate access to new technologies like EndoBarrier,” said Joe Virgilio, President and Chief Executive Officer of GI Dynamics. “Given the widespread incidence of type 2 diabetes and obesity throughout the country, there appears to be a significant need for alternative treatments for patients who, in particular, struggle to control their HbA1c.”
EndoBarrier is not approved for sale in the US and is limited by federal law to investigational use only.