Trial to focus on reduction of hemoglobin A1c for patients diagnosed with type 2 diabetes and obesity
BOSTON & HYDERABAD, India–(BUSINESS WIRE)– GI Dynamics Inc., a medical device company that is developing the EndoBarrier® System for patients diagnosed with type 2 diabetes and obesity, is pleased to announce the first patient in the India I-STEP clinical study has been treated at Apollo Speciality Hospital in Chennai, India in January.
Apollo Speciality Hospital, OMR, Chennai, is one of four clinical study sites and is led by Dr. Usha Ayyagari, MBBS, MRCP (UK), MRCPE (Edin), CCT (Oxford, UK), FRCP (London), FRCPE (Edin), Senior Consultant in Diabetes and Endocrinology, and Dr. Bharath Kumar Mookiah, MBBS, MD, MRCP (UK), DNB, Consultant Gastroenterologist.
“I am honored and delighted to be the first site to enroll participants into the I-STEP clinical trial,” said Dr. Ayyagari. “The twin epidemics of diabetes and obesity, with the consequent co-morbidity, affect a significant proportion of Indians, usually at a younger age. We believe that EndoBarrier is a novel and powerful clinical tool for us to treat individuals with type 2 diabetes and obesity.” The implanting Gastroenterologists were Dr. Barath Kumar Mookiah and Dr. Ubal Dhus.
I-STEP is a multi-center, randomized (3 EndoBarrier: 1 Control), controlled, pivotal trial of EndoBarrier in India. The trial is designed to evaluate the safety and efficacy of EndoBarrier for glycemic improvement in patients with inadequately controlled type 2 diabetes and obesity. All enrolled patients will fall within a predetermined hemoglobin A1c range, follow a moderate intensity lifestyle, and receive dietary counseling along with standard practice medication management.
The I-STEP trial’s lead investigators are Dr. K. S. Soma Sekhar Rao, MBBS, MD, DM, 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 hemoglobin A1c levels and weight, and we look forward to gathering data in the I-STEP trial.”
Dr. Harpal Singh Malhotra, Head, Medical Services, Apollo Sugar Clinics said, “We have taken a first step forward for a newer option/medical device, EndoBarrier for high BMI type 2 diabetes patients. 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.”
This is the first of 100 patients whom we expect to be enrolled into the I-STEP trial. Patients treated with EndoBarrier will receive diabetes medication monitoring and counseling throughout the 24-month study period.
Commenting on the collaboration, Joe Virgilio, President and Chief Executive Officer of GI Dynamics said, “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. 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.”
About GI Dynamics
GI Dynamics Inc. is the developer of the EndoBarrier® System, an endoscopically delivered device therapy which offers a non-surgical, alternative treatment for the treatment of 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.