GI Dynamics Announces Approval of the I-STEP Clinical Study in India
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Monday, January 31, 2022
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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 that it has received regulatory approval to begin enrollment in the I-STEP clinical trial in India.
Key Points:
- 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 that it has received regulatory approval to begin enrollment in the I-STEP clinical trial in India.
- This study, which is intended to follow 100 subjects up to 24 months, will evaluate EndoBarrier in patients who fall within a predetermined hemoglobin A1c range.
- 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.
- 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.