A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Metformin and/or Sulfonylurea Anti-Diabetes Agents
||Aida Saliby, MD
||David Carr-Locke, MD
frame of study:
||Mount Sinai Beth Israel
name, number and email
Kamala Mantha-Thaler at 212-420-3569
This study is being run in coordination with the division of Endocrinology (the Friedman Diabetes Institute). The purpose of the study is to evaluate the safety and effectiveness of a new device called the EndoBarrier Gastrointestinal Liner System on controlling blood sugar in research subjects. The device is placed in the intestine through a small tube that is inserted through the mouth. There are no incisions or scars. The device acts as a physical barrier between food and that part of the intestine wall where the medical device is present. The researchers will examine the change in blood sugar from before the liner is in place, until one year after (52 weeks). Participants will be randomized to either the device or the sham group (no device) in a 2:1 ratio. Patients given the sham will not receive the device but will be given an opportunity to have it after the study is complete under a different research study. All patients will be followed for 52 weeks. Those randomized to the device group will have the device removed at week 52, and will come in for additional follow-up visits to assess treatment effect and safety. Compensation for participation in this study is provided, and the costs for all required research procedures are covered by the sponsor GI Dynamic.
- At least 18 years of age
- Type 2 diabetes that is not adequately controlled with standard therapies. care
For additional information, or to participate, please contact Kamala Mantha-Thaler at 212-420-3569 or firstname.lastname@example.org.