Obesity Clinical Trial
Official title:
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier® System for Glycemic Improvement in Patients With Inadequately Controlled Type 2 Diabetes and Obesity
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the EndoBarrier System plus moderate intensity lifestyle and dietary counseling compliant with 2019 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (EndoBarrier):1 (Sham).
The objective of this study is to evaluate the safety and effectiveness of the EndoBarrier System when used with moderate intensity lifestyle and dietary counseling and medical management, in patients with baseline HbA1c ≥ 8.0% and ≤10%, and BMI ≥ 30 kg/m2 and ≤ 50kg/m2, whose diabetes medications consist of at least dual therapy for 3 months, excluding insulin, yet have not achieved adequate HbA1c control (<7%). Specific objectives of this study are: 1. To determine if the EndoBarrier System significantly improves glycemic control 2. To determine that the EndoBarrier System can be safely used to improve glycemic control ;
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