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 Oral Anti-Diabetes Agents

Location:

Rochester, Minn., Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to a treatment group if they qualify for the study. Subjects will receive either a device or sham procedure. Throughout the study glycemic control and various laboratory tests will be evaluated. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement.

Who is eligible to participate?

Inclusion Criteria: - HbA1c ≥ 7.5% and ≤ 10% - BMI ≥ 30 and ≤ 55 Exclusion Criteria: - Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis - C-peptide < 1.0 ng/mL - Previous GI surgery or abnormal GI anatomical finding - Prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent)

Last updated:

10/29/2014

NCT ID:

NCT01728116

IRB Number:

12-007710