Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese

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.

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)