A Study of the GI Sleeve for the Treatment of Type 2 Diabetes

Inclusion Criteria: * Age \> 18 years and \< 55 years - Male or Female * Patients with type 2 diabetes, treated for 10 years or less * HbA1c level ≥ 7.0 and ≤ 10.0% * Fasting glucose ≤ 240 mg/dl * Patients taking metformin, sulfonylureas or thiazolidinediones (TZDs), either alone or in combination * BMI \> 30 and \<50 * Patients willing to comply with study requirements * Patients who have signed an informed consent form * Women who are post-menopausal, surgically sterile, or on oral contraceptives for at least three months and who do not plan on becoming pregnant during the course of the study. Exclusion Criteria: * Patients taking oral medications to control their diabetes other than sulfonylureas, metformin or thiazolidinediones * Patients diagnosed with type 1 diabetes mellitus or had a history of ketoacidosis * Patients requiring insulin * Patients with lab evidence of probable insulin production failure (fasting C peptide serum level \< 1ng/ml) * Patients with a weight loss of \> 10 lbs within the three months of screening * Patients requiring prescription anticoagulation therapy * Patients with iron deficiency and iron deficiency anemia * Patients with a history of abnormal pathologies of the GI tract * Patients with known gallstones or kidney stones prior to implant * Known infection at the time of implant * Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia * Pregnant or has the intention of becoming pregnant in the next 12 months * Patients with a history of active kidney stones * Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial * Previous GI surgery that could affect the ability to place the sleeve or the function of the implant * Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period * H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated) * Patients receiving weight loss medications such as Meridia and Xenical * Family or patient history of a known diagnosis or pre-existing symptom of systemic lupus erythematous, scleroderma or other autoimmune connective tissue disorder * Patients with Gastrointestinal Reflux Disease (GERD) * Participating in another ongoing investigational clinical trial * Patients taking corticosteroids or drugs known to affect gastrointestinal motility (such as reglan)