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

A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes

The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.

The study was designed as a randomized, single blind, sham controlled, pilot efficacy study of subjects with Type 2 diabetes enrolled at 2 centers in Santiago, Chile. Subjects were enrolled at a 2:1 ratio (EndoBarrier to sham). Following implantation or sham procedure, subjects were treated for 24 weeks or 52 weeks. Following explant, subjects were followed for an additional 8-12 weeks.

Subject evaluations included measurements of HbA1c, glucose, insulin, weight, changes in diabetic medications, and meal tolerance tests. Safety was monitored through the collection of clinical labs, physical assessments, endoscopy and adverse events.

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)