Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

Study Overview
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Brief Summary
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The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.

Official Title
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A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: EndoBarrier Liner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects Age > 18 years and ≤ 55 years Male or Female Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications Subjects with an HbA1C > 7.5 and ≤ 10.0% Subjects with a BMI > 26 - < 50 Subjects willing to comply with study requirements Subjects who have signed an informed consent form Women who are post-menopausal, surgically sterile or on oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial. Exclusion Criteria: Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis Subjects requiring insulin Subjects with probable insulin production failure (fasting C Peptide serum <1ng/mL) Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening Subjects requiring prescription anticoagulation therapy Subjects with or a history of iron deficiency and/or iron deficiency anemia Subjects with or a history of abnormalities of the GI tract Subjects with symptomatic gallstones or kidney stones at the time of screening Subjects with a known infection Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia Subjects 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 participation Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated) Subjects receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder Subjects with active and uncontrolled GERD Subjects with a known history of substance abuse Subjects participating in another ongoing investigational clinical trial Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes<br>Single Arm | Device: EndoBarrier Liner<br>* 52 week treatment of EnoBarrier Liner<br>* Other names: GI Sleeve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Glycemic Control (HbA1c) Over Time | HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12 | Baseline to 12 Months with device implanted | 
| Change in Anti-diabetes Medications | Medications were classified as increased if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as decreased if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as not assessable. | Baseline to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Weight Change (kg) at Week 52 Compared to Baseline Weight |  | Baseline to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Weight Loss, GI Dynamics, EndoBarrier