Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner

Study Overview
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Brief Summary
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The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.

Detailed Description
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Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' EndoBarrier represents a viable alternative to other short-term pre-surgical weight loss methods. EndoBarrier is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality

Official Title
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Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Device: EndoBarrier Gastrointestinal Liner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects Age > 18 years and ≤65 years - Male or Female Subjects with Type 2 Diabetes > 1 and ≤ 10 years in duration Subjects with an Hb A1c level > 7.5 and ≤ 10.0 Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required. Subjects with a BMI > 30 and< 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 contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study. Exclusion Criteria: Subjects taking Inhibitors of dipeptidyl peptidase 4 inhibitors (ie. Januvia (sitagliptin), Galvus (vildagliptin) or incretins (ie. Byetta (exenatide), Victoza (liraglutide) Subjects requiring insulin >150 units per day • Subjects with probable insulin production failure (fasting C Peptide serum <1.0 ng/mL) Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis Subjects requiring NSAIDs (non-steroidal anti-inflammatory drugs) or prescription anticoagulation therapy during the implant period 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 study participation Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated. If Subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enroll to the study.) 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 gastroesophageal reflux disease (GERD) Subjects with severe liver or kidney failure (serum creatinine >180mmol/l) Subjects with poor dentition who can not adequately chew their food

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Device<br> | Device: EndoBarrier Gastrointestinal Liner<br>* EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (%) Measured at Week 52 |  | 12 months | 
| Total Weight Change From Baseline to Week 52 | Total weight change at 12 months (kg) compared to baseline | 12 months | 
| Changes in Diabetic Medications at Treatment Completion Compared to Baseline | number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion) | 12 months | 
| Change From Baseline in SF 36v2 Quality of Life Assessment | Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case. | Baseline, 12 months (explant), 6 months post explant (18 months post baseline) |