Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of a second generation EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes. This is a randomized, controlled study which will enroll approximately 70 Subjects with Type 2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will be offered the EndoBarrier device after 12 months on study at the investigator's discretion if treatment of the device subjects indicates adequate efficacy. This study will be conducted at three (3) investigational sites. The primary efficacy endpoint is: Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline between the two groups. Secondary endpoints are: Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit from baseline. Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or discontinued at week 24 or last visit from baseline. Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from baseline. Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline. Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12 months. Compare physical component summary (PCS), mental component summary (MCS) and quality adjusted life years (QALYs)via analysis of the SF-36v2 QOL.

Detailed Description
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Utilization of the EndoBarrier Gastrointestinal Liner in obese subjects with T2DM demonstrated an acceptable safety profile with clinically significant improvements in glycemic control and body weight when compared to a similar diet controlled group of subjects.

Official Title
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An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrier™ Liner vs. Diet Control for the Treatment of Type 2 Diabetes

Conditions
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Type II Diabetes

Intervention / Treatment
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* Device: EndoBarrier
* Behavioral: Diet + Lifestyle Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years and < 65 years Male or Female Subjects with Type 2 Diabetes who have been treated for ≤10 years BMI> 30 - < 50 Subjects with an HbA1c level > 7.5 and ≤ 10.0% Subjects taking a combination of metformin and sulfonylureas and/or insulin (other than pre-mixed long and short acting insulins, ie. NovoMix 30) Patients willing to comply with study requirements Patients who have signed an informed consent form Exclusion Criteria: Subjects taking oral medications to control their diabetes other than sulfonylureas and metformin Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis Subjects on insulin > 10 years Subjects requiring insulin > 70 units per day Subjects on pre-mixed insulin (ie. NovoMix 30)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>EndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted. | Device: EndoBarrier<br>* EndoBarrier implant<br>Behavioral: Diet + Lifestyle Counseling<br>* Multidisciplinary lifestyle and nutritional counseling<br>|
| Active Comparator: Diet + Lifestyle counseling<br>Multidisciplinary lifestyle and nutritional counseling for 12 months | Behavioral: Diet + Lifestyle Counseling<br>* Multidisciplinary lifestyle and nutritional counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type II Diabetes, Obesity