A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier [?] Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Metformin and/or Sulfonylurea Anti-Diabetes Agents
a fundamental design feature of the endoBarrier Liner is its reversibility design feature. The device can easily be removed endoscopically. Because of the option for its removal, use of the endoBarrier Liner device could be discontinued at any point in time during the 12 month target duration. This is a key aspect of its use that serves to potentially lower the severity and consequence of adverse events overall and, particularly, the profile of adverse events in comparison with permanent bariatric surgical procedures. in spite of this option for easy removal, the majority of subjects in the pilot clinical trials have completed the full period of endoBarrier implantation.
The endoBarrier Liner offers an approach to the management of blood glucose control in obese type 2 diabetics that is minimally invasive and reversible. it is designed to provide a novel mechanism for improving glycemic control and simultaneously achieving significant weight loss as well as some improvement in select cardio-metabolic parameters. These substantial benefits in an obese type 2 diabetic population that commonly does not achieve accepted targets for glycemic control with current therapies, together with an overall favorable safety profile, result in a risk-benefit profile for the endoBarrier Liner that warrants the advancement of clinical evaluation of the endoBarrier device from pilot phase to pivotal study.
This is a randomized; double blinded, sham-controlled study in obese adults with type 2 diabetes who are taking metformin, and/or a sulfonylurea, but have not achieved adequate glycemic control after a minimum of 3 months treatment at a required dose. The duration of the study is 18 months (78 weeks) for device subjects and 12 months for sham subjects. The first 12 months (52 weeks) are blinded and the primary endpoints are assessed at 12 months post-procedure.
* Mean change in Hba1c value from baseline to 12 months (52 weeks). a superiority margin of 0.4% Hba1c change from baseline to 12 months (52 weeks) for endoBarrier over sham control must be demonstrated in the modified intent-to-Treat population (miTT).
* The incidence of device related serious adverse events (Sae) requiring an early removal shall be demonstrated to be [Less Than] 15% in the modified intent-to-Treat population (miTT). a Clinical events Committee (CeC) will make the decisions on the primary safety endpoint.
The following secondary endpoints shall be statistically tested for potential labeling claims:
* Proportion of subjects who achieve an Hba1c value of [Less Than] 7 % at 12 months (52 weeks).
* Proportion of subjects who achieve percent total body weight loss [GreaterThanorequalTo] 5% at 12 months (52 weeks).
* assessment of total cholesterol at 12 months (52 weeks), compared to baseline.
* assessment of LDL at 12 months (52 weeks), compared to baseline.
assessment of triglycerides at 12 months (52 weeks), compared to baseline.
The following secondary endpoints shall be collected and evaluated to characterize product
* assessment of systolic and diastolic blood pressure values at 12 months (52 weeks), compared to baseline.
* assessment of fasting blood glucose values at 12 months (52 weeks), compared to baseline.
* Quality of Life using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and weight impact validated questionnaire impact of Weight on Quality of Life (iWQoL-lite) at 6 months (26 weeks), 12 months (52 weeks) post procedure compared to baseline and at 18 months (78 weeks) in subjects treated with the device in comparison to baseline.
* assessment of the incidence and severity of adverse events. adverse event forms will not be available to the study staff that must remain blinded during the study.
1. Age >=21 years and <= 65 years
2. Have signed an informed consent form
3. Diagnosis of type 2 diabetes for <= 20 years
4. HbA1c >= 8.0% and <= 10%
5. Anti-diabetes medication for a minimum of 3 months prior to screening with at least one at minimum required dose as outlined below:
a. MET (>=1500 mg/day)
6. BMI >= 30 and <= 50
7. Willing to comply with study requirements
8. Documented negative pregnancy test in women of childbearing potential
9. Women of childbearing potential not intending to become pregnant for the duration of their trial participation