Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrier™ Liner vs. Diet Control for the Treatment of Type 2 Diabetes|
- Percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Diet + Lifestyle counseling||
Behavioral: Diet + Lifestyle Counseling
Multidisciplinary lifestyle and nutritional counseling