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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
52 week treatment of EnoBarrier Liner
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
Assessment of Glycemic Control (HbA1c) Over Time
HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Time frame: 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."
Time frame: Baseline to 52 weeks
Total Weight Change (kg) at Week 52 Compared to Baseline Weight
Time frame: Baseline to 52 weeks
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