Type 2 Diabetes Mellitus Clinical Trial
Official title:
The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study
The main purpose of this research study is to investigate whether the TANTALUS II System is
effective in improving glycemic (blood sugar) control in subjects who have type 2 diabetes
(high blood sugar) and are overweight. The research will also evaluate the impact on weight
loss and will study other health conditions related to obesity.
This research study involves an experimental system. The experimental system is the TANTALUS
System, which consists of the implantable portion that includes the implantable pulse
generator (IPG) and three pairs of implantable leads. There are also three external parts
(items that are used outside your body): the programmer, the charger, and the Patient Wand.
This is a randomized, double-blind and controlled, multi-center study. Three hundred (300)
subjects with type 2 diabetes ranging from low BMI to BMI 45 (BMI ≥ 28 and ≤ 45) will be
enrolled.
The duration of subject participation in the main portion of the study which includes the
initial study and study extension periods is expected to be approximately 12 months. Upon
completion of this period, subjects with a TANTALUS device shall continue to be followed
clinically at six-month intervals (Safety Monitoring Period) until the FDA has made a
determination regarding the safety and efficacy of the device.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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