A Prospective, Clinical Trial of the TANTALUS® System in Treatment of Obese to Morbidly Obese Patients

Inclusion Criteria:

• Age 21-70 years
• Diabetic subjects having HbA1c greater than or equal to 7.5% and less than or equal to 9.5 % at Visit 1
• Sex: male or female. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
• Type 2 diabetes duration less than 10 years but at least 6 months
• Type 2 diabetic Subjects taking no more than two (2) oral anti-diabetic agents [Sulfonylurea, Metformin or thiazolinedione (TZD)].
• Stable anti-diabetic drugs for at least three (3) months prior to enrollment and six (6) months for thiazolinedione (TZD).
• Fasting blood glucose values > 120 and < 240 mg/dl at baseline
• Stable HbA1c, described as no significant change (≤ 0.5% variation) between a historical value in the subjects' medical record within 3 months prior to enrollment and the A1c value gathered at baseline.
• If subject is under anti-depressant medication, the treatment needs to be stable for at least six (6) months prior to enrollment.
• BMI between 28 and 45 (kg/m2)
• Stable weight, defined as no significant weight change over the three months prior to enrollment as reported by the subject (±5 kg).
• Stable medications (including anti-hypertensive and lipid-lowering) for at least one month prior to enrollment.
• Compliant, willing and able to participate in the follow-up visits for the study duration.
• Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial.
• Able to provide voluntary informed consent.

Exclusion Criteria:

• Gastroparesis or intestinal pseudo-obstruction.
• Receiving medications known to affect gastric motility.
• Taking appetite suppressant or weight loss medications within 1 month of enrollment.
• Diabetic subjects on insulin.
• Past or current psychiatric condition that may impair his or her ability to comply with the study procedures.
• Severe eating disorders such as bulimia or binge eating.
• Obese due to a clinically diagnosed endocrine problem.
• Pregnant (proven by positive βhCG), or lactating.
• History of anemia (<10 g/dl) over past 3-months.
• Prior bariatric surgery.
• History of peptic ulcer disease.
• Use of another investigational device or agent in the 30 days prior to enrollment.
• Participation in another clinical study.
• Life threatening co-morbidity or life expectancy of less than one year.
• Myocardial Infarction or one or more episodes of unstable angina within six months prior to enrollment.
• Implanted with a permanent pacemaker, an automatic implantable defibrillator, or other electro-stimulation device.
• History of life threatening disease within 5 years of enrollment.
• Use of routine ulcerogenic drugs.
• Use of prescription, over the counter or herbal weight loss products.