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.