The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

Inclusion Criteria:

1. Body mass index (BMI) ≥ 28 and ≤ 45 (kg/m2)
2. Type 2 diabetes >6 months
3. Type 2 diabetic subjects treated with oral anti-diabetic
4. Stable anti-diabetic medications ≥3 months prior to enrollment, six months for TZD
5. HbA1c ≥7.5% and ≤ 9.5 % at Visit 1, subjects with T2DM duration > 10 yrs should have HbA1c ≥7.5% and ≤ 9.0
6. Stable HbA1c, Stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications
7. Fasting blood glucose >120 and < 240 mg/dl at Visit 1, subjects with T2DM duration > 10 yrs should be >120 and ≤180.
8. Women with childbearing potential must agree to use adequate birth control methods
9. Stable weight - no significant change (variation < 5%) in the last 6 months
10. Willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study
11. Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
12. Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II System
13. Alert, mentally competent,
14. Able to provide voluntary informed consent and HIPAA Authorization

Exclusion Criteria:

1. Receiving insulin therapy
2. Taking GLP-1, Amylin treatment (Byetta, Symlin)
3. Blood pressure levels of >180/100
4. Patients with an EF less than 35% (obtained within last 6 months) or indicated for an ICD; if echocardiogram outdated or unavailable, procedure to be done
5. Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
6. Use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment
7. Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
8. Prior wound healing problems due to Staphylococcus and Candida
9. Prior bariatric surgery
10. History of pancreatitis
11. History of peptic ulcer disease within 5 years of enrollment
12. Diagnosed with gastroparesis
13. Use of active medical devices (either implantable or external) such as ICD, pacemaker, neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
14. Cardiac history that physician feels should exclude the patient
15. Use of another investigational device or agent in the 30 days prior to enrollment
16. A history of life-threatening disease within 5 years of enrollment
17. Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study