Balance System Study in Type 2 Diabetic Patients

Inclusion Criteria:

• Type 2 Diabetes inadequately controlled on a maximum of three oral anti-diabetic agents
• HbA1c between 7 and 10% inclusive
• Fasting Blood Glucose between 126 and 200 mg/dL
• Body Mass Index (BMI) in the range of 30.0 to 45.0 kg/m2
• Stable oral anti-diabetic therapy for at least 3 months
• Subjects who are able and willing to perform self monitoring of plasma glucose for the entire trial period
• Able and willing to sign informed consent and return for follow-up assessments

Exclusion Criteria:

• Type 1 Diabetes
• Subjects at high risk of general anesthesia or surgery
• Subjects with prior pancreatitis
• Subjects treated with insulin within three months of screening
• Female with a positive pregnancy test, planning to become pregnant during screening, active treatment, or the follow up period, breastfeeding, or judged to be using inadequate contraceptive methods.
• Subjects who underwent previous intra abdominal, GI tract surgery or a major abdominal trauma.
• Subjects with other implanted electrical stimulation devices
• Subjects with motility disorders of the GI tract such as gastroparesis
• Subjects who are receiving medications known to affect gastric motility
• Subjects with history of peptic ulcer disease
• Subjects with any serious health condition, such as cancer, cardiac diseases, immunodeficiency disorders, liver disease, pulmonary disease, renal insufficiency, coagulopathy or a major depressive disorder.
• Subjects with severe diabetic complications, such as retinopathy or nephropathy
• Subjects with metabolic or endocrine disorders like primary or secondary Cushing syndrome
• Subjects who received another investigational agent within 30 days prior to screening
• Evidence of current or recent alcohol or drug abuse within the past year prior to screening
• Subjects who are unlikely to be available for follow-up as specified in the protocol
• Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
• Subjects with history of volvulus
• Subjects with history of known small bowel adhesions or any known GI adhesions
• Subjects with deficiencies of known vitamins, e.g. B12
• Subjects with known celiac disease or inflammatory bowel disease
• Subjects with conditions that, in the judgment of the investigator, precludes successful participation to the study.