Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DM

Inclusion Criteria

• Male or female subjects with type 2 diabetes ≥ 12 months.
• Age ≥ 21 and ≤ 75 years.
• Stable treatment with diet and exercise or stable treatment with metformin monotherapy. Stable treatment is defined as no change in treatment during the last 3 months.
• HbA1c > 6.5% and 150 mm Hg and/or diastolic blood pressure > 95 mm Hg at screening. (Subjects may be re-checked once on the same day).
• Treatment with antihypertensive medication is not allowed, unless antihypertensive medication is given on a stable dose for at least 2 months prior to screening.
• Subjects with a clinically significant history or active disease of any of the following body systems: pulmonary, neurological (including dementia, neurodegenerative disease, movement disorder, spinal disorders), pancreatic (including pancreatitis), immunological or systemic inflammatory (including systemic lupus erythematosus [SLE], rheumatoid arthritis [RA]), dermatological, endocrine, genitourinary or hematological (including sickle cell anemia or other anemia syndromes, monocytosis, thrombocytopenia).
• Subjects with a history or clinically active malignancy (history of basal cell carcinoma [BCC] is allowed).
• History or current diagnosis of cardiac dysrhythmias or heart disease, defined as symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, unstable angina requiring medication.
• Transient ischemic attack [TIA], cerebral infarct, or cerebral hemorrhage.
• Invasive cardiovascular procedure, such as coronary artery bypass graft surgery (CABG), or angioplasty/percutaneous coronary intervention (PCI) within 6 months of screening.
• PHistory of or presence of clinically significant ECG findings (e.g., QTcF > 450 msec for males, QTcF > 470 msec for females, LBBB) at Screening, or cardiac arrhythmia requiring medical or surgical treatment within 6 months prior to screening.
• History of renal disease or abnormal kidney function tests at Screening (glomerular filtration rate [GFR] 2 x ULN), total bilirubin > 1 x ULN).
• Subjects with a history or presence of any psychiatric disorder that, in the opinion of the Principal Investigator, might confound the results of the trial or pose additional risk in administering the investigational product to the subject.
• Personal or family history of hypercoagulability or thromboembolic disease, including deep vein thrombosis and/or pulmonary embolism (PE)
• History of surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal surgery (including appendectomy, cholecystectomy), any malabsorption disorder, severe gastroparesis, any GI procedure for weight loss (including LAP-BAND®), as well as clinically significant gastrointestinal disorders (e.g. peptic ulcers, severe GERD) at Screening.
• History of any major surgery within 3 months prior to screening.
• Any nerve stimulation study or implanted stimulator, including previously or currently implanted vagus nerve stimulator, previously or currently implanted spinal cord stimulator, other implanted electronic medical device, such as implanted pacemaker or cardioverter/defibrillator (AICD) or history of seizures.
• Diagnosis of sleep apnea.
• Participation in an investigational study within 30 days of screening or 5 half-lives within the last dose of any investigational product given during the investigational study, whichever is longer.
• Current use of any drugs (other than current treatment for diabetes mellitus) that are known to interfere with glucose or insulin metabolism as stated below in table prohibited medication.
• Thyroid hormone use is not allowed unless medication is given on a stable dose for at least 3 months prior to screening.
• Chronic use of acetaminophen, and inability to wash-out and abstain from use during the study, as it would interfere with the CGMS assessment.
• Subject is unable to tolerate adhesive tape or has any unresol