Table 1 Inclusion/Exclusion Criteria

Diagnosis Type 2 Diabetes

≥ 6 months prior to enrollment

Age

30–80 years

Hba1c at screening

≤ 10

Male or Female

Female of child bearing age must use definitive contraceptive therapy

Exclusion

Taken Prescription sympathomimetic

Taken seven days prior to screening

Drugs not permitted during study

Ergot alkaloid derivatives, or anti-migrane medications

History of alcoholism or drug abuse

Within 3 years of study entry

Donation of blood

30 days prior to study entry

Has received any experimental drug or used an experimental device

Within 30 days of study entry

Pregnant or lactating women

Known hypersensitivity to any of the formulation components

Subjects with clinically significant major organ system disease:

• seizure disorder,

• significant gastroparesis or orthostatic hypotension (autonomic neuropathy),

• cerebrovascular accident in the previous 6 months,

• uncontrolled hypertension (systolic BP >160 or diastolic BP > 100 at screening)

• coronary artery bypass graft or coronary angioplasty in the previous 3 months, myocardial infarction in the previous 6 months, or unstable angina pectoris (chest pain at rest, worsening chest pain, or admission to the ER or hospital for chest pain) within the previous 3 months,

• congestive heart failure defined by NYHA as Class III or IV

• clinical nephrotic syndrome, or renal impairment with a serum creatinine > 1.4 mg/dl if female receiving treatment with metformin, > 1.5 mg/dl if male receiving treatment with metformin, and > 1.6 mg/dl in not on metformin,

• impaired liver function, including having AST or ALT greater than three times the upper limit of normal,

• active infection (e.g., HIV, hepatitis), or a history of severe infection during the 30 days prior to screening,

• major surgical operation during the 30 days prior to screening,

• cancer, other than non-melanoma skin or non metastatic prostate cancer within the past 5 years

• Any concurrent illness, other than diabetes mellitus, not controlled by a stable therapeutic regimen.

• Working rotating, varying or night shifts

• Patients taking unapproved herbal supplements that may be associated with a risk of cardiovascular events (such as ephedra, yohimbe etc)

• Patients who have started therapy with an erectile dysfunction drug within 2 weeks prior to screening; patients may not begin treatment with an erectile dysfunction drug during the study period; patients previously taking erectile dysfunction drugs should do so only under medical supervision.

• Subjects with circumstances or abnormalities (e.g., blindness or a history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.