QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes

Exclusion Criteria

• •1. Pregnancy or Lactating,
• •2. Type 1 Diabetes,
• •3. Concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications,
• •4. Patients with history of drug or alcohol abuse within 3 years of enrollment,
• •5. Patients at risk for hypotension, including those who have:
• •* Recent blood donation within 30 days of enrollment,
• •* A history of syncopal migraines, or
• •* Significant gastroparesis or orthostatic hypotension which could signify advanced autonomic neuropathy.
• •6. Uncontrolled mental illness especially with history of psychosis,
• •7. Any severe, uncontrolled or terminal medical condition which the investigator feels would interfere with the patient's ability to participate and comply with the study protocol,
• •8. Serum creatinine \>1.4mg/dL in females or \>1.5mg/dL in males that would preclude the patient from taking metformin,
• •9. LFTs elevated \>3x upper limit of normal,
• •10. Patients working rotating, varying or night shifts, or
• •11. Patient with circumstances or abnormalities (e.g. blindness or history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.