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

To assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.

Inclusion criteria

• Male and female patients, age 30 to 65 years of age,
• Clinical diagnosis of type 2 diabetes at least 6 months prior to enrollment,
• Stable on current treatment consisting of either human or recombinant multi-dose insulin therapy (MDI) with metformin,
• HbA1c of 7.5-12%, inclusive,
• Demonstrated willingness to check and record blood glucose readings at seven time points as instructed in the study protocol.
• Medically controlled hypertension, at least on one anti-hypertensive
• Medically controlled hyperlipidemia, on or off cholesterol-lowering therapy
• BMI >30

Exclusion criteria

• Pregnancy or Lactating,
• Type 1 Diabetes,
• Concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications,
• Patients with history of drug or alcohol abuse within 3 years of enrollment,
• 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.
• Uncontrolled mental illness especially with history of psychosis,
• 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,
• Serum creatinine >1.4mg/dL in females or >1.5mg/dL in males that would preclude the patient from taking metformin,
• LFTs elevated >3x upper limit of normal,
• Patients working rotating, varying or night shifts, or
• 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.