QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: QR-bromocriptine
Intervention description: The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study.
Intervention MeSH terms: Bromocriptine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2
      diabetes will result in improved glycemic control, reduced exogenous insulin requirement,
      increased lean fat mass and improved pancreatic beta-cell function.
    

Eligibility criteria:

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