Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Bromocriptine Mesylate
Intervention description: 0.8 mg tablet
Intervention MeSH terms: Bromocriptine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; diabetes mellitus

Summary:

      The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo
      when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in
      persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with type 2 diabetes mellitus, for at least six months prior to screening.

          2. 18-75 years of age, inclusive.

          3. Male or if female, is either:

               -  postmenopausal or

               -  of childbearing potential and has used appropriate contraceptive methods

          4. Treated with a stable dose of metformin at least 3 months.

          5. Has not been treated with a sulfonylurea, thiazolidinedione, meglitinide,
             alpha-glucosidase inhibitor, or combination oral anti-diabetic therapy within 3 months
             prior to screening.

          6. Has not been on a regimen of lipid-lowering agents or if on such a regimen, it has
             been stable for a minimum of 6 weeks at screening.

          7. HbA1c value between ≥ 7.5% and < 11%, at screening (Visit 1) and Visit 3.

          8. Fasting plasma glucose measurement of ≤260 mg/dL at screening (Visit 1) and Visit 3.

          9. Fasting C-peptide value equal to or greater than the normal accepted minimum value
             (e.g. < 0.9 NG/ml).

         10. Stable body weight, i.e., not varying by > 10% for at least3 months prior to screening

         11. Body mass index (BMI) at screening of 25 kg/m2 to 42 kg/m2,inclusive.

         12. If treated for hypertension, the individual has been on stable therapy for 1 month
             prior to screening.

        Exclusion Criteria:

          1. Prior exogenous insulin therapy as part of an outpatient diabetes treatment regimen.

          2. Type 1 diabetes mellitus

          3. Clinically significant history of cardiac disease or presence of cardiac disease,
             including MI, clinically significant arrhythmia, unstable angina pectoris, moderate to
             severe congestive heart failure, CABG, or angioplasty; or expected to require CABG or
             angioplasty during the study.

          4. Uncontrolled hypertension, defined as systolic blood pressure > 160 or diastolic blood
             pressure > 100 mmHg measured in sitting position at screening(Visit 1)

             Clinically significant history or presence of:

          5. Hepatic disease (i.e. impaired liver function, including having AST or ALT greater
             than three times the upper limit of normal)

          6. Renal disease (i.e. renal impairment with a serum creatinine ≥ 1.4 mg/dl)

          7. Central nervous system disease, including epilepsy

          8. CVA within the last 3 years.

          9. Less than 5 years remission from clinically significant malignancy.

         10. Major surgical operation within 3 months of screening.

         11. Organ transplantation.

         12. Evidence of acute or chronic illness including known or suspected HIV,HBV, or HCV
             infection.

         13. Currently abuses drugs or alcohol, including binge drinking, or history of abuse that
             in the investigator's opinion would cause the individual to be noncompliant.

         14. Regularly uses medications with addictive potential such as opiates,narcotics,
             tranquilizers, etc.

         15. Used drugs for weight loss, e.g., Xenical® (orlistat), Meridia® (sibutramine),Acutrim®
             (phenylpropanolamine), or similar over-the-counter medications within 3 months of
             screening.

         16. Known hypersensitivity to any components of the study drugs.

         17. Received any experimental drug or used an experimental device within 3 months of
             screening or will do so during the study.

         18. Has received unstable dose of fibric acid derivatives within 3 months of the
             screening.

         19. Requires regular use of systemic corticosteroids by oral, intravenous (IV),or
             intramuscular (IM) route, or regular use of potent, inhaled intranasal steroids that
             are known to have a high rate of systemic absorption.

         20. Prescription sympathomimetic drugs within 7 days of screening.

         21. Started therapy with an erectile dysfunction drug within 2 weeks prior to screening.
             The subject may not begin treatment with an erectile dysfunction drug during the study
             period; subjects previously taking erectile dysfunction drugs should do so only under
             medical supervision.

         22. Donated blood within 60 days of screening. Donation of blood also is prohibited during
             the study and for 30 days after completion of the study.

         23. Occupation that requires a rotation of shift work or working over night shifts.