Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Cycloset
Intervention description: Bromocriptine QR 0.8 mg tablet 0.8 mg/day with dose increased to a maximum of 3.2 mg/day or as tolerated to a minimum of 2.4 mg/day Other names: Cycloset, B-QR
Intervention MeSH terms: Bromocriptine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 30 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; T2DM; Cycloset; Glycemic Control; GLP-1

Summary:

      Purpose This study will examine the effect of the addition of Cycloset upon glucose
      metabolism (glycemic control including post prandial glucose metabolism) in individuals with
      inadequately controlled (HbA1c 7.5-10.0) type 2 diabetes (T2DM) who are already on Bydureon
      (exenatide once weekly) or Victoza (liraglutide once daily) as part of their standard care.

      Both a mechanistic rationale and empirical experimental evidence implicate a beneficial
      interaction between bromocriptine and the incretin mimetics (GLP-1 analogs) upon postprandial
      hyperglycemia in insulin resistant states. One of the actions of the incretin mimetics such
      as the GLP-1 analogs is to stimulate postprandial beta cell insulin secretory response to
      plasma glucose (see drug labeling information; www.fda.gov). Thus the combination of Cycloset
      that is working as a post prandial insulin sensitizier with therapies that increase post
      prandial insulin would be expected to provide complimentary glucose lowering effects. To
      date, however, no such studies investigating the interactive effects of a GLP-1 analog and
      Bromocriptine-QR (QR=extended release) (Cycloset) have been conducted in humans.

      Condition - Type 2 Diabetes. Intervention - Cycloset. Phase - Phase 4

      Study Type: Interventional Study Design: Treatment, Single Group Assignment, Open Label, N/A,
      Safety/Efficacy Study

      Official Title: Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients
      Inadequately Controlled on GLP-1 Analogue Therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes male or female subjects between the ages of 30 and 70 years of age,
             inclusive, at Screening

          -  BMI = 24-40 kg/m2

          -  HbA1c = 7.5-10.0%

          -  Stable body weight (±3-4lbs) over the preceding 3 months

          -  Subjects currently receiving a stable dose of exenatide (2mg/week) or liraglutide
             (1.2-1.8 mg/day) for at least 90 days prior to determination of baseline HbA1C and
             eligibility for enrollment in the study protocol.

          -  Subjects with a daytime feeding/night time sleeping schedule

          -  Subjects with no evidence of major organ system disease as determined by physical
             exam, history, and screening laboratory data

          -  Women must be of non-childbearing potential as defined by one of the following:

          -  Women >45 and < 60 years of age at Screening, who have been amenorrheic for at least 2
             years

          -  Women who have had a documented hysterectomy and/or bilateral oophorectomy

          -  Women > 60 years of age

          -  Females of childbearing potential with a negative pregnancy test at Screening and
             Treatment visits, using one of the following forms of contraception for the duration
             of participation in the study (i.e., until Follow-up 7-14 days post last dose): Oral
             contraceptive, Injectable progesterone, subdermal implant, spermicidal
             foam/gel/film/cream/suppository, diaphragm with spermicide, copper or hormonal
             containing IUD (intrauterine device), sterile male partner vasectomized > 6 month
             pre-dosing

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject has been informed of all pertinent aspects of the study

          -  Subjects must be willing and able to comply with scheduled visits, treatment,
             laboratory tests and study procedures.

        Exclusion Criteria:

          -  Recent (i.e., within three (3) months prior to Screening) evidence or medical history
             of unstable concurrent disease such as: documented evidence or history of clinically
             significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular,
             hepatic, psychiatric, immunological, or clinically significant neurological disease.

          -  No history of T2DM

          -  BMI of less 24 and greater 40 kg/m2

          -  Unstable body weight (change of greater than ±3-4lbs over the preceding 3 months

          -  Subjects not currently receiving exenatide or liraglutide

          -  Subjects participating in an excessively heavy exercise program

          -  Subject with a feeding/sleeping schedule different from a daytime feeding/night time
             sleeping schedule

          -  Subjects taking medications known to alter glucose metabolism (with the exception of
             metformin and/or pioglitazone) or which effect brain neuro synaptic function are
             excluded.

          -  Subjects with evidence of major organ system disease as determined by physical exam,
             history, and screening laboratory data

          -  Pregnant subjects or subjects unwilling to use birth control during their study
             enrollment

          -  Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening 12.
             Subjects that are allergic to bromocriptine or any of the other ingredients in
             Cycloset, or take ergot medicines, breastfeeding or have history of syncope or Type 1
             diabetes mellitus

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results that, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study subjects of reproductive potential