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 (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
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 A1C 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, 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
Eugenio Cersosimo, MD, Phone: 210-358-7200, Email: Eugenio.Cersosimo@uhs.sa.com
