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
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      This is a single-site, prospective, cohort study that will assess the effect of Cycloset as
      add-on therapy in adult subjects with T2DM that is inadequately controlled (HbA1c 7.5% to
      10.0%) on GLP-1 analog therapy with either exenatide (Bydureon) once weekly or liraglutide
      (Victoza) once daily.

      Entry criteria will be checked at the screening visit. All qualified subjects will undergo
      baseline studies including non-invasive hemodynamic testing for assessment of aortic
      stiffness and pulse wave velocity, assessment of body weight composition by dual-energy X-ray
      absorptiometry (DXA), assessment of endothelial function using the Endo-PAT device,
      measurement of cytokines and inflammatory biomarkers in the peripheral blood and urine,
      assessment of oxidative stress and inflammatory markers in white blood cells isolated from a
      peripheral whole blood sample, a 5-hour mixed meal tolerance test (MMT) for assessment of
      postprandial glucose metabolism and 24-hour ambulatory BP monitoring.

      Following completion of all the baseline studies as above, subjects will be started on
      Cycloset, 0.8 mg/day in addition to their stable dose of Bydureon (exenatide) (2mg/week) or
      Victoza (liraglutide) (1.2-1.8 mg/day), and the dose will be increased by 0.8 mg/day every
      week to a maximum of 3.2 mg/day, or as tolerated to a minimum of 2.4 mg/day.

      Subjects will return at months 1, 2, 3, and 4 for interim medical history, body weight,
      HbA1c, and FPG (Fasting plasma glucose). Postural blood pressure measurements will be
      obtained with the subject lying down and then after standing for 5 minutes at each of the
      visits. At month 4, all of the baseline studies detailed above will be repeated.

      All tests will be performed in the Clinical Research Center at the Texas Diabetes
      Institute/University of Texas Health Science Center, San Antonio.
    

Intervention name(s): Cycloset
Intervention type(s): Drug
Intervention description(s): 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
Other intervention name(s): Bromocriptine Mesylate Quick Release
Intervention MeSH terms: Bromocriptine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; T2DM; Cycloset; Glycemic Control; GLP-1