Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy
Status:
Completed
Trial end date:
2018-04-30
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio