Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces
blood sugar by the proposed mechanism of reversing many of the metabolic alterations
associated with insulin resistance and obesity by resetting central (hypothalamic) circadian
organization of monoamine neuronal activities.
The primary analysis of this study will test the hypothesis that the rate of all-cause severe
adverse events for those receiving usual drug therapy for diabetes management plus Cycloset
is not greater than that for usual drug therapy plus placebo by more than an acceptable
margin. While the primary purpose of this study is to establish the safety profile of
Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated
as well.