Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes
Completed
VeroScience
Phase 3
2004-07-01
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.
Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin
Terminated
VeroScience
Phase 3
2005-02-01
The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo
when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in
persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy
alone.
Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg
Completed
Mylan Pharmaceuticals
Phase 1
2007-04-01
The objective of this study was to assess the single-dose relative bioavailability of Mylan
Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine
mesylate capsules, following the administration of a 10 mg dose, under fed conditions.
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