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January 23, 2013
07:07 EDTSNTSSantarus' Cycloset for diabetes shows positive results in efficacy study
Santarus and VeroScience announced publication of positive data from a double-blind, placebo-controlled, multi-center pivotal study with Cycloset (bromocriptine mesylate) tablets, a dopamine receptor agonist to improve glycemic control in adults with type 2 diabetes mellitus. Patient groups that added Cycloset achieved a 0.60% to 0.70% reduction in HbA1c relative to placebo after 24 weeks, the primary endpoint of the study. The discontinuation rate due to any adverse event was 20% for Cycloset-treated and 9% for placebo-treated patients. The most frequent adverse events were, respectively, nausea (33% vs. 6%), fatigue (11% vs. 8%), dizziness (14% vs. 11%), headache (12% vs. 8%), constipation (7% vs. 3%), back pain (6% vs. 3%) and vomiting (6% vs. 2%).
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