Santarus Inc (SNTS)

[surf1944]

7:01AM Santarus and VeroScience announce publication of 'positive' data from pivotal CYCLOSET (bromocriptine mesylate) efficacy study; CYCLOSET add-on therapy provided significant improvement in glycemic control versus placebo in patients with type 2 diabetes poorly controlled on one or two oral anti-diabetes medications (SNTS) 12.37 : Co and VeroScience announced publication of positive data from a double-blind, placebo-controlled, multi-center pivotal study with CYCLOSET (bromocriptine mesylate) tablets. Patient groups in the evaluable per protocol (EPP) population that added CYCLOSET to their treatment regimen achieved a 0.60% to 0.70% reduction in HbA1c (p<0.0001) relative to placebo after 24 weeks, the primary endpoint of the study. These results appear in the Nov/Dec 2012 print edition of Endocrine Practice, a peer-reviewed medical journal. Additionally, among the EPP population with no concomitant change in diabetes medication, treatment with CYCLOSET resulted in reductions in HbA1c levels of 0.69% to 0.83% (CYCLOSET vs. placebo between group difference, p<0.0001) as well as five to seven times more subjects reaching the goal of HbA1c =7.0 in the CYCLOSET treated groups compared with placebo (32%-42% vs 5%-7%, respectively) (p<0.0001).