Santarus, Inc. (NASDAQ: SNTS) and VeroScience, LLC today 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 November/December 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)
- 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).
CYCLOSET is a unique, quick release form of bromocriptine, a dopamine receptor agonist that is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The study included 515 patients with type 2 diabetes with baseline HbA1c of ≥7.5% and ≤10.0% (average baseline HbA1c: 8.3) taking one or two oral anti-diabetes medications (metformin, sulfonylurea and/or thiazolidinediones). These poorly controlled patients were randomized 2:1 to CYCLOSET add-on (1.6 mg/day to 4.8 mg/day) or placebo add-on for a 24-week treatment period. Study investigators were allowed to adjust patient anti-diabetes medications during the study to attempt to achieve glycemic control in case of glycemic deterioration. The impact of CYCLOSET treatment was assessed in patients taking: (1) one or two oral anti-diabetes medications, (2) metformin with or without another oral anti-diabetes medication, or (3) metformin plus a sulfonylurea. The study was conducted in a cohort of patients imbedded in a larger randomized safety study.