A 24-week, placebo-controlled, monotherapy study of the impact of CYCLOSET on glycemic control in 159 overweight adults (BMI ?‰? 26.0 kg/m2 for males and ?‰? 28.0 kg/m2 for females) with type 2 diabetes and baseline HbA1c of 7.5% - 11% indicated that once-daily morning dosing of CYCLOSET provided significant postprandial plasma glucose reductions throughout the day without increasing plasma insulin concentrations and significantly improved HbA1c.

Additional data from a prospective 24-week assessment of the efficacy of CYCLOSET in improving glycemic control in type 2 diabetes, patients poorly controlled on one or two oral anti-diabetes agents indicated that 35% - 40% of patients reached an HbA1c goal of ?‰¤ 7.0% with CYCLOSET versus approximately 10% of placebo treated patients. When added to other oral antidiabetic agents, once-daily morning administration of CYCLOSET improved glycemic control after 24 weeks of treatment, as demonstrated by a significant reduction in mean HbA1c (0.6% - 0.9% versus placebo, data on file). These findings were from a prospective 24-week assessment for treatment differences in the change from baseline to Week 24 in HbA1c among patients with a baseline HbA1c ?‰?7.5%, taking one or two oral antidiabetic medications, and completing 24 weeks of therapy within a 52-week, randomized controlled study to evaluate the safety and efficacy of CYCLOSET. In this 52-week study, CYCLOSET was not associated with an increased risk for adverse cardiovascular events relative to placebo.

Source: Santarus, Inc.