Phase III study suggests CYCLOSET tablets improve glycemic control

Santarus, Inc.Nov 4 2010

Santarus, Inc. (NASDAQ:SNTS) and VeroScience LLC today announced that analyses of 379-patient subset data from a 3,070-patient Phase III safety study conducted with CYCLOSET^® (bromocriptine mesylate) tablets suggested that CYCLOSET as an add-on to oral antidiabetes drugs produced improvements in glycemic control irrespective of baseline duration of disease. The findings will be presented Thursday, November 4, 2010 in a poster session at the 8^th Annual World Congress on Insulin Resistance, Diabetes & CVD (WCIR) in Los Angeles.

The poster, Duration of Type 2 Diabetes Illness Influence on the Glycemic Control Effect of Cycloset, a Quick Release Formulation of Bromocriptine (M Ezrokhi, et al, Abstract #123), featured a subset analysis of the safety study, investigating the relationship between duration of type 2 diabetes disease and response to treatment with CYCLOSET as an add-on therapy to one or two oral antidiabetes drugs. The subset included 379 patients who had a baseline HbA1c (%) of ≥7.5 and ≤10.0, were taking one or two oral antidiabetes drugs (usual diabetic therapy, or UDT), had follow-up data at week 24 of the study and were ≥127 days drug-compliant. Changes in HbA1c were assessed using linear regression models adjusted for various covariates and stratified by duration of illness. HbA1c is a standard measurement of blood glucose used to determine the efficacy of antidiabetes agents.

The 379 subjects had a mean baseline HbA1c level of 8.3, and mean age was 58 years. The mean duration of type 2 diabetes was 8.1 years (tertiles of duration were defined as <4.74, 4.74-8.56, and >8.56 years). For each tertile, the between group differences in HbA1c for patients treated with CYCLOSET plus UDT compared with those receiving placebo plus UDT were -0.86 (-0.66 CYCLOSET, +0.20 Placebo), -0.66 (-0.47 CYCLOSET, +0.18 Placebo), and -0.53 (-0.62 CYCLOSET, -0.10 Placebo), respectively (P<0.001 for any tertile). Also, for each tertile of duration of disease, 31%, 31% and 35% of subjects on CYCLOSET with UDT versus 12%, 3% and 7% of subjects on placebo plus UDT, respectively, reached goal of HbA1c ≤ 7.0 (P<0.02 for any tertile, unadjusted analysis).

The overall difference in HbA1c for the 379 subjects, adjusting only for baseline HbA1c, was -0.60 (p<0.0001) in favor of the CYCLOSET plus UDT treated group versus those treated with placebo plus UDT. In the fully adjusted model, which adjusted for baseline HbA1c (%), gender (male/female), screening body mass index (kg/m²), age (years), duration (years) as well as diabetes regimen intensification, the between group difference in HbA1c between CYCLOSET plus UDT and placebo plus UDT was -0.62 (p<0.0001).

As in previous studies with the drug, comparison of the improvements in HbA1c versus fasting plasma glucose level suggests that the effect of CYCLOSET to improve glycemic control is via improving both fasting and postprandial glucose levels.