Phase III study suggests CYCLOSET tablets improve glycemic control

November 26, 2015

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.

Source: Santarus, Inc.