For the primary endpoint analysis, intraindividual differences between treatment and control group in the 2HPG value obtained during an OGTT from baseline to 3 months were assessed in the per protocol population. Using two-sided testing and a standard deviation of 20% in relative changes of 2HPG OGTT glucose values, a¼0.05 and b¼0.2, a sample size of 16 patients per group was chosen to detect a difference in 2HPG of 20mg/dL when comparing baseline levels to levels on months 3. SPSS 19 (SPSS, Inc., Chicago, IL) was used for all statistical analyses.