Of the 262 patients screened, 152 patients were randomized; 1 patient (in the sitagliptin group) was judged ineligible by the investigator and was discontinued from the study prior to administration of study drug, thus 151 patients were subject to analysis. One other patient (in the placebo group) was excluded from the efficacy analyses because there were no data available during the treatment period (Fig. 1). The treatment groups were generally well balanced with respect to baseline patient characteristics (Table 1). At baseline, the mean HbA1c level was 7.6%, with 70% of patients having HbA1c levels ≤8.0%, and mean FPG was 163.5 mg/dL. The mean duration of known diabetes was 4 years, and 43% of patients had not been taking an OHA at screening. Compliance with study drug was 99.1% and 97.5% in the sitagliptin and placebo groups, respectively.