The study population included patients not previously treated with antidiabetic medication (naïve; 31%) and patients who were receiving antidiabetic medication at the time of study enrollment (previously treated; 69%). The data for the naïve and previously-treated patient subsets are shown in Table 3. All patients entered an 8 week washout/run-in period prior to double-blind treatment. This run-in period was associated with little change in HbA_1c and FPG values from screening to baseline for the naïve patients; however, for the previously-treated group, washout from previous antidiabetic medication resulted in deterioration of glycemic control and increases in HbA_1c and FPG. Although most patients in the previously-treated group had a decrease from baseline in HbA_1c and FPG with ACTOS, in many cases the values did not return to screening levels by the end of the study. The study design did not permit the evaluation of patients who switched directly to ACTOS from another antidiabetic agent.

Table 3 Glycemic Parameters in a 26-Week Placebo-Controlled Dose-Ranging Study

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