In the two other monotherapy studies (24 weeks and 16 weeks) and in combination therapy studies with sulfonylurea (24 weeks and 16 weeks) and metformin (24 weeks and 16 weeks), the results were generally consistent with the data above. In placebo-controlled trials, the placebo-corrected mean changes from baseline decreased 5% to 26% for triglycerides and increased 6% to 13% for HDL in patients treated with ACTOS. A similar pattern of results was seen in 24-week combination therapy studies of ACTOS with sulfonylurea or metformin.

In a combination therapy study with insulin (16 weeks), the placebo-corrected mean percent change from baseline in triglyceride values for patients treated with ACTOS was also decreased. A placebo-corrected mean change from baseline in LDL cholesterol of 7% was observed for the 15 mg dose group. Similar results to those noted above for HDL and total cholesterol were observed. A similar pattern of results was seen in a 24-week combination therapy study with ACTOS with insulin.

Clinical Studies

Monotherapy

In the U.S., three randomized, double-blind, placebo-controlled trials with durations from 16 to 26 weeks were conducted to evaluate the use of ACTOS as monotherapy in patients with type 2 diabetes. These studies examined ACTOS at doses up to 45 mg or placebo once daily in 865 patients.

In a 26-week, dose-ranging study, 408 patients with type 2 diabetes were randomized to receive 7.5 mg, 15 mg, 30 mg, or 45 mg of ACTOS, or placebo once daily. Therapy with any previous antidiabetic agent was discontinued 8 weeks prior to the double-blind period. Treatment with 15 mg, 30 mg, and 45 mg of ACTOS produced statistically significant improvements in HbA_1c and fasting plasma glucose (FPG) at endpoint compared to placebo (Figure 1, Table 2).

Figure 1 shows the time course for changes in FPG and HbA_1c for the entire study population in this 26-week study.

Figure 1 Mean Change from Baseline for FPG and HbA_1c in a 26-Week Placebo-Controlled Dose-Ranging Study

Table 2 shows HbA_1c and FPG values for the entire study population.

Table 2 Glycemic Parameters in a 26-Week Placebo-Controlled Dose-Ranging Study

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