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Actos

Clinical Pharmacology
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Clinical Pharmacology

Actos

In a 24-week, placebo-controlled study, 260 patients with type 2 diabetes were randomized to one of two forced-titration ACTOS treatment groups or a mock titration placebo group. Therapy with any previous antidiabetic agent was discontinued 6 weeks prior to the double-blind period. In one ACTOS treatment group, patients received an initial dose of 7.5 mg once daily. After four weeks, the dose was increased to 15 mg once daily and after another four weeks, the dose was increased to 30 mg once daily for the remainder of the study (16 weeks). In the second ACTOS treatment group, patients received an initial dose of 15 mg once daily and were titrated to 30 mg once daily and 45 mg once daily in a similar manner. Treatment with ACTOS, as described, produced statistically significant improvements in HbA1c and FPG at endpoint compared to placebo (Table 4).

Table 4 Glycemic Parameters in a 24-Week Placebo-Controlled Forced-Titration Study


  Placebo ACTOS
30 mg+
Once Daily		 ACTOS
45 mg+
Once Daily
Total Population      
HbA1c (%) N=83 N=85 N=85
Baseline (mean) 10.8 10.3 10.8
Change from baseline (adjusted mean++) 0.9 -0.6 -0.6
Difference from placebo (adjusted mean++)   -1.5* -1.5*
FPG (mg/dL) N=78 N=82 N=85
Baseline (mean) 279 268 281
Change from baseline (adjusted mean++) 18 -44 -50
Difference from placebo (adjusted mean++)   -62* -68*
+ Final dose in forced titration
++ Adjusted for baseline, pooled center, and pooled center by treatment interaction
* p ≤ 0.050 vs. placebo

For patients who had not been previously treated with antidiabetic medication (24%), mean values at screening were 10.1% for HbA1c and 238 mg/dL for FPG. At baseline, mean HbA1c was 10.2% and mean FPG was 243 mg/dL. Compared with placebo, treatment with ACTOS titrated to a final dose of 30 mg and 45 mg resulted in reductions from baseline in mean HbA1c of 2.3% and 2.6% and mean FPG of 63 mg/dL and 95 mg/dL, respectively. For patients who had been previously treated with antidiabetic medication (76%), this medication was discontinued at screening. Mean values at screening were 9.4% for HbA1c and 216 mg/dL for FPG. At baseline, mean HbA1c was 10.7% and mean FPG was 290 mg/dL. Compared with placebo, treatment with ACTOS titrated to a final dose of 30 mg and 45 mg resulted in reductions from baseline in mean HbA1c of 1.3% and 1.4% and mean FPG of 55 mg/dL and 60 mg/dL, respectively. For many previously-treated patients, HbA1c and FPG had not returned to screening levels by the end of the study.

In a 16-week study, 197 patients with type 2 diabetes were randomized to treatment with 30 mg of ACTOS or placebo once daily. Therapy with any previous antidiabetic agent was discontinued 6 weeks prior to the double-blind period. Treatment with 30 mg of ACTOS produced statistically significant improvements in HbA1c and FPG at endpoint compared to placebo (Table 5).

Table 5 Glycemic Parameters in a 16-Week Placebo-Controlled Study


  Placebo ACTOS 30 mg
Once Daily
Total Population    
HbA1c (%) N=93 N=100
Baseline (mean) 10.3 10.5
Change from baseline (adjusted mean+) 0.8 -0.6
Difference from placebo (adjusted mean+)   -1.4*
FPG (mg/dL) N=91 N=99
Baseline (mean) 270 273
Change from baseline (adjusted mean+) 8 -50
Difference from placebo (adjusted mean+)   -58*
+ Adjusted for baseline, pooled center, and pooled center by treatment interaction
* p ≤ 0.050 vs. placebo
Brand Name: Actos
Generic Name: Pioglitazone hydrochloride
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