Free Fatty Acids N Baseline (mean) % Change from baseline (mean) 207 18.1 +0.2% 428 17.5 -7.8% 436 17.9 -14.7% 181 26.4 -2.4% 168 26.4 -4.7% 166 26.9 -20.8% 145 26.6 -21.5% LDL N Baseline (mean) % Change from baseline (mean) 190 123.7 +4.8% 400 126.8 +14.1% 374 125.3 +18.6% 175 142.7 -0.9% 160 141.9 -0.5% 161 142.1 +11.9% 133 142.1 +12.1% HDL N Baseline (mean) % Change from baseline (mean) 208 44.1 +8.0% 429 44.4 +11.4% 436 43.0 +14.2% 184 47.2 +4.3% 170 47.7 +8.7% 170 48.4 +14.0% 145 48.3 +18.5% * Once daily and twice daily dosing groups were combined. Monotherapy A total of 2,315 patients with type 2 diabetes, previously treated with diet alone or antidiabetic medication( s), were treated with AVANDIA as monotherapy in 6 double-blind studies, which included two 26-week placebo-controlled studies, one 52-week glyburide-controlled study, and 3 placebo-controlled dose-ranging studies of 8 to 12 weeks duration. Previous antidiabetic medication( s) were withdrawn and patients entered a 2 to 4 week placebo run-in period prior to randomization. Two 26-week, double-blind, placebo-controlled trials, in patients with type 2 diabetes with inadequate glycemic control (mean baseline FPG approximately 228 mg/ dL and mean baseline HbA1c 8.9%), were conducted. Treatment with AVANDIA produced statistically significant improvements in FPG and HbA1c compared to baseline and relative to placebo (see Table 3). Table 3. Glycemic Parameters in Two 26-Week Placebo-Controlled Trials Study A Placebo AVANDIA 2 mg twice daily AVANDIA 4 mg twice daily N 158 166 169 FPG (mg/ dL) Baseline (mean) 229 227 220 Change from baseline (mean) 19 -38 -54 Difference from placebo (adjusted mean) -58 * -76 * Responders ( 30 mg/ dL decrease from baseline) 16% 54% 64% HbAlc (%) Baseline (mean) 9.0 9.0 8.8 Change from baseline (mean) 0.9 -0.3 -0.6 Difference from placebo (adjusted mean) -1.2 * -1.5 * Responders ( 0.7% decrease from baseline) 6% 40% 42% | ||||
Email this article
Printer friendly
Bookmark this pageadvertisement
