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Tabl 4 summaizs th incidnc and typs common advs vnts potd in tials ACTOS add-on tinsulin. Tms that a potd psnt thos that occud at an incidnc >5% and mcommonly with th highst tstd dos ACTOS.

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Clinical studis dmonstat that ACTOS impovs insulin snsitivity in insulin-sistant patints. ACTOS nhancs cllula sponsivnss tinsulin, incass insulin-dpndnt glucos disposal and impovs hpatic snsitivity tinsulin. In patints with typ 2 diabts, th dcasd insulin sistanc poducd by ACTOS sults in low plasma glucos concntations, low plasma insulin concntations, and low HbA1c valus. In contolld clinical tials, ACTOS had an additiv ct on glycmic contol whn usd in combination with a sulonylua, mtomin, insulin [s Clinical Studis ].

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Tumos w obsvd in th uinay bladd mal ats in th two-ya cacinognicity study [s Nonclinical Toxicology ]. In addition, duing th th ya POactiv clinical tial, 14 patints out 2605 (0.54%) andomizd tACTOS and 5 out 2633 (0.19%) andomizd tplacbw diagnosd with bladd canc. At xcluding patints in whom xposu tstudy dug was lss than on ya at th tim diagnosis bladd canc, th w 6 (0.23%) cass on ACTOS and tw(0.08%) cass on placbo. At compltion th tial, a lag subst patints was obsvd up t10 additional yas, with littl additional xposu tACTOS. Duing th 13 yas both POactiv and obsvational ollow-up, th occunc bladd canc did not di btwn patints andomizd tACTOS placb(H =1.00; [95% CI: 0.59-1.72]).

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Tabl 22. Glycmic Paamts in a 16-Wk Placbo-Contolld, Add-on tMtomin Tial.

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ACTOS xts its antihypglycmic ct only in th psnc ndognous insulin. ACTOS should not b usd ttat typ 1 diabts diabtic ktoacidosis, as it would not b ctiv in ths sttings.

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