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OPEN LABEL LONG TERM TOLERABILITY OF PIOGLITAZONE AD 48333 IN NIDDM PATIENTS

$0M01FY2001RRNIH

Washington University, Saint Louis MO

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Abstract

Multicenter study in approximately 600 NIDDM patients. All patients will be given 7.5 mg of AD-4833 orally, once daily. Based on the level of fasting blood glucose (FBG) a decision of further titrating the dose or maintaining the same level will be made after four weeks. The dose will be adjusted if the FBG does not meet the criteria <140mg/dl at each visit. Echocardiogram and electrocardiogram should be performed for any patients experiencing unacceptable hemodilution or who experiences a>5% office measured weight gain from baseline.

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