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

$0M01FY2000RRNIH

Washington University, Saint Louis MO

Investigators

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Abstract

This is an open label, open ended, long-term, dose titration, multicenter study in approximately 600 NIDDM patients. Treatment duration will be at least 12 months. Patients elibible for participation in this study may have completed or withdrawn from other AD-4833 studies, or may have never previously recieved AD-4833. All patients will begin active dosing with 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. Doses will be decreased if the administration of AD-4833 is not tolerable for the patient.

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