SIX MONTH PHASE II TRIAL OF PIOGLITAZONE GROUP IN NIDDM PATIENTS

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This is a double-blind, randomized, placebo controlled, parallel, and efficacy trial of 7.5,15,30,45mg QD of Pioglitazone group, fixed dose multicenter study in approximately 310 NIDDM patients. Patients will enter into a six-week washout phase, followed by a two-week baseline phase, which can be prolonged by an additional two weeks if patients do not meet entry criteria. After qualifying for the study, patients will be randomized to placebo, 7.5, 15, 30 and 45 mg given orally, once daily for 26 weeks. Any patients experiencing unacceptable hemodilution (defined as a reduction of hematocrit <35% for male and <32% for female) or who experiences a >5% office measured weight gain from baseline will be referred for examination by a cardiologist. If appropriate in the cadiologist's opinion, such patients shall be discontinued from the trial and given the option to participate in a long-term open label trial. In those instances where the decrease in hematocrit cannot be explained by the cardiovascular examination, the patients may be referred for a hematological examination.