SIX MONTH PHASE II TRIAL OF PIOGLITAZONE GROUP IN NIDDM PATIENTS

这是一项双盲、随机、安慰剂对照、平行、 吡格列酮组7.5、15、30、45 mg QD的疗效试验，固定剂量 在约310例NIDDM患者中进行的多中心研究。 患者将 进入为期6周的洗脱期，然后是为期2周的基线期 阶段，如果患者这样做，可以延长两周 不符合准入标准。 在获得研究资格后，患者将 随机分配至安慰剂组，口服7.5、15、30和45 mg，每日一次， 26周 任何发生不可接受的血液稀释（定义为 男性红细胞压积下降<35%，女性<32%）或 将经历>5%的诊室测量体重从基线增加， 由心脏病专家进行检查。 如果合适在 心脏病学家的意见，此类患者应停止试验 并给予参与长期开放标签试验的选择。 在 红细胞压积降低不能用以下原因解释的情况 心血管检查，病人可能会被转介到 血液学检查

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.