SIX MONTH PHASE II TRIAL OF PIOGLITAZONE GROUP IN NIDDM PATIENTS

这是一种双盲、随机、安慰剂对照、平行和 吡格列酮组固定剂量7.5、15、30、45 mg每日1次的疗效试验 对大约310名NIDDM患者进行了多中心研究。患者会 进入为期六周的淘汰阶段，然后是为期两周的基线 阶段，如果患者这样做，可以再延长两周 不符合入围标准。在获得研究资格后，患者将被 随机分为安慰剂、7.5毫克、15毫克、30毫克和45毫克口服，每日一次 26周。任何接受不可接受血液稀释的患者(定义为 男性红细胞压积下降35%，女性下降32%)或世卫组织 体验&>5%的办公室测量体重将比基线增加 转介给心脏病专家检查。如果合适，请在 心内科医生的意见，这样的患者应该停止试验 并给予参与长期开放标签试验的选择权。在……里面 那些红细胞压积下降不能用 心血管检查，患者可转诊至 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.