单用罗格列酮治疗早期2型糖尿病的临床研究

目的 :观察国产罗格列酮片治疗2型糖尿病的临床疗效及安全性。方法 :按双盲、随机及安慰剂对照的方法进行Ⅱ期临床试验 ,试验组给予罗格列酮4mg(n=27) ,对照组给予安慰剂(n=27) ,每日1次 ,疗程均为8wk。结果与结论 :试验组空腹血糖及餐后2h血糖比基础值分别下降27 1 %和55 7 % ,对照组分别下降10 6 %和19 8 % ,试验组空腹及餐后2h血糖下降明显大于对照组(P均<0 01)。罗格列酮不良反应发生率与对照组接近 ,未见肝功能损害等严重不良反应

Clinical Study on Rosiglitazone Monotherapy of Early Type 2 Diabetes

OBJECTIVE:To evaluate the efficacy and safety of domestic rosiglitazone monotherapy in newly diagnosed patients whose type 2 diabetes is inadequately controlled.METHODS:In a double-blind,randomized,with placebo controlled phase Ⅱ clinical trial,patients were assigned to receive 4mg/d of rosiglitazone(n=27) or placebo(n=27) for 8 weeks.RESU-LTS & CONCLUSION:Fasting and postprandial plasma glucose levels of the rosiglitazone group decreased by 27.1% and 55.7%,and fasting and postprandial plasma glucose levels of the control group decreased by 10.6% and 19.8% respectively.These changes of fasting and postprandial plasma glucose levels in the rosiglitazone group were significantly higher than those in the placebo group(P<0.01 for both).The proportion of patients reporting adverse experiences was comparable between two groups.No liver damage has been found.