OBJECTIVE: To evaluate the efficacy and safety of pioglitazone hydrochloride in the treatment of type 2diabetes mellitus patients, a double-blind double-dummy metformin-controlled trial was carried out. METHODS:A randomized, double-blind, metformin-controlled, and multicenter clinical trial was conducted. A total of 227 patients with type 2 diabetes mellitus were enrolled in this study, in which 113 patients received pioglitazone 30mg once daily, and 114 patients received metfbrmin 250mg b.i.d, for 12 weeks. RESULTS:Comparing to the baseline, the fasting blood glucose (FBG), 2h postprandial blood glucose (P2hBG) and HbA1C levels in tow groups were significantly reduced after 12-week treatment (P<0.01). In pioglitazone group, the mean reductions of FBG, P2hBG and HbA1C levels were 1.42±1.93mmol.L-1 (13.41 ±18.65%), 4.42±3.96mmol.L-1(26.94±21.32%), 0.80±1.57% respectively, the efficacy rate of reduction of FBG and P2hBG were 75.82% and 86.24%. In metformin group, the mean reductions of FBG, P2hBG and HbA1C levels were 1.62±2.17mmol. L-1( 15.45±20.13%), 3.89±3.75mmol.L-1(24.27±21.54%), 0.89±1.39% respectively, the efficacy rate of reduction of FBG and 2hPBG were 82.42%,77.36%.,The differencesin reductions of FBG, P2hBG and HbA1C level between the groups were not statistically significant. The incidence of adverse effects in tow groups was similar. Hepatic function did not significantly change after treatment. CONCLUSION: This result provides an efficacy in glycemic control and a safety profile of pioglitazone in the treatment of type 2 diabetes mellitus.
The Chinese Journal of Clinical Pharmacology
diabetes mellitus,non-insulin dependent