To observe the efficacy and safety of pigolitazone/metformin fixed-dose combination therapy replacing metformin alone or combined with other anti-diabetes drugs in type 2 diabetes with poor glycemic control.

80 cases were recruited, with an average age of (54.79±13.99) years, diabetes history of (9.76±6.59) and baseline HbA1c (9.06±1.34) %. All participants received pigolitazone/metformin instead of metformin without other treatment changes. Glycemic control (level of fast blood glucose, HbA1c) was evaluated at 12 weeks, as well as lipid profiles, liver and renal function, adverse events and body weight.

8 cases were lost to visit, 4 cases were withdrawn for edema, only 68 subjects finished the study. Compared to the baseline, after 12-week treatment, FPG decreased for (2.06+0.16) mmol/L, HbA1c decreased for (0.84+0.23) %, both of the differences were statistically significant (P<0.001, P<0.001) . Body weight increased (0.34+1.13) kg, with no difference compared to the baseline. The lipid profile presented elevated high density lipoprotein cholesterol (P=0.012) and decreased total cholesterol, low density lipoprotein cholesterol, triglyceride, while the latter three items showed no differences (P>0.05, P>0.05, P>0.05) . Indexes reflecting liver and renal function, such as ALT, AST, TBIL, DBIL, Urea, UA, Cr showed no differences compared with the baseline. Adverse events analysis showed at the end of the study, no severe hypoglycemia and serious cardiovascular events occurred, 6 cases suffered edema, among whom 4 patients exited the study for severe lower limb edema. No extra gastrointestinal symptom happened.

Pigolitazone/metformin fixed-dose combination exhibits an excellent efficacy and safety for T2DM, with satisfying tolerability and compliance, which is a selection for those patients with poor glycemic control.

Pioglitazone/metformin fixed-dose combination; Glycemic; HbA1c; T2DM