Objective: To compare the efficacy and tolerability of nateglinide with those of acarbose in Chinese type 2 diabetes mellitus (T2DM) patients.
Methods: This multi-center, randomized, double-blind, parallel-arm study compared the efficacy and tolerability of nateglinide (120 mg, 3/d, n = 119) and those of acarbose (100 mg, 3/d, n = 118) during a 12-week treatment in T2DM patients uncontrolled by diet with glycosylated haemoglobin (HbA1c) 6.5% - 11.0%.
Results: Monotherapy with nateglinide (120 mg, 3/d) or acarbose (100 mg, 3/d) decreased HbA1c to a similar extent during 12-week treatment. The mean change from baseline to end-point in HbA1c was (-0.90 +/- 0.98)% and (-0.83 +/- 0.81)% in patients receiving nateglinide and acarbose, respectively, with no significant difference between the two groups (P > 0.05). The decrease in fasting plasma glucose (FPG) was similar between nateglinide and acarbose (P > 0.05). The mean change in 2-hour postprandial plasma glucose (PG2h) was (-1.45 +/- 2.74) mmol/L and (-2.20 +/- 2.21) mmol/L in patients receiving nateglinide and acarbose (P = 0.0017). Body weight was significantly decreased in both groups at the end-point (P < 0.05), although the decrease was more with acarbose than nateglinide [(-0.66 +/- 1.79) kg vs (-2.06 +/- 2.00) kg, P = 0.0000]. And the proportion of patients experiencing any presumed drug related adverse events was not significantly different between the two groups.
Conclusions: Nateglinide (120 mg, 3/d) is effective and well tolerated in T2DM patients uncontrolled by diet, demonstrating similar HbA1c reductions as compared with acarbose (100 mg, 3/d).