Abstract
This was a multi-center, open-label, randomized, active-control, parallelgroup study which compared the effects of nateglinide paralleled with those of acarbose on postprandial glucose excursions in Chinese anti-hyperglycemic agent naïve subjects with type 2 diabetes mellitus by continuous glucose monitoring system (CGMS). A total of 103 anti-hyperglycemic agent naïve subjects with type 2 diabetes mellitus [age: 53.5±9.81 yrs, duration of diabetes: 0.1 (0.8) yrs] from four hospitals in China were randomized (1:1) to nateglinide 120mg TID or acarbose 50mg TID groups. After 14 days treatment, compared with baseline, both nateglinide and acarbose reduced the area under curve of 0-4 hours postprandial glucose (AUCpp) significantly (P<0.001).Whereas no significant differences were found between two groups (P= 0.6908). The mean blood glucose (MBG), mean amplitude glycemic excursions (MAGE) and standardized difference of daily blood glucose excursion (SDBG) decreased significantly in both groups (all P<0.001). No significant differences were found between two groups in reductions of MBG, MAGE, SDBG after treatment. Both the two agents had comparable effects on reducing glycated albumin [2.0 (2.5) % and 1.0 (1.6) %, P<0.0001].The rates of adverse events (AE) and AE related to trial products were significantly higher in acarbose group than nateglinide group (P<0.05). No serious AE was noted. The rates of hypoglycemic episodes were comparable in two groupsThere was no severe hypoglycemic episode being noted in either group. Our study suggests that nateglinide was well tolerated among patients recruited in this study. It showed that natiglinide had comparable effectiveness with acarbose in reducing postprandial glucose excursions in Chinese anti-hyperglycemic agent naïve subjects with type 2 diabetes mellitus.