Effects of Nateglinide on Postprandial Plasma Glucose Excursion and Metabolism of Lipids in Chinese Patients with Type 2 Diabetes：A 4-week, randomized, active-control, open-label, parallel-group, multicenter trial.

Abstract

Abstract Background and objective Both nateglinide and acarbose can decrease postprandial plasma glucose through different mode of action, therefore may improve oxidative stress and inflammation in patients with type 2 diabetes mellitus (T2DM). There is lack of comprehensive data on effects of nateglinide versus acarbose on plasma glucose level, lipid profiles and inflammatory response of postprandial status in drug naïve Chinese patients with T2DM, therefore we conducted a clinical trial to answer these questions. Methods In a 4-week, randomized, active-control, open-label, parallel-group, multicenter trial, 160 anti-diabetic drug-naïve T2DM patients were randomized to receive either nateglinide or acarbose for 4 weeks. Postprandial glucose profiles with postprandial glucose excursion (PPGE), postprandial lipids profile and the postprandial pro-inflammatory factor of high sensitivity C - reactive protein (hsCRP) were assessed in a standardized meal test. Results Both nateglinide and acarbose could reduce PPGE 2 h significantly (P<0.01) and the two drugs had comparable effects on reducing glycated albumin (-1.2+1.57% and -1.2+2.13%, P<0.01). Nateglinide markedly decreased free fatty acids (FFA) at postprandial 30, 60, 90 minute (P<0.05), however acarbose had no effect on FFA. Furthermore, acarbose decreased fasting HDL-C significantly (P<0.01). No significant effect on hsCRP was found in either group. The number of people experiencing adverse events was similar (nateglinide 13.8%, acarbose 18.8%, P=0.521) and there was low frequency of symptomatic hypoglycemia in both groups (nateglinide 5%, acarbose 1.3%). No confirmed hypoglycemia or serious hypoglycemia was observed. Several limitations in the present study include that we cannot exclude the effect of behavior change in the glycemic control through the study, and the number of subjects was relatively small. Conclusions Nateglinide and acarbose were similar in controlling the postprandial glucose in Chinese drug naïve patients with T2DM. In addition, nateglinide had better performance on improving lipids metabolism under postprandial status in comparison with acarbose. Overall, nateglinide had a safety profile similar to acarbose in this study.