Randomized controlled multicenter clinical trial of domestic nateglinide and imported repaglinide in the treatment of types 2 diabetes

Objective To compare the efficiency and safety of domestic nateglinide and imported repaglinide. Methods The study was designed in double blind and double simulation fashion. Two hundreds ten patients with type 2 diabetes were randomized to two groups, one to receive domestic na- teglinide (105 cases) and the other imported repaglinide (105 cases). The study was concluded after 14 weeks. Results After 14 weeks of treatments, mean HbA1c levels of patients in both groups receiving nateglinide and repaglinide were lowered with statistical significance [nateglinide was (9.06±1.54)% vs (7.85±1.00)%, P0.05 and repaglinide was (8.95±1.56)% vs (7.76±1.04)%, P0.05]. The levels of postprandial plasma glucose were lowered also[nateglinide was (14.17±3.44) mmol·L~ -1 vs (10.90±2.97) mmol·L~ -1, P0.05 and repaglinide was (14.14±3.11) mmol·L~ -1 vs (10.89±3.09) mmol·L~ -1, P0.05]. Both fast insulin and plasma glucose levels in the testing groups were lowered as well, but the differences were not statistically significant. Major adverse effect observed was mild hypoglycemia. Conclusion With satisfactory level of safety, the domestic nateglinide and imported repaglinide demonstrated same level of efficiency in the treatment of patients with types 2 diabetes.