Efficacy and safety of glipizide/metformin hydrochloride combination tablets for patients with type 2 diabetes

Objective To assess efficacy and safety of glipizide/metformin hydrochloride combination tablets in patients with type 2 diabetes mellitus. Methods A multicenter, double–masked, parallel–group, double–mimic active–controlled study was peformed. 240 patients (43 new diagnoses, 197 oral mono–therapy)with lifestyle inventions and oral mono–therapy type 2 diabetes mellitus from 4 centers were enrolled in this study and blindly into the A group( n=120, glipizide combined with metformin hydrochloride) and the B group(n=120, glipizide/metformin hydrochloride combination tablets). The whole observation lasted for 12 weeks. The efficacy indicators measured include glycohemoglobin A1c (HbA1c), fasting plasma glucose and 2 hours postprandial plasma glucose and the safety parameters measure include renal and hepatic function, serum lipids, blood profiles, urea profiles and adverse events. The data of statistics were analyzed by non–inferiority evaluation. Results After 12 weeks' treatment, the decreased values of HbA1c was 2.64%(A group) vs 2.68%(B group) in new diagnoses and 1.06%(A group) vs 1.26%(B group) in oral mono–therapy. Glipizide/metformin hybroch loride tablets also reduced fasting plasma glucose and 2 hours postprandial plasma glucose, Similar decrease in fasting plasma glucose, 2 hours postprandial plasma glucose and HbA1c were found in both A and B group without significant differences. No severe adverse events were noted. The hypoglycemia event reports were not significantly different between these two groups. Conclusion Glipizide/metformin hydrochloride tablets were similar efficacy and safety profiles with glipizide combined with metformin in patients with type 2 diabetes mellitus. Key words: Diabetes mellitus; Treatment outcome; Safety