OBJECTIVE

To study the efficacy and safety of extended-release metformin and Glucophage in treatment of type 2 diabetes mellitus.

METHODS

150 out-patients with type 2 diabetes mellitus visiting 3 hospitals in Beijing were randomly divided into two equal groups: study group treated with extended-release metformin 1500 mg qd for 12 weeks, and control group treated with Glucophage (tablet of metformin, 500 mg, tid) and in for 12 weeks. The levels of fasting plasma glucose (FPG), plasma glucose 2 h after meal (2 hPG), and glycated hemoglobin (HbA1c) were examined before and 12 weeks after treatment. Plasma insulin was detected by radioimmunoassay.

RESULTS

Completed study had been obtained in 140 patients, 71 in the control group and 69 in the study group. 12 weeks after treatment there was no significant difference in the FPG level between these two groups (P = 0.07), the postprandial plasma glucose level decreased by 0.4 (-1.4 approximately 1.7) mmol/L in the control group and increased slightly in the study group (P = 0.002), however, the levels plasma glucose area under curve 2 hours after meal in these 2 groups did not changed significantly (P = 0.64). HbA1c decreased in both groups and there was not significant difference between these two groups (P = 0.73). The adverse event rates of the study and control groups were 10.8% and 4.3% respectively (P = 0.21), and the main adverse events were gastrointestinal side effects. No serious adverse events were found in both groups, and no patient was withdrawn due to adverse events of medication.

CONCLUSION

The efficacy and safety of extended-release metformin within 12 week treatment for type 2 diabetes mellitus is comparable to those of Glucophage treatment with good compliance and mild adverse side effects.