[Efficacy and safety of extended-release metformin in treatment of type 2 diabetes mellitus].
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 No serious adverse events were found in both groups, and no patient was withdrawn due to adverse events of medication.


CONCLUSIONS
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.
Zhang
Jin-ping
JP
Department of Endocrionology, China-Japan Friendship Hospital, Beijing 100029, China.
Yang
Wen-ying
WY
Hong
Tian-pei
TP
Yang
Jin-kui
JK
Xiao
Wen-hua
WH
Gao
Hong-wei
HW
Yang
Yi
Y
D001786:Blood Glucose / Q000378:metabolism; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000097:blood; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011863:Radioimmunoassay; D016896:Treatment Outcome
D001786:Blood Glucose; D003692:Delayed-Action Preparations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin