Effect of glyburide-metformin combination tablet in patients with type 2 diabetes.
BACKGROUND
To evaluate the efficacy and safety of glyburide/metformin combined tablet compared to glyburide or metformin alone in patients with type 2 diabetes.


METHODS
In this 16-week, multicenter, randomized, double-blind, 4-arm and parallel clinical trial study, 100 patients with type 2 diabetes mellitus were recruited and 76 patients were available for statistical analysis at the end of the study. After 1 week of placebo washout period, eligible patients were randomly assigned into 1 of 4 treatment groups: glyburide 5 mg b.i.d.; metformin 500 mg b.i.d.; glyburide/metformin 2.5 mg/500 mg b.i.d.; or glyburide/metformin 5.0 mg/500 mg b.i.d. The doses were titrated every 2 weeks to a maximum of 4 tablets per day if the patients fasting plasma glucose (FPG) still exceeded 140 mg/dL. Efficacy was evaluated by the changes from baseline in glycosylated hemoglobin (HbA1c) and FPG at week 16. Adverse events were recorded and summarized by treatment group.


RESULTS
At week 16, patients who received glyburide/metformin 2.5 mg/500 mg or 5.0 mg/500 mg tablets had greater reductions in FPG (all p<0.001) compared with glyburide or metformin monotherapy. Patients who took glyburide/ metformin 2.5 mg/500 mg tablet and glyburide/metformin 5.0 mg/500 mg tablet had significant decreases in HbA1c (both p<0.0125). Furthermore, treatment with glyburide/metformin 2.5 mg/500 mg resulted in significantly greater reduction in HbA1c compared to glyburide or metformin (-1.77%, p<0.001 and -1.34%, p=0.002), and treatment with glyburide/metformin 5.0 mg/500 mg resulted in significant lowering of HbA1c compared to glyburide or metformin alone (-1.73%, p<0.001 and -1.30%, p=0.005). Both the glyburide/metformin 2.5 mg/500 mg and glyburide/metformin 5.0 mg/500 mg combination therapy groups experienced fewer gastrointestinal adverse events than the metformin monotherapy group.


CONCLUSIONS
Both glyburide/metformin 2.5 mg/500 mg and glyburide/metformin 5.0 mg/500 mg combination therapy were efficacious and well tolerated in the treatment of Chinese patients with type 2 diabetes mellitus.
Chien
Hsin-Hsi
HH
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan, ROC.
Chang
Chwen-Tzuei
CT
Chu
Nain-Feng
NF
Hsieh
Sheng-Hwu
SH
Huang
Yu-Yao
YY
Lee
I-Te
IT
Lee
Wen-Jane
WJ
Tang
Yih-Jing
YJ
Sheu
Wayne H H
WH
D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005215:Fasting / Q000097:blood; D005260:Female; D005905:Glyburide / Q000009:adverse effects / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010349:Patient Compliance
D001786:Blood Glucose; D005905:Glyburide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; C417231:Glucovance