Effect of glyburide-metformin combination tablet in patients with type 2 diabetes.

Abstract

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.

CONCLUSION:

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.

• Authors: Hsin-Hsi Chien, Chwen-Tzuei Chang, Nain-Feng Chu, Sheng-Hwu Hsieh, Yu-Yao Huang, I-Te Lee, Wen-Jane Lee, Yih-Jing Tang, Wayne H H Sheu
• Journal: Journal of the Chinese Medical Association : JCMA (J Chin Med Assoc) Vol. 70 Issue 11 Pg. 473-80 (Nov 2007) ISSN: 1726-4901 [Print] Netherlands
• PMID: 18063500 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• Glucovance
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Metformin
• Glyburide

Topics

• Aged
• Blood Glucose (analysis)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Double-Blind Method
• Fasting (blood)
• Female
• Glyburide (adverse effects, therapeutic use)
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemic Agents (therapeutic use)
• Male
• Metformin (adverse effects, therapeutic use)
• Middle Aged
• Patient Compliance