Comparison of the efficacy of glimepiride, metformin, and rosiglitazone monotherapy in korean drug-naïve type 2 diabetic patients: the practical evidence of antidiabetic monotherapy study

Abstract

Background: Although many anti-diabetic drugs have been used to control hyperglycemia for decades, the efficacy of commonly-used oral glucose-lowering agents in Korean type 2 diabetic patients has yet to be clearly demonstrated.

Methods: We evaluated the efficacy of glimepiride, metformin, and rosiglitazone as initial treatment for drug-naïve type 2 diabetes mellitus patients in a 48-week, double-blind, randomized controlled study that included 349 Korean patients. Our primary goal was to determine the change in HbA1c levels from baseline to end point. Our secondary goal was to evaluate changes in fasting plasma glucose (FPG) levels, body weight, frequency of adverse events, and the proportion of participants achieving target HbA1c levels.

Results: HbA1c levels decreased from 7.8% to 6.9% in the glimepiride group (P<0.001), from 7.9% to 7.0% in the metformin group (P<0.001), and from 7.8% to 7.0% (P<0.001) in the rosiglitazone group. Glimepiride and rosiglitazone significantly increased body weight and metformin reduced body weight during the study period. Symptomatic hypoglycemia was more frequent in the glimepiride group and diarrhea was more frequent in the metformin group.

Conclusion: The efficacy of glimepiride, metformin, and rosiglitazone as antidiabetic monotherapies in drug-naïve Korean type 2 diabetic patients was similar in the three groups, with no statistical difference. This study is the first randomized controlled trial to evaluate the efficacy of commonly-used oral hypoglycemic agents in Korean type 2 diabetic patients. An additional subgroup analysis is recommended to obtain more detailed information.

Keywords: Diabetes mellitus, type 2; Glimepiride; Metformin; Rosiglitazone.

Figures

Fig. 1

Enrollment and study outcomes. The total number of patients assigned to the three treatment groups was 349. A total of 36 patients left the glimepiride group, 43 left the metformin group, and 43 left the rosiglitazone group during the study period.

Fig. 2

Changes in HbA1c from baseline to end point. The black bar indicates the HbA1c level at baseline and gray bar at end point. Bars represent mean + standard deviation. aSignificant differences between HbA1c at 0 week and 48 weeks (P value<0.001). Repeated measured ANOVA test was used for statistical analysis. Between the three groups, HbA1c levels and changes were not statistically different (P value=0.62). ΔHbA1c Mean doses at end point

Fig. 3

Changes in HbA1c (A), fasting plasma glucose (FPG) (B), and body weight (C) over time, by treatment group. All panels, data are presented as mean±standard error of mean. aSignificant differences between the three treatment groups (P value<0.05).

Fig. 4

Proportion of patients achieving target HbA1c levels. Black bar indicates the proportion of patients achieving HbA1c levels less than 7.0% and white bar less than 6.5%. The χ2 test was used for comparison of differences in the three groups.