Efficacy comparison and preliminary safety analysis of gliclazide modified-release combined with morning or evening taking metformin in patients with newly diagnosed type 2 diabetes mellitus

Abstract

Objective To compare the effect of gliclazide modified-release combined with morn ing or evening taking metformin to glycosylated hemoglobin A1 c (HbA1 c)and homeostasis model assessment(HOMA-IR and HOMA-β)on patients with newly diagnosed type 2 diabetes mellitus and its safety.Methods This 12-week study included 60 newly diagnosed type 2 diabetic patients who were randomly divided into two groups.Based on diet controlling and exercise therapy,patients in group A received gliclazide modified-release (diamicron) 60 mg (2 tablets) once daily before breakfast and metformin (glucophage) 850 mg(1 tablet) once daily after breakfast; patients in group B received gliclazide modifiedrelease tablet (diamicron) 60 mg (2 tablets) once daily before breakfast and metformin (glucophage) 850 mg (1 tablet) once daily after supper.Fasting blood glucose (FBG),Postprandial 2 h plasma glucose (2 h PG),Fasting insulin (F-ins),Postprandial 2 h insulin (P-ins),HbA1 c,Body weight,liver and kidney functions,triglyceride (TG),total cholesterol (TC),electrocardiogram (ECG),adverse drug reactions were measured and recorded.Results Glycosylated henoglobin A1c (HbA1c) in group A and B decreased (0.93 ± 0.63) ％ and (0.99 ± 0.89) ％,respectively,there was no significant differences between the two groups (P ＞ 0.05),HOMA-IR decreased 0.52 ± 0.62 in group A and 0.34 ± 0.59 in group B,there was no significant difference between the two groups (P ＞ 0.05).HOMA-βincreased (13.59 ± 12.83) ％ in group A and (11.35 ± 15.40) ％ in group B,there was no significant difference between the two groups (P ＞ 0.05).Conclusions Combination of gliclazide modified-release and metformin could decrease HbA1c,improve insulin resistence and increase β-cell function effectively,there is no significantly difference in morning or evening taking metformin. Key words: Type 2 diabetes mellitus; Chronotherapy ; Gliclazide modified-release ; Metformin