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Efficacy and safety of fixed-dose combination therapy with gemigliptin (50 mg) and rosuvastatin compared with monotherapy in patients with type 2 diabetes and dyslipidaemia (BALANCE): A multicentre, randomized, double-blind, controlled, phase 3 trial

 Ji Cheol Bae  ;  Kyung Wan Min  ;  Yong Hyun Kim  ;  Kyoung‐Ah Kim  ;  Eun‐Gyoung Hong  ;  Cheol‐Young Park  ;  Song Han  ;  Bong‐Soo Cha 
 DIABETES OBESITY & METABOLISM, Vol.21(1) : 103-111, 2019 
Journal Title
Issue Date
Aged ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy* ; Dipeptidyl-Peptidase IV Inhibitors*/adverse effects ; Dipeptidyl-Peptidase IV Inhibitors*/therapeutic use ; Double-Blind Method ; Dyslipidemias/complications ; Dyslipidemias/drug therapy* ; Female ; Glycated Hemoglobin A/analysis ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors*/adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors*/therapeutic use ; Male ; Middle Aged ; Piperidones*/adverse effects ; Piperidones*/therapeutic use ; Pyrimidines*/adverse effects ; Pyrimidines*/therapeutic use ; Rosuvastatin Calcium*/adverse effects ; Rosuvastatin Calcium*/therapeutic use
DPP IV inhibitor ; dyslipidaemia ; statin ; type 2 diabetes
AIM: To evaluate the efficacy and safety of a fixed-dose combination (FDC) of gemigliptin and rosuvastatin in patients with type 2 diabetes and dyslipidaemia.

RESEARCH DESIGN AND METHODS: A total of 33 hospitals in Korea participated in this randomized, double-blind trial of diabetic patients with dyslipidaemia. A total of 290 participants were randomly assigned at a 1:1:1 ratio to receive an FDC of gemigliptin (50 mg) and rosuvastatin (20 mg) (GEMI/ROSU FDC group), gemigliptin (50 mg) (GEMI group) or rosuvastatin (20 mg) (ROSU group). Rosuvastatin was up-titrated from 5 to 20 mg/d throughout the study period. Primary efficacy measures were changes in HbA1c and LDL-C from baseline to Week 24 between the GEMI/ROSU FDC and ROSU groups and between the GEMI/ROSU FDC and GEMI groups, respectively. Secondary efficacy measures were changes in HbA1c and LDL-C between the GEMI/ROSU FDC and GEMI groups and between the GEMI/ROSU FDC and ROSU groups, respectively.

RESULTS: After 24 weeks of treatment, a significant reduction in HbA1c from baseline was noted in the GEMI/ROSU FDC group (-0.81% of LS mean; P < 0.0001 vs ROSU group), in addition to a significant reduction in LDL-C concentration (-51.9% of LS mean percentage changes, P < 0.0001 vs GEMI group). HbA1c was significantly reduced from baseline in both the GEMI/ROSU FDC and GEMI groups, but the reduction in HbA1c was significantly greater in the GEMI group than in the GEMI/ROSU FDC group, despite receiving the same dose of gemigliptin. The decrease in LDL-C over time was similar between the GEMI/ROSU FDC and ROSU groups. There were no significant differences in adverse events among the groups.

CONCLUSION: The FDC of gemigliptin and rosuvastatin is safe and is effective in reducing both blood glucose and LDL-C levels; thus, it could be a good therapeutic choice for type 2 diabetic patients with dyslipidaemia.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cha, Bong Soo(차봉수) ORCID logo https://orcid.org/0000-0003-0542-2854
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