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. Issue 1 (4th September 2018)

• Record Type: Journal Article
• Authors: Bae, Ji Cheol; Min, Kyung Wan; Kim, Yong Hyun; Kim, Kyoung‐Ah; Hong, Eun‐Gyoung; Park, Cheol‐Young; Han, Song; Cha, Bong‐Soo
• Is Part Of: Diabetes, obesity & metabolism. Volume 21:Issue 1(2019)
• Page Start: 103
• Page End: 111
• Publication Date: 2018-09-04
• Subjects: DPP IV inhibitor -- dyslipidaemia -- statin -- type 2 diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.13491
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract : 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.