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

doi:10.1111/dom.13491

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

Department of Medicine

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

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.

Original language	English
Pages (from-to)	103-111
Number of pages	9
Journal	Diabetes, Obesity and Metabolism
Volume	21
Issue number	1
DOIs	https://doi.org/10.1111/dom.13491
State	Published - Jan 2019

Keywords

DPP IV inhibitor
dyslipidaemia
statin
type 2 diabetes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Dive into the research topics of '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'. Together they form a unique fingerprint.

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Bae, J. C., Min, K. W., Kim, Y. H., Kim, K. A., Hong, E. G., Park, C. Y., Han, S., & Cha, B. S. (2019). 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. Diabetes, Obesity and Metabolism, 21(1), 103-111. https://doi.org/10.1111/dom.13491

Bae, Ji Cheol ; Min, Kyung Wan ; Kim, Yong Hyun et al. / 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. In: Diabetes, Obesity and Metabolism. 2019 ; Vol. 21, No. 1. pp. 103-111.

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title = "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",

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.",

keywords = "DPP IV inhibitor, dyslipidaemia, statin, type 2 diabetes",

author = "Bae, {Ji Cheol} and Min, {Kyung Wan} and Kim, {Yong Hyun} and Kim, {Kyoung Ah} and Hong, {Eun Gyoung} and Park, {Cheol Young} and Song Han and Cha, {Bong Soo}",

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year = "2019",

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doi = "10.1111/dom.13491",

language = "English",

volume = "21",

pages = "103--111",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

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Bae, JC, Min, KW, Kim, YH, Kim, KA, Hong, EG, Park, CY, Han, S & Cha, BS 2019, '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', Diabetes, Obesity and Metabolism, vol. 21, no. 1, pp. 103-111. https://doi.org/10.1111/dom.13491

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. / Bae, Ji Cheol; Min, Kyung Wan; Kim, Yong Hyun et al.
In: Diabetes, Obesity and Metabolism, Vol. 21, No. 1, 01.2019, p. 103-111.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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)

T2 - A multicentre, randomized, double-blind, controlled, phase 3 trial

AU - Bae, Ji Cheol

AU - Min, Kyung Wan

AU - Kim, Yong Hyun

AU - Kim, Kyoung Ah

AU - Hong, Eun Gyoung

AU - Park, Cheol Young

AU - Han, Song

AU - Cha, Bong Soo

PY - 2019/1

Y1 - 2019/1

N2 - 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.

AB - 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.

KW - DPP IV inhibitor

KW - dyslipidaemia

KW - statin

KW - type 2 diabetes

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U2 - 10.1111/dom.13491

DO - 10.1111/dom.13491

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AN - SCOPUS:85052959262

SN - 1462-8902

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JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

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Bae JC, Min KW, Kim YH, Kim KA, Hong EG, Park CY et al. 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. Diabetes, Obesity and Metabolism. 2019 Jan;21(1):103-111. doi: 10.1111/dom.13491

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

Abstract

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