BALANCE study : Safety and Efficacy of Gemigliptin and Rosuvastatin as Fixed dose combination therapy Ji Cheol Bae, Kyungwan Min, Yong Hyun Kim, Kyoung-ah Kim, Eun-Gyoung Hong, Cheol-Young Park, Song Han, Hye Jin Yoon, Bong-Soo Cha Background Diabetes is highly likely to be accompanied with dyslipidemia and the risk of cardiovascular disease occurrence is significantly increased. Controlling of blood glucose and LDL-C in patients with type 2 diabetes mellitus (T2DM) have direct effects on the occurrence of cardiovascular disease, a complex treatment approach is necessary. Aim This study was to demonstrate the efficacy and safety of the fixed-dose combination (FDC) therapy of gemigliptin, a potent and selective DPP-4 inhibitor and rosuvastatin, a potent HMG-CoA reductase inhibitor compared to each mono-therapy in T2DM patients with dyslipidemia. Method In this randomized, placebo-controlled, double-blind, phase III trial, a total 290 T2DM patients with dyslipidemia who couldn’t achieve adequate glycemic control with more than 6 weeks before screening of stable metformin mono therapy (≥1000mg/day) were randomized (1:1:1) to gemigliptin/ rosuvastatin FDC (n=96), gemigliptin (n=97) or rosuvastatin (n=97). Subjects received gemigliptin 50 mg and rosuvastatin with forced up-titration from 5 mg to 20 mg at 8-week interval, while maintained metformin dose during the study period. The primary endpoints were changes from baseline in HbA1c and low-density lipoprotein cholesterol (LDL-C) after 24 weeks. Results : Baseline demographics and clinical characteristics were well balanced among treatment groups (mean HbA1c 7.79 ± 0.78 %; LDL-C 136.3 ± 27.8 mg/dL; age 55.9 ± 10.1 years; BMI 25.5 ± 3.2 kg/m2, duration of T2DM 6.6 ± 5.7 years). At 24 weeks, the LSM (least square mean+SE) difference of change of HbA1c (%) [(gemigliptin/rosuvastatin FDC)-(rosuvastatin)] was -0.81 ± 0.11% [95% CI(-1.04, -0.59)] and the LSM difference of % change of LDL-C (mg/dL) [(gemigliptin/rosuvastatin FDC)-(gemigliptin)] was -51.9 ± 2.7 % [95% CI (-57.3, -46.5)]. The differences in proportions achieving an HbA1c < 7% or LDL-C < 100 mg/dL were also statistically significant (p<0.001) between the FDC and the mono-therapy group, respectively. There were no significant differences in adverse event among gemigliptin/rosuvastatin FDC, gemigliptin and rosuvastatin group(45.8%, 30.9% and 39.2% respectively). Discussion Gemigliptin/rosuvastatin FDC helps to achieve adequate blood glucose and LDL-C levels, it is expected that gemigliptin/rosuvastatin FDC could be a new therapeutic choice in T2DM patients with dyslipidemia.
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