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Pharmacokinetic/Pharmacodynamic Interaction between Evogliptin and Pioglitazone in Healthy Male Subjects
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  • Inyoung Hwang,
  • Yun Kim,
  • Hyounggyoon Yoo,
  • In-Jin Jang,
  • Kyung-Sang Yu,
  • SeungHwan Lee
Inyoung Hwang
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Yun Kim
Seoul National University College of Medicine and Hospital
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Hyounggyoon Yoo
Seoul National University College of Medicine
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In-Jin Jang
Seoul National University College of Medicine
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Kyung-Sang Yu
Seoul National University Hospital
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SeungHwan Lee
Seoul National University College of Medicine and Hospital
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Abstract

Aims: Evogliptin is a newly developed oral glucose-lowering medication of dipeptidyl peptidase 4 (DPP-4) inhibitor class for type 2 diabetes mellitus. Combination of DPP-4 inhibitor with pioglitazone is a promising therapeutic option. The aim of present study was to evaluate pharmacokinetic and pharmacodynamic interaction between evogliptin and pioglitazone. Methods: A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence crossover study was conducted in healthy Korean male subjects. All subjects received evogliptin 5 mg once daily for 7 days (EVO), pioglitazone 30 mg once daily for 7 days (PIO) and co-administration of evogliptin 5 mg and pioglitazone 30 mg once daily for 7 days (EVO+PIO) according to the assigned sequence and period. Serial blood samples were collected for 24 hours for pharmacokinetic analysis and 3 hours after oral glucose tolerance test for pharmacodynamic analysis. Results: Thirty-four subjects completed the study. EVO+PIO and EVO showed similar maximum plasma concentration at steady state (Cmax,ss) and the area under the concentration-time curve during dosing interval at steady state (AUCτ,ss) of evogliptin, with geometric mean ratios (GMRs) (90% confidence interval (CI)) of 1.01 (0.97-1.05) and 1.01 (0.98-1.04), respectively. EVO+PIO and PIO showed similar Cmax,ss and AUCτ,ss of pioglitazone, with GMRs (90% CI) of 1.07 (0.99-1.17) and 1.08 (0.99-1.17), respectively. Reduction of glucose level after EVO+PIO was larger compared to PIO, and similar with EVO. Conclusion: Concomitant administration of evogliptin and pioglitazone showed similar glucose lowering effects with those of evogliptin alone without pharmacokinetic interactions when compared to intake of each drug alone.