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Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects.

Abstract：

BACKGROUND AND OBJECTIVE:Gemigliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes mellitus. This study evaluated possible pharmacodynamic and pharmacokinetic interactions between gemigliptin and metformin and investigated their tolerability. METHODS:A randomized, open-label, multiple-dose, three-treatment, three-period, three-sequence crossover study was conducted in healthy male subjects. Twenty-seven subjects received gemigliptin (50 mg once daily), metformin (1,000 mg twice a day), or both drugs for 7 days per dosing period. Blood samples were drawn over 24 h on the seventh day of each period for pharmacokinetic and pharmacodynamic evaluations, including plasma DPP-4 activity and total/active glucagon-like peptide-1 (GLP-1) levels. Meal tolerance tests were conducted for pharmacodynamic assessment on the eighth day. Safety and tolerability were evaluated using adverse events, vital signs, ECGs, and clinical laboratory tests. RESULTS:Coadministration of gemigliptin and metformin had no significant effect on the pharmacokinetics of gemigliptin or metformin. The inhibition of DPP-4 by gemigliptin was not affected by coadministration with metformin. Co-therapy of gemigliptin and metformin showed additional effects by increasing plasma active GLP-1 concentrations and lowering serum glucose levels. The plasma glucagon level was lower in co-therapy than with metformin monotherapy. The coadministration of gemigliptin and metformin was well-tolerated without serious adverse events. CONCLUSIONS:Coadministration of gemigliptin and metformin showed beneficial anti-diabetic effects without pharmacokinetic drug-drug interactions.

journal_name

Clin Drug Investig

journal_title

Clinical drug investigation

authors

Shin D,Cho YM,Lee S,Lim KS,Kim JA,Ahn JY,Cho JY,Lee H,Jang IJ,Yu KS

doi

10.1007/s40261-014-0184-3

subject

Has Abstract

pub_date

2014-06-01 00:00:00

pages

383-93

issue

6

eissn

1173-2563

issn

1179-1918

journal_volume

34

pub_type

杂志文章,随机对照试验

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