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Fig. 1
Adjusted mean change from baseline in HbA1c at week 24. Data are for the full-analysis set of participants (LOCF).
Fig. 2
Change from baseline in HbA1c over time. Data are for the full-analysis set of participants (LOCF).
Fig. 3
Change from baseline in HbA1c at week 24 by (A) duration of T2DM, (B) renal function and (C) race. eGFR, estimated glomerular filtration rate. Data are for the full-analysis set of participants (LOCF).
Abstract
Aims
Liver disease is highly prevalent among people with type 2 diabetes mellitus (T2DM). We evaluated the dipeptidyl peptidase-4 inhibitor linagliptin in subjects with T2DM and hepatic disorders.
Methods
Data were pooled from 17 randomized, double-blind, placebo-controlled clinical trials of linagliptin in T2DM subjects that included individuals with self-reported history of hepatic disorders at baseline. The primary endpoint was change in HbA1c from baseline to week 24.
Results
Of the 7009 participants (56% white, 39% Asian), 574 had hepatic disorders, most commonly hepatic steatosis (60%). At week 24, adjusted mean ± standard error (SE) change in HbA1c from baseline in those with hepatic disorders was −0.75% ± 0.05 with linagliptin and −0.20% ± 0.08 with placebo [treatment difference: −0.54% (95% confidence interval −0.72 to −0.36); P < .0001]. There was no significant difference in HbA1c reduction between subjects with or without baseline hepatic disorders (P = .4042). Among subjects with hepatic disorders, 13.5% and 14.8% of the linagliptin and placebo groups, respectively, reported drug-related adverse events while 10.4% and 15.9%, respectively, reported hypoglycemia. Overall, adverse event rates were similar in individuals with or without hepatic disorders.
Conclusions
This large pooled analysis suggests that linagliptin is effective and well tolerated in people with T2DM and liver disease.
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Conflict of Interest: N.I. has received speaker fees from Sanofi, Astellas Pharma and Boehringer Ingelheim; clinical research grants from MSD, Mitsubishi Tanabe Pharma, Eli Lilly, Roche Diagnostics and Shiratori Pharmaceutical; and scholarship grants from Sanofi, Takeda Pharmaceutical, Japan Tobacco, Mitsubishi Tanabe Pharma, MSD, AstraZeneca, Daiichi Sankyo, Boehringer Ingelheim, Ono Pharmaceutical, Taisho Toyama Pharmaceutical, and Sumitomo Dainippon Pharma. W.H.-H.S. has no conflicts of interest to declare. D.R.O. has received consultancy fees, speaker fees and/or travel grants from Boehringer Ingelheim. A.B. and Y.G. are employees of Boehringer Ingelheim. S.C. was an employee of Boehringer Ingelheim at the time of the study. S.P. was an employee of Boehringer Ingelheim at the time of the study, but is now an employee of Daiichi Sankyo Developments Ltd.
N.I., W.H.-H.S. and D.R.O. participated in the design of the study, interpretation of data and preparation of the manuscript. S.C. performed the statistical analysis, and participated in interpretation of data and preparation of the manuscript. A.B., Y.G. and S.P. participated in the design and conduct of the study, interpretation of data and preparation of the manuscript. All authors approved the final version of the manuscript.
