ArticleClinical drug investigation2014
Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment.
Article in Clinical drug investigation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00976326 (A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal Hepatic Function), which is not on this map. Cited by 16 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal Hepatic Function
Who cites it
16 citing papers in PubMed.
- The Effect of Various Degrees of Renal or Hepatic Impairment on the Pharmacokinetic Properties of Once-Weekly Insulin Icodec.Clinical pharmacokinetics · 2024Trial
- Safety and Effectiveness of Insulin Degludec in Patients With Type 2 Diabetes Mellitus With Chronic Liver Disease.Cureus · 2026Article
- In-Hospital Management of Hyperglycemia: The Role of Insulin Degludec.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Review
- Considerations for Insulin-Treated Type 2 Diabetes Patients During Hospitalization: A Narrative Review of What We Need to Know in the Age of Second-Generation Basal Insulin Analogs.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Review
- Clinical implications, diagnosis, and management of diabetes in patients with chronic liver diseases.World journal of hepatology · 2020Review
- The Clinical Role of Insulin Degludec/Insulin Aspart in Type 2 Diabetes: An Empirical Perspective from Experience in Australia.Journal of clinical medicine · 2020Review
- A Review of Insulin Degludec/Insulin Aspart: Pharmacokinetic and Pharmacodynamic Properties and Their Implications in Clinical Use.Clinical pharmacokinetics · 2017Review
- Pharmacokinetic and pharmacodynamic properties of insulin degludec in Japanese patients with type 1 diabetes mellitus reflect similarities with Caucasian patients.Journal of diabetes investigation · 2016Article
- Current Concepts in Diabetes Mellitus and Chronic Liver Disease: Clinical Outcomes, Hepatitis C Virus Association, and Therapy.Digestive diseases and sciences · 2016Review
- Concentrated insulins: the new basal insulins.Therapeutics and clinical risk management · 2016Review
- Long-term safety and efficacy of insulin degludec in the management of type 2 diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2015Review
- Degludec: the new ultra-long insulin analogue.Diabetology & metabolic syndrome · 2015Article
- A review of the pharmacological properties of insulin degludec and their clinical relevance.Clinical pharmacokinetics · 2014Review
- Insulin degludec/insulin aspart combination for the treatment of type 1 and type 2 diabetes.Vascular health and risk management · 2014Review
- Patient safety and minimizing risk with insulin administration - role of insulin degludec.Drug, healthcare and patient safety · 2014Review
- Consensus Statement on Dose Modifications of Antidiabetic Agents in Patients with Hepatic Impairment.Indian journal of endocrinology and metabolismReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveInsulin degludec is a basal insulin with a slow and distinct absorption mechanism resulting in an ultra-long, flat, and stable pharmacokinetic profile in patients with diabetes mellitus. The aim of this study was to examine the effect of hepatic impairment on the single-dose pharmacokinetics of insulin degludec.
methodsTwenty-four subjects, allocated to one of four groups (n=6 per group) based on level of hepatic impairment (normal hepatic function, Child-Pugh grade A, B, or C), were administered a single subcutaneous dose of 0.4 U/kg insulin degludec. Blood samples up to 120 h post-dose and fractionated urine samples were collected to measure pharmacokinetic parameters.
resultsNo difference was observed in pharmacokinetic parameters [area under the 120-h serum insulin degludec concentration-time curve (AUC120 h), maximum insulin degludec concentration (C max), and apparent clearance (CL/F)] for subjects with impaired versus normal hepatic function after a single dose of insulin degludec. The geometric mean [coefficient of variation (CV) %] AUC120 h values were 89,092 (16), 83,327 (15), 88,944 (23), and 79,846 (19) pmol·h/L for normal hepatic function and mild, moderate, and severe hepatic impairment, respectively. Simulated steady-state insulin degludec pharmacokinetic profiles showed an even distribution of exposure across a 24-h dosing interval regardless of hepatic function status.
conclusionsThe ultra-long pharmacokinetic properties of insulin degludec were preserved in subjects with hepatic impairment and there were no statistically significant differences in absorption or clearance compared with subjects with normal hepatic function.
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