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Study · Non-randomized trial · n = 30 · 2009

6 results

Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide.

Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M

British journal of clinical pharmacology1 Dec 2009Cited by 144 (Europe PMC)

PMID20002084 (opens in a new tab)PMCIDPMC2810801 (opens in a new tab)DOI10.1111/j.1365-2125.2009.03536.x (opens in a new tab)PepBankPUB-20002084
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In subjects given a single liraglutide dose, the degree of renal impairment did not appear to be associated with an increased risk of adverse events.

    In plain wordsAfter one liraglutide dose, worse kidney function did not seem to raise the risk of side effects.

    Peptide
    Liraglutide
    Outcome
    No significant changeAdverse events by degree of renal impairment
    Study

    n = 30

    Outcome group
    Adverse events · Kidney and urinary
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Degree of renal impairment did not appear to be associated with an increased risk of adverse events.
    1 context sentence
    Summary · context
    A cohort of 30 subjects, of whom 24 had varying degrees of renal impairment and six had normal renal function, were given a single dose of liraglutide, 0.75 mg subcutaneously, and completed serial blood sampling for plasma liraglutide measurements for pharmacokinetic estimation.
  2. 02HumanNon-randomized trialPharmacokinetics

    In subjects with severe renal impairment, the liraglutide AUC ratio versus healthy subjects was 0.73, and equivalence was not demonstrated.

    In plain wordsAfter one liraglutide dose, people with severe kidney impairment had somewhat lower drug exposure than people with healthy kidneys.

    Peptide
    Liraglutide
    Outcome
    DecreaseLiraglutide AUC ratio, severe renal impairment versus healthy
    Study

    n: not reported in source

    Comparator
    Normal renal function
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    AUC ratio severe/healthy
    0.73 ratio
    90% CI 0.57 to 0.94

    Source sentences

    Summary
    While the between-group comparisons of the area under the liraglutide concentration-curve (AUC) did not demonstrate equivalence [estimated ratio AUC(severe)/AUC(healthy) 0.73, 90% confidence interval (CI) 0.57, 0.94;
    1 context sentence
    Summary · context
    A cohort of 30 subjects, of whom 24 had varying degrees of renal impairment and six had normal renal function, were given a single dose of liraglutide, 0.75 mg subcutaneously, and completed serial blood sampling for plasma liraglutide measurements for pharmacokinetic estimation.
  3. 03HumanNon-randomized trialPharmacokinetics

    In subjects on continuous ambulatory peritoneal dialysis, the liraglutide AUC ratio versus healthy subjects was 0.74, and equivalence was not demonstrated.

    In plain wordsAfter one liraglutide dose, people on peritoneal dialysis had somewhat lower drug exposure than people with healthy kidneys.

    Peptide
    Liraglutide
    Outcome
    DecreaseLiraglutide AUC ratio, CAPD versus healthy
    Study

    n: not reported in source

    Comparator
    Normal renal function
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    AUC ratio CAPD/healthy
    0.74 ratio
    90% CI 0.56 to 0.97

    Source sentences

    Summary
    AUC (continuous ambulatory peritoneal dialysis)(CAPD)/AUC(healthy) 0.74, 90% CI 0.56, 0.97]
    1 context sentence
    Summary · context
    A cohort of 30 subjects, of whom 24 had varying degrees of renal impairment and six had normal renal function, were given a single dose of liraglutide, 0.75 mg subcutaneously, and completed serial blood sampling for plasma liraglutide measurements for pharmacokinetic estimation.
  4. 04HumanNon-randomized trialPharmacokinetics

    No clear trend in liraglutide pharmacokinetics was evident across groups with increasing renal dysfunction.

    In plain wordsLiraglutide exposure did not show a clear trend as kidney function got worse.

    Peptide
    Liraglutide
    Outcome
    No significant changePharmacokinetic trend across renal dysfunction
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    No clear trend for change in pharmacokinetics was evident across groups with increasing renal dysfunction.
    1 context sentence
    Summary · context
    A cohort of 30 subjects, of whom 24 had varying degrees of renal impairment and six had normal renal function, were given a single dose of liraglutide, 0.75 mg subcutaneously, and completed serial blood sampling for plasma liraglutide measurements for pharmacokinetic estimation.
  5. 05HumanNon-randomized trialPharmacokinetics

    In subjects with normal renal function and mild-to-severe renal impairment, decreasing creatinine clearance had no significant effect on liraglutide AUC.

    In plain wordsPoorer kidney function did not significantly change how much liraglutide the body was exposed to.

    Peptide
    Liraglutide
    Outcome
    No significant changeEffect of creatinine clearance on log(AUC)
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    the regression analysis of log(AUC) for subjects with normal renal function and mild-to-severe renal impairment showed no significant effect of decreasing creatinine clearance on the pharmacokinetics of liraglutide.
    1 context sentence
    Summary · context
    A cohort of 30 subjects, of whom 24 had varying degrees of renal impairment and six had normal renal function, were given a single dose of liraglutide, 0.75 mg subcutaneously, and completed serial blood sampling for plasma liraglutide measurements for pharmacokinetic estimation.
  6. 06HumanNon-randomized trialPharmacokinetics

    The expected liraglutide AUC ratio between the subjects with the lowest and highest creatinine clearance was 0.88 and not significant.

    In plain wordsLiraglutide exposure in people with the poorest and best kidney function did not differ significantly.

    Peptide
    Liraglutide
    Outcome
    No significant changeExpected AUC ratio, lowest versus highest creatinine clearance
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    expected AUC ratio
    0.88 ratio
    95% CI 0.58 to 1.34

    Source sentences

    Summary
    The expected AUC ratio between the two subjects with the lowest and highest creatinine clearance in the study was estimated to be 0.88 (95% CI 0.58, 1.34) (NS).
    1 context sentence
    Summary · context
    A cohort of 30 subjects, of whom 24 had varying degrees of renal impairment and six had normal renal function, were given a single dose of liraglutide, 0.75 mg subcutaneously, and completed serial blood sampling for plasma liraglutide measurements for pharmacokinetic estimation.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01847313

The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease

Karl Neffn = 20Apr 2013 to Nov 2015

Diabetic Kidney Disease

Trial pageClinicalTrials.govUpdated 8 Feb 2019
CompletedPhase 1NCT01508806

Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function

Novo Nordisk A/Sn = 30Aug 2005 to Mar 2006

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 24 Jan 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    12 Oct 2026, 12:10 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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