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Study · Randomized controlled trial · n = 24 · 2008

12 results

Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study.

Irie S, Matsumura Y, Zdravkovic M, Jacobsen LV, Kageyama S

International journal of clinical pharmacology and therapeutics1 Jun 2008Cited by 31 (Europe PMC)

PMID18541123 (opens in a new tab)DOI10.5414/cpp46273 (opens in a new tab)PepBankPUB-18541123
Publisher pagePubMedAsk about this study
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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 study12

12 results from studies that gave the peptide. 12 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy Japanese men, no safety issues or other adverse events were observed with stepped once-daily liraglutide up to 25 microg/kg.

    In plain wordsIn healthy Japanese men, no safety issues or other side effects were seen with liraglutide.

    Peptide
    Liraglutide
    Outcome
    No significant changeAdverse events overall
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    No safety issues, hypoglycemia, gastrointestinal or any other adverse events were observed.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  2. 02HumanRandomized controlled trialSafety outcome

    In healthy Japanese men, no hypoglycemia was observed with stepped once-daily liraglutide.

    In plain wordsIn healthy Japanese men, liraglutide caused no low blood sugar events.

    Peptide
    Liraglutide
    Outcome
    No significant changeHypoglycemia
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    No safety issues, hypoglycemia, gastrointestinal or any other adverse events were observed.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  3. 03HumanRandomized controlled trialSafety outcome

    In healthy Japanese men, no gastrointestinal adverse events were observed with stepped once-daily liraglutide.

    In plain wordsIn healthy Japanese men, liraglutide caused no stomach or gut side effects.

    Peptide
    Liraglutide
    Outcome
    No significant changeGastrointestinal adverse events
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    No safety issues, hypoglycemia, gastrointestinal or any other adverse events were observed.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In healthy Japanese men, liraglutide produced dose-dependent decreases in mean plasma glucose, within normal ranges.

    In plain wordsIn healthy Japanese men, liraglutide lowered average blood sugar in a dose-related way, but values stayed normal.

    Peptide
    Liraglutide
    Outcome
    DecreaseMean plasma glucose
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    but dose-dependent decreases in mean and postprandial plasma glucose were seen with liraglutide, although all values remained within normal ranges.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In healthy Japanese men, liraglutide produced dose-dependent decreases in postprandial plasma glucose, within normal ranges.

    In plain wordsIn healthy Japanese men, liraglutide lowered blood sugar after meals in a dose-related way, but values stayed normal.

    Peptide
    Liraglutide
    Outcome
    DecreasePostprandial plasma glucose
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    but dose-dependent decreases in mean and postprandial plasma glucose were seen with liraglutide, although all values remained within normal ranges.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In healthy Japanese men, weight showed only a tendency to decrease with liraglutide compared with placebo.

    In plain wordsIn healthy Japanese men, weight tended to fall more with liraglutide than with placebo, without a clear effect.

    Peptide
    Liraglutide
    Outcome
    No significant changeBody weight
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    There was a tendency for weight to decrease with liraglutide in comparison to placebo.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  7. 07HumanRandomized controlled trialPharmacokinetics

    In healthy Japanese men, liraglutide AUC0-24 h increased with dose.

    In plain wordsIn healthy Japanese men, the liraglutide level in blood over 24 hours rose as the dose rose.

    Peptide
    Liraglutide
    Outcome
    IncreaseAUC0-24 h
    Study

    n = 18

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    Liraglutide showed dose-dependent increases in the pharmacokinetic parameters of AUC0-24 h, C(max) and C(trough)
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  8. 08HumanRandomized controlled trialPharmacokinetics

    In healthy Japanese men, liraglutide Cmax increased with dose.

    In plain wordsIn healthy Japanese men, the peak liraglutide level in blood rose as the dose rose.

    Peptide
    Liraglutide
    Outcome
    IncreaseCmax
    Study

    n = 18

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    Liraglutide showed dose-dependent increases in the pharmacokinetic parameters of AUC0-24 h, C(max) and C(trough)
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  9. 09HumanRandomized controlled trialPharmacokinetics

    In healthy Japanese men, liraglutide Ctrough increased with dose.

    In plain wordsIn healthy Japanese men, the lowest liraglutide level between doses rose as the dose rose.

    Peptide
    Liraglutide
    Outcome
    IncreaseCtrough
    Study

    n = 18

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    Liraglutide showed dose-dependent increases in the pharmacokinetic parameters of AUC0-24 h, C(max) and C(trough)
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  10. 10HumanRandomized controlled trialPharmacokinetics

    In healthy Japanese men, liraglutide tmax stayed constant across doses.

    In plain wordsIn healthy Japanese men, the time to the peak liraglutide level did not change with dose.

    Peptide
    Liraglutide
    Outcome
    No significant changetmax
    Study

    n = 18

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    while t(max), t(1/2) and V(d/F) were constant.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  11. 11HumanRandomized controlled trialPharmacokinetics

    In healthy Japanese men, liraglutide half-life stayed constant across doses.

    In plain wordsIn healthy Japanese men, the liraglutide half-life did not change with dose.

    Peptide
    Liraglutide
    Outcome
    No significant changeHalf-life (t1/2)
    Study

    n = 18

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    while t(max), t(1/2) and V(d/F) were constant.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.
  12. 12HumanRandomized controlled trialPharmacokinetics

    In healthy Japanese men, liraglutide apparent volume of distribution stayed constant across doses.

    In plain wordsIn healthy Japanese men, the liraglutide volume of distribution did not change with dose.

    Peptide
    Liraglutide
    Outcome
    No significant changeApparent volume of distribution (Vd/F)
    Study

    n = 18

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 to 25 microg/kg once daily, stepped titration · subcutaneous · 35 daysAs given in this study (human).

    Source sentences

    Summary
    while t(max), t(1/2) and V(d/F) were constant.
    2 context sentences
    Summary · context
    This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach.
    Summary · context
    Subjects were randomized to three groups in each of which 6 received liraglutide, and 2 placebo for 35 consecutive days.

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

Registered trials1

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

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT01515592

Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

Novo Nordisk A/Sn = 24Jan 2006 to Apr 2006

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 25 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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