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Study · Randomized controlled trial · 2008

8 results

Pharmacokinetics, pharmacodynamics, tolerability, and safety of exenatide in Japanese patients with type 2 diabetes mellitus.

Kothare PA, Linnebjerg H, Isaka Y, Uenaka K, Yamamura A, Yeo KP, de la Peña A, Teng CH, Mace K, Fineman M, Shigeta H, Sakata Y, Irie S

Journal of clinical pharmacology1 Dec 2008Cited by 54 (Europe PMC)

PMID19047364 (opens in a new tab)DOI10.1177/0091270008323750 (opens in a new tab)PepBankPUB-19047364
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 study8

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

  1. 01HumanRandomized controlled trialSafety outcome

    In Japanese patients with T2D, exenatide was generally well tolerated up to 10 microg.

    In plain wordsJapanese patients generally tolerated exenatide up to 10 microg.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Direction not reportedTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    up to 10 microg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Exenatide was generally well tolerated up to 10 microg.
    2 context sentences
    Summary · context
    In this single-blind, parallel, placebo-controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were evaluated in 40 Japanese patients with type 2 diabetes.
    Summary · context
    Patients were allocated to 4 groups and randomized to receive exenatide (n = 8/group) or placebo (n = 2/group), with all receiving placebo on day 1.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In Japanese patients with T2D, exenatide had a median time to peak concentration of 1.5 hours.

    In plain wordsExenatide reached peak blood levels at a median of 1.5 hours in Japanese patients with T2D.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableTime to maximum concentration
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2.5 to 15 microg · subcutaneousAs given in this study (human).

    Measurements

    Median tmax
    1.5 hours
    exenatide

    Source sentences

    Summary
    Exenatide was well absorbed with a median t(max) of 1.5 hours and mean t((1/2)) of 1.6 hours; exposure increased with dose.
    2 context sentences
    Summary · context
    In this single-blind, parallel, placebo-controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were evaluated in 40 Japanese patients with type 2 diabetes.
    Summary · context
    Patients were allocated to 4 groups and randomized to receive exenatide (n = 8/group) or placebo (n = 2/group), with all receiving placebo on day 1.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In Japanese patients with T2D, exenatide had a mean half-life of 1.6 hours.

    In plain wordsExenatide had a mean half-life of 1.6 hours in Japanese patients with T2D.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableHalf-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2.5 to 15 microg · subcutaneousAs given in this study (human).

    Measurements

    Mean half-life
    1.6 hours
    exenatide

    Source sentences

    Summary
    Exenatide was well absorbed with a median t(max) of 1.5 hours and mean t((1/2)) of 1.6 hours; exposure increased with dose.
    2 context sentences
    Summary · context
    In this single-blind, parallel, placebo-controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were evaluated in 40 Japanese patients with type 2 diabetes.
    Summary · context
    Patients were allocated to 4 groups and randomized to receive exenatide (n = 8/group) or placebo (n = 2/group), with all receiving placebo on day 1.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In Japanese patients with T2D, exenatide exposure increased with dose.

    In plain wordsHigher exenatide doses produced higher exposure in Japanese patients with T2D.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseDose-dependent exposure
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2.5 to 15 microg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Exenatide was well absorbed with a median t(max) of 1.5 hours and mean t((1/2)) of 1.6 hours; exposure increased with dose.
    2 context sentences
    Summary · context
    In this single-blind, parallel, placebo-controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were evaluated in 40 Japanese patients with type 2 diabetes.
    Summary · context
    Patients were allocated to 4 groups and randomized to receive exenatide (n = 8/group) or placebo (n = 2/group), with all receiving placebo on day 1.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with T2D, exenatide reduced postprandial glucose dose-dependently versus placebo up to 10 microg.

    In plain wordsExenatide lowered after-meal glucose more than placebo, with greater effects at higher doses up to 10 microg.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreasePostprandial glucose versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    up to 10 microg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Up to 10 microg, exenatide reduced postprandial glucose concentrations in a dose-dependent fashion compared with placebo; decreases were similar for 10 and 15 microg.
    2 context sentences
    Summary · context
    In this single-blind, parallel, placebo-controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were evaluated in 40 Japanese patients with type 2 diabetes.
    Summary · context
    Patients were allocated to 4 groups and randomized to receive exenatide (n = 8/group) or placebo (n = 2/group), with all receiving placebo on day 1.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with T2D, postprandial glucose reductions were similar with 10 and 15 microg exenatide.

    In plain wordsAfter-meal glucose fell similarly with 10 and 15 microg exenatide.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changePostprandial glucose at higher doses
    Study

    n: not reported in source

    Comparator
    10 microg exenatide
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    15 microg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Up to 10 microg, exenatide reduced postprandial glucose concentrations in a dose-dependent fashion compared with placebo; decreases were similar for 10 and 15 microg.
    2 context sentences
    Summary · context
    In this single-blind, parallel, placebo-controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were evaluated in 40 Japanese patients with type 2 diabetes.
    Summary · context
    Patients were allocated to 4 groups and randomized to receive exenatide (n = 8/group) or placebo (n = 2/group), with all receiving placebo on day 1.

Studies that did not test the peptide alone2

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

  1. 07HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome

    In Japanese patients with T2D, all reported adverse events were mild or moderate.

    In plain wordsAll reported side effects were mild or moderate in Japanese patients receiving study treatments.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Direction not reportedAdverse event severity
    Study

    n = 40

    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    All adverse events were mild or moderate in severity.
    2 context sentences
    Summary · context
    In this single-blind, parallel, placebo-controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were evaluated in 40 Japanese patients with type 2 diabetes.
    Summary · context
    Patients were allocated to 4 groups and randomized to receive exenatide (n = 8/group) or placebo (n = 2/group), with all receiving placebo on day 1.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

  2. 08HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialMechanism

    In Japanese patients with T2D, an E(max) model indicated that adequate glycemic response required doses above 2.5 microg.

    In plain wordsIn computer modelling, an E(max) model indicated that adequate glucose response required exenatide doses above 2.5 microg.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableModeled glycemic response threshold
    Study

    n: not reported in source

    E(max) model of exenatide glycemic response
    Outcome group
    Glycemic control · Metabolic and weight

    Source sentences

    Summary
    An E(max) model demonstrated that doses higher than 2.5 microg were necessary for adequate glycemic response.
    2 context sentences
    Summary · context
    In this single-blind, parallel, placebo-controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were evaluated in 40 Japanese patients with type 2 diabetes.
    Summary · context
    Patients were allocated to 4 groups and randomized to receive exenatide (n = 8/group) or placebo (n = 2/group), with all receiving placebo on day 1.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

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

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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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