A thorough QT study to evaluate the effects of singledose exenatide 10 μg on cardiac repolarization in healthy subjects.

Linnebjerg H, Seger M, Kothare PA, Hunt T, Wolka AM, Mitchell MI

International journal of clinical pharmacology and therapeutics1 Oct 2011Cited by 29 (Europe PMC)

PMID21961484DOI10.5414/cp201462PepBankPUB-21961484

Publisher page PubMedAsk about this study

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 study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialSafety outcome
In healthy subjects, exenatide did not cause clinically significant QTcF prolongation compared with placebo.
In plain wordsIn healthy people, exenatide did not cause clinically significant QTcF prolongation compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeQTcF prolongation
Study
n = 62
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
10 μg · subcutaneous · single doseAs given in this study (human).
Measurements
Upper confidence bound of largest mean difference
< 10 msec
QTcF versus placebo
Source sentences
Summary
Based on ΔQTcF and ΔQTcI assessments, exenatide 10 μg did not show a clinically significant prolongation of QT compared with placebo; the upper bound of the 2-sided 90% confidence interval (CI) for the largest mean difference from placebo was < 10 msec with both corrections.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a singledose, randomized, positive- and placebo-controlled, double-dummy, double-blinded, 3-period crossover thorough QT study of exenatide, a glucagon-like peptide-1 receptor agonist for the treatment of Type 2 diabetes that enhances insulin secretion in a glucose- dependent fashion.
Summary · context
Subjects who passed tolerability screening (n = 62) received exenatide 10 μg, placebo, and moxifloxacin (400 mg orally; positive control) separated by washout periods of approximately 5 days.
Report a problemFND-2196148401
02HumanRandomized controlled trialSafety outcome
In healthy subjects, exenatide did not cause clinically significant QTcI prolongation compared with placebo.
In plain wordsIn healthy people, exenatide did not cause clinically significant QTcI prolongation compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeQTcI prolongation
Study
n = 62
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
10 μg · subcutaneous · single doseAs given in this study (human).
Measurements
Upper confidence bound of largest mean difference
< 10 msec
QTcI versus placebo
Source sentences
Summary
Based on ΔQTcF and ΔQTcI assessments, exenatide 10 μg did not show a clinically significant prolongation of QT compared with placebo; the upper bound of the 2-sided 90% confidence interval (CI) for the largest mean difference from placebo was < 10 msec with both corrections.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a singledose, randomized, positive- and placebo-controlled, double-dummy, double-blinded, 3-period crossover thorough QT study of exenatide, a glucagon-like peptide-1 receptor agonist for the treatment of Type 2 diabetes that enhances insulin secretion in a glucose- dependent fashion.
Summary · context
Subjects who passed tolerability screening (n = 62) received exenatide 10 μg, placebo, and moxifloxacin (400 mg orally; positive control) separated by washout periods of approximately 5 days.
Report a problemFND-2196148402
03HumanRandomized controlled trialSafety outcome
In healthy subjects, plasma exenatide concentrations had a positive association with placebo-adjusted QTcF change, though the analysis may be confounded by exenatide's glucose-lowering effect.
In plain wordsIn healthy people, higher exenatide concentrations were linked to greater placebo-adjusted QTcF changes, but the link may be confounded by glucose lowering.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseExenatide concentration versus QTcF
Study
n = 62
Outcome group
Heart function · Cardiovascular
Studied dose
10 μg · subcutaneous · single doseAs given in this study (human).
Measurements
Slope
0.02 not stated
plasma exenatide versus ΔΔQTcF
Source sentences
Summary
A positive slope was observed between plasma exenatide and ΔΔQTcF (0.02 (95% CI 0.01, 0.03), p < 0.001); no significant slope was observed between plasma exenatide concentrations and ΔΔQTcI (0.01 (95% CI 0.00, 0.02), p = 0.064).
3 context sentences(design, population, supporting numbers)
Summary · context
This was a singledose, randomized, positive- and placebo-controlled, double-dummy, double-blinded, 3-period crossover thorough QT study of exenatide, a glucagon-like peptide-1 receptor agonist for the treatment of Type 2 diabetes that enhances insulin secretion in a glucose- dependent fashion.
Summary · context
Subjects who passed tolerability screening (n = 62) received exenatide 10 μg, placebo, and moxifloxacin (400 mg orally; positive control) separated by washout periods of approximately 5 days.
Summary · context
The plasma exenatide versus QTc analyses may be confounded by exenatide's glucose-lowering effect.
Report a problemFND-2196148403
04HumanRandomized controlled trialSafety outcome
In healthy subjects, plasma exenatide concentrations had no significant association with placebo-adjusted QTcI change, though the analysis may be confounded by exenatide's glucose-lowering effect.
In plain wordsIn healthy people, exenatide concentrations had no significant link to placebo-adjusted QTcI changes, though glucose lowering may confound the analysis.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeExenatide concentration versus QTcI
Study
n = 62
Outcome group
Heart function · Cardiovascular
Studied dose
10 μg · subcutaneous · single doseAs given in this study (human).
Measurements
Slope
0.01 not stated
plasma exenatide versus ΔΔQTcI
Source sentences
Summary
A positive slope was observed between plasma exenatide and ΔΔQTcF (0.02 (95% CI 0.01, 0.03), p < 0.001); no significant slope was observed between plasma exenatide concentrations and ΔΔQTcI (0.01 (95% CI 0.00, 0.02), p = 0.064).
3 context sentences(design, population, supporting numbers)
Summary · context
This was a singledose, randomized, positive- and placebo-controlled, double-dummy, double-blinded, 3-period crossover thorough QT study of exenatide, a glucagon-like peptide-1 receptor agonist for the treatment of Type 2 diabetes that enhances insulin secretion in a glucose- dependent fashion.
Summary · context
Subjects who passed tolerability screening (n = 62) received exenatide 10 μg, placebo, and moxifloxacin (400 mg orally; positive control) separated by washout periods of approximately 5 days.
Summary · context
The plasma exenatide versus QTc analyses may be confounded by exenatide's glucose-lowering effect.
Report a problemFND-2196148404

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.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
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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