Safety and tolerability of exenatide twice daily in patients with type 2 diabetes: integrated analysis of 5594 patients from 19 placebo-controlled and comparator-controlled clinical trials.

Macconell L, Brown C, Gurney K, Han J

Diabetes, metabolic syndrome and obesity : targets and therapy20 Feb 2012Cited by 54 (Europe PMC)

PMID22375098PMCIDPMC3287409DOI10.2147/dmso.s28387PepBankPUB-22375098

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanOther designSafety outcome
In patients with diabetes, nausea occurred in 36.9% with exenatide versus 8.3% with pooled comparators.
In plain wordsIn patients with diabetes, nausea occurred more often with exenatide than pooled placebo and insulin comparators.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseNausea
Study
n = 5,594
Comparator
Pooled placebo and insulin comparator
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Measurements
Nausea incidence
36.9%
exenatide twice daily
Nausea incidence
8.3%
pooled comparator
Source sentences
Summary
Transient, mild- to-moderate nausea was the most frequent adverse event with exenatide (36.9% versus 8.3% in the pooled comparator).
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509801
02HumanOther designSafety outcome
In patients with diabetes, serious adverse event frequency was similar with exenatide and pooled comparators.
In plain wordsIn patients with diabetes, serious side effects occurred similarly with exenatide and pooled placebo and insulin comparators.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSerious adverse events
Study
n = 5,594
Comparator
Pooled placebo and insulin comparator
Outcome group
Adverse events · Whole body
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Source sentences
Summary
Serious adverse events, discontinuations due to serious adverse events, and deaths were reported with similar frequency in the exenatide and pooled comparator groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509805
03HumanOther designSafety outcome
In patients with diabetes, discontinuations due to serious adverse events occurred similarly with exenatide and pooled comparators.
In plain wordsIn patients with diabetes, stopping treatment for serious side effects occurred similarly with exenatide and pooled comparators.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeDiscontinuation due to serious adverse events
Study
n = 5,594
Comparator
Pooled placebo and insulin comparator
Outcome group
Adverse events · Whole body
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Source sentences
Summary
Serious adverse events, discontinuations due to serious adverse events, and deaths were reported with similar frequency in the exenatide and pooled comparator groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509806
04HumanOther designSafety outcome
In patients with diabetes, death frequency was similar with exenatide and pooled comparators.
In plain wordsIn patients with diabetes, deaths occurred similarly with exenatide and pooled placebo and insulin comparators.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeDeaths
Study
n = 5,594
Comparator
Pooled placebo and insulin comparator
Outcome group
Mortality · Whole body
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Source sentences
Summary
Serious adverse events, discontinuations due to serious adverse events, and deaths were reported with similar frequency in the exenatide and pooled comparator groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509807
05HumanOther designSafety outcome
In patients with diabetes, exposure-adjusted pancreatitis incidence did not differ significantly between exenatide and pooled comparators.
In plain wordsIn patients with diabetes, pancreatitis rates adjusted for exposure did not differ significantly between exenatide and pooled comparators.
Peptide
Exenatide (exendin-4)
Outcome
No significant changePancreatitis
Study
n = 5,594
Comparator
Pooled placebo and insulin comparator
Outcome group
Adverse events · Gastrointestinal
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Source sentences
Summary
Composite exposure-adjusted incidence rates were not statistically different between groups for pancreatitis, renal impairment, or major adverse cardiac events; there was a difference in incidence rates for benign thyroid neoplasm (0.3% versus 0%).
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509808
06HumanOther designSafety outcome
In patients with diabetes, exposure-adjusted renal impairment incidence did not differ significantly between exenatide and pooled comparators.
In plain wordsIn patients with diabetes, kidney impairment rates adjusted for exposure did not differ significantly between exenatide and pooled comparators.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeRenal impairment
Study
n = 5,594
Comparator
Pooled placebo and insulin comparator
Outcome group
Kidney function · Kidney and urinary
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Source sentences
Summary
Composite exposure-adjusted incidence rates were not statistically different between groups for pancreatitis, renal impairment, or major adverse cardiac events; there was a difference in incidence rates for benign thyroid neoplasm (0.3% versus 0%).
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509809
07HumanOther designSafety outcome
In patients with diabetes, exposure-adjusted major adverse cardiac event incidence did not differ significantly between exenatide and pooled comparators.
In plain wordsIn patients with diabetes, major cardiac event rates adjusted for exposure did not differ significantly between exenatide and pooled comparators.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeMajor adverse cardiac events
Study
n = 5,594
Comparator
Pooled placebo and insulin comparator
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Source sentences
Summary
Composite exposure-adjusted incidence rates were not statistically different between groups for pancreatitis, renal impairment, or major adverse cardiac events; there was a difference in incidence rates for benign thyroid neoplasm (0.3% versus 0%).
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509810
08HumanOther designSafety outcome
In patients with diabetes, benign thyroid neoplasm incidence differed between exenatide and pooled comparators, 0.3% versus 0%.
In plain wordsIn patients with diabetes, benign thyroid tumors occurred in 0.3% with exenatide versus 0% with pooled comparators.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseBenign thyroid neoplasm
Study
n = 5,594
Comparator
Pooled placebo and insulin comparator
Outcome group
Adverse events · Endocrine and hormones
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Measurements
Benign thyroid neoplasm incidence
0.3%
exenatide twice daily
Benign thyroid neoplasm incidence
0%
pooled comparator
Source sentences
Summary
Composite exposure-adjusted incidence rates were not statistically different between groups for pancreatitis, renal impairment, or major adverse cardiac events; there was a difference in incidence rates for benign thyroid neoplasm (0.3% versus 0%).
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509811
09HumanOther designSafety outcome
In patients using sulfonylurea, hypoglycemia occurred in 26.5% with exenatide versus 20.7% with pooled comparators.
In plain wordsIn patients using sulfonylurea, hypoglycemia occurred in 26.5% with exenatide versus 20.7% with pooled comparators.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHypoglycemia with sulfonylurea
Study
n: not reported in source
Comparator
Pooled placebo and insulin comparator
Outcome group
Adverse events · Metabolic and weight
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Measurements
Hypoglycemia incidence
26.5%
exenatide with sulfonylurea
Hypoglycemia incidence
20.7%
pooled comparator with sulfonylurea
Source sentences
Summary
The incidence of hypoglycemia (minor or major) with concomitant sulfonylurea (exenatide 26.5%, pooled comparator 20.7%) was higher than that without sulfonylurea (exenatide 3.1%, pooled comparator 2.7%) in all groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509802
10HumanOther designSafety outcome
In patients without sulfonylurea, hypoglycemia occurred in 3.1% with exenatide versus 2.7% with pooled comparators.
In plain wordsIn patients without sulfonylurea, hypoglycemia occurred in 3.1% with exenatide versus 2.7% with pooled comparators.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedHypoglycemia without sulfonylurea
Study
n: not reported in source
Comparator
Pooled placebo and insulin comparator
Outcome group
Adverse events · Metabolic and weight
Studied dose
5 μg and 10 μg twice daily · 12-52 weeksAs given in this study (human).
Measurements
Hypoglycemia incidence
3.1%
exenatide without sulfonylurea
Hypoglycemia incidence
2.7%
pooled comparator without sulfonylurea
Source sentences
Summary
The incidence of hypoglycemia (minor or major) with concomitant sulfonylurea (exenatide 26.5%, pooled comparator 20.7%) was higher than that without sulfonylurea (exenatide 3.1%, pooled comparator 2.7%) in all groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Data from 19 completed, randomized, controlled clinical trials of exenatide twice daily (5 μg and 10 μg) were pooled and analyzed; the pooled data included 5594 intent-to-treat patients who were followed for 12-52 weeks.
Report a problemFND-2237509803

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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

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