A randomized, open-label, crossover study examining the effect of injection site on bioavailability of exenatide (synthetic exendin-4).

Calara F, Taylor K, Han J, Zabala E, Carr EM, Wintle M, Fineman M

Clinical therapeutics1 Feb 2005Cited by 77 (Europe PMC)

PMID15811484DOI10.1016/j.clinthera.2005.02.008PepBankPUB-15811484

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 study17

17 results from studies that gave the peptide. 17 results from people.

01HumanRandomized controlled trialSafety outcome
Three patients with diabetes received an inadvertent exenatide overdose and immediately withdrew.
In plain wordsThree patients immediately withdrew after accidental exenatide overdose.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableOverdose withdrawal
Study
n = 3
Outcome group
Adverse events · Whole body
Studied dose
10-fold overdose · subcutaneousAs given in this study (human).
Measurements
Patients withdrawn after overdose
3 patients
Inadvertent 10-fold overdose
Source sentences
Summary
Three patients received an inadvertent 10-fold overdose and were withdrawn from the study immediately.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148412
02HumanRandomized controlled trialSafety outcome
All patients with inadvertent exenatide overdose experienced severe nausea.
In plain wordsAll patients with accidental exenatide overdose had severe nausea.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSevere nausea after overdose
Study
n = 3
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10-fold overdose · subcutaneousAs given in this study (human).
Source sentences
Summary
All experienced severe nausea and vomiting, and 1 patient experienced severe hypoglycemia requiring aid.
2 context sentences(design, population, supporting numbers)
Summary · context
Three patients received an inadvertent 10-fold overdose and were withdrawn from the study immediately.
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148413
03HumanRandomized controlled trialSafety outcome
All patients with inadvertent exenatide overdose experienced severe vomiting.
In plain wordsAll patients with accidental exenatide overdose had severe vomiting.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSevere vomiting after overdose
Study
n = 3
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10-fold overdose · subcutaneousAs given in this study (human).
Source sentences
Summary
All experienced severe nausea and vomiting, and 1 patient experienced severe hypoglycemia requiring aid.
2 context sentences(design, population, supporting numbers)
Summary · context
Three patients received an inadvertent 10-fold overdose and were withdrawn from the study immediately.
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148414
04HumanRandomized controlled trialSafety outcome
One patient with inadvertent exenatide overdose experienced severe hypoglycemia requiring assistance.
In plain wordsOne patient needed help for severe low blood sugar after accidental exenatide overdose.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSevere hypoglycemia after overdose
Study
n = 3
Outcome group
Adverse events · Metabolic and weight
Studied dose
10-fold overdose · subcutaneousAs given in this study (human).
Measurements
Patients with severe hypoglycemia requiring aid
1 patients
after inadvertent 10-fold overdose
Source sentences
Summary
All experienced severe nausea and vomiting, and 1 patient experienced severe hypoglycemia requiring aid.
2 context sentences(design, population, supporting numbers)
Summary · context
Three patients received an inadvertent 10-fold overdose and were withdrawn from the study immediately.
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148415
05HumanRandomized controlled trialSafety outcome
All patients with inadvertent exenatide overdose recovered without mishap.
In plain wordsAll patients recovered without mishap after accidental exenatide overdose.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableRecovery after overdose
Study
n = 3
Outcome group
Adverse events · Whole body
Studied dose
10-fold overdose · subcutaneousAs given in this study (human).
Source sentences
Summary
All recovered without mishap and were excluded from statistical and tolerability results.
2 context sentences(design, population, supporting numbers)
Summary · context
Three patients received an inadvertent 10-fold overdose and were withdrawn from the study immediately.
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148416
06HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, exenatide AUC values differed numerically among abdomen, arm and thigh injections.
In plain wordsExenatide exposure values varied by injection site in patients with diabetes.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableAUC by injection site
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
AUC(0-infinity) geometric LS mean
63,935 pg./mL
abdomen injection
AUC(0-infinity) geometric LS mean
59,573 pg./mL
arm injection
AUC(0-infinity) geometric LS mean
62,148 pg./mL
thigh injection
Source sentences
Summary
AUC(0-infinity) values (geometric LS mean SE for SC injections into the abdomen arm and thigh were 63,935 (6608), 59,573 (6157), and 62,148 (6424) pg./mL, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148401
07HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, arm versus abdomen exenatide relative bioavailability was 0.93.
In plain wordsArm injection gave similar exenatide exposure to abdomen injection in patients with diabetes.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableArm relative bioavailability
Study
n: not reported in source
Comparator
Abdomen injection
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
AUC geometric LS mean ratio
0.93 ratio
arm versus abdomen
Source sentences
Summary
The AUC (geometric LS mean ratio for relative bioavailability) for arm versus abdomen was 0.93 (geometric 90% CI, 0.82-1.05); for thigh versus abdomen it was 0.97 (geometric 90% CI, 0.86-1.10).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148402
08HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, thigh versus abdomen exenatide relative bioavailability was 0.97.
In plain wordsThigh injection gave similar exenatide exposure to abdomen injection in patients with diabetes.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableThigh relative bioavailability
Study
n: not reported in source
Comparator
Abdomen injection
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
AUC geometric LS mean ratio
0.97 ratio
thigh versus abdomen
Source sentences
Summary
The AUC (geometric LS mean ratio for relative bioavailability) for arm versus abdomen was 0.93 (geometric 90% CI, 0.82-1.05); for thigh versus abdomen it was 0.97 (geometric 90% CI, 0.86-1.10).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148403
09HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, within-subject exenatide AUC variability was low across injection sites, with a coefficient of variation of 26%.
In plain wordsExenatide exposure varied little within each patient across injection sites.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableWithin-subject AUC variability
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
Intrasubject variability of AUC(0-infinity), coefficient of variation
26%
across the 3 injection sites
Source sentences
Summary
Consistent with the observed data, intrasubject variability of AUC(0-infinity) was low among the 3 treatments (coefficient of variation, 26%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148404
10HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, exenatide peak concentrations were 220, 218 and 193 pg/mL for abdomen, arm and thigh injections.
In plain wordsExenatide peak levels varied numerically by injection site in patients with diabetes.
Peptide
Exenatide (exendin-4)
Outcome
Not applicablePeak concentration by injection site
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
Cmax geometric LS mean
220 pg/mL
abdomen injection
Cmax geometric LS mean
218 pg/mL
arm injection
Cmax geometric LS mean
193 pg/mL
thigh injection
Source sentences
Summary
C(max) values (geometric LS mean [SE]) were 220 (24) pg/mL, abdomen; 218 (23) pg/mL, arm; and 193 (21) pg/mL, thigh.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148405
11HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, the arm versus abdomen exenatide peak concentration ratio was 0.99.
In plain wordsArm and abdomen injections gave similar exenatide peak levels in patients with diabetes.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableArm peak concentration ratio
Study
n: not reported in source
Comparator
Abdomen injection
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
Cmax geometric LS mean ratio
0.99 ratio
arm vs abdomen, exenatide 10 microg SC
Cmax ratio 90% CI
0.85 to 1.15 ratio
arm vs abdomen, geometric 90% CI
Source sentences
Summary
The C(max) (geometric LS mean ratio) for arm versus abdomen was 0.99 (geometric 90% CI, 0.85-1.15), and for thigh versus abdomen it was 0.88 (geometric 90% CI, 0.75-1.02).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148406
12HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, the thigh versus abdomen exenatide peak concentration ratio was 0.88.
In plain wordsThigh injection gave numerically lower exenatide peak levels than abdomen injection in patients with diabetes.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableThigh peak concentration ratio
Study
n: not reported in source
Comparator
Abdomen injection
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
Cmax geometric LS mean ratio
0.88 ratio
thigh vs abdomen, exenatide 10 microg SC
Cmax ratio 90% CI
0.75 to 1.02 ratio
thigh vs abdomen, geometric 90% CI
Source sentences
Summary
The C(max) (geometric LS mean ratio) for arm versus abdomen was 0.99 (geometric 90% CI, 0.85-1.15), and for thigh versus abdomen it was 0.88 (geometric 90% CI, 0.75-1.02).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148407
13HumanRandomized controlled trialSafety outcome
In patients with diabetes, mild to moderate nausea occurred in 36% during exenatide treatment.
In plain wordsMild to moderate nausea occurred in 36% of patients during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
Incidence of nausea
36%
treatment-emergent adverse events, mild to moderate
Source sentences
Summary
The most common treatment-emergent adverse events were mild to moderate nausea (36%), headache (25%), vomiting (21%), and dizziness (18%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148408
14HumanRandomized controlled trialSafety outcome
In patients with diabetes, headache occurred in 25% during exenatide treatment.
In plain wordsHeadache occurred in 25% of patients during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHeadache
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
Incidence of headache
25%
treatment-emergent adverse events
Source sentences
Summary
The most common treatment-emergent adverse events were mild to moderate nausea (36%), headache (25%), vomiting (21%), and dizziness (18%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148409
15HumanRandomized controlled trialSafety outcome
In patients with diabetes, vomiting occurred in 21% during exenatide treatment.
In plain wordsVomiting occurred in 21% of patients during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableVomiting
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
Incidence of vomiting
21%
treatment-emergent adverse events
Source sentences
Summary
The most common treatment-emergent adverse events were mild to moderate nausea (36%), headache (25%), vomiting (21%), and dizziness (18%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148410
16HumanRandomized controlled trialSafety outcome
In patients with diabetes, dizziness occurred in 18% during exenatide treatment.
In plain wordsDizziness occurred in 18% of patients during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableDizziness
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
10 microg · subcutaneousAs given in this study (human).
Measurements
Incidence of dizziness
18%
treatment-emergent adverse events
Source sentences
Summary
The most common treatment-emergent adverse events were mild to moderate nausea (36%), headache (25%), vomiting (21%), and dizziness (18%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148411
17HumanRandomized controlled trialSafety outcome
In patients with diabetes, no adverse events related to exenatide injection or injection site occurred.
In plain wordsPatients had no adverse events related to the exenatide injection or its site.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableInjection-related adverse events
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
10 microg · subcutaneousAs given in this study (human).
Source sentences
Summary
There were no adverse events related to the injection or the injection site.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with type 2 DM were randomized in an open-label, crossover study to assess relative bioavailability of exenatide (10 microg) injected into the arm and thigh versus injection into the abdomen.
Report a problemFND-1581148417

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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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