Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes.

Iwamoto K, Nasu R, Yamamura A, Kothare PA, Mace K, Wolka AM, Linnebjerg H

Endocrine journal25 Aug 2009Cited by 36 (Europe PMC)

PMID19706990DOI10.1507/endocrj.k09e-147PepBankPUB-19706990

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 study13

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialPharmacokinetics
In Japanese patients with type 2 diabetes, exenatide 0.8 mg once weekly produced a geometric mean steady-state plasma concentration of 81.2 pg/mL (90% CI 68.3-96.4).
In plain wordsIn Japanese patients with diabetes, weekly exenatide at 0.8 mg reached a steady blood level of 81.2 pg/mL.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSteady-state plasma concentration
Study
n = 8
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg once weekly · subcutaneous · 10 weeksAs given in this study (human).
Measurements
Geometric mean steady-state concentration
81.2 pg/mL
exenatide QW 0.8 mg
90% CI of geometric mean steady-state concentration
68.3 to 96.4 pg/mL
exenatide QW 0.8 mg
Source sentences
Summary
For the evaluable pharmacokinetic population, geometric mean (90% confidence interval) steady-state plasma concentrations (pg/mL) were 81.2 (68.3-96.4) and 344.5 (256.5-462.7) with exenatide QW 0.8 mg (n=8) and exenatide QW 2.0 mg (n=5), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
Report a problemFND-1970699002
02HumanRandomized controlled trialPharmacokinetics
In Japanese patients with type 2 diabetes, exenatide 2.0 mg once weekly produced a geometric mean steady-state plasma concentration of 344.5 pg/mL (90% CI 256.5-462.7).
In plain wordsIn Japanese patients with diabetes, weekly exenatide at 2.0 mg reached a steady blood level of 344.5 pg/mL.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSteady-state plasma concentration
Study
n = 5
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.0 mg once weekly · subcutaneous · 10 weeksAs given in this study (human).
Measurements
Geometric mean steady-state concentration
344.5 pg/mL
exenatide QW 2.0 mg
90% CI of geometric mean steady-state concentration
256.5 to 462.7 pg/mL
exenatide QW 2.0 mg
Source sentences
Summary
For the evaluable pharmacokinetic population, geometric mean (90% confidence interval) steady-state plasma concentrations (pg/mL) were 81.2 (68.3-96.4) and 344.5 (256.5-462.7) with exenatide QW 0.8 mg (n=8) and exenatide QW 2.0 mg (n=5), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
Report a problemFND-1970699003
03HumanRandomized controlled trialPharmacokinetics
In Japanese patients with type 2 diabetes, once-weekly exenatide reached steady-state plasma concentrations by Week 8.
In plain wordsIn Japanese patients with diabetes, weekly exenatide reached steady blood concentrations by Week 8.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableTime to steady state
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneous · 10 weeksAs given in this study (human).
Measurements
Week by which steady-state concentrations were observed
≤ 8 weeks
once-weekly exenatide
Source sentences
Summary
Steady-state plasma exenatide concentrations were observed by Week 8 of the study.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
Report a problemFND-1970699001
04HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, no serious adverse events occurred in any group, including weekly exenatide.
In plain wordsIn Japanese patients with diabetes, no serious adverse events occurred in any group, including weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSerious adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneous · 10 weeksAs given in this study (human).
Source sentences
Summary
No serious adverse events (AEs) were reported and no AEs led to study discontinuation in any group.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
Report a problemFND-1970699010
05HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, no adverse events caused discontinuation in any group, including weekly exenatide.
In plain wordsIn Japanese patients with diabetes, no adverse events caused discontinuation in any group, including weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableDiscontinuations due to adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneous · 10 weeksAs given in this study (human).
Source sentences
Summary
No serious adverse events (AEs) were reported and no AEs led to study discontinuation in any group.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
Report a problemFND-1970699011
06HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, mild-to-moderate injection site induration was the most frequent adverse event in the weekly exenatide study.
In plain wordsIn Japanese patients with diabetes, mild-to-moderate injection site hardening was the most frequent adverse event in the weekly exenatide study.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableInjection site induration
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
Dose not stated · subcutaneous · 10 weeksAs given in this study (human).
Source sentences
Summary
The most frequent AE observed was mild-to-moderate injection site induration.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
Report a problemFND-1970699012
07HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, no serious hypoglycemia occurred in the weekly exenatide study.
In plain wordsIn Japanese patients with diabetes, no serious low blood sugar occurred in the weekly exenatide study.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSerious hypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · subcutaneous · 10 weeksAs given in this study (human).
Source sentences
Summary
No serious hypoglycemia was reported.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
Report a problemFND-1970699013

Studies that did not test the peptide alone6

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).

08HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, HbA1c decreased from baseline in the 0.8 mg exenatide arm, as in placebo.
In plain wordsIn Japanese patients with diabetes, HbA1c decreased from baseline with lower-dose exenatide and also with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n = 10
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c change
−1%
0.8 mg once weekly
HbA1c change
−0.4%
placebo once weekly
Source sentences
Summary
Baseline-to-Week 10 glycemic improvements with placebo QW, exenatide QW 0.8 mg, and exenatide QW 2.0 mg, respectively, were: HbA(1c) (%): -0.4+/-0.3, -1.0+/-0.7, and -1.5+/-0.7; FPG (mg/dL): -20.5+/-20.4, -25.2+/-10.9, and -50.8+/-27.8; and 2-hour postprandial plasma glucose excursions (mg/dL): -8.8…
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
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).
Report a problemFND-1970699004
09HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, fasting plasma glucose decreased from baseline in the 0.8 mg exenatide arm, as in placebo.
In plain wordsIn Japanese patients with diabetes, fasting plasma glucose decreased from baseline with lower-dose exenatide and also with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change
Study
n = 10
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Measurements
Fasting plasma glucose change
−25.2 mg/dL
0.8 mg once weekly
Fasting plasma glucose change
−20.5 mg/dL
placebo once weekly
Source sentences
Summary
Baseline-to-Week 10 glycemic improvements with placebo QW, exenatide QW 0.8 mg, and exenatide QW 2.0 mg, respectively, were: HbA(1c) (%): -0.4+/-0.3, -1.0+/-0.7, and -1.5+/-0.7; FPG (mg/dL): -20.5+/-20.4, -25.2+/-10.9, and -50.8+/-27.8; and 2-hour postprandial plasma glucose excursions (mg/dL): -8.8…
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
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).
Report a problemFND-1970699006
10HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, postprandial glucose excursions decreased from baseline in the 0.8 mg exenatide arm, as in placebo.
In plain wordsIn Japanese patients with diabetes, postprandial glucose excursions decreased from baseline with lower-dose exenatide and also with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial glucose excursion change
Study
n = 10
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Measurements
Postprandial glucose excursion change
−50 mg/dL
0.8 mg once weekly
Postprandial glucose excursion change
−8.8 mg/dL
placebo once weekly
Source sentences
Summary
Baseline-to-Week 10 glycemic improvements with placebo QW, exenatide QW 0.8 mg, and exenatide QW 2.0 mg, respectively, were: HbA(1c) (%): -0.4+/-0.3, -1.0+/-0.7, and -1.5+/-0.7; FPG (mg/dL): -20.5+/-20.4, -25.2+/-10.9, and -50.8+/-27.8; and 2-hour postprandial plasma glucose excursions (mg/dL): -8.8…
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
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).
Report a problemFND-1970699008
11HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, HbA1c decreased from baseline in the 2.0 mg exenatide arm, as in placebo.
In plain wordsIn Japanese patients with diabetes, HbA1c decreased from baseline with higher-dose exenatide and also with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n = 9
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c change
−1.5%
2.0 mg once weekly
HbA1c change
−0.4%
placebo once weekly
Source sentences
Summary
Baseline-to-Week 10 glycemic improvements with placebo QW, exenatide QW 0.8 mg, and exenatide QW 2.0 mg, respectively, were: HbA(1c) (%): -0.4+/-0.3, -1.0+/-0.7, and -1.5+/-0.7; FPG (mg/dL): -20.5+/-20.4, -25.2+/-10.9, and -50.8+/-27.8; and 2-hour postprandial plasma glucose excursions (mg/dL): -8.8…
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
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).
Report a problemFND-1970699005
12HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, fasting plasma glucose decreased from baseline in the 2.0 mg exenatide arm, as in placebo.
In plain wordsIn Japanese patients with diabetes, fasting plasma glucose decreased from baseline with higher-dose exenatide and also with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change
Study
n = 9
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Measurements
Fasting plasma glucose change
−50.8 mg/dL
2.0 mg once weekly
Fasting plasma glucose change
−20.5 mg/dL
placebo once weekly
Source sentences
Summary
Baseline-to-Week 10 glycemic improvements with placebo QW, exenatide QW 0.8 mg, and exenatide QW 2.0 mg, respectively, were: HbA(1c) (%): -0.4+/-0.3, -1.0+/-0.7, and -1.5+/-0.7; FPG (mg/dL): -20.5+/-20.4, -25.2+/-10.9, and -50.8+/-27.8; and 2-hour postprandial plasma glucose excursions (mg/dL): -8.8…
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
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).
Report a problemFND-1970699007
13HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, postprandial glucose excursions decreased from baseline in the 2.0 mg exenatide arm, as in placebo.
In plain wordsIn Japanese patients with diabetes, postprandial glucose excursions decreased from baseline with higher-dose exenatide and also with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial glucose excursion change
Study
n = 9
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Measurements
Postprandial glucose excursion change
−59.7 mg/dL
2.0 mg once weekly
Postprandial glucose excursion change
−8.8 mg/dL
placebo once weekly
Source sentences
Summary
Baseline-to-Week 10 glycemic improvements with placebo QW, exenatide QW 0.8 mg, and exenatide QW 2.0 mg, respectively, were: HbA(1c) (%): -0.4+/-0.3, -1.0+/-0.7, and -1.5+/-0.7; FPG (mg/dL): -20.5+/-20.4, -25.2+/-10.9, and -50.8+/-27.8; and 2-hour postprandial plasma glucose excursions (mg/dL): -8.8…
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomized in a 1:1:1 ratio to subcutaneous placebo QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks.
Summary · context
All evaluable patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 2.0 mg, n=9), unless otherwise stated.
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).
Report a problemFND-1970699009

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 1NCT00612794

A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes

AstraZenecan = 30Sept 2007 to May 2008

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 24 Feb 2015

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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