Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial.

Wysham CH, MacConell LA, Maggs DG, Zhou M, Griffin PS, Trautmann ME

Mayo Clinic proceedings1 Mar 2015Cited by 45 (Europe PMC)

PMID25744115DOI10.1016/j.mayocp.2015.01.008PepBankPUB-25744115

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

12 results from studies that gave the peptide. 12 results from people.

01HumanNon-randomized trialOther
In the T2DM extension, 153 of 258 patients completed five years of exenatide treatment.
In plain wordsIn diabetes, 153 of 258 extension participants completed five years of exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableTreatment completion
Study
n = 258
Outcome group
Treatment adherence and retention · Whole body
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Measurements
completers
153 patients
extension patients
completion
59.3%
extension patients
Source sentences
Summary
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Report a problemFND-2574411501
02HumanNon-randomized trialEfficacy outcome
In the T2DM extension, 65 of 148 patients achieved HbA1c below 7.0% during weekly exenatide treatment.
In plain wordsIn diabetes, 65 of 148 patients achieved HbA1c below 7.0% during weekly exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHbA1c below 7.0%
Study
n = 148
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Measurements
patients achieving HbA1c <7.0%
65 patients
148 patients
HbA1c target attainment
43.9%
148 patients
Source sentences
Summary
Hemoglobin A1c levels were significantly and durably reduced from baseline (least-squares mean, -1.6%; 95% CI, -1.8% to -1.4%; vs -1.9% for exenatide once weekly at week 30), and 65 (43.9%) of 148 patients achieved hemoglobin A1c levels of less than 7.0%.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411504
03HumanNon-randomized trialEfficacy outcome
In T2DM extension participants, weekly exenatide durably reduced HbA1c from baseline.
In plain wordsIn diabetes extension participants, weekly exenatide reduced HbA1c compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Measurements
HbA1c change
−1.6%
five years
95% CI lower
−1.8%
HbA1c change
95% CI upper
−1.4%
HbA1c change
HbA1c change
−1.9%
exenatide once weekly at week 30
Source sentences
Summary
Hemoglobin A1c levels were significantly and durably reduced from baseline (least-squares mean, -1.6%; 95% CI, -1.8% to -1.4%; vs -1.9% for exenatide once weekly at week 30), and 65 (43.9%) of 148 patients achieved hemoglobin A1c levels of less than 7.0%.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411502
04HumanNon-randomized trialEfficacy outcome
In T2DM extension participants, weekly exenatide reduced fasting plasma glucose from baseline.
In plain wordsIn diabetes extension participants, weekly exenatide reduced fasting glucose compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose
Study
n: not reported in source
Comparator
baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Measurements
fasting glucose change
−28.8 mg/dL
five years
95% CI lower
−36.2 mg/dL
fasting glucose change
95% CI upper
−21.5 mg/dL
fasting glucose change
Source sentences
Summary
Significant improvements in fasting plasma glucose level (-28.8 mg/dL; 95% CI, -36.2 to -21.5 mg/dL), weight (-3.0 kg; 95% CI, -4.6 to -1.3 kg), lipids, and diastolic blood pressure were observed, with minimal heart rate increase.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411505
05HumanNon-randomized trialEfficacy outcome
In T2DM extension participants, weekly exenatide reduced weight from baseline.
In plain wordsIn diabetes extension participants, weekly exenatide reduced weight compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight
Study
n: not reported in source
Comparator
baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Measurements
weight change
−3 kg
five years
95% CI lower
−4.6 kg
weight change
95% CI upper
−1.3 kg
weight change
Source sentences
Summary
Significant improvements in fasting plasma glucose level (-28.8 mg/dL; 95% CI, -36.2 to -21.5 mg/dL), weight (-3.0 kg; 95% CI, -4.6 to -1.3 kg), lipids, and diastolic blood pressure were observed, with minimal heart rate increase.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411506
06HumanNon-randomized trialEfficacy outcome
In T2DM extension participants, weekly exenatide significantly improved unspecified lipids from baseline.
In plain wordsIn diabetes extension participants, weekly exenatide improved blood lipids compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedLipids
Study
n: not reported in source
Comparator
baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Source sentences
Summary
Significant improvements in fasting plasma glucose level (-28.8 mg/dL; 95% CI, -36.2 to -21.5 mg/dL), weight (-3.0 kg; 95% CI, -4.6 to -1.3 kg), lipids, and diastolic blood pressure were observed, with minimal heart rate increase.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411507
07HumanNon-randomized trialEfficacy outcome
In T2DM extension participants, weekly exenatide improved diastolic blood pressure from baseline.
In plain wordsIn diabetes extension participants, weekly exenatide improved diastolic blood pressure compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseDiastolic blood pressure
Study
n: not reported in source
Comparator
baseline
Outcome group
Blood pressure · Cardiovascular
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Source sentences
Summary
Significant improvements in fasting plasma glucose level (-28.8 mg/dL; 95% CI, -36.2 to -21.5 mg/dL), weight (-3.0 kg; 95% CI, -4.6 to -1.3 kg), lipids, and diastolic blood pressure were observed, with minimal heart rate increase.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411508
08HumanNon-randomized trialSafety outcome
In T2DM extension participants, weekly exenatide was accompanied by minimal heart rate increase.
In plain wordsIn diabetes extension participants, heart rate increased minimally from baseline during weekly exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHeart rate
Study
n: not reported in source
Comparator
baseline
Outcome group
Adverse events · Cardiovascular
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Source sentences
Summary
Significant improvements in fasting plasma glucose level (-28.8 mg/dL; 95% CI, -36.2 to -21.5 mg/dL), weight (-3.0 kg; 95% CI, -4.6 to -1.3 kg), lipids, and diastolic blood pressure were observed, with minimal heart rate increase.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411509
09HumanNon-randomized trialSafety outcome
In the T2DM extension, nausea frequency with exenatide decreased versus the initial controlled phase.
In plain wordsIn diabetes, nausea was less frequent during the exenatide extension than during the initial controlled phase.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseNausea frequency
Study
n: not reported in source
Comparator
initial 30-week controlled phase
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Source sentences
Summary
Frequencies of nausea and injection-site reactions or nodules were decreased vs the initial 30-week controlled phase.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411510
10HumanNon-randomized trialSafety outcome
In the T2DM extension, injection-site reactions or nodules with exenatide decreased versus the initial controlled phase.
In plain wordsIn diabetes, injection-site reactions or nodules were less frequent during the exenatide extension than during the initial phase.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseInjection-site reactions or nodules
Study
n: not reported in source
Comparator
initial 30-week controlled phase
Outcome group
Adverse events · Skin and wound
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Source sentences
Summary
Frequencies of nausea and injection-site reactions or nodules were decreased vs the initial 30-week controlled phase.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411511
11HumanNon-randomized trialSafety outcome
In the T2DM exenatide extension, no major hypoglycemia was observed.
In plain wordsIn diabetes, no major low blood sugar events occurred during the exenatide extension.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMajor hypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Source sentences
Summary
Minor hypoglycemia occurred predominantly with sulfonylurea use, and no major hypoglycemia or new safety signals were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411513
12HumanNon-randomized trialSafety outcome
In the T2DM exenatide extension, no new safety signals were observed.
In plain wordsIn diabetes, the exenatide extension showed no new safety signals.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNew safety signals
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · 5 yearsAs given in this study (human).
Source sentences
Summary
Minor hypoglycemia occurred predominantly with sulfonylurea use, and no major hypoglycemia or new safety signals were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
Report a problemFND-2574411514

Studies that did not test the peptide alone1

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).

13HumanNot a test of Exenatide (exendin-4) aloneNon-randomized trialSafety outcome
In the T2DM exenatide extension, minor hypoglycemia occurred predominantly with sulfonylurea use.
In plain wordsIn diabetes, mild low blood sugar during exenatide treatment occurred mainly with sulfonylurea use.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMinor hypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
Minor hypoglycemia occurred predominantly with sulfonylurea use, and no major hypoglycemia or new safety signals were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly.
Summary · context
Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment.
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-2574411512

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00308139

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

AstraZenecan = 303Apr 2006 to Aug 2014

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 26 Aug 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

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Terms as the source lists them.

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