Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study.

Philis-Tsimikas A, Wysham CH, Hardy E, Han J, Iqbal N

Journal of diabetes and its complications5 Dec 2018Cited by 20 (Europe PMC)

PMID30600137DOI10.1016/j.jdiacomp.2018.11.012PepBankPUB-30600137

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

Results from this study7

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

01HumanNon-randomized trialOther
In DURATION-1, 122 of 295 patients completed seven years of exenatide treatment.
In plain wordsIn DURATION-1, 122 of 295 patients completed seven years of exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableTreatment completion
Study
n = 295
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · 7 yearsAs given in this study (human).
Measurements
Patients completing 7 years of treatment
122 patients
intention-to-treat population, n=295
Patients completing 7 years of treatment
41%
intention-to-treat population, n=295
Source sentences
Summary
Of 295 patients in the intention-to-treat population, 122 (41%) completed 7 years of treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years.
Report a problemFND-3060013701
02HumanNon-randomized trialEfficacy outcome
In type 2 diabetes completers, exenatide reduced HbA1c from baseline by 1.53% at seven years.
In plain wordsIn patients who completed treatment, exenatide lowered HbA1c from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c
Study
n = 122
Comparator
baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 7 yearsAs given in this study (human).
Measurements
7-year LSM change in HbA1c
−1.53%
7-year completers, change from baseline
Source sentences
Summary
Patients in the 7-year completer population showed sustained glycemic improvements from baseline (7-year least-squares mean [LSM] change in HbA_1C, -1.53%)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years.
Report a problemFND-3060013702
03HumanNon-randomized trialEfficacy outcome
In type 2 diabetes completers, body weight improved significantly from baseline during exenatide treatment.
In plain wordsIn patients who completed treatment, body weight improved from baseline during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n = 122
Comparator
baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · 7 yearsAs given in this study (human).
Source sentences
Summary
and significant improvements in several cardiovascular risk factors, including body weight, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
2 context sentences(design, population, supporting numbers)
Summary · context
Seven-year completers who received no additional glucose-lowering therapies (n = 65 [53%]) had similar improvements in HbA_1C, and numerically greater reductions in body weight (7-year LSM change, -6.46 kg vs -3.87 kg), compared with the overall cohort.
Summary · context
Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years.
Report a problemFND-3060013703
04HumanNon-randomized trialEfficacy outcome
In seven-year completers with type 2 diabetes, cardiovascular risk factors improved from baseline during exenatide treatment, including diastolic pressure and cholesterol measures.
In plain wordsIn treatment completers, cardiovascular risk factors improved from baseline during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedCardiovascular risk factors
Study
n = 122
Comparator
baseline
Outcome group
Cardiometabolic risk factors · Cardiovascular
Studied dose
2 mg once weekly · 7 yearsAs given in this study (human).
Source sentences
Summary
Patients in the 7-year completer population showed sustained glycemic improvements from baseline (7-year least-squares mean [LSM] change in HbA_1C, -1.53%) and significant improvements in several cardiovascular risk factors, including body weight, diastolic blood pressure, total cholestero…
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years.
Report a problemFND-3060013704
05HumanNon-randomized trialEfficacy outcome
In exenatide completers without additional glucose-lowering therapy, HbA1c improvements resembled those in the overall cohort.
In plain wordsExenatide completers without additional glucose-lowering drugs had similar HbA1c improvements to the overall cohort.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c without additional therapies
Study
n = 65
Comparator
overall cohort
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 7 yearsAs given in this study (human).
Source sentences
Summary
Seven-year completers who received no additional glucose-lowering therapies (n = 65 [53%]) had similar improvements in HbA_1C, and numerically greater reductions in body weight (7-year LSM change, -6.46 kg vs -3.87 kg), compared with the overall cohort.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years.
Report a problemFND-3060013705
06HumanNon-randomized trialEfficacy outcome
Exenatide completers without additional glucose-lowering therapies had numerically greater weight reductions than the overall cohort, -6.46 versus -3.87 kg.
In plain wordsExenatide completers without additional glucose-lowering drugs lost numerically more weight than the overall cohort.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight reduction without additional therapies
Study
n = 65
Comparator
overall cohort
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · 7 yearsAs given in this study (human).
Measurements
7-year LSM change in body weight
−6.46 kg
completers with no additional glucose-lowering therapy
7-year LSM change in body weight
−3.87 kg
overall cohort
Source sentences
Summary
Seven-year completers who received no additional glucose-lowering therapies (n = 65 [53%]) had similar improvements in HbA_1C, and numerically greater reductions in body weight (7-year LSM change, -6.46 kg vs -3.87 kg), compared with the overall cohort.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years.
Report a problemFND-3060013706
07HumanNon-randomized trialSafety outcome
In the exenatide extension study, no unexpected safety findings occurred.
In plain wordsThe exenatide extension study reported no unexpected safety findings.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableUnexpected safety findings
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · 7 yearsAs given in this study (human).
Source sentences
Summary
There were no unexpected safety findings.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years.
Report a problemFND-3060013707

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

Subjects

Terms as the source lists them.

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