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Study · Randomized controlled trial · 2020

5 results

Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial.

Jabbour SA, Frías JP, Ahmed A, Hardy E, Choi J, Sjöström CD, Guja C

Diabetes care18 Aug 2020Cited by 51 (Europe PMC)

PMID32816874 (opens in a new tab)PMCIDPMC7510043 (opens in a new tab)DOI10.2337/dc19-1350 (opens in a new tab)PepBankPUB-32816874
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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 study5

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In T2D completers without rescue therapy, adding exenatide to dapagliflozin reduced HbA1c more than dapagliflozin plus placebo at week 104.

    In plain wordsIn T2D completers without rescue therapy, adding exenatide to dapagliflozin reduced HbA1c more than dapagliflozin plus placebo at week 104.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c change versus dapagliflozin
    Study

    n: not reported in source

    Comparator
    Dapagliflozin plus placebo
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg QW · 104 weeksAs given in this study (human).

    Measurements

    HbA1c change from baseline
    −1.7%
    exenatide QW plus dapagliflozin, week 104
    HbA1c change from baseline
    −1.06%
    dapagliflozin plus placebo, week 104

    Source sentences

    Summary
    The adjusted least squares mean change (SE) from baseline to week 104 in HbA1c was greater with exenatide QW plus dapagliflozin (-1.70% [0.11]) versus exenatide QW plus placebo (-1.29% [0.12]; P = 0.007) and dapagliflozin plus placebo (-1.06% [0.12]; P < 0.001).
    2 context sentences
    Summary · context
    DURATION-8 was a 104-week, multicenter, double-blind, randomized, active-controlled, phase 3 trial.
    Summary · context
    were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In T2D completers without rescue therapy, exenatide plus placebo reduced HbA1c from baseline at week 104.

    In plain wordsIn T2D completers without rescue therapy, exenatide plus placebo reduced HbA1c from baseline at week 104.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c change with exenatide alone
    Study

    n: not reported in source

    Comparator
    Baseline
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg QW · 104 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.29%
    exenatide plus placebo

    Source sentences

    Summary
    The adjusted least squares mean change (SE) from baseline to week 104 in HbA1c was greater with exenatide QW plus dapagliflozin (-1.70% [0.11]) versus exenatide QW plus placebo (-1.29% [0.12]; P = 0.007) and dapagliflozin plus placebo (-1.06% [0.12]; P < 0.001).
    2 context sentences
    Summary · context
    DURATION-8 was a 104-week, multicenter, double-blind, randomized, active-controlled, phase 3 trial.
    Summary · context
    were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo.

Studies that did not test the peptide alone3

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).

  1. 03HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In T2D completers without rescue therapy, exenatide plus dapagliflozin reduced HbA1c more than exenatide plus placebo at week 104.

    In plain wordsIn T2D completers without rescue therapy, exenatide plus dapagliflozin reduced HbA1c more than exenatide plus placebo at week 104.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c change versus exenatide
    Study

    n: not reported in source

    Comparator
    Exenatide plus placebo
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    HbA1c change from baseline
    −1.7%
    exenatide QW plus dapagliflozin, week 104
    HbA1c change from baseline
    −1.29%
    exenatide QW plus placebo, week 104

    Source sentences

    Summary
    The adjusted least squares mean change (SE) from baseline to week 104 in HbA1c was greater with exenatide QW plus dapagliflozin (-1.70% [0.11]) versus exenatide QW plus placebo (-1.29% [0.12]; P = 0.007) and dapagliflozin plus placebo (-1.06% [0.12]; P < 0.001).
    2 context sentences
    Summary · context
    DURATION-8 was a 104-week, multicenter, double-blind, randomized, active-controlled, phase 3 trial.
    Summary · context
    were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo.

    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).

  2. 04HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome

    In T2D, exenatide plus dapagliflozin produced no unexpected safety findings.

    In plain wordsIn T2D, exenatide plus dapagliflozin produced no unexpected safety findings.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableUnexpected safety findings
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    There were no unexpected safety findings, and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia.
    2 context sentences
    Summary · context
    DURATION-8 was a 104-week, multicenter, double-blind, randomized, active-controlled, phase 3 trial.
    Summary · context
    were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo.

    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).

  3. 05HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome

    In T2D, no major hypoglycemia episodes occurred with exenatide plus dapagliflozin.

    In plain wordsIn T2D, no major low blood sugar episodes occurred with exenatide plus dapagliflozin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableMajor hypoglycemia
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Adverse events · Metabolic and weight

    Source sentences

    Summary
    There were no unexpected safety findings, and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia.
    2 context sentences
    Summary · context
    DURATION-8 was a 104-week, multicenter, double-blind, randomized, active-controlled, phase 3 trial.
    Summary · context
    were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo.

    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).

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 postedNCT02229396

Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

AstraZenecan = 6954 Sept 2014 to 28 Dec 2017

Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 31 Dec 2018

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. 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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