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Study · Not a test of the peptide alone · 2017

10 results

Dapagliflozin once-daily and exenatide once-weekly dual therapy: A 24-week randomized, placebo-controlled, phase II study examining effects on body weight and prediabetes in obese adults without diabetes.

Lundkvist P, Sjöström CD, Amini S, Pereira MJ, Johnsson E, Eriksson JW

Diabetes, obesity & metabolism26 Sept 2016Cited by 83 (Europe PMC)

Summary

AimsTo explore the effects of dual therapy with dapagliflozin and exenatide on body weight, body composition, glycaemic variables and systolic blood pressure (SBP) in obese adults without diabetes.Materials and methodsIn this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or placebo. MRI was used to assess change in body composition. Participants were instructed to follow a balanced diet and exercise moderately.ResultsOf 25 dapagliflozin/exenatide- and 25 placebo-treated participants, 23 (92.0%) and 20 (80.0%) completed 24 weeks of treatment, respectively. At baseline, the mean participant age was 52 years, 61% were female, the mean body weight was 104.6 kg, and 73.5% of participants had prediabetes (impaired fasting glucose or impaired glucose tolerance). After 24 weeks, for dapagliflozin/exenatide versus placebo: the difference in body weight change was -4.13 kg (95% confidence interval -6.44, -1.81; P < .001), which was mostly attributable to adipose tissue reduction without lean tissue change; 36.0% versus 4.2% of participants achieved ≥5% body weight loss, respectively; and prediabetes was less frequent with active treatment (34.8% vs 85.0%, respectively; P < .01). The difference in SBP change for dapagliflozin/exenatide versus placebo was -6.7 mm Hg. As expected, nausea and injection-site reactions were more frequent with dapagliflozin/exenatide than with placebo. Only two and three participants, respectively, discontinued because of adverse events.ConclusionsCompared with placebo, dapagliflozin/exenatide dual therapy reduced body weight, frequency of prediabetes and SBP over 24 weeks and was well tolerated in obese adults without diabetes.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone10

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. 01HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with obesity without diabetes, dapagliflozin plus exenatide reduced body weight more than placebo after 24 weeks.

    In plain wordsIn adults with obesity without diabetes, dapagliflozin plus exenatide reduced weight more than placebo.

    Outcome
    DecreaseBody weight change
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Body weight change difference
    −4.13 kg
    versus placebo

    Source sentences

    Summary
    After 24 weeks, for dapagliflozin/exenatide versus placebo: the difference in body weight change was -4.13 kg (95% confidence interval -6.44, -1.81; P < .001), which was mostly attributable to adipose tissue reduction without lean tissue change
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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. 02HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with obesity without diabetes, weight loss with dapagliflozin plus exenatide versus placebo was mostly attributable to adipose tissue reduction.

    In plain wordsIn adults with obesity without diabetes, greater weight loss with dapagliflozin plus exenatide than placebo mainly reflected fat reduction.

    Outcome
    DecreaseAdipose tissue reduction
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Body weight · Metabolic and weight

    Source sentences

    Summary
    After 24 weeks, for dapagliflozin/exenatide versus placebo: the difference in body weight change was -4.13 kg (95% confidence interval -6.44, -1.81; P < .001), which was mostly attributable to adipose tissue reduction without lean tissue change
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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. 03HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with obesity without diabetes, dapagliflozin plus exenatide reduced weight versus placebo without lean tissue change.

    In plain wordsIn adults with obesity without diabetes, dapagliflozin plus exenatide reduced weight versus placebo without changing lean tissue.

    Outcome
    No significant changeLean tissue change
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Body weight · Musculoskeletal

    Source sentences

    Summary
    After 24 weeks, for dapagliflozin/exenatide versus placebo: the difference in body weight change was -4.13 kg (95% confidence interval -6.44, -1.81; P < .001), which was mostly attributable to adipose tissue reduction without lean tissue change
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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).

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

    In adults with obesity without diabetes, 36.0% on dapagliflozin plus exenatide versus 4.2% on placebo achieved at least 5% weight loss.

    In plain wordsIn adults with obesity without diabetes, more participants achieved at least 5% weight loss with dapagliflozin plus exenatide than placebo.

    Outcome
    IncreaseAt least 5% weight loss
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Weight-loss responders
    36%
    combination
    Weight-loss responders
    4.2%
    placebo

    Source sentences

    Summary
    36.0% versus 4.2% of participants achieved ≥5% body weight loss, respectively
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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).

  5. 05HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with obesity without diabetes, prediabetes was less frequent with dapagliflozin plus exenatide than placebo after 24 weeks.

    In plain wordsIn adults with obesity without diabetes, prediabetes was less frequent with dapagliflozin plus exenatide than placebo.

    Outcome
    DecreasePrediabetes frequency
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Prediabetes frequency
    34.8%
    combination
    Prediabetes frequency
    85%
    placebo

    Source sentences

    Summary
    and prediabetes was less frequent with active treatment (34.8% vs 85.0%, respectively; P < .01).
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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).

  6. 06HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In adults with obesity without diabetes, systolic blood pressure change was 6.7 mm Hg lower with dapagliflozin plus exenatide than placebo.

    In plain wordsIn adults with obesity without diabetes, dapagliflozin plus exenatide lowered systolic blood pressure more than placebo.

    Outcome
    DecreaseSystolic blood pressure change
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Blood pressure · Cardiovascular

    Measurements

    SBP change difference
    −6.7 mm Hg
    versus placebo

    Source sentences

    Summary
    The difference in SBP change for dapagliflozin/exenatide versus placebo was -6.7 mm Hg.
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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).

  7. 07HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome

    In adults with obesity without diabetes, nausea was more frequent with dapagliflozin plus exenatide than placebo.

    In plain wordsIn adults with obesity without diabetes, nausea occurred more often with dapagliflozin plus exenatide than placebo.

    Outcome
    IncreaseNausea
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Source sentences

    Summary
    As expected, nausea and injection-site reactions were more frequent with dapagliflozin/exenatide than with placebo.
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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).

  8. 08HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome

    In adults with obesity without diabetes, injection-site reactions were more frequent with dapagliflozin plus exenatide than placebo.

    In plain wordsIn adults with obesity without diabetes, injection-site reactions occurred more often with dapagliflozin plus exenatide than placebo.

    Outcome
    IncreaseInjection-site reactions
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Adverse events · Skin and wound

    Source sentences

    Summary
    As expected, nausea and injection-site reactions were more frequent with dapagliflozin/exenatide than with placebo.
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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).

  9. 09HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome

    In adults with obesity without diabetes, two participants on dapagliflozin plus exenatide versus three on placebo discontinued because of adverse events.

    In plain wordsIn adults with obesity without diabetes, two combination recipients and three placebo recipients stopped treatment because of adverse events.

    Outcome
    DecreaseDiscontinuation due to adverse events
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body

    Measurements

    Discontinuation due to adverse events
    2 participants
    dapagliflozin/exenatide
    Discontinuation due to adverse events
    3 participants
    placebo

    Source sentences

    Summary
    Only two and three participants, respectively, discontinued because of adverse events.
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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).

  10. 10HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialOther

    In adults with obesity without diabetes, 92.0% receiving dapagliflozin plus exenatide versus 80.0% receiving placebo completed 24 weeks of treatment.

    In plain wordsIn adults with obesity without diabetes, treatment completion was higher with dapagliflozin plus exenatide than placebo.

    Outcome
    IncreaseTreatment completion
    Study

    n = 50

    Comparator
    placebo
    Outcome group
    Treatment adherence and retention · Whole body

    Measurements

    Treatment completion
    92%
    combination
    Treatment completion
    80%
    placebo

    Source sentences

    Summary
    Of 25 dapagliflozin/exenatide- and 25 placebo-treated participants, 23 (92.0%) and 20 (80.0%) completed 24 weeks of treatment, respectively.
    1 context sentence
    Summary · context
    In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or 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.

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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