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Study · Randomized controlled trial · n = 30 · 2021

7 results

Combined exenatide and dapagliflozin has no additive effects on reduction of hepatocellular lipids despite better glycaemic control in patients with type 2 diabetes mellitus treated with metformin: EXENDA, a 24-week, prospective, randomized, placebo-controlled pilot trial.

Harreiter J, Just I, Leutner M, Bastian M, Brath H, Schelkshorn C, Klepochova R, Krššák M, Kautzky-Willer A

Diabetes, obesity & metabolism10 Feb 2021Cited by 45 (Europe PMC)

PMID33464703 (opens in a new tab)PMCIDPMC8247845 (opens in a new tab)DOI10.1111/dom.14319 (opens in a new tab)PepBankPUB-33464703
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study7

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, adding exenatide to dapagliflozin did not change hepatocellular lipid reduction versus placebo plus dapagliflozin.

    In plain wordsIn type 2 diabetes, liver fat reduction was similar with exenatide plus dapagliflozin and placebo plus dapagliflozin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeHepatocellular lipids
    Study

    n = 30

    Comparator
    Placebo plus dapagliflozin
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    HCL absolute change from baseline
    −4.4%
    EXE + DAPA
    HCL absolute change from baseline
    −3.9%
    PLAC + DAPA
    HCL relative change
    −35.6%
    EXE + DAPA
    HCL relative change
    −32.3%
    PLAC + DAPA

    Source sentences

    Summary
    After 24 weeks, HCLs were reduced in both treatment groups (absolute change from baseline: EXE + DAPA -4.4%, 95% confidence interval [CI] -8.2, -0.7, P < 0.05; PLAC + DAPA -3.9%, 95% CI -6.0, -1.7, P < 0.01; relative change: EXE + DAPA -35.6%, PLAC + DAPA -32.3%) with no difference between groups.
    1 context sentence
    Summary · context
    Thirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, subcutaneous adipose tissue results were similar with exenatide plus dapagliflozin and placebo plus dapagliflozin.

    In plain wordsIn type 2 diabetes, subcutaneous fat results were similar with exenatide plus dapagliflozin and placebo plus dapagliflozin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeSubcutaneous adipose tissue
    Study

    n = 30

    Comparator
    Placebo plus dapagliflozin
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Similar findings were observed for subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT).
    2 context sentences
    Summary · context
    After 24 weeks, HCLs were reduced in both treatment groups (absolute change from baseline: EXE + DAPA -4.4%, 95% confidence interval [CI] -8.2, -0.7, P < 0.05; PLAC + DAPA -3.9%, 95% CI -6.0, -1.7, P < 0.01; relative change: EXE + DAPA -35.6%, PLAC + DAPA -32.3%) with no difference between groups.
    Summary · context
    Thirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, visceral adipose tissue results were similar with exenatide plus dapagliflozin and placebo plus dapagliflozin.

    In plain wordsIn type 2 diabetes, visceral fat results were similar with exenatide plus dapagliflozin and placebo plus dapagliflozin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeVisceral adipose tissue
    Study

    n = 30

    Comparator
    Placebo plus dapagliflozin
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Similar findings were observed for subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT).
    2 context sentences
    Summary · context
    After 24 weeks, HCLs were reduced in both treatment groups (absolute change from baseline: EXE + DAPA -4.4%, 95% confidence interval [CI] -8.2, -0.7, P < 0.05; PLAC + DAPA -3.9%, 95% CI -6.0, -1.7, P < 0.01; relative change: EXE + DAPA -35.6%, PLAC + DAPA -32.3%) with no difference between groups.
    Summary · context
    Thirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, exenatide plus dapagliflozin reduced HbA1c more than placebo plus dapagliflozin.

    In plain wordsIn type 2 diabetes, exenatide plus dapagliflozin lowered HbA1c more than placebo plus dapagliflozin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c
    Study

    n = 30

    Comparator
    Placebo plus dapagliflozin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    HbA1c change from baseline
    −17.8 mmol/mol
    EXE + DAPA
    HbA1c change from baseline
    −6.9 mmol/mol
    PLAC + DAPA
    HbA1c adjusted difference
    −6 mmol/mol
    EXE + DAPA versus PLAC + DAPA

    Source sentences

    Summary
    HbA1c (EXE + DAPA -17.8 mmol/mol, [95% CI -24.8, -10.8], P <0.001; PLAC + DAPA -6.9 mmol/mol, [95% CI -10.5, -3.3], P = 0.001) and fasting glucose significantly decreased in both groups, although EXE + DAPA achieved better glycaemic control than PLAC + DAPA (adjusted difference: HbA1c -6.0 mmol/mol…
    1 context sentence
    Summary · context
    Thirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, weight reduction was comparable with exenatide plus dapagliflozin and placebo plus dapagliflozin.

    In plain wordsIn type 2 diabetes, weight loss was similar with exenatide plus dapagliflozin and placebo plus dapagliflozin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeBody weight
    Study

    n = 30

    Comparator
    Placebo plus dapagliflozin
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    Body weight change
    −7.3 kg
    EXE + DAPA
    Body weight change
    −4.6 kg
    PLAC + DAPA

    Source sentences

    Summary
    Body weight was reduced in both treatment groups (EXE + DAPA -7.3 kg, 95% CI -9.9, -4.8, P <0.001; PLAC + DAPA -4.6 kg, 95% CI -7.4, -1.8, P <0.01) with comparable results between groups.
    1 context sentence
    Summary · context
    Thirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14).

Studies that did not test the peptide alone2

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

    In type 2 diabetes, fasting glucose decreased in both exenatide plus dapagliflozin and placebo plus dapagliflozin groups.

    In plain wordsIn type 2 diabetes, fasting glucose fell in both combination treatment and comparator groups.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseFasting glucose
    Study

    n = 30

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight

    Source sentences

    Summary
    and fasting glucose significantly decreased in both groups
    1 context sentence
    Summary · context
    Thirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14).

    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. 07HumanNot a test of Exenatide (exendin-4) aloneObservational studyOther

    In the EXENDA trial, hepatocellular lipid changes correlated positively with changes in weight, hip and waist circumference, and adipose tissue.

    In plain wordsIn the trial, liver fat changes were linked to changes in weight, hip and waist size, and body fat.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableCorrelates of hepatocellular lipid change
    Study

    n = 30

    Outcome group
    Liver fat and liver function · Liver

    Source sentences

    Summary
    Changes in HCLs and weight, hip and waist circumference, VAT and SAT were positively associated.
    1 context sentence
    Summary · context
    Thirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14).

    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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT03007329

Effects of Combined Dapagliflozin and Exenatide Versus Dapagliflozin and Placebo on Ectopic Lipids in Patients With Uncontrolled Type 2 Diabetes Mellitus.

Medical University of Viennan = 348 Mar 2017 to 16 Jan 2020

Steatosis, Liver · Type2 Diabetes

Trial pageClinicalTrials.govUpdated 15 Apr 2022

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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