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Study · Randomized controlled trial · n = 90 · 2026

4 results

Effect of lixisenatide on arterial stiffness in people with type 2 diabetes and kidney disease: Results of a randomised controlled trial.

Fountoulakis N, Pavlou P, Stathi D, Goubar A, Corcillo A, Flaquer M, Ayis S, Gnudi L, Karalliedde J

Diabetes, obesity & metabolism18 Feb 2026Cited by 2 (Europe PMC)

Summary

ObjectivePeople with chronic kidney disease (CKD) and diabetes are at high risk of cardiovascular disease (CVD). Aortic pulse wave velocity (Ao-PWV) is an independent predictor of CVD. Cardiovascular outcome trials (CVOTs) with glucagon like peptide-1 receptor agonist (GLP-1 RA) class demonstrate notable differences, with lixisenatide having neutral effects as compared to longer acting GLP-1 RA. It is unknown if shorter acting GLP-1 RA have an impact on Ao-PWV and if this may explain the discordance observed in GLP-1RA CVOTs.Materials and methodsWe studied people with type 2 diabetes and CKD in a proof-of-concept single centre, randomised, double-blind parallel-group placebo-controlled study that evaluated 24 weeks' treatment with lixisenatide as compared to placebo on the primary endpoint of Ao-PWV.ResultsIn total, 101 participants (male 66%) were randomised of whom 90 were eligible for analyses (lixisenatide [n = 47] and placebo [n = 43]). Ao-PWV did not change significantly from baseline after 24 weeks of treatment with final mean (95% confidence intervals) of 9.65 (9.17, 10.13) m/s with lixisenatide and 9.96 (9.45, 10.46) m/s with placebo, p = 0.38. Similarly, no significant changes were observed in cardio-renal risk biomarkers including albuminuria and Klotho levels. HbA1c decreased with lixisenatide as compared to placebo.ConclusionsIn people with CKD and type 2 diabetes the use of short-acting GLP-1 RA lixisenatide did not significantly influence Ao-PWV. Further studies are needed to understand mechanisms that may explain discordance in CVOTs results observed with GLP-1 RA.Clinical trial registrationISRCTN: ISRCTN97699312; EudraCT/CTIS number: 2016-001758-17.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In people with type 2 diabetes and CKD, Ao-PWV did not change significantly from baseline after 24 weeks; final means were 9.65 m/s with lixisenatide and 9.96 m/s with placebo (p = 0.38).

    In plain wordsIn people with diabetes and kidney disease, lixisenatide did not significantly change aortic stiffness compared with placebo.

    Outcome
    No significant changeAortic pulse wave velocity
    Study

    n = 90

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Vascular function · Cardiovascular
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    Final mean Ao-PWV at 24 weeks
    9.65 m/s
    lixisenatide (95% CI 9.17-10.13)
    Final mean Ao-PWV at 24 weeks
    9.96 m/s
    placebo (95% CI 9.45-10.46)
    Between-group p value for Ao-PWV
    0.38 p-value
    lixisenatide versus placebo

    Source sentences

    Summary
    Ao-PWV did not change significantly from baseline after 24 weeks of treatment with final mean (95% confidence intervals) of 9.65 (9.17, 10.13) m/s with lixisenatide and 9.96 (9.45, 10.46) m/s with placebo, p = 0.38.
    2 context sentences
    Summary · context
    We studied people with type 2 diabetes and CKD in a proof-of-concept single centre, randomised, double-blind parallel-group placebo-controlled study that evaluated 24 weeks' treatment with lixisenatide as compared to placebo on the primary endpoint of Ao-PWV.
    Summary · context
    In total, 101 participants (male 66%) were randomised of whom 90 were eligible for analyses (lixisenatide [n = 47] and placebo [n = 43]).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In people with diabetes and CKD, lixisenatide decreased HbA1c compared with placebo.

    In plain wordsIn people with diabetes and kidney disease, lixisenatide lowered HbA1c compared with placebo.

    Outcome
    DecreaseHbA1c
    Study

    n = 90

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

    Source sentences

    Summary
    HbA1c decreased with lixisenatide as compared to placebo.
    2 context sentences
    Summary · context
    We studied people with type 2 diabetes and CKD in a proof-of-concept single centre, randomised, double-blind parallel-group placebo-controlled study that evaluated 24 weeks' treatment with lixisenatide as compared to placebo on the primary endpoint of Ao-PWV.
    Summary · context
    In total, 101 participants (male 66%) were randomised of whom 90 were eligible for analyses (lixisenatide [n = 47] and placebo [n = 43]).
  3. 03HumanNon-randomized trialEfficacy outcome

    In a trial of lixisenatide versus placebo in people with type 2 diabetes and CKD, no significant changes in albuminuria were observed.

    In plain wordsIn people with diabetes and kidney disease in a lixisenatide trial, urine albumin did not change significantly.

    Outcome
    No significant changeAlbuminuria
    Study

    n: not reported in source

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Similarly, no significant changes were observed in cardio-renal risk biomarkers including albuminuria and Klotho levels.
    2 context sentences
    Summary · context
    We studied people with type 2 diabetes and CKD in a proof-of-concept single centre, randomised, double-blind parallel-group placebo-controlled study that evaluated 24 weeks' treatment with lixisenatide as compared to placebo on the primary endpoint of Ao-PWV.
    Summary · context
    In total, 101 participants (male 66%) were randomised of whom 90 were eligible for analyses (lixisenatide [n = 47] and placebo [n = 43]).
  4. 04HumanNon-randomized trialEfficacy outcome

    In a trial of lixisenatide versus placebo in people with type 2 diabetes and CKD, no significant changes in Klotho levels were observed.

    In plain wordsIn people with diabetes and kidney disease in a lixisenatide trial, Klotho levels did not change significantly.

    Outcome
    No significant changeKlotho levels
    Study

    n: not reported in source

    Outcome group
    Cardio-Renal Biomarkers · Kidney and urinary
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Similarly, no significant changes were observed in cardio-renal risk biomarkers including albuminuria and Klotho levels.
    2 context sentences
    Summary · context
    We studied people with type 2 diabetes and CKD in a proof-of-concept single centre, randomised, double-blind parallel-group placebo-controlled study that evaluated 24 weeks' treatment with lixisenatide as compared to placebo on the primary endpoint of Ao-PWV.
    Summary · context
    In total, 101 participants (male 66%) were randomised of whom 90 were eligible for analyses (lixisenatide [n = 47] and placebo [n = 43]).

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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