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Study · Randomized controlled trial · n = 6,063 · 2018

9 results

Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial.

Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH

The lancet. Diabetes & endocrinology3 Oct 2018Cited by 203 (Europe PMC)

PMID30292589 (opens in a new tab)DOI10.1016/s2213-8587(18)30268-7 (opens in a new tab)PepBankPUB-30292589
Publisher pagePubMedAsk about this study
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In ELIXA patients, serum creatinine doubling was numerically more frequent with lixisenatide than placebo, without a statistically significant difference.

    In plain wordsDoubling of a kidney blood marker was numerically more frequent with lixisenatide than placebo, but the difference was not statistically significant.

    Peptide
    Lixisenatide
    Outcome
    IncreaseDoubling of serum creatinine
    Study

    n = 6,063

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Measurements

    Events
    41
    lixisenatide
    Patients
    3031
    lixisenatide
    Incidence
    1%
    lixisenatide
    Events
    35
    placebo
    Patients
    3032
    placebo
    Incidence
    1%
    placebo
    Hazard ratio
    1.163
    lixisenatide versus placebo
    95% CI lower
    0.741
    hazard ratio

    2 more measurements in the study.

    Source sentences

    Summary
    In the trial safety population, doubling of serum creatinine occurred in 35 (1%) of 3032 patients in the placebo group and 41 (1%) of 3031 patients in the lixisenatide group (HR 1·163, 95% CI 0·741-1·825; p=0·5127).
    2 context sentences
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and acute coronary syndrome with normoalbuminuria, lixisenatide numerically reduced UACR versus placebo without statistical significance.

    In plain wordsIn patients with normal baseline urine albumin, lixisenatide numerically lowered urine albumin versus placebo, but the difference was not statistically significant.

    Peptide
    Lixisenatide
    Outcome
    DecreaseUACR change at 108 weeks, normoalbuminuria
    Study

    n = 4,441

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Measurements

    Placebo-adjusted UACR change
    −1.69%
    normoalbuminuria
    95% CI lower
    −11.69%
    normoalbuminuria
    95% CI upper
    8.3%
    normoalbuminuria
    P value
    0.7398
    normoalbuminuria

    Source sentences

    Summary
    After 108 weeks, the placebo-adjusted least-squares mean percentage change in UACR from baseline with lixisenatide was -1·69% (95% CI -11·69 to 8·30; p=0·7398) in patients with normoalbuminuria,
    2 context sentences
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In ELIXA patients with baseline normoalbuminuria, eGFR decline did not differ significantly between lixisenatide and placebo.

    In plain wordsKidney filtration decline did not differ significantly between lixisenatide and placebo in patients with normal baseline urine albumin.

    Peptide
    Lixisenatide
    Outcome
    No significant changeeGFR decline, normoalbuminuria subgroup
    Study

    n = 4,441

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    No significant differences in eGFR decline were identified between treatment groups in any UACR subgroup.
    3 context sentences
    Summary · context
    4441 (74%; 2191 assigned to placebo and 2250 assigned to lixisenatide) had normoalbuminuria, 1148 (19%; 596 assigned to placebo and 552 assigned to lixisenatide) had microalbuminuria, and 389 (7%; 207 assigned to placebo and 182 assigned to lixisenatide) had macroalbuminuria.
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and acute coronary syndrome with microalbuminuria, lixisenatide numerically reduced UACR versus placebo without statistical significance.

    In plain wordsIn patients with moderately elevated baseline urine albumin, lixisenatide numerically lowered urine albumin versus placebo without a statistically significant difference.

    Peptide
    Lixisenatide
    Outcome
    DecreaseUACR change at 108 weeks, microalbuminuria
    Study

    n = 1,148

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Measurements

    Placebo-adjusted UACR change
    −21.1%
    microalbuminuria
    95% CI lower
    −42.25%
    microalbuminuria
    95% CI upper
    0.04%
    microalbuminuria
    P value
    0.0502
    microalbuminuria

    Source sentences

    Summary
    -21·10% (-42·25 to 0·04; p=0·0502) in patients with microalbuminuria,
    2 context sentences
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…
  5. 05HumanRandomized controlled trialEfficacy outcome

    In ELIXA patients with baseline microalbuminuria, eGFR decline did not differ significantly between lixisenatide and placebo.

    In plain wordsKidney filtration decline did not differ significantly between lixisenatide and placebo in patients with moderately elevated baseline urine albumin.

    Peptide
    Lixisenatide
    Outcome
    No significant changeeGFR decline, microalbuminuria subgroup
    Study

    n = 1,148

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    No significant differences in eGFR decline were identified between treatment groups in any UACR subgroup.
    3 context sentences
    Summary · context
    4441 (74%; 2191 assigned to placebo and 2250 assigned to lixisenatide) had normoalbuminuria, 1148 (19%; 596 assigned to placebo and 552 assigned to lixisenatide) had microalbuminuria, and 389 (7%; 207 assigned to placebo and 182 assigned to lixisenatide) had macroalbuminuria.
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…
  6. 06HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and acute coronary syndrome with macroalbuminuria, lixisenatide significantly reduced UACR versus placebo.

    In plain wordsIn patients with highly elevated baseline urine albumin, lixisenatide lowered urine albumin more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseUACR change at 108 weeks, macroalbuminuria
    Study

    n = 389

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Measurements

    Placebo-adjusted UACR change
    −39.18%
    macroalbuminuria
    95% CI lower
    −68.53%
    macroalbuminuria
    95% CI upper
    −9.84%
    macroalbuminuria
    P value
    0.007
    macroalbuminuria

    Source sentences

    Summary
    and -39·18% (-68·53 to -9·84; p=0·0070) in patients with macroalbuminuria.
    2 context sentences
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…
  7. 07HumanRandomized controlled trialEfficacy outcome

    In ELIXA patients with baseline macroalbuminuria, eGFR decline did not differ significantly between lixisenatide and placebo at week 108.

    In plain wordsKidney filtration decline did not differ significantly between lixisenatide and placebo in patients with highly elevated baseline urine albumin.

    Peptide
    Lixisenatide
    Outcome
    No significant changeeGFR decline, macroalbuminuria subgroup
    Study

    n = 389

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    At week 108, the largest eGFR decline from baseline was observed in the macroalbuminuric group, but no significant differences were observed between the two treatment groups. No significant differences in eGFR decline were identified between treatment groups in any UACR subgroup.
    2 context sentences
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…
  8. 08HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and acute coronary syndrome, lixisenatide was associated with a reduced risk of new-onset macroalbuminuria versus placebo after adjustment for baseline HbA1c.

    In plain wordsLixisenatide was associated with a lower risk of newly high urine albumin than placebo after adjustment for starting blood sugar.

    Peptide
    Lixisenatide
    Outcome
    DecreaseNew-onset macroalbuminuria adjusted for baseline HbA1c
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Measurements

    Hazard ratio
    0.808
    baseline HbA1c adjustment
    95% CI lower
    0.66
    baseline HbA1c adjustment
    95% CI upper
    0.991
    baseline HbA1c adjustment
    P value
    0.0404
    baseline HbA1c adjustment

    Source sentences

    Summary
    Lixisenatide was associated with a reduced risk of new-onset macroalbuminuria compared with placebo when adjusted for baseline HbA1c (hazard ratio [HR] 0·808 [95% CI 0·660 to 0·991; p=0·0404])
    2 context sentences
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…
  9. 09HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and acute coronary syndrome, lixisenatide was associated with a reduced risk of new-onset macroalbuminuria versus placebo after adjustment for baseline and on-trial HbA1c.

    In plain wordsLixisenatide was associated with a lower risk of newly high urine albumin than placebo after adjustment for starting and during-trial blood sugar.

    Peptide
    Lixisenatide
    Outcome
    DecreaseNew-onset macroalbuminuria adjusted for baseline and on-trial HbA1c
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    10-20 μg daily · subcutaneousAs given in this study (human).

    Measurements

    Hazard ratio
    0.815
    baseline and on-trial HbA1c adjustment
    95% CI lower
    0.665
    baseline and on-trial HbA1c adjustment
    95% CI upper
    0.999
    baseline and on-trial HbA1c adjustment
    P value
    0.0491
    baseline and on-trial HbA1c adjustment

    Source sentences

    Summary
    or baseline and on-trial HbA1c (HR 0·815 [0·665 to 0·999; p=0·0491]);
    2 context sentences
    Summary · context
    ELIXA was a randomised, double-blind, placebo-controlled trial, done at 828 sites in 49 countries.
    Summary · context
    Patients with type 2 diabetes and a recent coronary artery event were randomly assigned (1:1) to a daily subcutaneous injection of lixisenatide (10-20 μg) or volume-matched placebo, in addition to usual care, until at least 844 patients had an adjudicated major adverse cardiovascular event included…

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 postedNCT01147250

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

Sanofin = 6,068Jun 2010 to Feb 2015

Acute Coronary Syndrome

Trial pageClinicalTrials.govUpdated 20 Dec 2016

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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