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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name ELIXA

NCTNCT01147250 (opens ClinicalTrials.gov in a new tab)Other idEFC11319Other id2009-012852-26Other idU1111-1116-5558Other id2009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
6,068 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Triple masking
Countries
30 countries

United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Guatemala, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway

Start
Jun 2010
Primary completion
Feb 2015
Completion
Feb 2015
First posted
22 Jun 2010 (estimated)
Last update posted
20 Dec 2016 (estimated)
Conditions
Acute Coronary Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013201420152016
  1. Ph 3

    ELIXA

    NCT01147250

    Jun 2010 to Feb 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Primary Objective: \- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event. Secondary Objectives: To demonstrate that when compared to placebo, lixisenatide can reduce: * composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure. * composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. * urinary albumin excretion (based on the urinary albumin/creatinine ratio). To assess the safety and tolerability of lixisenatide.

Interventions

  • Lixisenatide (AVE0010)Drug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

    Placebo matched to lixisenatide once daily (QD) up to end of treatment.

  • Experimental

    Lixisenatide

    Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina

    Time frame · From randomization up to the end of study (median follow-up of 25 months)

    Registry description

    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.

Secondary outcomes(3)

  1. Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure

    Time frame · From randomization up to the end of study (median follow-up of 25 months)

    Registry description

    All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.

  2. Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure

    Time frame · From randomization up to the end of study (median follow-up of 25 months)

    Registry description

    All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.

  3. Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108

    Time frame · Baseline to Week 108 (LOCF)

    Registry description

    Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· From randomization up to the end of study (median follow-up of 25 months)

Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina

GroupValue (participants)
Placebo399
Lixisenatide406
Secondary and other outcome results(3)
Secondary outcomeNumber· From randomization up to the end of study (median follow-up of 25 months)

Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure

GroupValue (participants)
Placebo469
Lixisenatide456
Secondary outcomeNumber· From randomization up to the end of study (median follow-up of 25 months)

Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure

GroupValue (participants)
Placebo659
Lixisenatide661
Secondary outcomeGeometric mean· Baseline to Week 108 (LOCF)

Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108

GroupValue (percent change)Spread
Placebo34.213.09
Lixisenatide24.172.84

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)–669 / 30321270 / 3032
LixisenatideParticipants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)–625 / 30311597 / 3031

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies9

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

PubMed tag: none · 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 et al. 2018The lancet. Diabetes & endocrinologycited by 203

PMID 30292589DOI 10.1016/s2213-8587(18)30268-7PUB-30292589

Full text at the publisher9 results
Publisher pageSee results (9)

Indexing hint: Randomized controlled trial · 2015

8 results

Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.

Pfeffer et al. 2015The New England journal of medicinecited by 1,765

PMID 26630143DOI 10.1056/nejmoa1509225PUB-26630143

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Animal study · 2013

10 results

Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies.

Wohlfart et al. 2013Journal of translational medicinecited by 62

PMID 23537041PMC3637243DOI 10.1186/1479-5876-11-84PUB-23537041

CC BY10 results
Download PDFSee results (10)

More studies

5 studies on this page

Indexing hint: Clinical trial · 2022

Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study.

Gerstein et al. 2022Diabetes carecited by 7

PMID 35817031DOI 10.2337/dc22-0453PUB-35817031

Full text at the publisher
Publisher page

Indexing hint: Observational study · 2020

Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial.

Wijkman et al. 2020Cardiovascular diabetologycited by 4

PMID 33046070PMC7552471DOI 10.1186/s12933-020-01150-0PUB-33046070

CC BY
Download PDF

PubMed tag: none · 2018

Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.

Wittbrodt et al. 2018The American journal of managed carecited by 21

PMID 29693361PUB-29693361

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2018

Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration.

Seferovic et al. 2018Journal of diabetes researchcited by 23

PMID 30648112PMC6311850DOI 10.1155/2018/1631263PUB-30648112

CC BY
Download PDF

Indexing hint: Randomized controlled trial · 2015

Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo.

Bentley-Lewis et al. 2015American heart journalcited by 61

PMID 25965710DOI 10.1016/j.ahj.2015.02.002PUB-25965710

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGerstein HC, Wolsk E, Claggett B, Diaz R, Dickstein K, Hess S, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Effect of lixisenatide on natriuretic peptides in people with type 2 diabetes and recent acute coronary syndrome: The ELIXA trial. Diabetes Obes Metab. 2023 Apr;25(4):1125-1129. doi: 10.1111/dom.14954. Epub 2023 Jan 3. No abstract available. PMID 36546588
  • DerivedShin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25. PMID 32212368
  • DerivedWolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Kober L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6):e004743. doi: 10.1161/JAHA.116.004743. PMID 28554908

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: * Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable angina) with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an ACS which lead to admission to an acute care facility, within 180 days following the ACS event and prior to screening. * Participants with a history of type 2 diabetes (for participants newly diagnosed, diagnosis was based on the World Health Organization (WHO) criteria: i.e., either a fasting venous plasma glucose concentration ≥ 7.0 mmol/L \[126 mg/dL\] or 2-hour post glucose load venous plasma glucose ≥ 11.1 mmol/L \[200 mg/dL\], confirmed on 2 occasions) prior to the screening visit. Exclusion criteria: * Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening. * Glycosylated hemoglobin (HbA1c) \<5.5 % or \>11% measured at screening visit. * Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the double-blind treatment period. * Participants who had undergone coronary artery bypass graft (CABG) surgery following the qualifying ACS event. * Participants who had undergone percutaneous coronary intervention (PCI) within 15 days prior to screening. * Participants with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit. * History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes). * Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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