Phase 3
Completed N=6,068
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
Source: ClinicalTrials.gov NCT01147250 ↗Enrolled (actual)
6,068
Serious AEs
21.3%
Results posted
Oct 2016
Primary outcomePrimary: Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina — 399; 406 participants — p=0.8542
◆ Published Evidence
Highly cited
2,327citations · ~212 / year
Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.
Summary
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.
Linked Publications (5)
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Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.
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Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
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Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study.
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Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial.
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Effect of lixisenatide on natriuretic peptides in people with type 2 diabetes and recent acute coronary syndrome: The ELIXA trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina |
399; 406 | 0.8542 |
| SECONDARY Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure |
469; 456 | — |
| SECONDARY 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 |
659; 661 | — |
| SECONDARY Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108 |
34.21; 24.17 | — |
Eligibility Criteria
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) 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.
Data sourced from ClinicalTrials.gov (NCT01147250) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.