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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT01147250

Run by

Sanofi

People needed

6068

Starts

2010-06-01

Expected to finish

2015-02-01

Last updated by the study team

2016-12-20

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840307 — Foley, Alabama, United States
• Investigational Site Number 840692 — Mobile, Alabama, United States
• Investigational Site Number 840037 — Mobile, Alabama, United States
• Investigational Site Number 840210 — Mobile, Alabama, United States
• Investigational Site Number 840326 — Muscle Shoals, Alabama, United States
• Investigational Site Number 840393 — Toney, Alabama, United States
• Investigational Site Number 840656 — Mesa, Arizona, United States
• Investigational Site Number 840506 — Phoenix, Arizona, United States
• Investigational Site Number 840520 — Phoenix, Arizona, United States
• Investigational Site Number 840322 — Phoenix, Arizona, United States
• Investigational Site Number 840250 — Tempe, Arizona, United States
• Investigational Site Number 840042 — Tucson, Arizona, United States
• Investigational Site Number 840303 — Hot Springs, Arkansas, United States
• Investigational Site Number 840184 — Jonesboro, Arkansas, United States
• Investigational Site Number 840361 — Little Rock, Arkansas, United States
• Investigational Site Number 840023 — Little Rock, Arkansas, United States
• Investigational Site Number 840706 — Anaheim, California, United States
• Investigational Site Number 840497 — Anaheim, California, United States
• Investigational Site Number 840667 — Downey, California, United States
• Investigational Site Number 840150 — Fresno, California, United States
• Investigational Site Number 840624 — Hawthorne, California, United States
• Investigational Site Number 840623 — Inglewood, California, United States
• Investigational Site Number 840636 — Inglewood, California, United States
• Investigational Site Number 840455 — La Mesa, California, United States
• Investigational Site Number 840415 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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