Diabetes Mellitus type 2
Conditions
Interventions
Screening phase: 7 days placebo-run in
Double-blind treatment phase: maximum of 58 months treatment with lixisenatide
or placebo and minimum of 10 months treatment with lixisenatide or placebo.
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 99 Years
Inclusion 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 myocardial infarction [NSTEMI] or unstable angina [USA]) with the following requirements: - a documented elevation above the normal reference range of a cardiac biomarker (Troponin or CK-MB), - The presentation of the event must be consistent with an acute coronary syndrome which leads to admission to an acute care facility (eg, ER, CCU, Cath Lab, hospital - the screening visit must occur only after the patient is discharged from the acute care facility, and must take place within 180 days following the date of admission for the qualifying ACS event. . *Patients with history of type 2 diabetes (for patients newly diagnosed, diagnosis will be based on the WHO criteria: i.e., 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 ccasions) prior to the screening visit.
Exclusion criteria
Exclusion criteria: . Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.;. HbA1c <5.5 % or >11% measured at screening Visit (1 retest within a week of receipt of the result is permitted with the result of the last sample being decisive).;. Required to use incretin-based agents (eg, GLP-1 agonists or DPP-4 inhibitors) other than the study drug during the doubleblind treatment period.;. Patients who have undergone CABG surgery following the qualifying ACS event.;. Patients who have undergone PCI within 15 days prior to screening.;. Patients with planned revascularization procedure (PCI or CABG) 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 (eg, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate cardiovascular outcomes with lixisenatide compared to placebo (time to first occurence: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina) in type 2 diabetic patients who experienced an acute coronary syndrome event. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of lixisenatide compared to placebo on: Composite cardiovascular endpoints * Time to the first occurrence of any of the following clinical events, positively adjudicated by the CAC: • Cardiovascular death. • Non-fatal MI. • Non-fatal stroke. • Hospitalization for unstable angina. • Hospitalization for heart failure. * Time to the first occurrence of any of the following clinical events, positively adjudicated by the CAC: • Cardiovascular death. • Non-fatal MI. • Non-fatal stroke. • Hospitalization for unstable angina. • Hospitalization for heart failure. • Coronary revascularization procedure • Urinary albumin/creatinine ratio: Percent change in the urinary albumin/creatinine ratio from baseline to Week 108 (i.e., approximately 2 years). To assess the safety and tolerability of lixisenatide. | — |
Countries
Netherlands
Outcome results
None listed