None listed
Conditions
Interventions
Group 1 Type of group
Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.
Group name:Group 2 Type of group
Placebo matched to lixisenatide once daily (QD) up to end of treatment.
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Sex/Gender
All
Age
30 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Men and women who experienced an ACS event (ie, myocardial infarction with ST-segment elevation [STEMI] or myocardial infarction without ST-segment elevation [NSTEMI] or unstable angina [USA]), for at least 5 days and no more than 12 weeks before the selection visit and on condition that they are discharged from the Intensive Care Center (ie emergency room, intensive care unit, etc.) • Patients with a history of type 2 diabetes (for newly diagnosed patients, said diagnosis will be based on the WHO criteria, that is, fasting venous plasma glucose concentration 5 7.0 mmol / L [126 mg / dL] or venous plasma glucose). 2 hour post glucose load s 11.1 mmol / L [200 mg / dL], confirmed twice) prior to the selection visit.
Exclusion criteria
Exclusion criteria: • HbA1c 10.0% at the last value obtained prior to the selection visit. • Fasting Plasma Glucose> 13.9 mmol / L (> 250 mg / dL), at the last value obtained prior to the selection visit. • HbA1c 10.0% measured in the selection visit. • Fasting Plasma Glucose> 13.9 mmol / L {> 250 mg / dL) measured at the selection visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina Timepoints:From randomization up to the end of study (median follow-up of 25 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure Timepoints:From randomization up to the end of study (median follow-up of 25 months) ; Outcome name: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. Measure: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 Timepoints:From randomization up to the end of study (median follow-up of 25 months) ; Outcome name: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. Measure:Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108 Timepoints:Baseline to Week 108 (LOCF) | — |
Countries
Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latovia, Lithuania, Netherlands, Norway, Peru, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactSandra Mendez
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed