Lixisenatide vs Placebo: Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.134 | 0.122 | 0.146 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.132 | 0.12 | 0.144 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00231 | -0.0148 | 0.0194 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.895 | 1.16 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.88 | 1.18 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Lixisenatide than on Placebo | 433 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Lixisenatide | Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months). | 406 | 3,034 | OG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months). | 399 | 3,034 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina | ClinicalTrials.gov |
| 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. | ClinicalTrials.gov |
| Time frame | From randomization up to the end of study (median follow-up of 25 months) | ClinicalTrials.gov |
| Population | Intent-to-treat (ITT) population defined as all randomized participants analyzed according to the treatment group allocated at randomization. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide) | ClinicalTrials.gov |
| NCT number | NCT01147250 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Acute Coronary Syndrome | ClinicalTrials.gov |
| Interventions | Lixisenatide (AVE0010), Placebo | ClinicalTrials.gov |
| Lead sponsor | Sanofi | ClinicalTrials.gov |
| Results first posted | 2016-10-14 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01147250?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.