Exenatide Once Weekly vs Placebo: Primary Safety Outcome MACE Events
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 | 0.114 | 0.107 | 0.122 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.122 | 0.115 | 0.13 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00831 | -0.0187 | 0.00212 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.932 | 0.853 | 1.02 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.923 | 0.835 | 1.02 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Exenatide Once Weekly than on Placebo | 120 | 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 | Exenatide Once Weekly | Exenatide 2mg once weekly subcutaneous injections | 839 | 7,356 | OG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Matching placebo subcutaneous injections | 905 | 7,396 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Primary Safety Outcome MACE Events | ClinicalTrials.gov |
| Description | The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.~The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo. | ClinicalTrials.gov |
| Time frame | Time to first event. Information collected during study period (anticipated to be up to 7.5 years). | ClinicalTrials.gov |
| Population | ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus | ClinicalTrials.gov |
| NCT number | NCT01144338 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Type 2 Diabetes Mellitus | ClinicalTrials.gov |
| Interventions | Exenatide Once Weekly, Placebo | ClinicalTrials.gov |
| Lead sponsor | AstraZeneca | ClinicalTrials.gov |
| Results first posted | 2018-08-08 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01144338?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.