Comparison · NCT01798706-sae
Lixisenatide vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Lixisenatide vs Placebo: serious adverse events. Trial comparisons, record NCT01798706-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01798706-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0455 | 0.0232 | 0.0871 | wilson | |
| Risk in group 2 | 0.0575 | 0.0315 | 0.103 | wilson | |
| Risk difference, group 1 minus group 2 | -0.012 | -0.0623 | 0.0371 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.791 | 0.32 | 1.96 | log | |
| Odds ratio, group 1 over group 2 | 0.781 | 0.301 | 2.03 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lixisenatide than on Placebo | 83.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lixisenatide | Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.(Median exposure: 169 days) | 8 | 176 | EG000 |
| Group 2 | Placebo | Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. (Median exposure: 169 days) | 10 | 174 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (Day 171) regardless of seriousness or relationship to investigational medicinal product (IMP).
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
- NCT number
- NCT01798706
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes
- Interventions
- Lixisenatide (AVE0010), Placebo, Antidiabetic background therapy
- Lead sponsor
- Sanofi
- Results first posted
- 2016-10-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01798706?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.
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