Comparison · NCT03211858-sae
SAR341402 vs NovoLog/NovoRapid: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. SAR341402 vs NovoLog/NovoRapid: serious adverse events. Trial comparisons, record NCT03211858-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03211858-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 | 0.12 | 0.0877 | 0.161 | wilson | |
| Risk in group 2 | 0.098 | 0.0691 | 0.137 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0216 | -0.0289 | 0.0722 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.22 | 0.769 | 1.94 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.745 | 2.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SAR341402 than on NovoLog/NovoRapid | 46.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SAR341402 | SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. | 36 | 301 | EG000 |
| Group 2 | NovoLog/NovoRapid | NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. | 29 | 296 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All Adverse Events (AEs) weeks were collected from signature of the informed consent form up to the study completion (up to 52 Weeks) regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
- NCT number
- NCT03211858
- Phases
- PHASE3
- Conditions
- Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus
- Interventions
- Insulin aspart, NovoLog/NovoRapid, Insulin glargine (HOE901)
- Lead sponsor
- Sanofi
- Results first posted
- 2019-08-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03211858?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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