Comparison · NCT02735044-sae
HOE901-U300 vs Lantus: 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. HOE901-U300 vs Lantus: serious adverse events. Trial comparisons, record NCT02735044-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02735044-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 | 0.15 | 0.11 | 0.202 | wilson | |
| Risk in group 2 | 0.136 | 0.0975 | 0.187 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0142 | -0.0503 | 0.0786 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.706 | 1.73 | log | |
| Odds ratio, group 1 over group 2 | 1.12 | 0.666 | 1.89 | log | |
| Number needed to harm, for one more participant with a serious adverse event on HOE901-U300 than on Lantus | 70.2 | 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 | HOE901-U300 | Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months. | 35 | 233 | EG000 |
| Group 2 | Lantus | Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months. | 31 | 228 | 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 until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
- NCT number
- NCT02735044
- Phases
- PHASE3
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Insulin glargine,300 U/mL, Insulin glargine (100 units /mL), Background therapy
- Lead sponsor
- Sanofi
- Results first posted
- 2019-06-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02735044?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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