Comparison · NCT02688933-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
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ConductScience Library. HOE901-U300 vs Lantus: serious adverse events. Trial comparisons, record NCT02688933-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02688933-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 | 0.0531 | 0.0334 | 0.0834 | wilson | |
| Risk in group 2 | 0.044 | 0.0264 | 0.0725 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0091 | -0.0255 | 0.0441 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.605 | 2.41 | log | |
| Odds ratio, group 1 over group 2 | 1.22 | 0.59 | 2.52 | log | |
| Number needed to harm, for one more participant with a serious adverse event on HOE901-U300 than on Lantus | 110 | 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 | HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL. | 17 | 320 | EG000 |
| Group 2 | Lantus | Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL. | 14 | 318 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All Adverse Events (AE) were collected from signature of informed consent form up to study completion (Week 16) regardless of seriousness or relationship to study drug.
Source ClinicalTrials.gov
Trial
- Title
- A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
- NCT number
- NCT02688933
- Phases
- PHASE4
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- HOE901-U300 (Insulin Glargine 300 U/ml), Lantus (Insulin Glargine 100 U/ml), Mandated back ground therapy
- Lead sponsor
- Sanofi
- Results first posted
- 2018-08-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02688933?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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