Comparison · NCT02383940-sae
Sotagliflozin 400 mg 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
Cite this record
ConductScience Library. Sotagliflozin 400 mg vs Placebo: serious adverse events. Trial comparisons, record NCT02383940-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02383940-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 | 0.0465 | 0.0128 | 0.155 | wilson | |
| Risk in group 2 | 0.0714 | 0.0246 | 0.19 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0249 | -0.148 | 0.0928 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.651 | 0.115 | 3.7 | log | |
| Odds ratio, group 1 over group 2 | 0.634 | 0.101 | 4 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sotagliflozin 400 mg than on Placebo | 40.1 | 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 | Sotagliflozin 400 mg | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks. | 2 | 43 | EG001 |
| Group 2 | Placebo | Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks. | 3 | 42 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All Adverse Events (AEs) were collected from Baseline (Day 1) until the end of study (up to Week 12).
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
- NCT number
- NCT02383940
- Phases
- PHASE2
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Sotagliflozin, Placebo
- Lead sponsor
- Lexicon Pharmaceuticals
- Results first posted
- 2019-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02383940?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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