Comparison · NCT02531035-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 NCT02531035-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02531035-sae
On this page
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 | 0.0687 | 0.0522 | 0.0899 | wilson | |
| Risk in group 2 | 0.0327 | 0.0219 | 0.0486 | wilson | |
| Risk difference, group 1 minus group 2 | 0.036 | 0.013 | 0.0598 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.1 | 1.29 | 3.41 | log | |
| Odds ratio, group 1 over group 2 | 2.18 | 1.31 | 3.62 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sotagliflozin 400 mg than on Placebo | 27.8 | 16.7 | 76.6 | from the risk difference interval |
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 24 weeks. | 48 | 699 | EG001 |
| Group 2 | Placebo | Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks. | 23 | 703 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline (Day 1) to 30 days after end of treatment (Up to 28 Weeks)
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
- NCT number
- NCT02531035
- Phases
- PHASE3
- Conditions
- Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood
- Interventions
- Sotagliflozin, Placebo
- Lead sponsor
- Lexicon Pharmaceuticals
- Results first posted
- 2019-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02531035?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02531035-sae