Comparison · NCT02926950-sae
Placebo + Metformin vs Sotagliflozin 400 mg + Metformin: 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. Placebo + Metformin vs Sotagliflozin 400 mg + Metformin: serious adverse events. Trial comparisons, record NCT02926950-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02926950-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 | 0.0888 | 0.0599 | 0.13 | wilson | |
| Risk in group 2 | 0.0734 | 0.0475 | 0.112 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0154 | -0.0326 | 0.0639 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.676 | 2.17 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.653 | 2.32 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Placebo + Metformin than on Sotagliflozin 400 mg + Metformin | 64.8 | 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 | Placebo + Metformin | Following a 2-week run-in period, matching placebo was administered as 2 tablets, once daily, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks. | 23 | 259 | EG000 |
| Group 2 | Sotagliflozin 400 mg + Metformin | Following a 2-week run-in period, Sotagliflozin 400 mg was administered as 2 tablets, once daily, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks. | 19 | 259 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- First dose of study drug to last dose of study drug (up to 79 weeks) + 4 weeks
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin
- NCT number
- NCT02926950
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sotagliflozin (SAR439954), Placebo, Metformin
- Lead sponsor
- Lexicon Pharmaceuticals
- Results first posted
- 2021-05-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02926950?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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