Comparison · NCT03066830-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 NCT03066830-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03066830-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 | 0.126 | 0.0907 | 0.172 | wilson | |
| Risk in group 2 | 0.158 | 0.118 | 0.208 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0321 | -0.0934 | 0.0291 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.797 | 0.518 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.768 | 0.465 | 1.27 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sotagliflozin 400 mg than on Placebo | 31.1 | 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 | Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 milligrams (mg), orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks. One participant randomized to Placebo who was dosed with Sotagliflozin 400 mg treatment during the study is included in the Sotagliflozin 400 mg arm in the safety population. | 32 | 254 | EG001 |
| Group 2 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks. One participant randomized to Placebo who was dosed with Sotagliflozin 400 mg treatment during the study is included in the Sotagliflozin 400 mg arm in the safety population. | 40 | 253 | EG000 |
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 82.9 weeks) + 2 weeks
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
- NCT number
- NCT03066830
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sotagliflozin (SAR439954), Placebo, Metformin, Sulfonylurea
- Lead sponsor
- Lexicon Pharmaceuticals
- Results first posted
- 2021-05-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03066830?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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