Comparison · NCT01137812-sae
Canagliflozin 300 mg vs Sitagliptin 100 mg: 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. Canagliflozin 300 mg vs Sitagliptin 100 mg: serious adverse events. Trial comparisons, record NCT01137812-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01137812-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 | 0.0637 | 0.0431 | 0.093 | wilson | |
| Risk in group 2 | 0.0556 | 0.0366 | 0.0834 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0081 | -0.0265 | 0.043 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.649 | 2.02 | log | |
| Odds ratio, group 1 over group 2 | 1.16 | 0.632 | 2.11 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Canagliflozin 300 mg than on Sitagliptin 100 mg | 123 | 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 | Canagliflozin 300 mg | Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea. | 24 | 377 | EG000 |
| Group 2 | Sitagliptin 100 mg | Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea. | 21 | 378 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
Source ClinicalTrials.gov
Trial
- Title
- The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
- NCT number
- NCT01137812
- Phases
- PHASE3
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Sitagliptin 100 mg, Canagliflozin 300 mg, Metformin, Sulphonylurea
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2013-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01137812?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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