Comparison · NCT03764631-sae
Empagliflozin vs DPP-4 Inhibitors: 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. Empagliflozin vs DPP-4 Inhibitors: serious adverse events. Trial comparisons, record NCT03764631-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03764631-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 | 0.00799 | 0.00367 | 0.0173 | wilson | |
| Risk in group 2 | 0.00266 | 0.000731 | 0.00966 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00533 | -0.0029 | 0.0149 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.607 | 14.8 | log | |
| Odds ratio, group 1 over group 2 | 3.02 | 0.607 | 15 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Empagliflozin than on DPP-4 Inhibitors | 188 | 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 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | 6 | 751 | EG000 |
| Group 2 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | 2 | 751 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 12 months.
Source ClinicalTrials.gov
Trial
- Title
Post-authorization Safety Study in Type 2 Diabetic Patients in Saudi Arabia Treated With Empagliflozin to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration
- NCT number
- NCT03764631
- Phases
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Empagliflozin, Dipeptidyl-peptidase 4 (DPP-4) inhibitors
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2022-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03764631?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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