Comparison · NCT03596450-sae
Semaglutide vs Standard of Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Semaglutide vs Standard of Care: serious adverse events. Trial comparisons, record NCT03596450-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03596450-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 | 0.0599 | 0.044 | 0.0812 | wilson | |
| Risk in group 2 | 0.0628 | 0.0463 | 0.0847 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00287 | -0.03 | 0.0241 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.954 | 0.619 | 1.47 | log | |
| Odds ratio, group 1 over group 2 | 0.951 | 0.6 | 1.51 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Semaglutide than on Standard of Care | 349 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Semaglutide | Participants received semaglutide subcutaneous (s.c.) injection once weekly in addition to up to 2 oral antidiabetic medications as treatment intensification for 2 years. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants. | 38 | 634 | EG000 |
| Group 2 | Standard of Care | Participants received standard of care (any commercially available oral or injectable antidiabetic medication, excluding semaglutide) in addition to up to 2 oral antidiabetic medications as treatment intensification for 2 years. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants. | 39 | 621 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to year 2 (week 104)
Source ClinicalTrials.gov
Trial
- Title
- Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial
- NCT number
- NCT03596450
- Phases
- PHASE4
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Semaglutide, Standard of care
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2023-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03596450?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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