Comparison · NCT03689374-sae
Semaglutide vs Insulin Aspart: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
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ConductScience Library. Semaglutide vs Insulin Aspart: serious adverse events. Trial comparisons, record NCT03689374-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03689374-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 | 0.0744 | 0.0588 | 0.0937 | wilson | |
| Risk in group 2 | 0.0972 | 0.0792 | 0.119 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0229 | -0.0495 | 0.00356 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.765 | 0.561 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.746 | 0.532 | 1.05 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Semaglutide than on Insulin Aspart | 43.8 | 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 | Semaglutide | Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety. | 65 | 874 | EG000 |
| Group 2 | Insulin Aspart | Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety. | 84 | 864 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From week 0 to week 52
Source ClinicalTrials.gov
Trial
- Title
- A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes
- NCT number
- NCT03689374
- Phases
- PHASE3
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Semaglutide, Insulin aspart, Insulin glargine U100
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2022-05-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03689374?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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